Sterile Water for Injection Solvent for parenteral use 100

Երկիր: Տանզանիա

Լեզու: անգլերեն

Աղբյուրը: Tanzania Medicinces & Medical Devices Authority

Ակտիվ բաղադրիչ:

Sterile Water for Injection

Հասանելի է:

KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED, TANZANIA

ATC կոդը:

All other non-therapeutic products

INN (Միջազգային անվանումը):

Sterile Water for Injection

Դոզան:

100

Դեղագործական ձեւ:

Solvent for parenteral use

Պատրաստված է:

Kairuki Pharmaceutics Industry Limited, TANZANIA

Ապրանքի ամփոփագիր:

Physical description: Clear, colourless diluent; Local technical representative: KAIRUKI PHARMACEUTICALS INDUSTRY LIMITED (44106)

Լիազորման կարգավիճակը:

Registered/Compliant

Հաստատման ամսաթիվը:

2022-09-23

Ապրանքի հատկությունները

WATER FOR INJECTIONS
1. NAME OF THE MEDICINAL PRODUCT
Water for Injections.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag contains 100 % w/v Water for Injections.
3. PHARMACEUTICAL FORM
Solvent for parenteral use. It is clear, colorless diluent.
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 contraindications 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.
Haemolysis
may
occur
following
infusion
of
Sterile
Water
for
Injections.
Haemoglobin
induced renal failure has been reported following haemolysis.
When administering large volumes, the ionic balance should be
regularly monitored.
The large volume presentations (500 and 1000ml) are for use as a bulk
source of diluent in
pharmacy compounding. They are not for direct intravenous
administration.
4.5.
INTERACTION WITH