FrancophonIA/ELRC3.0 huggingface dataset:
English: Changes made to the product information of zolpidem-containing medicines include strengthened warnings and precautions.
Croatian: Promjene načinjene u informacijama o lijekovima koji sadrže zolpidem uključuju pojačana upozorenja i mjere opreza.
English: Zolpidem should be taken just before going to bed, and it should not be taken again during the same night.
Croatian: Zolpidem treba uzimati neposredno pred odlazak na spavanje i ne smije se uzimati ponovno tijekom iste noći.
English: Zolpidem is a medicine used for the short-term treatment of insomnia.
Croatian: Zolpidem je lijek koji se koristi za kratkotrajno liječenje nesanice.
English: On 24 April 2014, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed by majority new recommendations for zolpidem-containing medicines, used for the short-term treatment of insomnia (difficulty sleeping).
Croatian: Skupina za koordinaciju za međusobno priznavanje i decentralizirane postupke za humane lijekove(CMDh)1, 24. travnja 2014. preporučila je većinu novih preporuka za lijekove koji sadrže zolpidem, a koji se koriste za kratkotrajno liječenje insomnije (poteškoća sa spavanjem).
English: These recommendations are based on a careful assessment of the available data on the safety and efficacy of zolpidem from clinical studies, post-marketing reports and the published literature.
Croatian: Te preporuke temelje se na pažljivoj procjeni dostupnih podataka o sigurnosti i djelotvornosti iz kliničkih ispitivanja, izvješća nakon stavljanja lijeka u promet i objavljene literature.
English: The data analysed during the review showed that, while most cases of impaired driving were linked to the intake of a 10 mg daily dose of zolpidem, lower doses were not shown to significantly reduce the risk of impaired driving and were not consistently shown to be effective at population level.
Croatian: Podatci analizirani tijekom procjene pokazuju da dok je većina slučajeva narušene sposobnosti upravljanja vozilima bila povezana s unosom dnevne doze od 10 mg zolpidema, nije dokazano da niže doze znatno smanjuju rizik od narušene sposobnosti upravljanja vozilima te se nisu prikazale kao dosljedno djelotvorne na razini populacije.
English: The normal recommended daily dose in adults, which must not be exceeded, remains at 10 mg, and for older patients and patients with reduced liver function it remains at 5 mg.
Croatian: Normalna preporučena dnevna doza za odrasle koja se ne smije premašiti ostaje na 10 mg, a za starije bolesnike i bolesnike sa smanjenom funkcijom jetre ostaje 5 mg.
English: • Zolpidem-containing medicines are used for the short-term treatment of insomnia (difficulty sleeping).
Croatian: • Lijekovi koji sadrže zolpidem koriste se za kratkoročno liječenje nesanice (poteškoća sa spavanjem).
English: • Patients taking zolpidem should make sure there is a period of at least 8 hours between taking the medicine and driving or operating other machinery.
Croatian: • Bolesnici koji uzimaju zolpidem trebaju se pobrinuti da između uzimanja lijeka i upravljanja vozilima ili drugim strojevima prođe najmanje osam sati.
English: Some studies showed an association between intake of zolpidem in the middle of the night and impaired driving ability the next day.
Croatian: Neka ispitivanja pokazala su povezanost između unosa zolpidema usred noći i oštećenja sposobnosti upravljanja vozilima sljedeći dan.
English: • It is important that patients do not exceed the recommended dose of zolpidem, which is 10 mg by mouth once a day; a lower dose may be prescribed to some adults.
Croatian: • Važno je da bolesnici ne premaše preporučenu dozu zolpidema od 10 mg peroralno jednom na dan; nekim odraslim osobama mora se propisati niža doza.
English: • Patients should take the lowest effective dose, in a single intake just before bedtime.
Croatian: • Bolesnici moraju uzeti najnižu djelotvornu dozu u jednom unosu i neposredno pred spavanje.
