FrancophonIA/ELRC3.0 huggingface dataset:
English: Disorders of the gut such as nausea, vomiting, abdominal pain and diarrhoea.
Croatian: Poremećaji s probavom poput mučnine, povraćanja, bolova u trbuhu i proljeva.
English: METHOD AND ROUTE(S) OF ADMINISTRATION To be administered intramuscularly into the deltoid muscle.
Croatian: Primjenjuje se intramuskularno u deltoidni mišić.
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Croatian: Poremećaji probavnog sustava Poremećaji probavnog sustava poput mučnine, povraćanja, bolova u trbuhu i proljeva.
English: Seronegative at baseline N=25
Croatian: Seronegativni na početku n=25
English: Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE
Croatian: Vrućica ≥38°C do 38,9°C Vrućica 39°C do 39,9°C Vrućica ≥ 40° C Bilo koji drugi štetni događaj
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Croatian: Potreban je oprez kod primjene ovog cjepiva osobama s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju pomoćnu tvar i na ostatne tvari (jaja, pileći protein, ovalbumin, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonijev bromid (CTAB)).
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
Croatian: Potreban je oprez kod primjene ovog cjepiva osobama s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju pomoćnu tvar, na tiomersal i na ostatne tvari (jaja, pileći protein, ovalbumin, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonijev bromid (CTAB)).
English: Multidose vial:
Croatian: BROJ SERIJE Serija:
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 307 to 873 (N=66) and an increase in GMT from 243 to 733 in children who were seronegative at baseline (N=45).
Croatian: Podaci o odgovorima na drugu dozu primijenjenu nakon razmaka od tri tjedna pokazali su povećanje ukupnog GMT-a s 307 na 873 (n=66) i povećanje GMT-a s 243 na 733 u djece koja su bila seronegativna na početku (n=45).
English: In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the mock-up vaccines.
Croatian: U kliničkim ispitivanjima s različitim formulacijama (H5N3, H9N2 i H5N1) približno 3400 ispitanika bilo je izloženo je „mock-up“ cjepivima.Većina reakcija bila je blage naravi, kratkog trajanja i kvalitativno slična onima koje izazivaju konvencionalna sezonska cjepiva protiv influence.
English: Data on responses to a second dose administered after an interval of three weeks showed an increase in overall GMT from 307 to 873 (N=66) and an increase in GMT from 243 to 773 in children who were seronegative at baseline (N=45).
Croatian: Podaci o odgovorima na drugu dozu primijenjenu nakon razmaka od tri tjedna pokazali su povećanje ukupnog GMT-a s 307 na 873 (n=66) kao i povećanje GMT-a s 243 na 773 u djece koja su bila seronegativna na početku (n=45).
English: One dose of 0.5 ml contains: Active Ingredients: Influenza virus surface antigens (haemagglutinin and neuraminidase), propagated in eggs, and adjuvanted with MF59C.1, of strain:
Croatian: TVARI Jedna doza od 0,5 ml sadrži: Djelatni sastojci: površinski antigeni virusa influence (hemaglutinin i neuraminidaza), umnoženi na jajima i adjuvantirani s MF59C.1, soja: A/California/07/2009 (H1N1)- iz kojeg je izveden korišten soj NYMC X-181
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor ** for anti-HA antibody to A/H1N1v in adult and elderly subjects by HI assay after administration of 7.5 µg of Focetria were as follows:
Croatian: Stopa serozaštite*, stopa serokonverzije* i faktor serokonverzije** za anti-HA protutijelo na A/H1N1v u odraslih i starijih ispitanika pomoću HI analize nakon primjene 7,5 µg Focetrie bili su kako slijedi:
English: Toddlers (12 to 35 months of age)
Croatian: Bilo koji drugi štetni događaj Mala djeca (u dobi od 12 do 35 mjeseci)
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children and adolescents aged 9-17 years by HI assay after administration of 7.5 µg of Focetria were as follows:
Croatian: Stopa serozaštite*, stopa serokonverzije* i faktor serokonverzije** za anti-HA protutijelo na H1N1v u djece i adolescenata u dobi od 9-17 godina pomoću HI analize nakon primjene 7,5 µg Focetrie bili su kako slijedi:
English: NAME OF THE MEDICINAL PRODUCT Focetria suspension for injection in pre-filled syringe Influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
Croatian: Focetria suspenzija za injekciju u višedoznom spremniku cjepivo protiv influence H1N1v (površinski antigen, inaktivirano, adjuvantirano)
