natgillin/translations-raw huggingface dataset:
Stearyl alcohol
Stearilni alkohol
It is used specifically in adults with advanced cancer in the following situations:
Primjenjuje se isključivo u odraslih bolesnika s uznapredovalim rakom u sljedećim situacijama:
The tablets should be taken without food and no food should be eaten for at least 3 hours before and 1 hour after taking the tablets.
Tablete se uzimaju bez hrane, a hrana se ne smije konzumirati najmanje tri sata prije te najmanje jedan sat poslije uzimanja lijeka.
The full EPAR for Giotrif can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Giotrif nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Treatment should continue for as long as possible, until the disease worsens or the side effects become too severe.
Terapiju treba nastaviti koliko je god dugo moguće, dok se bolest ne pogorša ili dok nuspojave ne postanu preozbiljne.
Giotrif is available as tablets (20, 30, 40 and 50 mg) and is only available with a prescription.
Giotrif je dostupan u tabletama (od 20, 30, 40 i 50 mg) i izdaje se samo na liječnički recept.
The recommended dose is 40 mg once daily but this may be increased to up to 50 mg per day in patients who tolerate the 40 mg dose, or interrupted and reduced in patients experiencing side effects.
Preporučena doza je 40 mg jedanput dnevno, no može se povećati do 50 mg dnevno u bolesnika koji dobro podnose dozu od 40 mg, a u bolesnika s nuspojavama liječenje se može prekinuti ili se doza može smanjiti.
The most common side effects with Giotrif (which may affect more than 1 in 10 people) are paronychia (nail bed infection), reduced appetite, epistaxis (nosebleeds), diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the lining of the mouth), rash, acneiform dermatitis (acne-like skin conditions), pruritus (itching), and dry skin.
Najčešće nuspojave lijeka Giotrif (koje se mogu javiti u više od 1 na 10 osoba) su paronihija (upala podloge nokta), smanjeni apetit, epitaksa (krvarenje iz nosa), proljev, mučnina (osjećaj slabosti), povraćanje, stomatitis (upala sluznice usne šupljine), osip, akneformni dermatitis (stanje kože slično aknama), pruritus (svrbež) i suha koža.
This means that it blocks the action of a group of proteins known as ‘ErbB family' which are found on the surface of cancer cells and are involved in stimulating the cells to divide.
To znači da blokira djelovanje skupine proteina poznate pod nazivom „obitelj ErbB” koji se nalaze na površini stanica raka i uključeni su u poticanje diobe stanica.
This is a summary of the European public assessment report (EPAR) for Giotrif.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Giotrif.
In addition, the side effects of the medicine were considered to be manageable and similar to those seen with medicines of the same class.
Nadalje, smatra se da se nuspojave lijeka mogu kontrolirati te da su slične onima za lijekove istog razreda.
The European Commission granted a marketing authorisation valid throughout the European Union for Giotrif on 25 September 2013.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Giotrif na snazi u Europskoj uniji od 25. rujna 2013.
Other information about Giotrif
Ostale informacije o lijeku Giotrif
It is not intended to provide practical advice on how to use Giotrif.
Svrha sažetka nije davati praktične savjete o načinu primjene lijeka Giotrif.
EGFR proteins are part of the ErbB family.
Proteini EGFR dio su obitelji ErbB.
Lung cancer cells with mutated EGFR proteins are particularly sensitive to afatinib.
Stanice raka pluća s mutiranim proteinima EGFR posebno su osjetljive na afatinib.
What measures are being taken to ensure the safe and effective use of Giotrif?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Giotrif?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Giotrif outweigh its risks and recommended that it be granted marketing authorisation in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Giotrif nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
Why is Giotrif approved?
Zašto je Giotrif odobren?
What is Giotrif and what is it used for?
Što je Giotrif i za što se koristi?
Treatment with Giotrif should be started and supervised by a doctor experienced in the use of cancer medicines.
Liječenje lijekom Giotrif mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
A risk management plan has been developed to ensure that Giotrif is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Giotrif.
By blocking these proteins, afatinib helps to control cell division and thereby slows down the growth and spread of the non-small cell lung cancer.
Inhibiranjem tih proteina afatinib pomaže pri kontroli diobe stanica, a terapija usporava rast i širenje raka pluća nemalih stanica.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Giotrif, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Giotrif nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
• when the cancer has a mutation in the gene for a protein called EGFR and has not been previously treated with tyrosine kinase inhibitor medicines.
• kada rak ima mutaciju na genu za protein naziva EGFR, a prethodno nije liječen inhibitorima tirozin kinaze.
