Water For Injections
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Water for Injections 5 ml, solvent for parenteral use Water for Injections 10 ml, solvent for parenteral use Water for Injections 15 ml, solvent for parenteral use Water for Injections 20 ml, solvent for parenteral use Water for Injections 30 ml, solvent for parenteral use
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
- Water for Injections 5 ml is presented as a solvent for parenteral use containing 5 ml of Water for Injections (Ph. Eur.)
- Water for Injections 10 ml is presented as a solvent for parenteral use containing 10 ml of Water for Injections (Ph. Eur.)
- Water for Injections 15 ml is presented as a solvent for parenteral use containing 15 ml of Water for Injections (Ph. Eur.)
- Water for Injections 20 ml is presented as a solvent for parenteral use containing 20 ml of Water for Injections (Ph. Eur.)
- Water for Injections 30 ml is presented as a solvent for parenteral use containing 30 ml of Water for Injections (Ph. Eur.)
3. PHARMACEUTICAL FORM
Solvent for parenteral use
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Used for the reconstitution of freeze-dried human plasma fractions
4.2. Posology and method of administration
As for the product to be reconstituted
4.3. Contraindications
As for the product to be reconstituted.
4.4. Special warnings and precautions for use
The product should not be used if the solution is unclear or if the container is damaged.
As for the product to be reconstituted.
4.5. Interactions with other medicinal products and other forms of interaction
As for the product to be reconstituted.
4.6. Pregnancy and lactation
As for the product to be reconstituted.
4.7. Effects on ability to drive and use machines
As for the product to be reconstituted.
4.8. Undesirable effects
As for the product to be reconstituted
4.9. Overdose
As for the product to be reconstituted
Not applicable.
5.2. Pharmacokinetic properties
Not applicable
5.3. Preclinical safety data
Not applicable
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
None
6.2. Incompatibilities
None known.
6.3. Shelf life
42 months
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze.
6.5
Nature and contents of container
Water for Injections is supplied in colourless Type I glass vials with a bromobutyl rubber stopper and covered with a flip off cap.
The carton contains one vial with the solvent Water for Injections (Ph. Eur.) and the package leaflet.
Water for Injections is supplied in five pack sizes with the following filling volumes: 5 ml, 10ml, 15 ml, 20 ml and 30 ml.
6.6 Instruction for use and handling (, and disposal)
Before use, the flip-off cap is removed and the rubber stopper cleaned with an alcohol swab. A sterile syringe is used to withdraw the contents of the vial and to reconstitute the freeze-dried human plasma fractions.
7 MARKETING AUTHORISATION HOLDER
Octapharma Ltd.
The Zenith Building,
26 Spring Gardens Manchester M2 1AB United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 10673/0023
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/12/2008
10 DATE OF REVISION OF THE TEXT
31/01/2012