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 12-35 months by HI assay after administration of 7.5 µg of Focetria were as follows:
Croatian: Stopa serozaštite*, stopa serokonverzije* i faktor serokonverzije** za anti-HA protutijelo na H1N1v u djece u dobi od 12-35 mjeseci pomoću HI analize nakon primjene 7,5 µg Focetrie bili su kako slijedi:
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in children aged 3-8 years by HI assay after administration of 7.5 µg of Focetria were as follows:
Croatian: Stopa serozaštite*, stopa serokonverzije* i faktor serokonverzije** za anti-HA protutijela na H1N1v u djece u dobi 3-8 godina pomoću HI analize nakon primjene 7,5 µg Focetrie bili su kako slijedi:
English: Skin and subcutaneous tissue disorders Common: sweating Uncommon: urticaria Rare: eye swelling
Croatian: Manje često: urtikarija Rijetko: oticanje oka
English: The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H1N1v in infants aged 6-11 months by HI assay after administration of 7.5 µg of Focetria were as follows:
Croatian: Stopa serozaštite*, stopa serokonverzije* i faktor serokonverzije** za anti-HA protutijelo na H1N1v u dojenčadi u dobi 6-11 mjeseci pomoću HI analize nakon primjene 7,5 µg Focetrie bili su kako slijedi:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/California/07/2009 (H1N1)-derived strain used NYMC X-181 7.5 micrograms ** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja: A/California/07/2009 (H1N1) -iz kojeg je izveden korišten soj NYMC X-181
English: General disorders and administration site conditions Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue, malaise and shivering
Croatian: Vrlo često: oticanje na mjestu primjene, bol na mjestu injekcije, otvrdnuće na mjestu injekcije, crvenilo na mjestu injekcije, umor, malaksalost i drhtanje Često: ekhimoza na mjestu injekcije i vrućica
English: MARKETING AUTHORISATION HOLDER Novartis Vaccines and Diagnostics S.r.l.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1 - Siena,
English: Signifor pasireotide
Croatian: Signifor pasireotid
English: The full EPAR for Signifor can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Signifor nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Signifor
Croatian: Ostale informacije o lijeku Signifor
English: The European Commission granted a marketing authorisation valid throughout the European Union for Signifor on 24 April 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Signifor u promet koje vrijedi na prostoru Europske unije od 24. travnja 2012.
English: What measures are being taken to ensure the safe and effective use of Signifor?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Signifor?
English: The summaries of the opinions of the Committee for Orphan Medicinal Products for Signifor can be found on the Agency's website:
Croatian: Sažetke mišljenja Odbora za lijekove za rijetke bolesti o lijeku Signifor možete naći na internetskim stranicama Agencije:
English: What is Signifor and what is it used for?
Croatian: Što je Signifor i za što se koristi?
English: Pre-defined levels were less than 2.5 micrograms/liter for growth hormone or within normal limits for IGF-1.
Croatian: Prethodno definirane razine bile su manje od 2,5 mikrograma po litri za hormon rasta ili unutar normalnih granica za IGF-1.
English: Those patients who do not experience clinical benefit can stop treatment.
Croatian: Bolesnici u kojih se ne postigne klinička korist mogu prekinuti liječenje.
English: Signifor must not be used in patients with severe liver problems.
Croatian: Signifor se ne smije primjenjivati u bolesnika koji imaju ozbiljne probleme s jetrom.
English: This is a summary of the European public assessment report (EPAR) for Signifor.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Signifor.
English: The dose may need to be adjusted according to response, or if side effects develop.
Croatian: Dozu će možda trebati prilagoditi ovisno o odgovoru ili ako se razviju nuspojave.
English: Although its side effects are similar to those of other somatostatin analogues, high blood sugar occurred more frequently and was more severe with Signifor.
Croatian: Iako su nuspojave slične onima kod drugih analoga somatostatina, visoke razine šećera u krvi bile su češće i ozbiljnije kod primjene lijeka Signifor.