English: Zolpidem may cause drowsiness and slower reactions the day after taking the medicine, which could cause impaired driving ability and increase the risk of road accidents; a warning of these risks is included in the package leaflet.
Croatian: Zolpidem može uzrokovati omamljenost i sporije reakcije dan nakon uzimanja lijeka što može uzrokovati narušenu sposobnost vožnje i upravljanja strojevima te povećati rizik od prometnih nesreća; upozorenje za ove rizike uključeno je u uputi o lijeku.
English: In older patients and patients with reduced liver function a lower dose of 5 mg is recommended.
Croatian: Kod starijih bolesnika i bolesnika sa smanjenom funkcijom jetre preporučuje se niža doza.
English: • The risk of impaired mental alertness is higher if zolpidem is taken with less than a full night of sleep remaining; therefore, a period of at least 8 hours is recommended between taking zolpidem and performing activities such as driving or operating other machinery.
Croatian: • Rizik od oštećene mentalne pribranosti viši je ako se zolpidem uzima na manje od jedne noći sna; stoga se preporučuje razdoblje od najmanje 8 sati između uzimanja zolpidema i provođenja aktivnosti poput upravljanja vozilima i drugim strojevima.
English: Patients should take the lowest effective dose of zolpidem in a single intake just before going to bed and should not take another dose during the same night.
Croatian: Bolesnici moraju uzimati najnižu djelotvornu dozu zolpidema u jednom unosu neposredno pred odlazak na spavanje te ne smiju uzeti drugu dozu tijekom iste noći.
English: These recommendations followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety of zolpidem with regards to the risk of impaired driving, somnambulism, and reduced mental alertness (such as drowsiness and slower reactions) after taking the medicine, and information on its effectiveness at lower doses.
Croatian: Te su preporuke uslijedile nakon procjene dostupnih podataka o sigurnosti zolpidema od strane Povjerenstva za ocjenu rizika u farmakovigilanciji (PRAC) Europske agencije za lijekove, a u vezi s rizikom od narušene sposobnosti upravljanja vozilima, somnambulizma i smanjene mentalne pribranosti (poput omamljenosti i sporijih reakcija) nakon uzimanja lijeka te informacije o njegovoj djelotvornosti pri nižim dozama.
English: • The daily dose of zolpidem remains 10 mg a day in adults and 5 mg a day in the elderly and in patients with hepatic impairment; this dose must not be exceeded.
Croatian: • Dnevna doza zolpidema ostaje 10 mg na dan kod odraslih te 5 mg na dan kod starijih bolesnika te u bolesnika s oštećenjem jetre; ova se doza ne smije premašiti.
English: Since the risk of impaired driving seems to increase if zolpidem is taken together with other medicines that have an effect on the central nervous system (brain and spinal cord), or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.
Croatian: S obzirom da se čini da se rizik od narušene sposobnosti upravljanja vozilima povećava ako se zolpidem uzima skupa s drugim lijekovima koji imaju učinak na središnji živčani sustav (mozak i leđnu moždinu) ili s alkoholom ili drogama, te tvari ne smiju se uzimati istovremeno sa zolpidemom.
English: • The risk of impaired mental alertness also increases if zolpidem is taken at higher than recommended doses, or if it is co-administered with other CNS depressants, alcohol, or illicit drugs.
Croatian: • Rizik od oštećene mentalne pribranosti također se povećava ako se zolpidem uzima u dozama većim od preporučenih ili ako se istodobno primjenjuje s drugim depresantima SŽS, alkoholom ili drogama.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 23 June 2014.
Croatian: S obzirom da je većina usvojila stajalište CMDh, isto je poslano Europskoj komisiji koja ga je potvrdila i usvojila kao konačnu pravno obvezujuću odluku koja vrijedi diljem EU-a 23. lipnja 2014.
English: As the CMDh position on zolpidem was adopted by majority vote, it was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 23 June 2014.
