OFEV nintedanib (as esilate) 100 mg soft capsule blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

nintedanib esilate, Quantity: 120.4 mg (Equivalent: nintedanib, Qty 100 mg)

Mevcut itibaren:

Boehringer Ingelheim Pty Ltd

INN (International Adı):

nintedanib esilate

Farmasötik formu:

Capsule, soft

Kompozisyon:

Excipient Ingredients: Hard fat; lecithin; glycerol; iron oxide red; Gelatin; medium chain triglycerides; titanium dioxide; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Uygulama yolu:

Oral

Paketteki üniteler:

60 soft capsules

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

OFEV is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after failure of first line chemotherapy.,OFEV is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).,OFEV is also indicated for the treatment of other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype.,OFEV is indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Ürün özeti:

Visual Identification: Peach-coloured, opaque, oblong, soft gelatin capsules imprinted in black on one side with the Boehringer Ingelheim company logo and 100; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2015-09-01

Bilgilendirme broşürü

OFEV
®
_SOFT CAPSULES_
_nintedanib (as esilate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ofev.
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 Ofev against
the benefits they expect it will have
for you.
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.medicines.org.au (Australia)
and may contain important
information about the medicine and
its use of which you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OFEV IS USED FOR
Ofev contains the active ingredient
nintedanib (as esilate).
Nintedanib is a tyrosine kinase
inhibitor that works by blocking the
activity of a group of proteins which
are involved in the building and the
growth of blood vessels. These blood
vessels are necessary to provide
growing cancer cells with nutrients
and oxygen. By blocking the activity
of these proteins, nintedanib can
inhibit the growth and the spread of
cancer cells.
Ofev is used in combination with the
chemotherapy docetaxel to treat a
type of lung cancer called Non-Small
Cell Lung Cancer (NSCLC). It is
used in adult patients with a certain
type of lung cancer called
adenocarcinoma who have already
received one treatment with another
medicine to treat this cancer but
whose tumour started to grow again.
Ofev is also used for the treatment of
Idiopathic Pulmonary Fibrosis (IPF).
IPF is a condition in which the tissue
in your lungs becomes thickened,
stiff and scarred over time. As a
result, scarring reduces the ability to
transfer oxygen from the lungs into
the bloodstream and it becomes
difficult to breathe deeply. Ofev
helps to reduc

Ürün özellikleri

OFEV PI0153-14
1
AUSTRALIAN PRODUCT INFORMATION – OFEV
® NINTEDANIB (AS ESILATE) CAPSULES
1 NAME OF THE MEDICINE
nintedanib esilate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
OFEV are soft gelatin capsules for oral administration containing 100
mg or 150 mg nintedanib
(as nintedanib esilate).
Excipients with known effect:
Each OFEV 100 mg capsule contains 1.2 mg of soya lecithin.
Each OFEV 150 mg capsule contains 1.8 mg of soya lecithin.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
OFEV 100 mg capsules are peach-coloured, opaque, oblong, soft gelatin
capsules imprinted
in black on one side with the Boehringer Ingelheim company logo and
“100”. The capsules
contain a bright yellow viscous suspension.
OFEV 150 mg capsules are brown-coloured, opaque, oblong, soft gelatin
capsules imprinted
in black on one side with the Boehringer Ingelheim company logo and
“150”. The capsules
contain a bright yellow viscous suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OFEV is indicated in combination with docetaxel for the treatment of
patients with locally
advanced, metastatic or recurrent non-small cell lung cancer (NSCLC)
of adenocarcinoma
tumour histology after failure of first line chemotherapy.
OFEV is indicated for the treatment of Idiopathic Pulmonary Fibrosis
(IPF).
OFEV is also indicated for the treatment of other chronic fibrosing
Interstitial Lung Diseases
(ILDs) with a progressive phenotype.
OFEV is indicated for slowing the rate of decline in pulmonary
function in patients with systemic
sclerosis-associated interstitial lung disease (SSc-ILD).
4.2 DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
OFEV capsules should be taken orally, preferably with food, swallowed
whole with water, and
should not be chewed.
If a dose is missed, administration should resume at the next
scheduled time at the
recommended dose. If a dose is missed, the patient should not be given
an additional dose.
The capsule should not be opened or crushed. If contact wi