FrancophonIA/ELRC3.0 huggingface dataset:
English: Following an IV dose of 125 µg, 38% of the dose was recovered in the urine within 6 hours in healthy volunteers compared with 25% of the dose being recovered in opioid-dependent patients in the same time period.
Croatian: Nakon primjene i.v. doze od 125 µg, 38 % doze nađeno je u mokraći unutar 6 sati kod zdravih dobrovoljaca u usporedbi s 25 % doze nađene kod bolesnika ovisnih o opioidima u istom razdoblju.
English: Naloxone, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors.
Croatian: Nalokson je polusintetski derivat morfija (N-alil-nor-oksimorfon) i specifični antagonist opioida koji kompetitivno djeluje na opioidne receptore.
English: The MAH shall ensure that in each MS where Nyxoid is marketed, all relevant health care professionals (HCP) who are expected to prescribe and/or supply Nyxoid are provided with:
Croatian: Nositelj odobrenja će osigurati da u svakoj državi članici u kojoj je Nyxoid stavljen na tržište, svi zdravstveni radnici za koje se očekuje da će propisivati i/ili davati Nyxoid dobiju:
English: Nyxoid is a nasal spray used for the emergency treatment of opioid overdose or possible opioid overdose in adults and adolescents over 14 years.
Croatian: Nyxoid je sprej za nos koji se upotrebljava za hitno liječenje predoziranja opioidima ili mogućeg predoziranja opioidima u odraslih osoba i adolescenata od navršene 14. godine.
English: No clinical data on effects of naloxone on fertility are available, however data from rat studies (see section 5.3) indicate no effects.
Croatian: Nema dostupnih kliničkih podataka o utjecaju naloksona na plodnost, međutim podaci iz ispitivanja na štakorima (vidjeti dio 5.3) nisu pokazali nikakav utjecaj.
English: Naloxone does not possess the "agonistic" or morphine-like properties characteristic of other opioid antagonists.
Croatian: Nalokson ne posjeduje karakteristike „agonista” ili morfinu slične karakteristike drugih opioidnih antagonista.
English: If this happens, further doses may be given after 2 to 3 minutes using a new nasal spray.
Croatian: Ako se to dogodi, mogu se dati dodatne doze nakon 2 do 3 minute primjenom novog spreja.
English: If the patient does not respond, the second dose should be administered after 2-3 minutes.
Croatian: Ako bolesnik ne reagira, drugu dozu treba dati nakon 2-3 minute.
English: Nyxoid is not for use in children or adolescents under 14 years.
Croatian: Nyxoid nije za upotrebu u djece ili adolescenata mlađih od 14 godina.
English: • Changes in behaviour including violent behaviour, nervousness, anxiety, excitement,
Croatian: • promjene u ponašanju, uključujući nasilno ponašanje, nervozu i tjeskobu, uzbuđenost, nemir ili razdražljivost
English: Watch out for the following symptoms in your baby during the first 24 hours after the baby is born: seizures (fits) crying more than usual increased reflexes.
Croatian: Pazite na sljedeće simptome kod svojeg djeteta u prva 24 sata nakon rođenja djeteta: • napadaji
English: When administering naloxone to patients who have received buprenorphine as an analgesic, complete analgesia may be restored.
Croatian: Kod davanja naloksona bolesnicima koji su primali buprenorfin kao analgetik, može se povratiti potpuna analgezija.
English: Remove the nasal spray nozzle from the nostril after giving the dose.
Croatian: Uklonite mlaznicu spreja iz nosnice nakon primjene doze.
English: Patients who are receiving opioids for the relief of chronic pain may experience pain and opioid withdrawal symptoms when Nyxoid is administered.
Croatian: Bolesnici koji primaju opioide za ublažavanje kronične boli mogu iskusiti bol i simptome ustezanja opioida nakon primjene Nyxoida.
English: Naloxone had no effect on fertility and reproduction in the rat or on early embryonic development of the rat and rabbit.
Croatian: Nalokson nije imao utjecaja na plodnost i reprodukciju štakora ili rani razvoj embrija kod štakora ili zečeva.