Croatian: S obzirom da je većina usvojila stajalište CMDh o zolpidemu, isto je poslano Europskoj komisiji koja ga je potvrdila i usvojila kao konačnu pravno obvezujuću odluku koja vrijedi diljem EU-a 23. lipnja 2014.
English: The CMDh agreed that the benefit-risk balance of these medicines remains positive; however, some changes have been made to the product information to minimise the known risk of reduced mental alertness and impaired ability to drive and use machinery the morning after use.
Croatian: CMDh se složio da omjer koristi i rizika tih lijekova ostaje pozitivan; međutim, načinjene su neke izmjene u informacijama o lijeku kako bi se smanjio poznati rizik od smanjene mentalne pribranosti i oštećena sposobnost upravljanja vozilima i strojevima jutro nakon primjene lijeka.
English: • Since the risk of reduced mental alertness and driving ability seems to increase if zolpidem is taken together with other medicines that cause drowsiness or lack of alertness, or with alcohol or illicit drugs, these substances should not be used when taking zolpidem.
Croatian: • S obzirom da se čini da se rizik od smanjene mentalne pribranosti i sposobnosti upravljanja vozilima ako se zolpidem uzima skupa s drugim lijekovima koji uzrokuju omamljenost ili nedostatak pribranosti ili s alkoholom ili drogama povećava, te tvari ne smiju se uzimati istovremeno sa zolpidemom.
English: • A review of the available data confirmed that the benefit-risk balance of zolpidem-containing medicines remains positive but changes have been introduced to the product information of these medicines, aimed at further minimising the known risks of next-morning reduced mental alertness and impaired driving ability.
Croatian: • Procjena dostupnih podataka potvrdila je da omjer koristi i rizika lijekova koji sadrže zolpidem ostaje pozitivan, ali uvedene su promjene u informacije o ovim lijekovima koje teže ka daljnjem smanjenju poznatih rizika od smanjene pribranosti jutro nakon uzimanja lijeka i oštećene sposobnosti vožnje.
English: As zolpidem-containing medicines are all authorised nationally, the PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position on 24 April 2014.
Croatian: Svi lijekovi koji sadrže zolpidem odobreni su nacionalno, a preporuke PRAC-a poslane su Koordinacijskoj skupini za međusobno priznavanje i decentralizirane postupke - za humane lijekove (CMDh) koja je usvojila konačno stajalište 24. travnja 2014. CMDh, tijelo koje predstavlja države članice EU-a odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene nacionalnim postupcima širom EU-a.
English: Your body's response to NovoNorm may change if you take other medicines, especially these:
Croatian: Reakcija tijela na NovoNorm može se promijeniti ako uzimate druge lijekove, posebice ove:
English: Be aware that the desired effect is not achieved if you stop taking NovoNorm.
Croatian: Imajte na umu da željeni učinak nije postignut ako prestanete uzimati NovoNorm.
English: Warnings and precautions Talk to your doctor before taking NovoNorm:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete NovoNorm:
English: NovoNorm may not be suitable for you.
Croatian: NovoNorm Vam možda neće odgovarati.
English: What NovoNorm is and what it is used for
Croatian: Što je NovoNorm i za što se koristi
English: Do not take more NovoNorm than your doctor has recommended.
Croatian: Nemojte uzeti više lijeka NovoNorm nego što Vam je preporučio liječnik.
English: NovoNorm with alcohol
Croatian: NovoNorm s alkoholom
English: NovoNorm should not be taken if you have a severe liver disease (see Do not take NovoNorm).
Croatian: NovoNorm ne smijete uzimati ako imate tešku bolest jetre (vidjeti Nemojte uzimati NovoNorm).
English: Polacrilin potassium Povidone (polyvidone) Glycerol 85%
Croatian: Povidon (polividon) Glicerol 85%
English: Other medicines and NovoNorm
Croatian: Drugi lijekovi i NovoNorm
English: Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Denmark.
