FrancophonIA/ELRC3.0 huggingface dataset:
English: Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate
Croatian: Dinatrijev fosfatdihidrat Magnezijev kloridheksahidrat Kalcijev kloriddihidrat
English: No effect other than those already mentioned in section on “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Croatian: Nisu primijećene nikakve druge nuspojave osim onih spomenutih u odjeljku “Nuspojave” nakon primjene nekoliko doza te hipertermije koja iznimno može trajati 5 dana.
English: Casein hydrolysate Collagen hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Potassium hydroxide Sodium chloride
Croatian: Kazein hidrolizat Kolagen hidrolizat Dikalijev fosfat Kalijev dihidrogenfosfat Kalijev hidroksid Natrijev klorid Dinatrijev hidrogenortofosfat Monokalijev fosfatanhidrid Kalijev klorid
English: The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Croatian: Proizvod ima učinak smanjenja ekskrecije mačjeg kalicivirusa na početku imunosti i tijekom godine dana nakon vakcinacije.
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the feline leukaemia component.
Croatian: Trajnost imuniteta nakon zadnje re-vakcinacije je 3 godine za komponente rinotraheitisa, kaliciviroze i panleukopenije i 1 godinu za komponentu leukemije mačaka.
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age borne from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Croatian: Kada se očekuje prisutnost visoke razine majčinih antitijela protiv komponenti rinotraheitisa, kaliciviroze ili panleukopenije (npr. kod mačića u dobi od 9-12 tjedana od mačaka koje su bile cijepljene prije graviditeta i/ili su prethodno bile izložene ili se sumnja da su bile izložene patogenima), prvo cijepljenje treba odgoditi do dobi od 12 tjedana.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottle
Croatian: OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination schedule:
Croatian: Nakon rekonstitucije liofilizata s otapalom, injicirajte supkutano jednu dozu (1 ml) cjepiva, prema sljedećem rasporedu cijepljenja:
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Croatian: Pokazalo se da imunitet nastupa 1 tjedan nakon prvog cijepljenja protiv komponenti rinotraheitisa, kalicivirusa i panleukopenije, i 2 tjedna nakon prvog cijepljenja protiv komponente leukemije mačaka.
English: Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Croatian: Liofilizat (50 x 1 doza) + otapalo (50 x 1 ml).
English: Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus.
Croatian: Potiče aktivni imunitet protiv virusnog rinotraheitisa mačaka, kaliciviroze mačaka, virusa panleukopenije i virusa leukemije mačaka.
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Croatian: I staklena bočica s 1 ml otapala, obje zatvorene gumenim čepom i aluminijskom kapicom.
English: Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Croatian: Pakovanje sadrži 10 bočica s 1 dozom liofilizata i 10 bočica s 1ml otapala.
English: Gentamicin, at most .......................................................................................................................... 23 µg Solvent:
Croatian: Gentamicin, najviše .......................................................................................................................... 23 µg Otapalo:
English: FeLV recombinant canarypox virus (vCP97)................................................................... ≥ 107.2 CCID50.
Croatian: FeLV rekombiniran s virusom boginja kanarinca (vCP97) ............................................... ≥ 107,2 CCID50
English: Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Croatian: Pakovanje sadrži 50 bočica s 1 dozom liofilizata i 50 bočica sa po 1ml otapala.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate bottle
Croatian: OSNOVNI DJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica s liofilizatom
English: Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Croatian: Svaka doza od 1ml sadrži: FHV (soj F2) ...................................................................................................................... ≥ 104,9 CCID50
English: PACKAGE LEAFLET FOR: Purevax RCP FeLV lyophilisate and solvent for suspension for injection
Croatian: UPUTA O VMP: Purevax RCP FeLV liofilizat i otapalo za suspenziju za injekcije.
English: FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 10 7.2 CCID501 1 cell culture infective dose 50%.
Croatian: FeLV rekombinantni virus boginja kanarinca (vCP97) ................................................. ≥ 10 7,2 CCID501 1 količina virusa koja zarazi 50% stanica kulture u koju je dodan virus.
English: Gentamicin, at most .......................................................................................................................... 23 µg
Croatian: Gentamicin, najviše .......................................................................................................................... 23 µg
English: Purevax RCP FeLV Lyophilisate and solvent for suspension for injection.