English: What Nyxoid is and what it is used for What you need to know before you receive Nyxoid How Nyxoid is to be given Possible side effects
Croatian: Što je Nyxoid i za što se koristi Što morate znati prije nego dobijete Nyxoid Kako se Nyxoid daje
English: Check for signs of overdose, such as: no response to touch or sounds, slow uneven breathing or no breathing, snoring, gasping or gulping, blue or purple fingernails or lips.
Croatian: Provjerite znakove predoziranja puput: izostanak reakcije na dodir ili zvukove, polagano, neravnomjerno disanje ili izostanak disanja, hrkanje, dahtanje ili gutanje, plavi ili ljubičasti nokti prstiju ruka ili usne.
English: This may necessitate repeat doses of naloxone - though the need for repeat naloxone doses is dependent on the quantity, type and route of administration of the opioid agonist that is being treated.
Croatian: To će možda zahtijevati ponovljeno doziranja naloksona - jer potreba za dozama naloksona ovisi o količini, vrsti i putevima primjene agonista opioida zbog kojeg se liječi.
English: Naloxone temporarily reverses the effects of opioids such as heroin, methadone, fentanyl, oxycodone, buprenorphine and morphine.
Croatian: Nalokson privremeno poništava učinak opioida kao što je heroin, metadon, fentanil, oksikodon, buprenorfin i morfin.
English: Do not prime or test before use.
Croatian: Nemojte isprobavati prije uporabe.
English: Detailed instructions on how to use Nyxoid are provided in the Package Leaflet and a Quick Start Guide is printed on the back of each blister.
Croatian: Detaljne upute o načinu primjene Nyxoida navedene su u uputi o lijeku i brzom vodiču na poleđini svakog blistera.
English: Reversal of buprenorphine-induced respiratory depression may be incomplete.
Croatian: Poništavanje respiratorne depresije uzrokovane buprenorfinom može biti nekompletno.
English: It is to be given right away and does not take the place of emergency medical care.
Croatian: Mora se primijeniti odmah i nije zamjena za hitnu medicinsku skrb.
English: Nyxoid can cause acute withdrawal symptoms if the patient is dependent on opioid drugs.
Croatian: Nyxoid može izazvati simtpome akutnog ustezanja ako je bolesnik ovisan o opioidnim lijekovima.
English: Receiving Nyxoid can lead to a rapid reversal of the opioid effect which can cause an acute withdrawal syndrome (see section 4.8).
Croatian: Dobivanje Nyxoida može dovesti do brzog poništavanja opioidnog učinka što može uzrokovati akutni sindrom ustezanja (vidjeti dio 4.8).
English: Bard Pharmaceuticals Limited Cambridge Science Park Milton Road
Croatian: Bard Pharmaceuticals Limited Cambridge Science Park
English: Medis Adria d.o.o.
Croatian: Hrvatska Medis Adria d.o.o.
English: • A brief introduction on Nyxoid
Croatian: • Kratak uvod u lijek Nyxoid
English: How to store Nyxoid
Croatian: Kako čuvati Nyxoid
English: The side effects below may happen with this medicine.
Croatian: Nuspojave navedene u nastavku mogu se pojaviti uz ovaj lijek.
English: The prescriber should describe the symptoms which allow presumptive diagnosis of central nervous system (CNS) / respiratory depression, the indication and the instructions for use with the patient and / or person who might be in a position to administer this product to a patient experiencing a known or suspected opioid overdose event.
Croatian: Osobe koje propisuju lijek moraju opisati simptome koji omogućuju vjerojatno dijagnosticiranje depresije središnjeg živčanog sustava (SŽS)/respiratorne depresije, indikacije i upute za uporabu za bolesnike i/ili osobe koje bi se mogle naći u situaciji da daju ovaj lijek bolesnicima s poznatim predoziranjem opioidima ili sumnjom na njega.
English: Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia.
