natgillin/translations-raw huggingface dataset:
Individual patients may require additional titration of their methadone dosage when Victrelis is started or stopped to ensure clinical effect of methadone.
Pojedinim bolesnicima može biti potrebna dodatna titracija doze metadona kada se Victrelis uvodi ili prekida, kako bi se osigurao klinički učinak metadona.
Medicinal products by therapeutic areas
Lijekovi po terapijskim područjima
The European Medicines Agency has deferred the obligation to submit the results of studies with Victrelis in one or more subsets of the paediatric population in chronic viral hepatitis C (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Victrelis u jednoj ili više podskupina pedijatrijske populacije u kroničnom hepatitisu C (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
ASSESSMENT* (HCV-RNA Results
PROCJENA* (razina HCV-RNK
%, (n/N) 69 (72/105) 75 (77/103) EOT % (n/N) 79 (83/105) 86 (89/103)
%, (n/N) 69 (72/105) 75 (77/103) EOT %, (n/N) 79 (83/105) 86 (89/103) Relaps
• oral midazolam or oral triazolam - a sedative, given by mouth
• oralni midazolam ili oralni triazolam - sedativ koji se uzima kroz usta
Use in patients with an organ transplant
Primjena u bolesnika s transplantiranim organom
Talk to your doctor or pharmacist before taking your medicine if you:
Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek:
Continue with all three medicines (PR + Victrelis) and finish through TW 36; and then
Nastavite sa sva tri lijeka (PR + Victrelis) i završite tijekom TL 36; a zatim
Victrelis contains lactose (a type of sugar).
Victrelis sadrži laktozu (vrstu šećera).
Boceprevir covalently, yet reversibly, binds to the NS3 protease active site serine (Ser139) through a (alpha)-ketoamide functional group to inhibit viral replication in HCV-infected host cells.
Boceprevir se kovalentno, ali reverzibilno, veže na aktivno mjesto NS3 serinske proteaze (Ser139) pomoću (alfa)-ketoamidne funkcionalne skupine, kako bi spriječio replikaciju virusa u HCV-om zaraženim stanicama domaćina.
Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Bolesnike koji uzimaju estrogene kao zamjensku hormonsku terapiju treba klinički nadzirati zbog moguće pojave znakova nedostatka estrogena.
Patients should be monitored for signs of opiate toxicity associated with buprenorphine.
Bolesnike treba nadzirati zbog moguće pojave znakova opioidne toksičnosti povezane s buprenorfinom.
Venous thrombosis
venska tromboza
Clear polychlorotrifluoroethylene /PVC/aluminium blisters containing 4 hard capsules per blister cavity.
Prozirni poliklorotrifluoroetilen/PVC/aluminij blisteri sa 4 tvrde kapsule u blisterskoj jažici.
Subjects randomized to receive ribavirin dose reduction (N=249)
Ispitanici randomizirani da primaju sniženu dozu ribavirina (N=249)
Do not take Victrelis in combination with peginterferon alfa and ribavirin if you: • are allergic to boceprevir or any of the other ingredients of this medicine (listed in section 6)
Nemojte uzimati Victrelis u kombinaciji s peginterferonom alfa i ribavirinom: • ako ste alergični na boceprevir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
Boceprevir has a mean apparent volume of distribution (Vd/F) of approximately 772 l at steady state.
Boceprevir ima prividan volumen distribucije (Vd/F) od oko 772 l u stanju dinamičke ravnoteže.
Maraviroc 150 mg twice daily when co-administered with boceprevir.
Maravirok 150 mg dvaput na dan kada se primjenjuje istodobno s boceprevirom.
• have hepatitis C other than genotype 1
• ako imate hepatitis C koji nije genotipa 1
The percent change and arrows (↑ = increase, ↓ = decrease, ↔ = no change) are used to show the magnitude and direction of change in mean ratio estimate for each pharmacokinetic parameter.
Postotak promjene i strelice (↑ = povećanje, ↓ = smanjenje, ↔ = nema promjene) pokazuju opseg i smjer promjene procijenjene srednje vrijednosti omjera za svaki farmakokinetički parametar.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne smiju uzimati ovaj lijek.
