Gabapen

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Gabapentin

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• Dominican Republic


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Yisafer

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Ferrous Gluconate

Ferrous Gluconate is reported as an ingredient of Yisafer in the following countries:

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In some countries, this medicine may only be approved for veterinary use.

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Sulfadimethoxine

Sulfadimethoxine is reported as an ingredient of Cunicoxil in the following countries:

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Drithocreme Topical

Generic Name: anthralin (Topical route)

AN-thra-lin

Commonly used brand name(s)

In the U.S.

• Drithocreme


• Dritho-Scalp


• Psoriatec


• Zithranol-RR

In Canada

• Anthraforte 2%


• Anthraforte 3%


• Anthrascalp

Available Dosage Forms:

• Paste


• Ointment


• Cream

Therapeutic Class: Antipsoriatic

Uses For Drithocreme

Anthralin is used to treat psoriasis. It may also be used to treat other skin conditions as determined by your doctor.

In the U.S., this medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, anthralin is used in certain patients with the following medical condition:

• Alopecia areata (patchy hair loss)

Before Using Drithocreme

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of anthralin in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of anthralin in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Skin diseases or problems (other)—Anthralin may make the condition worse

Proper Use of anthralin

This section provides information on the proper use of a number of products that contain anthralin. It may not be specific to Drithocreme. Please read with care.

Keep this medicine away from the eyes and mucous membranes, such as the mouth and the inside of the nose.

Do not apply this medicine to blistered, raw, or oozing areas of the skin or scalp.

Do not use this medicine on your face or sex organs or in the folds and creases of your skin. If you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Anthralin may be used in different ways. In some cases, it is applied at night and allowed to remain on the affected areas overnight, then washed off the next morning or before the next application. In other cases, it may be applied and allowed to remain on the affected areas for a short period of time (usually 10 to 30 minutes), then washed off. (This is called short contact treatment.) Make sure you understand exactly how you are to use this medicine. If you have any questions about this, check with your doctor.

Anthralin may cause irritation of normal skin. If it does, petrolatum may be applied to the skin or scalp around the affected areas for protection.

Apply a thin layer of anthralin to only the affected area of the skin or scalp and rub in gently and well.

Immediately after applying this medicine, wash your hands to remove any medicine that may be on them.

For patients using anthralin for short contact (usually 10 to 30 minutes) treatment:

• After applying anthralin, allow the medicine to remain on the affected area for 10 to 30 minutes or as directed by your doctor. Then remove the medicine by bathing, if the anthralin was applied to the skin, or by shampooing, if it was applied to the scalp.

For patients using the cream form of anthralin for overnight treatment:

• If anthralin cream is applied to the skin, any medicine remaining on the affected areas the next morning should be removed by bathing.


• If anthralin cream is applied to the scalp, shampoo to remove the scales and any medicine remaining on the affected areas from the previous application. Dry the hair and, after parting, rub the cream into the affected areas. Check with your doctor to see when the cream should be removed.

For patients using the ointment form of anthralin for overnight treatment:

• If anthralin ointment is applied to the skin at night, any ointment remaining on the affected areas the next morning should be removed with warm liquid petrolatum followed by bathing.


• If anthralin ointment is applied to the scalp at night, shampoo the next morning to clean the scalp.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For psoriasis:
  
  • For cream dosage form:
    
    • Adults—Apply to the dry, affected area(s) of the skin once a day, preferably at night, or as directed by your doctor. Wash medicine off skin at the proper time.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For ointment dosage form:
    
    • Adults—Apply to the dry, affected area(s) of the skin once a day or as directed by your doctor. Wash medicine off skin at the proper time.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Drithocreme

Anthralin may stain the skin, hair, fingernails, clothing, bed linens, or bathtub or shower. The stain on the skin or hair will wear off in several weeks after you stop using this medicine. Some ways to prevent or lessen anthralin staining include:

• Wear plastic gloves when you apply this medicine.


• Avoid getting the medicine on your clothing or on bed linens. Ask your doctor if you can wear a plastic cap while sleeping if you apply your medicine to your scalp at bedtime.


• Remove any medicine on the surface of the bathtub or shower stall by immediately rinsing it with hot water after bathing or showering. Afterwards wash the bathtub or shower stall with a household cleanser to remove any remaining deposits.

Drithocreme Side Effects

Anthralin has been shown to cause tumors in animals. However, there have been no reports of anthralin causing tumors in humans.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Redness or other skin irritation of treated or uninvolved skin not present before use of this medicine

Rare

• Skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Drithocreme Topical resources

• Drithocreme Topical Use in Pregnancy & Breastfeeding
• Drithocreme Topical Support Group
• 0 Reviews for Drithocreme Topical - Add your own review/rating

Compare Drithocreme Topical with other medications

• Psoriasis

Slipiren

Slipiren may be available in the countries listed below.