Croatian: Znaci i simptomi sindroma ustezanja lijeka uključuju nemir, razdražljivost, hiperesteziju, mučninu, povraćanje, bol u probavnom sustavu, grčevi u mišićima, disforiju, nesanicu, anksioznost, hiperhidrozu, piloerekciju, tahikardiju, povećani krvni tlak, zijevanje, vrućicu.
English: Patients who have received naloxone to reverse the effects of opioids should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the opioids may return.
Croatian: Bolesnici koji su primili nalokson radi poništavanja učinka opioida moraju se upozoriti da ne upravljanju vozilima i da ne rade sa strojevima i da ne prakticiraju neku drugu fizički ili psihički zahtjevnu aktivnost najmanje 24 sata, jer se utjecaj opioida može povratiti.
English: There are no data available on the excretion of naloxone following intranasal administration, however, the disposition of labelled naloxone following IV administration was studied in healthy volunteers and opioid-dependent patients.
Croatian: Nema dostupnih podataka o izlučivanju naloksona nakon intranazalne primjene, međutim, dispozicija označenog naloksona nakon i.v. primjene ispitivana je kod zdravih dobrovoljaca i bolesnika ovisnih o opioidima.
English: It is not a substitute for emergency medical care.
Croatian: On nije zamjena za hitnu medicinsku skrb.
English: Name and address of the manufacturer(s) responsible for batch release BARD PHARMACEUTICALS LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD,
Croatian: BARD PHARMACEUTICALS LIMITED UNIT 191, CAMBRIDGE SCIENCE PARK, MILTON ROAD,
English: • Reference to the QSG on the back of the product immediate packaging
Croatian: • Referencu na brzi vodič na stražnjoj strani unutarnjeg pakiranja
English: Tlf: + 47 67 51 89 00
Croatian: Mundipharma AS Tlf: + 47 67 51 89 00
English: • Steps detailing management of a patient which are aligned with information in PIC and package leaflet
Croatian: • Detaljne korake u postupanju s bolesnikom koji su usklađeni s informacijama navedenim u Kartici s informacijama za bolesnika i uputi o lijeku
English: Naloxone elicits a pharmacological response due to the interaction with opioids and opioid agonists.
Croatian: Nalokson izaziva farmakološki odgovor zbog interakcije s opioidima i agonistima opioidnih receptora.
English: Hypertension, cardiac arrhythmias, pulmonary oedema and cardiac arrest have been described, more typically when naloxone is used post-operatively (see sections 4.4 and 4.8).
Croatian: Opisan je povišen krvni tlak, srčana aritmija, plućni edem i srčani arest, češće kada se nalokson primjenjivao nakon kirurškog zahvata (vidjeti dijelove 4.4 i 4.8).
English: • The patient/carer information card
Croatian: • Karticu s informacijama za bolesnika/skrbnika
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INTRANASAL SPRAY/DEVICE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA SPREJ ZA NOS/UREĐAJ
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: The most common adverse drug reaction (ADR) seen with naloxone administration is nausea (frequency very common).
Croatian: Najčešća nuspojava lijeka (engl. adverse drug reaction, ADR) uočena kod primjene naloksona je mučnina (s učestalošću „vrlo često“).
English: Trisodium citrate dihydrate Sodium chloride Hydrochloric acid Sodium hydroxide Purified water
Croatian: Natrijev citrat dihidrat Natrijev klorid Kloridna kiselina Natrijev hidroksid
English: Puh/Tel: + 358 (0)9 8520 2065
Croatian: Suomi/Finland Mundipharma Oy Puh/Tel: + 358 (0)9 8520 2065
English: Nyxoid is not a substitute for emergency medical care.
Croatian: Nyxoid nije zamjena za hitnu medicinsku skrb.
English: If an overdose is suspected Nyxoid should be given.
Croatian: Ako se sumnja na predoziranje, potrebno je dati Nyxoid.
English: • It should be available as o A link for online access in the HPD and PIC o Memory stick for HCP use to train, if WiFi not accessible
Croatian: • Video treba biti dostupan putem o Poveznice za on-line pristup navedene u dokumentima za zdravstvene radnike i uputi o lijeku o USB prijenosne memorije za zdravstvene radnike namijenjene za obuku, ako bežična veza (WiFi) nije dostupna
English: The following adverse reactions have been reported with Nyxoid and/or other naloxone-containing medicinal products during clinical studies and post marketing experience.
