FrancophonIA/ELRC3.0 huggingface dataset:
English: Myalepta is a medicine used to treat lipodystrophy, where patients have loss of fatty tissue under the skin and build-up of fat elsewhere in the body such as in the liver and muscles.
Croatian: Myalepta je lijek koji se upotrebljava za liječenje lipodistrofije, stanja u kojem bolesnici gube potkožno masno tkivo i skladište ga u nekom drugom dijelu tijela, primjerice u jetri ili mišićima.
English: Dose of Myalepta in mL
Croatian: Doza lijeka Myalepta u ml
English: You will need to use the 3 ml syringe to withdraw the water from the vial or ampoule and transfer it into the vial containing Myalepta powder.
Croatian: Štrcaljkom od 3 ml trebat ćete izvući vodu iz bočice ili ampule i prenijeti je u bočicu s praškom lijeka Myalepta.
English: The recommended daily dose depends on the patient's bodyweight and sex, which the doctor can then adjust based on the patient's response to treatment.
Croatian: Preporučena dnevna doza ovisi o tjelesnoj težini i spolu bolesnika, a liječnik je može prilagoditi na temelju odgovora bolesnika na liječenje.
English: Using the wrong syringe to make up the medicine or not withdrawing the correct dose could cause dosing errors.
Croatian: Moguće su pogreške doziranja ako upotrijebite pogrešnu štrcaljku ili ne povučete pravilnu dozu.
English: • The recommended daily dose depends on the patient's bodyweight and sex as shown in the following table, and is adjusted based on the patient's response to treatment.
Croatian: • Preporučena dnevna doza ovisi o tjelesnoj težini bolesnika i spolu, kako je prikazano u tablici u nastavku, te se prilagođava na temelju odgovora bolesnika na liječenje.
English: In order to convert the dose for the 0.3 mL U100 insulin syringe the following table should be used:
Croatian: Za konverziju doze za inzulinsku štrcaljku od 0,3 ml U100 poslužite se tablicom u nastavku:
English: • Patients, their parents or carers can inject the medicine once they have been trained.
Croatian: • Bolesnici, njihovi roditelji ili njegovatelji mogu ubrizgavati lijek kada ih se za to osposobi.
English: The pharmacist must also dispense the corresponding needles, alcohol swabs and sharps bin.
Croatian: Ljekarnik također mora izdati odgovarajuće igle, vatice natopljene alkoholom i spremnik za odlaganje oštrih predmeta.
English: With each vial of Myalepta the pharmacist will dispense an ampoule or vial of water for injection to prepare the solution as well as two syringes (one to make up the medicine and one to give it) and needles.
Croatian: Uz bočicu lijeka Myalepta ljekarnik će izdati i ampulu ili bočicu vode za injekciju za pripremu otopine te dvije štrcaljke (jednu za pripremu lijeka i drugu za primjenu) i igle.
English: • Myalepta (metreleptin), used treat lipodystrophy, is given as a daily subcutaneous injection in the abdomen, thigh or upper arm.
Croatian: • Myalepta (metreleptin) je lijek za liječenje lipodistrofije i primjenjuje se svakodnevno, potkožnom injekcijom u abdomen, bedro ili nadlakticu.
English: This includes written training materials as well as a video with instructions on how to prepare the solution for injection and how to inject it.
Croatian: Materijal se sastoji od pisanih materijala i videozapisa s uputama o načinu pripreme otopine za injekciju i načinu ubrizgavanja.
English: Myalepta is given as a daily injection under the skin of the abdomen (belly), thigh or upper arm.
Croatian: Myalepta se primjenjuje svakodnevno kao potkožna injekcija u abdomen (trbuh), bedro ili nadlakticu.
English: Myalepta dose range to be administered daily
Croatian: Raspon doze lijeka Myalepta koju je potrebno svakodnevno primijeniti
English: • Together with the vial containing Myalepta powder, your pharmacist will give you a vial or ampoule of water for injection as well as a 3 ml syringe.