IL28B rs12979860 Genotype
Genotip IL28B rs12979860
Food enhanced the exposure of boceprevir by up to 60% at the 800 mg three times daily dose when administered with a meal relative to the fasting state.
Hrana je pojačala izloženost bocepreviru za do 60% pri dozi od 800 mg triput na dan kad se primjenjivao uz obrok u odnosu na primjenu natašte.
If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Ako Vaša partnerica nije trudna, ali je reproduktivne dobi, mora raditi test na trudnoću svaki mjesec tijekom liječenja i 7 mjeseci po njegovu završetku.
An increase in plasma concentrations of substrates of the P-gp efflux transporter, such as digoxin or dabigatran, should be anticipated (see table 2).
Treba očekivati povećanje plazmatskih koncentracija supstrata za efluksni transporter P-gp, poput digoksina ili dabigatrana (vidjeti Tablicu 2).
Prolonged exposure resulted in a 2-log decrease in RNA levels by Day 15.
Produljena izloženost dovela je do smanjenja razine RNK od 2-log do 15. dana.
%, (n/N) 73 (80/110) 79 (90/114) EOT %, (n/N) 86 (95/110) 89 (101/114) Relapse
%, (n/N) 73 (80/110) 79 (90/114) EOT %, (n/N) 86 (95/110) 89 (101/114)
• medicine used to treat symptoms of an enlarged prostate - doxazosin and tamsulosin
• lijekove koji se koriste za liječenje simptoma povećane prostate - doksazozin i tamsulozin
The last available value in the period at and after FW 24.
Posljednja dostupna vrijednost u ili nakon 24. tjedna praćenja.
• Detailed information about the risk of haematological disorders (notably anaemia) associated with Victrelis, consisting of factual description of the haematological disorders in terms of frequency and time to onset and related clinical symptoms
Detaljne informacije o riziku od hematoloških poremećaja (osobito anemije) povezanih s lijekom Victrelis, koje se sastoje od činjeničnog opisa hematoloških poremećaja u smislu učestalosti i vremena do nastupa te s njima povezanih kliničkih simptoma.
Victrelis is a strong inhibitor of CYP3A4/5.
Victrelis je snažan inhibitor CYP3A4/5.
Given the incremental risk of adverse events with Victrelis (anaemia notably); in case the patient cannot tolerate the treatment, consideration could be given to pursue with 12 weeks of bitherapy for the final 12 weeks of treatment instead of tritherapy (see sections 4.8 and 5.1).
Obzirom na povećan rizik od nuspojava s lijekom Victrelis (osobito anemije), u slučaju da bolesnik ne podnosi liječenje, može se razmotriti da se u posljednjih 12 tjedana liječenja primjenjuje dvojna umjesto trojne terapije (vidjeti dijelove 4.8 i 5.1).
• antimicrobial medicine - pentamidine
• antibiotik - pentamidin
Victrelis may be used in adults who are previously untreated for HCV infection or who have previously used medicines called ‘interferons' and ‘pegylated interferons'.
Victrelis se može primjenjivati u odraslih osoba koje prethodno nisu liječile HCV infekciju kao i u onih koji su ranije koristili lijekove koji se nazivaju "interferonima" i "pegiliranim interferonima".
In an in vitro dog Purkinje fiber study, boceprevir prolonged the action potential duration with inverse frequency dependence; the clinical relevance remains uncertain.
U jednom in vitro istraživanju Purkinjeovih vlakana u pasa, boceprevir je produljio trajanje akcijskog potencijala uz inverznu frekvencijsku ovisnost; važnost za kliničku primjenu nije poznata.
Pharmacokinetic results were similar between healthy subjects and HCV-infected subjects.
Farmakokinetički rezultati zdravih ispitanika bili su slični rezultatima ispitanika zaraženih HCV-om.
Continue with all three medicines (peginterferon alfa and ribavirin [PR] + Victrelis) and finish through Treatment Week 28 (TW 28).
Nastavite sa sva tri lijeka (peginterferon alfa i ribavirin [PR] + Victrelis) i završite tijekom 28. tjedna liječenja (TL 28).
