Trisequens (Combination pack)

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %);  ;  ;  ; Norethisterone acetate 1mg;  ;  ;  ; Estradiol hemihydrate 1.03mg (adjustment for water content 3.2%); Estradiol hemihydrate 2.07mg (adjustment for water content 3.2%); Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %); Estradiol hemihydrate 1.03mg (adjustment for water content 3.2 %); Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %); Norethisterone acetate 1mg

Saatavilla:

Novo Nordisk Pharmaceuticals Ltd

INN (Kansainvälinen yleisnimi):

Estradiol hemihydrate 2.07 mg (adjustment for water content 3.2 %)

Lääkemuoto:

Film coated tablet

Koostumus:

Active: Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %)       Norethisterone acetate 1mg       Excipient: Hyprolose Hypromellose Lactose monohydrate Magnesium stearate Maize starch Purified talc Purified water Triacetin Active: Estradiol hemihydrate 1.03mg (adjustment for water content 3.2%) Excipient: Hyprolose Hypromellose Iron oxide red As red paste, with titanium dioxide, hypromellose, talc and propylene glycol Lactose monohydrate Magnesium stearate Maize starch Propylene glycol Purified talc   Purified water Titanium dioxide Active: Estradiol hemihydrate 2.07mg (adjustment for water content 3.2%) Excipient: Hyprolose Hypromellose Indigo carmine Lactose monohydrate Macrogol 400 Magnesium stearate Maize starch Purified talc   Purified water Titanium dioxide Active: Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %) Estradiol hemihydrate 1.03mg (adjustment for water content 3.2 %) Estradiol hemihydrate 2.07mg (adjustment for water content 3.2 %) Norethisterone acetate 1mg

Kpl paketissa:

Calendar pack, of polypropylene/polystyrene, 28 tablets, 10 Kliogest, 12 Estrofem 2 mg, 6 Estrofem 1 mg, 28 tablets

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Aspen Oss B.V

Käyttöaiheet:

Trisequens is indicated for the treatment of oestrogen deficiency syndrome, including prevention of bone mineral content loss in postmenopausal women at increased risk of developing fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis (see also Warnings and Precautions)

Tuoteyhteenveto:

Package - Contents - Shelf Life: Calendar pack, of polypropylene/polystyrene, 28 tablets, 10 Kliogest, 12 Estrofem 2 mg, 6 Estrofem 1 mg - 28 tablets - 48 months from date of manufacture stored at or below 25°C

Valtuutus päivämäärä:

1990-12-06

Pakkausseloste

Trisequens®
®
Tablets 28.02.2022
Page 0 of 10
PACKAGE LEAFLET
TRISEQUENS
®
FILM-COATED TABLETS
Estradiol/norethisterone acetate
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Trisequens
®
is and what it is used for
2.
What you need to know before you take Trisequens
®
3.
How to take Trisequens
®
4.
Possible side effects
5.
How to store Trisequens
®
6.
Contents of the pack and other information
1.
WHAT TRISEQUENS
® IS AND WHAT IT IS USED FOR
Trisequens
®
is a sequential combined Hormone Replacement Therapy (HRT) which is
taken every
day without interruption.
Trisequens contains 2 hormones, an oestrogen (estradiol) and a
progestagen (norethisterone acetate).
The estradiol in Trisequens is identical to the estradiol produced in
the ovaries of women, and is
classified as a natural oestrogen. Norethisterone acetate is a
synthetic progestagen, which acts in a
similar manner as progesterone, another important female sex hormone.
Trisequens
®
is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This can
cause symptoms such as hot face, neck and chest (‘hot flushes’).
Trisequens
®
alleviates these
symptoms after menopause. You will only be prescribed Trisequens
®
if your symptoms seriously
hinder your daily life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all
available options with your doctor.
If you are at an incr

Valmisteyhteenveto

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
TRISEQUENS
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
17ß-oestradiol and Norethisterone acetate tablets.
3 PHARMACEUTICAL FORM
Trisequens calendar dial pack contains 28 tablets as described below:
12 blue, round, film coated tablets with diameter 6mm and stamped
“Novo 280" on one side.
The other side is plain. Each tablet contains 2mg of 17ß-oestradiol
and weighs about 80mg.
10 white, round, film coated tablets with diameter 6mm and stamped
“Novo 281" on one side.
The other side is plain. Each tablet contains 2mg of 17ß-oestradiol
and 1mg of norethisterone
acetate and weights about 80mg.
6 red, film coated tablets with diameter 6mm and stamped “Novo 282"
on one side. The
other side is plain. Each tablet contains 1mg of 17ß-oestradiol and
weighs about 80mg.
Excipient with known effect: lactose monohydrate. For the full list of
excipients, see section
6.1.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Trisequens is indicated for the treatment of oestrogen deficiency
syndrome, including
prevention of bone mineral content loss in postmenopausal women at
increased risk of
developing fractures who are intolerant of, or contraindicated for,
other medicinal products
approved for the prevention of osteoporosis (see section 4.4).
The experience of treating women older than 65 years is limited.
4.2 Dose and method of administration
Trisequens is a continuous sequential HRT product for women with an
intact uterus. The
oestrogen is dosed continuously. The progestagen is added for 10 days
of every 28 day cycle,
in a sequential manner.
One tablet should be taken orally once a day without interruption,
preferably at the same time
of the day starting with oestrogen therapy (blue film-coated tablet)
over 12 days, followed by
10 days’ of oestrogen/progestagen therapy (white film-coated tablet)
and 6 days’ of oestrogen
therapy (red film-coated tablet). A regular shedding of the
endometrium is usually induced
during the red tablet phase. After intake of the last red tablet,