Water for Injections CSL Behring solvent for parental use

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

WATER FOR, INJECTION

Beschikbaar vanaf:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

ATC-code:

V07AB

INN (Algemene Internationale Benaming):

WATER FOR INJECTION

farmaceutische vorm:

SOLVENT FOR PARENTERAL USE

Samenstelling:

WATER FOR INJECTION

Prescription-type:

POM

Therapeutisch gebied:

ALL OTHER NON-THERAPEUTIC PRODUCTS

Autorisatie-status:

Authorised

Autorisatie datum:

2019-03-04

Bijsluiter

Page 1 of 4
PACKAGE LEAFLET: INFORMATION FOR THE USER
WATER FOR INJECTIONS CSL BEHRING
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.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Water for Injections CSL Behring is and what it is used for
2.
What you need to know before you use Water for Injections CSL Behring
3.
How to use Water for Injections CSL Behring
4.
Possible side effects
5.
How to store Water for Injections CSL Behring
6.
Contents of the pack and other information
1.
WHAT WATER FOR INJECTIONS CSL BEHRING IS AND WHAT IT IS USED FOR
Sterilised Water for Injections is used to dissolve and dilute other
medicines that require
mixing with water before they can be given as an injection or an
infusion (a drip) into your
veins, muscles or other tissues in the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE WATER FOR INJECTIONS CSL BEHRING
The following sections contain information that you and your doctor
should consider before
you use Water for Injections CSL Behring.
DO NOT USE WATER FOR INJECTIONS CSL BEHRING
•
as an injection or infusion on its own
Water for Injections CSL Behring must only be used to dissolve or
dilute necessary drugs.
You should read the Patient Information Leaflet of your medicine or
medicines that are being
mixed with Water for Injections CSL Behring. This will tell you
whether or not you can
receive the solution.
WARNINGS AND PRECAUTIONS
Water for Injections CSL Behring should not be used on its own. Before
you use Water for
Injections CSL Behring:
•
it should always be mixed

Productkenmerken

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Water for Injections CSL Behring
solvent for parenteral use
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
1 vial contains 2, 2.5, 3, 4, 5, 5.6, 10, 15, 20, 40 or 50 ml water
for injections
_ _
3.
PHARMACEUTICAL FORM
Solvent for parenteral use.
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use as a solvent for reconstitution of suitable medicinal products
for parenteral use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and method of administration depend on the instructions given
for the medicinal
product to be dissolved or diluted.
4.3
CONTRAINDICATIONS
Do not administer Water for Injections CSL Behring on its own.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Water for injection is hypotonic and it should not be administered
alone.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None
4.6
FERTILITY, PREGNANCY AND LACTATION
None
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None
Page 2 of 4
4.8
UNDESIRABLE EFFECTS
None
4.9
OVERDOSE
None
5.
PHARMACOLOGICAL PROPERTIES
5.1
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Solvent and diluting agent
ATC code: V07AB
Pharmacodynamics: Not applicable
5.2
PHARMACOKINETIC PROPERTIES
Not applicable
5.3
PRECLINICAL SAFETY DATA
Not applicable
6.
PHARMACEUTICAL PARTICULARS
6.1
LIST OF EXCIPIENTS
Not applicable
6.2
INCOMPATIBILITIES
For possible interactions and incompatibilities check Summary of
Product
Characteristics and Package Information Leaflet of the medicinal
product which is
intended to be reconstituted with Water for Injections CSL Behring.
Those medicinal
products known to be incompatible with water for injections must not
be used.
6.3
SHELF LIFE
2.5, 3, 4, 5, 6, 10, 15, 20, 40, 50 mL: 5 years
2 mL: 30 months
After opening, the product must be used immediately.
For in use shelf life, after reconstitution of the medicinal product,
check Summary of
Product Characteristics and Package Information Leaflet of the