Croatian: Sljedeće nuspojave prijavljene su za Nyxoid i/ili druge lijekove koji sadrže nalokson u kliničkim ispitivanjima i nakon stavljanja lijeka u promet.
English: Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.
Croatian: Nyxoid je predviđen za neposrednu primjenu kao hitna terapija kod poznatog predoziranja opioidima ili sumnje na predoziranje koje se manifestira respiratornom depresijom i/ili depresijom središnjeg živčanog sustava u medicinskom i nemedicinskom okruženju.
English: Tilt head back.
Croatian: Zabaciti glavu unatrag.
English: The signs and symptoms of an opioid overdose can return after this nasal spray is given.
Croatian: Znaci i simptomi predoziranja opioidima mogu se vratiti nakon primjene ovog spreja za nos.
English: Administration of Nyxoid may decrease the analgesic effects of opioids used primarily to provide pain relief, due to its antagonist properties (see section 4.4).
Croatian: Davanje Nyxoida može smanjiti analgetske učinke opioida koji se primarno koriste za ublažavanje boli, zbog svojih antagonističkih svojstava (vidjeti dio 4.4).
English: Typical opioid withdrawal syndrome is expected with naloxone which may be caused by the abrupt withdrawal of opioid in persons physically dependent on them.
Croatian: Tipični sindrom ustezanja opioida očekuje se uz primjenu naloksona što može biti uzrokovano naglim prestankom uzimanja opioida kod osoba kod kojih postoji fizička ovisnost o njima.
English: It reveals very high affinity for the opioid receptor sites and therefore displaces both opioid agonists and partial antagonists.
Croatian: Pokazuje vrlo visoku sklonost za opioidne receptore te istiskuje opioidne agoniste i parcijalne opioidne agoniste.
English: The half value duration (HVD) values for intranasal administration were longer than for IM administration (intranasal, 2 mg, 1.27h, IM, 0.4 mg 1.09h) from which we can infer a longer duration of action of naloxone given by the intranasal rather than the IM route.
Croatian: Vremenski period koncentracije u plazmi > 50% tmax (engl. half value duration, HVD) za intranazalnu primjenu trajao je dulje nego kod i.m. primjene (za 2 mg intranazalno 1,27 h, za 0,4 mg i.m. 1,09 h) iz čega možemo zaključiti da je trajanje djelovanja lijeka kod intranazalne primjene dulje nego kod i.m..
English: • Skin problems such as itching, rash, redness, swelling, severe flaking or peeling of the skin.
Croatian: • Problemi s kožom kao što su svrbež, osip, crvenilo, oticanje, jako prhutanje ili ljuštenje kože
English: Signs of overdose include:
Croatian: Znaci predoziranja uključuju:
English: Nyxoid is indicated in adults and adolescents aged 14 years and over.
Croatian: Nyxoid je indiciran u odraslih i adolescenata u dobi od 14 i više godina.
English: • Instructions that the HCP has to provide the patient/carer with the PIC and to make sure that the patients/carers will have access to the video (either through the PIC or memory stick) and are encouraged to read the quick starting guide (QSG) and package leaflet included in the medicinal product outer carton.
Croatian: • Upute da zdravstveni radnici moraju dati bolesniku/skrbniku karticu s informacijama za bolesnika/skrbnika i osigurati da bolesnici/skrbnici imaju pristup videu (bilo putem kartice s informacijama za bolesnika/skrbnika ili putem USB prijenosne memorije) te poticati da pročitaju brzi vodič i uputu o lijeku uključene u vanjsko pakiranje lijeka.
English: The effect of some opioids can be longer than the effect of naloxone, which could lead to reoccurrence of respiratory depression and therefore further doses of naloxone may be required.
