WATER FOR INJECTION DEMO Solvent for parenteral use 10ml

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Water for injection

Available from:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

Water for injection

Units in package:

10ml mL

Manufactured by:

DEMO S.A. PHARMACEUTICAL INDUSTRY

Summary of Product characteristics

WATER FOR INJECTION / DEMO
SOLVENT FOR PARENTERAL USE
5 ML, 10 ML PLASTIC AMPOULES
1.
DESCRIPTION OF THE MEDICINAL PRODUCT
1.1 NAME OF THE MEDICINAL PRODUCT:
WATER FOR INJECTION / DEMO.
1.2
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ampoule contains 100% water for
injections.
1.3
PHARMACEUTICAL FORM:
Solvent for parenteral use.
1.4
DESCRIPTION - PACKAGING:
WATER FOR INJECTION / DEMO is a clear, colourless liquid.
It is distributed in plastic ampoules of 5 mL and 10 mL.
1.5
PHARMACODYNAMIC PROPERTIES:
Solvents and dilution agents (ATC: V07AB).
1.6
MANUFACTURER:
DEMO S.A. Pharmaceutical Industry, 21
st
km National Road Athens-
Lamia, 145 68 Krioneri, Attiki, Greece, T.: [phone], F.: +30
2108161587.
2.
WHAT YOU SHOULD KNOW ABOUT THE MEDICINE YOUR DOCTOR HAS
PRESCRIBED TO YOU
2.1
GENERAL INFORMATION:
Since WATER FOR INJECTION / DEMO is only the vehicle used
for administration of other medicines, pharmacokinetic and
pharmacodynamic properties depend
on the nature of the medicine that has been added.
2.2
THERAPEUTIC INDICATIONS:
WATER FOR INJECTION / DEMO is used as a vehicle for
dilution or reconstitution of medicines for parenteral administration.
2.3
CONTRAINDICATIONS:
WATER FOR INJECTION / DEMO should not be administered as is.
Contraindications related to the medicine that has been added should
be taken into account.
2.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
2.4.1
GENERAL:
WATER
FOR INJECTION / DEMO is hypotonic and therefore it should not be
administered as is. It should not be used for intravenous infusion,
unless the isotonicity has been
adjusted using an appropriate agent. When WATER FOR INJECTION / DEMO
is used for
dilution of hypertonic solutions, the final solution should be
isotonic.
Haemolysis may be induced after infusion of large volumes of hypotonic
solutions of water for
injections. When large volumes of solutions of water for injections
are administered, electrolyte
balance should be checked regularly.
2.4.2
PREGNANCY:
Risks of use during pregnancy depend on the nature of the medicine