FrancophonIA/ELRC3.0 huggingface dataset:
English: Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the hair shaft by the hair follicle.
Croatian: Eflornitin nepovratno inhibira ornitin dekarboksilazu, enzim uključen u stvaranje stabljike dlake u folikulu dlake.
English: Vaniqa has been shown to reduce the rate of hair growth.
Croatian: Pokazano je da Vaniqa smanjuje brzinu rasta dlake.
English: It is not known whether eflornithine/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se eflornitin/metaboliti u majčino mlijeko.
English: Vaniqa is not a depilatory cream, so you may need to continue with your hair removal method, for example by shaving or plucking.
Croatian: Vaniqa nije krema za depilaciju tako da možete nastaviti s metodom uklanjanja dlaka primjerice brijanjem ili čupanjem pincetom.
English: The active substance is eflornithine.
Croatian: Djelatna tvar je eflornitin.
English: Almirall, S.A. Teл/Tel/Tlf/Tηλ/Sími: +34 93 291 30 00
Croatian: Teл//Tel/Tlf/Tηλ/Sími: +34 93 291 30 00
English: Do not use Vaniqa if you are pregnant or breast-feeding.
Croatian: Nemojte primjenjivati kremu Vaniqa ako ste trudni ili ako dojite.
English: The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment.
Croatian: Najčešće prijavljivane nuspojave povezane su s kožom, a uglavnom su bile blagog intenziteta i povukle su se bez prekida liječenja kremom Vaniqa ili bez početka liječenja samih nuspojava.
English: Do not use this medicine after the expiry date which is stated on the box and on the bottom of the tube after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakovanju i pri dnu tube iza „Rok valjanosti“.
English: Vaniqa has no or negligible influence on the ability to drive and use machines.
Croatian: Vaniqa ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: • if you are unsure whether or not to use this medicine contact your doctor or pharmacist for advice.
Croatian: • ako niste sigurni da li koristiti ovaj lijek ili ne, obratite se svom liječniku ili ljekarniku za savjet.
English: Tiny amounts of sodium hydroxide (E524) are sometimes added to keep acidity levels (pH levels) normal.
Croatian: Ponekad se dodaju male količine natrijevog hidroksida (E524) za održavanje normalne kiselosti (pH vrijednosti).
English: EXP Discard the tube 6 months after opening.
Croatian: Rok valjanosti Tubu bacite 6 mjeseci nakon otvaranja.
English: Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving women was 0.8%.
Croatian: Ravnotežna penetracija eflornitina iz kreme Vaniqa u kožu lica žena koje briju kožu lica je 0,8%.
English: Marked improvement
Croatian: Znatno poboljšanje
English: Each gram of cream contains 47.2 mg of cetostearyl alcohol, 14.2 mg of stearyl alcohol, 0.8 mg of methyl parahydroxybenzoate and 0.32 mg of propyl parahydroxybenzoate.
Croatian: Jedan gram kreme sadrži 47,2 mg cetilnog i stearilnog alkohola, 14,2 mg stearilnog alkohola, 0,8 mg metilparahidroksibenzoata i 0,32 mg propilparahidroksibenzoata.
English: Vaniqa contains the active substance eflornithine.
Croatian: Vaniqa sadrži djelatnu tvar eflornitin.
English: What you need to know before you use Vaniqa 3.
Croatian: Što morate znati prije nego počnete primjenjivati kremu Vaniqa
English: These factors should be considered in the overall medical treatment of patients who might be prescribed Vaniqa.
Croatian: Takve čimbenike potrebno je razmotriti pri sveobuhvatnom pristupu liječenja bolesnice kojoj se planira propisati Vaniqa.
English: In the vehicle controlled trials (n= 596), acne was observed in 41% of patients at baseline; 7% of patients treated with Vaniqa and 8% treated with vehicle experienced a worsening of their condition.
Croatian: U ispitivanjima u kojima se u kontrolnoj skupini koristi podloga kreme Vaniqa (n=596) akne su primijećene u 41% bolesnica prije samog ispitivanja; 7% bolesnica liječenih kremom Vaniqa i 8% bolesnica liječenih podlogom osjetili su pogoršanje stanja.
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite kremu Vaniqa točno onako kako Vam je rekao liječnik.
English: • Wash your hands after applying the cream.
Croatian: • Nakon primjene kreme operite ruke.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na eflornitin ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: In a dermal fertility study in rats, no adverse effects on fertility were observed at up to 180 times the human dose.
