Zecal D3 Soft Gelatin Capsule 500 mg & 500IU

Country: Tanzania

Bahasa: Inggeris

Sumber: Tanzania Medicinces & Medical Devices Authority

Bahan aktif:

Calcium carbonate , colecalciferol

Boleh didapati daripada:

INDCHEMIE HEALTH SPECIALITIES PVT. LIMITED, INDIA

Kod ATC:

Calcium carbonate and colecalciferol

INN (Nama Antarabangsa):

Calcium carbonate and colecalciferol

Dos:

500 mg & 500IU

Borang farmaseutikal:

Soft Gelatin Capsule

Dikeluarkan oleh:

Indchemie Health Specialities Pvt. Ltd, INDIA

Ringkasan produk:

Physical description: a white and pink coloured,opaque,oval shaped soft gelatin capsules containing off white oily paste; Local technical representative: JILICHEM (T) Limited (5053)

Status kebenaran:

Registered/Compliant

Tarikh kebenaran:

2022-09-21

Ciri produk

PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS)
1. NAME OF THE MEDICINAL PRODUCT
BRAND NAME: ZECAL –D
3
GENERIC NAME: CALCIUM and Vitamin D
3
Capsules
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Soft gelatin capsule contains:
Calcium Carbonate
BP……………………………………………………….
1250 mg
(Equivalent to elemental Calcium 500 mg)
Vitamin D3 BP
…………………………………………………………..……..
500 IU
3.PHARMACEUTICAL FORM
Solid Capsules
DESCRIPTION: A white and pink coloured, opaque, oval shaped soft
gelatin capsule
containing off white oily paste
4.CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcium plays a very important role in the body. It is necessary for
normal functioning
of nerves, cells, muscle and bone. If calcium in blood is deficient,
then the body
removes calcium from bones, thereby weakening bones. Prolonged bone
resorption
from
chronic
dietary
deficiency
results
in
osteoporosis
either
by
inadequate
accumulation
of
bone
mass
during
growth
or
increased
rate
of
bone
loss
at
menopause.
Vitamin D3 is fat-soluble sterol essential for the proper regulation
of calcium and
phosphate homeostasis and bone mineralization.
As
an
adjunct
to
specific
therapy
for
osteoporosis
and
in
situations
requiring
therapeutic
supplementation
such
as
in
pregnancy
and
established
Vitamin
D
dependent osteomalacia. Prevention and treatment of Calcium
deficiency/Vitamin D
deficiency especially in elderly subjects.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual recommended dose is 1 to 2 capsules daily, do not exceed
recommended
dose. And as prescribed by the physician.
Oral administration
4.3 CONTRAINDICATIONS
Hypercalcaemia, Osteoporosis due to prolong immobilization, renal
stones and
severe
hypercalciuria.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Patients
with
mild
to
moderate
renal
failure
or
mild
hypercalcuria
should
be
supervised
carefully
including
periodic
checks
of
plasma
calcium
and
urinary
excretion In patients with a history