ZOLADEX 3,6mg IMPLANTE

Country: Peru

Language: Spanish

Source: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

Active ingredient:

ACETATO DE GOSERELINA;

Available from:

ASTRAZENECA PERU S.A.

ATC code:

L02AE03

INN (International Name):

ACETATE, GOSERELIN;

Pharmaceutical form:

IMPLANTE

Composition:

POR PASTILLA

Administration route:

SUBCUTANEA

Units in package:

Caja de cartón conteniendo un sobre de tereftalato de polietileno/hoja de aluminio/polietileno con un implante en jeringa prelle

Prescription type:

Con receta médica

Manufactured by:

ASTRAZENECA UK LIMITED; REINO UNIDO

Therapeutic group:

Goserelina

Product summary:

Presentación: Caja de cartón conteniendo un sobre estéril de teraftalato de polietileno/hoja de aluminio/polietileno, con un implante inyectable en una cámara de copolímero estireno butadieno, en una jeringa prellenada de polietileno de alta densidad blanco con funda protectora de aguja.

Authorization status:

VIGENTE

Authorization date:

2023-03-13

Summary of Product characteristics

ZOLADEX 3.6MG
IMPLANT
1.
NAME OF THE MEDICINAL PRODUCT
Zoladex 3.6 mg, implant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Goserelin acetate (equivalent to 3.6 mg goserelin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implant, pre-filled syringe
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
(i)
Treatment of prostate cancer in the following settings (see also
section 5.1):

In the treatment of metastatic prostate cancer where Zoladex has
demonstrated
comparable survival benefits to surgical castrations (see section 5.1)

In the treatment of locally advanced prostate cancer, as an
alternative to surgical
castration where Zoladex has demonstrated comparable survival benefits
to an
anti-androgen (see section 5.1)

As adjuvant treatment to radiotherapy in patients with high-risk
localised or locally
advanced prostate cancer where Zoladex has demonstrated improved
disease-free
survival and overall survival (see section 5.1)

As neo-adjuvant treatment prior to radiotherapy in patients with high-
risk localised
or locally advanced prostate cancer where Zoladex has demonstrated
improved
disease-free survival (see section 5.1)

As adjuvant treatment to radical prostatectomy in patients with
locally advanced
prostate
cancer
at
high
risk
of
disease
progression
where
Zoladex
has
demonstrated improved disease-free survival (see section 5.1)
(ii)
Advanced breast cancer in pre and perimenopausal women suitable for
hormonal
manipulation.
(iii)
Zoladex 3.6 mg is indicated as an alternative to chemotherapy in the
standard of
care for pre/perimenopausal women with oestrogen receptor (ER)
positive early
breast cancer.
(iv)
Endometriosis: In the management of endometriosis, Zoladex alleviates
symptoms,
including pain, and reduces the size and number of endometrial
lesions.
(v)
Endometrial thinning: Zoladex is indicated for the prethinning of the
uterine
endometrium prior to endometrial ablation or resection.
(vi)
Uterine
fibroids:
In
conjunction
with
iron
therapy
in
the
haematological