Ofev
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
29-02-2024
Valmisteyhteenveto
(SPC)
29-02-2024
Julkisesta arviointikertomuksesta
(PAR)
28-07-2020
Aktiivinen ainesosa:
nintedanib
Saatavilla:
Boehringer Ingelheim International GmbH
ATC-koodi:
L01XE
INN (Kansainvälinen yleisnimi):
nintedanib
Terapeuttinen ryhmä:
Antineoplastic agents
Terapeuttinen alue:
Idiopathic Pulmonary Fibrosis
Käyttöaiheet:
Ofev is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Tuoteyhteenveto:
Revision: 24
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2015-01-14
Pakkausseloste
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OFEV 100 MG SOFT CAPSULES
nintedanib
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
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, and it is used for the treatment of idiopathic
pulmonary fibrosis (IPF), other 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 further
scarring and stiffening of the lungs.
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 interstitia
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ofev 100 mg soft capsules
Ofev 150 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ofev 100 mg soft capsules
One soft capsule contains 100 mg nintedanib (as esilate)
_Excipient with known effect_
Each 100 mg soft capsule contains 1.2 mg of soya lecithin.
Ofev 150 mg soft capsules
One soft capsule contains 150 mg nintedanib (as esilate)
_Excipient with known effect_
Each 150 mg soft capsule contains 1.8 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule (capsule).
Ofev 100 mg soft capsules
Ofev 100 mg soft capsules are peach-coloured, opaque, oblong
soft-gelatin capsules
(approx. 16 x 6 mm) marked on one side with the Boehringer Ingelheim
company symbol and “100”.
Ofev 150 mg soft capsules
Ofev 150 mg soft capsules are brown-coloured, opaque, oblong
soft-gelatin capsules
(approx. 18 x 7 mm) marked on one side with the Boehringer Ingelheim
company symbol and “150”.
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).
Ofev is indicated in adults for the treatment of systemic sclerosis
associated interstitial lung disease
(SSc-ILD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by physicians experienced in the
management of diseases for which
Ofev is approved.
Posology
_Adults_
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.
3
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 take an additional dose.
The recommended maximum daily
dose of
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