Croatian: Purevax RCP FeLV liofilizat i otapalo za suspenziju za injekcije.
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Croatian: Cjepivo protiv virusnog rinotraheitisa mačaka, kaliciviroze mačaka i panleukopenije i leukemije mačaka.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Croatian: Inaktivirani antigenikalicivirus mačaka (soj FCV 431 i G1) .......................................... ≥ 2,0 ELISA U.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČBIOLOŠKI DJELATNIH TVARI I NOSITELJ
English: How often will you be given HALAVEN?
Croatian: Koliko često ćete dobivati HALAVEN?
English: Your doctor will determine how many cycles of treatment you should receive.
Croatian: Liječnik će odrediti koliko ciklusa terapije morate primiti.
English: Includes Grade 5 events.
Croatian: Uključuje događaje 5. stupnja.
English: Rare or not known
Croatian: Rijetko ili nepoznato
English: Any Grade 3 or 4 in the previous cycle
Croatian: Svaka nuspojava 3. ili 4. stupnja u prethodnom ciklusu
English: PROBABILITY OF SURVIVAL
Croatian: VJEROJATNOST PREŽIVLJENJA
English: The use of gloves, goggles, and protective clothing is recommended.
Croatian: Preporuča se uporaba rukavica, zaštitnih naočala i zaštitne odjeće.
English: Date of latest renewal: 19 November 2015
Croatian: Datum posljednje obnove odobrenja: 19. studenog 2015.
English: Creatinine clearance was estimated with the Cockcroft-Gault formula.
Croatian: Klirens kreatinina procijenjen je pomoću Cockcroft-Gaultove formule.
English: If you experience any of the following serious symptoms, stop taking HALAVEN and seek medical attention straightaway:
Croatian: Ako osjetite bilo koji od sljedećih ozbiljnih simptoma, prekinite uzimanje lijeka HALAVEN i odmah potražite liječničku pomoć:
English: What HALAVEN is and what it is used for
Croatian: Što je HALAVEN i za što se koristi
English: The doctor may also then decide to reduce the dose you are given.
Croatian: Liječnik može odlučiti i da Vam smanji dozu koju primate.
English: HALAVEN is usually given on Days 1 and 8 of every 21-day cycle.
Croatian: HALAVEN se obično daje 1. i 8. dana svakog 21-dnevnog ciklusa.
English: This result was confirmed with an updated overall survival analysis carried out at 77% of events.
Croatian: Ovaj je rezultat potvrđen kasnijom analizom ukupnog preživljenja u 77% događaja.
English: HALAVEN 71 Dacarbazine
Croatian: HALAVEN 71 Dakarbazin
English: Time (months) NUMBER OF PATIENTS AT RISK:
Croatian: Vrijeme (mjeseci) BROJ BOLESNIKA POD RIZIKOM:
English: Number of Events
Croatian: Broj događaja
English: The frequency of this condition is not known but it can be life-threatening.
Croatian: Učestalost ovog stanja je nepoznata, ali ono može ugroziti život.
English: What HALAVEN looks like and contents of the pack
Croatian: Kako HALAVEN izgleda i sadržaj pakiranja
English: These may be signs of a condition called sepsis - a severe and serious reaction to an infection.
Croatian: To mogu biti znakovi stanja koje se naziva sepsa, a ona je teška i ozbiljna reakcija na infekciju.
English: If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.
Croatian: Ako imate nešto od navedenog, obavijestite o tome svog liječnika, koji će možda htjeti prekinuti liječenje ili smanjiti dozu.
English: Effects of eribulin on the pharmacokinetics of other medicines
Croatian: Učinci eribulina na farmakokinetiku drugih lijekova
English: Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal.
Croatian: Ovisno o Vašoj krvnoj slici, liječnik će možda morati odgoditi primjenu lijeka dok se vrijednosti krvne slike ne vrate na normalu.
English: What HALAVEN contains
Croatian: Što HALAVEN sadrži
English: Antiemetic prophylaxis including corticosteroids should be considered.
Croatian: Potrebno je razmotriti primjenu antiemetičke profilakse uključujući kortikosteroide.