Croatian: • Uz bočicu s praškom lijeka Myalepta, ljekarnik će Vam dati bočicu ili ampulu vode za injekciju te štrcaljku od 3 ml.
English: Baseline weight
Croatian: Tjelesna težina
English: • Myalepta is available as a vial of powder to which water for injection is added to make a solution for injection.
Croatian: • Lijek Myalepta isporučuje se u obliku praška u bočici kojem se dodaje voda za injekciju radi pripreme otopine za injekciju.
English: • You should speak to your doctor, pharmacist or nurse if you have any questions about your treatment.
Croatian: • Imate li pitanja o liječenju, obratite se svojem liječniku, ljekarniku ili medicinskoj sestri.
English: The medicine comes as a vial of powder to which water is added to make a solution for injection.
Croatian: Lijek se isporučuje u obliku praška u bočici kojem se dodaje voda radi pripreme otopine za injekciju.
English: Females > 40 kg
Croatian: Muškarci > 40 kg žene > 40 kg drugu štrcaljku za ubrizgavanje doze.
English: It is available as a vial that contains a powder that is made into a solution for injection.
Croatian: Lijek je dostupan u bočici koja sadržava prašak za pripremu otopine za injekciju.
English: The potential risk to humans is unknown.
Croatian: Mogući rizik za ljude nije poznat.
English: D-21465 Reinbek Germany
Croatian: D-21465 Reinbek
English: Application should be limited to these areas.
Croatian: Primjenu je potrebno ograničiti na ova područja.
English: If you put too much cream on your skin, it is unlikely to harm you.
Croatian: Ako stavite previše kreme na kožu, nije vjerojatno da će Vam naškoditi.
English: To date, no other relevant epidemiological data are available.
Croatian: Do danas nisu dostupni drugi relevantni epidemiološki podaci.
English: Patient comfort in various social and work settings was also improved.
Croatian: Osjećaj ugode bolesnica u različitim društvenim i radnim okruženjima također je poboljšana.
English: Special population Elderly: (> 65 years) no dosage adjustment is necessary.
Croatian: Posebne populacije Stariji: (> 65 godina) nije potrebna prilagodba doze.
English: It is important to continue using the cream.
Croatian: Važno je nastaviti koristiti kremu.
English: Continued treatment may result in further improvement and is necessary to maintain beneficial effects.
Croatian: Nastavak liječenja može rezultirati daljnjim poboljšanjima i potrebno je za održavanje korisnih učinaka.
English: Date of first authorisation: 20 March 2001 Date of latest renewal: 07 March 2011
Croatian: Datum prvog odobrenja: 20. ožujak 2001. Datum posljednje obnove odobrenja: 7. ožujak 2011
English: Make sure the cap of the tube is tightly closed after each use.
Croatian: Pobrinite se da je čep tube čvrsto zatvoren nakon svake uporabe.
English: About 12% of women in the clinical trials were postmenopausal.
Croatian: Otprilike 12% žena u kliničkim ispitivanjima bilo je u postmenopauzi.
English: Excessive growth of hair may be a result of underlying diseases.
Croatian: Prekomjerni rast dlaka može biti rezultat postojećih bolesti.
English: For patients who discontinued therapy during the trial last observations were carried forward to Week 24.
Croatian: Za bolesnike koji su prekinuli liječenje tijekom ispitivanja posljednja su zapažanja prenesena u 24.tjedan.
English: Talk to your doctor if you need to use other medicines on the areas of skin where you are using the cream.
Croatian: Razgovarajte sa svojim liječnikom ako morate koristiti druge lijekove na područjima kože na kojima koristite kremu.
English: It may take 8 weeks before you see results.
Croatian: Može proći i 8 tjedana prije nego se uoče rezultati.
English: Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
Croatian: S obzirom na minimalnu kutanu penetraciju eflornitina (vidjeti dio 5.2) predoziranje je vrlo malo vjerojatno.