Ingredient matches for Slipiren

Lorazepam

Lorazepam is reported as an ingredient of Slipiren in the following countries:

• Italy

International Drug Name Search

Taclonex Scalp

See also: Generic Taclonex

Taclonex Scalp is a brand name of betamethasone/calcipotriene topical, approved by the FDA in the following formulation(s):

TACLONEX SCALP (betamethasone dipropionate; calcipotriene hydrate - suspension; topical)

• 
  Manufacturer: LEO PHARM PRODS
  
  Approval date: May 9, 2008
  
  Strength(s): 0.064%;0.005% ^[RLD]

Has a generic version of Taclonex Scalp been approved?

No. There is currently no therapeutically equivalent version of Taclonex Scalp available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Taclonex Scalp. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Pharmaceutical composition
  Patent 6,753,013
  Issued: June 22, 2004
  Inventor(s): Erik; Didriksen & Gert; Høy
  Assignee(s): Leo Pharmaceutical Products, Ltd. A/S
  A pharmaceutical composition for dermal use, wherein the composition has a first pharmacologically active component A consisting of at least one vitamin D or vitamin D analogue, and a second pharmacologically active component B consisting of at least one corticosteroid, wherein the difference between the maximum stability pH of said first component A and the maximum stability pH of said second component B is at least 1. The composition can also have at least one solvent component C, where component C is compounds of the general formula R3 (OCH2C(R1)H)xOR2 (I), wherein x is in the range of 2-60, R1 in each of the x units independently is H or CH3, R2 is straight chain or branched C1-20alkyl or benzoyl, and R3 is H or phenylcarbonyloxy; di-(straight or branched)-C4-10alkyl esters of C4-C8dicarboxylic acids; straight or branched C12-18-alkyl benzoates; straight or branched C2-4-alkyl esters of straight or branched C10-18-alkanoic or -alkenoic acids; propylenglycol diesters with C8-14-alkanoic acids; and branched primary C18-24alkanols.
  
  Patent expiration dates:
  
  
  • January 27, 2020
    
    ✓ 
    Patent use: PSORIASIS
    ✓ 
    Drug product
  
  
  
  • January 27, 2020
    
    ✓ 
    Patent use: TREATMENT OF MODERATE PLAQUE PSORIASIS
    ✓ 
    Drug product
  
  



• 
  Topical composition
  Patent 6,787,529
  Issued: September 7, 2004
  Inventor(s): Gert; Høy & Erik Johannes; Didriksen
  Assignee(s): Leo Pharmaceutical Products Ltd. A/S
  The present invention relates to a pharmaceutical gel composition for application on skin, said composition comprising at least one vitamin D or vitamin D analogue and at least one corticosteroid as well as a viscosity-increasing excipient.
  
  Patent expiration dates:
  
  
  • January 27, 2020
    
    ✓ 
    Patent use: TREATMENT OF MODERATE PLAQUE PSORIASIS
    ✓ 
    Drug product
  
  
  
  • January 27, 2020
    
    ✓ 
    Patent use: PSORIASIS
    ✓ 
    Drug product
  
  



• 
  Crystalline form of a vitamin D analogue
  Patent RE39706
  Issued: June 26, 2007
  Inventor(s): Hansen; Erik Torngaard & Andersen; Niels Smidt Rastrup & Ringborg; Lene Hoffmeyer
  Assignee(s): Leo Pharma A/S
  The present invention relates to calcipotriol hydrate—a new crystalline form of calcipotriol—with superior technical properties and with superior stability.
  
  Patent expiration dates:
  
  
  • June 9, 2015
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • May 9, 2011 - NEW DOSAGE FORM
  
  

See also...

• Taclonex Scalp Suspension Consumer Information (Wolters Kluwer)
• Taclonex Scalp topical Consumer Information (Cerner Multum)
• Taclonex Scalp Advanced Consumer Information (Micromedex)
• Betamethasone/Calcipotriene Ointment Consumer Information (Wolters Kluwer)
• Betamethasone/Calcipotriene Suspension Consumer Information (Wolters Kluwer)
• Betamethasone and calcipotriene topical Consumer Information (Cerner Multum)
• Betamethasone and calcipotriene Topical application Advanced Consumer Information (Micromedex)

Nevirapox

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Nevirapine

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Alprazolam

Alprazolam is reported as an ingredient of Alprazol in the following countries:

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Omeprazole

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Buterol

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Bambuterol is reported as an ingredient of Buterol in the following countries:

• Bangladesh

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Irinostad

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Irinotecan

Irinotecan hydrochloride trihydrate (a derivative of Irinotecan) is reported as an ingredient of Irinostad in the following countries:

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Gabapentin beta

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Gabapentin

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Sulpirol

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Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Penbene in the following countries:

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Spectramast

In some countries, this medicine may only be approved for veterinary use.

