Water for injections, solvent for parenteral use

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Water for injections

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

V07AB

INN (International Name):

Water for injections

Dosage:

100 percent

Pharmaceutical form:

Solvent for parenteral use

Therapeutic area:

Solvents and diluting agents, incl. irrigating solutions

Authorization status:

Marketed

Authorization date:

2009-08-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Water for injections
solvent for parenteral use
Water for injections
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
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 use Water for injections
Do not use Water for injections:
You must 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 whether or not you can receive
the solution.
Warnings and precautions
Talk to your doctor or pharmacist before using Water for
injections.
Water for injections should n

Summary of Product characteristics

Health Products Regulatory Authority
01 May 2019
CRN008S80
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for injections, solvent for parenteral use
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Water for injections 1 g per 1 ml
pH between 4.5 and 7.0.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solvent for parenteral use.
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sterile Water for injections 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 on 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 patients, 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 a diluent of hypertonic
solutions, appropriate dilution should be applied to bring the
solution close to isotonicity.
Haemolysis may occur following infusion of large volumes of hypotonic
solutions using sterile water for injections as diluent.
When administering large volumes, the ionic balance should be
regularly monitored.
The large volume presentations (500 and 1