Croatian: U ispitivanjima plodnosti nakon dermalne primjene u štakora nisu primijećeni štetni učinci na plodnost u dozama do 180 puta većim od doze za ljude.
English: Vaniqa significantly reduced how bothered patients felt by their facial hair and by the time spent removing, treating, or concealing facial hair.
Croatian: Vaniqa značajno smanjuje zabrinutost bolesnica zbog doživljaja dlaka na licu i vrijeme koje provode u uklanjanju, liječenju ili prikrivanju dlaka na licu.
English: Talk to your doctor if you suffer from polycystic ovary syndrome (PCOS) or specific hormone producing tumours, or if you take medicines that can induce hair growth, e.g. cyclosporine (following organ transplants), glucocorticoids (e.g. against rheumatic or allergic diseases), minoxidil (against high blood pressure), phenobarbitone (against seizures), phenytoin (against seizures) or hormone replacement therapy with male hormone like effects.
Croatian: Razgovarajte sa svojim liječnikom ako patite od sindroma policističnih jajnika (PCOS) ili specifičnog tumora koji proizvodi hormone ili ako uzimate lijekove koji mogu uzrokovati rast dlaka, primjerice, ciklosporin (nakon presađivanja organa), glukokortikoide (primjerice protiv reumatskih ili alergijskih bolesti), minoksidil (protiv visokog krvnog tlaka), fenobarbiton (protiv napadaja), fenitoin (protiv napadaja) ili nadomjesnu hormonsku terapiju s učincima nalik onima muških hormona.
English: The steady state peak and trough plasma concentrations of eflornithine were approximately 10 ng/ml and 5 ng/ml, respectively.
Croatian: Vršne i najniže koncentracije eflornitina u stanju dinamičke ravnoteže u plazmi iznosile su približno 10 ng/ml odnosno 5 ng/ml.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBES
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE TUBE
English: However, should very high dose cutaneous administration or accidental oral ingestion occur, attention should be paid to the effects seen with therapeutic doses of intravenous eflornithine (400 mg/kg/day or approximately 24 g/day) used in the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness): hair loss, facial swelling, seizures, hearing impairment, gastrointestinal disturbance, loss of appetite, headache, weakness, dizziness, anaemia, thrombocytopenia and leucopenia.
Croatian: Međutim, u slučaju vrlo visoke doze lijeka primijenjenog na kožu ili nenamjernog gutanja lijeka, pozornost je potrebno obratiti na učinke opažene pri intravenskoj primjeni terapijskih doza eflornitina (400 mg/kg/dan ili približno 24 g/dan) pri liječenju infekcije Trypanosoma brucei gambiense (afrička bolest spavanja): gubitak kose, oticanje lica, napadi, oštećenje sluha, gastrointestinalni poremećaji, gubitak apetita, glavobolja, slabost, omaglica, anemija,
English: Subgroup analysis also showed that 29% of obese women (BMI ≥ 30) and 43% of normal weight women (BMI < 30) showed a marked or better improvement.
Croatian: Analiza podskupina pokazala je također da je 29% pretilih žena (indeks tjelesne mase ≥ 30) i 43% žena normalne težine
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU TEKST NA VANJSKOM PAKOVANJU
English: Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.
Croatian: U skupini bolesnica bez akni prije ispitivanja, sličan je postotak (14%) prijavljenih akni nakon liječenja kremom Vaniqa ili podlogom.
English: The most frequently reported adverse reaction was acne, which was generally mild.
Croatian: Najčešće prijavljene nuspojave bile su akne koje su općenito blagog intenziteta.
English: Almirall BV Tel.: +31 (0) 307991155
Croatian: Tel.: +31 (0) 307991155
English: In dermal teratology studies, no teratogenic effects were observed in rats and rabbits at doses up to 180 and 36 times the human dose, respectively.
Croatian: U dermalnim ispitivanjima teratogenosti nisu primijećeni teratogeni učinci u štakora i kunića u dozama do 180 odnosno 36 puta većim od doze za ljude.
English: The steady state 12-hour area under the plasma concentration versus time curve was 92.5 ng.hr/ml.
Croatian: Površina ispod krivulje ovisnosti koncentracije lijeka u plazmi prema vremenu tijekom 12 sati u stanju dinamičke ravnoteže je iznosila 92,5 ng.h/ml.
English: Vaniqa also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Croatian: Vaniqa sadrži također i metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216) koji mogu uzrokovati (moguće odgođene) alergijske reakcije.
