Elevit Pronatal tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

vitamin A, vitamin D3, vitamin E, vitamin C, folic acid, vitamin B1,vitamin B2, vitamin B6, vitamin B12, nicotinamide, biotin, calcium pantothenate, calcium, magnesium, phosphor, ferrum, zinc, copper, manganese

Available from:

Rottendorf Pharma GmbH

ATC code:

A11AA

INN (International Name):

vitamin A, vitamin D3, vitamin E, vitamin C, folic acid, vitamin B1,vitamin B2, vitamin B6, vitamin B12, nicotinamide, biotin, calcium pantothenate, calcium, magnesium, phosphor, ferrum, zinc, copper, manganese

Dosage:

3600IU+ 500IU+ 15mg+ 100mg+ 0,8mg+ 1,6mg+ 1,8mg+ 2,6mg+ 4mcg+ 19mg+ 0,2mg+ 10mg+ 125mg+ 100mg+ 125mg+ 60mg+ 7,5mg+ 1mg+ 1mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister, (100/10x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-04-27

Summary of Product characteristics

Page 1 of 5
Summary of Product Characteristics
Elevit
®
Pronatal, film-coated tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Elevit Pronatal
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains:
_Vitamins: _
Vitamin A
3600 IU
Vitamin D
3
500 IU
Vitamin E
15 mg
Vitamin C
100 mg
Folic acid
0,8 mg
Vitamin B
1
1,6 mg
Vitamin B
2
1,8 mg
Vitamin B
6
2,6 mg
Vitamin B
12
4 mcg
Nicotinamide
19 mg
Biotin
200 mcg
Calcium pantothenate
10 mg
_Minerals and Trace Elements _
Calcium
125 mg
Magnesium
100 mg
Phosphorus
125 mg
Iron
60 mg
Zinc
7,5 mg
Copper
1 mg
Manganese
1 mg
3.
PHARMACEUTICAL FORM
Film-coated tablet
4.
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
In
preparation
for
pregnancy,
and
during
pregnancy
and
lactation
for
the
prevention and treatment of vitamin and mineral deficiencies.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
As for every medicinal product, please consult your health care
professional
before use.
One tablet daily to be taken with water and preferably with a meal
when planning a
pregnancy, throughout pregnancy and lactation.
The recommended duration of administration is one month before
conception
(when planning a pregnancy), throughout pregnancy and lactation.
Page 2 of 5
Summary of Product Characteristics
Elevit
®
Pronatal, film-coated tablets
_ _
_4.3 _
_CONTRAINDICATIONS _
Known
hypersensitivity
to
any
ingredient
in
the
drug
product;
existing
hypervitaminosis
A
and/or
D;
hypercalcaemia,
severe
hypercalciuria,
severe
impaired
renal
function,
iron
and/or
copper
metabolism
disorders;
galactose
intolerance, lactase deficiency or glucose-galactose malabsorption
(the medicinal
product contains lactose).
_4.4 _
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE _
The recommended dosage must not be exceeded. Very high doses of some
ingredients, in particular vitamin A, vitamin D, can be harmful to
health. Patients
receiving other single vitamins or multivitamin preparations should
consult a health
care professional before taking this product.
_4.5