Pays: Singapour
Langue: anglais
Source: HSA (Health Sciences Authority)
Estradiol (as hemihydrate) micronized; Norethisterone Acetate micronized
NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
G03FA01
1 mg
TABLET, FILM COATED
Estradiol (as hemihydrate) micronized 1 mg; Norethisterone Acetate micronized 0.5 mg
ORAL
Prescription Only
Novo Nordisk A/S
ACTIVE
1999-06-01
ACTIVELLE ® 1 mg/0.5 mg film-coated tablets ___________________________________________________________________________ Each Activelle ® film-coated tablet contains estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg. TABLET CORE CONTAINS: Lactose monohydrate, maize starch, copovidone, talc and magnesium stearate. FILM-COATING: Hypromellose, triacetin, talc. White film-coated, round, biconvex tablets with a diameter of 6 mm. The tablets are engraved with NOVO 288 on one side and APIS bull on the other. MANUFACTURER Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The experience of treating women older than 65 years is limited. POSOLOGY AND METHOD OF ADMINISTRATION Activelle ® is a continuous combined hormone replacement product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also _Special warnings and precautions for use_) should be used. A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for satisfactory symptom relief. In women with amenorrhea and not taking HRT or women transferring from another continuous combined HRT product, treatment with Activelle ® may be started on any convenient day. In women transferring from sequential HRT regimens, treatment should start Lire le document complet
1 1. NAME OF THE MEDICINAL PRODUCT ACTIVELLE ® 1 mg/0.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. White film-coated, round, biconvex tablets with a diameter of 6 mm. The tablets are engraved with NOVO 288 on one side and the APIS bull on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Activelle ® is a continuous combined HRT product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used. A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for symptom relief. In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Activelle ® may be started on any convenient day. In women in transition from a sequential HRT regimen, treatment should start right after their withdrawal bleeding has ended. 2 If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose may increas Lire le document complet