Examples of using Ofev in English and their translations into German
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Colloquial
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Official
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Ecclesiastic
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Medicine
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Financial
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Ecclesiastic
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Political
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Computer
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Programming
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Official/political
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Political
Ofev 150 mg twice daily.
Other information about Ofev.
Do not stop taking Ofev without consulting your doctor first.
If you stop taking Ofev.
Ofev should only be initiated at least 4 weeks after abdominal surgery.
Other medicines and Ofev.
In this case your doctor will prescribe Ofev 100 mg capsules for your treatment.
The CHMP considered that Ofev has been shown to be effective at slowing down the worsening of lung function in patients with IPF.
There is no specific antidote or treatment for Ofev overdose.
Do not breastfeed during the treatment with Ofev since there may be a risk for harm to the breast- feeding child.
Ofev has been compared with placebo(a dummy treatment) in two main studies involving a total of 1,066 patients with IPF.
If the patient becomes pregnant while receiving Ofev, she should be apprised of the potential hazard to the foetus.
Patients with mild hepatic impairment(Child Pugh A)should be treated with a reduced dose of Ofev see sections 4.2 and 5.2.
You should take your next 100mg dose of Ofev as planned at the next scheduled time recommended by your doctor or pharmacist.
Ofev must not be used in patients who are hypersensitive(allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Do not take more than the recommended dose of two Ofev 100 mg capsules per day if your daily dose was reduced to 200 mg per day.
Ofev can only be obtained with a prescription, and treatment should be started by a doctor experienced in the diagnosis and treatment of IPF.
If you do not tolerate the recommended dose of two Ofev 150 mg capsules per day(see possible side effects in section 4) your doctor may reduce the daily dose of Ofev.
Ofev 150 mg soft capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and“150”.
If transaminase(AST or ALT) elevations> 3x ULN are measured,dose reduction or interruption of the therapy with Ofev is recommended and the patient should be monitored closely.
The safety and efficacy of Ofev has not been studied in patients with moderate(Child Pugh B) or severe(Child Pugh C) hepatic impairment.
A further analysis of the results of the 2 main studies, which took into account that some patients stopped treatment,confirmed the benefits of Ofev over placebo, although the difference in FVC between the two was less pronounced.
In the INPULSIS trials with Ofev, the frequency of patients who experienced bleeding AEs was slightly higher in the Ofev arm(10.3%) than in the placebo arm 7.8.
In case of interruptions due to aspartate aminotransferase(AST) or alanine aminotransferase(ALT) elevations> 3x upper limit of normal(ULN), oncetransaminases have returned to baseline values, treatment with Ofev may be reintroduced at a reduced dose(100 mg twice daily) which subsequently may be increased to the full dose(150 mg twice daily) see sections 4.4 and 4.8.
Treatment with Ofev should therefore only be initiated or- in case of perioperative interruption- resumed based on clinical judgement of adequate wound healing.
The summary of the opinion of the Committee for Orphan Medicinal Products for Ofev can be found on the Agency's website: ema. europa.eu/Find medicine/Human medicines/Rare disease designation.
In both studies, patients taking Ofev had a smaller decline in FVC than patients taking placebo, meaning that Ofev slowed down the worsening of the condition.
If you do not tolerate the recommended dose of two Ofev 100 mg capsules per day(see possible side effects in section 4) your doctor may advise you to stop taking this medicine.
Once transaminases have returned to baseline values, treatment with Ofev may be resumed at the full dose(150 mg twice daily) or reintroduced at a reduced dose(100 mg twice daily) which subsequently may be increased to the full dose see section 4.2.