English: TIME (months) NUMBER OF PATIENTS AT RISK HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Capecitabine 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
Croatian: VRIJEME (mjeseci) BROJ BOLESNIKA POD RIZIKOM HALAVEN 554 530 505 464 423 378 349 320 268243214193173151133119 99 77 52 38 32 26 22 15 13 9 7 2 2 0 Kapecitabin 548 513 466 426 391 352 308 277 242214191175155135122108 81 62 42 33 27 23 17 13 12 10 2 2 1 0
English: The safety and efficacy of HALAVEN in children from birth to 18 years of age have not yet been established in soft tissue sarcoma.
Croatian: Sigurnost i djelotvornost lijeka HALAVEN u djece u dobi od rođenja do 18 godina još nisu ustanovljene kod sarkoma mekog tkiva.
English: There was no significant difference in progression-free survival or overall response rate between the treatment arms in the overall population.
Croatian: Nije bilo značajne razlike u preživljenju bez progresije bolesti ili ukupnoj stopi odgovora između te dvije terapijske skupine u cjelokupnoj populaciji.
English: In the pivotal trials, the corresponding publications and in some other regions e.g. the United States and Switzerland, the recommended dose is based on the salt form (eribulin mesilate).
Croatian: U ključnim ispitivanjima, radovima objavljenima na temelju tih ispitivanja i u nekim drugim zemljama, npr. Sjedinjenim Američkim Državama i Švicarskoj, preporučena doza temelji se na eribulinu u obliku soli (eribulinmesilat).
English: HALAVEN will be given to you by a doctor or nurse as an injection into a vein, over a period of 2 to 5 minutes.
Croatian: HALAVEN će Vam dati liječnik ili medicinska sestra injekcijom u venu tijekom 2 do 5 minuta.
English: Halaven is not recommended for children aged under 18 with paediatric sarcomas as it is not yet known how well it works in this age group.
Croatian: Halaven se ne preporučuje za djecu mlađu od 18 godina sa sarkomima dječje dobi jer još nije poznato koliko dobro djeluje u ovoj dobnoj skupini.
English: HALAVEN is for intravenous use.
Croatian: HALAVEN je za intravensku primjenu.
English: Management of overdose should include supportive medical interventions to treat the presenting clinical manifestations.
Croatian: Liječenje predoziranja mora uključivati potporne medikamentozne mjere, kako bi se liječile prisutne kliničke manifestacije.
English: The dose you will receive is based on your body surface area (expressed in squared metres, or m2) which is calculated from your weight and height.
Croatian: Doza koju ćete dobiti ovisit će o veličini površine Vašeg tijela (izraženo u kvadratnim metrima ili m2) koja se izračunava na temelju
English: Insomnia Depression
Croatian: Nesanica Depresija
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX41
Croatian: Farmakoterapijska skupina: drugi antineoplastični lijekovi, ATK oznaka: L01XX41
English: HER2 Positive
Croatian: HER2-pozitivan
English: No in vivo data are available.
Croatian: Podaci in vivo nisu dostupni.
English: Nail disorder Night sweats Dry skin
Croatian: Poremećaji noktiju Noćno znojenje Suha koža Eritem
English: Dose reduction recommendations for retreatment are shown in the following table.
Croatian: Preporučena smanjenja doze kod ponovnog liječenja prikazana su u sljedećoj tablici.
English: Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Croatian: Kategorije po učestalosti definirane su na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
English: New onset or worsening of pre-existing peripheral neuropathy has also been reported.
Croatian: Također je zabilježen nastanak ili pogoršanje postojeće periferne neuropatije.
English: Note: Concomitant anti-HER2 therapy was not included in Study 305 and Study 301.
Croatian: Napomena: Istodobna anti-HER2 terapija nije bila uključena u Ispitivanje 305 i Ispitivanje 301.
English: Treatment of Physician's Choice
Croatian: Terapija po izboru liječnika
English: A risk to newborns/infants cannot be excluded and therefore HALAVEN must not be used during breast-feeding (see section 4.3).
Croatian: Ne može se isključiti rizik za novorođenče i dojenče pa se stoga HALAVEN ne smije primjenjivati tijekom dojenja (vidjeti dio 4.3).