English: The cream should be rubbed in thoroughly.
Croatian: Kremu je potrebno temeljito utrljati.
English: • When using on the face, avoid contact with your eyes or the inside of your nose or mouth.
Croatian: • Pri nanošenju kreme na lice izbjegavajte kontakt s očima ili unutrašnjim dijelom nosa ili usta.
English: Maximal applied doses used safely in clinical trials were up to 30 grams per month.
Croatian: Maksimalne primijenjene doze koje su se sigurno koristile u kliničkim ispitivanjima iznosile su do 30 grama mjesečno.
English: It is supplied in tubes of 15 g, 30 g and 60 g but not all pack sizes may be marketed.
Croatian: Dostupna je u tubama od 15 g, 30 g i 60 g, ali na tržištu se ne moraju nalaziti sve veličine pakovanja.
English: Higher doses resulted in maternal and foetal toxicity without evidence of teratogenicity.
Croatian: Više doze rezultirale su maternalnom i fetalnom toksičnošću bez dokaza teratogenosti.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da lijek uzrokuje reproduktivnu toksičnost (vidjeti dio 5.3).
English: It may harm them,
Croatian: voda, pročišćena;
English: Therefore, women who are pregnant or planning pregnancy should use an alternative means to manage facial hair.
Croatian: Stoga žene koje su trudne ili planiraju trudnoću moraju koristiti alternativne metode liječenja problema dlakavosti lica.
English: Other medicines and Vaniqa
Croatian: Drugi lijekovi i Vaniqa
English: Apply straight away, but wait at least 8 hours before using it again.
Croatian: Odmah nanesite kremu ali pričekajte barem 8 sati prije ponovne primjene.
English: Shelf-life after first opening: 6 months.
Croatian: Rok valjanosti nakon prvog otvaranja: 6 mjeseci.
English: If you should accidentally get Vaniqa into your eyes, mouth or nose, rinse well with water.
Croatian: Ako Vaniqa slučajno dospije u oči, usta ili nos, isperite ih temeljito vodom.
English: The safety and efficacy of Vaniqa in children aged 0 to 18 years has not been established.
Croatian: Sigurnost i djelotvornost kreme Vaniqa u djece u dobi od 0 do 18 godina nije ustanovljena.
English: If you stop using it your original hair growth may return within 8 weeks.
Croatian: Ako prestanete koristiti kremu, dlake će opet početi rasti unutar 8 tjedana.
English: If you do not see any improvement after using it for 4 months contact your doctor.
Croatian: Ako ne uočite nikakvo poboljšanje nakon 4 mjeseca, obratite se svom liječniku.
English: Significant improvement (p < 0.001) versus vehicle was seen in postmenopausal women.
Croatian: Značajno je poboljšanje (p < 0,001) opaženo naspram podloge u žena u postmenopauzi.
English: Subgroup analysis revealed a difference in treatment success where 27% of non-white women and 39% of white women showed a marked or better improvement.
Croatian: Analiza podskupina otkrila je razliku u uspjehu liječenja gdje je 27% žena koje nisu bjelkinje i 39% bjelkinja pokazalo znatno poboljšanje ili čak bolje od toga.
English: Vaniqa is not recommended for use in anyone younger than 18 years of age.
Croatian: Vaniqa se ne preporučuje za primjenu u osoba mlađih od 18 godina.
English: If you use more Vaniqa than you should
Croatian: Ako primijenite više kreme Vaniqa nego što ste trebali
English: If you or anyone else accidentally swallows Vaniqa, contact your doctor immediately.
Croatian: Ako Vi ili netko drugi slučajno proguta kremu Vaniqa, odmah se obratite liječniku.
English: What Vaniqa is and what it is used for
Croatian: Što je Vaniqa i za što se koristi
English: Vaniqa cream should be applied to the affected area twice daily, at least eight hours apart.
