natgillin/translations-raw huggingface dataset:
Carmustine Obvius (carmustine) 
Carmustine Obvius (karmustin)
By damaging the DNA of cancer cells, carmustine can help kill them and prevent the cancer from growing and spreading. 
Oštećivanjem DNA stanica raka karmustin doprinosi njihovom odumiranju i sprječavanju razvoja i širenja raka.
Because Carmustine Obvius is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Budući da je Carmustine Obvius generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
What is Carmustine Obvius and what is it used for? 
Što je Carmustine Obvius i za što se koristi?
The European Medicines Agency concluded that, in accordance with EU requirements, Carmustine Obvius has been shown to be comparable to Carmubris. 
Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da je lijek Carmustine Obvius usporediv s lijekom Carmubris.
This means that Carmustine Obvius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Carmubris. 
To znači da Carmustine Obvius sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Carmubris.
Side effects reported with Carmustine Obvius are carefully evaluated and any necessary action taken to protect patients. 
Nuspojave prijavljene za lijek Carmustine Obvius pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
There was no need for ‘bioequivalence' studies to investigate whether Carmustine Obvius is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. 
Nisu bila potrebna ispitivanja „bioekvivalencije” kako bi se istražilo apsorbira li se lijek Carmustine Obvius slično referentnom lijeku kako bi doveo do iste razine djelatne tvari u krvi.
Studies on the benefits and risks of the active substance carmustine in the authorised uses have already been carried out with the reference medicine, Carmubris, and do not need to be repeated for Carmustine Obvius. 
Ispitivanja koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Carmubris i stoga ih nije potrebno ponavljati za lijek Carmustine Obvius.
An overview of Carmustine Obvius and why it is authorised in the EU 
Pregled informacija o lijeku Carmustine Obvius i zašto je odobren u EU-u
What measures are being taken to ensure the safe and effective use of Carmustine Obvius? 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Carmustine Obvius?
It must be given under the supervision of a doctor experienced in the use of cancer medicines and can only be obtained with a prescription. 
Lijek se mora primjenjivati pod nadzorom liječnika s iskustvom u uporabi lijekova protiv raka i izdaje se samo na liječnički recept.
Carmustine Obvius is a cancer medicine that is used, on its own or with other cancer medicines and treatments, to treat the following types of cancer: 
Carmustine Obvius lijek je protiv raka koji se primjenjuje kao monoterapija ili u kombinaciji s drugim lijekovima protiv raka i terapijama s ciljem liječenja sljedećih vrsta raka:
Carmustine, the active substance in this medicine, is a type of cancer medicine known as an alkylating agent. 
Karmustin, djelatna tvar ovoga lijeka, vrsta je lijeka protiv raka poznatog pod nazivom alkilirajući agens.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Carmustine Obvius have been included in the summary of product characteristics and the package leaflet. 
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Carmustine Obvius nalaze se u sažetku opisa svojstava i u uputi o lijeku.
Why is Carmustine Obvius authorised in the EU? 
Zašto je lijek Carmustine Obvius odobren u EU-u?
Other information about Carmustine Obvius 
Ostale informacije o lijeku Carmustine Obvius
What are the benefits and risks of Carmustine Obvius? 
Koje su koristi i rizici od lijeka Carmustine Obvius?
This is because Carmustine Obvius is given by infusion into a vein, so the active substance is delivered straight into the bloodstream. 
To je zbog toga što se lijek Carmustine Obvius daje infuzijom u venu te tako djelatna tvar dospijeva izravno u krvotok.
For more information about using Carmustine Obvius, see the package leaflet or contact your doctor or pharmacist. 
Više informacija o primjeni lijeka Carmustine Obvius pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
Carmustine Obvius is given by infusion (drip) into a vein. 
Lijek Carmustine Obvius daje se intravenskom infuzijom (drip).
As for all medicines, data on the use of Carmustine Obvius are continuously monitored. 
Kao za sve lijekove, podatci o primjeni lijeka Carmustine Obvius kontinuirano se prate.
