AXA AQUA Solvent for parenteral use 10

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Water for injection

Available from:

AXA PARENTERALS LIMITED, INDIA

ATC code:

Various ATC structures

INN (International Name):

Water for injection

Dosage:

10

Pharmaceutical form:

Solvent for parenteral use

Manufactured by:

AXA Parenterals Limited, INDIA

Product summary:

Physical description: A clear colourless liquid; Local technical representative: SkillMix Consulting Group (80681)

Authorization status:

Registered/Compliant

Authorization date:

2021-10-09

Summary of Product characteristics

PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS)
1.
NAME OF THE MEDICINAL PRODUCT:
AXA AQUA (Sterile Water for Injection USP)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
QUALITATIVE COMPOSITION
Product Name: AXA AQUA
Generic Name: Sterile Water of Injection USP
Label Claim : Each ml contains:
Water for Injections USP
3.
PHARMACEUTICAL FORM:
Solvent for parenteral use
Description: a clear colourless liquid
4.
CLINICAL PARTICULARS:
4.1.
THERAPEUTIC INDICATIONS:
Sterile Water for Injections is indicated to be used 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.
The solution should only be used if it is clear without visible
particles.
Method of administration
For parenteral use.
The directions for use will be dependent upon the appropriate
medicinal
product to which this solvent is added, which will dictate the
appropriate
volumes as well as administration route.
4.3.
CONTRAINDICATIONS:
Sterile Water for Injections should not be administered alone because
it may
cause
hemolysis.
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 it should not be administered
alone,
because it may cause hemolysis.
4.5.
INTERACTION
WITH
OTHER
FINISHED
PHARMACEUTICAL
PRODUCTS
AND
OTHER
FORMS OF INTERACTIONS:
The possible clinical interactions between the different medicinal
products to
be dissolved should be considered.
4.6.
USE DURING PREGNANCY AND LACTATION:
May be used during fertility, pregnancy and lactation.
The risks during use are determined by the