Water for Injections BP, solvent for parenteral use

Solvent for parenteral use Clear, colourless solution

4.1 Therapeutic indications Preparation and dilution of parenteral preparations4.2 Posology and method of administration **Posology** Water for Injection BP is used for dilution or dissolution of parenteral medicinal products. Dosage and duration of use depend on the instructions given for the medicinal product to be dissolved or diluted. *Paediatric population* The dosage has to be considered based on the instructions given for the medicinal product to be dissolved or diluted. **Method of administration** The method of administration depends on the instructions given for the medicinal product to be dissolved/diluted. The medicinal products should be reconstituted or diluted immediately before use.4.3 Contraindications There are no contraindications for water for injections as such.4.4 Special warnings and precautions for use Water for Injections BP must not be used alone for intravenous administration.4.5 Interaction with other medicinal products and other forms of interaction Interactions between water for injections and other medicinal products are not known.4.6 Fertility, pregnancy and lactation Pregnancy Generally, water for injections can be used during pregnancy. Breast-feeding Water for injections can be used during breast-feeding. Fertility No data available.4.7 Effects on ability to drive and use machines Water for Injections BP has no influence on the ability to drive and use machines.4.8 Undesirable effects None known if used according to the instructions given. **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 or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose Symptoms and treatment Not applicable because this medicinal product is only for preparation and dilution of parenteral preparations.

5.1 Pharmacodynamic properties Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions ATC code: V07AB5.2 Pharmacokinetic properties None5.3 Preclinical safety data Non-clinical data on water for injection reveal no special hazard for humans. Studies of toxicity to reproduction, genotoxicity or carcinogenic potential have not been performed, but based on the chemical properties of water and the fact that water is essential to life, pure water would not be expected to generate positive mutagenic or carcinogenic data.

6.1 List of excipients None6.2 Incompatibilities Not applicable6.3 Shelf life *Unopened* | | | | --- | --- | | Polyethylene containers Polyethylene ampoules: 5 ml, 10 ml, 30 ml Polypropylene ampoules: 10 ml, 20 ml | 36 months 30 months 36 months | *After first opening* Not applicable. See section 6.6. *After admixture of additives* From a microbiological point of view, the product should be used immediately. 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 dilution has taken place in controlled and validated aseptic conditions.6.4 Special precautions for storage Product in plastic ampoules: Do not store above 25 °C. Product in polyethylene containers: This medicinal product does not require any special storage conditions. For storage conditions of ready-to-use preparations see section 6.3.6.5 Nature and contents of container ● Bottles of low-density polyethylene (LD-PE), contents: 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml pack sizes: 20 x 50 ml, 10 x 100 ml, 20 x 100 ml, 10 x 250 ml, 20 x 250 ml, 10 x 500 ml, 10 x 1000 ml ● Polyethylene ampoules, contents: 5 ml, 10 ml, 20 ml pack sizes: 20 x 5 ml, 20 x 10 ml, 20 x 20 ml, 100 x 5 ml, 100 x 10 ml, 100 x 20 ml ● Polypropylene ampoules, contents 10 ml, 20 ml pack sizes: 20 x 10 ml, 20 x 20 ml, 50 x 10 ml, 50 x 20 ml, 100 x 10 ml, 100 x 20 ml Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling No special requirements for disposal. Only to be used if solution is clear, colourless and the container and its closure are undamaged. The containers are for single use only. After use discard container and any remaining contents. Use the liquid immediately after opening of the container.