Hemovit Capsules 180.75 mg

Valsts: Tanzānija

Valoda: angļu

Klimata pārmaiņas: Tanzania Medicinces & Medical Devices Authority

Lejuplādēt Produkta apraksts (SPC)
07-03-2023

Aktīvā sastāvdaļa:

ferrous sulphate , folic acid ,zinc sulphate monoh

Pieejams no:

Shelys Pharmaceuticals Limited, TANZANIA

ATĶ kods:

Haematinics iron and all combinations

SNN (starptautisko nepatentēto nosaukumu):

ferrous sulphate + folic acid +zinc sulphate monoh

Deva:

180.75 mg

Zāļu forma:

Capsules

Ražojis:

Beta Healthcare International Limited, KENYA

Produktu pārskats:

Physical description: Body -Deep Red Coloured with yellow “HEMOVIT” print; Cap -Deep Red Coloured with white “Shelys” print; Local technical representative: Shelys Pharmaceuticals Limited (9387)

Autorizācija statuss:

Registered/Compliant

Autorizācija datums:

2022-04-11

Produkta apraksts

                                SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Hemovit Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains: Ferrous Fumarate (Equivalent to Elemental Iron)
100 mg, Ascorbic Acid
(Vitamin C) 75 mg, Folic Acid 0.75 mg, Cyanocobalamin (Vitamin B
12
) 5 mcg and Zinc Sulphate
5 mg.
_For full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
Capsule
Body – Deep Red Coloured with yellow “HEMOVIT” print; Cap –
Deep Red Coloured with white
_“SHELYS”_ Print capsules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hemovit Capsules are indicated in case of iron deficiency as in
nutritional microcytic anaemia,
iron deficiency anaemia, for prophylaxis of anaemia in pregnant and
lactating women growing
children, anaemia following blood loss, tropical disease, worm
infestation, bacterial or protozoal
infection
or
following
surgery,
as
nutritional
supplement
during
old
age,
adolescence
or
covalescence.
4.2 POSOLOGY AND ROUTE OF ADMINISTRATION
_DOSAGE _
Capsules – Children: 1 Capsule daily
- Adult: 1-2 Capsule daily
_ADMINISTRATIVE ROUTE _
Oral Administration only
4.3 CONTRAINDICATIONS
Hemovit
Capsules
should
not
be
given
to
patients
who
are
receiving
repeated
blood
transfusions or in patients with anaemia not produced by iron
deficiency.
4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE
Hemovit Capsules should not be given together with antibiotics like
tetracycline or antacid since
they reduce the iron absorption.
It should be given with care to patients with hyperoxpaluria because
of ascorbic acid.
Hemovit Capsules should be used with caution in patients with
sideroblastic anaemia not due to
iron deficiency.
History of peptic ulcer. Keep the medicine out of reach of children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
If you use other drugs or over the counter products at the same time,
the effects of Hemovit
Capsules may change. This may increase your risk for side-effects or
cause your drug not to
work properly. Tell your do
                                
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