FrancophonIA/ELRC3.0 huggingface dataset:
English: For some serious skin infections, the recommended dose is 600 mg every 8 hours, with each infusion lasting 120 minutes.
Croatian: Kod teških infekcija kože preporučena doza je 600 mg svakih 8 sati pri čemu svaka infuzija traje najmanje 120 minuta.
English: Zinforo (ceftaroline fosamil)
Croatian: Zinforo (ceftarolinfosamil)
English: Side effects reported with Zinforo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zinforo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: In adults and adolescents from 12 years of age weighing at least 33 kg, the usual dose is 600 mg every 12 hours.
Croatian: U odraslih osoba i adolescenata u dobi od 12 godina i više te tjelesne težine od najmanje 33 kg uobičajena doza je 600 mg svakih 12 sati.
English: What are the risks associated with Zinforo?
Croatian: Koji su rizici povezani s lijekom Zinforo?
English: This weakens the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
Croatian: To uzrokuje slabost bakterijskih staničnih stijenki, koje zatim postaju podložne kolapsu, što naposljetku uzrokuje odumiranje bakterija.
English: The most common side effects with Zinforo (seen in more than 3% of patients) are diarrhoea, headache, nausea (feeling sick) and pruritus (itching).
Croatian: Najčešće nuspojave lijeka Zinforo (zabilježene u više od 3 % bolesnika) jesu proljev, glavobolja, mučnina (osjećaj slabosti) i pruritus (svrbež).
English: Patients with complicated skin and soft tissue infections should be treated for 5 to 14 days and patients who have community-acquired pneumonia should be treated for 5 to 7 days.
Croatian: Bolesnici s kompliciranim infekcijama kože i mekog tkiva trebaju se liječiti 5 do 14 dana, a bolesnici s izvanbolnički stečenom upalom pluća trebaju se liječiti 5 do 7 dana.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinforo have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zinforo nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The Agency decided that Zinforo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi od lijeka Zinforo nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: For more information about using Zinforo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Zinforo pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Other information about Zinforo
Croatian: Ostale informacije o lijeku Zinforo
English: An overview of Zinforo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zinforo i zašto je odobren u EU-u
English: It interferes with the production of complex molecules called peptidoglycans, which are essential components of bacterial cell walls.
Croatian: Utječe na stvaranje složenih molekula pod nazivom „peptidoglikani”, ključnih komponenti bakterijskih staničnih stijenki.
English: Zinforo must not be used in people who are hypersensitive (allergic) to ceftaroline fosamil or any of the other ingredients.
Croatian: Zinofro se ne smije davati osobama koje su preosjetljive (alergične) na ceftarolinfosamil ili bilo koji drugi sastojak lijeka.
English: In laboratory studies Zinforo was active against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work (meticillin-resistant Staphylococcus aureus (MRSA) and penicillin non-susceptible Streptococcus pneumoniae (PNSP)).
Croatian: U laboratorijskim ispitivanjima lijek Zinforo djelovao je protiv određenih bakterija protiv kojih drugi antibiotici koji pripadaju skupini beta-laktamaza ne djeluju (sojevi bakterije otporni na meticilin Staphylococcus aureus (MRSA) te u sojeva bakterije Streptococcus pneumoniae (PNSP)) neosjetljivih na penicilin.
English: As for all medicines, data on the use of Zinforo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Zinforo kontinuirano se prate.
English: Zinforo was as effective as other antibiotics in curing skin and soft tissue infections and pneumonia in adults.
Croatian: Zinforo je bio jednako djelotvoran kao i drugi antibiotici u liječenju infekcija kože i mekog tkiva te upale pluća u odraslih osoba.
English: It does so by blocking enzymes, called penicillin-binding protein transpeptidases, that are involved in the last steps of bacterial cell wall production.
Croatian: Djeluje inhibirajući enzime naziva proteini transpeptidaze koji se vežu na penicilin i koji su uključeni u posljednje faze stvaranja bakterijske stanične stijenke.
English: The active substance in Zinforo, ceftaroline fosamil, is a type of antibiotic called cephalosporin belonging to the group ‘beta-lactams'.
Croatian: Djelatna tvar lijeka Zinforo, ceftarolinfosamil, vrsta je antibiotika pod nazivom cefalosporin, koji pripada skupini „beta-laktamaza”.
English: The European Medicines Agency concluded that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and its side effects in both adults and children were manageable.