Croatian: Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Danska
English: What NovoNorm looks like and contents of the pack
Croatian: Kako NovoNorm izgleda i sadržaj pakiranja
English: NovoNorm has no direct influence on the ability to drive and use machines but may cause hypoglycaemia.
Croatian: NovoNorm nema izravnog učinka na sposobnost upravljanja vozilima i rada sa strojevima, ali može uzrokovati hipoglikemiju.
English: Iron oxide, red (E172)
Croatian: Željezov oksid, crveni (E172)
English: Rare (may affect up to 1 in 1,000 patients) • Acute coronary syndrome (but it may not be due to the medicine).
Croatian: Rijetko (mogu se javiti u do 1 na 1000 bolesnika) • akutni koronarni sindrom (možda nije uzrokovan lijekom).
English: What NovoNorm is and what it is used for What you need to know before you take NovoNorm How to take NovoNorm
Croatian: Što je NovoNorm i za što se koristi Što morate znati prije nego počnete uzimati NovoNorm Kako uzimati NovoNorm
English: Vomiting, constipation
Croatian: Povraćanje, konstipacija
English: What NovoNorm contains
Croatian: Što NovoNorm sadrži
English: If you take more NovoNorm than you should
Croatian: Ako uzmete više lijeka NovoNorm nego što ste trebali
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 August 1998
Croatian: Datum prvog odobrenja: 17. kolovoza 1998.
English: Alcohol can change the ability of NovoNorm to reduce the blood sugar.
Croatian: Alkohol može izmijeniti učinkovitost lijeka NovoNorm u snižavanju razine šećera u krvi.
English: What you need to know before you take NovoNorm).
Croatian: Što morate znati prije nego počnete uzimati NovoNorm).
English: The amount of NovoNorm, food or exercise may need to be adjusted.
Croatian: Možda će biti potrebno uskladiti dozu lijeka NovoNorm, prehranu ili tjelovježbu.
English: Do not take NovoNorm
Croatian: Nemojte uzimati NovoNorm
English: Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch
Croatian: Mikrokristalinična celuloza (E460) Bezvodni kalcijev hidrogenfosfat Kukuruzni škrob
English: NovoNorm is not recommended in patients with moderate liver disease.
Croatian: NovoNorm se ne preporučuje u bolesnika koji imaju srednje tešku bolest jetre.
English: Poloxamer
Croatian: Poloksamer
English: If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take NovoNorm.
Croatian: Ako uzimate gemfibrozil (koristi se za snižavanje povišene razine masnoća u krvi) ne smijete uzimati
English: When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue NovoNorm treatment.
Croatian: Kad simptomi hipoglikemije nestanu ili Vam se stabilizira razina šećera u krvi, nastavite terapiju lijekom NovoNorm.
English: What you need to know before you take NovoNorm
Croatian: Što morate znati prije nego počnete uzimati NovoNorm
English: The following substances may enhance and/or prolong the hypoglycaemic effect of repaglinide: Gemfibrozil, clarithromycin, itraconazole, ketokonazole, trimethoprim, ciclosporin, deferasirox, clopidogrel, other antidiabetic substances, monoamine oxidase inhibitors (MAOI), non selective beta blocking substances, angiotensin converting enzyme (ACE)-inhibitors, salicylates, NSAIDs, octreotide, alcohol, and anabolic steroids.
Croatian: Sljedeće tvari mogu pojačati i/ili produljiti hipoglikemijski učinak repaglinida: gemfibrozil, klaritromicin, itrakonazol, ketokonazol, trimetoprim, ciklosporin, deferasiroks, klopidogrel, drugi antidijabetici, inhibitori monoamino oksidaze (MAO inhibitori), neselektivni beta-blokatori, inhibitori angiotenzin konvertirajućeg enzima (ACE inhibitori), salicilati, NSAIL, oktreotid, alkohol i anabolički steroidi.
