OFEV Soft Capsules 100 mg

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

Nintedanib esilate

Διαθέσιμο από:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Διεθνής Όνομα):

Nintedanib esilate

Μονάδες σε πακέτο:

60capsule Capsules; 120capsule Capsules

Κατασκευάζεται από:

Catalent Germany Eberbach GmbH

Φύλλο οδηγιών χρήσης

OFEV
® SOFT CAPSULES
Nintedanib (100 mg, 150 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What OFEV is used for
2.
How OFEV works
3.
Before you use OFEV
4.
How to use OFEV
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of OFEV
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
1. WHAT OFEV
IS USED FOR
OFEV is used for the treatment of
Idiopathic Pulmonary Fibrosis (IPF).
OFEV is used to treat people with other
chronic (long lasting) fibrosing
interstitial lung diseases (ILDs) in which
lung fibrosis continues to worsen
(progressive phenotype).
OFEV is used to slow the rate of decline
in lung function in patients with systemic
sclerosis-associated interstitial lung
disease (SSc-ILD).
2. HOW OFEV WORKS
OFEV capsules contain the active
substance nintedanib, a medicine
belonging to the class of
tyrosine kinase
inhibitors.
_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.
_Other 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 of
these conditions are hypersensitivity
pneumonitis, autoimmune ILDs (e.g.
rheumatoid arthritis associated ILD),
idiopathic nonspecific interstitial
pneumonia, unclassifiable idiopathic
interstitial pneumonia, and other ILDs.
_Systemic sclerosis associated interstitial _
_lung disease (SSc-ILD) _
Systemic sclerosis (SSc), also known as
scleroderma, is a rare chronic
autoimmune disease that affects
connective tissue in many parts of the
body. SSc causes fibrosis of the skin and
other internal organs such as the lungs.
When the

Αρχείο Π.Χ.Π.

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Ofev
®
Abcd
1. NAME OF THE MEDICINAL PRODUCT
OFEV Soft Capsules 100 mg
OFEV Soft Capsules 150 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 100 mg nintedanib (as esilate)
One capsule contains 150 mg nintedanib (as esilate)
Excipient of animal origin: Gelatin (porcine)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Soft capsule.
100 mg 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.
150 mg 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 adults for the treatment of Idiopathic Pulmonary
Fibrosis (IPF).
OFEV is also indicated in adults for the treatment of other chronic
fibrosing interstitial lung diseases
(ILDs) with a progressive phenotype (see section 5.1 “Clinical
Trials”).
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
Adults
Treatment should be initiated by physicians experienced in the
diagnosis and treatment of conditions for
which OFEV is indicated.
Posology
The recommended dose is 150 mg nintedanib twice daily administered
approximately 12 hours apart.
The 100 mg twice daily dose is only recommended to be used in patients
who do not tolerate the 150 mg
twice daily dose.
If a dose is missed, administration should resume at the next
scheduled time at the recommended dose.
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If a dose is missed the patient should not take an additional dose.
The recommended maximum daily
dose of 300 mg should not be exceeded.
_Dose adjustments _
In addition to symptomatic treatment if applicable, the management of
adverse effe