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Ceftiofur

Ceftiofur hydrochloride (a derivative of Ceftiofur) is reported as an ingredient of Spectramast in the following countries:

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Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Calsivas in the following countries:

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Ozagrel

Ozagrel hydrochloride (a derivative of Ozagrel) is reported as an ingredient of Domenan in the following countries:

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Tamoxifen

Tamoxifen citrate (a derivative of Tamoxifen) is reported as an ingredient of Tamoxifeno Lepori in the following countries:

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Carbamazepine

Carbamazepine is reported as an ingredient of Carbamazepina Merck in the following countries:

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Potassio cloruro Monico

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Potassium Chloride

Potassium Chloride is reported as an ingredient of Potassio cloruro Monico in the following countries:

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Bio Mycin

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Oxytetracycline

Oxytetracycline is reported as an ingredient of Bio Mycin in the following countries:

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Calciumfolinat ONCOtrade

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Folinic Acid

Folinic Acid disodium (a derivative of Folinic Acid) is reported as an ingredient of Calciumfolinat ONCOtrade in the following countries:

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Guaifenesin

Guaifenesin is reported as an ingredient of Fagusan in the following countries:

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Ansyn

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Anastrozole

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Fluconazole

Fluconazole is reported as an ingredient of Fluconazol Edigen in the following countries:

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Pamidronic Acid

Pamidronic Acid disodium salt (a derivative of Pamidronic Acid) is reported as an ingredient of Pamitor in the following countries:

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Cisapride

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Optimide

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Sulfacetamide Sodium

Sulfacetamide sodium salt (a derivative of Sulfacetamide) is reported as an ingredient of Optimide in the following countries:

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Ampicillin

Ampicillin sodium salt (a derivative of Ampicillin) is reported as an ingredient of Ampicillin + Sulbactam DeltaSelect in the following countries:

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Sulbactam sodium salt (a derivative of Sulbactam) is reported as an ingredient of Ampicillin + Sulbactam DeltaSelect in the following countries:

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Methista

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Carbocisteine

Carbocisteine is reported as an ingredient of Methista in the following countries:

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Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Dichlotride in the following countries:

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Citobal

Citobal may be available in the countries listed below.

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Chlorphenamine

Chlorphenamine is reported as an ingredient of Citobal in the following countries:

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Votum

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Olmesartan

Olmesartan Medoxomil is reported as an ingredient of Votum in the following countries:

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Chlorhexidine Gluconate

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Chlorhexidine

Chlorhexidine Gluconate (BANM, USAN) is known as Chlorhexidine in the US.

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Glossary

BANM	British Approved Name (Modified)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Belozok

Belozok may be available in the countries listed below.

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Metoprolol

Metoprolol succinate (a derivative of Metoprolol) is reported as an ingredient of Belozok in the following countries:

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Trimétazidine Teva

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Trimetazidine

Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Trimétazidine Teva in the following countries:

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Calciumfolinat biosyn

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Calcium Folinate

Calcium Folinate is reported as an ingredient of Calciumfolinat biosyn in the following countries:

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Fluyesyva

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In some countries, this medicine may only be approved for veterinary use.

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Flumequine

Flumequine is reported as an ingredient of Fluyesyva in the following countries:

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Arotin

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Paroxetine

Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Arotin in the following countries:

• Brazil

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Onsudil

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Procaterol

Procaterol hydrochloride hemihydrate (a derivative of Procaterol) is reported as an ingredient of Onsudil in the following countries:

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Inlyta

Inlyta is a brand name of axitinib, approved by the FDA in the following formulation(s):

INLYTA (axitinib - tablet; oral)

• 
  Manufacturer: PFIZER
  
  Approval date: January 27, 2012
  
  Strength(s): 1MG, 5MG ^[RLD]

Has a generic version of Inlyta been approved?

No. There is currently no therapeutically equivalent version of Inlyta available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Inlyta. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Inlyta.

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • January 27, 2017 - NEW CHEMICAL ENTITY
  
  

See also...

• Inlyta Consumer Information (Drugs.com)

Artrolyt

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Diacerein

Diacerein is reported as an ingredient of Artrolyt in the following countries:

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• Portugal

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Trimethosulf

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In some countries, this medicine may only be approved for veterinary use.

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Sulfadiazine

Sulfadiazine sodium (a derivative of Sulfadiazine) is reported as an ingredient of Trimethosulf in the following countries:

• Netherlands

Trimethoprim

Trimethoprim is reported as an ingredient of Trimethosulf in the following countries:

• Netherlands

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Clobetasol MK

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Clobetasol

Clobetasol is reported as an ingredient of Clobetasol MK in the following countries:

• Romania

Clobetasol 17α-propionate (a derivative of Clobetasol) is reported as an ingredient of Clobetasol MK in the following countries:

• Belize


• Costa Rica


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Nervolta

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Calcium Bromolactobionate

Calcium Bromolactobionate is reported as an ingredient of Nervolta in the following countries:

• Chile

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Poscarl

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Ingredient matches for Poscarl

Polystyrene Sulfonic Acid

Polystyrene Sulfonic Acid calcium salt (a derivative of Polystyrene Sulfonic Acid) is reported as an ingredient of Poscarl in the following countries:

• Japan

International Drug Name Search

Erdon Gel

Erdon Gel may be available in the countries listed below.

Ingredient matches for Erdon Gel

Diclofenac

Diclofenac diethylamine (a derivative of Diclofenac) is reported as an ingredient of Erdon Gel in the following countries:

• Sri Lanka

International Drug Name Search

Ramipril Generichealth

Ramipril Generichealth may be available in the countries listed below.

Ingredient matches for Ramipril Generichealth

Ramipril

Ramipril is reported as an ingredient of Ramipril Generichealth in the following countries:

• Australia

International Drug Name Search

Caldoral

Caldoral may be available in the countries listed below.