Croatian: Europska agencija za lijekove zaključila je da je lijek Zinforo učinkovit u liječenju kompliciranih infekcija kože i mekog tkiva te izvanbolnički stečene upale pluća i da se njegove nuspojave u odraslih osoba i djece mogu kontrolirati.
English: The Agency also noted that in laboratory studies Zinforo had shown activity against certain bacteria, such as MRSA, against which other beta-lactam antibiotics do not work.
Croatian: Agencija je također ocijenila da je lijek Zinforo u laboratorijskim ispitivanjima pokazao djelovanje protiv određenih bakterija, kao što je MRSA, protiv kojih drugi antibiotici iz skupine betalaktamaza ne djeluju.
English: Zinforo must also not be used in patients who are hypersensitive to other antibiotics belonging to the cephalosporin class and in patients who are severely allergic to other betalactam antibiotics.
Croatian: Zinforo se ne smije davati ni bolesnicima koji su preosjetljivi na druge antibiotike iz skupine cefalosporina i bolesnicima koji su izrazito alergični na druge antibiotike betalaktamske skupine.
English: Zinforo contains the active substance ceftaroline fosamil.
Croatian: Zinforo sadrži djelatnu tvar ceftarolinfosamil.
English: • complicated infections of the skin and soft tissue (tissue below the skin).
Croatian: • komplicirane infekcije kože i mekog tkiva (tkiva ispod kože). „Komplicirana” znači da se infekcija teško liječi.
English: What benefits of Zinforo have been shown in studies?
Croatian: Koje su koristi od lijeka Zinforo utvrđene u ispitivanjima?
English: How is Zinforo used?
Croatian: Kako djeluje Zinforo?
English: In a children's study of complicated skin and soft tissue infection, 94% of the children receiving Zinforo were cured (101 out of 107), compared with 87% of those receiving vancomycin or cefazolin, with or without aztreonam (45 out of 52).
Croatian: U slučaju komplicirane infekcije kože i mekog tkiva u djece izliječeno je 94 % djece koja su dobivala lijek Zinforo (101 od 107), u usporedbi s 87 % djece koja su dobivala vankomicin ili cefazolin, s aztreonamom ili bez njega (45 od 52).
English: In another study, 81% of patients receiving Zinforo were cured (235 out of 289) compared with 76% of the patients receiving ceftriaxone (206 out of 273).
Croatian: U drugom ispitivanju izliječeno je 81 % bolesnika koji su dobivali lijek Zinforo (235 od 289), u usporedbi sa 76 % bolesnika koji su dobivali lijek ceftriakson (206 od 273).
English: In a second study, 85% of patients receiving Zinforo were cured (291 out of 342) compared with 86% of the patients receiving the combination of vancomycin and aztreonam (289 out of 338).
Croatian: U drugom ispitivanju izliječeno je 85 % bolesnika koji su dobivali lijek Zinforo (291 od 342), u usporedbi s 86 % bolesnika koji su dobivali kombinaciju lijekova vankomicin i aztreonam (289 od 338).
English: For community-acquired pneumonia, one study showed that 84% of the patients receiving Zinforo were cured (244 out of 291), compared with 78% of the patients receiving ceftriaxone (233 out of 300).
Croatian: U slučaju izvanbolnički stečene upale pluća jedno je ispitivanje pokazalo da je izliječeno 84 % bolesnika koji su dobivali lijek Zinforo (244 od 291), u usporedbi sa 78 % bolesnika koji su dobivali lijek ceftriakson (233 od 300).
English: Among children with community-acquired pneumonia that required hospital stay, 88% of those on Zinforo were cured (94 out of 107), compared with 89% of those receiving ceftriaxone.
Croatian: U slučaju izvanbolnički stečene upale pluća u djece za koju je bilo potrebno bolničko liječenje izliječeno je 88 % djece koja su dobivala lijek Zinforo (94 od 107), u usporedbi s 89 % djece koja su dobivala lijek ceftriakson.
English: Among those with complicated community-acquired pneumonia, 90% of the patients treated with Zinforo were cured, compared with 100% of those receiving ceftriaxone plus vancomycin.
Croatian: U djece oboljele od komplicirane izvanbolnički stečene upale pluća izliječeno je 90 % djece koja su dobivala lijek Zinforo, u usporedbi sa 100 % djece koja su dobivala lijekove ceftriakson i vankomicin.
English: How does Zinforo work?
Croatian: Kako se Zinforo primjenjuje?
