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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
 لم يتم إدخال بيانات نشرة معلومات المريض لهذا الدواء حتى الآن
 لم يتم إدخال بيانات نشرة معلومات المريض لهذا الدواء حتى الآن
 Read this leaflet carefully before you start using this product as it contains important information for you

Water for injections

Each 500 ml of solution contains 500 ml of sterilized water for injections.

Solution for injection. Clear, colorless, odorless, solution

For the reconstitution, dilution and making-up of appropriate drugs where Sterilised
Water for Injections is the diluent of choice, and for use as an irrigant .


Method of administration:
Route of administration: As appropriate to the reconstituted drug .
Dosage: 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 age, weight and clinical condition of the patient as well as laboratory determinations .
Administration
The solution is for dilution and delivery of the therapeutic additives. The directions for use related to the added medicinal product will dictate the appropriate volumes as well as the administration route .


Water for Injections should not be administered alone . The contraindications related to the added medicinal product should be considered .

Water for Injections is hypotonic and should not be administered alone .

Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute .
When Water for Injections is used as a diluent for hypertonic solutions, appropriate dilution should be applied to bring the solution close to isotonicity .
Haemolysis may occur following infusion of large volumes of hypotonic solutions using sterile Water for Injections as a diluent
When administering large volumes, the ionic balance should be regularly monitored .
The large volume presentations (500 ml and 1000 ml) are for use as a bulk source of diluent in pharmacy compounding. They are not for direct intravenous administration.


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


The risks during use in pregnancy and in lactating women are determined by the nature of the added medicinal products .


Not relevant.


Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
The physician should also be alert to the possibility of adverse reactions to drug additives.
Prescribing information for drug additives to be administered in this manner should be consulted.
Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.
Intravenous injections of Water for Injections may cause haemolysis if Water for Injections is administered alone .
The nature of the additive will determine the likelihood of any other undesirable effects .


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 .
Emergency measures
In the event of a fluid or solute overload during parenteral therapy, revaluate the patient's condition and initiate appropriate corrective treatment.


Group: solvents and diluting agents including irrigating solutions
Pharmacotherapeutic group Code: V07AB


Not applicable .


Not relevant


Not applicable .


Many injectable drugs cannot be mixed together with water for injections, as some drugs cannot be safely diluted. Incompatibility can involve in precipitation, ionic reactions, evolution of gas and denaturation of biological molecules.
Knowledge of added drug compatibility is needed before mixing drugs.
If drugs mixed together, the mixture should be inspected for precipitations, turbidity or change in colour, however not all incompatibilities are visible.


5years for glass container 4 years for plastic container 2 years for NON-PVC Bag container . From a microbiological point of view, unless the method of opening 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.

Do not store above 25°C.


50 ml ,100 ml, 500 ml and 1000 ml glass container
5ml,10,ml, 10 ml ,500 ml and 1000 ml plastic Container .


Before administration, the product should be visually inspected for any particulate matter and discoloration.
For single use only.
Any unused solution should be discarded.


Pharmaceutical Solutions Industry Ltd. Industrial Estate, Phase-2, Road No. 208, Str. - 203 P O Box 17476 Jeddah 21484 Western Province Saudi Arabia Phone: +966-2-6361383 FAX: +966-2-6379460 Website: http://www.psiltd.com To report any side effect(s): • Saudi Arabia: National Pharmacovigilance Center (NPC) Fax: +966-11-2057662 E-mail: npc.drug@sfda.gov.sa Website: www.sfda.gov.sa/npc Other GCC States: Please contact the relevant competent authority.

19th December, 2013
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