English: Almirall Limited Tel: +44 (0) 800 0087399
Croatian: Tel.: +44 (0) 800 0087399
English: If it persists contact your doctor.
Croatian: Ako potraju, obavijestite svog liječnika.
English: Transient stinging or burning may occur when the cream is applied to abraded or broken skin.
Croatian: Prolazno žarenje ili peckanje može se dogoditi pri primjeni kreme na oštećenu ili abradiranu kožu.
English: The steady state plasma half-life of eflornithine was approximately 8 hours.
Croatian: Poluvrijeme eliminacije eflornitina u plazmi u stanju dinamičke ravnoteže približno je iznosilo 8 sati.
English: This medicinal product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) as well as methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Croatian: Ova krema sadrži cetostearilni alkohol i stearilni alkohol koji mogu uzrokovati lokalnu iritaciju kože (primjerice kontaktni dermatitis) kao i metilparahidroksibenzoat i propilparahidroksibenzoat koji mogu uzrokovati (moguće odgođene) alergijske reakcije.
English: The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention.
Croatian: Sljedeći podaci navode učestalost kožnih nuspojava opaženih u kliničkim ispitivanjima u skladu s prikazom učestalosti prema MedDRA-i.
English: Patients may need to continue to use a hair removal method (e.g. shaving or plucking) in conjunction with Vaniqa.
Croatian: Bolesnice će moguće trebati nastaviti s metodama uklanjanja dlaka (primjerice, brijanje ili uklanjanje dlaka pincetom) u kombinaciji s kremom Vaniqa.
English: Package leaflet: Information for the user Vaniqa 11.5% cream
Croatian: Uputa o lijeku: Informacije za korisnika Vaniqa 11,5% krema eflornitin
English: Discard the opened tube with any remaining cream after 6 months.
Croatian: Otvorenu tubu s preostalom kremom treba baciti 6 mjeseci nakon prvog otvaranja.
English: If you stop using Vaniqa
Croatian: Ako prestanete primjenjivati kremu Vaniqa
English: Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).
Croatian: Učestalost nuspojava na koži zamijećenih u kliničkim ispitivanjima kreme Vaniqa (u skladu s prikazom učestalosti prema MedDRA-i):
English: Improvement was seen as early as 8 weeks after initiation of treatment.
Croatian: Poboljšanje je primijećeno već 8 tjedana nakon početka liječenja.
English: (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Croatian: (pogađa 1 do 10 korisnika na 10 000) vrlo rijetko (pogađa manje od 1 na 10 000 korisnika) nepoznato (ne može se procijeniti iz dostupnih podataka) uključujući izolirana izvješća
English: If you forget to use Vaniqa
Croatian: Ako ste zaboravili primijeniti kremu Vaniqa
English: Most events were reported at similar rates between Vaniqa and vehicle.
Croatian: Većina prijavljenih nuspojava u podjednakim omjerima odnosi se na kremu Vaniqa i podlogu.
English: To maintain the reduction of hair growth keep using Vaniqa continuously as indicated.
Croatian: Da biste održali smanjenje rasta dlaka nastavite primjenjivati kremu Vaniqa bez prekida kako Vam je to propisao liječnik.
English: Vaniqa is for cutaneous use only.
Croatian: Vaniqa je namijenjena samo za vanjsku primjenu na kožu.
English: Sodium hydroxide (E524) (to adjust pH)
Croatian: stearilni alkohol; natrijev hidroksid (E524) (za podešavanje pH).
English: The medicinal product should be applied such that no visual residual product remains on the treated areas after rub-in.
Croatian: Kremu treba primijeniti tako da nije moguće uočiti ostatke kreme na području primjene nakon utrljavanja.
English: o acne
Croatian: ○ akne
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET/ DATUM OBNOVE ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Vaniqa 11.5% cream Eflornithine
Croatian: Vaniqa 11,5% krema eflornitin
English: Also contains: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water; stearyl alcohol and sodium hydroxide (to adjust pH).
Croatian: Također sadrži: cetilni i stearilni alkohol; makrogolcetilstearileter; dimetikon; glicerolstearat; makrogolstearat; metilparahidroksibenzoat (E218); tekući parafin; fenoksietanol; propilparahidroksibenzoat (E216); pročišćenu vodu; stearilni alkohol i natrijev hidroksid (E524) (za podešavanje pH).
