natgillin/translations-raw huggingface dataset:
You will feel tired, very thirsty and hungry (without gaining weight) and will pass more urine than usual (common).
Osjećat ćete se umorno, vrlo žedno i gladno
An increase in the daily dose of Oslif Breezhaler beyond the maximum dose of 300 microgram is not appropriate.
Povećanje dnevne doze iznad doze od 300 mikrograma nije primjereno.
Musculoskeletal and connective tissue disorders Muscle spasm
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Grčevi mišića
Carton containing 10 capsules and one Oslif Breezhaler inhaler.
Kutija sadrži 10 kapsula i jedan Oslif Breezhaler inhalator.
Sympathomimetic medicinal products
Simpatomimetički lijekovi
INSTRUCTIONS FOR USE OF OSLIF BREEZHALER INHALER
UPUTE ZA PRIMJENU OSLIF BREEZHALER INHALATORA
Blisters
BLISTERI
Store in the original package in order to protect from moisture and do not remove until immediately before use.
Čuvati u originalnom pakiranju radi zaštite od vlage te izvaditi tek neposredno prije primjene.
Always use the new Oslif Breezhaler inhaler that comes with your new pack.
Uvijek koristite Oslif Breezhaler inhalator koji se nalazi u Vašem novom pakiranju.
Open inhaler:
Otvorite inhalator:
Store in the original blister in order to protect from moisture and do not remove until immediately before use.
Čuvati u originalnom blisteru radi zaštite od vlage i izvaditi tek neposredno prije primjene.
if you have epilepsy.
ako imate epilepsiju. ako imate problema sa štitnjačom (tireotoksikoza). ako imate šećernu bolest.
In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
T val, produljenje QT intervala i depresija ST segmenta, iako nije poznata klinička važnost tih pojava.
Never place a Oslif Breezhaler capsule directly into the mouthpiece of the Oslif Breezhaler inhaler.
Nikada ne stavljajte Oslif Breezhaler kapsulu direktno u nastavak za usta Oslif Breezhaler inhalatora.
Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Oslif Breezhaler.
Prema iskustvima nakon stavljanja gotovog lijeka u promet zabilježeni su slučajevi preosjetljivosti povezani s primjenom Oslif Breezhalera.
Upper respiratory tract infection
Infekcije gornjeg dišnog sustava
Transparent (uncoloured) capsules containing a white powder, with “IDL 300” printed in blue above a blue bar and company logo ( ) printed in blue below the blue bar.
Prozirne (bezbojne) kapsule koje sadrže bijeli prašak, s plavom oznakom „IDL 300“ otisnutom iznad plave crte te plavim logom proizvođača ( ) otisnutim ispod plave crte.
• Hold the inhaler upright with the mouthpiece pointing up.
• Držite inhalator uspravno tako da nastavak za usta gleda prema gore.
• Dispose of each inhaler after 30 days of use.
• Svaki inhalator treba baciti nakon 30 dana primjene.
60 capsules + 2 inhalers
60 kapsula + 2 inhalatora
Only use the Oslif Breezhaler inhaler contained in this pack.
Koristite samo Oslif Breezhaler inhalator koji se nalazi u ovom pakiranju.
The magnitude of exposure increases due to interactions does not raise any safety concerns given the safety experience of treatment with Oslif Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended therapeutic dose.
Iskustvo iz ispitivanja vezanih uz sigurnost liječenja Oslif Breezhalerom u trajanju do jedne godine u dozama dvostruko većim od najveće preporučene terapijske doze pokazuje da se s porastom izloženosti zbog interakcija ne smanjuje sigurnost primjene lijeka.
10 capsules and 1 inhaler.
10 kapsula i 1 inhalator.
• Only use the Oslif Breezhaler inhaler contained in this pack.
• Koristite samo Oslif Breezhaler inhalator koji se nalazi u ovom pakiranju.
• When you start a new pack, only use the new Oslif Breezhaler inhaler that is supplied in the pack.
• Kada otvorite novo pakiranje, koristite samo novi Oslif Breezhaler inhalator koji se nalazi u ovom pakiranju.
Transparent (uncoloured) capsules containing a white powder, with “IDL 150” printed in black above a black bar and company logo ( ) printed in black below the black bar.
Prozirne (bezbojne) kapsule koje sadrže bijeli prašak, s crnom oznakom „IDL 150“ otisnutom iznad crne crte te crnim logom proizvođača ( ) otisnutim ispod crne crte.
