WATER FOR INJECTIONS

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

WATER FOR INJECTIONS

Dostępny od:

Baxter Healthcare Limited

Kod ATC:

V07AB

INN (International Nazwa):

WATER FOR INJECTIONS

Dawkowanie:

100 %w/v

Forma farmaceutyczna:

Solvent for Parenteral Use

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Solvents and diluting agents, incl. irrigating solutions

Status autoryzacji:

Marketed

Data autoryzacji:

2002-05-03

Ulotka dla pacjenta

ARTWORK DESIGN CENTRE
Version:
02
Draft:
2st
Artworker: B. Chantry
Date: 22 mars 2016
Errors: Yes / No
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EMEA ARTWORK DESIGN CENTRE
ARTWORK APPROVAL
2nd DRAFT
DATE
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FORMAT
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HALLE ONLY
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SA-30-02-002
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

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections Ph. Eur., viaflo container.
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 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.
When administering large volumes, the ionic balance should be
regularly monitored.
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