English: • tell your doctor of any other medical problems you may be experiencing (especially related to your kidneys or liver).
Croatian: • obavijestite svog liječnika o drugim zdravstvenim problemima koje možda osjećate
English: Almirall SpA Tel.: +39 02 346181
Croatian: Tel.: +39 02 346181
English: How to store Vaniqa
Croatian: Kako čuvati kremu Vaniqa
English: Eflornithine slows down the growth of hair through its effect on a specific enzyme (a protein in the body involved in the production of hair).
Croatian: Eflornitin usporava rast dlaka djelovanjem na specifičan enzim
English: Vaniqa contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Croatian: Vaniqa sadrži cetostearilni alkohol i stearilni alkohol koji mogu uzrokovati lokalnu iritaciju kože
English: / Ελλάδα / España / Κύπρος / Latvija / Lietuva / Magyarország / Malta / România / Slovenija / Slovenská republika
Croatian: Magyarország / Malta / România / Slovenija / Slovenská republika
English: Vaniqa 11.5% cream
Croatian: Vaniqa 11,5% krema
English: Improvement in the condition may be noticed within eight weeks of starting treatment.
Croatian: Poboljšanje stanja može se uočiti unutar osam tjedana od početka liječenja.
English: Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness
Croatian: Rozacea, seboroični dermatitis, neoplazme na koži, makulopapularni osip, ciste na koži, vezikobulozni osip, poremećaji kože, hirzutizam, zategnutost kože
English: These patientobservable differences were seen 8 weeks after initiating treatment.
Croatian: Takve razlike koje su primjećivale same bolesnice zapažene su osam tjedana nakon početka liječenja.
English: Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness
Croatian: Urastanje dlaka, edem lica, dermatitis, edem usta, papularni osip, krvarenje iz kože, herpes simplex, ekcem, heilitis, furunkuloza, kontaktni dermatitis, poremećena tekstura kose i poremećen rast kose, hipopigmentacija, crvenilo kože uz osjećaj vrućine, utrnulost usana, bolna koža
English: The condition returned to pre-treatment levels within eight weeks after discontinuation of treatment.
Croatian: Stanje se vratilo na razine prije liječenja unutar 8 tjedana nakon prekida liječenja.
English: Very common (affects more than 1 user in 10)
Croatian: Vrlo često (pogađa više od 1 na 10 korisnika)
English: very rare
Croatian: rijetko
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
English: Almirall Hermal GmbH Tel./ Tél: +49 (0)40 72704-0
Croatian: Tél: +49 (0)40 72704-0
English: Rare (≥1/10,000 to
Croatian: Rijetko (≥1/10 000 i <1/1000)
English: Hands should be washed after applying this medicinal product.
Croatian: Nakon nanošenja ove kreme nužno je oprati ruke.
English: Common (affects 1 to 10 users in 100)
Croatian: Često (pogađa 1 do 10 korisnika na 100)
English: Almirall, S.A. Ronda General Mitre, 151,
Croatian: Almirall, S.A Ronda General Mitre, 151 08022 Barcelona Španjolska
English: България / Česká republika / Hrvatska / Eesti
Croatian: България / Česká republika / Hrvatska /Eesti / Ελλάδα / España / Κύπρος / Latvija / Lietuva /
English: How to use Vaniqa
Croatian: Kako primjenjivati kremu Vaniqa
English: Almirall Sp. z o.o.
Croatian: Almirall SpA
English: Steady state was reached within four days.
Croatian: Stanje dinamičke ravnoteže koncentracije lijeka u plazmi postiže se unutar četiri dana.
English: o dry skin o hair loss o inflammation around the hair shaft o itching o rash o redness o skin irritation and bumps caused by shaving o skin irritation o stinging, tingling or burning feeling on the skin
Croatian: ○ suha koža ○ gubitak kose ○ upala uz dlaku ○ svrbež ○ osip ○ crvenilo ○ iritacija kože i čvorići uzrokovani brijanjem ○ iritacija kože ○ osjećaj peckanja, trnaca ili žarenja na koži
English: The other ingredients are: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water and stearyl alcohol.
Croatian: 6.1 Popis pomoćnih tvari cetilni i stearilni alkohol; makrogolcetilstearileter; dimetikon; glicerolstearat; makrogolstearat; metilparahidroksibenzoat (E218); parafin, tekući; fenoksietanol; propilparahidroksibenzoat (E216);
English: Propyl parahydroxybenzoate (E216); Purified water;
Croatian: metilparahidroksibenzoat (E218); tekući parafin; fenoksietanol; propilparahidroksibenzoat (E216); pročišćena voda i stearilni alkohol.