Ingredient matches for Caldoral

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Caldoral in the following countries:

• Colombia

International Drug Name Search

Spectrocef

Spectrocef may be available in the countries listed below.

Ingredient matches for Spectrocef

Cefotaxime

Cefotaxime sodium salt (a derivative of Cefotaxime) is reported as an ingredient of Spectrocef in the following countries:

• Italy

International Drug Name Search

Rilménidine Ranbaxy

Rilménidine Ranbaxy may be available in the countries listed below.

Ingredient matches for Rilménidine Ranbaxy

Rilmenidine

Rilmenidine dihydrogen phosphate (a derivative of Rilmenidine) is reported as an ingredient of Rilménidine Ranbaxy in the following countries:

• France

International Drug Name Search

Calciumfolinat Ebewe

Calciumfolinat-Ebewe may be available in the countries listed below.

Ingredient matches for Calciumfolinat-Ebewe

Calcium Folinate

Calcium Folinate is reported as an ingredient of Calciumfolinat-Ebewe in the following countries:

• Austria


• Bulgaria


• Estonia


• Hong Kong


• Hungary


• Russian Federation


• Serbia


• Switzerland


• Tunisia


• Vietnam

Calcium Folinate pentahydrate (a derivative of Calcium Folinate) is reported as an ingredient of Calciumfolinat-Ebewe in the following countries:

• Czech Republic


• Slovenia

Folic Acid

Folic Acid is reported as an ingredient of Calciumfolinat-Ebewe in the following countries:

• Lithuania


• Poland

International Drug Name Search

Warlin

Warlin may be available in the countries listed below.

Ingredient matches for Warlin

Warfarin

Warfarin potassium salt (a derivative of Warfarin) is reported as an ingredient of Warlin in the following countries:

• Japan

International Drug Name Search

Propafenon Alkaloid

Propafenon Alkaloid may be available in the countries listed below.

Ingredient matches for Propafenon Alkaloid

Propafenone

Propafenone hydrochloride (a derivative of Propafenone) is reported as an ingredient of Propafenon Alkaloid in the following countries:

• Croatia (Hrvatska)

International Drug Name Search

Sertralin Sandoz

Sertralin Sandoz may be available in the countries listed below.

Ingredient matches for Sertralin Sandoz

Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertralin Sandoz in the following countries:

• Austria


• Czech Republic


• Denmark


• Estonia


• Germany


• Hungary


• Sweden


• Switzerland

International Drug Name Search

Felodipin AWD

Felodipin AWD may be available in the countries listed below.

Ingredient matches for Felodipin AWD

Felodipine

Felodipine is reported as an ingredient of Felodipin AWD in the following countries:

• Germany

International Drug Name Search

Sepidnarin

Sepidnarin may be available in the countries listed below.

Ingredient matches for Sepidnarin

Cefotiam

Cefotiam dihydrochloride (a derivative of Cefotiam) is reported as an ingredient of Sepidnarin in the following countries:

• Japan

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Magniton-R

Magniton-R may be available in the countries listed below.

Ingredient matches for Magniton-R

Indapamide

Indapamide is reported as an ingredient of Magniton-R in the following countries:

• Greece

International Drug Name Search

Cetirizina Actavis

Cetirizina Actavis may be available in the countries listed below.

Ingredient matches for Cetirizina Actavis

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetirizina Actavis in the following countries:

• Italy

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Tetridamina

Tetridamina may be available in the countries listed below.

Ingredient matches for Tetridamina

Tetridamine

Tetridamina (DCIT) is also known as Tetridamine (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Trimétazidine Torlan

Trimétazidine Torlan may be available in the countries listed below.

Ingredient matches for Trimétazidine Torlan

Trimetazidine

Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Trimétazidine Torlan in the following countries:

• France

International Drug Name Search

Fem7

Fem7 may be available in the countries listed below.

Ingredient matches for Fem7

Estradiol

Estradiol is reported as an ingredient of Fem7 in the following countries:

• Brazil


• China


• Luxembourg


• Poland


• Romania

Estradiol hemihydrate (a derivative of Estradiol) is reported as an ingredient of Fem7 in the following countries:

• Chile


• Germany


• Slovakia

Levonorgestrel

Levonorgestrel is reported as an ingredient of Fem7 in the following countries:

• Germany

International Drug Name Search

Delflex Neutral pH

Dosage Form: injection
DELFLEX® Neutral pH

Peritoneal Dialysis Solutions

With Attached stay•safe® Exchange Set

For Intraperitoneal Administration Only

89-905-65  Rev. 09/09

NO LATEX

Delflex Neutral pH Description

DELFLEX® Neutral pH peritoneal dialysis solutions (supplied in standard, low magnesium and low magnesium/low calcium as 2 or 3 Liter product) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. In comparison to conventional peritoneal dialysis solutions, DELFLEX® Neutral pH solutions are formulated to lower levels of glucose degradation products and provide a neutral pH of 7.0 ± 0.4, which is closer to the physiologic pH. The osmotic and buffer solutions are stored separately and mixed by the patient prior to use. The stay•safe® exchange set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH and ionic concentrations of the mixed solutions are shown in Table 2.

