natgillin/translations-raw huggingface dataset:
No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects.
Nisu dostupni podaci o štetnim događajima kod dojene dojenčadi, ali se ne očekuje da će unesene količine uzrokovati štetne događaje.
The causes of deaths were related to
Uzroci smrti bili su povezani s PAH-om.
Mysildecard brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Mysildecard snižava krvni tlak u plućima tako što proširuje krvne žile u plućima.
Other medicines and Mysildecard
Drugi lijekovi i Mysildecard
What Mysildecard contains - The active substance is sildenafil.
Što Mysildecard sadrži - Djelatna tvar je sildenafil.
In case of clinical deterioration in spite of Mysildecard treatment, alternative therapies should be considered.
U slučaju kliničkog pogoršanja unatoč liječenju lijekom Mysildecard, treba razmotriti druge mogućnosti liječenja.
Mysildecard film-coated tablets are white and round in shape.
Mysildecard filmom obložene tablete su bijele i okrugle.
Limited data suggests that the abrupt discontinuation of sildenafil is not associated with rebound worsening of pulmonary arterial hypertension.
Ograničeni podaci upućuju na to da nagli prekid primjene sildenafila nije povezan s povratnim pogoršanjem plućne arterijske hipertenzije.
Mysildecard has moderate influence on the ability to drive and use machines.
Mysildecard umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Mysildecard, before driving or using machines.
S obzirom na to da su u kliničkim ispitivanjima sildenafila prijavljene omaglica i promjene vida, bolesnici moraju biti svjesni kako bi Mysildecard na njih mogao djelovati prije nego upravljaju vozilom ili rukuju strojevima.
If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (e.g. epoprostenol) should be considered (see section 4.2).
Ako se klinička situacija pogoršava, mora se razmotriti primjena lijekova koji se preporučuju u teškoj fazi bolesti (npr. epoprostenol) (vidjeti dio 4.2).
Taking more Mysildecard than you should may increase the risk of known side effects.
Uzimanje više lijeka Mysildecard nego što je potrebno može povećati rizik od poznatih nuspojava.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će zadatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RPM), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
- ako uzimate lijekove za liječenje gljivičnih infekcija, kao što su ketokonazol ili itrakonazol, ili lijekove koji sadrže ritonavir (za liječenje HIV infekcije).
Mylan S.A.S 117 Allee des parcs 69800 Saint Priest France
Mylan S.A.S 117 Allee des parcs 69800 Saint Priest Francuska
Mysildecard is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Mysildecard se koristi za liječenje odraslih bolesnika te djece i adolescenata u dobi od 1 do 17 godina koji imaju visok krvni tlak u krvnim žilama u plućima (plućnu arterijsku hipertenziju).
When sildenafil and doxazosin were administered simultaneously to patients stabilised on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
Kada su se sildenafil i doksazosin istodobno primjenjivali u bolesnika stabiliziranih na terapiji doksazosinom, bilo je rijetkih prijava o bolesnicima u kojih se pojavila simptomatska posturalna hipotenzija.
What Mysildecard looks like and contents of the pack
Kako Mysildecard izgleda i sadržaj pakiranja
If you take more Mysildecard than you should
Ako uzmete više lijeka Mysildecard nego što ste trebali
What Mysildecard is and what it is used for What you need to know before you take Mysildecard How to take Mysildecard
Što je Mysildecard i za što se koristi Što morate znati prije nego počnete uzimati Mysildecard Kako uzimati Mysildecard
Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Infekcije i infestacije često celulitis, gripa, bronhitis, sinusitis, rinitis, gastroenteritis
In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
Općenito, bilo kakva prilagodba doze smije se primjeniti samo nakon pažljive procjene koristi i rizika.
Mysildecard can cause dizziness and can affect vision.
Mysildecard može izazvati omaglicu i može utjecati na vid.
90 film-coated tablets 300 film-coated tablets 90 x 1 film-coated tablets
90 filmom obloženih tableta 300 filmom obloženih tableta 90 × 1 filmom obloženih tableta
Mysildecard contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Mysildecard sadrži djelatnu tvar sildenafil, koji pripada skupini lijekova koji se nazivaju inhibitorima fosfodiesteraze tipa 5 (PDE5).
Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form due to the hypotensive effects of nitrates (see section 5.1).
Istodobna primjena s donorima dušikova oksida (poput amil nitrita) ili nitratima u bilo kojem obliku, zbog hipotenzivnih učinaka nitrata (vidjeti dio 5.1).
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Mylan Hungary Kft.
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Mylan Hungary Kft.
Film coat: hypromellose (6mPas), titanium dioxide (E171) and triacetin.
Film ovojnica: hipromeloza (6 mPas), titanijev dioksid (E171) i triacetin.
Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Riociguat: Pretklinička ispitivanja su pokazala dodatan učinak na sniženje sistemskog krvnog tlaka kada se PDE5 inhibitori koriste u kombinaciji sa riociguatom.
Other pharmaceutical forms are available for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets.
Drugi farmaceutski oblici su dostupni za primjenu u bolesnika tjelsne težine ≤ 20 kg i drugih mlađih bolesnika koji ne mogu progutati tablete.
The tablets are provided in blisters in packs containing 90, 300 and (90 x 1) tablets.
Tablete se isporučuju u blister pakiranjima koja sadrže 90, 300 i (90 x 1) tableta
The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients.
Tableta od 20 mg se ne bi trebala koristiti u slučajevima kada treba primijeniti 10 mg tri puta na dan u mlađih bolesnika.
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/min).
Nije potrebno prilagođavati početnu dozu u bolesnika s oštećenjem funkcije bubrega, uključujući i teško oštećenje bubrega (klirens kreatinina < 30 ml/min).
The tablets are marked with M on one side and SL over 20 on the other.
M na jednoj strani tablete i SL over 20 na drugoj strani tablete.
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost)
lijekove za liječenje plućne hipertenzije (npr. bosentan, iloprost).
The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (e.g. ambrisentan, iloprost) has not been studied in controlled clinical trials.
Djelotvornost i sigurnost sildenafila primijenjenog istodobno s drugim lijekovima za plućnu arterijsku hipertenziju (npr. ambrisentan, iloprost) nije ispitana u kontroliranim kliničkim ispitivanjima.
The European Medicines Agency has deferred the obligation to submit the results of studies with sildenafil in newborns with pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja sildenafila u novorođenčadi s plućnom arterijskom hipertenzijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
PVC-Al blister packs containing 90 or 300 film-coated tablets.
Blister od PVC Al koji sadrži 90 ili 300 filmom obloženih tableta.
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μM).
Sildenafil je slab inhibitor izoformi 1A2, 2C9, 2C19, 2D6, 2E1 i 3A4 citokroma P450 (IC50 > 150 m).
The primary objective of the study was to assess the efficacy of 16 weeks of chronic treatment with oral sildenafil in paediatric subjects to improve exercise capacity as measured by the Cardiopulmonary Exercise Test (CPET) in subjects who were developmentally able to perform the test, n = 115).
Primarni cilj istraživanja bio je procijeniti djelotvornost 16-tjednog kroničnog peroralnog liječenja sildenafilom u pedijatrijskih ispitanika na poboljšanje tjelesne sposobnosti, mjereno testom srčano-plućnog opterećenja (CPET test) u ispitanika koji su s obzirom na stupanj razvoja bili sposobni izvesti taj test (n = 115).
• Alpha-blocker therapy (e.g. doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of the two medicines may cause symptoms resulting in the lowering of your blood pressure (e.g. dizziness, light headedness).
alfa-blokatore (npr. doksazosin) za liječenje visokog krvnog tlaka ili tegoba s prostatom, jer kombinacija ovih dvaju lijekova može izazvati simptome niskog krvnog tlaka (npr. omaglicu, ošamućenost).
Patients with left ventricular ejection fraction < 45% or left ventricular shortening fraction < 0.2 were not studied.
Bolesnici s istisnom frakcijom lijeve klijetke od < 45% ili frakcijom skraćenja lijeve klijetke od < 0,2 nisu ispitivani.
• have low blood pressure at rest.
- imate nizak krvni tlak u mirovanju.
This medicinal product does not require any special storage condition.
Za ovaj se lijek ne primjenjuju posebne mjere čuvanja.
Mysildecard should not be given to women of child bearing potential unless using appropriate contraceptive methods.