Croatian: Djelovanje nekih opioida može biti dulje nego djelovanje naloksona što može dovesti do ponavljanja respiratorne depresije i stoga će možda biti potrebne daljnje doze naloksona.
English: • Dizziness, headache
Croatian: • Omaglica, glavobolja
English: It is unknown whether naloxone is excreted in human breast milk and it has not been established whether infants who are breast-fed are affected by naloxone.
Croatian: Nije poznato izlučuje li se nalokson u majčino mlijeko i nije utvrđeno utječe li nalokson na dojenčad koja doje.
English: • HCP Guidance Document with training delivery instructions
Croatian: • Dokument sa smjernicama za zdravstvene radnike s uputama o obuci u davanju lijeka
English: Intranasal administration of naloxone has demonstrated naloxone to be rapidly absorbed, as evidenced by very early appearance (as early as 1 minute after administration) of the active substance in systemic circulation.
Croatian: Intranazalna primjena naloksona pokazala je da se nalokson brzo apsorbira, što dokazuje vrlo brza pojava (već 1 minutu nakon primjene) djelatne tvari u sistemskoj cirkulaciji.
English: Hypotension, Hypertension Respiratory, thoracic and mediastinal disorders Uncommon Hyperventilation Very rare
Croatian: Hipotenzija, hipertenzija Poremećaji dišnog sustava, prsišta i sredoprsja Manje često Hiperventilacija
English: Mundipharma Pharmaceuticals B.V.
Croatian: Nederland Mundipharma Pharmaceuticals B.V.
English: This medicine contains naloxone in 0.1 ml of a clear, colourless to pale yellow solution in a pre-filled nasal spray, solution in a single dose container.
Croatian: Ovaj lijek sadrži nalokson u 0,1 ml bistre, bezbojne do svijetložute otopine u napunjenom spreju za nos, otopini u jednodoznom spremniku.
English: In opioid dependent pregnant women, naloxone administration can cause withdrawal symptoms in newborn infants (see section 4.4).
Croatian: Kod trudnica ovisnih o opioidima, primjena naloksona može uzrokovati simptome ustezanja kod novorođenčadi (vidjeti dio 4.4).
English: • Life-threatening irregular heartbeat, heart attack
Croatian: • Nepravilni otkucaji srca opasni po život, srčani udar
English: • Sweating, fever, goose bumps, shivering or trembling
Croatian: • znojenje, vrućicu, ježenje kože, drhtanje ili jako drhtanje
English: Mundipharma Ges.m.b.H.-o.z.
Croatian: Slovenská republika Mundipharma Ges.m.b.H.-o.z.
English: Uncommon Arrhythmia, Bradycardia Very rare
Croatian: Manje često Aritmija, bradikardija Vrlo rijetko Srčana fibrilacija, srčani zastoj
English: As the duration of action of some opioid agonists may be longer than that of naloxone, the effects of the opioid agonist may return as the effects of naloxone disappear.
Croatian: Budući da trajanje djelovanja nekih agonista opioida može biti dulje nego djelovanje naloksona, učinak agonista opioida može se vratiti nakon prestanka djelovanja naloksona.
English: A study investigating intranasal naloxone at doses of 1, 2, 4 mg (MR903-1501) shows that the median (range) tmax associated with intranasal administration of naloxone was 15 (10, 60) minutes for
Croatian: Ispitivanja koja su proučavala intranazalnu primjenu naloksona u dozama od 1, 2, 4 mg (MR903-1501) pokazala su da je medijan (raspon) tmax povezan s intranazalnom primjenom naloksona 15 (10, 60) minuta za 1 mg, 30 (8, 60) minuta za 2 mg i 15 (10, 60) minuta za intranazalne doze od 4 mg.
English: Mundipharma GmbH
Croatian: Deutschland Mundipharma GmbH
English: Nasal use.
Croatian: Nazalna primjena.
English: Nyxoid is intended to be administered as a part of a resuscitation intervention in suspected overdose casualties, where opioid drugs may be involved or suspected, likely in a non-medical setting.