English: Rare (affects 1 to 10 users in 10,000)
Croatian: Manje često (pogađa 1 do 10 korisnika na 1000)
English: Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis
Croatian: Pseudofolikulitis brade, alopecija, pečenje kože*, peckanje kože*, suha koža,
English: The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.
Croatian: Stanje se može pogoršati na razine prije liječenja unutar 8 tjedana nakon prekida liječenja.
English: Phenoxyethanol;
Croatian: trombocitopenija i leukopenija.
English: The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*).
Croatian: Učinci na kožu poput žarenja, peckanja, osipa i eritema prijavljeni su u većim razinama u bolesnica liječenih kremom
English: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare
Croatian: (pogađa 1 do 10 korisnika na 100) manje često (pogađa 1 do 10 korisnika na 1000)
English: It may sting or burn if you put this cream on cut or irritated skin.
Croatian: Ako stavite kremu na posjekotinu ili nadraženu kožu možete osjetiti peckanje ili žarenje.
English: Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome, androgen secreting neoplasm) or certain active substances (e.g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy).
Croatian: Prekomjerni rast dlaka može biti rezultat ozbiljnih osnovnih bolesti (primjerice, sindroma policističnih jajnika, tumora koji luče androgene) ili određenih djelatnih tvari (primjerice,
English: Almirall ApS Tel.: +45 70 25 75 75
Croatian: Almirall Sp. z o.o. Tel.: +48 22 330 02 57
English: The frequency of possible side effects listed below is defined using the following convention:
Croatian: Učestalost mogućih nuspojava navedenih u nastavku definirana je uporabom sljedećih kategorija: vrlo često (pogađa više od 1 na 10 korisnika) često
English: o abnormal skin growth (skin neoplasm) o excessive hair growth o flushing, facial redness and pimples possibly with pus o other skin disorders o red, scaly and itchy skin inflammation (seborrhoeic dermatitis) o red, bumpy or blistering rash o skin cysts o skin tightness
Croatian: ○ abnormalni rast kože (neoplazme kože) ○ prekomjerni rast dlaka ○ crvenilo lica uz osjećaj vrućine i prištići s mogućim gnojem
English: o bumpy rash (papular rash) o cold sores o redness and irritation at the site where the cream is applied o eczema o inflammed, dry, cracked or numb lips o ingrowing hairs o pale areas on the skin o skin bleeding o skin boils o skin flushing o skin inflammation o sore skin o swelling of the mouth or face o unusual hair texture or hair growth
Croatian: ○ osip sa sitnim kvržicama (papularni osip) ○ herpes simplex (groznica) ○ crvenilo i iritacija na mjestu primjene kreme ○ ekcem ○ upaljene, suhe, ispucale ili utrnule usne ○ urasle dlake
English: Eflornithine
Croatian: FARMACEUTSKI
English: This is called ‘myeloablation'.
Croatian: To se naziva „mijeloablacija”.
English: There were two main studies involving 103 adults and one involving 55 children.
Croatian: Provedena su dva glavna ispitivanja koja su obuhvatila 103 odrasle osobe kao i jedno ispitivanje koje je obuhvatilo 55 djece.
English: The full EPAR for Busilvex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Busilvex nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Busilvex can affect fertility in both sexes.
Croatian: Busilvex može utjecati na plodnost oba spola.
English: The European Commission granted a marketing authorisation valid throughout the EU for Busilvex on 9 July 2003.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Busilvex na snazi u Europskoj uniji od 9. srpnja 2003.
English: This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Croatian: Ovaj tip presađivanja primjenjuje se u bolesnika u kojih je potrebna zamjena krvotvornih stanica, jer imaju bolest krvi (poput rijetkog tipa anemije) ili rak krvi.
English: Because of this, female patients should not become pregnant during treatment and for up to six months afterwards, and male patients are advised not to father a child during and for up to six months after treatment with Busilvex.
Croatian: S obzirom na prethodno navedeno, ženski bolesnici ne smiju zatrudnjeti tijekom liječenja i do šest mjeseci nakon liječenja, a muškim bolesnicima se preporuča da ne začinju dijete tijekom i do šest mjeseci nakon liječenja lijekom Busilvex.
English: These substances are ‘cytotoxic'.
Croatian: Ove su tvari „citotoksične”.