Hydrochloric acid and sodium hydroxide may be added for pH adjustment. The patient mixed solution pH is 7.0 ± 0.4.

Dextrose USP is chemically designated D-glucose monohydrate (C6H12O6 • H2O) a hexose sugar freely soluble in water. The structural formula is shown here:

These solutions do not contain antimicrobial agents or additional buffers. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Since the flexible inner bag is compounded from a specific polyvinyl chloride, water may permeate from the inner bag into the outerwrap in quantities insufficient to affect the solution significantly. Solutions in contact with the plastic inner bag can cause certain chemical components of the bag to leach out in very small amounts; however, the safety of the plastic formulation is supported by biological tests for plastic containers.

Nominal glucose degradation product (GDP) levels (immediately following sterilization) in DELFLEX®Neutral pH solution and DELFLEX® solution are reported in Table 1.  The clinical relevance of these differences in GDP levels is unknown.

	Table 1. Glucose Degradation Product Levels*
Dextrose Concentration	DELFLEX®  Neutral pH	DELFLEX®
*This is the sum (μmol/L) of the various component GDPs including: formaldehyde, acetaldehyde, furaldehyde, glyoxal, methylglyoxal, 5-hydroxymethylfurfural (5-HMF), and 3-deoxyglucosone (3DG).
1.5%	23	267
2.5%	51	362
4.25%	106	437

Table 2. Composition, Calculated Osmolarity, pH, and Ionic Concentration
2 Liter DELFLEX® Neutral pH
		Standard Magnesium, Standard Calcium			Low Magnesium, Standard Calcium			Low Magnesium, Low Calcium
		1.5% Dextrose	2.5% Dextrose	4.25% Dextrose	1.5% Dextrose	2.5% Dextrose	4.25% Dextrose	1.5% Dextrose	2.5% Dextrose	4.25% Dextrose
		Main Bag Contents
Composition / 100ml	Dextrose Hydrous, USP (C6H12O6• H2O)	1.52g	2.56g	4.36g	1.54g	2.56g	4.36g	1.54g	2.56g	4.36g
	Sodium Chloride, USP (NaCl)	581mg	581 mg	581mg	552mg	552 mg	552 mg	552 mg	552 mg	552 mg
	Calcium Chloride, USP (CaCl2• 2H2O)	26.3mg	26.3mg	26.3mg	26.3mg	26.3mg	26.3mg	18.9mg	18.9mg	18.9mg
	Magnesium Chloride, USP (MgCl2 • 6H2O)	15.6mg	15.6mg	15.6mg	5.21mg	5.21mg	5.21mg	5.21mg	5.21mg	5.21mg
	Mini-bag Contents
	Sodium Lactate(C3H5NaO3)	14.4mg	14.4mg	14.4mg	16.7mg	16.7mg	16.7mg	16.7mg	16.7mg	16.7mg
	Sodium Bicarbonate(NaHCO3)	1.20g	1.20g	1.20g	1.20g	1.20g	1.20g	1.20g	1.20g	1.20g
	Total ingredient content AFTER mixing Main Bag and Mini-bag solutions
	Dextrose Hydrous, USP (C6H12O6• H2O)	1.5g	2.5g	4.25g	1.5g	2.5g	4.25g	1.5g	2.5g	4.25g
	Sodium Chloride, USP (NaCl)	567mg	567mg	567mg	538mg	538mg	538mg	538mg	538mg	538mg
	Sodium Lactate(C3H5NaO3)	353mg	353mg	353mg	409mg	409mg	409mg	409mg	409mg	409mg
	Sodium Bicarbonate(NaHCO3)	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg
	Calcium Chloride, USP (CaCl2• 2H2O)	25.7 mg	25.7 mg	25.7 mg	25.7 mg	25.7 mg	25.7 mg	18.4 mg	18.4 mg	18.4 mg
	Magnesium Chloride, USP (MgCl2 • 6H2O)	15.2 mg	15.2 mg	15.2 mg	5.08 mg	5.08 mg	5.08 mg	5.08 mg	5.08 mg	5.08 mg
Osmolarity(mOsmoL/L)(calc)		347	398	486	346	396	485	344	394	483
pH 7.0 ± 0.4		7.0	7.0	7.0	7.0	7.0	7.0	7.0	7.0	7.0
Main Bag Contents
Ionic Composition(mEq/L)	Sodium	99.4	99.4	99.4	94.3	94.3	94.3	94.3	94.3	94.3
	Calcium	3.59	3.59	3.59	3.59	3.59	3.59	2.56	2.56	2.56
	Magnesium	1.54	1.54	1.54	0.51	0.51	0.51	0.51	0.51	0.51
	Chloride	105	105	105	98.4	98.4	98.4	97.4	97.4	97.4
	Mini-bag Contents
	Sodium	1428	1428	1428	1632	1632	1632	1632	1632	1632
	Lactate	1285	1285	1285	1489	1489	1489	1489	1489	1489
	Bicarbonate	143	143	143	143	143	143	143	143	143
	Total ingredient content AFTER mixing Main Bag and Mini-bag solutions
	Sodium	132	132	132	132	132	132	132	132	132
	Calcium	3.5	3.5	3.5	3.5	3.5	3.5	2.5	2.5	2.5
	Magnesium	1.5	1.5	1.5	0.5	0.5	0.5	0.5	0.5	0.5
	Chloride	102	102	102	96	96	96	95	95	95
	Lactate	31.5	31.5	31.5	36.5	36.5	36.5	36.5	36.5	36.5
	Bicarbonate	3.5	3.5	3.5	3.5	3.5	3.5	3.5	3.5	3.5

