Bromocriptin-Richter

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

bromcriptine (bromocriptine mesilate)

متاح من:

Gedeon Richter OJSC

INN (الاسم الدولي):

bromcriptine (bromocriptine mesilate)

جرعة:

2,5mg

الشكل الصيدلاني:

tablets

نوع الوصفة الطبية :

Prescription

خصائص المنتج

OGYI/3076/2013
1.
NAME OF THE MEDICINAL PRODUCT
BROMOCRIPTIN-RICHTER 2.5 MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: 2.5 mg bromocriptine as 2.87 mg bromocriptine
mesilate in each tablet.
Excipient with known effect: 41.0 mg lactose monohydrate in each
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Almost white, flat-faced, bevel-edged bisect tablets with an
inscription of “2.5” on the plain side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inhibition or suppression of lactation for medical reasons
This preparation is not recommended for the routine suppression of
lactation or for the relief of
symptoms of post-partum pain and engorgement of the breasts.
Hyperprolactinaemia
Treatment of hyperprolactinaemia in men and women (with and/or without
galactorrhoea).
Infertility
Treatment of hyperprolactinaemic infertility.
Bromocriptine has been used successfully in the treatment of a number
of infertile women without
demonstrable hyperprolactinaemia.
Prolactinomas
Bromocriptine can be a first choice of treatment in case of
macroadenomas and an alternative to the
surgical procedure (transsphenoidal hypophysectomy) in patients with
microadenomas.
Acromegaly
Bromocriptine is an appropriate adjunct to surgery and/or radiotherapy
in reducing the level of growth
hormone in the systemic circulation of acromegalic patients.
Parkinson's disease
In the treatment of idiopathic Parkinson's disease, bromocriptine has
been used both as monotherapy
and in combination with levodopa in the management of previously
untreated patients and those
disabled by 'on-off' phenomena. Treatment is of benefit in patients
who do not respond to or are
unable to tolerate levodopa, as well as in those whose response to
levodopa is declining.
Treatment of cyclical benign breast disease; premenstrual syndrome
(see section 4.4 “Special
warnings and precautions for use”).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2
T