RALOVERA Medroxyprogesterone acetate 5mg tablet

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

medroxyprogesterone acetate, Quantity: 5 mg

Disponible des:

Pfizer Australia Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: calcium stearate; liquid paraffin; sucrose; lactose monohydrate; indigo carmine; maize starch; purified talc

Vía de administración:

Oral

Unidades en paquete:

56 tablets, 28 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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. Adjunct to oestrogen therapy: Combination hormone replacement therapy should only be used in non-hysterectomised women.

Resumen del producto:

Visual Identification: Pale blue, round tablets. One surface is engraved with the logo "286" on both sides of a break-score. The other surface is engraved with the logo "U"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

1993-10-14

Informació per a l'usuari

RALOVERA
®
_Medroxyprogesterone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RALOVERA. It
does not contain all 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 RALOVERA
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RALOVERA IS
USED FOR
RALOVERA is a progestogen that
comes from progesterone, a natural
sex hormone. RALOVERA works in
a similar way to progesterone.
RALOVERA is used to treat:
•
endometriosis - a condition in
which tissue similar to the lining
of the uterus (womb) grows
outside the uterus, causing pain
and bleeding. RALOVERA helps
to stop the growth of this tissue
•
secondary amenorrhoea (a lack of
menstrual periods not due to
pregnancy). RALOVERA, with
or without an estrogen, helps to
re-establish a regular menstrual
cycle
•
abnormal bleeding from the
uterus, when the lining of the
uterus breaks down during the
menstrual cycle rather than at the
end, resulting in vaginal spotting
or bleeding. RALOVERA helps
to re-establish a regular menstrual
cycle
•
certain types of cancer including
cancer of the breast, kidney and
endometrium
•
RALOVERA, in combination
with an estrogen containing
medicine, is used to relieve
symptoms of menopause in
women with an intact uterus. This
is called hormone replacement
therapy (HRT). RALOVERA is
used to protect the lining of the
uterus while the estrogens relieve
the symptoms of menopause.
RALOVERA is not suitable as a
HRT treatment in women who
have undergone a hysterectomy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RALOVERA
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
RALOVERA
_

Fitxa tècnica

Version: pfpralvt10420
Supersedes: pfpralvt10317
Page 1 of 13
AUSTRALIAN
PRODUCT
INFORMATION
–
RALOVERA
®
(MEDROXYPROGESTERONE
ACETATE) TABLETS
1.
NAME OF THE MEDICINE
Medroxyprogesterone acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RALOVERA tablets contain 2.5 mg, 5 mg or 10 mg medroxyprogesterone
acetate as the active
ingredient.
EXCIPIENT(S) WITH KNOWN EFFECT:
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
2.5 mg tablets: orange, circular, scored on one side, marked U64 on
the other side.
5 mg tablets: pale blue, circular, scored on one side and marked 286
on both sides of the score
line, marked U on the other side.
10 mg tablets:
white, circular, scored on one side, marked UPJOHN 50 on the other
side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CARCINOMA
Palliative treatment of recurrent and/or metastatic breast or renal
cell cancer and of inoperable
recurrent or metastatic endometrial carcinoma.
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.
SECONDARY AMENORRHOEA PROVEN NOT DUE TO PREGNANCY
In amenorrhoea associated with a poorly developed proliferative
endometrium, conventional
estrogen therapy may be employed in conjunction with
medroxyprogesterone acetate.
Version: pfpralvt10420
Supersedes: pfpralvt10317
Page 2 of 13
ABNORMAL UTERINE BLEEDING IN THE ABSENCE OF ORGANIC PATHOLOGY
ADJUNCT TO ESTROGEN THERAPY
Combination hormone replacement therapy (HRT) should only be used in
non-hysterectomised
women (see Section 4.4 Special warnings and precautions for use).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_INOPERABLE, RECURRENT, METASTATIC, ENDOMETRIAL CARCINOMA _
200 mg to 400 mg daily.
_BREAST CARCINOMA _
500 mg daily until progression of disease.
_RENAL CELL CARCINOMA _
200 mg to 400 mg daily.
_ENDOMETRIOSIS _
Beginning the first day of the men