3 Liter DELFLEX® Neutral pH
		Standard Magnesium, Standard Calcium			Low Magnesium, Standard Calcium			Low Magnesium, Low Calcium
		1.5% Dextrose	2.5% Dextrose	4.25% Dextrose	1.5% Dextrose	2.5% Dextrose	4.25% Dextrose	1.5% Dextrose	2.5% Dextrose	4.25% Dextrose
		Main Bag Contents
Composition / 100ml	Dextrose Hydrous, USP (C6H12O6• H2O)	1.52 g	2.54 g	4.32g	1.52g	2.54 g	4.32g	1.52g	2.54g	4.32g
	Sodium Chloride, USP (NaCl)	576mg	576 mg	576 mg	547mg	547 mg	547 mg	547 mg	547 mg	547mg
	Calcium Chloride, USP (CaCl2• 2H2O)	26.1mg	26.1mg	26.1mg	26.1mg	26.1mg	26.1mg	18.7mg	18.7mg	18.7mg
	Magnesium Chloride, USP (MgCl2 • 6H2O)	15.4mg	15.4mg	15.4mg	5.16mg	5.16mg	5.16mg	5.16mg	5.16mg	5.16mg
	Mini-bag Contents
	Sodium Lactate(C3H5NaO3)	21.6 mg	21.6mg	21.6mg	25.0mg	25.0mg	25.0 mg	25.0mg	25.0 mg	25.0 mg
	Sodium Bicarbonate(NaHCO3)	1.80 g	1.80g	1.80 g	1.80g	1.80g	1.80g	1.80g	1.80g	1.80g
	Total ingredient content AFTER mixing Main Bag and Mini-bag solutions
	Dextrose Hydrous, USP (C6H12O6• H2O)	1.5g	2.5g	4.25g	1.5g	2.5g	4.25g	1.5g	2.5g	4.25g
	Sodium Chloride, USP (NaCl)	567mg	567mg	567mg	538mg	538mg	538mg	538mg	538mg	538mg
	Sodium Lactate(C3H5NaO3)	353mg	353mg	353mg	409mg	409mg	409mg	409mg	409mg	409mg
	Sodium Bicarbonate(NaHCO3)	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg	29.4mg
	Calcium Chloride, USP (CaCl2• 2H2O)	25.7 mg	25.7 mg	25.7 mg	25.7 mg	25.7 mg	25.7 mg	18.4 mg	18.4 mg	18.4 mg
	Magnesium Chloride, USP (MgCl2 • 6H2O)	15.2 mg	15.2 mg	15.2 mg	5.08 mg	5.08 mg	5.08 mg	5.08 mg	5.08 mg	5.08 mg
Osmolarity(mOsmoL/L)(calc)		347	398	486	346	396	485	344	394	483
pH 7.0 ± 0.4		7.0	7.0	7.0	7.0	7.0	7.0	7.0	7.0	7.0
Main Bag Contents
Ionic Composition(mEq/L)	Sodium	98.6	98.6	98.6	93.5	93.5	93.5	93.5	93.5	93.5
	Calcium	3.56	3.56	3.56	3.56	3.56	3.56	2.54	2.54	2.54
	Magnesium	1.52	1.52	1.52	0.51	0.51	0.51	0.51	0.51	0.51
	Chloride	104	104	104	97.6	97.6	97.6	96.6	96.6	96.6
	Mini-bag Contents
	Sodium	2142	2142	2142	2448	2448	2448	2448	2448	2448
	Lactate	1927	1927	1927	2233	2233	2233	2233	2233	2233
	Bicarbonate	214	214	214	214	214	214	214	214	214
	Total ingredient content AFTER mixing Main Bag and Mini-bag solutions
	Sodium	132	132	132	132	132	132	132	132	132
	Calcium	3.5	3.5	3.5	3.5	3.5	3.5	2.5	2.5	2.5
	Magnesium	1.5	1.5	1.5	0.5	0.5	0.5	0.5	0.5	0.5
	Chloride	102	102	102	96	96	96	95	95	95
	Lactate	31.5	31.5	31.5	36.5	36.5	36.5	36.5	36.5	36.5
	Bicarbonate	3.5	3.5	3.5	3.5	3.5	3.5	3.5	3.5	3.5

Delflex Neutral pH - Clinical Pharmacology

Peritoneal dialysis is the process of filtering excess water and toxins from the bloodstream through a semi-permeable membrane. This process does not cure the disease, but prevents progression of symptoms. Dialysis for chronic kidney failure is essential to maintain life, unless the patient receives a kidney transplant. A peritoneal dialysis procedure utilizes the peritoneum (lining of the abdomen) as the semi-permeable membrane. The procedure is conducted by instilling peritoneal dialysis solution through a catheter in the abdomen into the peritoneal cavity. Since the peritoneum is heavily supplied with blood vessels, the contact of the solution with the peritoneum causes excess water and toxins in the bloodstream to be drawn across the membrane into the solution. This osmosis and diffusion occurs between the plasma of the patient and the peritoneal dialysis solution. After a period of time called “dwell time,” the solution is then drained from the patient.

