Thursday, 31 March 2011

Prefer




Prefer may be available in the countries listed below.


Ingredient matches for Prefer



Paracetamol

Paracetamol is reported as an ingredient of Prefer in the following countries:


  • Bangladesh

International Drug Name Search

Friday, 25 March 2011

Epinitril




Epinitril may be available in the countries listed below.


Ingredient matches for Epinitril



Nitroglycerin

Nitroglycerin is reported as an ingredient of Epinitril in the following countries:


  • France

  • Greece

  • Italy

  • Portugal

  • Spain

International Drug Name Search

Thursday, 24 March 2011

Antizol




In the US, Antizol (fomepizole systemic) is a member of the drug class antidotes and is used to treat Ethylene Glycol Poisoning and Methanol Poisoning.

US matches:

  • Antizol

Ingredient matches for Antizol



Fomepizole

Fomepizole is reported as an ingredient of Antizol in the following countries:


  • Canada

  • Israel

  • United States

International Drug Name Search

Monday, 21 March 2011

Bacteriostatic Sodium Chloride




Bacteriostatic 0.9% Sodium Chloride 0.9% Injection, USP 30 mL Multi Dose Vial

Bacteriostatic Sodium Chloride Description


This preparation is designed for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.


Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride in water for injection. Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic preservative. May contain hydrochloric acid for pH adjustment. It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for medication. The pH is 5.0 (4.5 to 7.0).


Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.


The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.



Bacteriostatic Sodium Chloride - Clinical Pharmacology


Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl−) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance.


The distribution and excretion of sodium (Na+) and chloride (Cl−) are largely under the control of the kidney which maintains a balance between intake and output.


The small volume of fluid and amount of sodium chloride provided by Bacteriostatic 0.9% Sodium Chloride Injection, USP, when used only as a vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants.


Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).


Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.



Indications and Usage for Bacteriostatic Sodium Chloride


This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.



Contraindications


Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population.


Parenteral preparations with benzyl alcohol should not be used for fluid or sodium chloride replacement.


Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthetic procedures.



WARNINGS


Benzyl alcohol, a preservative in Bacteriostatic Sodium Chloride Injection, USP has been associated with toxicity in neonates. Data are unavailable on the toxicity of other preservatives in this age group. Preservative-free Sodium Chloride Injection should be used for flushing intravascular catheters. Where a sodium chloride solution is required for preparing or diluting medications for use in neonates, only preservative-free Sodium Chloride Injection should be used.



Precautions


Consult the manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.


Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.


Pregnancy Category C.

Animal reproduction studies have not been conducted with Bacteriostatic 0.9% Sodium Chloride Injection, USP. It is also not known whether Bacteriostatic 0.9% Sodium Chloride Injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacteriostatic 0.9% Sodium Chloride Injection containing additives should be given to a pregnant woman only if clearly needed.


Pediatric Use

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. However, due to potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol are contraindicated in this patient population.


Drug Interactions

Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.


Use aseptic technique for single or multiple entry and withdrawal from all containers.


When diluting or dissolving drugs, mix thoroughly and use promptly.


Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.


Do not use unless the solution is clear and seal intact.



Adverse Reactions


Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.


If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.


Although adverse reactions to intravenous, intramuscular or subcutaneous injection of 0.9% benzyl alcohol are not known to occur in man, experimental studies of small volume parenteral preparations containing 0.9% benzyl alcohol in several species of animals have indicated that an estimated intravenous dose up to 30 mL may be safely given to an adult without toxic effects. Administration of an estimated 9 mL to a 6 kg neonate or infant is potentially capable of producing blood pressure changes.



Overdosage


Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of sodium chloride or fluid overload except possibly in neonates and very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS.



Bacteriostatic Sodium Chloride Dosage and Administration


The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer.


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



How is Bacteriostatic Sodium Chloride Supplied


Bacteriostatic 0.9% Sodium Chloride Injection, USP is supplied in multiple-dose 10, 20 and 30 mL plastic fliptop vials (List No. 1966) or in multiple-dose 10 and 30 mL plastic LifeShield® fliptop vials*. (List No. 1966).


*Intended for use with the LifeShield® Blunt Cannula.


Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]


Rev: April, 2005













©Hospira 2005



EN-1169



Printed in USA


HOSPIRA, INC., LAKE FOREST, IL 60045 USA



SAMPLE OUTER PACKAGE LABEL
















BACTERIASTATIC SODIUM CHLORIDE  
sodium chloride  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)52584-966 (0409-1966)
Route of AdministrationINTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (Sodium Cation)Sodium Chloride9 mg  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






























Packaging
#NDCPackage DescriptionMultilevel Packaging
152584-966-041 VIAL In 1 BAGcontains a VIAL, MULTI-DOSE
110 mL In 1 VIAL, MULTI-DOSEThis package is contained within the BAG (52584-966-04)
252584-966-071 VIAL In 1 BAGcontains a VIAL, MULTI-DOSE
230 mL In 1 VIAL, MULTI-DOSEThis package is contained within the BAG (52584-966-07)
352584-966-121 VIAL In 1 BAGcontains a VIAL, MULTI-DOSE
310 mL In 1 VIAL, MULTI-DOSEThis package is contained within the BAG (52584-966-12)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01880006/01/2010


Labeler - General Injectables & Vaccines, Inc. (108250663)
Revised: 01/2011General Injectables & Vaccines, Inc.

More Bacteriostatic Sodium Chloride resources


  • Bacteriostatic Sodium Chloride Drug Interactions
  • Bacteriostatic Sodium Chloride Support Group
  • 0 Reviews for Bacteriostatic Sodium Chloride - Add your own review/rating


Compare Bacteriostatic Sodium Chloride with other medications


  • Postural Orthostatic Tachycardia Syndrome

Thursday, 17 March 2011

Amitriptyline HCl Sandoz




Amitriptyline HCl Sandoz may be available in the countries listed below.


Ingredient matches for Amitriptyline HCl Sandoz



Amitriptyline

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


  • Netherlands

International Drug Name Search

Friday, 11 March 2011

Atralcilina




Atralcilina may be available in the countries listed below.


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

Ingredient matches for Atralcilina



Benzylpenicillin

Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Atralcilina in the following countries:


  • Portugal

International Drug Name Search

Sunday, 6 March 2011

Paracetamol Belmac




Paracetamol Belmac may be available in the countries listed below.


Ingredient matches for Paracetamol Belmac



Paracetamol

Paracetamol is reported as an ingredient of Paracetamol Belmac in the following countries:


  • Spain

International Drug Name Search