Water for Injection

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

WATER FOR, INJECTIONS

Prieinama:

DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece

ATC kodas:

V07AB

INN (Tarptautinis Pavadinimas):

WATER FOR INJECTIONS 100 % (W/V)

Vaisto forma:

SOLUTION FOR INFUSION OR INJECTION

Sudėtis:

WATER FOR INJECTIONS 100 % (W/V)

Recepto tipas:

POM

Gydymo sritis:

ALL OTHER NON-THERAPEUTIC PRODUCTS

Autorizacija statusas:

Withdrawn

Leidimo data:

2007-04-04

Pakuotės lapelis

 
WATER FOR INJECTION/DEMO 
5ML, 10ML & 20ML

COMPOSITION: 
Active ingredient: Water for Injections 
Excipients: None 
PHARMACEUTICAL FORM:  
Solvent for parenteral use 
COMPOSITION IN ACTIVE INGREDIENT: 
Each ampoule contains 100% w/v Water for Injections. 
DESCRIPTION – PACKAGING:  
Water for Injection/ DEMO is a clear, colorless liquid and is packed
in polypropylene 
ampoules of 5, 10 and 20 ml. 
PHARMACOTHERAPEUTIC CATEGORY: 
Solvents and dilution agents (ATC: V07AB). 
MANUFACTURER – RESPONSIBLE FOR MARKETING:  

DEMO S.A. Pharmaceutical Industry 
21st Km National Road Athens-Lamia, 14568 Kryoneri, Athens, Greece. 
Tel.: + 30 210 8161802, Fax: + 30 210 8161587 
GENERAL INFORMATION: 
Since Water for Injection is only the vehicle used for the
administration of other 
pharmaceutical products, pharmacokinetic and pharmacodynamic
properties depend on 
the nature of the drug being added. 
INDICATIONS: 
Water for Injection/DEMO is used as a dilution and reconstitution
agent for appropriate 
pharmaceutical products for parenteral administration. 
CONTRA-INDICATIONS: 
Water for Injection/DEMO should not be administered as it is.
Contraindications related 
to the drug being added should be taken into account. 
SPECIAL PRECAUTIONS AND WARNINGS DURING USE: 
_General: _
Water for Injection/ DEMO is hypotonic and therefore it should not
be administered as it 
is. It should not be used for intravenous infusion, unless it has
been adjusted in the 
appropriate isotonicity with an appropriate solvent. 
When Water for Injection/ DEMO is used as a dilution agent for
hypertonic solutions, 
appropriate dilution should be made so as to make the final
solution as isotonic as 
possible. 
Haemolysis may be induced after infusion of large volumes of
hypotonic solutions using 
sterile Water for Injection/ DEMO as a dilution agent.  
When large volumes are administered, ionic balance should be checked
regularly. 
_Pregnancy: _
Risks from use during pregnan

Prekės savybės

Page 1 of 2 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  N
AME 
OF

THE

MEDICINAL

PRODUCT 
Water for Injection. 
2.  QUALITATIVE

AND

QUANTITATIVE

COMPOSITION 
Each ampoule contains 100%w/v water for injection 
3.  P
HARMACEUTICAL 
F
ORM

Solvent for parenteral use. A clear colorless liquid 
4.  C
LINICAL PARTICULARS

4.1  THERAPEUTIC INDICATIONS 
It is used for the preparation of parenteral solutions of
some pharmaceutical substances that 
remain stable only in a dry state. 
4.2  POSOLOGY AND METHOD OF ADMINISTRATION 
Intravenous, intravenous drip infusion and intramuscular.  
4.3  CONTRA-INDICATIONS 
Water for injections must not be administrated alone.
Contraindications related to the drug added 
should be taken into account. 
4.4  SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
Water for injection is hypotonic and it should not be
administered as it is, because it may cause 
haemolysis.  
Water for injection should not be used for intravenous infusion,
unless it has been adjusted in the 
appropriate isitonicity with an appropriate solvent. 
When water for injection is used as a dilution agent for hypertonic
solutions, appropriate dilution 
should be made so as to make the final solution as isotonic as
possible. 
When large volumes are administrated ionic balance should be checked
regularly 
Aseptic methods should be used for the preparation of the infusion
product (sterilization of the 
cap and the infusion point, usage of a new and sterile infusion
machine).  
The clarity, the shade and the absence of visible particles should be
checked before usage.  
4.5  INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 
Not applicable. 
4.6  PREGNANCY AND LACTATION 
Not applicable. 
4.7  EFFECT ON ABILITY TO DRIVE AND USE MACHINES 
Not applicable. 
4.8  UNDESIRABLE EFFECTS 
If the water for injection is injected as it is, it may cause
haemolysis.  
Page 2 of 2 
4.9  OVERDOSE 
Not applicable. 
5.  P
HARMAC