English: In a study of patients with complicated skin and soft tissue infection, 87% of the patients receiving Zinforo were cured (304 out of 351), compared with 86% of the patients receiving the combination of vancomycin and aztreonam (297 out of 347).
Croatian: U slučaju komplicirane infekcije kože i mekog tkiva jedno je ispitivanje pokazalo da je izliječeno 87 % bolesnika koji su dobivali lijek Zinforo (304 od 351), u usporedbi s 86 % bolesnika koji su dobivali kombinaciju lijekova vankomicin i aztreonam (297 od 347).
English: For the full list of side effects of Zinforo, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Zinofro potražite u uputi o lijeku.
English: The significance for man is unknown.
Croatian: Značenje ove činjenice za čovjeka je nepoznato.
English: Date of first authorisation: 18/09/1998 Date of last renewal: 03/09/2008
Croatian: Datum prvog odobrenja: 18/09/1998 Datum obnove odobrenja: 03/09/2008
English: The maximum recommended dose is one sachet.
Croatian: Najveća preporučena doza je jedna vrećica.
English: Continue treatment for four weeks.
Croatian: Nastavite s uporabom četiri tjedna.
English: Dose proportionality was not observed.
Croatian: Proporcionalnost doze nije uočena.
English: Imiquimod has no direct antiviral activity.
Croatian: Imikvimod nema neposredno antivirusno djelovanje.
English: Treatment should be initiated and monitored by a physician.
Croatian: Liječenje treba započeti i nadgledati liječnik.
English: Serious skin reactions have been reported rarely.
Croatian: Ozbiljne kožne reakcije prijavljene su rijetko.
English: White to slightly yellow cream.
Croatian: Bijela do blago žuta krema.
English: All patients were followed-up until withdrawal or up to 3 years after randomisation.
Croatian: Svi su bolesnici praćeni do povlačenja ili do 3 godine nakon randomizacije.
English: - if you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na imikvimod ili bilo koji drugi sastojak ovoga lijeka (naveden u dijelu 6).
English: Alternative forms of contraception should be considered.
Croatian: Potrebno je primijeniti druge oblike kontracepcije.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Molimo obavijestite svojeg liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali ili bi mogli uzimati bilo koje druge lijekove.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi drugi lijekovi, ovaj lijek može prouzročiti nuspojave, iako se one ne pojavljuju kod svih bolesnika.
English: If this occurs you should seek medical help immediately.
Croatian: Ako to primijetite, odmah potražite medicinsku pomoć.
English: Studies in animals do not indicate direct or indirect harmful effects in pregnancy.
Croatian: Ispitivanja na životinjama nisu ukazala na izravne ili neizravne učinke tijekom trudnoće.
English: Package leaflet: Information for the user
Croatian: Uputa o lijeku: informacija za korisnika
English: Do not apply the cream on Saturday and Sunday.
Croatian: Nemojte ju primjenjivati u subotu i nedjelju.
English: Mice were maintained for an additional 12 weeks for a total of 52 weeks.
Croatian: Miševi su živjeli dodatnih 12 tjedana, što je ukupno iznosilo 52 tjedna.
English: Results are emerged from a meta-analysis of both trials.
Croatian: Rezultati su dobiveni iz metaanalize obaju ispitivanja.
English: The complete clearance rate (imiquimod minus placebo) for the combined trials was 46.1% (CI 39.0%,
Croatian: Stopa potpunog nestanka (imikvimod minus placebo) za kombinirana ispitivanja bila je 46,1% (CI 39,0%,
English: As soon as the problem has stopped you may restart to apply the cream.
Croatian: Čim problem nestane, možete ponovo početi primjenjivati kremu.
English: A different therapy is recommended if the treated lesion(s) shows insufficient response to Aldara.
Croatian: Preporučuje se drugačija terapija ako liječena(e) lezija(e) iskaže(u) nedovoljan odgovor na Aldaru.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja.
English: Treatment in this patient population is therefore recommended only in men who are able or willing to follow the daily foreskin hygiene routine.
Croatian: Liječenje ove populacije bolesnika preporučuje se samo u onih muškaraca koji su u mogućnosti ili su voljni provoditi svakodnevnu higijenu prepucija.
English: This includes studies with immunosuppressive drugs.
Croatian: To uključuje i ispitivanja s imunosupresivnim lijekovima.
English: However the cream should not be applied more than once a day.
Croatian: Međutim, kremu se ne smije primjenjivati više od jednom dnevno.