This solution does not contain potassium. In situations in which there is a normal serum potassium level or hypokalemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia.

Addition of potassium chloride should be made after careful evaluation of serum and total body potassium and only under the direction of a physician.

Clinical studies have demonstrated that the use of low magnesium solutions resulted in significant increases in serum CO2 and decreases in serum magnesium levels. The decrease in magnesium levels did not cause clinically significant hypomagnesemia.

Indications and Usage for Delflex Neutral pH

DELFLEX® peritoneal dialysis solutions are indicated in the treatment of chronic renal failure patients being maintained on peritoneal dialysis when nondialytic medical therapy is judged to be inadequate.

Contraindications

None Known

Warnings

Not for Intravenous Injection.

Use Aseptic Technique.

It is important to mix the buffer (mini-bag) and main solutions thoroughly. Administer within 24 hours after mixing. Once buffer (mini-bag) and main solutions are mixed, medication may be added prior to administration.

Peritoneal dialysis should be done with great care in patients with a number of conditions, including disruption of the peritoneal membrane or diaphragm by surgery or trauma, extensive adhesions, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, fecal fistula or colostomy, tense ascites, obesity, large polycystic kidneys, recent aortic graft replacement, lactic acidosis and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in such extreme situations, the benefits to the patient must be weighed against the possible complications.

Solutions containing lactate ion should be used with great care in patients with metabolic or respiratory alkalosis. Lactate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.

An accurate fluid balance record must be kept and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences, including congestive heart failure, volume depletion and shock.

Excessive use of DELFLEX® peritoneal dialysis solution with 4.25% dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

Stable patients undergoing maintenance peritoneal dialysis should have routine periodic evaluation of electrolyte blood chemistries and hematologic factors, as well as other indicators that determine the patient’s ongoing status.

After removing the outer wrap, check for minute leaks by squeezing the container firmly. If leaks are found, discard the solution because the sterility may be impaired. (A small amount of moisture may be present inside the overwrap, which is normal condensation from the sterilization process).

Serum calcium levels in patients using low calcium concentrations should be monitored and if found to be low, the peritoneal solution in use should be altered to one with a higher calcium concentration.

Precautions

General:

Administer only if the solution is clear, all seals are intact, and there is no evidence of leaking.

It is important to mix the buffer (mini-bag) and main solutions thoroughly.  Administer within 24 hours after mixing. Once buffer and main solutions are mixed, medication may be added prior to administration.

Do Not Heat In A Microwave Oven

Care should be taken to see that the catheter is inserted completely, since leakage around the catheter, if not controlled, can create edema from subcutaneous infiltration of the dialysis solution. This will also create an inaccurate fluid balance measurement.

DELFLEX® Peritoneal Dialysis solutions do not include potassium.  Potassium chloride should only be added under the direction of a physician after careful evaluation of both serum and total body potassium.

The overwrap must be removed immediately before use and is provided with a “Tear Open” feature to make removal easy. See instructions in Directions for Use section.

Disconnect from disk only when knob is in position 4 (••••).

Aseptic technique must be used throughout the procedure and at its termination in order to reduce the possibility of infection.

Significant loss of protein, amino acids and water soluble vitamins may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.

Laboratory Tests

Serum electrolytes, magnesium, bicarbonate levels and fluid balance should be periodically monitored.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term animal studies with DELFLEX® peritoneal dialysis solutions have not been performed to evaluate the carcinogenic potential, mutagenic potential or effect on fertility.

Pregnancy:  Teratology Effects

Pregnancy Category C. Animal reproduction studies have not been conducted with DELFLEX peritoneal dialysis solutions. It is also not known whether DELFLEX peritoneal dialysis solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DELFLEX peritoneal dialysis solutions should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when DELFLEX peritoneal dialysis solutions are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Adverse reactions to peritoneal dialysis include mechanical and solution related problems as well as the results of contamination of equipment or improper technique in catheter placement. Abdominal pain, bleeding, peritonitis, subcutaneous infection around a peritoneal catheter, catheter blockage, difficulty in fluid removal, and ileus are among the complications of the procedure. Solution related adverse reactions might include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, hypotension, disequilibrium syndrome and muscle cramping.

If an adverse reaction does occur, institute appropriate therapeutic procedures according to the patient’s needs and conditions, and save the remainder of the fluid in the bag for evaluation if deemed necessary.

Delflex Neutral pH Dosage and Administration

DELFLEX peritoneal dialysis solutions are provided for intraperitoneal administration only. The mode of therapy, frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for the treatment of the individual patient.

