natgillin/translations-raw huggingface dataset:
Manufacturer for the Batch Release: 
Izdelovalec, odgovoren za sprostitev serije:
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT 
C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABO
MARKETING AUTHORISATION NUMBER(S) EU/2/00/028/002-008 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/00/028/002-008
At a therapeutic dose of 10 mg/kg, the Cmax of tepoxalin was 1.08 ± 0.37 μg/ml in dogs fed a low fat meal and 1.19 ± 0.29 μg/ml in dogs fed a high fat meal. 
Pri psih, ki so bili hranjeni z obroki z visoko vsebnostjo maščob je bila Cmax 1.19 ± 0.29 μg/ml.
Do not use if your dog 
Ne uporabljajte pri živalih:
Marketing Authorisation Holder 
IMETNIKA DOVOLJENJA ZA PROMET
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če
Typical undesirable side-effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite, lethargy and renal disorders. 
Značilni stranski učinki uporabe nesteroidnih protivnetnih zdravil (NSPVZ)so bruhanje, mehko blato/driska, kri v blatu, zmanjšan apetit , letargija in ledvične motnje.
INDICATION(S) Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders. 
INDIKACIJA(E) Zmanjšanje vnetja in bolečine, ki jih povzročajo akutna in kronična mišičnoskeletna obolenja.
Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders. 
Zmanjšanje vnetja in bolečine, ki jih povzročajo akutna in kronična mišičnoskeletna obolenja.
• has had gastrointestinal ulceration or bleeding 
• z želodčnimi ali črevesnimi razjedami ali s krvavitvijo
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only 
BESEDILO “SAMO ZA ŽIVALI” Samo za živali.
PHARMACEUTICAL FORM Oral lyophilisates 
FARMACEVTSKA OBLIKA peroralni liofilizat
Not applicable 
Ni smiselno.
BATCH NUMBER Batch {number} 
ŠTEVILKA SERIJE Serija {številka}
Special care should be taken when treating dogs with marked renal insufficiency. 
Posebni previdnostni ukrepi so potrebni pri uporabi zdravila pri psih z okvaro ledvic.
INDICATIONS Reduction of inflammation and relief of pain caused by acute and chronic musculoskeletal disorders. 
INDIKACIJE Zmanjšanje vnetja in bolečine, ki jih povzročajo akutna in kronična mišičnoskeletna obolenja.
To be supplied only on veterinary prescription. 
Izdaja zdravila za uporabo v veterinarski medicini je le na recept.
Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates for dogs Tepoxalin 
Zubrin 50 mg peroralni liofilizat za pse Zubrin 100 mg peroralni liofilizat za pse Zubrin 200 mg peroralni liofilizat za pse Tepoksalin
SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte nedosegljivo otrokom.
6.5 Nature and composition of immediate packaging Zubrin oral lyophilisates are supplied in boxes with foil blisters. 
Zubrin peroralni liofilizati se dobavljajo v škatlah z pretisnimi omoti.
NSAID overdosage is characterised by vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite and lethargy. 
Preveliko odmerjanje NSPVZ se kaže z bruhanjem, mehkim blatom/drisko, pojavom krvi v blatu, zmanjšanim apetitom in letargijo.
Vomiting or diarrhoea may occur due to treatment. 
Posledice zdravljenja so lahko bruhanje in driska.
Peel back foil to reveal a single oral lyophilisate in the form of a round tablet. 
Za odprtje posameznega peroralnega liofilizata, ki je v obliki okrogle tablete, odlepi folijo na zadnji strani.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
50 mg / oral lyophilisate 
50 mg / peroralni liofilizat
No accumulation of tepoxalin or its acid metabolite was detected after multiple dosing over a broad dose range. 
Po večkratnih vnosih odmerkov različnih količinah ni bilo opaženih kopičenj tepoksalina ali njegovega kislega presnovka.
Use is contraindicated in animals suffering from cardiac or hepatic disease, or where there is a history of gastrointestinal ulceration, or bleeding, or where there is hypersensitivity to the product. 
Ne uporabljamo pri psicah v času brejosti in laktacije, ter pri psicah, ki so namenjene za razplod Zdravila ne dajemo živalim z boleznimi srca ali jeter ali tistim z želodčnimi ali črevesnimi razjedami ali s krvavitvijo in pri preobčutljivosti na zdravilo.
