natgillin/translations-raw huggingface dataset:
High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands). 
Visoke doze estrogena mogu imati protumorski učinak u ciljnim organima s estrogenim receptorima (mliječne žlijezde).
In case of overdose typical oestrogen effects may occur. 
U slučaju predoziranja mogu se pojaviti tipični estrogeni učinci.
This is probably due to the short-acting oestrogenic character of estriol. 
To je vjerojatno zbog kratkog djelovanja estrogenog učinka estriola.
The following dosing schedule is advised: start treatment with 1 tablet (1 mg estriol) every day. 
Savjetuje se slijedeći raspored doziranja: započeti s 1 tabletom (1 mg estriol) svaki dan.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children. 
I POGLEDA DJECE” Čuvati izvan dosega i pogleda djece.
To be supplied only on veterinary prescription 
Može se izdavati samo na veterinarski recept
A relationship between final effective dose and body weight has not been established and therefore the dose has to be determined for each dog on an individual basis. 
Odnos između konačne efektivne doze i tjelesne težine nije utvrđen, a time i doza mora biti utvrđena za svakog psa na individualnoj osnovi.
After oral administration of multiple doses no accumulation occurs. 
Nakon peroralne primjene više doze nema akumulacije događa.
PACKAGE SIZE Carton box with 1 blister. 
VELIČINA PAKOVANJA Kartonska kutija sa 1 blisterom.
Upon oral administration a steady state is reached after the second treatment day and no accumulation occurs after multiple dosing. 
Nakon peroralne primjene ravnotežno stanje se postiže nakon drugog dana tretmana i nema akumulacije nakon primjene višestruke doze.
Estriol is a short-acting natural oestrogen. 
Estriol je kratko-djelujući prirodni estrogen.
After oral administration Estriol is nearly completely absorbed from gastrointestinal tract. 
Nakon peroralne primjene gotovo sav estriol se apsorbira iz gastrointestinalnog trakta.
Pack size: carton box with 1 blister 
Veličina pakovanja: karton kutija sa 1 blisterom
Oestrogenic effects such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog. 
Estrogeni učinci kao što su oticanje stidnice, natečenost mliječne žlijezde i/ili privlačenje mužjaka i povraćanje su primijećene pri najvišim preporučenim dozama od 2 mg po psu.
SPECIAL STORAGE CONDITIONS Keep out of the reach and sight of children. 
11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE Čuvati izvan dosega i pogleda djece.
Some dogs do not need daily treatment; treatment every other day may be tried, once the effective daily dose has been established. 
Neki psi ne trebaju dnevni tretman, može se primijeniti tretman svaki drugi dan, nakon što je uspostavljena efektivna dnevna doza.
One blister contains 30 tablets. 
Jedan blister sadržava 30 tableta.
Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches. 
Ne koristiti kod intaktnih kuja, jer je djelotvornost jedino uspostavljena u ovariohisterektomiranih kuja.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: estriol 
KVALITATIVNI I KVANTITATIVNI SASTAV
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 
Wim de Körverstraat 35 5831 Boxmeer Nizozemska
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products 
6.6 Posebne mjere predostrožnosti za odlaganje neupotrjebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
EXPIRY DATE (Month / year) 
ROK VALJANOSTI (Mjesec / godina)
11 PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 
ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE
In ovarioectomised female dogs it has a beneficial effect on urinary incontinence. 
U ovarioektomiziranih kuja ima blagotvoran učinak na urinarnu inkontinenciju.
Amylopectin Potato starch Magnesium stearate Lactose 
Magnezij stearat Laktoza
OTHER INFORMATION Each push-through strip contains 30 tablets. 
15. OSTALE INFORMACIJE Svaka blister traka sadrži 30 tableta.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE VMP U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
ADVICE ON CORRECT ADMINISTRATION Not applicable. 
SAVJETI ZA ISPRAVNU PRIMJENU
Each blister contains 30 tablets. 
Blister sadrži 30 tableta.
In the incontinent female dog it has a beneficial effect on the urinary incontinence. 
U intaktnih kuja ima blagotvoran učinak na urinarnu inkontinenciju.
NAME OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V. 
Intervet International B.V.
Do not use this product during pregnancy or lactation. 
4.7 Primjena tijekom graviditeta, laktacije ili nesenja Nemojte koristiti ovaj proizvod tijekom graviditeta ili dojenja.
Name and address of the manufacturer(s) of the biological active substance(s) 
Naziv i adresa proizvođača biološki djelatne tvari
Round single-scored tablets. 