English: e) Paediatric population:
Croatian: e) Pedijatrijska populacija:
English: LE11 5SF, United Kingdom
Croatian: LE11 5SF, Ujedinjeno Kraljevstvo
English: During the 6 to 10 hour treatment period, showering or bathing should be avoided.
Croatian: Tijekom razdoblja liječenja od 6 do 10 sati, potrebno je izbjegavati tuširanje i kupanje.
English: Your doctor will discuss the risks and benefits of using Aldara cream during pregnancy.
Croatian: Liječnik će Vas upozoriti na rizike i korist od primjene kreme Aldara tijekom trudnoće.
English: If you use more Aldara cream than you should
Croatian: Ako primijenite više kreme Aldara nego što ste trebali
English: A small number of patients have experienced hair loss at the treatment site or surrounding area.
Croatian: Kod manjeg broja bolesnika došlo je do gubitka dlaka na mjestu liječenja ili u okolnom području.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što počnete primjenjivati ovaj lijek jer sadržava
English: 12 sachets.
Croatian: 12 vrećica.
English: The recurrence rate for individual lesions was 5.6% (41/737).
Croatian: Stopa povrata za pojedinačne lezije bila je 5,6% (41/737).
English: See 4.2 and 4.4 for information on rest periods.
Croatian: Vidjeti dio 4.2 i 4.4 za informacije tijekom razdoblja bez terapije.
English: If you decide to have sexual relations while you still have warts, apply Aldara cream after - not before - sexual activity.
Croatian: Ako se odlučite za spolne odnose dok još uvijek imate bradavice, nanesite kremu Aldara nakon - a ne prije - spolnog odnosa.
English: Do not apply the cream more than once per day.
Croatian: Ne primjenjujte kremu više od jednom dnevno.
English: For example, apply the cream from Monday to Friday.
Croatian: Na primjer kremu primjenjujte od ponedjeljka do petka.
English: These results were statistically significant (p<0.001) by comparison with the vehicle group, 3% (6/179) and 2% (3/179) respectively.
Croatian: Ti su rezultati bili statistički značajni (p < 0,001) u usporedbi sa skupinom u kojoj je primijenjena podloga, 3% (6/179) naspram 2% (3/179).
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na trudnoću, embrionalni/fetalni razvoj, porođaj i postnatalni razvoj (vidjeti dio 5.3).
English: Because of the way Aldara works, there is a possibility that the cream may worsen existing inflammation in the treatment area.
Croatian: Zbog načina djelovanja kreme Aldara postoji mogućnost da krema pogorša postojeću upalu na liječenom području.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity and teratogenicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosti farmakologije, mutagenosti i teratogenosti.
English: These reactions were at non-wart sites which may have been in contact with imiquimod cream.
Croatian: Te su reakcije nastale na mjestima bez bradavica koja su možda bila u kontaktu s imikvimod kremom.
English: The skin surface area treated should be protected from solar exposure.
Croatian: Područje kože koja se liječi potrebno je zaštiti od izlaganja suncu.
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja motornim vozilima i rada na strojevima
English: • External genital and perianal warts (condylomata acuminata) in adults.
Croatian: • vanjskih genitalnih i perianalnih bradavica (condylomata acuminata) u odraslih bolesnika.
English: They can be flat and scaly, or raised, rough, hard and warty.
Croatian: Može biti ravna i ljuskava ili uzdignuta, hrapava, tvrda i bradavičasta.
English: However, the incidences of hepatocellular tumours among treated animals were greater than those for controls.
Croatian: Međutim, incidencija hepatocelularnih tumora kod liječenih životinja bila je veća nego u kontrolnoj skupini.
English: These reductions are not considered to be clinically significant in patients with normal haematologic reserve.
Croatian: Ta se smanjenja ne smatraju klinički važnima za bolesnika s normalnom hematološkom rezervom.
English: Aldara cream may be used for three different conditions.
Croatian: Krema Aldara primjenjuje se za tri različita stanja.
English: Meda Pharma SIA 101 Mūkusalas str. Rīga LV‐1004
Croatian: SMeda Pharma SIA 101 Mūkusalas str. Rīga LV‐1004
English: If you are HIV positive you should inform your doctor as Aldara cream has not been shown to be as effective in HIV positive patients.
Croatian: Ako ste HIV pozitivni, morate o tome obavijestiti svojeg liječnika budući da djelotvornost kreme Aldara nije dokazana kod HIV pozitivnih bolesnika.