200 mg / oral lyophilisate 
200 mg / peroralni liofilizat
Absorption of tepoxalin is facilitated via administration to dogs in a fed state. 
Absorpcijo olajša dajanje tepoksalina v času sitosti.
10 oral lyophilisates (EU/2/00/028/006) 30 oral lyophilisates (EU/2/00/028/007) 60 oral lyophilisates (EU/2/00/028/008) 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/00/028/006 (1 pretisni omot) EU/2/00/028/007 (3 pretisni omoti) EU/2/00/028/008 (6 pretisnih omotov)
For animal treatment only - to be supplied only on veterinary prescription. 
BESEDILO “SAMO ZA ŽIVALI” Samo za živali uporablja se le na osnovi recepta veterinarja.
100 mg / oral lyophilisate 
100 mg /peroralni liofilizat
NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Zubrin 50 mg peroralni liofilizat za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 200 mg oral lyophilisates for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Zubrin 200 mg peroralni liofilizat za pse
Ensure hands are dry to prevent the oral lyophilisate from sticking to fingers 
Zato da preprečite lepljenja peroralnega liofilizata na prste, imejte suhe roke.
NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 100 mg oral lyophilisates for dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Zubrin 100 mg peroralni liofilizat za pse
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Active substance 
NAVEDBA ZDRAVILNE UČINKOVIN(E) IN DRUGE(IH) SESTAVIN(E) Zdravilna učinkovina
At doses of 30 mg/kg and above, oral administration of tepoxalin is associated with discoloured faeces ranging in colour from white to yellow, which is the result of unabsorbed drug. 
Barva blata je lahko bela do rumena, kar je posledica neabsorbiranega zdravila.
EU/2/00/028/005 (3 blisters) 
(EU/2/00/028/005)
EU/2/00/028/003 (3 blisters) 
(EU/2/00/028/003)
10 oral lyophilisates (EU/2/00/028/004) 30 oral lyophilisates (EU/2/00/028/005) 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/00/028/004 (1 pretisni omot) EU/2/00/028/005 (3 pretisni omoti)
Tepoxalin and its metabolites are excreted in the faeces (99%). 
Tepoksalin in njegovi presnovki se izločajo z blatom
10 oral lyophilisates (EU/2/00/028/002) 30 oral lyophilisates (EU/2/00/028/003) 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/00/028/002 (1 pretisni omot) EU/2/00/028/003 (3 pretisni omoti)
In the case of overdosage discontinue therapy. 
Če se pojavijo stranski učinki, takoj prenehamo z zdravljenjem.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDEOSKRBE IN UPORABE
EU/2/00/028/008 (6 blisters) 
(EU/2/00/028/008)
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation holders in the member states 
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
It is intended for long-term use. 
Namenjeno je dolgotrajni uporabi.
This effect was maintained for up to four years. 
Ta učinek je trajal do štiri leta.
The effect of these on the safety and effectiveness of the medicine is not fully known. 
Učinek teh na varnost in učinkovitost zdravila še ni v celoti znan.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 16 December 2015. 
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 16. decembra 2015.
The European Commission granted a marketing authorisation valid throughout the European Union for Aldurazyme on 10 June 2003. 
Evropska komisija je dovoljenje za promet z zdravilom Aldurazyme, veljavno po vsej Evropski uniji, izdala 10. junija 2003.
Some of these are severe, but the number of side effects tends to decrease with time. 
Nekateri učinki so resni, vendar njihovo število sčasoma upade.
The full EPAR for Aldurazyme can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Aldurazyme je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
After this, the study continued for up to four years and all of the patients were treated with Aldurazyme. 
Po tem se je študija nadaljevala še štiri leta, vsi bolniki pa so bili zdravljeni z zdravilom Aldurazyme.
Half of the children treated had a normal size liver at the end of the study. 
Polovica zdravljenih otrok je imela ob koncu študije jetra normalne velikosti.
These were measured before and after 26 weeks of treatment. 
Meritve so bile opravljene pred 26-tedenskim zdravljenjem in po njem.
In children under five years of age, Aldurazyme reduced the levels of GAGs in the urine by about 60%. 
