Sunday, 27 June 2010

Throsyn




Throsyn may be available in the countries listed below.


Ingredient matches for Throsyn



Roxithromycin

Roxithromycin is reported as an ingredient of Throsyn in the following countries:


  • South Africa

International Drug Name Search

Thursday, 24 June 2010

Pindome




Pindome may be available in the countries listed below.


Ingredient matches for Pindome



Adapalene

Adapalene is reported as an ingredient of Pindome in the following countries:


  • Taiwan

International Drug Name Search

Tuesday, 22 June 2010

Dextrose Electrolyte No. 75





Dosage Form: injection, USP

Dextrose Electrolyte No. 75 Description


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single dose container for intravenous administration. Each 100 mL contains 5 g Dextrose Hydrous, USP*, 220 mg Sodium Lactate (C3H5NaO3), 205 mg Potassium Chloride, USP (KCl), 120 mg Sodium Chloride, USP (NaCl), and 100 mg Monobasic Potassium Phosphate, NF (KH2PO4). It contains no antimicrobial agents. pH 5.0 (4.0 to 6.5).



5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) administered intravenously has value as a source of water, electrolytes, and calories. One liter has an ionic concentration of 40 mEq sodium, 35 mEq potassium, 48 mEq chloride, 20 mEq lactate, and 15 mEq phosphate as HPO4=. The osmolarity is 402 mOsmol/L (calc). Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. The caloric content is 180 kcal/L.


The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.



Dextrose Electrolyte No. 75 - Clinical Pharmacology


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) has value as a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) produce a metabolic alkalinizing effect. Lactate ions are metabolized in the liver to glycogen, and ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations.



Indications and Usage for Dextrose Electrolyte No. 75


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is indicated as a source of water, electrolytes and calories or as an alkalinizing agent.



Contraindications


Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.



Warnings


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with great care, if at all, in patients with hyperkalemia, severe renal failure, and in conditions in which potassium retention is present.


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care in those conditions in which there is an increased level or an impaired utilization of these ions, such as severe hepatic insufficiency.


The intravenous administration of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection.


In patients with diminished renal function, administration of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) may result in sodium or potassium retention.


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is not for use in the treatment of lactic acidosis.



Precautions


Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with caution. Excess administration may result in metabolic alkalosis.


Caution must be exercised in the administration of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) to patients receiving corticosteroids or corticotropin.


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be used with caution in patients with overt or subclinical diabetes mellitus.



Pregnancy


Teratogenic Effects

Pregnancy Category C


Animal reproduction studies have not been conducted with 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP). It is also not known whether 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) should be given to a pregnant woman only if clearly needed.



Pediatric Use


Safety and effectiveness of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) in pediatric patients have not been established by adequate and well controlled trials, however, the use of dextrose and electrolytes solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.


In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible hemorrhage.



Geriatric Use


Clinical studies of 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.



Carcinogenesis and Mutagenesis and Impairment of Fertility


Studies with 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.



Nursing Mothers


It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) is administered to a nursing mother.


Do not administer unless solution is clear and seal is intact.



Adverse Reactions


Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.


If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.



Dextrose Electrolyte No. 75 Dosage and Administration


As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.


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


All injections in VIAFLEX plastic containers are intended for intravenous administration using sterile equipment.


As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low weight infants, because of the increased risk of hyperglycemia/hypoglycemia.


Additives may be incompatible. Complete information is not available.


Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.



How is Dextrose Electrolyte No. 75 Supplied


5% Dextrose and Electrolyte No. 75 Injection (Multiple Electrolytes and Dextrose Injection, Type 3, USP) in VIAFLEX plastic containers is available as shown below:














CodeSize (mL)NDC
2B2112250NDC 0338-0141-02
2B2113500NDC 0338-0141-03
2B21141000NDC 0338-0141-04

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.



DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINERS


Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn in from the primary container before administration of the fluid from the secondary container is completed.



To Open


Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.



Preparation for Administration


1. Suspend container from eyelet support.


2. Remove plastic protector from outlet port at bottom of container.


3. Attach administration set. Refer to complete directions accompanying set.



To Add Medication


Warning: Additives may be incompatible.



