Water For Injections Fresenius
Clinical Summary
Quick overview from the medicine insert
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
For use as a solvent for parenteral products, such as sterile solids that must be distributed dry because of limited stability of their solutions, or for dilution of concentrated solutions.
4.2 Posology and method of administration
According to the concentration of the active ingredient required.
4.3 Contraindications
- WATER FOR INJECTIONS FRESENIUS should not be administered alone as it may cause haemolysis.
- The contraindications related to the added medicine should be considered prior to administration.
4.4 Special warnings and precautions for use
WATER FOR INJECTIONS FRESENIUS is hypotonic and it must not be administered alone, as it may cause haemolysis (see section 4.3).
4.5 Interaction with other medicines and other forms of interaction
There are no known interactions for WATER FOR INJECTIONS FRESENIUS. The possible clinical interactions between the different medicines to be dissolved should be considered.
4.6 Fertility, pregnancy and lactation
WATER FOR INJECTIONS FRESENIUS may be used during fertility, pregnancy and lactation. The risk during use is determined by the nature of the added medicines.
4.7 Effects on ability to drive and use machines
WATER FOR INJECTIONS FRESENIUS has no effect on the ability to drive or use machinery.
4.8 Undesirable effects
Not to be administered alone (see section 4.3). The nature of the additive will determine the likelihood of any undesirable effects. Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of WATER FOR INJECTIONS FRESENIUS is important. It allows continued monitoring of the benefit/risk balance of WATER FOR INJECTIONS FRESENIUS. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.
4.9 Overdose
No effects are anticipated if used as instructed. Haemolysis may occur following infusion of large volumes of hypotonic solutions using WATER FOR INJECTIONS FRESENIUS as diluent. The signs and symptoms of overdose will also be related to the nature of the medicines 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 medicine administered.