The active substance in Giotrif, afatinib, is an ErbB family blocker.
Djelatna tvar u lijeku Giotrif, afatinib, blokator je obitelji ErbB.
What are the risks associated with Giotrif?
Koji su rizici povezani s lijekom Giotrif?
• when the cancer is of a squamous cell type (from cells of the lining of the lungs) and has worsened despite treatment with platinum-based chemotherapy.
• kada se radi o raku skvamoznih stanica (stanica ovojnice pluća) koji se pogoršao unatoč kemoterapiji na bazi platine.
For more information about treatment with Giotrif, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Giotrif pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Giotrif has been shown to significantly delay disease progression in patients with non-small cell lung cancer.
Dokazano je da Giotrif značajno odgađa progresiju bolesti u bolesnika s rakom pluća nemalih stanica.
In a second study in 795 patients with the squamous cell cancer type, patients treated with Giotrif lived on average for 2.6 months without their disease worsening compared with 1.9 months for patients treated with another cancer medicine, erlotinib.
U drugom ispitivanju koje je obuhvatilo 795 bolesnika s rakom skvamoznih stanica bolesnici liječeni lijekom Giotrif živjeli su prosječno 2,6 mjeseci bez pogoršanja bolesti u usporedbi s 1,9 mjeseci u bolesnika koji su liječeni drugim lijekom protiv raka, erlotinibom.
In a main study in 345 patients with tumours that have mutated EGFR genes, patients treated with Giotrif lived on average for 11 months without their disease getting worse compared with 7 months for patients who were treated with two other cancer medicines, pemetrexed and cisplatin.
U glavnom ispitivanju, koje je obuhvatilo 345 bolesnika s tumorima koji imaju mutirane gene EGFR, bolesnici koji su liječeni lijekom Giotrif živjeli su prosječno 11 mjeseci bez pogoršanja bolesti u usporedbi sa 7 mjeseci u bolesnika koji su liječeni dvama drugim lijekovima protiv raka, pemetreksedom i cisplatinom.
Giotrif contains the active substance afatinib.
Giotrif sadrži djelatnu tvar afatinib.
Giotrif is a medicine used to treat a type of lung cancer known as non-small cell lung cancer.
Giotrif je lijek za liječenje vrste raka pluća poznatog pod nazivom rak pluća nemalih stanica.
The CHMP considered that in patients treated with Giotrif the improvement in progression-free survival (how long they lived without the disease getting worse) was a meaningful benefit for patients.
Mišljenje je CHMP-a da bolja stopa preživljenja bez progresije bolesti (koliko su dugo živjeli bez pogoršanja bolesti) u bolesnika liječenih lijekom Giotrif predstavlja značajnu korist za bolesnike.
How does Giotrif work?
Kako djeluje Giotrif?
What benefits of Giotrif have been shown in studies?
Koje su koristi lijeka Giotrif utvrđene u ispitivanjima?
For the full list of all side effects and restrictions with Giotrif, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Giotrif potražite u uputi o lijeku.
How is Giotrif used?
Kako se Giotrif koristi?
For practical information about using Giotrif, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Giotrif pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
The animals were split into four groups.
Životinje su podijeljene u četiri grupe.
Member State EU/EEA
Države članice EU/EGP
Most of the animals recovered within 2-3 days.
Većina se životinja oporavila u roku od 2-3 dana.
The clinical parameters improved.
Klinički parametri su poboljšani.
No data from other European countries/regions have been submitted, so it could not been evaluated if this situation is representative of the whole EU.
Nisu dostavljeni podaci iz drugih europskih država/regija, tako da se ne može ocijeniti je li ova situacija reprezentativna za cijelu EU.
This might potentially lead to problems of animal welfare.
Ovo može potencijalno rezultirati problemima u zdravlju životinja.
The bacteriological success was the first criteria of efficacy.
Bakteriološki uspjeh bio je prvi kriterij djelotvornosti.
These data are supported by published literature.
Ovi su podaci podržani objavljenom literaturom.
The clinical response rate was 92%.
Stopa kliničkog odgovora iznosila je 92%.
An extension of the treatment interval to 48 hours may be necessary in individual cases.
Produžavanje trajanja liječenja do 48 sati može biti neophodno u individualnim slučajevima.
Discussion of the data available
Razmatranje dostupnih podataka
These extrapolations were considered acceptable as goats are considered as minor species.
Ove se ekstrapolacije smatraju prihvatljivima budući da se koze smatraju manjim vrstama.
Types and mechanisms of resistance
Vrste i mehanizmi rezistencije
These data come from different bibliographic publications as well as publicly available reports from European monitoring programs and cover the period between 1998 and 2009.
