Water for Injection

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

WATER FOR, INJECTIONS

Dostupné s:

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

ATC kód:

V07AB

INN (Mezinárodní Name):

WATER FOR INJECTIONS 14.5 % (W/V)

Léková forma:

SOLUTION FOR INFUSION OR INJECTION

Složení:

WATER FOR INJECTIONS 14.5 % (W/V)

Druh předpisu:

POM

Terapeutické oblasti:

ALL OTHER NON-THERAPEUTIC PRODUCTS

Stav Autorizace:

Withdrawn

Datum autorizace:

2007-04-04

Informace pro uživatele

WATER FOR INJECTION 

COMPOSITION:  Active ingredient: Water for injections  
 Excipient: None 
PHARMACOTECHNICAL FORM: Solvent for parenteral use. 
CONTENT IN ACTIVE INGREDIENT: Each
container contains 100% w/v Water for 
injections. 
DESCRIPTION – PACKAGING: Water for Injection is a clear, colorless liquid and 
is packed in polyethylene bottles of 100, 250, 500 and 1000ml and
in 
polypropylene bags of 100, 250, 500 and 1000ml. 
PHARMACOTHERAPEUTIC CATEGORY: Solvents and dilution agents. 
MARKETING AUTHORIZATION HOLDER – MANUFACTURER:  
DEMO SA, 21
st
 km National Road Athens - Lamia, 145 68 Kryoneri, Athens, 
Greece, Tel. [phone], Fax: [phone] 
GENERAL INFORMATION: Since Water for Injection is only the
vehicle used for 
the administration of other pharmaceutical products, the pharmacokinetic 
and pharmacodynamic properties depend on the nature of the
drug being 
added. 
INDICATIONS: Water for Injection
is used as a dilution and reconstitution agent 
for other pharmaceutical products for
parenteral administration.  
CONTRAINDICATIONS:  Water for Injection
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: Water for Injection
is 
hypotonic and therefore 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 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 as a dilution
agent.  

When large volumes are administered,

Charakteristika produktu

Page 1  of  2 

SUMMARY OF PRODUCT CHARACTERISTICS 
1.  N
AME 
OF

THE

MEDICINAL

PRODUCT 
      Water for Injection 
2.  QUALITATIVE

AND

QUANTITATIVE

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

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

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 use, intravenous drip infusion.  
4.3 
CONTRAINDICATIONS 
i) Water for injections must not be administrated alone.  
ii) Contraindications related to the drug being 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 isotonicity 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 
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION 
Not applicable 
4.6 
PREGNANCY AND LACTATION 
Not applicable 
4.7 
EFFECTS ON THE ABILITY TO DRIVE AND OPERATE MACHINES 
Not applicable 
Page 2 of 2 
4.8 
UNDESIRABLE EFFECTS 
If the water for injection is injected as it is, it may cause
haemolysis.  
4.9 
OVERDOSE