Okrugla tableta.
6.2 Incompatibilities 
6.2 Inkompatibilnosti Nisu poznate.
Because of its short acting action, oestriol does not induce bone marrow suppression in the dog. 
Zbog kratkog djelovanja, estriol ne potiče supresiju koštane srži u pasa.
Mild, oestrogenic effects such as swollen vulva, swollen teats and/or attractiveness for males have been observed at the high dose of 2 mg. 
Estrogeni učinci kao što su oticanje stidnice, natečenost mliječne žlijezde i/ili privlačenje mužjaka i povraćanje su primijećeni na najvišim preporučenim dozama od 2 mg.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I> NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
If treatment is successful, lower the dose to half a tablet a day. 
Ako je liječenje uspješno, smanjiti dozu na pola tablete dnevno.
MANUFACTURER'S BATCH NUMBER Batch number. 
17. BROJ PROIZVODNE SERIJE PROIZVOĐAČA
4.9 Amount(s) to be administered and administration route 
4.9 Količine koje se primjenjuju i način primjene
If treatment is not successful, increase the dose to 2 tablets a day to be given in one dose. 
Ako liječenje ne uspije, povećati dozu na 2 tablete dnevno i dati u jednoj dozi.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT 
UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE PROIZVODA
Because of its short-acting oestrogenic properties, Incurin does not induce bone marrow suppression in the dog. 
Zbog kratkotrajnog djelovanja estrogenih svojstava, Inkurin ne izaziva supresiju koštane srži u psa.
None. 
Pas
Incurin is indicated for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs. 
INDIKACIJE Incurin je indiciran za liječenje hormonski ovisne urinarne inkontinencije, zbog nekompetentnosti mehanizma sfinktera u kuja.
7 MARKETING AUTHORISATION HOLDER 
NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET
1 mg/tablet For a full list of excipients, see section 6.1 
Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only - to be supplied only on veterinary prescription. 
Samo za primjenu na životinjama - izdaje se samo na veterinarski recept.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE 
UVJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE
B.V. Kloosterstraat 6 5349 AB Oss The Netherlands 
5349 AB Oss
Treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs. 
Liječenje hormonski uvjetovane urinarne inkontinencije, zbog nekompetentnosti sfinktera kod ovariohisterektomiranih kuja.
STATEMENT OF ACTIVE AND OTHER SUBTANCES Active substance: estriol 1 mg/tablet 
Djelatna tvar: estriol 1 mg/tableti
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE VMP U PROMET
PACKAGE LEAFLET INCURIN 1 mg tablet 
INCURIN 1 mg tableta
MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BLISTER 
OSNOVNI PODACI NAPISANI NA BLISTERIMA
6.4 Special precautions for storage 
Posebne mjere predostrožnosti za čuvanje
PHARMACEUTICAL FORM Round single-scored tablets 
Okrugla tableta
Name and address of the manufacturer(s) responsible for batch release 
Naziv i adresa proizvođača odgovorna za puštanje serije u promet:
None known. 
Nije primjenjivo
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
6.1 Popis pomoćnih tvari
SUMMARY OF PRODUCT CHARACTERISTICS 
BROJ PROIZVODNE SERIJE
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON BOX 
PODACI NA VANJSKOM PAKOVANJU OSOBINE/TIP
NAME OF THE VETERINARY MEDICINAL PRODUCT INCURIN 1 mg tablet. 
INCURIN 1 mg tableta.
Dog. 
C.
--1 Modified live Porcine Respiratory and Reproductive Syndrome Virus, strain 96V198: 102.2 - 105.2 CCID50* per 2 ml *Cell culture infectious dose 50% 
--1 Modificirani živi Virus respiratornog i reproduktivnog sindroma svinja PRRSV*, soj 96V198: 102.2 - 105.2 CCID50 *Doza virusa koja inficira 50 % uzoraka stanične kulture
Dogs should be treated for as long as is needed. 
Pse treba liječiti onoliko dugo koliko je potrebno.
Further information on Onsior can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Više informacija o VMP-u Onsior nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The tablets are given once a day at the same time every day, at a dose range of 1 - 2.4 mg per kg bodyweight depending on whether one or two tablets are required. 
Tablete se daju jedanput na dan svakog dana u isto doba, u rasponu doziranja od 1 do 2,4 mg po kilogramu tjelesne težine, ovisno o tome je li potrebna jedna ili dvije tablete.