Croatian: Kremu Vaniqa potrebno je primijeniti na zahvaćeno područje dva puta dnevno s razmakom od najmanje osam sati.
English: • If you have just shaved or used any other hair removal method, wait at least 5 minutes before using Vaniqa.
Croatian: • Ako ste se upravo obrijali ili ste koristili drugu metodu uklanjanja dlaka, pričekajte najmanje 5 minuta prije primjene kreme Vaniqa.
English: Vaniqa is used to reduce the growth of excessive hair (Hirsutism) on the face of women older than 18 years of age.
Croatian: Vaniqa se koristi za smanjenje prekomjernog rasta dlaka (hirzutizam) na licu žena starijih od 18 godina.
English: • Clean and dry the areas of the skin where you will be using the cream.
Croatian: • Očistite i osušite područja kože na kojima ćete koristiti kremu.
English: Statistically significant (p ≤ 0.001) improvement for Vaniqa versus vehicle was seen in each of these studies for women with marked improvement and clear/almost clear responses.
Croatian: Statistički značajno (p ≤ 0,001) poboljšanje za kremu Vaniqa u usporedbi s podlogom primijećeno je u svakom od ovih ispitivanja za žene sa znatnim poboljšanjem i jasnim/gotovo jasnim odgovorima.
English: • if you are allergic to eflornithine or any of the other ingredients of this medicine listed in section 6.
Croatian: • ako ste alergični na eflornitin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • Wait at least 5 minutes before using make-up or sunscreen on the same areas.
Croatian: • Pričekajte najmanje 5 minuta prije nanošenja šminke ili proizvoda za zaštitu od sunca na istom dijelu lica.
English: • If possible, do not wash these areas of skin for 4 hours after applying the cream
Croatian: • Ako je moguće, nemojte ispirati područja kože tijekom 4 sata nakon primjene kreme.
English: Ronda General Mitre, 151 08022 Barcelona Spain.
Croatian: Ronda General Mitre, 151 08022 Barcelona Španjolska
English: Patient self-assessments demonstrated a significantly reduced psychological discomfort with the condition, as measured by responses to 6 questions on a visual analogue scale.
Croatian: Samoprocjena bolesnica pokazala je značajno smanjenu psihološku nelagodu zbog stanja, a na osnovu njihovih odgovora na 6 pitanja na vizualnoj analognoj ljestvici.
English: There is no data available to support use in this age group.
Croatian: Nema dostupnih podataka koji bi poduprli primjenu u ovoj dobnoj skupini.
English: These improvements resulted in a corresponding reduction in the darkening appearance of the facial skin associated with the presence of terminal hair.
Croatian: Ta su poboljšanja rezultirala u odgovarajućem smanjenju zatamnjenja kože lica povezanog s prisutnošću terminalnih dlaka.
English: Clear / almost clear
Croatian: Čista/gotovo čista koža
English: even if their symptoms are the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: Treatment of facial hirsutism in women.
Croatian: Liječenje hirzutizma lica u žena.
English: Pharmacotherapeutic group: other dermatological preparations, ATC code: D11AX16.
Croatian: Farmakoterapijska skupina: drugi dermatološki pripravci, ATK oznaka: D11AX16.
English: You should use an alternative method to manage your facial hair if you are pregnant or trying to become pregnant.
Croatian: Trebate koristiti alternativne metode liječenje dlaka na licu ako ste trudni ili planirate trudnoću.
English: In such cases they normally resolve without discontinuation of Vaniqa.
Croatian: U takvim slučajevima obično se povlače bez prekida uzimanja kreme Vaniqa.
English: Vaniqa is a cream which is white to off white in colour.
Croatian: Vaniqa je krema bijele do bjelkaste boje.
English: Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy.
Croatian: Primjenu je potrebno prekinuti ako se ne uoče korisni učinci unutar četiri mjeseca od početka terapije.
English: Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred while the patient was using Vaniqa.
