Water for Injection is indicated to be used as a vehicle for dilution and reconstitution of suitable medicinal products for parenteral administration.

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.

Water for Injections is hypotonic and it should not be administered alone, because it may cause hemolysis.

The possible clinical interactions between the different medicinal products to be dissolved should be considered.

May be used during fertility, pregnancy and lactation. The risks during use are determined by the nature of the added medicinal products.

Not relevant.

May cause hemolysis if administered alone. The nature of the additive will determine the likelihood of any other undesirable effects.

Reporting of suspected adverse reactions
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

No effects are anticipated if used as instructed. Hemolysis 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.

Pharmacotherapeutic Group: Solvents and diluting agents, including irrigating solutions, ATC code: V07AB.
Water for Injection being only the vehicle for the administration of the added medicinal product, the pharmacodynamics will depend on the nature of the drug added.

Water for Injection being only the vehicle for the administration of the added medicinal product, the pharmacokinetics will depend on the nature of the drug added.

Water for Injection 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.

None.

Water for Injection should not be mixed with any other agents unless their compatibility has been established.

Store below 30°C for size:
500 ml, 1000 ml Plastic bottle
500 ml glass bottle
20 ml plastic ampoule
Store below 25°C for size:
50 ml, 100 ml glass bottle
5 ml, 10 ml plastic ampoule
Discard after single use.
Discard any unused portion.

Use only if the solution is clear without visible particles and container undamaged. In case an infusion set has been inserted, administer immediately.
Thorough and careful aseptic mixing of any additive is mandatory.
Additives may be introduced before administration or during administration through the resealable medication port. Solutions containing additives should be used immediately after preparation unless preparation has taken place in controlled and validated aseptic conditions.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

The product is a clear, colorless solution in variable forms as follows:
Ampoules: 5, 10 & 20ml
Glass Vials: 50ml
Glass Bottles: 100ml & 500ml
Plastic Bottles: 500ml
NPVC Bags: 1000ml

For single use only.
As appropriate to the reconstituted drug.
If only part of a bag is used, discard the remaining solution.
Use as directed by the physician.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.