90 capsules + 3 inhalers
90 kapsula + 3 inhalatora
30 capsules and 1 inhaler.
30 kapsula i 1 inhalator.
300 capsules + 30 inhalers
300 kapsula + 30 inhalatora
What Oslif Breezhaler is
Što je Oslif Breezhaler
Never take the Oslif Breezhaler inhaler apart.
Nikad nemojte rastavljati Oslif Breezhaler inhalator.
Do not swallow the capsules.
Ne gutajte kapsule.
• itching/rash
• svrbež/osip
Carton containing 30 capsules and 1 inhaler.
Kutija koja sadrži 30 kapsula i 1 inhalator.
Do not store the capsules in the Oslif Breezhaler inhaler.
Ne čuvajte kapsule u Oslif Breezhaler inhalatoru.
How to store Oslif Breezhaler Contents of the pack and other information
Kako Oslif Breezhaler izgleda i sadržaj pakiranja
Carton containing 10 capsules and 1 inhaler.
Kutija koja sadrži 10 kapsula i 1 inhalator.
Multipack: 90 (3 packs of 30 capsules and 1 inhaler).
Višestruko pakiranje: 90 (3 pakiranja od 30 kapsula i 1 inhalator).
Multipack: 300 (30 packs of 10 capsules and 1 inhaler).
Višestruko pakiranje: 300 (30 pakiranja od 10 kapsula i 1 inhalator).
Do not swallow Oslif Breezhaler capsules.
Ne gutajte Oslif Breezhaler kapsule.
Multipack: 60 (2 packs of 30 capsules and 1 inhaler).
Višestruko pakiranje: 60 (2 pakiranja od 30 kapsula i 1 inhalator).
Immediately before use, with dry hands, remove one capsule from the blister.
Suhim rukama izvadite jednu kapsulu iz blistera neposredno prije primjene.
10 capsules + 1 inhaler 30 capsules + 1 inhaler
Prašak inhalata, tvrde kapsule 10 kapsula + 1 inhalator 30 kapsula + 1 inhalator
Never blow into the mouthpiece of the Oslif Breezhaler inhaler.
Nikad ne pušite u nastavak za usta Oslif Breezhaler inhalatora.
How much Oslif Breezhaler to use
Koliko Oslif Breezhalera primijeniti
Oslif Breezhaler 150 microgram inhalation powder, hard capsules Oslif Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Oslif Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule Oslif Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule indakaterol
Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol.
Svaka kapsula sadrži 150 mikrograma indakaterola u obliku indakaterolmaleata.
Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol.
Svaka kapsula sadrži 300 mikrograma indakaterola u obliku indakaterolmaleata.
42 b
42 a b
Dizziness
Nuspojave
b: indacaterol 150 and
c: indakaterolom u dozi od
What Oslif Breezhaler is used for
Za što se koristi Oslif Breezhaler
Store in the blister in order to protect from moisture and only remove immediately before use.
Čuvati u blisteru radi zaštite od vlage te ih se smije vaditi samo neposredno prije primjene.
Oslif Breezhaler 150 microgram inhalation powder, hard capsules
Oslif Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule
Oslif Breezhaler 300 microgram inhalation powder, hard capsules
Oslif Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule
Oslif Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Oslif Breezhaler 300 mikrograma prašak inhalata, tvrde kapsule indakaterol
• chest pain
• bol u prsima
General disorders and administration site conditions Chest pain
Opći poremećaji i reakcije na mjestu primjene Bol u prsima
Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler).
Višestruko pakiranje koje sadrži 30 pakiranja (svaki sadrži 10 kapsula i 1 inhalator).
Oslif Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Oslif Breezhaler 150 mikrograma prašak inhalata, tvrde kapsule indakaterol
How to use Oslif Breezhaler
Kako primijeniti Oslif Breezhaler
Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler).
Višestruko pakiranje koje sadrži 3 pakiranja (svaki sadrži 30 kapsula i 1 inhalator).
Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler).
Višestruko pakiranje koje sadrži 2 pakiranja (svako sadrži 30 kapsula i 1 inhalator).
How to store Oslif Breezhaler
Kako čuvati Oslif Breezhaler
Never wash the Oslif Breezhaler inhaler with water.
Nikad nemojte prati Oslif Breezhaler vodom.
