البلد: أرمينيا
اللغة: الإنجليزية
المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
bromcriptine (bromocriptine mesilate)
Gedeon Richter PLC
G02CB01
bromcriptine (bromocriptine mesilate)
2,5mg
tablets
(30) glass bottle
Prescription
Registered
2019-10-11
OGYÉI/56403/2017 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BROMOCRIPTIN-RICHTER 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg bromocriptine as 2.87 mg bromocriptine mesilate. Excipient with known effect: each tablet contains 41.0 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Almost white, flat-faced, diameter about 7 mm, bevel-edged bisect tablets with an inscription of “2.5” on the plain side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Inhibition or suppression of lactation for medical reasons Prevention or suppression of post-partum physiological lactation only where medically indicated (such as in case of intrapartum loss, neonatal death, HIV infection of the mother). Bromocriptine is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and breast engorgement which can be adequately treated with non- pharmacological intervention (such as firm breast support, ice application) and/or analgesics. 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 female infertility 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 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 اقرأ الوثيقة كاملة