To avoid the risk of severe dehydration or hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with lowest level of osmolarity consistent with the fluid removal requirements for that exchange.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Additives may be incompatible. Do not store solutions containing additives.

For administration see Directions for Use section.

How is Delflex Neutral pH Supplied

DELFLEX peritoneal dialysis solutions are delivered in single-dose flexible bags. All DELFLEX peritoneal dialysis solutions have overfills declared on the container label. The flexible containers have the capacity for drainage in excess of their stated fill volume for ultrafiltration from the patient.

DELFLEX peritoneal dialysis solutions with an attached stay•safe® exchange set are available in containers as shown in the Table 2 in the Description section.

Storage Conditions

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Brief exposure to temperatures up to 40°C/104°F may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F).

Keep DELFLEX and all medicines out of the reach of children.

Fresenius Medical Care North America

920 Winter Street

Waltham, MA 02451

1-800-323-5188

Patent Pending

Revised 09/09

Not for Intravenous Injection.  Do not microwave.

Warm solution as directed by your healthcare provider.

Directions for Use

Get Ready

1. 
   

   Clean work surface.  Use aseptic technique.

   
   


2. 
   

   Gather supplies:

   
   
   • 
     

     Warmed Delflex Neutral pH Peritoneal Dialysis bag with the attached stay•safe Exchange Set.

     
     
   
   
   • 
     

     Povidone iodine prefilled stay•safe cap, a stand alone item provided separately.

     
     
   
   
   • 
     

     stay•safe® organizer, a stand alone item provided separately (Optional; FMCNA recommends its use)

     
     
   
   
   • 
     

     Prescribed medicine(s) if ordered by your healthcare provider

     
     
   
   
   • 
     

     Mask

     
     

     See Figure A for identification of each item described above.

     
     
     
     
   
   


3. 
   

   Put on the mask.  Wash your hands.

   
   


4. 
   

   Clamp the Extension Tube Set coming from the catheter.

   
   


5. 
   

   Tear the overwrap across from the slit edge to open.  Wipe away any moisture from the solution bags.

   
   


6. 
   

   Inspect DEFLEX Solution Bags:

   
   
   • 
     

     Place the DEFLEX Solution on the work surface. See Figure B.

     
     
     
     
   
   
   • 
     

     Position solution bags and drain bag as shown in Figure C.

     
     
     
     
   
   
   • 
     

     Squeeze the main bag and the mini bag to check for leaks.  When squeezing the mini-bag, the bag should remain firm.  No solution should leak into the main bag or into the drain line.

     
     
     
     
     
     
     
     
     
     
     
     

     Do not use Delflex Neutral pH Solution Set if:

     •  Leaks are found

     •  The solution bags are damaged

     •  Solution is cloudy or discolored

     •  Red or blue cone is broken

     Throw away Delflex Neutral pH Solution set and notify your healthcare provider.

   
   


7. 
   

   Turn the blue position indicator on the stay•safe® disc counter-clockwise until it fits into thecut-out portion of the colored plastic cover on the disc as illustrated in Figure D.  This will allow the effluent in your peritoneal cavity to drain.  Remove the plastic cover while the indicator is in this position (Position1:  •).  Once the cover is removed, do not turn counter-clockwise.

   
   

Mix Delflex® Neutral pH Solution

Important:  Mix the mini-bag and main solutions thoroughly.  Use the solution within 24 hours after mixing.

1. 
   

   With the solution bags stretched out on the work surface, break the red cone by bending.  See Figure E.

   
   
   
   


2. 
   

   Fold the min-bag in half.  Squeeze the solution from the mini-bag into the main solution bag by pressing the two halves together until the mini-bag is empty.  See Figure F(Step 1).

   
   
   
   


3. 
   

   Push down on main solution bag to flush solution back into the mini-bag.  Completely refill mini-bag with solution.  See Figure F (Step 2).

   
   


4. 
   

   Repeat steps 2 and 3 above to make sure that all of the contents of the mini-bag have been completely flushed into the main solution bag.

   
   


5. 
   

   Grab the tubing at the bottom of the main solution bag.  While keeping the top portion of the bag on the table, flip the bag lengthwise using a back and forth motion to mix solutions.  See Figure G.  Repeat this step to mix solutions.

   
   
   
   


6. 
   

   Fold mini-bag in half and squeeze it until there is no solution left.  Slide folded mini-bag into the slit of the white cover to show the blue cone.  See Figure H.

   
   

The solution is now ready for use.

Administer Peritoneal Dialysis Solution

1. 
   

   If adding medicine(s):

   
   
   • 
     

     Clean the medication port as instructed by your healthcare provider.

     
     
   
   
   • 
     

     Add the medicine(s).

     
     
   
   
   • 
     

     Turn the bag upside down several times to mix the medicine.

     
     
   
   


2. 
   

   Hang the solution bag from the I.V. pole.  Place the drain bag at floor level.

   
   


3. 
   

   Break the blue cone on the bottom of the mini-bag.  See Figure I. (if using the Organizer, place the stay•safe® disc in the organizer as shown in Figure J)

   
   
   
   
   
   


4. 
   

   Remove the new stay•safe® cap from its package.  The new stay•safe® cap is the stand alone item