Pri otrocih, mlajših od pet let, je zdravilo Aldurazyme zmanjšalo ravni GAG v urinu za približno 60 %.
The study was looking mainly at the safety of the medicine, but it also measured its ability to reduce the levels of GAGs in the urine and the size of the liver. 
S študijo so proučevali zlasti varnost zdravila, merili pa so tudi njegovo sposobnost zmanjšanja ravni GAG v urinu ter velikost jeter.
This is a summary of the European public assessment report (EPAR) for Aldurazyme. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Aldurazyme.
Other information about Aldurazyme 
Druge informacije o zdravilu Aldurazyme
Aldurazyme is given once a week as an infusion into a vein. 
Zdravilo se daje enkrat na teden kot infuzija v veno.
Aldurazyme should be given in a hospital or clinic where resuscitation equipment is available, and patients may need to receive some medicines before the infusion to prevent an allergic reaction. 
Zdravilo Aldurazyme je treba dati v ustreznem bolnišničnem ali kliničnem okolju, kjer je na voljo oprema za oživljanje, bolniki pa bodo pred infuzijo morda morali prejeti določena zdravila za preprečevanje alergijske reakcije.
For more information about treatment with Aldurazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Aldurazyme preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is produced by a method known as ‘recombinant DNA technology': the enzyme is made by cells into which a gene (DNA) has been introduced that makes them able to produce laronidase. 
Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri encim izdelajo celice, ki so prejele gen (DNK), kar jim omogoča tvorjenje laronidaze.
Aldurazyme must not be used in people who are severely allergic to laronidase or any of the other ingredients. 
Zdravila Aldurazyme ne smejo uporabljati osebe, ki so hudo alergične na laronidazo ali katero koli drugo sestavino zdravila.
Most of the side effects seen with Aldurazyme are reactions caused by the infusion procedure rather than the medicine itself. 
Večina neželenih učinkov, opaženih pri uporabi zdravila Aldurazyme, so reakcije, ki se pojavijo zaradi postopka infuzije, in ne reakcije na samo zdravilo.
What benefit has Aldurazyme shown during the studies? 
Kakšne koristi je zdravilo Aldurazyme izkazalo med študijami?
This means that substances called glycosaminoglycans (GAGs) are not broken down, so they build up in most of the organs in the body and damage them. 
To pomeni, da se nekatere snovi, imenovane glikozaminoglikani (GAG), ne razgradijo in se kopičijo v večini telesnih organov, v katerih povzročajo škodo.
Aldurazyme was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval. 
Zdravilo Aldurazyme je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi zdravila na voljo le omejene informacije.
Almost all patients who receive Aldurazyme develop antibodies (proteins that are produced in response to Aldurazyme). 
Skoraj pri vseh bolnikih, ki prejemajo zdravilo Aldurazyme, nastanejo protitelesa (beljakovine, ki nastanejo v odziv na zdravljenje s tem zdravilom).
Aldurazyme has also been studied in 20 children below the age of five years who received Aldurazyme for a year. 
Zdravilo so proučevali tudi pri 20 otrocih, mlajših od pet let, ki so zdravilo Aldurazyme prejemali eno leto.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aldurazyme. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The study showed that Aldurazyme had improved both the FVC and the walking ability of patients at 26 weeks. 
Študija je pokazala, da je zdravilo Aldurazyme izboljšalo forsirano vitalno kapaciteto (FVC) in zmožnost hoje bolnikov po 26 tednih.
What is the risk associated with Aldurazyme? 
Kakšna tveganja so povezana z zdravilom Aldurazyme?
Aldurazyme is used in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; α L iduronidase deficiency) to treat the non-neurological symptoms of the disease (symptoms that are not connected with the brain or nerves). 
Zdravilo Aldurazyme se uporablja pri bolnikih s potrjeno diagnozo mukopolisaharidoze tipa I (MPS I; tj. pomanjkanjem α-L-iduronidaze), in sicer za zdravljenje nenevroloških simptomov bolezni (ki niso povezani z možgani ali živčnim sistemom).
Laronidase is used as ‘enzyme replacement therapy', which means that it replaces the enzyme that is missing in patients with MPS I. This controls the symptoms of MPS I, improving the patient's quality of life. 