English: Eribulin is weakly bound to plasma proteins.
Croatian: Eribulin se slabo veže za proteine plazme.
English: These could be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).
Croatian: To mogu biti znakovi manje česte alergijske reakcije (može se javiti u manje od 1 na 100 osoba).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenim na europskom internetskom portalu za lijekove.
English: - A serious disorder of blood clotting resulting in the widespread formation of blood clots and internal bleeding.
Croatian: - ozbiljan poremećaj zgrušavanja krvi koji dovodi do opsežnog stvaranja krvnih ugrušaka i unutarnjeg krvarenja
English: What you need to know before you use HALAVEN
Croatian: Što morate znati prije nego počnete primjenjivati HALAVEN
English: In the event of extravasation, treatment should be symptomatic.
Croatian: U slučaju ekstravazacije lijeka, liječenje je simptomatsko.
English: There is no relevant use of HALAVEN in children and adolescents for the indication of breast cancer.
Croatian: Nema relevantne primjene lijeka HALAVEN u djece i adolescenata za indikaciju raka dojke.
English: Overall, the safety profiles in the breast cancer and soft tissue sarcoma patient populations were similar.
Croatian: Sveukupno, profili sigurnosti u populacije bolesnika s rakom dojke i populacije bolesnika sa sarkomom mekog tkiva su bili slični.
English: Eribulin is mainly (up to 70%) eliminated through biliary excretion.
Croatian: Eribulin se uglavnom (do 70%) eliminira izlučivanjem u žuč.
English: Patients must have progressed within 6 months of their last chemotherapeutic regimen.
Croatian: Bolesnici su morali imati progresiju bolesti unutar 6 mjeseci od zadnjeg kemoterapijskog režima.
English: Patients may experience nausea or vomiting.
Croatian: Bolesnici mogu osjećati mučninu ili povraćati.
English: In the event of an overdose, the patient should be closely monitored.
Croatian: U slučaju predoziranja bolesnika valja pomno nadzirati.
English: It is a structurally simplified synthetic analogue of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai.
Croatian: On je strukturalno pojednostavljen sintetički analog halikondrina B, prirodne tvari izolirane iz morske spužve Halichondria okadai.
English: If the skin comes into contact with the solution it should be washed immediately and thoroughly with soap and water.
Croatian: Ako otopina dođe u dodir s kožom, kožu treba odmah temeljito isprati vodom i sapunom.
English: Patients should be advised not to drive or use machines if they feel tired or dizzy.
Croatian: Bolesnicima valja savjetovati da ne voze i da ne upravljaju strojevima ako osjete umor ili omaglicu.
English: The development of severe peripheral neurotoxicity requires a delay or reduction of dose (see section 4.2)
Croatian: U slučaju razvoja teške periferne neurotoksičnosti potrebno je odgoditi primjenu ili smanjiti dozu (vidjeti dio 4.2).
English: Dose reduction during therapy
Croatian: Smanjenje doze za vrijeme liječenja
English: Adverse Reactions - all Grades Very Common (Frequency %)
Croatian: Nuspojave - svi stupnjevi Vrlo često (učestalost %)
English: What HALAVEN is and what it is used for What you need to know before you use HALAVEN How to use HALAVEN
Croatian: Što je HALAVEN i za što se koristi Što morate znati prije nego počnete primjenjivati HALAVEN
English: No dose adjustments are recommended for the elderly population.
Croatian: Nema preporuka za prilagodbu doze u starije populacije.
English: Pregnant staff should not handle HALAVEN.
Croatian: Zdravstvene djelatnice koje su trudne ne smiju rukovati lijekom HALAVEN.
English: These may be signs of a condition called Stevens Johnson syndrome/toxic epidermal necrolysis.
Croatian: To mogu biti znakovi stanja koje se zove Stevens-Johnsonov sindrom/toksična epidermalna nekroliza.
English: Patients experiencing febrile neutropenia, severe neutropenia or thrombocytopenia, should be treated according to the recommendations in section 4.2.
Croatian: Bolesnike s febrilnom neutropenijom, teškom neutropenijom ili trombocitopenijom treba liječiti u skladu s preporukama u dijelu 4.2.
