Israel - English - Ministry of Health
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
WATER FOR INJECTION
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml solution contain:
Water for injections 100 ml
3 PHARMACEUTICAL FORM
Solvent for parenteral use
Clear, colourless solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Preparation and dilution of medicines for parenteral administration.
4.2 Posology and method of administration
Water for injection 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.
The dosage should be based on the instructions given for the medicinal product to be dissolved or
Method of administration
The method of administration depends on the instructions given for the medicinal product to be
dissolved/diluted. The medicinal product should be dissolved or diluted immediately before use.
There are no contraindications for water for injections as such.
4.4 Special warnings and precautions for use
Water for injection must not be injected as such.
Precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
Interactions between water for injection and other medicinal products are not known.
4.6 Fertility, pregnancy and lactation
Generally, water for injection can be used during pregnancy.
Water for injection can be used during breasteeding.
4.7 Effects on ability to drive and use machines
Water for injection has no influence on the ability to drive and use machines.
4.8 Undesirable effects
None knownif used according to the instructions given.
If water for injection is administered intravenously without additives, it may cause haemolysis
and hypotonic disorders in the electrolte metabolism.
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.
Any suspected adverse events should be reported to the Ministry of Health according to the
National Regulation by using an online form
Haemolysis may occur following infusion of large volumes of hypotonic solutions using sterile
water for injections as diluent. In the event of accidental overdose, the treatment should be
discontinued.-In the case of massive haemolyis, intensive treatment must be instituted
Symptoms and treatment
Not applicable because this medicinal product is used only for preparation and dilution of
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solvents and diluting agents, including irrigation solutions
ATC code: V07AB
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
Preclinical data on water for injection reveal no special hazards 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 not be expected to generate positive mutagenic or carcinogenic data.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.3 Shelf life
The expiry date of the product is indicated on the packaging materials.
Following the addition of additives
For microbiological reasons, the product should be used immediately. If it is not used immediately,
storage times and conditions prior to use are the responsibility of the user. The ready-to-use
preparation must not be stored longer than 24 hours at 2 to 8
C, unless dilution has taken place
under controlled and validated aseptic conditions.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
See Section 6.3 for storage conditions of the ready-to0use preparation.
6.5 Nature and contents of container
ampoules LDPE Mini-Plasco ® 20x10ml and 20x20 ml.
ampoules LDPE Mini-Plasco-Conncet 20x10ml and 20x20 ml.
ampoules PP Mini-Plasco-Basic 100x10ml and 100x20 ml.
Bottle Plastic containers: 20x100 ml, 10x250 ml, 10x500 ml, 10x1000 ml
6.6 Special precautions for disposal
No special requirements for disposal.
Only to be used if the solution is clear and colousless, and the container and closure are
undamaged. The containers are for single use only. After use discard the container and any
Use the liquid immediately after opening the container.
B.Braun Melsungen AG, Germany
Car-Braun str.1, D-34212, Melsungen, Germany
8. REGISTRATION HOLDER:
Lapidot Medical Import and Marketing Ltd.
8 Hashita street, Caesarea Industrial Zone, 38900
9. LICENSE NUMBER(S)
Approved on 17.11.2020