English: • Severe liver problems, abnormal liver function such as increased liver enzymes in your blood.
Croatian: • smetnje vida • teški problemi s jetrom, poremećaji funkcije jetre kao što je porast jetrenih enzima u krvi.
English: NovoNorm has been shown to lower the blood sugar, which helps to prevent complications from your diabetes.
Croatian: NovoNorm snižava razinu šećera u krvi i time pomaže u sprječavanju komplikacija šećerne bolesti.
English: If you stop taking NovoNorm
Croatian: Ako prestanete uzimati NovoNorm
English: You can take NovoNorm with metformin, another medicine for diabetes, if your doctor prescribes it.
Croatian: NovoNorm možete uzimati u kombinaciji s metforminom, drugim lijekom protiv šećerne bolesti, ako ga liječnik propiše.
English: If you forget to take NovoNorm
Croatian: Ako ste zaboravili uzeti NovoNorm
English: - The other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, polacrilin potassium, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide yellow (E172) only in the 1 mg tablets and iron oxide red (E172) only in the 2 mg tablets.
Croatian: - Drugi sastojci su mikrokristalinična celuloza (E460), bezvodni kalcijev hidrogenfosfat, kukuruzni škrob, polakrilinkalij, povidon (polividon), glicerol 85%, magnezijev stearat, meglumin, poloksamer, željezov oksid, žuti (E172) samo u tabletama od 1 mg i željezov oksid, crveni (E172) samo u tabletama od 2 mg.
English: NovoNorm is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).
Croatian: NovoNorm je lijek protiv šećerne bolesti za primjenu kroz usta, a sadrži repaglinid koji pomaže gušterači da stvori više inzulina te tako snizi razinu šećera (glukoze) u krvi.
English: NovoNorm can also be given with metformin, another medicine for diabetes.
Croatian: NovoNorm se može primjenjivati i u kombinaciji s metforminom, drugim lijekom protiv šećerne bolesti.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Novo Nordisk A/S
English: The strengths are 0.5 mg, 1 mg and 2 mg. 0.5 mg tablets are white, 1 mg tablets are yellow and 2 mg tablets are peach-coloured.
Croatian: Tablete od 0,5 mg su bijele boje, tablete od 1 mg su žute, a tablete od 2 mg boje breskve.
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnom pakiranju radi zaštite od vlage.
English: How to take NovoNorm
Croatian: Kako uzimati NovoNorm
English: INFORMATION IN BRAILLE novonorm 1 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU novonorm 1 mg
English: Abdominal pain, diarrhoea
Croatian: Poremećaji probavnog sustava Bol u abdomenu, proljev
English: INFORMATION IN BRAILLE novonorm 2 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU novonorm 2 mg
English: NovoNorm should be taken with caution.
Croatian: Potreban je oprez pri uzimanju lijeka NovoNorm.
English: • If you take too little NovoNorm
Croatian: • ako uzmete premalo lijeka NovoNorm
English: How to store NovoNorm
Croatian: Kako čuvati NovoNorm
English: INFORMATION IN BRAILLE novonorm 0.5 mg
Croatian: novonorm 0,5 mg
English: • If you take too much NovoNorm
Croatian: • ako uzmete previše lijeka NovoNorm
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg of repaglinide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 0,5 mg repaglinida.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of repaglinide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 1 mg repaglinida.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of repaglinide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta sadrži 2 mg repaglinida.
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 1 mg tablets Repaglinide
Croatian: NAZIV LIJEKA NovoNorm 1 mg tablete repaglinid
English: You should not take NovoNorm if you are breast-feeding.
Croatian: Ne smijete uzimati NovoNorm ako dojite.