Croatian: Između 22 trudnoće koje su se dogodile tijekom ispitivanja samo 19 trudnoća dogodilo se dok je bolesnica koristila kremu Vaniqa.
English: Contents of the pack and other information What Vaniqa contains
Croatian: Sadržaj pakiranja i druge informacije Što Vaniqa sadrži
English: Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down's Syndrome to a 35 year old).
Croatian: Ishodi tih 19 trudnoća bili su: rođeno 9 zdrave djece, 5 elektivnih pobačaja, 4 spontana pobačaja i 1 prirođeni defekt (Downov sindrom, majka stara 35 godina).
English: Almirall, S.A. Keep out of the sight and reach of children.
Croatian: Almirall S.A. Čuvati izvan pogleda i dohvata djece.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity, genotoxicity and carcinogenic potential, including one photocarcinogenicity study in mice.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti, uključujući i jednu studiju fotokancerogenosti na miševima.
English: MedDRA conventions for frequency are 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), very rare (<1/10,000), or not known (cannot be estimated from the available data) including isolated reports.
Croatian: MedDRA-i su: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka) uključujući izolirana izvješća.
English: Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application.
Croatian: Kozmetički pripravci (uključujući i pripravke za zaštitu od sunca) mogu se primijeniti preko liječenih područja, ali najranije pet minuta nakon primjene kreme Vaniqa.
English: Cream 15 g 30 g 60 g
Croatian: Krema 15 g 30 g 60 g
English: Women should not use Vaniqa whilst breastfeeding.
Croatian: Žene ne smiju koristiti kremu Vaniqa za vrijeme dojenja.
English: • If you experience irritation (e.g. stinging burning), reduce the use of Vaniqa to once daily until the irritation has gone.
Croatian: • Ako osjetite iritaciju (primjerice, žarenje ili peckanje) smanjite primjenu kreme Vaniqa na jednom dnevno sve dok iritacije ne prestanu.
English: Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or foetuses.
Croatian: Podaci kliničkih ispitivanja na ograničenom broju izloženih trudnoća (22) ne ukazuju na postojanje kliničkog dokaza da liječenje kremom Vaniqa štetno utječe na majke ili fetuse.
English: • Use twice a day, at least 8 hours apart.
Croatian: • Primjenjujte kremu dva puta dnevno s razmakom od najmanje 8 sati.
English: What Vaniqa looks like and the contents of the pack
Croatian: Kako Vaniqa izgleda i sadržaj pakovanja
English: White to off white cream
Croatian: Bijela do bjelkasta krema
English: Paediatric population The adverse reactions observed in adolescents are similar to the ones observed in adults.
Croatian: Nuspojave primijećene u adolescentica slične su onima primijećenim u odraslih.
English: The safety and efficacy of Vaniqa was evaluated in two double-blind, randomised, vehicle-controlled clinical trials involving 596 women of skin types I-VI (395 on Vaniqa, 201 on vehicle) treated for up to 24 weeks.
Croatian: Sigurnost i djelotvornost kreme Vaniqa procijenjena je u dva dvostruko slijepa, randomizirana klinička ispitivanja kontrolirana podlogom koja uključuju 596 žena s tipovima kože I-VI (395 su primale kremu Vaniqa, a 201 podlogu) liječene u razdoblju do najdulje 24 tjedna.
English: For maximal efficacy, the treated area should not be cleansed within four hours of application.
Croatian: Za maksimalnu djelotvornost liječeno se područje ne smije čistiti četiri sata nakon primjene.
English: If irritation continues, treatment should be discontinued and the physician consulted.
Croatian: Ako se iritacija nastavi, liječenje se mora prekinuti uz savjetovanje s liječnikom.
English: The combined results of these two trials are presented below:
Croatian: Kombinirani rezultati ova dva ispitivanja prikazani su u nastavku: Ishod*
English: Patient self-assessments were found to correlate with physician observations of efficacy.
Croatian: Samoprocjena bolesnica korelira s liječničkim zapažanjima djelotvornosti.
