Elevit Pronatal tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

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

Disponibil de la:

Dragenopharm Apotheker Puschl GmbH

Codul ATC:

A11AA03

INN (nume internaţional):

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

Dozare:

3600IU+ 500IU+ 15mg+ 100mg+ 0,8mg+ 1,6mg+ 1,8mg+ 2,6mg+ 4mcg+ 19mg+ 200mcg+ 10mg+ 125mg+ 100mg+ 125mg+ 60mg+ 7,5mg+ 1mg+ 1mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(30/3x10/) in blister, (100/5x20/) in blister

Tip de prescriptie medicala:

OTC

Statutul autorizaţiei:

Registered

Data de autorizare:

2021-12-21

Caracteristicilor produsului

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 _
For
the
prevention
and
treatment
of
hypovitaminosis,
vitamin
and
mineral
deficiencies in preparation for pregnancy, during pregnancy, after
giving birth and
during lactation.
_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.
_4.3 _
_CONTRAINDICATIONS _
Known
hypersensitivity
to
any
ingredient
in
the
drug
product;
existing
hypervitaminosis A and/or D; hypercalcaemia, severe hypercalciuria,
severe
Page 2 of 5
Summary of Product Characteristics
Elevit
®
Pronatal, film-coated tablets
impaired
renal
function,
iron
and/or
copper
metabolism
disorders;
galactose
intolerance, lactase deficiency or glucose-galactose malabsorption
(the medicinal
product contains lactose).
Contraindication if patient is undergoing treatment with vitamin A or
treatment with
the synthetic isomers isotretinoin and etretinate. Beta-carotene is
considered as a
source of vitamin A supplementation; urinary stone disease, lactose
intolerance;
sucrose intolerance.
_4.4 _
_SPECIAL WARNINGS AND PREC