Sodium Chloride Solution For Injection 0.9% W/V
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride Solution for Injection 0.9% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride Ph. Eur. 9mg
3 PHARMACEUTICAL FORM
Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For use as a solvent for freeze dried products
4.2 Posology and method of administration
Usually 1ml as a solvent for injection
4.3 Contraindications
None stated
4.4 Special warnings and precautions for use
Each unit should be discarded after a single use
Interaction with other medicinal products and other forms of interaction
4.5
None stated
4.6 Fertility, Pregnancy and lactation
This solution does not present any hazard to pregnant women, to the foetus or to the breast-fed child.
4.7 Effects on ability to drive and use machines
None stated
4.8 Undesirable effects
None stated
4.9 Overdose
Administration of quantities, which may have adverse effects (i.e. over 3 litres) is very unlikely when each unit contains 1ml of solution only
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Solutions of sodium chloride closely approximate the composition of the extracellular fluid of the body; more than 90% of the cation of the extracellular fluid is sodium and more than 60% of the anion is chloride. Furthermore a 0.9% solution of sodium chloride is approximately isotonic with body fluids. Thus an injection of 0.9% sodium chloride will not appreciably affect the osmotic pressure of the body or the chemical composition of the extracellular fluid. A 0.9% solution of sodium chloride is therefore the choice of solvent for many drugs which have to be administered parenterally. The solution has the added advantage of being nonirritating to tissue.
5.2 Pharmacokinetic properties
Not appropriate
5.3 Preclinical safety data
No special particulars
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydrochloric acid Ph. Eur.
Sodium hydroxide Ph. Eur.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
Do not store above 30(
Nature and contents of container
6.5
1 ml glass ampoule.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00025/0542
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/07/1990
10 DATE OF REVISION OF THE TEXT
13/09/2013