WATER FOR INJECTIONS 100 %w/v Solvent for Parenteral Use

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

WATER FOR INJECTIONS

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

V07AB

INN (International Name):

WATER FOR INJECTIONS

Dosage:

100 %w/v

Pharmaceutical form:

Solvent for Parenteral Use

Prescription type:

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

Therapeutic area:

Solvents and diluting agents, incl. irrigating solutions

Authorization status:

Authorised

Authorization date:

1991-08-08

Patient Information leaflet

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, pharmacist or
nurse. 
- If you get any side effects, talk to your doctor, pharmacist or
nurse. 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 Water for Injections is given to you 
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, pharmacist or nurse before using Water for
Injections.
Water for Injections should not be

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 1 ml of Water for Injections
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solvent for parenteral use.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sterile Water for Injection 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
upon 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 patient 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 contra-indications 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 diluent of hypertonic solutions, appropriate dilution should be applied to bring the
solution close to isotonicity.
Hemolysis may occur following infusion of large volumes of hypotonic solutions using sterile Water for Injections as
diluent.
When ad