Water for Injections Ph. Eur.

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

WATER FOR, INJECTIONS

可用日期:

Baxter Healthcare Limited

ATC代码:

V07AB

INN（国际名称）:

WATER FOR, INJECTIONS

药物剂型:

SOLVENT FOR PARENTERAL USE

组成:

WATER FOR INJECTIONS 100 percent weight/volume

处方类型:

POM

治疗领域:

ALL OTHER NON-THERAPEUTIC PRODUCTS

授权状态:

Authorised

授权日期:

2006-02-14

资料单张

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PACKAGE LEAFLET: INFORMATION FOR THE USER
WATER FOR INJECTIONS PH. EUR.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Water for Injections is and what it is used for
2.
What you need to know before you are given Water for Injections
3.
How you will be given Water for Injections
4.
Possible side effects
5.
How to store Water for Injections
6.
Contents of the pack and other information
1.
WHAT WATER FOR INJECTIONS IS AND WHAT IT IS USED FOR
Water for Injections is pure, sterile water. It is used to dilute
medicines before use, for example medicines
that are given by:
-
injection (given using a needle, for example into your vein)
-
infusion (slow injection) into a vein, also called a ‘drip’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN WATER FOR INJECTIONS
DO NOT RECEIVE WATER FOR INJECTIONS ON ITS OWN. If injected into your
bloodstream on its own it can cause
your red blood cells to take in water and burst (haemolysis). This is
because Water for Injections does not
have the same consistency as your blood.
Water for Injections will always be mixed with one or more medicines
by a healthcare professional before
you receive it.
You should read the Patient Information Leaflet of your medicine or
medicines that are being mixed with
Water for Injections. These will tell you whether or not you can
receive the solution.
WARNINGS AND PRECAUTIONS
Water for Injections should not be used on its own. Before you use
Water for Injections:
-
it will always be mixed with one or more medicines
-
your healthcare professional will make sure that the mixture is
roughly the same consistency as your
blood (isotonic). Depending on the type of med

产品特点

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Water for Injections Ph. Eur.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag contains 100 % w/v Water for Injections.
3.
PHARMACEUTICAL FORM
Solvent for parenteral use.
Clear and Colourless solution.
pH between 4.5 and 7.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sterile Water for Injection is indicated to serve as a vehicle for
dilution and reconstitution of
suitable medicinal products for parenteral administration.
4.2
POSOLOGY AND METHOD OF 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.
METHOD OF 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.
4.3
CONTRAINDICATIONS
Water for Injections should not be administered alone.
The contraindications related to the added medicinal product should be
considered.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
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 diluent of hypertonic solutions,
appropriate dilution should be
applied to bring the solution close to isotonicity.
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Haemolysis may occur following infusion of Sterile Water for
Injections. Haemoglobin induced renal failure
has been reported following haemolysis.
When administering large volumes, the ionic balance should be
regularly monitored.
The large volume presentations (500 and 1000ml) are for use as a bulk
source of diluent in
pharmacy compounding. T