ERLOTINIB ARX erlotinib (as hydrochloride) 25 mg film-coated tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

erlotinib hydrochloride, Quantity: 27.317 mg (Equivalent: erlotinib, Qty 25 mg)

Tilgjengelig fra:

Accelagen Pty Ltd

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: propylene glycol; magnesium stearate; lactose monohydrate; sodium lauryl sulfate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; hyprolose

Administreringsrute:

Oral

Enheter i pakken:

30

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Non-Small cell lung cancer,ERLOTINIB ARX 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 ARX 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 ARX 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 ARX in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Produkt oppsummering:

Visual Identification: White-coloured, round shaped, biconvex film-coated tablets, debossed with E 25 on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisasjon status:

Registered

Autorisasjon dato:

2020-08-12

Informasjon til brukeren

Erlotinib APOTEX CMI Ver 0.2
1
ERLOTINIB APOTEX
_FILM-COATED TABLETS _
_contains the active ingredient erlotinib hydrochloride _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Erlotinib APOTEX 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
APOTEX 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 APOTEX IS
USED FOR
Erlotinib APOTEX contains the
active ingredient erlotinib
hydrochloride.
Erlotinib APOTEX 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 APOTEX is also used in
combination with gemcitabine for
the treatment of pancreatic
cancer.
Erlotinib APOTEX belongs to a
group of medicines called anti-
neoplastic (or anti-cancer) agents
which are used to treat cancer.
Erlotinib APOTEX 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 APOTEX for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ERLOTINIB
APOTEX HAS BEEN PRESCRIBED
FOR YOU.
Erlotinib APOTEX is not
addictive.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE ERLOTINIB
APOTEX
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ERLOTINIB APOTEX
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
bre

Preparatomtale

ERLOTINIB PI Ver 0.3
1
AUSTRALIAN PRODUCT INFORMATION – ERLOTINIB APOTEX (ERLOTINIB
HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Erlotinib hydrochloride
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Erlotinib APOTEX film coated tablets are available in 3 dosage
strengths containing erlotinib
hydrochloride equivalent to 25 mg, 100 mg or 150 mg of erlotinib.
Excipients with known effect
Each 25 mg film-coated tablet contains 17.47 mg Lactose monohydrate.
Each 100 mg film-coated tablet contains 69.86 mg Lactose monohydrate.
Each 150 mg film-coated tablet contains 104.80 mg Lactose monohydrate.
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Erlotinib APOTEX 25 mg film-coated tablets are white-coloured, round
shaped, biconvex film-coated
tablets, debossed with ‘E 25’ on one side and plain on the other
side.
Erlotinib APOTEX 100 mg film-coated tablets are white coloured, round
shaped, biconvex film-
coated tablets debossed with ‘E 100’ on one side and plain on the
other side.
Erlotinib APOTEX 150 mg film-coated tablets are white coloured, round
shaped, biconvex film-
coated tablets engraved with ‘E 150’ on one side and plain on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
Erlotinib APOTEX 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 APOTEX 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 APOTEX 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 APOTEX in combination with gemcitabine is indicated for the
treatment of patients with
locally advanced, unresectable or metastatic pancreatic cancer.
4.2 DO