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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 BP

Each 5 ml of solution contains 5 ml of sterilized water for injections . Each 10 ml of solution contains 10 ml of sterilized water for injections . Each 20 ml of solution contains 20 ml of sterilized water for injections .

Solution for injection (For the Preparation of solution for l.V., & l.M. or S.C. injection) Clear, colorless, odorless, sterile solution and non- pyrogenic

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.

- Risk of haemolysis! Water for injection must not be injected or
infused without suitable drug additives.
- Do not use if ampoule is leaking, Solution cloudy or contains particles.


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.


4 years. for plastic Ampoule 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.


5 ml, 10 ml & 20 ml plastic ampoules.


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.

12th August 2015
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