At Treatment Week 8
U 8. tjednu liječenja
The recommended dose of Victrelis is 800 mg administered orally three times daily (TID) with food (a meal or light snack).
Preporučena doza lijeka Victrelis je 800 mg peroralno triput na dan, s hranom (uz obrok ili lagani međuobrok).
Do not use this medicine after the expiry date which is stated on the carton and blisterfoil after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i foliji blistera iza oznake "EXP".
A genetic variant near the gene encoding interferon-lambda-3 (IL28B rs12979860, a C to T change) is a strong predictor of response to peginterferon alfa-2b/ribavirin.
Genetska varijanta na mjestu gena koji kodira interferon-lambda-3 (IL28B rs12979860, promjena C u T) je snažan pretkazatelj odgovora na peginterferon alfa2-b/ribavirin.
• pimozide or lurasidone - used for mental health problems
• pimozid ili lurasidon - za liječenje psihičkih problema
Subjects were treated with 4 weeks of PR followed by 44 weeks of Victrelis or placebo with PR.
Ispitanici su primali PR tijekom 4 tjedna, a zatim tijekom 44 tjedna Victrelis ili placebo s PR-om.
The D168V single substitution did not reduce sensitivity to boceprevir.
Pojedinačna supstitucija D168V nije smanjila osjetljivost na boceprevir.
Boceprevir is primarily metabolized by aldoketo reductase (AKR).
Boceprevir se prvenstveno metabolizira pomoću aldoketoreduktaze (AKR).
A 3-year follow-up study of subjects who achieved SVR with a Victrelis-based regimen showed that > 99% (693/696) of patients maintained their SVR (no relapse) through the available follow-up period
Trogodišnje ispitivanje praćenja ispitanika koji su postigli SVR uz terapiju temeljenu na lijeku Victrelis pokazalo je da je > 99% (693/696) bolesnika održalo SVR (bez relapsa) tijekom dostupnog razdoblja praćenja (medijan trajanja od 3,4 godine).
No effects on foetal development have been observed in rats and rabbits (see section 5.3).
Nisu opaženi učinci na fetalni razvoj u štakora i kunića (vidjeti dio 5.3).
If a patient misses a dose and it is 2 or more hours before the next dose is due, the patient should take the missed dose with food and resume the normal dosing schedule.
Ako bolesnik propusti dozu, a do sljedeće je doze ostalo 2 sata ili više, bolesnik treba uzeti propuštenu dozu s hranom i nastaviti s uobičajenim rasporedom doziranja.
Co-administration of atazanavir/ritonavir with boceprevir resulted in lower exposure of atazanavir which may be associated with lower efficacy and loss of HIV control.
Istodobna primjena atazanavira/ritonavira s boceprevirom izazvala je smanjenu izloženost atazanaviru, što može biti povezano sa slabijom djelotvornošću i gubitkom kontrole nad HIV-om.
Evaluation of varying combinations of boceprevir and interferon alfa-2b that produced 90% suppression of replicon RNA showed additivity of effect; no evidence of synergy or antagonism was
Ispitivanja različitih kombinacija boceprevira i interferona alfa-2b koje su dovele do 90%-tne supresije RNK replikona pokazala su aditivnost učinka; nisu pronađeni dokazi sinergije niti antagonizma.
Patients without cirrhosis who are previously untreated or who have failed previous therapy The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials (see section 5.1).
Bolesnici bez ciroze koji prethodno nisu bili liječeni ili koji nisu odgovorili na prethodnu terapiju Sljedeće preporuke za doziranje se za neke podskupine razlikuju u odnosu na doze ispitivane u ispitivanjima faze III (vidjeti dio 5.1).
It is unknown what effect therapy with Victrelis will have on the activity of subsequently administered HCV protease inhibitors, including re-treatment with Victrelis.
Nije poznato koji će učinak terapija lijekom Victrelis imati na djelovanje naknadno primijenjenih inhibitora HCV proteaze, uključujući i ponovno liječenje lijekom Victrelis.