Ti podaci potječu iz različitih bibliografskih publikacija kao i javno dostupnih izvještaja iz europskih programa praćenja te pokrivaju razdoblje između 1998. i 2009.
Several publications and proprietary studies were reviewed.
Pregledano je nekoliko publikacija i vlasničkih ispitivanja.
The overall recovery rate was 46.7%.
Cjelokupna stopa oporavka iznosila je 46,7%.
Data were available from two studies.
Podaci su dostupni iz dva ispitivanja.
An untreated group was included.
Uključena je i neliječena grupa.
Better clinical results were observed in 3-4 weeks old animals compared to 1-2 weeks old animals.
Bolji klinički rezultati uočeni su u 3-4 tjedna starih životinja u usporedbi s 1-2 tjedna starim životinjama.
The risk on individual level might be increased for rabbit as compared to other species.
Rizik na pojedinačnoj razini može se povećati u slučaju zečeva u odnosu na druge vrste.
Interaction with other medicinal products and other forms of interaction:
Interakcije s drugim lijekovima i drugi oblici interakcija:
In other cases, a combination of parenteral and oral administration or the parenteral route alone was used.
U drugim slučajevima korištena je parenteralna i oralna primjena ili samo parenteralan put.
The success rate was 76% on day 3 and 50% on day 10 in the test group versus 14.3% and 9.5%, respectively, for the same days, for the reference product.
Stopa uspjeha iznosila je 76% na 3. dan i 50% na 10. dana u testnoj grupi u odnosu na 14,3% odnosno 9,5%, za iste dane za referenti proizvod.
8501 Novo Mesto Slovenia
8501 Novo Mesto Slovenija
Regarding the ‘septicaemia' indication, this was present in the experimental study only.
Vezano uz indikaciju „septikemija”, ista je bila prisutna samo u eksperimentalnom ispitivanju.
Via Emilia, 285 Ozzano Emilia (BO) Italy
Via Emilia, 285 Ozzano Emilia (BO) Italija
If necessary, depending on the severity of clinical signs, this dosage can be doubled.
Ako je potrebno, ovisno o težini kliničkih simptoma, doza se može udvostručiti.
20037 Paderno Dugnano (MI) Italy
20037 Paderno Dugnano (MI) Italija
Friulchem via San Marco, 23 33099 Vivaro (PN) Italy
Friulchem via San Marco, 23 33099 Vivaro (PN) Italija
Antibacterial spectrum
Antibakterijski spektar
3641 RT Mijdrecht Netherlands
3641 RT Mijdrecht Nizozemska
Clinical and bacteriological cure were obtained.
Dobiven je klinički i bakteriološki lijek.
Several controlled experimental studies were conducted with induced infection (all of them together with M. haemolytica).
Nekoliko kontroliranih eksperimentalnih ispitivanja provedeno je s induciranom infekcijom (svi zajedno s M. haemolytica).
Siemensova 2717/4 155 00 Praha 5
Siemensova 2717/4 155 00 Praha 5 Češka
The highest success rate was observed in calves ≤ 2 years old (71.4%), but it decreased in older animals.
Najviša stopa uspješnosti uočena je u teladi ≤ 2 godine (71,4%), no ista se smanjuje sa starošću životinja.
The results of different well controlled studies with natural enteric infection were reviewed.
Pregledani su rezultati različitih dobro kontroliranih ispitivanja s prirodnom crijevnom infekcijom.
Add, to all products and delete the existing text: 5.1 Pharmacodynamic properties
Dodati za sve lijekove i izbrisati postojeći tekst: 5.1. Farmakodinamička svojstva
It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Ima antibakterijsko djelovanje protiv širokog spektra gram-pozitivnih i gram-negativnih bakterija.
In the 100 mg/ml strength, this indication should be restricted to cattle less than 2 years old.
U slučaju jačine od 100 mg/ml, ova se indikacija mora ograničiti na goveda mlađa od 2 godine.
The indications assessed are considered to be aligned with the principles of responsible use of fluoroquinolones in animals.
Ocjenjene indikacije smatraju se u skladu s načelima odgovorne primjene fluorkinolona u životinja.
Thus, it was considered that for consistency the target animal species for both strengths should harmonised to “Sheep” and “Goats”.
Stoga se smatra da za konzistenciju vrsta ciljnih životinja za obje jačine treba uskladiti „Ovce” i „Koze”.
It represents a practical approach in line with the aims of this procedure and is appropriate for the protection of consumer safety.
