RAVIMED TABLET 5MG

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Koop het nu

Bijsluiter Bijsluiter (PIL)
19-07-2021
Productkenmerken Productkenmerken (SPC)
30-06-2020

Werkstoffen:

MEDROXYPROGESTERONE ACETATE

Beschikbaar vanaf:

DUOPHARMA (M) SDN. BHD.

INN (Algemene Internationale Benaming):

MEDROXYPROGESTERONE ACETATE

Eenheden in pakket:

100 Tablets

Geproduceerd door:

DUOPHARMA (M) SDN. BHD.

Bijsluiter

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
RAVIMED TABLET
Medroxyprogesterone Acetate (5mg)
WHAT IS IN THIS LEAFLET
1.
What RAVIMED TABLET
is used for
2.
How RAVIMED TABLET
works
3.
Before you use RAVIMED
TABLET
4.
How to use RAVIMED
TABLET
5.
While
you
are
using
RAVIMED TABLET
6.
Side effects
7.
Storage and disposal of
RAVIMED TABLET
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT RAVIMED TABLET
IS USED FOR
RAVIMED TABLET is used
to
treat
the
following
conditions:

Endometriosis
(abnormal
growth of tissue layer outside
uterus)

Secondary
amenorrhoea
(absence
of
menstrual
bleeding for three months in
the absence of pregnancy).

Abnormal uterine bleeding

Adjunct to hormone estrogen
therapy
HOW RAVIMED TABLET
WORKS
RAVIMED
contains
a
progestogen that comes from
progesterone,
a
natural
sex
hormone.
Medroxyprogesterone
acetate
helps to re-establish a regular
menstrual cycle.
BEFORE
YOU
USE
RAVIMED
TABLET
_-_
_ _
_When you must not use it _
Do not
take
RAVIMED
TABLET if you have an
allergy
to
medroxyprogesterone
acetate
or
to
any
of
the
ingredients
listed at the end of this leaflet.
Do
not
use
RAVIMED
TABLET if you have had any
of
the
following
medical
conditions
unless
advised
otherwise by your doctor:

A blood clotting disorder

Liver problems

Unusual
or
irregular
vaginal bleeding

Any lumps in your breast

Any bleeding or discharge
from your nipples

Severe uncontrolled high
blood pressure

Blood in your urine

Missed abortion
_-_
_ _
_Before you start to use it _
Before
taking
RAVIMED
TABLET, you must tell your
doctor or pharmacist if you
have, or have had, any of the
following conditions:

Heart problems

Kidney problems

Migraine

Epilepsy (fits)

Asthma

Diabetes

Depression

Allergic
to
any
other
medicines
or
any
other
substances,
such
as
foods
preservatives or dyes.
_Pregnancy _
RAVIMED TABLETS ARE
NOT TO BE USED AS A TEST FOR
PREGNANCY
OR
WHERE
PREGNANCY IS SUSPECTED.
_-_
_ _
_Taking other
                                
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Productkenmerken

                                [DUOPHARMA (M) SDN BHD]
Page 1 of 2
[REVISION DATE: 14.05.2020]
RAVIMED TABLET 5MG
DESCRIPTION:
RAVIMED TABLET 5 MG: 7 mm, pink round tablet, scored on one side with
‘DUO 861’ marking and marking ‘duo’ on the other side.
COMPOSITION:
Each tablet contains Medroxyprogesterone Acetate 5 mg.
PHARMACODYNAMICS:
HUMAN: Medroxyprogesterone Acetate is a progestational agent. When
administered in recommended doses to women with adequate endogenous
oestrogen, it transforms
proliferative into secretory endometrium. Medroxyprogesterone Acetate
inhibits gonadotrophin production, which in turn prevents follicular
maturation and ovulation. Like
progesterone, Medroxyprogesterone Acetate is thermogenic. At the very
high dosage levels used in the treatment of certain cancers (500 mg
daily or more), corticoid-like activity
may be manifest.
PHARMACOKINETICS:
Medroxyprogesterone Acetate is an orally-active progestational steroid
having an apparent half-life of about 30 hours. Medroxyprogesterone
Acetate is rapidly absorbed after oral
administration. There is high interindividual variability in serum
levels after standard doses given by either route of administration.
Medroxyprogesterone Acetate is metabolised and conjugated in the
liver. Metabolic products are predominantly excreted in the urine both
as conjugated and free forms.
INDICATION:
1.
_CARCINOMA: _Palliative treatment of recurrent and or metastatic
breast or renal cell cancer and of inoperable recurrent or metastatic
endometrial carcinoma.
2.
_ENDOMETRIOSIS: _ For use in the treatment of visually proven
(laparoscopy) endometriosis where the required end-point of treatment
is pregnancy, or for the control of
symptoms when surgery is contraindicated or has been unsuccessful.
3.
Secondary amenorrhoea proven not due to pregnancy. In amenorrhoea
associated with a poorly developed proliferative endometrium,
conventional oestrogen therapy may be
employed in conjunction with Medroxyprogesterone Acetate.
4.
Abnormal uterine bleeding in the absence of organic pathology.
5.
Adj
                                
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