OFEV SOFT CAPSULES 150MG

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Nintedanib ethanesulfonate 180.60mg eqv Nintedanib

Disponível em:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

Código ATC:

L01XE31

Forma farmacêutica:

CAPSULE, LIQUID FILLED

Composição:

Nintedanib ethanesulfonate 180.60mg eqv Nintedanib 150mg

Via de administração:

ORAL

Tipo de prescrição:

Prescription Only

Fabricado por:

Catalent Germany Eberbach GmbH

Status de autorização:

ACTIVE

Data de autorização:

2016-01-14

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OFEV
® SOFT CAPSULES 100 MG
OFEV
® SOFT CAPSULES 150 MG
Nintedanib (as esilate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What OFEV is and what it is used for
2.
What you need to know before you take OFEV
3.
How to take OFEV
4.
Possible side effects
5.
How to store OFEV
6.
Contents of the pack and other information
7.
Marketing Authorisation Holder and Manufacturer
8.
Product registration number
9.
Date of revision
1. WHAT OFEV IS AND WHAT IT IS USED FOR
OFEV contains the active substance nintedanib, a medicine belonging to
the class of so-called
tyrosine kinase inhibitors. OFEV is used for the treatment of
non-small cell lung cancer (NSCLC),
idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial
lung diseases (ILDs) with a
progressive phenotype and systemic sclerosis associated interstitial
lung disease (SSc-ILD) in adults.
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 reduce scarring and
stiffening of the lungs.
CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES (ILDS) WITH A PROGRESSIVE
PHENOTYPE
Besides IPF, there are other conditions in which the tissue in your
lungs becomes thickened, stiff,
and scarred over time (lung fibrosis) and keeps worsening (progressive
phenotype). Examples

Características técnicas

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OFEV
®
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1. NAME OF THE MEDICINAL PRODUCT
OFEV Soft Capsules 100 mg
OFEV Soft Capsules 150 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
OFEV 100 MG SOFT CAPSULES
1 capsule contains 100 mg of nintedanib (= free base)
corresponding to 120.4 mg 1_H_-Indole-6-carboxylic acid,
2,3-dihydro-3-[[[4-[methyl[(4- methyl-1-
piperazinyl)acetyl] amino]phenyl] amino]phenylmethylene]-2-oxo-,
methyl ester, (3_Z_)-,
ethanesulfonate (1:1) (= nintedanib esilate).
OFEV 150 MG SOFT CAPSULES
1 capsule contains 150 mg of nintedanib (= free base)
corresponding to 180.6 mg 1_H_-Indole-6-carboxylic acid,
2,3-dihydro-3-[[[4-[methyl[(4- methyl-1-
piperazinyl)acetyl] amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl
ester, (3_Z_)-,
ethanesulfonate (1:1) (= nintedanib esilate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Soft capsule.
OFEV 100 MG SOFT CAPSULES: Peach-colored, opaque, oblong, soft gelatin
capsules, imprinted in black on
one side with Boehringer Ingelheim company symbol and with“100”,
and containing a bright yellow
viscous suspension.
OFEV 150 MG SOFT CAPSULES: Brown-colored, opaque, oblong, soft gelatin
capsules, imprinted in black on
one side with Boehringer Ingelheim company symbol and with“150”,
and containing a bright yellow
viscous suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OFEV is indicated in combination with docetaxel for the treatment of
adult patients with locally
advanced, metastatic or locally recurrent non-small cell lung cancer
(NSCLC) of adenocarcinoma tumour
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histology after first line chemotherapy.
OFEV
is indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
OFEV is indicated for the treatment of chronic fibrosing Interstitial
Lung Diseases (ILDs) with a
progressive phenotype [see section Clinical Efficacy and Safety]
OFEV is indicated to slow the rate of decline in pulmonary function in
patients with systemic sclerosis
associated interstitial lung disease (SSc-ILD).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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