Mysildecard se ne smije davati ženama reproduktivne dobi ako ne koriste odgovarajuće metode kontracepcije.
If you have an erection, which lasts continuously for more than 4 hours, stop taking Mysildecard and contact your doctor immediately (see also section 4).
Ako imate erekciju, koja neprekidno traje dulje od 4 sata, prestanite uzimati Mysildecard i odmah se javite liječniku (pogledajte i dio 4).
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilised on doxazosin therapy.
U tri specifična ispitivanja interakcija, lijekovi alfa-blokator doksazosin (4 mg i 8 mg) i sildenafil (25 mg, 50 mg ili 100 mg) su istovremeno primijenjeni bolesnicima s benignom hiperplazijom prostate (BHP), stabiliziranima na terapiji doksazosinom.
Patients were randomised to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5-125 mg twice a day).
Bolesnici su randomizirani u skupine sa placebom ili sa sildenafilom (20 mg tri puta na dan) u kombinaciji s bosentanom (62,5-125 mg dva puta na dan).
- The other ingredients are: Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate anhydrous, croscarmellose sodium and magnesium stearate.
- Drugi sastojci su: Jezgra tablete: mikrokristalična celuloza (PH 102), bezvodni kalcijev hidrogenfosfa, umreženi karmelozanatrij i magnezijev stearat.
175 patients (63%) included were diagnosed with primary pulmonary hypertension, 84 (30%) were diagnosed with PAH associated with connective tissue disease and 18 (7%) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions.
175 uključenih bolesnika (63%) imalo je dijagnozu primarne plućne hipertenzije, 84 (30%) dijagnozu PAH-a povezanog s bolešću vezivnog tkiva, a 18 (7%) dijagnozu PAH-a nastalog nakon kirurškog popravka prirođenih srčanih lezija.
In this trial, 63 of 234 (27%) patients were < 7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73%) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
U tom ispitivanju, 63 od 234 (27%) bolesnika bila su mlađa od 7 godina (niska doza sildenafila = 2; srednja doza = 17; visoka doza = 28; placebo = 16), dok je 171 od 234 (73%) bolesnika imao 7 ili više godina (niska doza sildenafila = 40; srednja doza = 38, visoka doza = 49; placebo = 44).
Subjects who had been in the placebo group in the short-term study were randomly reassigned to sildenafil treatment; subjects weighing ≤ 20 kg entered the medium or high dose groups (1:1), while subjects weighing > 20 kg entered the low, medium or high dose groups (1:1:1).
Ispitanici koji su bili u skupini koja je primala placebo u kratkotrajnom ispitivanju, bili su ponovno randomizirani za liječenje sildenafilom; ispitanici tjelesne težine ≤ 20 kg uključeni su u skupine sa srednjom ili visokom dozom (1:1), a ispitanici tjelesne težine > 20 kg uključeni su u skupine s niskom, srednjom ili visokom dozom (1:1:1).
Mysildecard is for oral use only.
Mysildecard je namijenjen samo za peroralnu primjenu.
Subjects (38% male and 62% female) had a body weight ≥8 kg, and had primary pulmonary hypertension (PPH) [33%], or PAH secondary to congenital heart disease [systemic-to-pulmonary shunt 37%, surgical repair 30%].
Ispitanici (38% muškog i 62% ženskog spola) su imali tjelesnu težinu  8 kg, a imali su primarnu plućnu hipertenziju (PPH) [33%] ili PAH kao posljedicu prirođene bolesti srca [sistemsko-plućni spoj u 37%, a kirurški zahvat u 30% slučajeva].
Suddenly stopping your treatment with Mysildecard may lead to your symptoms getting worse.
Nagli prekid liječenja lijekom Mysildecard može dovesti do pogoršanja simptoma.
• if you have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION).
- ako ste ikada doživjeli gubitak vida zbog problema s dotokom krvi u očni živac - stanja koje se zove nearterijska prednja ishemijska neuropatija vidnog živca.
• Medicines containing St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy)
lijekove koji sadrže gospinu travu (biljni lijek), rifampicin (koristi se za liječenje bakterijskih infekcija), karbamazepin, fenitoin i fenobarbital (koriste se, između ostalog, za liječenje epilepsije).
