TEMO 140 MG

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

TEMOZOLOMIDE

MAH:

PERRIGO ISRAEL AGENCIES LTD, ISRAEL

ATC_code:

L01AX03

pharmaceutical_form:

CAPSULES

composition:

TEMOZOLOMIDE 140 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

HAUPT PHARMA AMAREG GMBH, GERMANY

therapeutic_group:

TEMOZOLOMIDE

therapeutic_area:

TEMOZOLOMIDE

therapeutic_indication:

Temo 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. Temo 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.

authorization_date:

2016-01-31

PIL

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s prescription
only.
TEMO 5 MG, TEMO 20 MG,
TEMO 100 MG, TEMO 140 MG,
TEMO 250 MG
CAPSULES
EACH CAPSULE CONTAINS:
Temozolomide 5 mg, 20 mg, 100 mg, 140 mg, 250 mg
Inactive ingredients and allergens in the medicine - see
section 2
"
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF THE MEDICINE
"
and in section 6 of this
leaflet.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING 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 your treatment.
Do not pass it on to others. It might harm them, even if
you think that their medical condition is similar to yours.
• This medicine is not intended for children under 3 years
of age, since there is no information regarding use in
patients under the age of 3. The information concerning
children over 3 years of age is limited.
1. WHAT IS THE MEDICINE INTENDED FOR?
TEMO contains the active ingredient temozolomide.
This medicine is intended for the treatment of cancerous
tumors or different types of brain tumors.
TEMO
belongs
to
the
group
of
medicines
called
cytotoxic or chemotherapy medicines.
TEMO capsules are intended for the treatment of:
• Patients suffering from newly diagnosed glioblastoma
multiforme )a unique form of brain tumor( combined with
radiation treatment and subsequently as monotherapy
treatment.
• In patients suffering from malignant glioma such as
glioblastoma
multiforme
or
anaplastic
astrocytoma
)unique forms of brain tumors(, that recur or continue to
develop after standard treatment.
• A first line treatment for patients suffering from advanced
metastatic malignant melanoma.
THERAPEUTIC GROUP: Antineoplastic preparation.
2. BEFORE USING TEMO
DO NOT USE TEMO IF:
• you are hypersensitive )allergic( to the active ingredient
temozolomide
or
to
any
of
the
other
ingredients