Premia 2.5 Continuous

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Conjugated estrogens 0.625mg (15mg as a dessication with lactose, includes 3% overage.);  ; Medroxyprogesterone acetate 2.6mg (includes 4% overage.); Conjugated estrogens 0.625mg (15mg as a dessication with lactose, includes 3% overage.); Medroxyprogesterone acetate 2.6mg (includes 4% overage.)

Dostupno od:

Pfizer New Zealand Limited

INN (International ime):

Conjugated estrogens 0.625 mg (15mg as a dessication with lactose, includes 3% overage.)

Farmaceutski oblik:

Tablet

Sastav:

Active: Conjugated estrogens 0.625mg (15mg as a dessication with lactose, includes 3% overage.)   Medroxyprogesterone acetate 2.6mg (includes 4% overage.) Excipient: Calcium sulfate Carnauba wax Glyceryl mono-oleate Iron oxide red Lactose monohydrate Macrogol 20000 Magnesium stearate Methylcellulose Microcrystalline cellulose   Opacode black S-8-27741 Povidone Shellac Stearic acid Sucrose     Titanium dioxide   Active: Conjugated estrogens 0.625mg (15mg as a dessication with lactose, includes 3% overage.) Medroxyprogesterone acetate 2.6mg (includes 4% overage.) Excipient: Calcium sulfate Carnauba wax Glyceryl mono-oleate Iron oxide red Lactose monohydrate Macrogol 20000 Magnesium stearate Methylcellulose Microcrystalline cellulose Opacode black S-8-27741 Povidone Shellac Stearic acid Sucrose Titanium dioxide  

Jedinice u paketu:

Calendar pack, 4 weekpack, 28 tablets

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Pfizer Global Manufacturing

Proizvod sažetak:

Package - Contents - Shelf Life: Calendar pack, 4 week pack - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Calendar pack, 12 week pack - 84 tablets - 36 months from date of manufacture stored at or below 25°C

Datum autorizacije:

1995-06-14

Uputa o lijeku

PREMIA CONTINUOUS
1
PREMIA
®
2.5 CONTINUOUS
& PREMIA 5 CONTINUOUS
_Conjugated Oestrogens and Medroxyprogesterone acetate Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Premia
Continuous Tablets. It does not
contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Premia
Continuous against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Your doctor and pharmacist have
more information.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT PREMIA
CONTINUOUS IS USED
FOR
Premia Continuous is a type of
treatment called hormone
replacement therapy (HRT) and
contains the hormones conjugated
oestrogens and medroxyprogesterone
acetate (MPA).
Premia Continuous helps to relieve
the discomfort many women feel
during and after menopause,
including symptoms such as "hot
flushes", sweating and vaginal
dryness.
It also helps to prevent
thinning of the bones (osteoporosis),
which can cause fractures, in some
women. Premia Continuous is used
by women who still have a uterus
(womb).
If your doctor thinks you will need to
take HRT for a long time, including
for the prevention of osteoporosis,
your doctor will have considered the
benefits and risks of other treatments
before prescribing Premia
Continuous for you.
_HOW IT WORKS_
Menopause occurs naturally in
women usually between the ages of
45 and 55. During menopause, your
body produces less oestrogen than it
did beforehand. This can cause
symptoms such as "hot flushes", a
sudden, intense feeling of heat and
sweating throughout the body. Some
women also have problems with
dryness of the vagina causing
discomfort during or after sexual
intercourse. Some women develop
osteoporosis during or after
menopause. This is a thinning of the
bones that makes them weaker and
more likely to br

Svojstava lijeka

DATA SHEET
PREMIA
 2. 5 CONTINUOUS AND PREMIA 5 CONTINUOUS
Conjugated estrogens 0.625 mg and medroxyprogesterone acetate 2.5 mg
tablets.
Conjugated estrogens 0.625 mg and medroxyprogesterone acetate 5 mg
tablets.
NAME OF THE MEDICINE
PREMIA 2.5 Continuous 0.625 mg conjugated estrogens and 2.5 mg
medroxyprogesterone acetate
tablets.
PREMIA 5 Continuous 0.625 mg conjugated estrogens and 5 mg
medroxyprogesterone acetate as
tablets.
Conjugated estrogens (CE) are a mixture of natural estrogens of equine
origin.
Medroxyprogesterone acetate (MPA) is a progestogen and a derivative of
progesterone. The
chemical name is 6α-methyl-3,20-dioxopregn-4-en-17α-yl acetate and
the structural formula is:
The molecular formula is C
24
H
34
O
4
and molecular weight is 386.53. The CAS No. is 71-58-9.
DESCRIPTION
PREMIA 2.5 Continuous and PREMIA 5 Continuous combination tablets are
hormone replacement
therapy packs.
Each PREMIA Continuous tablet has an inner PREMARIN

core and an outer coat containing
micronised MPA. PREMIA 2.5 Continuous tablets contain 0.625 mg CE and
2.5 mg MPA as
active ingredients. PREMIA 5 Continuous tablets contain 0.625 mg CE
and 5 mg MPA as active
ingredients.
Each tablet also contains
lactose
monohydrate,
methylcellulose,
magnesium
stearate, shellac,
macrogol 20000, glyceryl mono-oleate, microcrystalline cellulose,
calcium phosphate, calcium
sulfate, sucrose, titanium dioxide, carnauba wax and black ink.
PREMIA 2.5 Continuous tablets are peach in colour and PREMIA 5
Continuous tablets are blue.
PREMIA 2.5 Continuous tablets contain iron oxide red as the colouring
agent while PREMIA 5
Continuous tablets contain indigo carmine as the colouring agent.
CE are composed principally of the sodium salts of water soluble
sulfate esters of estrone, equilin
and
17α-dihydroequilin,
together
with
smaller
amounts
of
17α-estradiol,
equilenin,
17α-
pfdpreit110716
supersedes pfdpreit10611
Page 1 of 19
dihydroequilenin,
17β-dihydroequilin,
17β-dihydroequilenin,
17β-estradiol
and
δ
8,9
dehydroestrone.
MPA is a wh