Onsior (robenacoxib) 
Onsior (robenakoksib)
The solution for injection can also cause pain on injection. 
Otopina za injekciju može prouzročiti i bol pri ubrizgavanju.
Onsior received a marketing authorisation valid throughout the EU on 16 December 2008. 
Za VMP Onsior izdano je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 16. prosinca 2008.
It works by blocking an enzyme called cyclooxygenase 2 (COX-2). 
Djeluje inhibirajuće na enzim naziva ciklooksigenaza 2 (COX-2).
If the tablets are accidentally swallowed by a person, in particular by small children, or self-injection occurs with the solution for injection, the advice of a doctor should be sought immediately. 
Ako osoba, a osobito mala djeca, slučajno proguta tabletu ili u slučaju samoinjektiranja otopinom za injekciju, potrebno je odmah potražiti savjet liječnika.
Hands should be washed after giving the medicine to a dog or cat. 
Potrebno je oprati ruke nakon davanja VMP-a mački ili psu.
The European Medicines Agency decided that Onsior's benefits are greater than its risks and it can be authorised for use in the EU. 
Europska agencija za lijekove zaključila je da koristi od VMP-a Onsior nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
After the end of the operation, sufficient pain control was seen up to 24 hours in dogs and up to 52 hours (2 days) in cats. 
Nakon kirurškog zahvata zabilježena je zadovoljavajuća kontrola boli do 24 sata u pasa i do 52 sata (dva dana) u mačaka.
Why is Onsior authorised in the EU? 
Zašto je Onsior odobren u EU-u?
Onsior is available as tablets in five different strengths (6 mg for cats and 5 mg, 10 mg, 20 mg, and 40 mg for dogs) and as a solution for injection (20 mg/ml for dogs and cats). 
VMP Onsior dostupan je u obliku tableta u pet različitih jačina (6 mg za mačke i 5 mg, 10 mg, 20 mg, i 40 mg za pse) te u obliku otopine za injekciju (20 mg/ml za pse i mačke).
What are the risks associated with Onsior? 
Koji su rizici povezani s VMP-om Onsior?
What is Onsior and what is it used for? 
Što je Onsior i za što se koristi?
Pain was assessed by the veterinarian based on the animal's behaviour and responses to touching the inflamed area or moving the affected joint. 
Bol je ocjenjivao veterinar na temelju ponašanja životinje i reakcija na dodir upaljenog područja ili na pokretanje zahvaćenog zgloba.
The solution for injection is given as an injection under the skin to cats or dogs around 30 minutes before the start of the operation at a dose of 2 mg/kg bodyweight. 
Otopina za injekciju primjenjuje se injekcijom pod kožu u mačaka ili pasa otprilike 30 minuta prije početka kirurškog zahvata u dozi od 2 mg/kg tjelesne težine.
An overview of Onsior and why it is authorised in the EU 
Pregled informacija o VMP-u Onsior i zašto je odobren u EU-u
After surgery in cats, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days. 
Nakon kirurškog zahvata, u mačaka se liječenje jednom dnevno može nastaviti pri istoj dozi i u isto vrijeme svaki dan još najviše dva dana.
The solution for injection caused a gradual decrease in pain scores in cats and dogs after surgery. 
Otopina za injekciju uzrokovala je postupno smanjenje procijenjene boli u mačaka i pasa nakon kirurškog zahvata.
Care should be taken when treating cats or dogs with known heart or kidney problems, animals that are dehydrated and cats with liver problems. 
Potrebno je pripaziti ako se liječe mačke ili psi za koje je poznato da imaju problema sa srcem ili bubrezima, životinje koje su dehidrirale i mačke s jetrenim problemima.
Other information about Onsior: 
Ostale informacije o VMP-u Onsior
Onsior tablets given once a day reduced pain and improved mobility in both cats and dogs. 
Primjena VMP-a Onsior u tabletama jedanput na dan smanjila je bol i poboljšala pokretljivost u mačaka i pasa.
After surgery in cats, a daily dose may be given for up to two further days. 
Nakon kirurškog zahvata mačkama se može davati dnevna doza još najviše dva dana.
Onsior must not be used with other NSAIDs or with glucocorticosteroids. 
Onsior se ne smije primjenjivati s drugim nesteroidnim protuupalnim lijekovima ili glukokortikosteroidima.
The active substance in Onsior, robenacoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). 
Djelatna tvar VMP-a Onsior, robenakoksib, pripada skupini lijekova naziva nesteroidni protuupalni lijekovi (NSPUL).
Onsior contains the active substance robenacoxib. 