ANTI-INFECTIVES Antifungals
ANTIINFEKTIVI Antimikotici
Subjects were on an antiretroviral regimen with stable HIV disease (HIV-1 viral load < 50 copies/mL and CD4 count ≥ 200 cells/µL).
Ispitanici su bili na antiretrovirusnoj terapiji i imali stabilnu HIV bolest (virusno opterećenje HIV-1 < 50 kopija/ml i broj CD4 stanica ≥ 200 stanica/µl).
Boceprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, human peripheral blood lymphocyte and mouse micronucleus assays.
Boceprevir nije bio genotoksičan u nizu testova in vitro ili in vivo, uključujući testove mutagenosti bakterija, humanih limfocita u perifernoj krvi i mišjih mikronukleusa.
The concomitant use of Victrelis with rifampicin or anticonvulsants (such as phenytoin, phenobarbital or carbamazepine) may significantly reduce the plasma exposure of boceprevir.
Istodobna primjena lijeka Victrelis s rifampicinom ili antikonvulzivima (kao što su fenitoin, fenobarbital ili karbamazepin) može značajno smanjiti izloženost bocepreviru u plazmi.
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
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
• quetiapine - used to treat schizophrenia, bipolar disorder and major depressive disorder
• kvetiapin - za liječenje shizofrenije, bipolarnog poremećaja te velikog depresivnog poremećaja
Table 2 provides dosing recommendations as a result of drug interactions with Victrelis.
U Tablici 2 navedene su preporuke za doziranje s obzirom na interakcije s lijekom Victrelis.
The most common HIV PI taken was atazanavir followed by lopinavir and darunavir.
Najčešće korišten inhibitor HIV proteaze bio je atazanavir, a zatim lopinavir i darunavir.
This regimen has only been tested in subjects who have failed previous therapy who were late responders (see section 5.1).
Ovaj režim liječenja ispitivan je samo u bolesnika koji nisu odgovorili na prethodnu terapiju, a koji su imali kasni odgovor (vidjeti dio 5.1).
Mental illness: changes in mood; feeling like your life is falling apart; seeing, feeling or hearing things that are not real (hallucinations); thoughts of killing yourself (suicide), trying to kill yourself; feeling of great happiness (mania) and then a feeling of deep sadness or not being
Psihičke bolesti: promjene raspoloženja; osjećaj da Vam se život raspada; halucinacije (kada vidite, osjećate ili čujete stvari koje nisu stvarne); razmišljanje o samoubojstvu, pokušaj samoubojstva; osjećaj velike sreće (manija), a nakon toga osjećaj duboke tuge ili bezvrijednosti
The safety profile of Victrelis in HCV/HIV-1 co-infected patients (n=64) was overall similar to the safety profile in mono-infected HCV patients.
Sigurnosni profil lijeka Victrelis u bolesnika s istodobnom HCV/HIV-1 infekcijom (n=64) sveukupno je bio sličan sigurnosnom profilu u bolesnika zaraženih samo HCV-om.
If you are not sure, talk to your doctor or pharmacist before taking Victrelis.
Ako niste sigurni, porazgovarajte s liječnikom ili ljekarnikom prije nego uzmete Victrelis.
Alternative contraceptives should be considered (see section 4.5).
Treba razmotriti primjenu nekog drugog kontraceptiva (vidjeti dio 4.5).
Co-administration of Victrelis with an oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is unlikely to alter the contraceptive effectiveness.
Nije vjerojatno da bi istodobna primjena lijeka Victrelis i oralnog kontraceptiva koji sadrži etinilestradiol i najmanje 1 mg noretindrona mogla izmijeniti djelotvornost kontraceptiva.
Multipack: 336 (4 packs of 84) hard capsules
Višestruko pakiranje: 336 tvrdih kapsula (4 kutije sa 84 tvrde kapsule)
After this period, the medicinal product should be disposed.
Nakon tog razdoblja lijek se treba zbrinuti.
Adverse reactions are listed by System Organ Class (see Table 3).
Nuspojave su navedene prema klasifikaciji organskih sustava (vidjeti Tablicu 3).
