ACTIVELLE TABLET

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

Estradiol (as hemihydrate) micronized; Norethisterone Acetate micronized

Prieinama:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC kodas:

G03FA01

Dozė:

1 mg

Vaisto forma:

TABLET, FILM COATED

Sudėtis:

Estradiol (as hemihydrate) micronized 1 mg; Norethisterone Acetate micronized 0.5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

Prescription Only

Pagaminta:

Novo Nordisk A/S

Autorizacija statusas:

ACTIVE

Leidimo data:

1999-06-01

Pakuotės lapelis

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

Prekės savybės

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