Giotrif

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Afatinib dimaleate 29.56mg equivalent to Afatinib 20 mg

Tillgänglig från:

Boehringer Ingelheim (NZ) Ltd

INN (International namn):

Afatinib dimaleate 29.56 mg (= Afatinib 20 mg)

Dos:

20 mg

Läkemedelsform:

Film coated tablet

Sammansättning:

Active: Afatinib dimaleate 29.56mg equivalent to Afatinib 20 mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Lactose monohydrate Macrogol 400 Magnesium stearate Microcrystalline cellulose Polysorbate 80 Purified talc Titanium dioxide

Receptbelagda typ:

Prescription

Tillverkad av:

Boehringer Ingelheim Pharma GmbH & Co KG

Terapeutiska indikationer:

GIOTRIF is indicated as monotherapy for the treatment of patients with: Locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. Tumours must have Epidermal Growth Factor Receptor (EGFR) mutations. Locally advanced or metastatic non-small cell carcinoma of the lung of squamous histology progressing on or after platinum-based chemotherapy.

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, PVC/PvDC/Al blister sheet in Alu laminate pouch in carton - 7 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/PvDC/Al blister sheet in Alu laminate pouch in carton - 14 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Blister pack, PVC/PvDC/Al blister sheet in Alu laminate pouch in carton - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

Tillstånd datum:

2014-01-06

Bipacksedel

GIOTRIF NZ CMI v02
1
GIOTRIF
®
_FILM-COATED TABLETS _
_afatinib (as dimaleate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Giotrif.
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 this medicine
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor or from
www.medsafe.govt.nz/
Consumers/cmi/CMIForm.asp and
may contain important information
about the medicine and its use of
which you should be aware.
KEEP THIS INFORMATION WITH THE
MEDICINE.
You may need to read it again.
WHAT GIOTRIF IS USED
FOR
Giotrif contains the active substance
afatinib (as afatinib dimaleate).
Giotrif belongs to a group of
medicines called antineoplastic (or
anti-cancer) agents.
It works by blocking the activity of a
group of proteins from the ErbB
family, which includes a protein
called Epidermal Growth Factor
Receptor (EGFR). These proteins are
known to be involved in the growth
and spread of cancer cells. By
blocking the activity of these proteins
Giotrif stops the cancer cells from
growing and multiplying.
Giotrif is used to treat adult patients
with a type of lung cancer called
non-small cell lung cancer (NSCLC):
•
of non-squamous type identified
with a change (mutation) in the
gene for EGFR. Giotrif can be
prescribed to you as your first
treatment or if your cancer has
progressed after receiving
chemotherapy
•
of squamous type if your cancer
has progressed after receiving
chemotherapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY GIOTRIF HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Giotrif for another reason.
This medicine is available only wi

Produktens egenskaper

1
GIOTRIF NZ DS v06
NEW ZEALAND DATASHEET
1. PRODUCT NAME
GIOTRIF 20 mg film-coated tablets
GIOTRIF 30 mg film-coated tablets
GIOTRIF 40 mg film-coated tablets
GIOTRIF 50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
GIOTRIF 20 mg film-coated tablets
One film-coated tablet contains 20 mg afatinib (as dimaleate)
Excipient
with
known
effect:
One
film-coated
tablet
contains
123.86
mg
of
lactose
monohydrate
GIOTRIF 30 mg film-coated tablets
One film-coated tablet contains 30 mg afatinib (as dimaleate)
Excipient
with
known
effect:
One
film-coated
tablet
contains
185.79
mg
of
lactose
monohydrate
GIOTRIF 40 mg film-coated tablets
One film-coated tablet contains 40 mg afatinib (as dimaleate)
Excipient
with
known
effect:
One
film-coated
tablet
contains
247.72
mg
of
lactose
monohydrate
GIOTRIF 50 mg film-coated tablets
One film-coated tablet contains 50 mg afatinib (as dimaleate)
Excipient
with
known
effect:
One
film-coated
tablet
contains
309.65
mg
of
lactose
monohydrate
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
GIOTRIF 20 mg film-coated tablets
White to slightly yellowish, round, biconvex and bevel-edged
film-coated tablet debossed with
the code “T20” on one side and the Boehringer Ingelheim company
logo on the other.
GIOTRIF 30 mg film-coated tablets
Dark blue, round, biconvex and bevel-edged film-coated tablet debossed
with the code “T30”
on one side and the Boehringer Ingelheim company logo on the other.
GIOTRIF 40 mg film-coated tablets
Light blue, round, biconvex and bevel-edged film-coated tablet
debossed with the code “T40”
on one side and the Boehringer Ingelheim company logo on the other.
GIOTRIF 50 mg film-coated tablets
Dark blue, oval and biconvex film-coated tablet debossed with the code
“T50” on one side and
the Boehringer Ingelheim company logo on the other.
Afatinib dimaleate is a white to brownish yellow powder. It is highly
soluble in water and
in aqueous buffer media up to pH 6 (> 50 mg/mL). Between pH 6 and 7,
the solub