FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with mild to moderate renal impairment, the pharmacokinetic profile of zaleplon is not significantly different than that in healthy subjects.
Croatian: farmakokinetički profil zaleplona nije značajno drugačiji od onog u zdravih ispitanika.
English: Psychiatric disorders Uncommon:
Croatian: Psihijatrijski poremećaji Manje često:
English: As with other benzodiazepines or benzodiazepine-like agents, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).
Croatian: Kao i kod drugih benzodiazepina ili lijekova srodnih benzodiazepinima , predoziranje ne predstavlja opasnost po život, osim ako se ne kombiniraju s drugim depresorima središnjeg živčanog sustava
English: Printing inks on the shell contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172).
Croatian: Tinta kojom je otisnuta oznaka na ovojnici sadrži sljedeće (zlatna tinta SB-3002): šelak, amonijev hidroksid, željezov oksid, žuti (E172).
English: Suomi/Finland
Croatian: Suomi/Finland Meda Oy
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 10 MG CAPSULE BLISTERS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI S KAPSULAMA OD 10 MG
English: • if you have severe kidney or liver problems.
Croatian: • ako imate teške probleme s bubrezima ili jetrom
English: Solvang 8
Croatian: Krijgsman 20
English: The active substance in each Sonata hard capsule is zaleplon 10 mg.
Croatian: Djelatna tvar u svakoj Sonata tvrdoj kapsuli je 10 mg zaleplona.
English: Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).
Croatian: Manje česte nuspojave uključuju: omaglicu; slabost; smanjenu koordinaciju pokreta; zanošenje pri hodu i/ili padanje (ataksija); smanjenu koncentraciju; apatiju; nemir; depresiju; uznemirenost; razdražljivost; smetenost, abnormalno razmišljanje i ponašanje (ekstrovertnost koja se čini neuobičajena, smanjena inhibicija, agresivnost, bijes, deluzija, depersonalizacija, psihoza); noćne more; halucinacije; dvoslike ili druge probleme s vidom; povećanu osjetljivost na buku (hiperakuzija);
English: anaphylactic/anaphylactoid reactions
Croatian: anafilaktične/anafilaktoidne reakcije
English: Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon's plasma concentrations.
Croatian: Istodobna primjena Sonate i lijekova za koje je poznato da utječu na CYP3A4 može rezultirati promjenama koncentracije zaleplona u plazmi (vidjeti dio 4.5).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI S KAPSULAMA OD 5 MG
English: Uncommon:
Croatian: Vrlo rijetko:
English: Zaleplon binds selectively to the benzodiazepine type I receptor.
Croatian: Zaleplon se selektivno veže za benzodiazepinski receptor tipa I.
English: Rebound insomnia and anxiety
Croatian: Povratna (engl. rebound) nesanica i tjeskoba
English: Reproductive system and breast disorders Common:
Croatian: Poremećaji reproduktivnog sustava i dojki
English: Sonata has major influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Sonata značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medicines used for the treatment of seizures/convulsions (antiepileptic medicines), medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of allergies (sedative antihistamines).
Croatian: hipnotici, anksiolitici/sedativi, antidepresivi), lijekove koji se koriste za ublažavanje jake boli (narkotički analgetici), lijekove koji se koriste za liječenje napadaja/konvulzija (antiepileptici), lijekove koji se koriste za gubitak osjeta/neosjetljivost (anestetici) i lijekove koji se koriste za liječenje alergija (sedativni antihistaminici).
English: Common (1/100 to <1/10)
Croatian: Česte (≥1/100 do <1/10) Manje česte (≥1/1,000 do <1/100)
English: In severe cases the following symptoms may occur: unreality, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Croatian: depersonalizacija, hiperakuzija, obamrlost i trnci u ekstremitetima, preosjetljivost na svjetlo, buku i fizički kontakt, halucinacije ili epileptički napadaji.
English: Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately studied in those patients.
Croatian: Oštećenje funkcije bubrega Sonata nije indicirana za liječenje bolesnika s teškim oštećenjem funkcije bubrega jer još nije dovoljno ispitana u tih bolesnika.
English: The active substance in each Sonata hard capsule is zaleplon 5 mg.
Croatian: Djelatna tvar u svakoj Sonata tvrdoj kapsuli je 5 mg zaleplona.
English: Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up to 4-fold and 7-fold in compensated and decompensated patients, respectively) relative to healthy subjects.
Croatian: Posljedično, oralni klirens zaleplona smanjen je za 70% u bolesnika s kompenziranom, odnosno 87% u bolesnika s dekompenziranom cirozom jetre što dovodi do značajnih povećanja srednje vrijednosti
English: How to store Sonata
Croatian: Kako čuvati Sonatu
English: Capsules have an opaque white and opaque light brown hard shell with the strength “5 mg”.
