Examples of using Opsumit in English and their translations into Polish
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Computer
Opsumit contains the active substance macitentan,
Patients in the study received either Opsumit or placebo(a dummy treatment)
Opsumit is supplied as 10 mg film-coated tablets in blister packs of 15
Around 37% of patients taking placebo had a worsening of their PAH symptoms compared with 24% of those who took Opsumit 10 mg.
Opsumit is contraindicated during pregnancy and in women of
Opsumit must therefore not be used in pregnant
If a patient is hypersensitive to soya, Opsumit must not be used see section 4.3.
healthcare professionals with information on the precautions to be taken when using Opsumit.
age of 75 years, therefore Opsumit should be used with caution in this population see section 4.2.
However, as animal studies showed an adverse effect on the development of embryos, Opsumit must never be used in pregnant women
Opsumit had been shown to be effective in reducing illness or deaths due to PAH
your doctor will ask you to take a pregnancy test before you start taking Opsumit and regularly(once a month) while you are taking Opsumit.
The most common side effects with Opsumit(which may affect more than 1 in 10 people) are nasopharyngitis(inflammation of the nose
by clinical symptoms of liver injury(e.g., jaundice), Opsumit treatment should be discontinued.
You need to use a reliable form of birth control(contraception) while you are taking Opsumit.
therefore Opsumit is not recommended in this population see sections 4.2 and 5.2.
The MAH shall ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Opsumit are provided with a Prescriber Kit containing the following.
If the patient misses a dose of Opsumit, the patient should be told to take it as soon as possible and then take the next dose at the regularly scheduled time.
Opsumit treatment should only be initiated in women of childbearing potential when the absence of pregnancy has been verified, appropriate advice on contraception provided, and reliable contraception is practised see sections 4.3 and 4.4.
Opsumit must not be initiated in patients with severe hepatic impairment,