English: Wash hands with soap and water.
Croatian: Operite ruke sapunom i vodom.
English: Do not shower or bathe during this time.
Croatian: Za to se vrijeme nemojte tuširati ni kupati.
English: Data from an open label clinical trial suggest that large tumours (>7.25 cm 2) are less likely to respond to imiquimod therapy.
Croatian: Podaci iz otvorenog kliničkog ispitivanja upućuju na činjenicu da će veliki tumori (> 7,25 cm2) će manje vjerojatno reagirati na terapiju imikvimodom.
English: While these changes have tended to improve with time, in some patients they may be permanent.
Croatian: Iako te promjene u većine bolesnika nestaju tijekom vremena, u nekih bolesnika ostaju trajno.
English: Where such reactions have occurred at the urethral meatus, some women have experienced difficulty in urinating, sometimes requiring emergency catheterisation and treatment of the affected area.
Croatian: Pri pojavi takvih reakcija u području uretralnog ušća u nekih su se žena pojavile poteškoće pri mokrenju koje su ponekad zahtijevale hitnu kateterizaciju i liječenje zahvaćenog područja.
English: This is a common slow-growing form of skin cancer with a very small likelihood of spread to other parts of the body.
Croatian: To je čest oblik raka kože koji napreduje polako, s malom vjerojatnošću širenja na ostale dijelove tijela.
English: Remember, Aldara cream does not protect against giving HIV or other sexually transmitted diseases to someone else.
Croatian: Zapamtite da krema Aldara ne štiti od prenošenja virusa HIV-a ni drugih spolno prenosivih bolesti.
English: • Do not use more cream than your doctor has advised.
Croatian: • Nemojte primijeniti kremu u količini većoj od preporučene od strane Vašeg liječnika.
English: Children and adolescents: Use in children and adolescents is not recommended.
Croatian: Djeca i adolescenti: Ne preporučuje se uporaba lijeka u djece i adolescenata.
English: Follow-up information suggests that these skin colour changes may be permanent in some patients.
Croatian: Podaci dobiveni praćenjem pokazuju da promjene boje kože kod nekih bolesnika mogu biti trajne.
English: There are no data available on the use of imiquimod in children and adolescents in the approved indications.
Croatian: Nema dostupnih podataka o primjeni imikvimoda u djece i adolescenata u odobrenim indikacijama.
English: If these symptoms occur, the treatment should be stopped immediately.
Croatian: U slučaju pojave ovih simptoma nužno je odmah prekinuti liječenje.
English: Some patients have experienced changes in skin colour in the area where Aldara cream was applied.
Croatian: Neki bolesnici uočili su promjene u boji kože na području nanošenja kreme Aldara.
English: Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended.
Croatian: Vrlo rijetke nuspojave su teške i bolne reakcije, osobito u slučajevima primjene veće količine kreme od preporučene.
English: It usually occurs in middle-aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure.
Croatian: Obično se pojavljuje kod osoba srednje i starije životne dobi, osobito onih svijetle puti, a posljedica je prekomjernog izlaganja suncu.
English: In some individuals a lowering of blood counts was noted.
Croatian: U nekih bolesnika primijećeno je smanjenje broja stanica u krvi.
English: Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects.
Croatian: Manje od 0,9% topikalno primijenjene jednokratne doze radiooznačenog imikvimoda apsorbira se kod ljudi kroz kožu.
English: If you have internal warts: do not use Aldara cream in the urethra (the hole from which urine is passed), the vagina (birth canal), the cervix (internal female organ), or anywhere inside your anus (rectum).
Croatian: Ako imate bradavice na unutrašnjim površinama, ne primjenjujte kremu Aldara u mokraćnoj cijevi (kanalu kroz koji prolazi urin), u vagini (porođajnom kanalu), vratu materice (unutrašnji ženski organ) ili bilo gdje unutar anusa (izlaz debelog crijeva).
English: If left untreated, basal cell carcinoma can disfigure, especially on the face - therefore early recognition and treatment are important.
Croatian: Ako se ne liječi, bazeocelularnih karcinom može narušiti izgled kože, posebno na licu - stoga je iznimno važno njegovo rano otkrivanje i liječenje.
English: If you notice any of these symptoms, tell your doctor.
Croatian: Ako primijetite bilo koji od ovih simptoma, obavijestite o tome svojeg liječnika.
English: Treatments were given as officially recommended.
Croatian: Liječenje je provedeno prema službenim preporukama.