Croatian: Kapsule s neprozirnom bijelom i neprozirnom svijetlosmeđom tvrdom ovojnicom jačine “5 mg”.
English: Coadministration of a single zaleplon 10 mg dose and venlafaxine (extended release) 75 mg or 150 mg daily did not produce any interaction on memory (immediate and delayed word recall) or psychomotor performance (digit symbol substitution test).
Croatian: od 75 mg ili 150 mg dnevno nije imala utjecaj na pamćenje (neposredno i odgođeno prisjećanje riječi)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Croatian: TEKST ZA SONATU OD 10 MG - VELIČINE PAKIRANJA OD 7, 10 I 14 KAPSULA
English: Meda Pharma SIA Vienības gatve 109 LV-1058 Riga, Latvia Tel.: +371 67616137
Croatian: LV-1058 Riga, Latvia Tel.: +371 67616137
English: Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Belgique/Belgien Tél/Tel: +32 2 5 04 08 11
Croatian: Luxembourg/Luxemburg MEDA Pharma S.A./N.V. Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Belgique/Belgien Tél/Tel: +32 2 5 04 08 11
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku
English: If you have any further questions, ask your doctor or pharmacist.
Croatian: − Ako imate bilo kakvih dodatnih pitanja, obratite se svom liječniku ili ljekarniku.
English: Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Croatian: Što je Sonata i za što se koristi Sonata pripada skupini tvari zvanih lijekovi srodni benzodiazepinima, koja sadržava pripravke uspavljujućeg djelovanja.
English: The dose of zaleplon should be reduced in patients with mild to moderate hepatic impairment, and zaleplon is not recommended for use in patients with severe hepatic impairment.
Croatian: U bolesnika s blagim do umjerenim oštećenjem funkcije jetre dozu zaleplona potrebno je smanjiti te se zaleplon ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre.
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet MEDA Manufacturing GmbH
English: Ear and labyrinth disorders Uncommon:
Croatian: Poremećaji uha i labirinta Manje često:
English: D-61352 Bad Homburg v.d.H.
Croatian: D-61352 Bad Homburg v.d.H. Tel: + 49 6172 888 01
English: Literature articles regarding next day effects on driving and mental alertness were published during the reporting period which examined these effects with zaleplon and other agents of the class.
Croatian: objavljeni su tijekom izvještajnog razdoblja te su istražili te učinke sa zaleplonom i drugim lijekovima iste skupine.
English: Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon.
Croatian: Nakon uzimanja prve ili sljedećih doza sedativa-hipnotika, uključujući zaleplon, zabilježeni su slučajevi angioedema koji zahvaća jezik, glotis ili grkljan.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/102/001-003
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/102/001-003
English: NAME OF THE MARKETING AUTHORISATION HOLDER Meda AB
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Meda AB
English: Therapy of overdose
Croatian: Terapija predoziranja
English: MEDA PHARMA Hungary Kereskedelmi Kft. H-1139 Budapest
Croatian: H-1139 Budapest
English: Česká republika MEDA Pharma s.r.o.
Croatian: MEDA Pharma s.r.o.
English: As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg. For severe hepatic impairment see section 4.3.
Croatian: Zbog smanjenja klirensa, bolesnici s blagim do umjerenim oštećenjem funkcije jetre moraju se liječiti dozom Sonate od 5 mg.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/102/004-006
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/102/004-006
English: The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Croatian: Druge pomoćne tvari su mikrokristalična celuloza, prethodno geliran škrob, silicijev dioksid, natrijev laurilsulfat, magnezijev stearat, laktoza hidrat, indigo carmine (E132), titanijev dioksid (E171).
English: Capsules have an opaque white hard shell with the strength “10 mg”.
Croatian: Kapsule s neprozirnom bijelom i neprozirnom svijetlosmeđom tvrdom ovojnicom jačine “10 mg”.
English: Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
Croatian: nepoznato (učestalost nije moguće procijeniti iz dostupnih podataka) Nuspojave koje se mogu pojaviti često su: omamljenost; otežano pamćenje; osjećaj poput trnaca, npr. u udovima (parestezija); bolne mjesečnice.
English: In a subsequent cross-fostering study, adverse effects on offspring viability and growth appeared to result from both in utero and lactational exposure to zaleplon.
Croatian: U narednom „cross-fostering“ ispitivanju (u kojem je mladunčad prebačena iz svog legla u drugo) pojavili su se štetni događaji za preživljenje i rast mladunčadi koji su bili rezultat njihovog izlaganja zaleplonu u maternici i tijekom laktacije.
English: Immune system disorders Very rare:
Croatian: Poremećaji probavnog sustava Manje često:
English: Sonata has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
Croatian: U kontroliranim ispitivanjima koja su mjerila postotak vremena provedenog u svakoj fazi sna pokazalo se da Sonata održava faze sna.
