Water for Injections solvent for parenteral use

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Water for injection

MAH:

CSL Behring GmbH

ATC_code:

V07AB

INN:

Water for injection

dosage:

.

pharmaceutical_form:

Solvent for parenteral use

therapeutic_area:

Solvents and diluting agents, incl. irrigating solutions

authorization_status:

Not marketed

authorization_date:

2019-08-02

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
WATER FOR INJECTIONS
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 is and what it is used for
2.
What you need to know before you use Water for Injections
3.
How to use 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
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
The following sections contain information that you and your doctor
should consider before you
use Water for Injections.
DO NOT USE WATER FOR INJECTIONS
•
as an injection or infusion on its own
Water for Injections 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. This 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 should always be mixed with one or more medicines
Before you are given medicines mixed with Water for Injections your
doctor will check that:
•
the medicines are stable in Water for Injec

SPC

Health Products Regulatory Authority
24 January 2022
CRN00CGVY
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections 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 50ml 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 on its own
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Water for Injections is hypotonic and it should not be administered
alone
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None
4.6 FERTILITY, PREGNANCY AND LACTATION
None
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None
4.8 UNDESIRABLE EFFECTS
None
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected
adverse reactions via:
HPRA Pharmacovigilance Section, Earlsfort Terrace, IRL - Dublin 2;
Tel: [phone];
Fax: [phone]; website: www.hpra.ie; Email: [e-mail]
Health Products Regulatory Authority
24 January 2022
CRN00CGVY
Page 2 of 3
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 Sum