As for every medicine, the company provided studies on the quality of Carmustine Obvius. 
Kao za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće za lijek Carmustine Obvius.
Therefore, the Agency's view was that, as for Carmubris, the benefit of Carmustine Obvius outweighs the identified risk and it can be authorised for use in the EU. 
Stoga je stav Agencije da korist od lijeka Carmustine Obvius, kao i od lijeka Carmubris, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
Because cancer cells tend to grow and multiply more than normal 
S obzirom na to da, u odnosu na normalne stanice, stanice raka uobičajeno više rastu i umnožavaju se, lijek na njih jače djeluje.
How does Carmustine Obvius work? 
Kako djeluje Carmustine Obvius?
How is Carmustine Obvius used? 
Kako se Carmustine Obvius koristi?
How has Carmustine Obvius been studied? 
Kako je Carmustine Obvius ispitivan?
That expiry date refers to the last day of that month. 
Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
Results beyond 48 weeks of treatment: 
Rezultati nakon 48 tjedana liječenja:
Baraclude with food and drink 
Baraclude s hranom i pićem
In most cases you may take Baraclude with or without food. 
U većini slučajeva možete uzimati Baraclude s hranom ili bez nje.
After each use, rinse the spoon with water and allow it to air dry. 
Nakon svake uporabe, isperite žlicu vodom i ostavite da se osuši na zraku.
Baraclude will not control your HIV infection. 
Baraclude neće kontrolirati Vašu HIV infekciju.
Your doctor will monitor you regularly while you are receiving Baraclude. 
Liječnik će Vas redovito pratiti dok primate Baraclude.
Date of first authorisation: 26 June 2006 Date of latest renewal: 26 June 2011 
Datum prvog odobrenja: 26. lipnja 2006.
Baraclude reduces the amount of virus in your body, and improves the condition of the liver. 
Baraclude smanjuje količinu virusa u Vašem tijelu i poboljšava stanje jetre.
The randomization was stratified by age group (2 to 6 years; > 6 to 12 years; and > 12 to < 18 years). 
Randomizacija je stratificirana prema dobnim skupinama (2 do 6 godina; > 6 do12 godina i > 12 do< 18 godina).
Hold the spoon in a vertical (upright) position and fill it gradually to the mark corresponding to the prescribed dose. 
Držite žlicu u okomitom položaju (uspravno) i postupno je napunite do oznake koja odgovara propisanoj dozi.
What Baraclude is and what it is used for What you need to know before you take Baraclude How to take Baraclude 
Što je Baraclude i za što se koristi Što morate znati prije nego počnete uzimati Baraclude
Stable or improved CTP scoreb,d MELD score 
Stabilan ili poboljšan CTP indeksb,d
When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months. 
Nakon prestanka liječenja lijekom Baraclude, liječnik će Vas tijekom nekoliko mjeseci nastaviti pratiti i raditi krvne pretrage.
If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily. 
Ako su Vas prebacili na Baraclude zato što liječenje lamivudinom nije bilo uspješno, morate uzimati Baraclude na prazan želudac jednom dnevno.
It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant. 
Važno je da žene u reproduktivnoj dobi koje se liječe lijekom Baraclude koriste učinkovitu metodu kontracepcije, kako bi se izbjegla trudnoća.
Take Baraclude as long as your doctor has told you. 
Uzimajte Baraclude onoliko dugo koliko Vam je rekao liječnik.
If you forget to take Baraclude 
Ako ste zaboravili uzeti Baraclude
What Baraclude looks like and contents of the pack 
Kako Baraclude izgleda i sadržaj pakiranja
ULN=upper limit of normal, LLN=lower limit of normal. 
GGN=gornja granica normale, DGN=donja granica normale.
Belgique/België/Belgien 
Belgique/België/Belgien N.V.
For children and adolescents (from 2 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight. 
Za djecu i adolescente (od 2 do manje od 18 godina): Liječnik Vašeg djeteta odredit će pravu dozu na temelju tjelesne težine djeteta.
If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time. 