Onsior sadrži djelatnu tvar robenakoksib.
Treatment in cats is limited to six days for acute musculoskeletal disorders and longer term for chronic musculoskeletal disorders, with monitoring by the veterinarian. 
U mačaka je liječenje ograničeno na šest dana u slučaju akutnih mišićno-koštanih poremećaja, a dulje u slučaju kroničnih mišićno-koštanih poremećaja, uz nadzor veterinara.
Onsior was as effective as the comparator NSAIDs and more effective than placebo. 
VMP Onsior bio je jednako učinkovit kao i usporedni nesteroidni protuupalni lijekovi i učinkovitiji od placeba.
The side effects of Onsior are similar to those seen with other NSAIDs. 
Nuspojave VMP-a Onsior slične su onima zabilježenima kod drugih NSPUL-ova.
This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation. 
Taj je enzim uključen u stvaranje tvari naziva prostaglandini, koje sudjeluju u nastanku boli i upale.
In dogs, an increase in liver enzymes after long-term treatment with the tablets is common (which may affect up to 1 in 10 animals). 
Nakon dugotrajnog liječenja tabletama u pasa često dolazi do povišene razine jetrenih enzima (može se javiti u manje od 1 na 10 životinja).
Onsior is an anti-inflammatory veterinary medicine for use in cats and dogs to treat pain and inflammation. 
Onsior je protuupalni veterinarsko-medicinski proizvod (VMP) koji se primjenjuje u mačaka i pasa za liječenje boli i upale.
How is Onsior used? 
Kako se Onsior koristi?
For more information about using Onsior, see the package leaflet or contact your veterinarian or pharmacist. 
Za dodatne informacije o primjeni VMP-a Onsior pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
In a clinical study, Onsior tablets increased the activity in 10 of 35 cats with chronic musculoskeletal disorders (as measured by activity monitors on a neck collar) and scores of behaviour, quality of life, temperament and apparent happiness of cats compared to placebo (a dummy treatment). 
Primjena VMP-a Onsior u tabletama u okviru kliničkog ispitivanja dovela je do povećane aktivnosti u 10 od 35 mačaka s kroničnim mišićno-koštanim poremećajima (izmjereno monitorom aktivnosti na ovratniku) te boljih rezultata u pogledu ponašanja, kvalitete života, naravi i vidljivog zadovoljstva mačaka, u usporedbi s placebom (prividno liječenje).
By blocking the production of prostaglandins, robenacoxib reduces the pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis. 
Inhibicijom stvaranja prostaglandina robenakoksib smanjuje bol i upalu uzrokovanu mišićno-koštanim poremećajima, kirurškim zahvatom ili osteoartritisom.
What benefits of Onsior have been shown in studies? 
Koje su koristi VMP-a Onsior utvrđene u ispitivanjima?
Onsior tablets must not be used in dogs or cats with existing problems affecting the stomach and gut, such as stomach ulcers or bleeding, or in dogs with liver problems. 
Onsior u tabletama ne smije se primjenjivati u pasa ili mačaka s postojećim problemima sa želucem i crijevima kao što su čir na želucu ili gastrointestinalno krvarenje ni u pasa s jetrenim problemima.
In cats, the 6-mg tablet and the solution for injection can be used interchangeably when used to reduce pain and inflammation associated with orthopaedic surgery. 
U mačaka se tableta od 6 mg i otopina za injekciju mogu primjenjivati naizmjence ako se primjenjuju za smanjenje boli i upale povezane s ortopedskim kirurškim zahvatima.
In cats, Onsior tablets reduced moderate pain and inflammation associated with orthopaedic surgery for up to 2 days post operation when compared to animals that received placebo. 
VMP Onsior u obliku tableta smanjio je umjerenu bol i upale povezane s ortopedskim kirurškim zahvatima u mačaka do dva dana nakon kirurškog zahvata, u usporedbi sa životinjama koje su primale placebo.
For pregnant women, particularly those in the later stages of pregnancy, accidental ingestion or selfinjection of Onsior might be dangerous for the unborn child. 
Slučajno gutanje ili samoinjektiranje VMP-a Onsior u trudnica može biti opasno za nerođeno dijete, osobito u kasnijim stadijima trudnoće.
The most common side effects of the tablets and solution for injection are mild and transient effects on the stomach and gut, seen as vomiting, soft faeces and diarrhoea. 
Najčešće nuspojave tableta i otopine za injekciju su blagi i prolazni učinci na želudac i crijeva u obliku povraćanja, mekane stolice i proljeva.