Co-administration of oral contraceptives (ethinyloestradiol 30 μg and levonorgestrel 150 μg) did not affect the pharmacokinetics of sildenafil.
Istovremena primjena oralnih kontraceptiva (etinilestradiol 30 µg i levonorgestrel 150 µg) nije utjecala na farmakokinetiku sildenafila.
Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active Treatment Group Treatment group
Tablica 2: Za placebo korigirana postotna (%) promjena vršnog VO2 u odnosu na početne vrijednosti po aktivno liječenim skupinama
In pulmonary arterial hypertension patients, the oral bioavailability of sildenafil after 80 mg three times a day was on average 43% (90% CI: 27% - 60%) higher compared to the lower doses.
U bolesnika s plućnom arterijskom hipertenzijom je bioraspoloživost sildenafila nakon peroralne primjene doze od 80 mg tri puta na dan bila u prosjeku 43% (90% CI: 27% - 60%) veća u usporedbi s nižim dozama.
Other pharmaceutical forms may be more appropriate for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets.
Drugi farmaceutski oblici mogu biti primjereniji za primjenu kod bolesnika koji imaju 20 kg ili manje i kod drugih mađih bolesnika koji ne mogu progutati tablete.
Consequently, should signs of pulmonary oedema occur when sildenafil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered.
Stoga, pojave li se znakovi plućnog edema kod primjene sildenafila u bolesnika s plućnom hipertenzijom, mora se uzeti u obzir moguću povezanost s vensko-okluzivnom bolesti.
PVC-Al blisters unit dose perforated blister pack containing 90 x 1 film-coated tablets.
PVC aluminijski perforirani blister djeljiv na jedinične doze koji sadrži 90 x 1 filmom obloženu tabletu.
Due to lack of data, Mysildecard should not be used in pregnant women unless strictly necessary.
Zbog nedostatnih podataka Mysildecard se ne smije primjenjivati u trudnica, osim ako to nije izričito potrebno.
• Recent history of stroke or myocardial infarction,
• u bolesnika koji su nedavno imali moždani udar ili infarkt miokarda,
In the placebo-controlled study of sildenafil in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients > 20 kg; no patients ≤ 20 kg received the low dose), medium (10 mg in patients ≥ 8-20 kg; 20 mg in patients ≥ 20-45 kg; 40 mg in patients > 45 kg) or high dose (20 mg in patients ≥ 8-20 kg; 40 mg in patients ≥ 20-45 kg; 80 mg in patients > 45 kg) regimens of sildenafil and 60 were treated with placebo.
U placebom kontroliranom ispitivanju sildenafil u bolesnika u dobi od 1 do 17 godina s plućnom arterijskom hipertenzijom ukupno su 174 bolesnika tri puta na dan primala nisku (10 mg u bolesnika tjelesne težine > 20 kg; niti jedan bolesnik tjelesne težine ≤ 20 kg nije primao nisku dozu), srednju (10 mg u bolesnika tjelesne težine ≥ 8-20 kg, 20 mg u bolesnika tjelesne težine ≥ 20-45 kg, 40 mg u bolesnika tjelesne težine > 45 kg) ili visoku dozu (20 mg u bolesnika tjelesne težine ≥ 8-20 kg, 40 mg u bolesnika tjelesne težine ≥ 20-45 kg; 80 mg u bolesnika tjelesne težine > 45 kg) sildenafila, dok je 60 bolesnika primalo placebo.
Mysildecard should not be used during pregnancy unless strictly necessary.
Mysildecard se ne smije primjenjivati u trudnoći, osim ako to nije izričito nužno.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg sildenafila (u obliku citrata).
What you need to know before you take Mysildecard
Što morate znati prije nego počnete uzimati Mysildecard
Sildenafil is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Sildenafil je kontraindiciran u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (vidjeti dio 4.3).
For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance < 325 metres, the treatment effect was 2.3 metres in favour of placebo.