To add medication before solution administration


1. Prepare medication site.


2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.


3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.



To add medication during solution administration


1. Close clamp on the set.


2. Prepare medication site.


3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.


4. Remove container from IV pole and/or turn to an upright position.


5. Evacuate both ports by squeezing them while container is in the upright position.


6. Mix solution and medication thoroughly.


7. Return container to in use position and continue administration.


Baxter Healthcare Corporation


Deerfield, IL 60015 USA


BAXTER, VIAFLEX and PL 146 are trademarks of Baxter International Inc.


07-19-47-766

Rev. June 2005.








DEXTROSE AND ELECTROLYTE NO. 75 
sodium lactate, sodium chloride, potassium chloride, potassium phosphate and dextrose  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0338-0141
Route of AdministrationINTRAVENOUSDEA Schedule    























INGREDIENTS
Name (Active Moiety)TypeStrength
Dextrose Hydrous (dextrose)Active5 GRAM  In 100 MILLILITER
Sodium Lactate (sodium lactate)Active220 MILLIGRAM  In 100 MILLILITER
Potassium Chloride (potassium chloride)Active205 MILLIGRAM  In 100 MILLILITER
Sodium Chloride (sodium chloride)Active120 MILLIGRAM  In 100 MILLILITER
Potassium Phosphate, monobasic (potassium phosphate, monobasic)Active100 MILLIGRAM  In 100 MILLILITER
WaterInactive 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
10338-0141-02250 mL (MILLILITER) In 1 BAGNone
20338-0141-03500 mL (MILLILITER) In 1 BAGNone
30338-0141-041000 mL (MILLILITER) In 1 BAGNone

Revised: 08/2006Baxter Healthcare Corporation

Saturday, 19 June 2010

Sandostatina




Sandostatina may be available in the countries listed below.


Ingredient matches for Sandostatina



Octreotide

Octreotide is reported as an ingredient of Sandostatina in the following countries:


  • Italy

  • Portugal

International Drug Name Search

Arteolol




Arteolol may be available in the countries listed below.


Ingredient matches for Arteolol



Carteolol

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


  • Spain

International Drug Name Search

Tuesday, 15 June 2010

Wick Formel 44 Husten-Löser




Wick Formel 44 Husten-Löser may be available in the countries listed below.


Ingredient matches for Wick Formel 44 Husten-Löser



Guaifenesin

Guaifenesin is reported as an ingredient of Wick Formel 44 Husten-Löser in the following countries:


  • Austria

International Drug Name Search

Thursday, 10 June 2010

Cethexonium




Scheme

DCF

ATC (Anatomical Therapeutic Chemical Classification)

D08AJ

CAS registry number (Chemical Abstracts Service)

0006810-42-0

Chemical Formula

C24-H50-N-O

Molecular Weight

368

Therapeutic Categories

Antiseptic

Disinfectant

Chemical Names

Cyclohexanaminium, N-hexadecyl-2-hydroxy-N,N-dimethyl-

N-Hexadecyl-2-hydroxy-N,N-dimethylcyclohexanaminium

Foreign Names

  • Cethexonium (German)
  • Céthexonium (French)
  • Cetexonio (Spanish)

Generic Name

  • Céthexonium (OS: DCF)

Brand Names

  • Bactyl
    Cooperation Pharmaceutique Française, Tunisia; Europhta, Tunisia


  • Biocidan
    Menarini, France


  • Monosept
    Horus, France

International Drug Name Search

Glossary

DCFDénomination Commune Française
OSOfficial Synonym

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

Saturday, 5 June 2010

Cefotetan Sodium




Cefotetan Sodium may be available in the countries listed below.


Ingredient matches for Cefotetan Sodium



Cefotetan

Cefotetan Sodium (JAN) is known as Cefotetan in the US.

International Drug Name Search

Glossary

JANJapanese Accepted Name

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

Diazen




Diazen may be available in the countries listed below.


Ingredient matches for Diazen



Metformin

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


  • Philippines

International Drug Name Search