Ako propustite dozu lijeka Baraclude, uzmite je čim prije, a onda sljedeću dozu uzmite prema rasporedu u uobičajeno vrijeme.
Holding the spoon with the volume marks facing you, check that it has been filled to the proper mark. 
Držeći žlicu tako da su oznake količine okrenute prema Vama, provjerite je li napunjena do odgovarajuće oznake.
Children and adolescents (from 2 to less than 18 years of age) can take Baraclude with or without food. 
Djeca i adolescenti (u dobi od 2 do manje od 18 godina) mogu uzimati Baraclude s hranom ili bez nje.
The correct dose of Baraclude oral solution for children and adolescents is calculated by body weight and is taken once daily orally (by mouth) as shown below: 
Točna doza Baraclude oralne otopine za djecu i adolescente izračunava se prema tjelesnoj težiti i uzima se jednom dnevno kroz usta, kako je prikazano u nastavku:
Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day. 
Liječnik Vam može propisati nižu dozu ili savjetovati da je uzimate rjeđe od jednom na dan. stanju
Baraclude tablets do not contain maltitol and can be taken by patients with fructose intolerance. 
Baraclude tablete ne sadrže maltitol i njih mogu uzimati bolesnici s nepodnošenjem fruktoze.
Some patients must take Baraclude on an empty stomach (see Baraclude with food and drink in Section 2). 
Neki bolesnici moraju uzimati Baraclude na prazan želudac (pogledajte pod Baraclude s hranom i pićem u dijelu 2).
Other medicines and Baraclude 
Drugi lijekovi i Baraclude
It is recommended that the dosing spoon be rinsed with water after each daily dose. 
Preporučuje se isprati doznu žličicu vodom nakon svake dnevne doze.
Authorised Representative in the EEA for Comar Plastics: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany 
Predstavnik nositelja odobrenja u EEA za Comar Plastics: MDSS GmbH, Schiffgraben 41, 30175 Hannover, Njemačka.
Do not dilute or mix this solution with water or anything else. 
Nemojte je razrjeđivati ni miješati s vodom ili nečim drugim.
If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach. 
Ako je bolest jetre jako uznapredovala, i liječnik će Vas upozoriti na to da uzimate Baraclude na prazan želudac.
This medicinal product must not be mixed with water, other solvents or other medicinal products. 
Lijek se ne smije miješati s vodom, drugim otapalima ili drugim lijekovima.
Patients may be dosed with or without food. 
Doza se bolesnicima može dati s hranom ili bez nje.
Luxembourg/Luxemburg 
Luxembourg/Luxemburg N.V.
The measuring spoon is manufactured by: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA. 
Mjernu žlicu proizvodi Comar Plastics Division, One Comar Place, Buena, NJ 08310, SAD.
discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Baraclude treatment may be. 
Upitajte liječnika radi li Vam jetra ispravno i, ukoliko to nije slučaj, kako bi to moglo utjecati na Vaše liječenje lijekom Baraclude.
Swallow the medicine directly from the measuring spoon. 
Progutajte lijek izravno iz mjerne žlice.
Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. 
Baraclude pripada klasi lijekova koji mogu prouzročiti laktacidozu (suvišak mliječne kiseline u krvi) i povećanje jetre.
Store in the original carton. 
Čuvati u originalnom pakiranju.
1.1%e 10.7% e 27% e 41.3% e 
1,1%e 10,7% e
HBV DNA < 50 IU/mLa 
HBV DNK < 50 IU/mla
do not stop taking Baraclude without your doctor's advice since your hepatitis may worsen after stopping treatment. 
Nemojte prestati uzimati Baraclude ako Vam to nije savjetovao liječnik, budući da Vam se hepatitis može pogoršati nakon prestanka liječenja.
Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted. 
To je važno zato što se Baraclude uklanja iz tijela putem bubrega i možda će Vam trebati prilagoditi dozu ili raspored doziranja.
Patients with rare hereditary problems of fructose intolerance should not take this medicine. 
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja fruktoze ne smiju uzimati ovaj lijek.
Maltitol: Baraclude oral solution contains maltitol. 