English: The single dose pharmacokinetics of zaleplon were studied in patients with mild (creatinine clearance 40 to 89 ml/min) and moderate (20 to 39 ml/min) renal impairment, and in patients on dialysis.
Croatian: 89 ml/min) i umjerenim (20 do 39 ml/min) oštećenjem funkcije bubrega te u bolesnika na dijalizi.
English: Frequency not known:
Croatian: Manje često:
English: nausea
Croatian: Nuspojave
English: Combination with other CNS-acting compounds should be taken into account.
Croatian: U obzir je potrebno uzeti kombinaciju s drugim spojevima koji djeluju na središnji živčani sustav.
English: Тел.
Croatian: Al.
English: Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Tél/Tel: +32 2 5 04 08 11
Croatian: België/Belgique/Belgien MEDA Pharma S.A./N.V. Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Tél/Tel: +32 2 5 04 08 11
English: Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Croatian: Jezgra kapsule celuloza, mikrokristalična škrob, prethodno geliran silicijev dioksid, natrijev laurilsulfat, magnezijev stearat, laktoza hidrat, indigo carmine (E132), titanijev dioksid (E171).
English: Attention to airway patency and supportive management of ventilation and haemodynamics are usually sufficient.
Croatian: Obično je dovoljno obratiti pozornost na prohodnost dišnih puteva i suportivno zbrinjavanje disanja te hemodinamike.
English: Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks.
Croatian: Nakon ponovljene primjene tijekom nekoliko tjedana, donekle se može smanjiti djelotvornost hipnotičkog učinka kratko djelujućih benzodiazepina i lijekova srodnih benzodiazepinima.
English: Excipient with known effect: Lactose monohydrate 54 mg. For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: 54 mg laktoze hidrata.
English: Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
Croatian: Tinta kojom je otisnuta oznaka na ovojnici sadrži sljedeće (ružičasta tinta SW-1105): šelak, titanijev dioksid (E171),
English: Excipient with known effect: Lactose monohydrate 49 mg. For the full list of excipients, see section 6.1.
Croatian: Pomoćna tvar s poznatim učinkom: 49 mg laktoze hidrata.
English: Tel: +420 234 064 203
Croatian: CZ 100 10 Praha 10 Tel: +420 234 064 203
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svojemu liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek Sonata se ne smije uzimati u navedenim razdobljima budući da nema dovoljno kliničkih podataka dostupnih za procjenu sigurnosti njene primjene tijekom trudnoće i dojenja.
English: Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate,
Croatian: Ovojnica kapsule želatina, titanijev dioksid (E171), željezov oksid, crveni (E172), željezov oksid, žuti (E172), željezov oksid, crni (E172), natrijev laurilsulfat,
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate.
Croatian: Sastojci ovojnice kapsule: želatina, titanijev dioksid (E171), željezov oksid, crveni (E172), željezov oksid, žuti (E172), željezov oksid, crni (E172) i natrijev laurilsulfat.
English: Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate,
Croatian: Ovojnica kapsule želatina, titanijev dioksid (E171), natrijev laurilsulfat,
English: Chromaturia (bluegreen urine discolouration) has been reported with zaleplon overdose.
Croatian: Kod predoziranja zaleplonom zabilježena je kromaturija (promjena boje mokraće u plavozelenu).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/001 7 capsules
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/102/001 7 kapsula
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/004 7 capsules
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/99/102/004 7 kapsula
English: Other complex behaviours (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
Croatian: U bolesnika koji nisu potpuno budni nakon uzimanja sedativa-hipnotika zabilježena su druga kompleksna ponašanja (tj. pripremanje i konzumiranje hrane, vođenje telefonskih razgovora ili spolni odnos).
English: EU/1/99/102/002 10 capsules EU/1/99/102/003 14 capsules
Croatian: EU/1/99/102/003 14 kapsula
English: Slovenská republika MEDA Pharma spol.
Croatian: Slovenská republika MEDA Pharma spol. s r.o..
English: NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules
Croatian: NAZIV LIJEKA Sonata 10 mg tvrde kapsule
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate.
Croatian: Sastojci ovojnice kapsule: želatina, titanijev dioksid (E171) i natrijev laurilsulfat.
English: Enhancement of the central sedation may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic medicinal products, anaesthetics, and sedative antihistamines.
Croatian: anksioliticima/sedativima, antidepresivima, narkotičkim analgeticima, antiepilepticima, anesteticima i sedativnim antihistaminicima može doći do pojačane središnje sedacije.
