Water for Injections Ph. Eur.

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

WATER FOR, INJECTIONS

זמין מ:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

קוד ATC:

V07AB

INN (שם בינלאומי):

WATER FOR INJECTIONS 100 % (W/V)

טופס פרצבטיות:

SOLVENT FOR PARENTERAL USE

הרכב:

WATER FOR INJECTIONS 100 % (W/V)

סוג מרשם:

POM

איזור תרפויטי:

ALL OTHER NON-THERAPEUTIC PRODUCTS

מצב אישור:

Authorised

תאריך אישור:

2006-02-14

עלון מידע

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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 Package 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 typ

מאפייני מוצר

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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.
Haemolysis may occur following infusion of Sterile Water for
Injections. Haemoglobin induced
renal failure has been reported following haemolysis.
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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. They are not for direct intravenous