OFEV 100 MG

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

NINTEDANIB AS ESILATE

Verfügbar ab:

BOEHRINGER INGELHEIM ISRAEL LTD.

Darreichungsform:

CAPSULES SOFT

Zusammensetzung:

NINTEDANIB AS ESILATE 100 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

Anwendungsgebiete:

Idiopathic Pulmonary Fibrosis OFEV is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adults. Systemic Sclerosis-Associated Interstitial Lung DiseaseOFEV is indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).Chronic Fibrosing Interstitial Lung Diseases with a Progressive PhenotypeOFEV is indicated in adults for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype

Berechtigungsdatum:

2020-10-31

Gebrauchsinformation

307860-09
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OFEV
®
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OFEV
®
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
OFEV
®
100 MG
Soft capsules
Nintedanib
Each capsule of Ofev 100 mg contains nintedanib 100 mg (as esilate)
OFEV
®
150 MG
Soft capsules
Nintedanib
Each capsule of Ofev 150 mg contains nintedanib 150 mg (as esilate)
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For a list of inactive ingredients - see Section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have further questions, refer
to the physician or
pharmacist. This medicine has been prescribed to treat your medical
condition. Do not pass it on to
others; it may harm them, even if it seems to you that their medical
condition is similar to yours.
IMPORTANT INFORMATION FOR WOMEN OF CHILDBEARING AGE:
OFEV MAY CAUSE BIRTH DEFECTS OR EVEN DEATH OF UNBORN BABIES. DO NOT
GET PREGNANT DURING
TREATMENT WITH OFEV. WOMEN CAPABLE OF GETTING PREGNANT MUST HAVE A
PREGNANCY TEST BEFORE
STARTING TREATMENT WITH OFEV. WOMEN CAPABLE OF GETTING PREGNANT MUST
USE HIGHLY EFFECTIVE
CONTRACEPTION AT THE START OF TREATMENT, DURING TREATMENT WITH OFEV
AND FOR AT LEAST 3 MONTHS AFTER
THE LAST DOSE. CONTRACEPTIVE MEDICINES MAY NOT WORK AS WELL IN WOMEN
HAVING VOMITING, DIARRHEA,
OR OTHER PROBLEMS REDUCING THE MEDICINE’S ABSORPTION. IF YOU HAVE
ANY OF THESE PROBLEMS, TALK WITH
YOUR PHYSICIAN ABOUT WHICH HIGHLY EFFECTIVE BIRTH CONTROL METHOD IS
RIGHT FOR YOU. IF YOU BECOME
PREGNANT OR PLAN TO BECOME PREGNANT WHILE TAKING OFEV, CONTACT YOUR
PHYSICIAN RIGHT AWAY.
1. WHAT IS THIS MEDICINE INTENDED FOR?
•
The medicine is intended to treat lung disease called idiopathic
pulmonary fibrosis (IPF) in adults.
•
The medicine is intended to treat adults with chronic (long lasting)
fibrosing interstitial lung
diseases (ILDs) with a progressive phenotype.
•
The medicine is intended to slow the rate of decline in pulmonary
function in patients with
systemic sclerosi

Fachinformation

Ofev
Prescribing Information
100 mg, 150 mg
February 2022
1
OFEV
NINTEDANIB
SOFT CAPSULES
100 MG, 150 MG
FULL PRESCRIBING INFORMATION
1 NAME OF THE MEDICINAL PRODUCT
Ofev 100 mg
Ofev 150 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Ofev 100 mg soft capsule contains 100 mg nintedanib;
Each Ofev 150 mg soft capsule contains 150 mg nintedanib;
3
PHARMACEUTICAL FORM
Soft capsules.
4
INDICATIONS AND USAGE
4.1 IDIOPATHIC PULMONARY FIBROSIS
OFEV
is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)
in adults.
4.2 CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES WITH A PROGRESSIVE
PHENOTYPE
OFEV is indicated in adults for the treatment of chronic fibrosing
interstitial lung diseases (ILDs)
with a progressive phenotype
4.3 SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE
OFEV is indicated to slow the rate of decline in pulmonary function in
patients with systemic
sclerosis associated interstitial lung disease (SSc-ILD).
5
DOSAGE AND ADMINISTRATION
_ _
5.1 TESTING PRIOR TO OFEV ADMINISTRATION
Conduct liver function tests in all patients and a pregnancy test in
females of reproductive potential
prior to initiating treatment with OFEV [see Warnings and Precautions
(8.2, 8.4)].
5.2 RECOMMENDED DOSAGE
The recommended dosage of OFEV is 150 mg taken orally twice daily
administered approximately 12
hours apart.
Ofev
Prescribing Information
100 mg, 150 mg
February 2022
Boehringer Ingelheim Israel Ltd. 2
Administration Information
OFEV capsules should be taken with food _[see Clinical Pharmacology
(14.3)]_
and swallowed
whole with liquid. OFEV capsules should not be chewed
or crushed because of a bitter taste.
The
effect of chewing or crushing of the capsule on the pharmacokinetics
of nintedanib is not known.
Information for Missed Dose
If a dose of OFEV
_ _
is missed, the next dose should be taken at the next scheduled time.
Advise the
patient to not make up for a missed dose. Do not exceed the
recommended maximum daily dosage of
300 mg.
5.3 RECOMMENDED DOSAGE FOR PATIENTS WITH HEPATIC IMPAIRMENT
Mild Hepa