English: NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules
Croatian: NAZIV LIJEKA Sonata 5 mg tvrde kapsule
English: EU/1/99/102/005 10 capsules EU/1/99/102/006 14 capsules
Croatian: EU/1/99/102/006 14 kapsula
English: General disorders and administration site conditions Uncommon:
Croatian: Opći poremećaji i reakcije na mjestu primjene Manje često:
English: Myasthenia gravis
Croatian: astenija, malaksalost
English: Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon.
Croatian: Uz primjenu sedativa-hipnotika, uključujući zaleplon, zabilježene su teške anafilaktičke/anafilaktoidne reakcije.
English: NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules zaleplon
Croatian: NAZIV LIJEKA Sonata 10 mg tvrde kapsule zaleplon
English: NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules zaleplon
Croatian: NAZIV LIJEKA Sonata 5 mg tvrde kapsule zaleplon
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg zaleplon
Croatian: Svaka tvrda kapsula sadrži 10 mg zaleplona
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 5 mg zaleplon
Croatian: Svaka tvrda kapsula sadrži 5 mg zaleplona
English: Cimetidine, a non-specific moderate inhibitor of several hepatic enzymes including both aldehyde oxidase and CYP3A4, produced an 85% increase in plasma concentrations of zaleplon because it inhibited both the primary (aldehyde oxidase) and secondary (CYP3A4) enzymes responsible for zaleplon's metabolism.
Croatian: CYP3A4, uzrokovao je povećanje koncentracije zaleplona u plazmi za 85%, jer inhibira oba enzima,
English: MEDA Pharma GmbH & Co. KG Benzstraße 1
Croatian: KG Benzstraße 1
English: MEDA Pharma B.V. Krijgsman 20
Croatian: MEDA Pharma B.V.
English: Capsule core
Croatian: Kapsula tvrda.
English: Depression Pre-existing depression may be unmasked during benzodiazepine or benzodiazepine-like agent use.
Croatian: Depresija Tijekom primjene benzodiazepina ili lijekova srodnih benzodiazepinima moguće je otkrivanje već postojeće depresije.
English: Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
Croatian: Tijekom primjene benzodiazepina i lijekovi srodni benzodiazepinima moguće su reakcije kao što su nemir, agitacija, razdražljivost, smanjena inhibicija, agresivnost, abnormalno razmišljanje, deluzija, bijes, noćne more, depersonalizacija, halucinacije, psihoze, neprikladno ponašanje, ekstrovertnost koja se čini neuobičajena i drugi poremećaji ponašanja.
English: Excretion
Croatian: mučnina
English: Oral use
Croatian: Peroralna primjena
English: Polska
Croatian: България
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Severe renal impairment
Croatian: Povratna (eng. rebound) nesanica i tjeskoba
English: Severe hepatic impairment
Croatian: Poremećaji probavnog sustava
English: • Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Sonata.
Croatian: abnormalnog razmišljanja, deluzije, bijesa, noćnih mora, depersonalizacije, halucinacija, psihoza, neprikladnog ponašanja, ekstrovertnosti koja se čini neuobičajena i drugih učinaka na ponašanje.
English: MA (EU) number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza
English: Strength Pharmaceutical form
Croatian: Farmaceutski oblik Put primjene
English: Immediate packaging
Croatian: Unutarnje pakovanje
English: Pack size
Croatian: Sastav
English: MA (EU) number (Invented) name Strength
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza
English: The process takes about 6 to 8 weeks.
Croatian: Taj postupak traje otprilike 6 do 8 tjedana.
English: 72 hours
Croatian: 72 sata
English: This may take up to one year.
Croatian: Taj program može trajati do godinu dana.
English: The risk of treatment failure may increase if you do not follow your rehabilitation schedule.
Croatian: Rizik od neuspjeha liječenja može biti veći ako ne slijedite svoj raspored rehabilitacije.
English: The physician will be informed immediately.
Croatian: Liječnik se smjesta obavješćuje o tome.
English: The program may take up to one year depending on the recommendation of the physician.
Croatian: Taj program može trajati do godinu dana, ovisno o preporuci liječnika.
English: The subchondral plate should not be damaged.
Croatian: Subhondralna ploča ne smije se oštetiti.
English: This leaflet was last revised in
Croatian: Ova je uputa zadnji put revidirana
English: Also it needs to be checked if the correct order number (lot number) is on the primary package.
Croatian: Također je potrebno provjeriti je li na primarnom pakiranju ispravan broj narudžbe (serijski broj).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svojem liječniku za savjet prije primjene ovog lijeka.
English: Read all of this leaflet carefully before you are given with this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži vama važne podatke.
English: Do not irradiate.
Croatian: Ne izlagati zračenju.
English: Your doctor might have to select an alternative treatment for you.
Croatian: Vaš će vam liječnik možda morati prepisati alternativno liječenje.
English: • Primary (generalised) osteoarthritis.
Croatian: • Primarni (generalizirani) osteoartritis.