Water for Injections, Ph.Eur, solvent for parenteral use

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Water for injections

Tilgjengelig fra:

B. Braun Medical Limited

ATC-kode:

V07AA

INN (International Name):

Water for injections

Dosering :

500 millilitre(s)

Legemiddelform:

Solvent for parenteral use

Resept typen:

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

Terapeutisk område:

Plasters

Autorisasjon status:

Not marketed

Autorisasjon dato:

1993-03-26

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
WATER FOR INJECTIONS, PH.EUR, SOLVENT FOR PARENTERAL USE
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
●
If you notice any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What Water for Injections Ph. Eur. is and what it is used for
2.
What you need to know before you use Water for Injections Ph. Eur.
3.
How to use Water for Injections Ph. Eur.
4.
Possible side effects
5.
How to store Water for Injections Ph. Eur.
6.
Contents of the pack and other information
1.
WHAT WATER FOR INJECTIONS PH. EUR. IS AND WHAT IT IS USED FOR
Water for Injections Ph. Eur. is sterile water for injections.
This is used for preparation and dilution of medicines that are to be
administered into your vein
(parenteral use).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE WATER FOR INJECTIONS PH. EUR.
DO NOT USE WATER FOR INJECTIONS PH. EUR.
There are no known situations in which Water for Injections Ph. Eur.
should not be used.
WARNING AND PRECAUTIONS
Water for Injections Ph. Eur. must not be used alone.Your doctor will
dissolve or dilute another
medicine in water for injection before the ready prepared medicine is
administered to you.
OTHER MEDICINES AND WATER FOR INJECTIONS PH. EUR.
There are no known interactions with other medicines.
WATER FOR INJECTIONS PH. EUR. WITH FOOD AND DRINK
There are no known interactions with food or drink.
PREGNANCY AND BREAST-FEEDING
Water for Injections Ph. Eur. can be used during pregnancy and
breast-feeding.
DRIVING AND USING MACHINES
Water for Injections Ph. Eur. has no influence on the ability to drive
and use machines.
3.
HOW TO USE WATER FOR INJECTIONS PH. EUR.
This medicine is administered to you by a doctor or healthcare
professional.
The method of administra

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections, Ph.Eur, solvent for parenteral use
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
500 ml of solvent contain:
Water for injections 500 ml.
3 PHARMACEUTICAL FORM
Solvent for parenteral use.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Preparation and dilution of
parenteral
preparations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Water for Injection is used for dilution or dissolution of parenteral
medicinal
products.
Dosage and duration of use
depend on the instructions given for the medicinal product to be
dissolved or diluted.
_Paediatric population_
The dosage has to be considered based on the instructions given for
the medicinal product to be dissolved or diluted.
Method of administration
The method of administration depends on the instructions given for the
medicinal product to be dissolved/diluted. The
medicinal products should be reconstituted or diluted immediately
before use.
4.3 CONTRAINDICATIONS
There are no contraindications for water for injections as such.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Water for Injections must not be used alone for intravenous
administration(see section 6.6).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Interactions between water for injections and other medicinal products
are not known.
4.6 FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Water for injections can be used during pregnancy as it does not bear
any risks for the woman or child if used
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