Laronidaza se uporablja kot „terapija z nadomestnimi encimi“, kar pomeni, da nadomešča encim, ki manjka bolnikom z mukopolisaharidozo tipa I. S tem se nadzorujejo simptomi te bolezni in izboljša bolnikova kakovost življenja.
Aldurazyme has been compared with placebo (a dummy treatment) in 45 patients aged six years and over with a confirmed diagnosis of MPS I. The main measure of effectiveness was the forced vital capacity (FVC, a measure of how well the lungs are working) and the distance the patients could walk over six minutes. 
Zdravilo Aldurazyme so primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 45 bolnikih, starejših od šest let, pri katerih je bila potrjena diagnoza MPS I. Glavno merilo učinkovitosti je bila forsirana vitalna kapaciteta (FVC, tj. merilo delovanja pljuč) in razdalja, ki so jo bolniki lahko prehodili v šestih minutah.
The most common side effects in patients over the age of five years (seen in more than 1 patient in 10) are headache, nausea (feeling sick), abdominal pain (stomach ache), rash, arthropathy (damage to the joints), arthralgia (joint pain), back pain, pain in the extremities (hands and feet), flushing, pyrexia (fever) and reactions at the site of the infusion. 
Najpogostejši neželeni učinki pri bolnikih, starejših od pet let (opaženi pri več kot 1 bolniku od 10), so glavobol, navzeja (slabost), bolečine v trebuhu, izpuščaji, artropatija (poškodbe sklepov), artralgija (bolečine v sklepih), bolečine v hrbtu, bolečine v okončinah (dlaneh in stopalih), zardevanje, pireksija (povišana telesna temperatura) ter reakcije na mestu infuzije.
MPS I is a rare, inherited disease, in which the level of α L iduronidase enzyme activity is much lower than normal. 
Mukopolisaharidoza tipa I je redka dedna bolezen, pri kateri je stopnja delovanja encima α-L-iduronidaze mnogo nižja od normalne.
For the full list of all side effects reported with Aldurazyme, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Aldurazyme, glejte navodilo za uporabo.
The active substance in Aldurazyme, laronidase, is a copy of the human enzyme α L iduronidase. 
Zdravilna učinkovina zdravila Aldurazyme, laronidaza, je kopija človeškega encima α-L-iduronidaza.
The CHMP decided that Aldurazyme gives effective control of the symptoms of MPS I. The Committee decided that Aldurazyme's benefits are greater than its risks and recommended that Aldurazyme be given marketing authorisation. 
CHMP je zaključil, da zdravilo Aldurazyme zagotavlja učinkovit nadzor simptomov mukopolisaharidoze tipa I. Zaključil je, da so koristi zdravila Aldurazyme večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The non-neurological symptoms of MPS I can be an enlarged liver, stiff joints that make moving more difficult, reduced lung volume, heart disease and eye disease. 
Nenevrološki znaki mukopolisaharidoze tipa I so lahko povečanje jeter, togost sklepov, ki otežuje gibanje, manjši volumen pljuč, srčne bolezni in očesna obolenja.
Aldurazyme treatment should be supervised by a doctor who has experience in the management of patients with MPS I or other inherited metabolic diseases. 
Zdravljenje z zdravilom Aldurazyme mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z mukopolisaharidozo tipa I ali drugimi dednimi presnovnimi boleznimi.
Why has Aldurazyme been approved? 
Zakaj je bilo zdravilo Aldurazyme odobreno?
In patients under five years of age, the most common side effects (seen in more than 1 patient in 10) are increased blood pressure, decreased oxygen saturation (a measure of how well the lungs are working), tachycardia (rapid heart rate), pyrexia and chills. 
Pri bolnikih, mlajših od pet let, so najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) zvišan krvni tlak, zmanjšana nasičenost s kisikom (merilo uspešnosti delovanja pljuč), tahikardija (hitro bitje srca), pireksija in mrzlica.
Aldurazyme is a solution for infusion (drip) into a vein that contains the active substance laronidase. 
Zdravilo Aldurazyme je raztopina za infundiranje (kapalno infuzijo v veno), ki vsebuje zdravilno učinkovino laronidaza.
What is Aldurazyme used for? 
Za kaj se zdravilo Aldurazyme uporablja?
How has Aldurazyme been studied? 