Gelatin
Tahikardija
46 b a n/e a
55 a n/p
Button
Poklopac
Tachycardia
Tipka
Reduction in puffs/day of rescue medication use vs. baseline a
Smanjenje broja inhalacija/dan primijenjenog lijeka za hitno ublažavanje simptoma naspram početne vrijednosti
1.5 b
1,3 a b b b
By 30 June 2019
Do 30. lipnja 2019.
In order to remove any traces of cow's milk proteins from their finished product, the MAHs should replace the current formulations in their marketing authorisations with formulations free from cow's milk proteins and submit for assessment the corresponding documentation to the relevant National Competent Authorities:
Kako bi uklonili sve tragove bjelančevina iz kravljeg mlijeka iz gotovog proizvoda, nositelji odobrenja za stavljanje u promet moraju zamijeniti postojeće formulacije u svojim odobrenjima za stavljanje u promet formulacijama koje ne sadrže bjelančevine iz kravljeg mlijeka i predati na procjenu odgovarajuću dokumentaciju mjerodavnim nacionalnim nadležnim tijelima:
Condition
Uvjet
Annex IV Condition to the marketing authorisations
Prilog IV. Uvjeti odobrenja za stavljanje u promet
Condition to the marketing authorisations
Uvjeti odobrenja za stavljanje u promet
Date of opening: _______
Datum otvaranja: _______
Risk Management Plan (RMP)
- Plan upravljanja rizikom (RMP)
Date of first authorisation: 8 February 2018
Datum prvog odobrenja: 8. veljače 2018.
Tablet dimension: 20 x 11 mm.
Dimenzije tablete: 20 x 11 mm.
Keep the tablet bottle with you so that you can easily describe what you have taken.
Ponesite sa sobom bočicu s tabletama, tako da možete lakše opisati što ste uzeli.
Resistance analysis by week 144
Analiza rezistencije do 144. tjedna
if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
ako je bilo koji član Vaše obitelji (roditelji ili njihovi roditelji, braća ili sestre) iznenada umro uslijed srčanih problema ili je rođen sa srčanim problemom.
M=Failure
M=neuspjeh
Test Reference
test referenca
Additional risk minimisation measures
- Dodatne mjere minimizacije rizika
LABEL for a bottle
NALJEPNICA za bočicu
3, catatonia
3, katatonija
→ Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Liječnika odmah obavijestite o novim ili neobičnim simptomima nakon što se prestanete liječiti, osobito o simptomima koje dovodite u vezu s infekcijom hepatitisom B.
Modified LOCF
Prilagođeni LOCF
Table 6: Summary of pharmacokinetic data from study GS-US-177-0105
Tablica 6: Sažetak farmakokinetičkih podataka iz ispitivanja GS-US-177-0105
Common: - anorexia
Često: - anoreksija
if you have severe liver disease.
ako bolujete od teške bolesti jetre.
if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
ako Vam je liječnik rekao da imate visoke ili niske razine elektrolita u krvi kao što je kalij ili magnezij.
EU/1/17/1263/001 30 film-coated tablets EU/1/17/1263/002 90 (3 x 30) film-coated tablets
EU/1/17/1263/001 30 filmom obloženih tableta EU/1/17/1263/002 90 (3 x 30) filmom obloženih tableta
*lower than recommended doses; similar findings are expected with recommended doses.
* manje od preporučenih doza; slični rezultati očekuju se s darunavir:
Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Neklinički podaci o emtricitabinu ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, reproduktivne i razvojne toksičnosti.
3, dizziness (8.5%)
3, omaglica (8,5%)
itchy rash to the skin caused by a reaction to sunlight
osip na koži koji svrbi uzrokovan reakcijom na sunce
3, paranoia hallucination
3, paranoja halucinacije
liver failure, in some cases leading to death or liver transplant.
zatajenje jetre koje u nekim slučajevima može dovesti do smrti ili presađivanja jetre.
Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study.
Slične rezultate dobili su i drugi istraživači, iako su u drugom ispitivanju postojale veće razlike u razinama MPA u plazmi.
→ If you think you may have lactic acidosis, contact your doctor immediately.
Mislite li da možda imate laktacidozu, odmah se obratite liječniku.
Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in every 1,000 patients) but serious side effect that can be fatal.
Laktacidoza (prekomjerna količina mliječne kiseline u krvi) je rijetka (može se pojaviti u do 1 na svakih 1000 bolesnika), ali ozbiljna nuspojava koja može biti smrtonosna.
The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Povećanje parametara farmakokinetike efavirenza ne smatra se klinički značajnim.