Maltitol: Baraclude oralna otopina sadrži maltitol.
You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced. 
Ne smijete uzimati Baraclude za liječenje infekcije hepatitisom B ako u isto vrijeme ne uzimate lijekove protiv HIV-a, jer to može smanjiti učinkovitost budućeg liječenja protiv HIV-a.
2 years After opening, the solution can be used up to the expiry date on the bottle. 
2 godine Nakon otvaranja: otopina se može primjenjivati do isteka roka valjanosti navedenog na boci.
Baraclude contains lactose 
Baraclude sadrži laktozu
Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to 1/10); uncommon (≥ 1/1,000 to < 1/100); rare(≥ 1/10,000 to < 1/1,000). 
Učestalost se definira kao vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10.000 i < 1/1000).
For children and adolescents (from 2 to less than 18 years of age), Baraclude oral solution or Baraclude 0.5 mg tablets are available 
Za djecu i adolescente (od 2 do manje od 18 godina): Dostupne su Baraclude oralna otopina ili Baraclude 0,5 mg tablete
Baraclude should not be used during pregnancy unless clearly necessary. 
Baraclude se ne smije primjenjivati tijekom trudnoće, osim ako to stvarno nije neophodno.
How to take BARACLUDE Not all patients need to take the same dose of Baraclude. 
Ne moraju svi bolesnici uzimati istu dozu lijeka Baraclude.
In addition, high exposures of entecavir had no relevant adverse effects on γ polymerase or mitochondrial DNA synthesis in HepG2 cells (Ki > 160 µM). 
Uz to, visoke izloženosti entekaviru nisu imale štetne učinke na γ polimerazu ili sintezu mitohondrijske DNK u HepG2 stanicama (Ki > 160 µM).
HBV DNA < 50 IU/mL and HBeAg seroconversiona HBV DNA < 50 IU/mLa HBeAg seroconversiona ALT normalizationa 
HBV DNK < 50 IU/ml i HBeAg serokonverzijaa HBV DNK < 50 IU/mla HBeAg serokonverzijaa Normalizacija ALT-aa
Use the spoon as follows: 
Koristite žlicu na sljedeći način:
HBV DNAa 
HBV DNKa
Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution. 
Baraclude 0,05 mg/ml oralna otopina isporučuje se u boci koja sadrži 210 ml oralne otopine.
OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT 
TEKST VANJSKE KUTIJE (ZA BOCU I BLISTERE) I TEKST NALJEPNICE NA BOCI
Baraclude must not be used during pregnancy unless specifically directed by your doctor. 
Baraclude ne smijete uzimati tijekom trudnoće osim ako to nije izričita uputa liječnika.
The lower Cmax and AUC when taken with food is not considered to be of clinical relevance in nucleoside-naive patients but could affect efficacy in lamivudine-refractory patients (see section 4.2). 
Niže Cmax i AUC kad se entekavir uzima s hranim ne smatraju se klinički značajnim u bolesnika prethodno neliječenih analozima nukleozida, ali mogle bi utjecati na djelotvornost u bolesnika refrakternih na lamivudin (vidjeti dio 4.2).
Also contains: maltitol, preservatives E216, E218. 
POPIS POMOĆNIH TVARI Također sadrži: maltitol, konzervanse E216, E218.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine. 
Bolesnici s rijetkim nasljednim poremećajima nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
* for doses < 0.5 mg Baraclude oral solution is recommended. 
* Za doze < 0,5 mg preporučuje se Baraclude oralna otopina.
It has not been demonstrated that Baraclude is safe to use during pregnancy. 
Nije se dokazala sigurnost lijeka Baraclude tijekom trudnoće.
By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA. 
Nadmetanjem s prirodnim supstratom deoksigvanozinom TP, entekavir-TP funkcionalno inhibira 3 aktivnosti virusne polimeraze: (1) pripremanje HBV polimeraze, (2) reverznu transkripciju negativnog lanca DNK iz pregenomske glasničke RNK i (3) sintezu pozitivnog lanca HBV DNK.
