Calcemin Silver tablets film-coated

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

calcium, vitamin D3, magnesium, zinc, copper, manganese, boron

MAH:

Contract Pharmacal Corporation

ATC_code:

առկա չէ (A12AX)

INN:

calcium, vitamin D3, magnesium, zinc, copper, manganese, boron

dosage:

500mg+ 400IU+ 40mg+ 7,5mg+ 1mg+ 1,8mg+ 250mcg

pharmaceutical_form:

tablets film-coated

units_in_package:

(30) and (60) in plastic container

prescription_type:

OTC

authorization_status:

Registered

authorization_date:

2017-07-10

SPC

2.
SUMMARY
OF PRODUCT
CHARACTERISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
CALCEMIN SILVER
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
1
film-coated tablet
contains:
Calcium
(citrate
and
carbonate)
500
mg
Vitamin
D3
(cholecalciferol)
400
lU
Magnesium
(in
the
form
of magnesium
oxide)
40
mg
Zinc
(in
form of zinc
oxide)
7,5
mg
Copper
(in
form of
copper
oxide)
1
mg
Manganese
(in
form
of
manganese
sulfate)
1,8
mg
Boron
(in
form of sodium
borate)
250
mcg
PHARMACEUTICAL
FORM
Film-coated
tablets
CLINICAL
PARTICULARS
erapeutic
lndications
Calcemin
Silver
is
used
for
prophylaxis
of
osteoporosis
and
other
conditions
characterized
with
calcium
deficiency.
It
is
recommended
as a
multimodality
therapy
for
osteoporosis
when
calcium
and
Vitamin Dr deficiency
is diagnosed.
It
is
also
used
to
reduce
the
risk
of
fractures
and
to
make
up
calcium,
vitamin
D
and
minerals deficiencies
in
elderly
people
(over
50
years
old).
Posology and Method
of
Adminis
tion
Adults and children over 12years
of
age.
1
tablet two times daily
at mealtimes.
Duration of
treatment
have
to
be determined by
physician.
Treatment course
may
be
repeated as appropriate.
Patients with
liver
dysfunction; dose
adjustments are
not
required
Patients
with impaired
renal
function:
do not
use
Calcemin
Silver
in
case
of
severe
3.
4.
4.1
4.2
renal
impairment.
l--l-J^,1,.
^^t:^^+^.
^^
^
l--
---
t-,-
--l
..lr-
t-)^^-:l--!^
-----l-
-
triLieriy
pAiieiiLS.
See
UOSiige
l(Jl
iiUults.
rOSSl(Jle
rlepllla[Otllil
consideration.
4.3
Cantraindications
l-r
hypersensitivity
to
any
components of
the
product;
tl
hypercalcaemia
and/or
conditions,
which
lead
to
hypercalciuria
(e.g
sarcoidosis,
malignant
hyperpa rathyroid
ism)
;
I
hypercalciuria;
ir
severe renal
impairment,
hypercalcaemia
and/or
neoplasms,
primary
Page
1
of
6
4.4
al
nephrolithiasis;
n
hypervitaminosis
D;
t.r
children
below
12
years
of
age.
Specia/
Warnings
and
Precautions
for
IJse
Consideration
must
be
given
to
concomitant
intake
of
vitamin
D
from
al
sources
including
dietary
for
the
avoidance
of
overdosage.
Total
dose
of
2500
mg
of