English: Why is Signifor approved?
Croatian: Zašto je lijek Signifor odobren?
English: It is not intended to provide practical advice on how to use Signifor.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Signifor.
English: What are the risks associated with Signifor?
Croatian: Koji su rizici povezani s lijekom Signifor?
English: The European Medicines Agency concluded that the benefits of Signifor are greater than its risk and recommended that it approved in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Signifor nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: Because the numbers of patients with these diseases are low, the diseases are considered ‘rare', and Signifor was designated an ‘orphan medicine' (a medicine used in rare diseases).
Croatian: Budući da je broj bolesnika s tim bolestima nizak, one se smatraju „rijetkima” a Signifor je dobio status „lijeka za liječenje rijetkih bolesti”.
English: This means that it works in the same way as the natural hormone, somatostatin, to block the release of growth hormone from the pituitary glands located at the base of the brain and indirectly block the release of cortisol from the adrenal gland found above the kidneys.
Croatian: To znači da djeluje na isti način kao i prirodni hormon, somatostatin, tako da blokira otpuštanje hormona rasta iz hipofize koja se nalazi u donjem dijelu mozga i posredno blokira otpuštanje kortizola iz nadbubrežne žlijezde.
English: For this reason, Signifor should be used for acromegaly only when the condition is not controlled by other medicines of its class.
Croatian: Zbog toga bi lijek Signifor trebalo primjenjivati za liječenje akromegalije samo kada se ta bolest ne može kontrolirati drugim lijekovima u tom razredu.
English: (To reduce cortisol, pasireotide first reduces the production of another hormone ACTH, which controls cortisol production.)
Croatian: (Kako bi se smanjilo otpuštanje kortizola, pasireotid prvo smanjuje proizvodnju drugog hormona, ACTH-a, koji upravlja stvaranjem kortizola.)
English: Signifor is used for these conditions when surgery has failed or is not possible and, in the case of acromegaly, when the condition is also not adequately controlled with other medicines similar to Signifor known as ‘somatostatin analogues'.
Croatian: Signifor se primjenjuje za liječenje tih stanja ako kirurški zahvat nije uspio ili nije moguć te, u slučaju akromegalije, ako nije postignuta odgovarajuća kontrola stanja drugim lijekovima koji su slični lijeku Signifor, poznatima pod nazivom „analozi somatostatina”.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Signifor 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 Signifor nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Although the number of patients whose cortisol levels returns to normal is small, Signifor is expected tp help patients whose surgical treatments have failed or who cannot have surgery.
Croatian: Iako je broj bolesnika u kojih se razine kortizola normaliziraju nizak, očekuje se da će Signifor pomoći bolesnicima kod kojih kirurško liječenje nije bilo uspješno ili kirurški zahvat nije moguć.
English: If side effects develop the dose may need to be temporarily reduced.
Croatian: U slučaju razvoja nuspojava, može biti potrebno privremeno smanjenje doze.
English: By reducing levels of cortisol and growth hormone, the medicine can help alleviate symptoms of Cushing's disease and acromegaly.
Croatian: Snižavanjem razina kortizola i hormona rasta, ovaj lijek može pomoći pri ublažavanju simptoma Cushingove bolesti i akromegalije.
English: For acromegaly, Signifor is given as an injection into the buttock muscle every 4 weeks.
Croatian: Za liječenje akromegalije Signifor se primjenjuje injekcijom u mišić stražnjice svaka četiri tjedna.
English: Continuation of both studies confirmed the long-term benefit of Signifor in patients with acromegaly.
Croatian: U nastavku obaju ispitivanja potvrđene su dugoročne koristi lijeka Signifor u bolesnika s akromegalijom.
English: Signifor is a medicine for treating adults with Cushing's disease (a condition caused by too much of a hormone called cortisol) and acromegaly (excessive growth, particularly of bones in the hands, feet and face caused by too much growth hormone).
Croatian: Signifor je lijek za liječenje odraslih osoba oboljelih od Cushingove bolesti (bolest uzrokovana prevelikim količinama hormona kortizol) i akromegalije (prekomjeran rast, osobito kostiju šaka, stopala i lica uzrokovan prevelikim količinama hormona rasta).
