Water for Injections Ph. Eur

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Water for injections

זמין מ:

B. Braun Medical Limited

קוד ATC:

V07AB

INN (שם בינלאומי):

Water for injections

כמות:

10 millilitre(s)

טופס פרצבטיות:

Solvent for parenteral use

סוג מרשם:

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

איזור תרפויטי:

Solvents and diluting agents, incl. irrigating solutions

מצב אישור:

Marketed

תאריך אישור:

1987-04-08

עלון מידע

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1d1d1d1d0d1d0d0d1d1d0d1d1
1d1d1d1d0d1d0d0d1d1d0d1d1
1d1d1d1d0d1d0d0d1d1d0d1d1
25/12614673/0120
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
dis-
solve 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 profes-
sional.
T

מאפייני מוצר

Health Products Regulatory Authority
25 February 2020
CRN0092RS
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections Ph. Eur
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 1ml water for injections.
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
INTERACTIONS
Interactions between water for injections and other medicinal products
are not known.
Health Products Regulatory Authority
25 February 2020
CRN0092RS
Page 2 of 4
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 according to this
product information.
The product information given for the medicinal product to be
dissolved or diluted must also be taken into consideration, to
evaluate whether the final prepared dilution or mixture can be used
during pregnancy.
Breast-feeding
Water for injections can be used during breast-feeding.
Fertility
No data available.
4.7 EFFECTS O