Croatian: Nyxoid je namijenjen za primjenu u sklopu intervencije za oživljavanje, vjerojatno izvan zdravstvene ustanove, u slučajevima sumnje na predoziranje kada je moguće da se radi o opioidima ili se na njih sumnja.
English: • Irregular heart beat
Croatian: • Nepravilni otkucaji srca
English: Each nasal spray contains one single dose of naloxone.
Croatian: Svaki sprej sadrži jednu dozu naloksona.
English: If the duration of action of the opioid agonist exceeds that of intranasal naloxone, the effects of the opioid agonist may return, necessitating a second intranasal naloxone administration.
Croatian: Ako trajanje djelovanje agonista opioida premašuje trajanje djelovanja intranazalnog naloksona , učinak agonista opioida se može vratiti te je potrebna druga primjena intranazalnog naloksona
English: • breathing problems
Croatian: • probleme s disanjem,
English: The Effectiveness of Nyxoid (intranasal naloxone) Administration by Lay People in Reversing Opioid Overdose.
Croatian: Učinkovitost primjene lijeka Nyxoid (intranazalni nalokson) primjenjenog od strane laika kod povrata predoziranja opioidima.
English: Nasal spray, solution in a single-dose container (nasal spray) Clear, colourless to pale yellow solution
Croatian: Sprej za nos, otopina u jednodoznom spremniku (sprej za nos) Bistra, bezbojna do svijetlo žuta otopina
English: Receiving Nyxoid close to giving birth Tell your midwife or doctor if you have received Nyxoid close to or during labour.
Croatian: Obratite se svojoj babici ili liječniku ako ste primili Nyxoid neposredno prije ili za vrijeme rađanja.
English: Vomiting Uncommon Diarrhoea, Dry mouth
Croatian: Manje često Proljev, suha usta
English: Tel: +44(0) 1223 424444
Croatian: Napp Pharmaceuticals Limited Tel: +44(0) 1223 424444
English: Caution should be exercised when naloxone is administered to a breast-feeding mother but there is no need to discontinue breast-feeding.
Croatian: Prilikom primjene naloksona dojilji, potreban je oprez, ali nema potrebe za prekidom dojenja.
English: Effectiveness of naloxone
Croatian: Učinkovitost naloksona
English: Mundipharma AB
Croatian: Sverige Mundipharma AB
English: Napp Pharmaceuticals Limited
Croatian: Pharmaceuticals Limited
English: The immediate container consists of a type I glass vial with siliconised chlorobutyl stopper containing 0.1 ml solution.
Croatian: I sa silikoniziranim klorobutilinim čepom, koja sadrži 0,1 ml otopine.
English: Clear the mouth and nose of any blockages.
Croatian: Uklonite sva začepljenja usta i nosa.
English: Nasal spray, solution in a single-dose container 2 single-dose containers
Croatian: Sprej za nos, otopina u jednodoznom spremniku 2 jednodozna spremnika
English: Intranasal absorption and efficacy of naloxone can be altered in patients with damaged nasal mucosa and septal defects.
Croatian: Intranazalna apsorpcija i djelotvornost naloksona može biti izmijenjena kod bolesnika s oštećenom nosnom sluznicom i poremećajem nosne pregrade.
English: General disorders and administration site conditions Uncommon Drug withdrawal syndrome (in patients dependent on opioids)
Croatian: Opći poremećaji i reakcije na mjestu primjene Manje često Sindrom ustezanja lijeka (kod bolesnika ovisnih o opioidima)
English: The patient should be monitored closely until emergency help has arrived after being given this medicine.
Croatian: Nakon primjene ovog lijeka, bolesnika je potrebno pažljivo nadzirati dok ne stigne hitna medicinska pomoć.
English: Excipients: Trisodium citrate dihydrate, sodium chloride, hydrochloric acid sodium hydroxide, purified water.
Croatian: Pomoćne tvari: natrijev citrat dihidrat, natrijev klorid, kloridna kiselina, natrijev hidroksid i pročišćena voda.
English: Conditions to look out for
Croatian: Stanja na koja treba obratiti pozornost
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien Mundipharma Comm.