Cmax: ↑ 64% (mechanism of interaction unknown)
Cmax: ↑ 64% (mehanizam interakcije nije poznat)
Cmax: ↑ 38% (competitive inhibition of oxidative metabolism)
Cmax: ↑ 38% (kompetitivna inhibicija oksidativnog metabolizma)
Rare completed suicide delusion
Rijetko izvršeno samoubojstvo deluzija
Common cerebellar coordination and balance disturbances somnolence (2.0%) headache (5.7%) disturbance in attention
Često cerebelarni poremećaji koordinacije i ravnoteže somnolencija (2,0%) glavobolja (5,7%) poremećaj pozornosti
No virus analysed contained the K65R or K70E mutation.
- Nijedan analizirani virus nije sadržavao mutaciju K65R ili K70E.
severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
- teške poremećaje ravnoteže elektrolita, npr. hipokalijemiju ili hipomagnezijemiju.
Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses (see also data from bioequivalence study described above) and 40 to 55 hours after multiple doses.
Efavirenz ima relativno dug poluvijek od najmanje 52 sata nakon primjene pojedinačnih doza (pogledajte i podatke iz ispitivanja bioekvivalencije opisane iznad) te 40 do 55 sati nakon primjene višekratnih doza.
- signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
pojava omaglice, otežanog spavanja, omamljenosti, problema u koncentraciji ili nenormalnih snova.
3, psychosis mania
3, psihoza manija
Pharmacotherapeutic group: Antiviral for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR06.
Farmakoterapijska skupina: Antivirusni lijek za sistemsku primjenu; antivirusni lijekovi za liječenje infekcije HIV-om, kombinacije; ATK oznaka: J05AR06.
In other studies (prospective and crosssectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
U drugim ispitivanjima (prospektivnim i presječnim), najizraženija smanjenja BMD-a bila su opažena u bolesnika liječenih tenofovirdizoproksilom u sklopu režima koji je sadržavao pojačan inhibitor proteaze.
Cross resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Profili križne rezistencije za efavirenz, nevirapin i delavirdin in vitro pokazali su da supstitucija K103N dovodi do gubitka osjetljivosti na sva tri NNRTI lijeka.
Interactions between efavirenz/emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”, once daily as “q.d.” and once every 8 hours as “q8h”).
Interakcije između efavirenza/emtricitabina/tenofovira ili njegovih pojedinačnih komponenti i drugih lijekova navedene su u nastavku u Tablici 1 (povećanje je označeno kao „↑”, smanjenje kao „↓”, bez promjene kao „↔”, dvaput na dan kao „b.i.d.”, jedanput na dan kao „q.d.” i svakih 8 sati kao „q8h”).
PVR (KM): Pure virologic response assessed using the Kaplan Meier (KM) method M: Missing
Pure virologic response), ocijenjen primjenom Kaplan-Meierove (KM) metode N: nedostaje
Stevens-Johnson syndrome,
Stevens-Johnsonov sindrom, multiformni eritem
Efavirenz resistance K103N
Rezistencija na efavirenz K103N
Verapamil, Felodipine, Nifedipine and
verapamil, felodipin, nifedipin i nikardipin
The HIV renal educational brochure should contain the following key messages:
Edukativna brošura o utjecaju terapije za liječenje HIV-a na bubrege mora sadržavati sljedeće ključne poruke:
3, euphoric mood
3, euforično raspoloženje
Sufficient data on the tolerability of efavirenz with low-dose ritonavir (100 mg, once or twice daily) are not available.
Nije dostupno dovoljno podataka o toleranciji efavirenza u kombinaciji s niskom dozom ritonavira (100 mg, jednom ili dvaput dnevno).
Genotoxicity and repeated-dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components.
Ispitivanja genotoksičnosti i toksičnosti ponovljenih doza u trajanju od jednog mjeseca ili manje s kombinacijom tih dvaju sastojaka nisu ustanovila egzacerbaciju toksikoloških učinaka u usporedbi s ispitivanjima provedenim sa svakom komponentom lijeka odvojeno.
if you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval that puts you at high risk for severe heart rhythm problems (Torsade de Pointes).
ako imate bolest srca, kao što je abnormalan električni signal koji se naziva produljenje QT intervala, zbog čega ste izloženi visokom riziku od teških problema sa srčanim ritmom (torsade de pointes).
Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Bolesnicima treba objasniti da će se, ako se pojave, ti česti simptomi vjerojatno ublažiti tijekom trajanja terapije te da se na temelju njih ne može predvidjeti naknadna pojava bilo kakvih manje čestih psihijatrijskih simptoma.