In cats, Onsior tablets are used to treat pain and inflammation associated with acute (short term) and chronic (long term) musculoskeletal disorders (problems with the muscles and bones) and to reduce moderate pain and inflammation associated with orthopaedic (bone) surgery. 
VMP Onsior u tabletama u mačaka se primjenjuje za liječenje boli i upale povezane s akutnim (kratkotrajnim) i kroničnim (dugotrajnim) mišićno-koštanim poremećajima i za smanjenje umjerene boli i upale povezane s ortopedskim kirurškim zahvatima (kirurškim zahvatima na kostima).
It must not be used in animals that are pregnant, nursing puppies or kittens or being used for breeding, or that are hypersensitive (allergic) to robenacoxib or any of the other ingredients. 
Ne smije se primjenjivati u gravidnih kuja ili mačaka, onih koje doje kao ni u životinja koje su namijenjene uzgoju te koje su preosjetljive (alergične) na robenakoksib ili bilo koji drugi sastojak.
How does Onsior work? 
Kako djeluje Onsior?
Onsior was as effective as the comparator NSAIDs. 
VMP Onsior bio je jednako učinkovit kao i usporedni nesteroidni protuupalni lijekovi.
In dogs, Onsior tablets are used to treat pain and inflammation associated with chronic osteoarthritis (a long-term disease causing pain and inflammation in the joints). 
VMP Onsior u tabletama u pasa se primjenjuje za liječenje boli i upale povezane s kroničnim osteoartritisom (dugotrajna bolest koja uzrokuje bol i upalu zglobova).
The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery. 
Otopina za injekciju primjenjuje se za liječenje boli i upale povezane s ortopedskim kirurškim zahvatima ili onima na mekom tkivu.
Cats should be given a single dose by mouth prior to orthopaedic surgery. 
Prije ortopedskog kirurškog zahvata mačke trebaju dobiti jednokratnu dozu kroz usta.
The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery, such as neutering. 
Otopina za injekciju primjenjuje se za liječenje boli i upale povezane s ortopedskim kirurškim zahvatima ili onima na mekom tkivu, kao što je sterilizacija.
For a full list of side effects of Onsior, see the package leaflet. 
Potpuni popis nuspojava VMP-a Onsior potražite u uputi o VMP-u.
16 December 2016 
16. prosinca 2016.
The withdrawal letter is available here. 
Pismo o povlačenju dostupno je ovdje.
The full European Public Assessment Report for Arzerra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Cjeloviti EPAR za lijek Arzerra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Arzerra has been authorised since April 2010. 
Lijek Arzerra odobren je u travnju 2010.
What is Arzerra? 
Što je Arzerra?
The main measure of effectiveness was based on the number of patients who showed a partial or complete response to treatment. 
Glavna mjera djelotvornosti temeljila se na broju bolesnika koji su u cijelosti ili djelomično reagirali na liječenje.
On 10 November 2016, the CHMP adopted a positive opinion recommending an extension to this indication: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127 
1 CHMP je 10. studenoga 2016. usvojio pozitivno mišljenje kojim se preporučuje proširenje ove indikacije: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
Additionally, although some patients (39 out of 53) responded to the combination Arzerra plus bendamustine, only a few patients (6 out of 53) had a complete response, and these data were not supported by further study results. 
Osim toga, iako su neki bolesnici (39 od 53) reagirali na kombinaciju lijeka Arzerra i bendamustina, samo je nekoliko bolesnika (6 od 53) imalo potpunu reakciju, no te podatke nisu potvrdila daljnja ispitivanja.
What is happening with Arzerra for the treatment of other diseases? 
Koji je status lijeka Arzerra za liječenje drugih bolesti?
There are no consequences on the use of Arzerra in its authorised indications. 
Nema posljedica na primjenu lijeka Arzerra za odobrene indikacije.
By attaching to CD20, ofatumumab stimulates the body's immune system to attack the cancerous cells, helping to control the disease. 
Vezivanjem na CD20, ofatumumab stimulira imunosni sustav tijela da napada stanice raka i tako pomaže u kontroli bolesti.
After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues. 
Nakon što je CHMP procijenio odgovore tvrtke na pitanja, još su uvijek nisu bila razjašnjena sva pitanja.
The company presented the results from a study involving 53 patients with relapsed CLL. 
Tvrtka je predstavila rezultate ispitivanja koje je obuhvatilo 53 bolesnika s relapsom KLL-a.