English: The active substance in Signifor, pasireotide is a somatostatin analogue.
Croatian: Djelatna tvar lijeka Signifor, pasireotid, analog je somatostatina.
English: In a second study in 150 adult patients which used the muscle injection, around 41% of patients responded to treatment within 7 months.
Croatian: U drugom ispitivanju na 150 odraslih bolesnika koji su primali injekciju u mišić, otprilike 41 % bolesnika odgovorilo je na liječenje unutar sedam mjeseci.
English: For more information about treatment with Signifor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Signifor pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svojem liječniku ili ljekarniku.
English: In patients with Cushing's disease, Signifor is given as an injection either under the skin (preferably at the top of the thigh and the belly) twice a day or into the buttock muscle every 4 weeks.
Croatian: U bolesnika s Cushingovom bolesti, Signifor se primjenjuje injekcijom pod kožu dvaput dnevno (po mogućnosti u gornji dio bedra i u trbuh) ili u mišić stražnjice svaka četiri tjedna.
English: Signifor is effective in reducing levels of growth hormone and IGF-1 (another hormone that is elevated in acromegaly patients).
Croatian: Lijek Signifor djelotvoran je u smanjivanju razina hormona rasta i hormona IGF-1 (još jedan hormon čije su razine povišene u bolesnika s akromegalijom).
English: How is Signifor used?
Croatian: Kako se Signifor koristi?
English: The most common side effects with Signifor (seen in more than 1 patient in 10) are hyperglycaemia (high blood sugar levels), diabetes, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick),
Croatian: Najčešće nuspojave lijeka Signifor (uočene u više od 1 na 10 bolesnika) su hiperglikemija (visoke razine šećera u krvi), dijabetes, proljev, abdominalna bol (bol u trbuhu), mučnina, kolelitijaza (žučni kamenci), reakcije na mjestu injiciranja i umor.
English: Signifor is available as a solution for injection under the skin and as a powder and liquid used for injection into the muscle.
Croatian: Lijek Signifor dostupan je u obliku otopine za potkožnu injekciju te praška i tekućine za injekciju u mišić.
English: What benefits of Signifor have been shown in studies?
Croatian: Koje su koristi lijeka Signifor utvrđene u ispitivanjima?
English: months, the patient's response to treatment should be evaluated, and the dose adjusted as appropriate or treatment stopped if no benefit is seen.
Croatian: Nakon dva do četiri mjeseca treba ocijeniti odgovor bolesnika na liječenje, a dozu primjereno prilagoditi ili prekinuti liječenje ako se ne uoče koristi.
English: For practical information about using Signifor, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Signifor bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: In a main study in 165 adult patients who were given the injection under the skin, 15% of patients receiving 0.6 mg Signifor and 26% of patients receiving 0.9 mg Signifor had normal urine cortisol levels within 6 months.
Croatian: U glavnom ispitivanju na 165 odraslih bolesnika koji su primali potkožnu injekciju, 15 % bolesnika koji su primali Signifor u dozi od 0,6 mg i 26 % bolesnika koji su primali Signifor u dozi od 0,9 mg imali su normalne razine kortizola u urinu unutar šest mjeseci.
English: In a main study in 358 previously untreated adults, 31% of patients receiving Signifor had their growth hormone and IGF-1 levels reduced to pre-defined low levels after 1 year, compared with 19% of patients receiving octreotide, another somatostatin analogue.
Croatian: U glavnom ispitivanju na 358 prethodno neliječenih odraslih osoba, u 31 % bolesnika koji su primali lijek Signifor razine hormona rasta i hormona IGF-1 smanjene su na prethodno definirane niske razine nakon jedne godine liječenja, u usporedbi s 19 % bolesnika koji su primali oktreotid, drugi analog somatostatina.
English: Signifor is effective at normalising cortisol levels in some patients with Cushing's disease.
Croatian: Lijek Signifor djelotvoran je u normalizaciji razina kortizola u nekih bolesnika s Cushingovom bolesti.
