Mezym Forte tablets film-coated

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

pancreatin (lipase, amylase, protease)

Доступно од:

Berlin-Chemie AG

АТЦ код:

A09AA02 կենսաբանական դեղ

INN (Међународно име):

pancreatin (lipase, amylase, protease)

Дозирање:

3500IU+ 4200IU+ 250IU (20/2x10/) in blister, (20/1x20/) in blister, (40/4x10/) in blister, (40/2x20/) in blister, (80/8x10/) in

Фармацеутски облик:

tablets film-coated

Јединице у пакету:

3500IU+4200IU+250IU (20/2x10/) in blister, (20/1x20/) in blister, (40/4x10/) in blister, (40/2x20/) in blister, (80/8x10/) in bl

Тип рецептора:

OTC

Статус ауторизације:

Registered

Датум одобрења:

2019-01-18

Карактеристике производа

SUMMARY
OF
PRODUCT
CHARACTERISTICS
1.
NAME
OF
THE
MEDICINAL
PRODUCT
Mezym® forte
3,500 Ph. Eur. Units of lipase
film-coated tablets
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
One film-coated tablet contains 93.33 - 107.69 mg porcine pancreas
powder with:
Minimum lipolytic activity
3,500 Ph. Eur. U./tablet
Minimum amylolytic activity
4,200 Ph. Eur. U./tablet
Minimum total proteolytic activity
250 Ph. Eur. U./tablet
Excipient(s) with known effect
One film coated tablet contains 0.076 mg azorubine (E122).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet
Pink, flat cylindrical film-coated tablets with almost biplanar
surfaces and bevelled edges.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Disturbances to exocrine pancreatic function that are accompanied by
maldigestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended dose per meal:
1 - 2 tablets are generally taken at the beginning of a meal.
The dosage of Mezym® forte is dictated by the severity of the
digestive disturbance. The
appropriate dose is usually to be defined individually.
Depending on the type of meal and on the known or estimated severity
of the digestive
disorder, further 2 - 4 tablets are to be taken during the meal.
The required dose may also be substantially above that. An increase in
the dose should take
place only under the supervision of a doctor and be aimed at an
improvement in the symptoms
(e.g. steatorrhoea, stomachache). In case an increase in dose is
deemed necessary other dosage
forms with a higher amount of active-substance viz. pancreatin are
available.
A daily enzyme dose of 10,000 units of lipase per kg of body weight
should not be exceeded.
Particularly in patients with cystic fibrosis, the dose should not
exceed the enzyme dose
necessary for adequate fat absorption, accounting for the quantity and
composition of meals.
_Paediatric population_
The doctor should decide as to the dosage in children.
Method of administration
The film-coated tablets should be swallowed w