ERLOTINIB SANDOZ erlotinib 100 mg tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

erlotinib hydrochloride, Quantity: 109.27 mg

Предлага се от:

Sandoz Pty Ltd

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate type A; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer

Начин на приложение:

Oral

Броя в опаковка:

30 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Non-small cell lung cancer Erlotinib Sandoz is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations.,Erlotinib Sandoz is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFRmutations who have not progressed on first-line chemotherapy.,Erlotinib Sandoz is also indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of prior chemotherapy.,Pancreatic cancer Erlotinib Sandoz in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Каталог на резюме:

Visual Identification: White to yellowish, round, biconvex, film-coated tablets with '100' engraved on one side. The diameter of the tablet is ~ 8.9 mm; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Registered

Дата Оторизация:

2020-10-28

Листовка

[MEDICINE NAME]
®
™
1
ERLOTINIB SANDOZ
®
_erlotinib hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Erlotinib Sandoz
tablets. 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 Erlotinib
Sandoz tablets against the benefits
they expect it will 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 ERLOTINIB SANDOZ
IS USED FOR
Erlotinib Sandoz contains the active
ingredient erlotinib.
Erlotinib Sandoz is used for the
treatment of non-small cell lung
cancer (NSCLC). It can be given
before or after initial chemotherapy if
your cancer has specific mutations in
a protein called epidermal growth
factor receptor (EGFR). It can also
be given later on when initial
chemotherapy has not worked.
Erlotinib Sandoz is also used in
combination with gemcitabine for the
treatment of pancreatic cancer.
Erlotinib Sandoz belongs to a group
of medicines called anti-neoplastic
(or anti-cancer) agents which are
used to treat cancer.
Erlotinib Sandoz prevents the activity
of the EGFR protein. This protein is
known to be involved in the growth
and spread of cancer cells.
Your doctor may have prescribed
Erlotinib Sandoz for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ERLOTINIB
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
Erlotinib Sandoz is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
ERLOTINIB SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ERLOTINIB SANDOZ IF:
1.
YOU HAVE HAD AN ALLERGIC
REACTION TO ERLOTINIB OR ANY
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Some symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body

Данни за продукта

200902-erlotinib sandoz-pi
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
ERLOTINIB SANDOZ
® (ERLOTINIB (AS HYDROCHLORIDE))
1.
NAME OF THE MEDICINE
Erlotinib (as hydrochloride)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Erlotinib Sandoz 25 mg film-coated tablet contains erlotinib
hydrochloride equivalent to
25 mg of erlotinib.
Each Erlotinib Sandoz 100 mg film-coated tablet contains erlotinib
hydrochloride equivalent
to 100 mg of erlotinib.
Each Erlotinib Sandoz 150 mg film-coated tablet contains erlotinib
hydrochloride equivalent
to 150 mg of erlotinib.
_Excipients with known effect: _
lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Erlotinib Sandoz 25 mg film-coated tablets are white to yellowish,
round biconvex, film-coated
tablets with ‘25’ engraved on one side. The diameter of the tablet
is ~ 6.1 mm.
Erlotinib Sandoz 100 mg film-coated tablets are white to yellowish,
round biconvex, film-
coated tablets with ‘100’ engraved on one side. The diameter of
the tablet is ~ 8.9 mm.
Erlotinib Sandoz 150 mg film-coated tablets are white to yellowish,
round biconvex, film-
coated tablets with ‘150’ engraved on one side. The diameter of
the tablet is ~ 10.5 mm.
_Not all strengths may be marketed in Australia._
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
Erlotinib Sandoz is indicated for the first-line treatment of patients
with advanced (Stage IIIB)
or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with
activating EGFR mutations.
Erlotinib Sandoz is indicated for maintenance therapy in patients with
locally advanced or
metastatic non-small cell lung cancer (NSCLC) with activating EGFR
mutations who have not
progressed on first-line chemotherapy.
Erlotinib Sandoz is also indicated for the treatment of patients with
locally advanced or
metastatic non- small cell lung cancer after failure of prior
chemotherapy.
PANCREATIC CANCER
Erlotinib Sandoz in combination with gemcitabine is indicated for th