English: In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur.
Croatian: U tom slučaju kremu je potrebno primjenjivati najranije pet minuta nakon brijanja ili uporabe drugih metoda uklanjanja dlaka jer inače može doći do pojačanog peckanja ili žarenja.
English: • Apply a thin layer of cream and rub it in thoroughly until no visual residual product remains on the treated areas.
Croatian: • Primijenite tanak sloj kreme i utrljajte ga temeljito sve dok ostaci kreme prestanu biti vidljivi na liječenim područjima.
English: Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months.
Croatian: Važno je napomenuti da je preko 1350 bolesnica liječeno kremom Vaniqa u ovim ispitivanjima u razdoblju od 6 mjeseci do godine dana, dok je nešto više od 200 bolesnica liječeno podlogom.
English: Contact with eyes or mucous membranes (e.g. nose or mouth) should be avoided.
Croatian: Kontakt s očima ili sluznicama (primjerice s nosom ili ustima) mora se izbjegavati.
English: Improved
Croatian: Poboljšano
English: Efficacy has only been demonstrated for affected areas of the face and under the chin.
Croatian: Djelotvornost lijeka dokazana je samo za zahvaćena područja lica i ispod brade.
English: High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream.
Croatian: Tuba od polietilena visoke gustoće s navojnim čepom od polipropilena koja sadrži 15 g, 30 g ili 60 g kreme.
English: Physicians assessed the change from baseline on a 4-point scale, 48 hours after women had shaved the treated areas of the affected areas of the face and under the chin, considering parameters such as hair length and density, and darkening of the skin associated with the presence of terminal hair.
Croatian: Liječnici su procijenili promjenu u odnosu na početak na ljestvici od četiri boda, 48 sati nakon što su žene obrijale liječena područja lica i podbratka promatrajući parametre poput duljine i gustoće dlaka te tamnjenja kože povezanog s prisutnošću terminalnih dlaka.
English: Talk to your doctor of pharmacist before using Vaniqa
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite kremu Vaniqa
English: If symptoms of overdose occur the use of the medicinal product should be stopped.
Croatian: Ako se pojave simptomi predoziranja mora se obustaviti primjena lijeka.
English: Vaniqa is not expected to have any effect on your ability to drive or use machines.
Croatian: Ne očekuje se da će Vaniqa imati utjecaja na Vašu sposobnost upravljanja vozilima i strojevima.
English: No improvement / worse * At end of therapy (Week 24).
Croatian: * Na kraju liječenja (tjedan 24).
English: Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
Croatian: Nije poznato metabolizira li se eflornitin, a eliminira se prvenstveno mokraćom.
English: If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day.
Croatian: U slučaju razvoja iritacije ili intolerancije potrebno je privremeno smanjiti učestalost primjene kreme na jednom dnevno.
English: As the safety of Vaniqa has not been studied in patients with severe renal impairment, caution should be used when prescribing Vaniqa for these patients.
Croatian: S obzirom da sigurnost kreme Vaniqa nije ispitivana u bolesnica s teškim oštećenjem bubrega potreban je oprez pri propisivanju kreme Vaniqa ovim bolesnicama.
English: Side effects are usually limited to the skin and mild in intensity.
Croatian: Nuspojave su obično ograničene na kožu te su blagog intenziteta.
English: Each gram of cream contains 115 mg of eflornithine (as hydrochloride monohydrate).
Croatian: Jedan gram kreme sadrži 115 mg eflornitina (u obliku eflornitinklorid hidrata).
English: A thin layer of the cream should be applied to clean and dry affected areas.
Croatian: Način primjene Tanki sloj kreme potrebno je nanijeti na čisto i suho zahvaćeno područje.
English: Hepatic/renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established.
Croatian: Oštećenje jetre/bubrega: sigurnost i djelotvornost kreme Vaniqa u žena s oštećenjem jetre i bubrega nije ustanovljena.