• have ever had a blood problem such as anaemia (when you lack enough healthy red blood cells, which transport oxygen around your body)
• ako ste nekad imali probleme s krvlju, kao što je anemija (premali broj zdravih crvenih krvnih stanica koje prenose kisik po organizmu)
At steady-state, the exposure ratio for the two diastereomers is approximately 2:1, with the predominant diastereomer being pharmacologically active.
U stanju dinamičke ravnoteže, omjer izloženosti za dva dijastereoizomera iznosi oko 2:1, s tim da je farmakološki aktivan onaj dijastereoizomer koji
Do not take Victrelis if any of the above apply to you.
Nemojte uzimati Victrelis ako se nešto od navedenog odnosi na Vas.
Boceprevir/metabolites are excreted in rat milk (see section 5.3).
Boceprevir/metaboliti izlučuju se u mlijeko štakorica (vidjeti dio 5.3).
No clinically significant differences in pharmacokinetic parameters were observed between patients with end-stage renal disease (ESRD) and healthy subjects.
Nisu opažene klinički značajne razlike u farmakokinetičkim parametrima između bolesnika s krajnjim stadijem bubrežne bolesti i zdravih ispitanika.
If serum haemoglobin concentrations continued to decrease to ≤ 8.5 g/dL, subjects could be treated with additional anaemia interventions, including the use of erythropoietin or ribavirin dose reduction.
Ako su ispitanicima koncentracije hemoglobina u serumu nastavile padati do ≤ 8,5 g/dl, moglo ih se liječiti dodatnim interventnim terapijama za anemiju, uključujući primjenu eritropoetina ili snižavanje
• immunosuppressants - tacrolimus, sirolimus, cyclosporine
• imunosupresive - takrolimus, sirolimus, ciklosporin
• hormonal replacement therapy - oestrogen-based medicines
• hormonsku nadomjesnu terapiju - lijekove na bazi estrogena
Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia (see section 5.1).
Snižavanje doze ribavirina je strategija kojoj se daje prednost u liječenju anemije koja se javlja pri liječenju (vidjeti dio 5.1).
Potent CYP3A4 inducers
Snažni induktori CYP3A4
Combined use with peginterferon alfa-2a as compared to alfa-2b:
Kombinacija s peginterferonom alfa-2a u usporedbi s alfa-2b:
ORAL CONTRACEPTIVES Drospirenone/Ethinyl estradiol*: (drospirenone
Drospirenon/etinilestradiol*: (drospirenon
Victrelis contains the active ingredient boceprevir which helps to fight against hepatitis C infection by stopping the virus multiplying.
Victrelis sadrži djelatnu tvar boceprevir koja pomaže u liječenju hepatitisa C tako što zaustavlja umnožavanje virusa.
Boceprevir was absorbed following oral administration with a median Tmax of 2 hours.
Boceprevir se apsorbira nakon peroralne primjene uz medijan Tmax od 2 sata.
Caution should be exercised with medicines known to prolong QT interval such as amiodarone, quinidine, methadone, pentamidine and some neuroleptics.
Potreban je oprez kod primjene lijekova koji produljuju QT-interval, kao što su amiodaron, kinidin, metadon, pentamidin i neki neuroleptici
In medicine interaction trials conducted with AKR inhibitors diflunisal and ibuprofen, boceprevir exposure did not increase to a clinically significant extent.
U ispitivanjima interakcija lijekova provedenima s inhibitorima AKR-a diflunisalom i ibuprofenom, izloženost bocepreviru nije se povećala do klinički značajne razine.
Do not take Victrelis if you are taking any of the medicines above.
Nemojte uzimati Victrelis ako uzimate neki od navedenih lijekova.
This is not observed in mice
Ovo nije opaženo u miševa niti majmuna.
A study with peginterferon alfa-2a in treatment experienced patients gave consistent results as compared to the study P05101 (see section 4.4).
Rezultati ispitivanja s peginterferonom alfa-2a u bolesnika koji su prethodno bili liječeni bili su konzistentni u usporedbi s ispitivanjem P05101 (vidjeti dio 4.4).
Close clinical monitoring is warranted.
Neophodan je poman klinički nadzor.
Peelable blisters containing 12 hard capsules (3x4 capsule blister strip).