U bolesnika koji su na početku ispitivanja mogli prehodati udaljenost od ≥ 325 metara, učinak liječenja iznosio je 38,4 metra u korist sildenafila; u bolesnika koji su na početku ispitivanja mogli prehodati udaljenost od < 325 metara, učinak liječenja iznosio je 2,3 metra u korist placeba.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
U ispitivanju hemodinamičkih učinaka jedne peroralne doze od 100 mg sildenafila u 14 bolesnika s teškom bolešću koronarnih arterija (stenoza > 70% u barem jednoj koronarnoj arteriji), srednja vrijednost sistoličkog krvnog tlaka u mirovanju snižena je za 7%, a dijastoličkog za 6% u odnosu na početne vrijednosti.
If you experience sudden decrease or loss of vision, stop taking Mysildecard and contact your doctor immediately (see also section 4).
Ako osjetite iznenadno smanjenje ili gubitak vida, prestanite uzimati Mysildecard i odmah se javite svom liječniku (pogledajte i dio 4.).
Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John's wort and rifampicine.
Mora se pomno nadzirati djelotvornost sildenafila u bolesnika koji istodobno uzimaju snažne induktore CYP3A4, poput karbamazepina, fenitoina, fenobarbitala, gospine trave i rifampicina.
The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43% and 66% higher, respectively, compared to patients not receiving these classes of medicines.
Izloženost sildenafilu u bolesnika koji su uzimali supstrate CYP3A4 bila je 43% veća, a u onih koji su uzimali supstrate CYP3A4 s beta-blokatorima 66% veća u usporedbi s bolesnicima koji nisu uzimali lijekove iz navedenih skupina.
The most common serious adverse events that occurred with a frequency ≥ 1% in sildenafil patients (combined doses) were pneumonia (7.4%), cardiac failure, pulmonary hypertension (each 5.2%), upper respiratory tract infection (3.1%), right ventricular failure, gastroenteritis (each 2.6%), syncope, bronchitis, bronchopneumonia, pulmonary arterial hypertension (each 2.2%), chest pain, dental caries (each 1.7%), and cardiogenic shock, gastroenteritis viral, urinary tract infection (each 1.3%).
Najčešća ozbiljna nuspojava koje se pojavila s učestalošću od ≥1% bolesnika koji su primali sildenafil (kombinirane doze) bila je pneumonija (7,4%), srčano zatajenje, plućna hipertenzija (svaki po 5,2%), infekcije gornjeg dišnog sustava (3,1%), zatajenje desnog ventrikula, gastroenteritis (svaki po 2,6%), sinkopa, bronhitis, bronhopneumonija, plućna arterijska hipertenzija (svaki 2,2%), bol u prsima, zubni karijes (svaki 1,7%) i kardiogeni šok, virusni gastroenteritis, infekcija urinarnog trakta (svaki 1,3%).
The most commonly reported adverse reactions that occurred (greater or equal to 10%) on sildenafil compared to placebo were headache, flushing, dyspepsia, diarrhoea and pain in extremity.
Najčešće prijavljene nuspojave koje su se javile (10% ili više) kod liječenja lijekom Mysildecard u odnosu na placebo bile su glavobolja, navale crvenila, dispepsija, proljev i bol u ekstremitetu.
If you stop taking Mysildecard
Ako prestanete uzimati Mysildecard
Efficacy and safety in adult patients with PAH (when used in combination with bosentan) A randomised, double-blind, placebo controlled study was conducted in 103 clinically stable subjects with PAH (WHO FC II and III) who were on bosentan therapy for a minimum of three months.
Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno je u 103 klinički stabilnih bolesnika s PAH-om (WHO FC II i III) koji su se liječili bosentanom najmanje tri mjeseca.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: DD month YYYY
DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
If you forget to take Mysildecard
Ako ste zaboravili uzeti Mysildecard
Marketing Authorisation Holder: Mylan S.A.S
Nositelj odobrenja za stavljanje lijeka u promet: Mylan S.A.S
Common pyrexia *These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
Opći poremećaji i reakcije na mjestu primjene često pireksija * Ove nuspojave prijavljene su u bolesnika koji su uzimali sildenafil za liječenje muške erekcijske disfunkcije.
Women of childbearing potential and contraception in males and females Due to lack of data on effects of sildenafil in pregnant women, Mysildecard is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Zbog nedostatka podataka o učincima sildenafila u trudnica ne preporučuje se primjena lijeka Mysildecard u žena reproduktivne dobi, osim ako istodobno ne primjenjuju odgovarajuće mjere kontracepcije.