Ona predstavlja praktičan pristup u skladu s ciljevima ovog postupka i primjerena je za zaštitu sigurnosti potrošača.
The CVMP recommended the removal of the indication from the product information.
CVMP je preporučio uklanjanje indikacije iz informacija o proizvodu.
However, clinical efficacy of the recommended dose for respiratory infection has not been demonstrated.
No, klinička djelotvornost preporučene doze za respiratornu infekciju nije dokazana.
No mortality was observed in the treatment groups.
U liječenim grupama nije uočena smrtnost.
Using the alternative approach8 this represents an unusually high safety span in relation to the data generated with the recommended dose but a reasonable safety span (20%) in relation to the lower dose study.
Primjenom alternativnog pristupa8 ovo predstavlja neobično visoki raspon sigurnosti s obzirom na podatke generirane s preporučenom dozom, no razuman raspon sigurnosti (20%) s obzirom na ispitivanje slabije doze.
Furthermore, it has to be considered that large differences exist in the pharmacokinetic behaviour of enrofloxacin among different species, which additionally will influence the decision about the correct dosage of “product name (to be completed nationally)”.
Nadalje, mora se uzeti u obzir da velike razlike u farmakokinetici enrofloksacina postoje kod različitih vrsta, što će dodatno utjecati na odluku o ispravnom doziranju „naziv lijeka (popunjava država članica)”.
The available data does fully demonstrate the efficacy of this veterinary medicinal product for the treatment of septicaemia.
Dostupni podaci u potpunosti demonstriraju djelotvornost ovog veterinarsko-medicinskog proizvoda za liječenje septikemije.
Rabbits are raised in continuous systems where resistant bacteria might be persistent over time, however the overall risk would remain low due to the low consumption of rabbit meat.
Zečevi se uzgajaju u kontinuiranim sustavima u kojima rezistentna bakterija može biti ustrajna tijekom vremena, no ukupan rizik ostaje nizak uslijed male konzumacije zečjeg mesa;
The study also unveiled very high resistance to quinolones (around 38% for ciprofloxacin).
Ispitivanje je također otkrilo vrlo visoku otpornost na kinolone (otprilike 38% za ciprofloksacin);
The withdrawal period was derived from the first study, but also bearing in mind the results of the second (confirmatory) study.
Razdoblje karencije izvedeno je iz prvog ispitivanja, uzimajući u obzir rezultate drugog (potvrdnog) ispitivanja.
Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenia
Novo mesto Smarjeska cesta 6 8501 Novo Mesto Slovenija
Burgos Spain
Burgos Španjolska
Reptiles are ectothermic, relying on external heat sources to maintain their body temperature at the optimum level for correct function of all body systems.
Gmazovi su ektotermni organizmi i ovise o vanjskim izvorima topline kako bi održali tjelesnu temperaturu na optimalnoj razini za pravilno funkcioniranje svih organskih sustava.
Low to moderate (8% to 20%) resistance rates to ciprofloxacin have been observed in indicator isolates of E. coli for the different target species in different European countries.
Niske do umjerene (8% do 20%) stope rezistencije na ciprofloksacin uočene su u indikatorskih izolata E. coli za različite ciljne vrste u različitim europskim državama.
B-2322 Hoogstraaten Belgium
B-2322 Hoogstraaten Belgija
Do not use in birds intended for human consumption.
Ne smije se primjenjivati pticama namijenjenim za hranu.
949 01, Nitra Slovakia
949 01, Nitra Slovačka
As regards to Mycoplasma bovis, this microorganism is difficult to be identified and assessed since it is often involved in mixed infections.
U slučaju patogena Mycoplasma bovis, ovaj mikroorganizam se teško identificira i ocjenjuje budući da je često uključen u kombinirane infekcije.
Fluoroquinolones represent a class of antimicrobials which is critically important in the treatment of severe and invasive infections in humans and animals and are therefore of special interest for public and animal health.
Fluorkinoloni predstavljaju klasu antimikrobika koji su od kritičnog značaja u liječenju ozbiljnih i invazivnih infekcija u ljudi i životinja, te su stoga od posebnog interesa za javno i životinjsko zdravlje.
48308 Senden-Bösensell Germany
48308 Senden-Bösensell Njemačka
Therefore, the recommendations made here can only be used as a starting point for individual dose setting.
Slijedom navedenog, ovdje navedene preporuke mogu se koristiti samo kao smjernice u određivanju individualnog doziranja.
A positive control group treated with oxytetracyclin and an untreated group were included.
Uključene su pozitivna kontrolna grupa tretirana oksitetraciklinom i netretirana grupa.
S.C. ROMVAC COMPANY S.A. Şos.