Kako je bilo zdravilo Aldurazyme raziskano?
What is Aldurazyme? 
Kaj je zdravilo Aldurazyme?
How does Aldurazyme work? 
Kako zdravilo Aldurazyme deluje?
How is Aldurazyme used? 
Kako se zdravilo Aldurazyme uporablja?
Content (concentration) 
Vsebina (koncen tracija)
This summary was last updated in 12-2013. 
Povzetek je bil nazadnje posodobljen 12-2013.
Skin reactions are seen in more than 80% of patients. 
Kožne reakcije so bile opažene pri več kot 80 % bolnikov.
The European Commission granted a marketing authorisation valid throughout the European Union for Erbitux on 29 June 2004. 
Evropska komisija je dovoljenje za promet z zdravilom Erbitux, veljavno po vsej Evropski uniji, izdala 29. junija 2004.
Erbitux is given once a week. 
Zdravilo Erbitux se daje enkrat na teden.
The following infusions are 250 mg/m2 given over one hour. 
Vsak naslednji odmerek je 250 mg/m2 in se infundira eno uro.
The full EPAR for Erbitux can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Erbitux je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Erbitux. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Erbitux.
The CHMP decided that Erbitux's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Erbitux večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Other information about Erbitux 
Druge informacije o zdravilu Erbitux
Erbitux is given in the following ways: 
Zdravilo Erbitux se uporablja na naslednje načine:
EPAR summary for the public cetuximab 
Povzetek EPAR za javnost cetuksimab
• together with anticancer treatments containing irinotecan; 
• skupaj z drugimi oblikami zdravljenja proti raku, ki vsebujejo irinotekan;
Between 79 and 89% of colorectal cancers and more than 90% of squamous cell cancers of the head and neck have EGFR on their cell surfaces. 
Pri 79 do 89 % primerov raka kolona ali danke in več kot 90 % ploščatoceličnega raka glave in vratu je na površini tumorskih celic prisoten receptor za epidermalni rastni faktor.
For more information about treatment with Erbitux, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Erbitux preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
All of the studies looked at how long the patients lived without their cancer getting worse or how long they survived. 
V vseh študijah so opazovali, kako dolgo se pri bolnikih bolezen ni poslabšala ali kako dolgo so živeli.
Patients must also be closely observed for any signs of allergic reaction for at least one hour after the end of the infusion. 
Poleg tega jih je treba pozorno opazovati še najmanj eno uro po koncu infundiranja, ali se pojavijo znaki alergijske reakcije.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Erbitux. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The first infusion is given at a dose of 400 mg per square metre body surface area (calculated using the patient's height and weight) over two hours. 
Odmerek pri prvem infundiranju znaša 400 mg na kvadratni meter telesne površine (izračunane na podlagi bolnikove mase in višine), ki ga bolniku infundiramo dve uri.
The most common side effects with Erbitux (seen in more than 1 patient in 10) are skin reactions such as rash, hypomagnesaemia (low blood magnesium levels), mild or moderate reactions linked to the infusion (such as fever, chills, dizziness and difficulty breathing), mucositis (inflammation of the lining of the mouth) and raised levels of some liver enzymes. 
Najpogostejši neželeni učinki zdravila Erbitux (opaženi pri več kot 1 bolniku od 10) so kožne reakcije, kot so izpuščaji, hipomagneziemija (nizke ravni magnezija v krvi), blage do zmerne reakcije na infundiranje (kot so povišana telesna temperatura, mrzlica, omotica in oteženo dihanje), mukozitis (vnetje sluznice ustne votline) in povišane ravni nekaterih jetrnih encimov.
What benefit has Erbitux shown during the studies? 
Kakšne koristi je zdravilo Erbitux izkazalo med študijami?
Erbitux should only be given under the supervision of a doctor who has experience in the use of anticancer medicines in a setting where facilities for resuscitation are available. 
Zdravilo Erbitux se lahko jemlje le pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje raka, in v ustanovi, v kateri je nemudoma na voljo oprema za oživljanje.
Erbitux can be associated with severe reactions during the infusion, so the patients must be monitored carefully while the medicine is being given. 
Pri infundiranju zdravila Erbitux se lahko pojavijo hude reakcije, zato je treba bolnike med dajanjem zdravila skrbno nadzorovati.