English: In the second study in 198 patients whose disease had not been adequately controlled with surgery or other medical treatment, 15% of patients receiving Signifor 40 mg and 20% of patients receiving Signifor 60 mg achieved pre-defined reductions in hormone levels after 24 weeks, compared with none of the 68 patients given the somatostatin analogues octreotide or lanreotide.
Croatian: U drugom ispitivanju na 198 bolesnika čija bolest nije primjereno kontrolirana kirurškim zahvatom ili drugom terapijom lijekovima, 15 % bolesnika koji su primali Signifor u dozi od 40 mg i 20 % bolesnika koji su primali Signifor u dozi od 60 mg postiglo je prethodno definirano smanjenje razine hormona nakon 24 tjedna liječenja, dok to nije postignuto niti kod jednog od 68 bolesnika koji su primali analoge somatostatina oktreotid ili lanreotid.
English: Signifor is also effective in reducing levels of growth hormone in patients with acromegaly.
Croatian: Lijek Signifor također je djelotvoran u smanjivanju razina hormona rasta u bolesnika s akromegalijom.
English: 34% of patients receiving 0.6 mg Signifor and 41% of patients receiving 0.9 mg Signifor partially responded to treatment, with their urine cortisol levels halved within 6 months.
Croatian: Na liječenje je djelomično odgovorilo 34 % bolesnika koji su primali 0,6 mg lijeka Signifor i 41 % bolesnika koji su primali 0,9 mg lijeka Signifor, a unutar šest mjeseci njihove su razine kortizola u mokraći prepolovljene.
English: For the full list of all side effects reported with Signifor, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Signifor potražite u uputi o lijeku.
English: How does Signifor work?
Croatian: Kako djeluje Signifor?
English: Signifor is effective at reducing elevated cortisol levels patients with Cushing's disease.
Croatian: Lijek Signifor djelotvoran je u smanjivanju povišenih razina kortizola u bolesnika s Cushingovom bolesti.
English: It contains the active substance pasireotide.
Croatian: Lijek sadržava djelatnu tvar pasireotid.
English: For the full list of restrictions with Signifor, see the package leaflet.
Croatian: Potpuni popis ograničenja za lijek Signifor potražite u uputi o lijeku.
English: Patients can inject themselves Signifor under the skin after they have been trained.
Croatian: Nakon što prođu odgovarajuću obuku, bolesnici si mogu samostalno injicirati lijek Signifor.
English: Around 25 days after the first injection the dog's response is evaluated before a second injection is given.
Croatian: Otprilike 25 dana nakon prve injekcije odgovor psa se ocjenjuje prije primjene prve injekcije.
English: Pregnant and breast-feeding women should avoid giving this medicine because it can affect the normal development of unborn and newborn children.
Croatian: Trudnice i dojilje trebaju izbjegavati primjenu ovog VMP-a jer može djelovati na normalni razvoj nerođenog djeteta i novorođenčeta.
English: The full EPAR for Zycortal can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Zycortal nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In case of skin or eye contact the affected area should be rinsed immediately with water.
Croatian: U slučaju kontakta s kožom ili očima, zahvaćeno se područje treba odmah isprati s puno vode.
English: Prolonged-release means that the active substance is released slowly over a few weeks after being injected.
Croatian: „Produljeno oslobađanje” znači da se djelatna tvar otpušta polako tijekom nekoliko tjedana nakon injektiranja.
English: When satisfactory results are obtained then the treatment should continue to be given long-term using the same dose and interval between treatments.
Croatian: Ako su prikupljeni zadovoljavajući rezultati terapiju treba nastaviti dugoročno primjenom iste doze i intervala između terapija.
English: Zycortal may cause adverse effects on male reproductive organs and as a result can affect fertility.
Croatian: Zycortal može uzrokovati nuspojave na muškim reproduktivnim organima, što kao rezultat može imati posljedica na plodnost.
English: Zycortal is given as an injection under the skin at an initial dose of 2.2 mg/kg.
Croatian: Zycortal se primjenjuje kao subkutana injekcija u početnoj dozi od 2,2 mg/kg.
English: The lack of aldosterone can cause fluid loss, dehydration and weight loss.
Croatian: Manjak aldosterona može uzrokovati gubitak tekućine, dehidraciju i gubitak tjelesne težine.