English: EU/1/98/076/011 30 tablets EU/1/98/076/012 90 tablets EU/1/98/076/013 120 tablets EU/1/98/076/024 270 tablets
Croatian: EU/1/98/076/011 30 tableta EU/1/98/076/012 90 tableta EU/1/98/076/013 120 tableta EU/1/98/076/024 270 tableta
English: MARKETING AUTHORISATION NUMBERS EU/1/98/076/004-006, EU/1/98/076/023
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/076/004-006, EU/1/98/076/023
English: MARKETING AUTHORISATION NUMBERS EU/1/98/076/011-013, EU/1/98/076/024
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/076/011-013, EU/1/98/076/024
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 2 mg tablets Repaglinide
Croatian: NAZIV LIJEKA NovoNorm 2 mg tablete repaglinid
English: EU/1/98/076/018 30 tablets EU/1/98/076/019 90 tablets EU/1/98/076/020 120 tablets EU/1/98/076/022 270 tablets
Croatian: EU/1/98/076/018 30 tableta EU/1/98/076/019 90 tableta EU/1/98/076/020 120 tableta EU/1/98/076/022 270 tableta
English: Package leaflet: Information for the user NovoNorm 0.5 mg tablets NovoNorm 1 mg tablets NovoNorm 2 mg tablets
Croatian: NovoNorm 0,5 mg tablete NovoNorm 1 mg tablete NovoNorm 2 mg tablete repaglinid
English: MARKETING AUTHORISATION NUMBERS EU/1/98/076/018-020, EU/1/98/076/022
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/98/076/018-020, EU/1/98/076/022
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 0.5 mg of repaglinide
Croatian: NAVOĐENJE DJELATNE TVARI Svaka tableta sadrži 0,5 mg repaglinida.
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 0.5 mg tablets
Croatian: NovoNorm 0,5 mg tablete
English: Very rare (may affect up to 1 in 10,000 patients)
Croatian: Vrlo rijetko (mogu se javiti u do 1 na 10 000 bolesnika) • povraćanje
English: EU/1/98/076/004 30 tablets EU/1/98/076/005 90 tablets EU/1/98/076/006 120 tablets EU/1/98/076/023 270 tablets
Croatian: EU/1/98/076/005 90 tableta EU/1/98/076/006 120 tableta EU/1/98/076/023 270 tableta
English: NovoNorm is used to control type 2 diabetes in adults as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar.
Croatian: S liječenjem se obično započinje kada se samo dijetom, tjelovježbom i smanjenjem tjelesne težine ne može postići zadovoljavajuća regulacija (ili snižavanje) razine šećera u krvi.
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 2 mg of repaglinide
Croatian: NAVOĐENJE DJELATNE TVARI Svaka tableta sadrži 2 mg repaglinida.
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 0.5 mg tablets Repaglinide
Croatian: NovoNorm 0,5 mg tablete repaglinid
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARDS TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Novo Nordisk A/S
English: • Vomiting
Croatian: • zatvor
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 2 mg tablets
Croatian: NovoNorm 2 mg tablete
English: NovoNorm tablets are round and convex and engraved with the Novo Nordisk logo (Apis bull).
Croatian: NovoNorm tablete su okrugle i ispupčene s utisnutim zaštitnim znakom tvrtke Novo Nordisk (Apis bik).
English: NAME OF THE MEDICINAL PRODUCT NovoNorm 1 mg tablets
Croatian: NovoNorm 1 mg tablete
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Croatian: Uputa o lijeku: Informacije za korisnika
English: You should not take NovoNorm if you are pregnant or you are planning to become pregnant.
Croatian: Ne smijete uzimati NovoNorm ako ste trudni ili planirate trudnoću.
English: Relative potency (R.P.)
Croatian: Relativna potentnost (R.P.)
English: ATC vet code: QI06AL01.
Croatian: ATCvet kod: QI06AL01.
English: Revaccination: one vaccination annually.
Croatian: Revakcinacija: jedno cijepljenje godišnje.
English: Adjuvant: mineral oil.
Croatian: Adjuvans: mineralno ulje.