Rumunjska S.C. ROMVAC COMPANY S.A. Şos.
At the European level, different actions and activities are constantly taken in order to maintain the efficacy of fluoroquinolone-containing veterinary medicinal products.
Na europskoj se razini kontinuirano poduzimaju različite radnje i aktivnosti s ciljem održavanja učinkovitosti veterinarsko-medicinskih proizvoda koji sadrže fluorkinolon.
Therefore the CVMP recommended the removal of the target pathogen Histophilus somni from the product information.
Stoga je CVMP preporučio uklanjanje ciljnog patogena Histophilus somni iz informacija o proizvodu.
For some serious animal indications, fluoroquinolones could be the only alternative available (EMEA/CVMP/SAGAM/184651/2005)7.
U slučaju određenih ozbiljnih životinjskih indikacija, fluorkinoloni mogu biti jedina dostupna alternativa (EMEA/CVMP/SAGAM/184651/2005)7.
Therefore, the veterinarian must be aware of the correct temperature requirements of the respective reptile species and the hydration status of the individual patient.
Stoga veterinar mora biti upoznat s pravilnim temperaturnim zahtjevima dotične vrste gmaza i hidratacijskim statusom pojedinog pacijenta.
Filiala Filipesti SRL Str. Principala nr. 944 Filipestii de Padure Jud.
Principala nr. 944 Filipestii de Padure Jud.
21 Montee De La Garde 69340 Francheville France
Francuska BIOLIS 21 Montee De La Garde 69340 Francheville Francuska
Thus, the indications in farm rabbits should be considered as an extrapolation from other data (oral route for farm rabbits and/or pet rabbits with the injectable route).
Stoga indikacije u zečeva na farmama treba uzeti u obzir kao ekstrapolaciju drugih podataka (oralni put u zečeva s farma i/ili zečeva koji su kućni ljubimci s injektibilnim putem).
05-651 Drwalew Poland
05-651 Drwalew Poljska
A 20% safety span was considered appropriate to compensate for the small number of animals used in the study.
Sigurnosni raspon od 20% smatran je primjerenim za kompenziranje malog broja životinja korištenih u ispitivanju.
It is expected that the use of these products for this indication may not be high, as the product is to be administered parenterally to rabbits with a frequency of daily injection for a period of 5 to 10 days.
Očekuje se da primjena tih proizvoda za ovu indikaciju neće biti česta, budući da se proizvod primjenjuje parenteralno u zečeva s učestalošću dnevne injekcije tijekom razdoblja od 5 do 10 dana.
In pigs, the injection should be made in the neck at the ear base.
U svinja, injekcija se daje u vrat uz bazu uha.
In view of the lack of therapeutic alternatives, if this indication was not accepted, this product as well as many other antimicrobial products, could be used off-label (under the so-called cascade).
U svjetlu nedostatka terapijskih alternativa, te za slučaj neprihvaćanja ove indikacije, ovaj proizvod kao i većina drugih antimikrobika mogli bi se koristiti mimo uputa (primjenom „kaskade“).
D-88326 Aulendorf Germany
D-88326 Aulendorf Njemačka
LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
Rumunjska LABORATORIOS VELVIAN S.L C/Vitoria 9, 2 B
It is not clear whether quinolone resistant Campylobacter infection is associated with adverse human health consequences.
Nije jasno je li infekcija Campylobacter otporna na kinolon povezana s neželjenim posljedicama po ljudsko zdravlje.
Moreover, the excessive volume of injection needed with the 50 mg/ml strength could lead to violation of allowed residues.
Nadalje, prekomjeran volumen injekcije potreban za jačinu od 50 mg/ml može rezultirati povredom dozvoljenih razina rezidua.
Non-inferiority of the test product was demonstrated.
Nije dokazana inferiornost u odnosu na testni proizvod.
Warning sentences have been included in sections 4.5 and 4.6 of the SPC regarding the potential articular cartilage damage in growing cattle and lambs, based on the available literature.
Rečenice koje sadrže upozorenja uključene su u dijelove 4.5. i 4.6. SPC-a u vezi s potencijalnim oštećenjem zglobne hrskavice u stoke i janjadi u razvoju, na temelju dostupne literature.
The results of these trials demonstrated good clinical evolution of animals at the tested doses, but microbiological results were not provided or they indicated an incomplete elimination of the pathogen.
Rezultati ovih ispitivanja pokazuju dobru kliničku evoluciju životinja u testiranim dozama, no mikrobiološki rezultati nisu dostavljeni ili ukazuju na nepotpunu eliminaciju patogena.