TARCEVA 150 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ERLOTINIB AS DIHYDROCHLORIDE

متاح من:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC رمز:

L01XX34

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

ERLOTINIB AS DIHYDROCHLORIDE 150 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HOFFMANN LA ROCHE, SWITZERLAND

المجموعة العلاجية:

ERLOTINIB

المجال العلاجي:

ERLOTINIB

الخصائص العلاجية:

Non-Small Cell Lung Cancer (NSCLC):Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.Tarceva is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations and stable disease after first-line chemotherapy.Tarceva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.Pancreatic cancer:Tarceva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

تاريخ الترخيص:

2020-09-30

نشرة المعلومات

starting treatment with this medicine. . HOW SHOULD YOU USE THE MEDICINE?
Always use this medicine according to your doctor’s
instructions.
Check with the doctor or pharmacist if you are not sure
about your dose or about how to take this medicine.
Usual dose
The dose and treatment regimen will be determined by
the doctor only.
For treatment of lung cancer: The usual dose is generally
one TARCEVA
® 150 MG tablet a day.
For treatment of metastatic pancreatic cancer: The usual
dose is generally one TARCEVA
® 100 MG tablet a day.
TARCEVA
®
will be given in combination with the standard
medicinal treatment for this disease (gemcitabine).
Your doctor may adjust your dose in 50 mg increments.
For the different dose regimens, TARCEVA
®
is available in
strengths of 100 mg or 150 mg.
DO NOT EXCEED THE RECOMMENDED DOSE.
If you accidentally took a higher dose
Contact your doctor or pharmacist immediately.
You may have increased side effects and your doctor
may stop your treatment.
If you took an overdose, or if a child has accidentally
swallowed the medicine, refer immediately to a doctor
or proceed to a hospital emergency room, and bring the
package of the medicine with you.
If you forget to take the medicine
If you forgot to take one or more doses of the medicine,
contact your doctor or pharmacist as soon as possible. If
you forgot to take the medicine at the scheduled time, do
not take a double dose. Take the next dose at the usual
time and consult the doctor.
If you stop taking the medicine
It is very important to keep taking TARCEVA
®
every day, as
long as your doctor prescribes it for you.
Adhere to the treatment regimen as recommended by
the doctor.
Even if there is an improvement in your health, do not
discontinue treatment with the medicine without consulting
the doctor.
How can you contribute to the success of the treatment?
DO NOT TAKE MEDICINES IN THE DARK! CHECK THE LABEL AND
THE DOSE EACH TIME YOU TAKE MEDICINE. WEAR GLASSES
IF YOU NEED THEM.
IF YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS
MEDICINE,

خصائص المنتج

1
TARCEVA_PI_VER 6.0
TARCEVA
®
ERLOTINIB
100 mg and 150 mg Tablets
1.
NAME OF THE MEDICINAL PRODUCT
Tarceva 100 mg & 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tarceva 100 mg: One film-coated tablet contains 100 mg erlotinib (as
erlotinib hydrochloride).
Excipients with known effect: Each film-coated tablet contains 69.21
mg Lactose monohydrate.
Tarceva 150 mg: One film-coated tablet contains 150 mg erlotinib (as
erlotinib hydrochloride).
Excipients with known effect: Each film-coated tablet contains 103.82
mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film Coated Tablets.
Tarceva 100 mg:
White to yellowish, round, biconvex film-coated tablets with ‘T
100’ engraved on one side.
Tarceva 150 mg:
White to yellowish, round, biconvex film-coated tablets with ‘T
150’ engraved on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
Tarceva is indicated for the first-line treatment of patients with
locally advanced or metastatic non-small
cell lung cancer (NSCLC) with EGFR activating mutations.
Tarceva is indicated for switch maintenance treatment in patients with
locally advanced or metastatic non-
small cell lung cancer (NSCLC) with EGFR activating mutations and
stable disease after first-line
chemotherapy.
Tarceva is indicated for the treatment of patients with locally
advanced or metastatic non-small cell lung
cancer after failure of at least one prior chemotherapy regimen.
Pancreatic cancer:
Tarceva is indicated in combination with gemcitabine for the
first-line treatment of patients with locally
advanced, unresectable or metastatic pancreatic cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tarceva treatment should be supervised by a physician experienced in
the use of anti-cancer therapies.
Patients with Non-Small Cell Lung Cancer
2
EGFR mutation testing should be performed in accordance with the
approved indications (see section 4.1).
The recommended daily dose of Tarceva is 150 mg