TEMODAL 100 MG

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

TEMOZOLOMIDE

Disponible depuis:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Code ATC:

L01AX03

forme pharmaceutique:

CAPSULES

Composition:

TEMOZOLOMIDE 100 MG

Mode d'administration:

PER OS

Type d'ordonnance:

Required

Fabriqué par:

ORION CORPORATION, ORION PHARMA, FINLAND

Groupe thérapeutique:

TEMOZOLOMIDE

Domaine thérapeutique:

TEMOZOLOMIDE

indications thérapeutiques:

Temodal capsules are indicated for the treatment of patients with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma. Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment.

Date de l'autorisation:

2016-02-29

Notice patient

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) 1986
This medicine is marketed upon physician prescription only
TEMODAL
®
5 mg, 20 mg, 100 mg, 250 mg
Capsules
Each capsule contains:
Temozolomide 5 mg, 20 mg, 100 mg, 250 mg
For a list of inactive ingredients see section 6 “Further
Information”. See also section 2.7
“Important information about some of the ingredients of TEMODAL”.
Read all of this leaflet carefully before you start taking this
medicine.
•
This leaflet contains concise information about the medicine. If you
have any further
questions, refer to the doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their medical condition seems similar to yours.
•
This medicine is not intended for children under 3 years of age, since
there are no data
related to the use in patients under the age of 3 years. The data
about children above the
age of 3 years are limited.
1.
WHAT TEMODAL IS INTENDED FOR?
1.1 What is TEMODAL?
TEMODAL contains a medicine called temozolomide. This medicine is an
antitumour agent
for the treatment of specific forms of brain tumours.
TEMODAL belongs to a group of medicines called cytotoxic or
chemotherapy medicines.
Therapeutic group: Antineoplastic preparation.
1.2 What is TEMODAL used for?
TEMODAL capsules are indicated for the treatment of:
-
Adult patients suffering from newly diagnosed glioblastoma multiforme
(a specific form of
brain tumour) in a combination treatment with radiation and
subsequently as monotherapy
treatment;
-
Children above the age of 3 years, adolescents and adults suffering
from malignant
glioma such as glioblastoma multiforme or anaplastic astrocytoma
(specific forms of brain
tumours), showing recurrence or progression after standard therapy;
-
TEMODAL capsules are also indicated as first line treatment for adult
patients with
advanced metastatic malignant melanoma.
2.
BEFORE USING TEMODAL
2.1 Do not use TEMODAL if:
-
you are sensitive (allergic

Résumé des caractéristiques du produit

1
1.
NAME OF THE MEDICINAL PRODUCT
Temodal
®
5, 20, 100 or 250 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5, 20, 100 or 250 mg temozolomide.
Excipient(s) with known effect:
Each Temodal 5 mg capsule contains 132.8 mg of anhydrous lactose.
Each Temodal 20 mg capsule contains 182.2 mg of anhydrous lactose
Each Temodal 100 mg capsule contains 175.7 mg of anhydrous lactose
Each Temodal 250 mg capsule contains 154.3 mg of anhydrous lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
Temodal 5 mg capsules have an opaque white body, an opaque green cap,
and are imprinted with black
ink. The cap is imprinted with “TEMODAL”. The body is imprinted
with "5 mg", the Schering-Plough
logo and two stripes.
Temodal 20 mg capsules have an opaque white body, an opaque yellow
cap, and are imprinted with black
ink. The cap is imprinted with “TEMODAL”. The body is imprinted
with "20 mg", the Schering-Plough
logo and two stripes.
Temodal 100 mg capsules have an opaque white body, an opaque pink cap,
and are imprinted with black
ink. The cap is imprinted with “TEMODAL”. The body is imprinted
with "100 mg", the Schering-Plough
logo and two stripes.
Temodal 250 mg capsules have an opaque white body and cap and are
imprinted with black ink. The cap
is imprinted with “TEMODAL”. The body is imprinted with "250 mg",
the Schering-Plough logo and two
stripes.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Temodal capsules are indicated for the treatment of:
-
Adult patients with newly diagnosed glioblastoma multiforme
concomitantly with radiotherapy (RT)
and subsequently as monotherapy treatment.
-
Children from the age of three years, adolescents and adult patients
with
malignant glioma, such as
glioblastoma multiforme or anaplastic astrocytoma, showing recurrence
or progression after standard
therapy.
-
Temodal capsules are also indicated as first line treatment for adult
patients with advanced metastatic
malignant melanoma.
4.2
Posology and method