Water For Injections
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections Ph.Eur.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml contains 1g water for injections 5ml contain 5g water for injections 10ml contain 10g water for injections 20ml contain 20g water for injections.
3 PHARMACEUTICAL FORM
Solvent for parenteral use.
A clear liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Water for Injections is used as a vehicle for dilution and reconstitution of suitable medicinal products for parenteral administration.
4.2. Posology and method of administration
Dosage:
The volume given and administration rate are dependent upon the additive.
Administration:
For parenteral use.
The directions for use of the additive will dictate the administration route. The solution should only be used if it is clear without visible particles.
4.3.
Contraindications
Contraindications related to the additive.
4.4 Special warnings and precautions for use
Water for Injections is hypotonic and it should not be administered alone, because it may cause haemolysis.
4.5. Interaction with other medicinal products and other forms of interaction
Interactions related to the additive.
4.6 Pregnancy and lactation
This solvent does not present any hazard to the pregnant woman, to the foetus or to the breast-fed child, however the hazard depends upon the additive.
4.7 Effects on ability to drive and use machines
Not known.
4.8 Undesirable Effects
None are known for Water for Injections, so any undesirable effects may be related to the additive.
Intravenous administration can lead to haemolysis if it is administered alone. Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: (www.mhra.gov .uk/yellowcard).
4.9 Overdose symptoms, emergency procedures, antidotes
Haemolysis may occur following infusion of large volumes of hypotonic solutions using sterile water for injections as diluent.
The signs and symptoms of overdose may also be related to the nature of the additive. In the event of accidental overdose, the treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the additive administered.
Pharmacodynamic properties
5.1
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating
solutions
V07A B01.
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 Major incompatibilities
Incompatible with oily liquids.
6.3 Shelf Life
5 years.
From a microbiological point of view, the product should be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution has taken place in controlled and validated aseptic conditions.
Unopened product: This medicinal product does not require any special storage conditions.
Opened product: For storage conditions of the opened, reconstituted or diluted medicinal product, see section 6.3.
6.5 Nature and contents of container
Polypropylene ampoules, of 5 or 10 ml, packed into cartons of 50 ampoules, or of 20 ml, packed into cartons of 20 ampoules.
6.6. Special precautions for disposal and handling
After single use, product should be discarded Any unused product should be discarded.
7. MARKETING AUTHORISATION HOLDER
Noridem Enterprises Ltd., (trading as Fannin)
Evagorou & Makariou,
Mitsi Building 3, Suit.115,
1065 Nicosia, Cyprus.
8 MARKETING AUTHORISATION NUMBER(S)
PL 24598/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/08/2009
10 DATE OF REVISION OF THE TEXT
13/05/2016