Blisteri koji se odljepljuju sadrže 12 tvrdih kapsula (blister kartice sa 3x4 kapsule).
Mean age of subjects randomized was 52.7 years.
Srednja dob randomiziranih ispitanika bila je 52,7 godina.
Injection-site reactions have not been included since Victrelis is administered orally.
Reakcije na mjestu injekcije nisu uključene jer se Victrelis primjenjuje peroralno.
The V55I and D168N single substitutions did not reduce sensitivity to boceprevir.
Pojedinačne supstitucije V55I i D168N nisu smanjile osjetljivost na boceprevir.
For data regarding drug-drug interactions with antiretroviral agents, see section 4.5.
Za podatke o interakcijama s antiretrovirusnim lijekovima vidjeti dio 4.5.
A clinical drug interaction study with digoxin demonstrated that boceprevir is a mild P-gp inhibitor in vivo, increasing digoxin exposure by 19%.
Kliničko ispitivanje interakcija lijekova s digoksinom pokazalo je da je boceprevir blag inhibitor P-gp-a in vivo te da povećava izloženost digoksinu za 19%.
• The other ingredients are sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-gelatinized starch, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin, and shellac.
• Drugi sastojci su: natrijev laurilsulfat, mikrokristalična celuloza, laktoza hidrat, umrežena karmelozanatrij, prethodno geliran škrob, magnezijev stearat, željezov oksid, žuti (E172), željezov oksid, crveni (E172), titanijev dioksid (E171), želatina i šelak.
In rats, boceprevir induced reversible effects on fertility and early embryonic development in female rats at exposures 1.2-fold the human exposure at the recommended therapeutic dose.
U štakora je boceprevir uzrokovao reverzibilne učinke na plodnost i rani embrionalni razvoj pri izloženosti ženki 1,2 puta većoj od izloženosti u ljudi pri preporučenim terapijskim dozama.
Boceprevir has not been studied in patients with decompensated cirrhosis (see section 5.2).
Boceprevir nije ispitivan u bolesnika s dekompenziranom cirozom (vidjeti dio 5.2).
If haemoglobin is < 10 g/dL (or < 6.2 mmol/L) management of anaemia may be warranted (see
Ako je koncentracija hemoglobina < 10 g/dl (ili < 6,2 mmol/l), možda će biti potrebno liječiti anemiju (vidjeti dio 4.8).
The data available (see section 5.3) warrant caution in patients at risk of QT prolongation (long
Dostupni podaci (vidjeti dio 5.3) upućuju na oprez u bolesnika s rizikom od produljenja QT-intervala (urođeni dugi QT, hipokalijemija).
Boceprevir was shown to be devoid of embryonic or teratogenic potential in both rats and rabbits at maternotoxic dose levels.
Pokazalo se da boceprevir nema embriogeni ili teratogeni potencijal ni u štakora ni u zečeva pri dozama toksičnim za majku.
Indeed, serum progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels indicated that ovulation was suppressed during coadministration of norethindrone 1 mg/ethinyl estradiol 0.035 mg with Victrelis (see section 4.6).
Štoviše, razine progesterona, luteinizirajućeg hormona (LH) i folikulostimulirajućeg hormona (FSH) u serumu ukazivale su na supresiju ovulacije kod istodobne primjene noretindrona 1 mg/etinilestradiola 0,035 mg i lijeka Victrelis (vidjeti dio 4.6).
• ‘ergot' type medicines, such as dihydro-ergotamine, ergonovine, ergotamine or methylergonovine - used for migraine and cluster headaches
• lijekove iz skupine derivata ergota, kao što su dihidroergotamin, ergonovin, ergotamin ili metilergonovin - za liječenje migrene i "cluster" glavobolja
• difficulty breathing or swallowing, wheezing, hives, itching, swelling of your face, eyes, lips,
• otežano disanje ili gutanje, piskanje pri disanju, koprivnjaču, svrbež, oticanje lica, očiju, usana,
Heart or circulation: abnormal or rapid heart rate; heart disease caused by poor blood flow in
Srce i cirkulacija: neuobičajeno ili vrlo brzo kucanje srca; srčana bolest uzrokovana slabim