Sterile water for injection
Marketing Authorization Holder: Pfizer LimitedRamsgate RoadSandwichKentCT13 9NJ
Prescription only medicine
Not classified
PL 00057/1436
Summary of Product Characteristics
Detailed prescribing information and pharmaceutical guidance from the UK Electronic Medicines Compendium.
Composition
Active and inactive ingredients
Sterile Water for Injection Ph. Eur. 100% w/v.
Pharmaceutical Form
Dosage form and administration route
Solution for injection or infusion
Clinical Particulars
Therapeutic indications and usage
4.1 Therapeutic indications To be used to reconstitute certain medicinal products.4.2 Posology and method of administration Intramuscular or intravenous injection.4.3 Contraindications Not applicable.4.4 Special warnings and precautions for use Not applicable.4.5 Interaction with other medicinal products and other forms of interaction Not applicable.4.6 Pregnancy and lactation Not applicable.4.7 Effects on ability to drive and use machines Not applicable.4.8 Undesirable effects Not applicable.4.9 Overdose Not applicable.
Pharmacological Properties
Pharmacodynamics and pharmacokinetics
5.1 Pharmacodynamic properties Not applicable.5.2 Pharmacokinetic properties Not applicable.5.3 Preclinical safety data Not applicable.
Pharmaceutical Particulars
Storage and handling information
6.1 List of excipients Not applicable.6.2 Incompatibilities Not applicable.6.3 Shelf life 60 months.6.4 Special precautions for storage Discard any remaining solution after use.6.5 Nature and contents of container | | | | --- | --- | | Ampoules: | Glass class I Ph. Eur., containing 1ml, 2ml, 3.2ml, 5ml or 10ml. | | Vials: | Glass class I Ph. Eur., containing 4ml, 7.8ml, 10ml, 15.6ml or 31.2ml. | All rubber stoppers for the vials used comply with Ph.Eur. testing for rubber closures.6.6 Special precautions for disposal and other handling No special requirements.