English: Each carton contains either 1 or 6 vials.
Croatian: Jedna kutija sadrži 1 ili 6 bočica.
English: The safety profile of eribulin in elderly patients (≥ 65 years of age) was similar to that of patients <65 years of age except for asthenia/fatigue which showed an increasing trend with age.
Croatian: Profil sigurnosti primjene eribulina u starijih bolesnika (u dobi od ≥ 65 godina) bio je sličan onom u bolesnika u dobi od < 65 godina, osim za asteniju/umor gdje se pokazao trend porasta s dobi.
English: Metabolite concentrations represented <0.6% of parent compound, confirming that there are no major human metabolites of eribulin.
Croatian: Koncentracije metabolita činile su < 0,6% ishodišnog spoja, čime se potvrdilo da u ljudi ne nastaju neki važni metaboliti eribulina.
English: - The active substance is eribulin.
Croatian: - Djelatna tvar je eribulin.
English: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom.
Croatian: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ujedinjeno Kraljevstvo.
English: Do not use HALAVEN: - if you are allergic to eribulin mesilate or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati HALAVEN - ako ste alergični na eribulinmesilat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako dojite
English: The transport protein involved in this process is unknown.
Croatian: Nije poznato koji prijenosni protein sudjeluje u tom procesu.
English: No specific dose adjustments are recommended based on the age of the patient (see section 4.8).
Croatian: Ne postoje posebne preporuke za prilagodbu doze na temelju dobi bolesnika (vidjeti dio 4.8).
English: There was no difference in efficacy between eribulin and dacarbazine in patients with advanced or metastatic leiomyosarcoma.
Croatian: Nije bilo razlike u djelotvornosti između eribulina i dakarbazina u bolesnika s uznapredovalim ili metastatskim leiomiosarkomom.
English: Hypokalaemia, hypocalcaemia or hypomagnesaemia should be corrected prior to initiating HALAVEN and these electrolytes should be monitored periodically during therapy.
Croatian: Hipokalijemiju, hipokalcijemiju ili hipomagnezijemiju treba korigirati prije početka liječenja lijekom HALAVEN i te elektrolite povremeno određivati tijekom liječenja.
English: - Serious skin rashes with blistering of the skin, mouth, eyes and genitals.
Croatian: - ozbiljni kožni osipi s mjehurima po koži, u ustima, na očima i spolnim organima.
English: HALAVEN contains ethanol (alcohol) This medicine contains small amounts of ethanol (alcohol), less than 100 mg in a vial.
Croatian: HALAVEN sadrži etanol (alkohol) Ovaj lijek sadrži male količine etanola (alkohol), manje od 100 mg u bočici.
English: Patients had received at least two prior chemotherapy regimens, one of which must have been an anthracycline (unless contraindicated).
Croatian: Bolesnici su prethodno primili najmanje dva kemoterapijska režima, od kojih je jedan morao sadržavati antraciklin (osim ako je bio kontraindiciran).
English: The dose of eribulin should not be re-escalated after it has been reduced.
Croatian: Nakon što je doza eribulina bila smanjena, ne smije se ponovno povećavati.
English: Patients should be closely monitored for signs of peripheral motor and sensory neuropathy.
Croatian: Bolesnike valja pomno pratiti zbog moguće pojave znakova periferne motoričke i senzoričke neuropatije.
English: It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution.
Croatian: Ne smije se miješati s drugim lijekovima i ne smije se razrjeđivati u 5%-tnoj otopini glukoze za infuziju.
English: Women of childbearing potential must be advised to avoid becoming pregnant whilst they or their male partner are receiving HALAVEN and have to use effective contraception during and up to 3 months after treatment.
Croatian: Ženama reproduktivne dobi mora se savjetovati da izbjegavaju trudnoću dok one ili njihovi partneri primaju HALAVEN i napomenuti da moraju koristiti učinkovitu kontracepciju tijekom liječenja i do 3 mjeseca nakon liječenja.
English: Testicular toxicity has been observed in rats and dogs (see section 5.3).
Croatian: U štakora i pasa primijećena je testikularna toksičnost (vidjeti dio 5.3).