Baraclude should be taken orally. 
Baraclude se uzima peroralno.
Excipients with known effect 380 mg maltitol/ml 1.5 mg methylhydroxybenzoate/ml 0.18 mg propylhydroxybenzoate/ml 0.3 mg sodium/ml 
Pomoćna tvar s poznatim učinkom 380 mg maltitola/ml 1,5 mg metilhidroksibenzoata/ml 0,18 mg propilhidroksibenzoata/ml 0,3 mg natrija/ml
Baraclude can be used in children whose liver is damaged but still functions properly (compensated liver disease). 
Baraclude se može primijeniti u djece čija je jetra oštećena, ali još uvijek ispravno radi (kompenzirana bolest jetre)
A reduction of the daily dose using Baraclude oral solution, as detailed in the table, is recommended. 
Preporučuje se smanjiti dnevnu dozu pomoću Baraclude oralne otopine, kako je prikazano u tablici.
If your doctor instructs you to take Baraclude on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal. 
Ako Vam liječnik da uputu da uzimate Baraclude na prazan želudac, to znači da ga morate uzeti najmanje 2 sata nakon obroka i najmanje 2 sata prije sljedećeg obroka.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijamaRMP-a..
Lactose: this medicinal product contains 120.5 mg of lactose in each 0.5 mg daily dose or 241 mg of lactose in each 1 mg daily dose. 
Laktoza: Ovaj lijek sadrži 120,5 mg laktoze po 0,5 mg dnevne doze odnosno 241 mg laktoze po 1 mg dnevne doze.
- emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd 
Kumulativna vjerojatnost: - pojave genotipske ETVrc - genotipske ETVrc s virološkim probojemd
What you need to know before you take BARACLUDE Do not take Baraclude if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6). 
Nemojte uzimati Baraclude ako ste alergični (preosjetljivi) na entekavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥ 21 times those in humans. 
U trudnih ženki štakora i kunića kojima se primjenjivao entekavir, razine bez embriotoksičnih i za majku toksičnih učinaka odgovarale su izloženostima koje su bile ≥ 21 puta veće od onih u ljudi.
Mechanism of action: entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours. 
Mehanizam djelovanja: Entekavir, nukleozidni analog gvanozina koji je aktivan protiv HBV polimeraze, učinkovito se fosforilira do aktivnog trifosfatnog (TP) oblika s unutarstaničnim poluvijekom od 15 sati.
The recommended once-daily dose in paediatric patients weighing at least 10 kg, is presented in the table below. 
Preporučena doza koja se primjenjuje jednom dnevno u pedijatrijskih bolesnika tjelesne težine od najmanje 10 kg navedena je u sljedećoj tablici.
An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacijerizika).
The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBVinfected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV. 
Sigurnost i djelotvornost entekavira provjerile su se i u aktivno kontroliranom kliničkom ispitivanju na 191 bolesniku inficiranom HBV-om s dekompenziranom bolešću jetre i u kliničkom ispitivanju sa 68 bolesnika istodobno inficiranih HBV-om i HIV-om.
The safety of entecavir in paediatric patients from 2 to < 18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189). 
Sigurnost entekavira u pedijatrijskih bolesnika u dobi od 2 do < 18 godina temelji se na dvama kliničkim ispitivanjima u ispitanika s kroničnom HBV infekcijom koja su još u tijeku; jednom farmakokinetičkom ispitivanju faze 2 (ispitivanje 028) i jednom ispitivanju faze 3 (ispitivanje 189).
Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci, blisteru ili kutiji iza oznake „EXP“.
Sodium: Each ml of this medicinal product contains 0.015 mmol (or 0.3 mg) sodium. 
Natrij: Jedan ml lijeka sadrži 0,015 mmol (ili 0,3 mg) natrija.
Name and address of the manufacturer responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italija
UNIQUE IDENTIFIER - 2D BARCODE 
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.>
The film-coated tablets (tablets) are pink and triangular-shaped. 
Filmom obložene tablete (tablete) su ružičaste tablete trokutastog oblika.