DEPOCON INJECTION

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

NORETHISTERONE ENANTHATE

Commercializzato da:

DUOPHARMA (M) SDN. BHD.

INN (Nome Internazionale):

NORETHISTERONE ENANTHATE

Confezione:

1ml10Units mL; 1ml30Units mL; 1ml50Units mL; 1ml100Units mL

Prodotto da:

DUOPHARMA (M) SDN. BHD.

Scheda tecnica

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[REVISION DATE: 31.01.2019] DEPOCON INJECTION
DESCRIPTION:
Is a clear yellowish oily solution.
COMPOSITION:
Each ml contains 200 mg of Norethisterone Enanthate in oily solution.
PHARMACODYNAMICS:
Norethisterone enanthate is a long-active derivative of norethisterone
which has been used similarly to medroxyprogesterone acetate as a
‘progestogen only’ contraceptive.
Depocon is a depot progestogen for hormonal contraception. Protection
against conception is based primarily upon an alteration of the
cervical
mucus which is present for the whole of the duration of action and
which prevents the ascent of the sperms into the uterine cavity.
Radioimmunological studies have shown that, within the first 5-7 weeks
after injection, ovulation is suppressed as a result of the high
plasma level
of norethisterone. In addition, Depocon causes morphological changes
in the endometrium which can be considered as having the effect of
rendering nidation of a fertilized egg difficult.
PHARMACOKINETICS:
Norethisterone is absorbed from the gastro-intestinal tract and its
effects last for at least 24 hours. When injected, it is detectable in
the plasma
after 2 days and is not completely excreted in the urine after 5 days.
INDICATION:
For parenteral hormonal contraception Depocon is particularly suitable
for women who for any reason cannot take oral contraceptives regularly
or
who tolerate such preparations poorly. Depocon should only be
administered to women with a history of normal biphasic cycles.
RECOMMENDED DOSAGE:
Before starting Depocon, a thorough general medical and gynaecological
examination (including the breasts) should be carried out and
pregnancy
must be excluded.
Depocon must always be injected deeply into the gluteal muscle. It is
advisable to cover the site of injection afterwards with a plaster in
order to
prevent partial reflux of the injection solution.
The first intramuscular injection of 200 mg is given within the first
five days of the cycle. The next three injections are to be given at
intervals of 8