Thursday, September 29, 2016

Chloromag



magnesium chloride

Dosage Form: injection, solution
Magnesium Chloride Injection 200 mg/mL (20% w/v) 2.951 mOsm/mL

Chloromag Description


Magnesium Chloride Injection is a sterile solution of

Magnesium Chloride Hexahydrate in Water for Injection

q.s. Each mL contains Magnesium Chloride Hexahydrate

200 mg, Sodium Chloride 9 mg, Benzyl Alcohol 1% as

a preservative, Water for Injection, q.s. pH adjusted

with Hydrochloric Acid and/or Sodium Hydroxide. Total

osmolarity equivalent to 2951 mOsm/L.

Contains 1.97 mEq of Mg++ and Cl- per mL.

The structural formula is MgCl2•6H2O.



ACTIONS


Magnesium is the second most plentiful cation within

cellular fluids. It is an important activator of many

enzyme systems and deficits are accompanied by a

variety of functional disturbances.



INDICATIONS


As an electrolyte replenisher in magnesium

deficiencies.



Contraindications


Magnesium Chloride Injection should not be administered

if there is renal impairment, marked myocardial disease

or to comatose patients.



Warning


Do not use if a precipitate is present.



Precautions


The usual precautions for parenteral administration

should be observed. Administer with caution if flushing

and sweating occurs. A preparation of a calcium salt

should be readily available for intravenous injection

to counteract potential serious signs of magnesium

intoxication. As long as deep tendon reflexes are active

it is probable that the patient will not develop respiratory

paralysis. Respiration and blood pressure should be

carefully observed during and after administration of

Magnesium Chloride Injection.











Chloromag 
magnesium chloride  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)30727-304
Route of AdministrationINTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Magnesium Chloride (Magnesium cation)Magnesium Chloride200 mg  in 1 mL














Inactive Ingredients
Ingredient NameStrength
Sodium Chloride9 mg  in 1 mL
Benzyl Alcohol1 mL  in 100 mL
Water 
Sodium Hydroxide 
Hydrochloric Acid 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
130727-304-9050 mL In 1 VIAL, MULTI-DOSENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/11/2011


Labeler - Merit Pharmaceutical (093370369)

Registrant - Merit Pharmaceutical (093370369)









Establishment
NameAddressID/FEIOperations
Merit Pharmaceutical093370369manufacture
Revised: 07/2011Merit Pharmaceutical




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