No effects are anticipated if used as instructed.
Haemolysis may occur following infusion of large volumes of hypotonic solutions using sterile water for injections as diluent.
The signs and symptoms of overdose will also be related to the nature of the medicinal product being added. 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 medicinal product administered.
Unopened
4 years.
Opened
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Sterilised Water for Injections should not be administered alone because it may cause haemolysis. The contraindications related to the added medicinal product should be considered.
Sterilised Water for Injections must not be mixed with other medicinal products unless their compatibility has been established.
None.
Solvent for parenteral use.
Single-use vial containing 2.5 or 5 mL of Sterilised Water for Injections
May cause haemolysis if administered alone.
The nature of the additive will determine the likelihood of any other undesirable effects.
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 the MHRA Yellow Card Scheme: Tel: Freephone 0808 100 3352. Website: www.mhra.gov.uk/yellowcard
Sterilised Water for Injections being only the vehicle for the administration of the added medicinal product, the preclinical safety data will depend on the nature of the drug added.
Sterilised Water for Injections is indicated to be used as a vehicle for dilution and reconstitution of suitable medicinal products for parenteral administration.
Pharmacotherapeutic Group: Solvents and diluting agents, including irrigating solutions, ATC code: V07AB.
Sterilised Water for Injections being only the vehicle for the administration of the added medicinal product, the pharmacodynamics will depend on the nature of the drug added.
Sterilised Water for Injections being only the vehicle for the administration of the added medicinal product, the pharmacokinetics will depend on the nature of the drug added.
15/08/2014
Sterilised Water for Injections
Bio Products Laboratory Limited,
Dagger Lane,
Elstree,
Hertfordshire,
WD6 3BX,
United Kingdom.
Tel: +44(0) 20 8957 2200
Fax: +44 (0) 20 8957 2608
E-mail: [email protected]
Do not store above 30°C. Do not freeze.
Type I clear glass 5 mL vial closed with a halobutyl rubber stopper and an aluminium overseal with a polypropylene flip off tamper evident cap.
Pack sizes: 2.5 mL or 5 mL
Not all pack sizes may be marketed.
PL 08801/0057
May be used during fertility, pregnancy and lactation.
The risks during use are determined by the nature of the added medicinal products.
Each mL contains 100% of Sterilised Water for Injections
Water for Injections is hypotonic and it should not be administered alone, because it may cause haemolysis.
Not relevant.
Posology
The dosage administered will be dictated by the nature of the additive used. The administration rate will be dependent upon the dose regimen of the prescribed drug.
Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.
The solution should only be used if it is clear without visible particles.
Method of administration
For parenteral use.
The directions for use will be dependent upon the appropriate medicinal product to which this solvent is added, which will dictate the appropriate volumes as well as administration route.
For single use.
Any unused product or waste material should be disposed of in accordance with local requirements.
Keep out of sight and reach of children.
15/08/2014
None known.
The possible clinical interactions between the different medicinal products to be dissolved should be considered.
