VITACORE Suspension, Oral

País: Tanzània

Idioma: anglès

Font: Tanzania Medicinces & Medical Devices Authority

Descargar Fitxa tècnica (SPC)
15-03-2023

ingredients actius:

Ferric Ammonium , Folic Acid , Pyridoxine , Thiamine , Nicotinamide

Disponible des:

CORE PHARMA LIMITED, TANZANIA

Codi ATC:

Haematinics iron and all combinations

Designació comuna internacional (DCI):

Ferric Ammonium + Folic Acid + Pyridoxine + Thiamine + Nicotinamide

Dosis:

200,0.5,(50mcg),1.5,2.33 mg

formulario farmacéutico:

Suspension, Oral

Fabricat per:

SANPRAS HEALTHCARE PRIVATE LIMITED, INDIA

Resumen del producto:

Physical description: Brown coloured syrup liquid; Local technical representative: CORE PHARMA LIMITED (1120)

Estat d'Autorització:

Registered/Compliant

Data d'autorització:

2022-12-05

Fitxa tècnica

                                SUMMARY OF PRODUCT CHARACTERISTIC
1.
NAME OF THE MEDICINAL PRODUCT
VITACORE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains:
Ferric Ammonium Citrate USP….200 mg
Cyanocobalamin (Vit. B12) BP… 50 mcg
Pyridoxine Hydrochloride (Vitamin B6) BP….0.5 mg
Folic acid BP
1.5 mg
....................................
Zinc Sulphate BP
2.33 mg
............................
In a flavored Syrup Base Approved color used.
_Excipient of safety concern _
Sucrose…2000 mcg as Sweetener
Liquid Glucose….1500 mcg as Sweetener
Sorbitol……500 mcg as Sweetener
Sodium Methyl Paraben…10 mcg as Preservative
Sodium Propyl Paraben….1 mcg as Preservative
Sodium benzoate….10 mcg as Preservative
Disodium EDTA….0.0025 mcg as Preservative
3.
PHARMACEUTICAL FORM
Oral Liquid.
Brown Colour Syrupy Liquid
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
It is used as a treatment for vitamin and mineral deficiency and as an
appetite stimulant during
and after illness.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Oral
Dosage:
Children 6 months to 3 years: 5 ml (1 teaspoonful) twice daily
Children 3 years to 12 years: 5 ml (1 teaspoonful) three times
daily Adults: 10 ml (2 teaspoonsful) three times daily
Elderly Patients: 10 ml (2 teaspoonsful) three times daily.
Iron is best absorbed on an empty stomach (usually if taken 1 hour
before or 2 hours after
meals).
4.3.
CONTRAINDICATIONS
Use in patients hypersensitive to any of the constituents.
Avoid taking antacids, dairy products, tea, or coffee within 2 hours
before or after this medication
because they will decrease its effectiveness.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
Vitacore contains ferric ammonium citrate which may stain teeth
2.
The stated dose should not be exceeded
3.
No other medicine containing iron or vitamins B6 should be taken
without prior medical
consultation
4.
This product contains glucose. Patients with rare glucose-galactose
malabsorption should
not take this medicine.
5.
This product also contains sucrose. Patients 
                                
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