The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.
Kliničke implikacije takve veze nisu poznate, međutim ne može se isključiti potencijal za povećanu učestalost i težinu nuspojava povezanih s efavirenzom.
Some patients accidentally taking 600 mg efavirenz twice daily have reported increased nervous system symptoms.
U nekih su bolesnika, koji su slučajno uzeli 600 mg efavirenza dvaput dnevno, uočeni pojačani simptomi na živčanom sustavu.
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
- na zahtjev Europske agencije za lijekove; - prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
Carcinogenicity studies in male mice, male and female rats were negative.
Ispitivanja kancerogenosti u muških miševa te muških i ženskih štakora bila su negativna.
Bupropion, a medicine used to treat depression or to help you stop smoking, as your doctor may need to change your dose of bupropion.
Bupropion, lijek koji se koristi za liječenje depresije ili kao pomoć za prestanak pušenja: liječnik će Vam možda morati promijeniti dozu bupropiona.
When efavirenz is coadministered with a calcium channel blocker that is a substrate of the CYP3A4 enzyme, there is a potential for reduction in the plasma concentrations of the calcium channel blocker.
Ako se efavirenz primjenjuje istodobno s blokatorom kalcijevih kanala koji je supstrat enzima CYP3A4, postoji mogućnost smanjenja plazmatske koncentracije blokatora kalcijevih kanala.
There have also been post-marketing reports of severe depression, death by suicide, delusions psychosis-like behaviour, and catatonia.
Iz razdoblja nakon stavljanja lijeka u promet postoje izvješća o teškoj depresiji, samoubojstvu, halucinacijama, ponašanju sličnome psihozi i katatoniji.
Skin and subcutaneous tissue disorders: Very common rash (moderate-severe, 11.6%, all grades, 18%)
Poremećaji kože i potkožnog tkiva: Vrlo često osip (umjeren do težak, 11,6%, svi stupnjevi,
Also, emtricitabine did not inhibit uridine 5' diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Isto tako, ni emtricitabin nije inhibirao uridin-5'-difosfoglukoriniltransferazu, enzim odgovoran za glukuronidaciju.
The following pack sizes are available: cartons containing 1 bottle of 30 film-coated tablets or 90 (3 bottles of 30) film-coated tablets.
Dostupne su sljedeće veličine pakiranja: kutije s 1 bočicom od 30 filmom obloženih tableta ili 90 (3 bočice po 30) filmom obloženih tableta.
Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Sertralin, lijek koji se koristi za liječenje depresije; liječnik će Vam možda morati promijeniti dozu sertralina.
Ginkgo biloba extracts (herbal preparation).
Ekstrakt Ginkgo bilobe (biljni pripravak).
3, amnesia convulsions thinking abnormal ataxia
3, amnezija abnormalno razmišljanje ataksija
Uncommon: dry mouth incoherent speech increased appetite libido decreased myalgia
Manje često: suha usta inkoherentan govor povećani apetit smanjeni libido mialgija
Thymidine analogue associated mutations included D67N (n=1) and K70R (n=1).
Mutacije povezane s analogom timidina uključivale su D67N (n=1) i K70R (n=1).
Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
U bolesnika koji istodobno primaju antikonvulzivne lijekove koji se primarno metaboliziraju u jetri, poput fenitoina, karbamazepina i fenobarbitala, može postojati potreba za povremenom kontrolom razine ovih lijekova u plazmi.
Hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, as reported post-marketing, were sometimes characterised by a fulminant course, progressing in some cases to transplantation or death.
Slučajevi zatajenja jetre, uključujući i slučajeve bolesnika bez prethodnih bolesti jetre ili drugih prepoznatljivih faktora rizika, prijavljene nakon stavljanja lijeka u promet, ponekad su karakterizirani fulminantnim tijekom koji je u nekim slučajevima doveo do transplantacije ili smrti.
Hormonal contraceptive, such as birth control pills, an injected contraceptive (for example, Depo-Provera), or a contraceptive implant (for example, Implanon): You must also use a reliable barrier method of contraception (see Pregnancy and breast-feeding).
Hormonski kontraceptivi, kao što su tablete za sprječavanje trudnoće, kontraceptivi koji se primjenjuju injiciranjem (na primjer Depo-Provera), ili kontracepcijski implantati (na primjer Implanon): Morate koristiti i pouzdanu mehaničku metodu kontracepcije (pogledajte Trudnoća i dojenje).