FrancophonIA/ELRC3.0 huggingface dataset:
English: - Reagila 3 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
Croatian: - Reagila 3 mg tvrde kapsule: Tvrda želatinska kapsula veličine „4“ (približne duljine 14,3 mm) s neprozirnom zelenom kapicom i neprozirnim bijelim tijelom te oznakom „GR 3“ otisnutom crnom tintom na tijelu kapsule.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 6 mg kariprazina u obliku kariprazinklorida.
English: Reagila 4.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, white ink (shellac, titanium dioxide (E 171), propylene glycol, simeticone).
Croatian: Reagila 4,5 mg tvrde kapsule: prethodno geliran škrob (kukuruzni), magnezijev stearat, boja allura red AC (E 129), boja brilliant blue FCF (E 133), titanijev dioksid (E 171), žuti željezov oksid (E 172), želatina, bijela tinta (šelak, titanijev dioksid (E 171), propilenglikol, simetikon).
English: Reagila 1.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Croatian: Reagila 1,5 mg tvrde kapsule: prethodno geliran škrob (kukuruzni), magnezijev stearat, titanijev dioksid (E 171), želatina, crna tinta (šelak, crni željezov oksid (E 172), propilenglikol, kalijev hidroksid).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-040
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1209/001-040
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 4,5 mg kariprazina u obliku kariprazinklorida.
English: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Croatian: Jedna tvrda kapsula sadrži 4,5 mg kariprazina u obliku kariprazinklorida.
English: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Croatian: Jedna tvrda kapsula sadrži 3 mg kariprazina u obliku kariprazinklorida.
English: If you get any side effects, talk to your doctor.
Croatian: Ako se to dogodi, obratite se svom liječniku.
English: Smoking status
Croatian: Pušenje
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/001-010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1209/001-010
English: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Croatian: Jedna tvrda kapsula sadrži 6 mg kariprazina u obliku kariprazinklorida.
English: - Reagila 6 mg hard capsules: ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
Croatian: - Reagila 6 mg tvrde kapsule: Tvrda želatinska kapsula veličine „3“ (približne duljine 15,9 mm) s neprozirnom ljubičastom kapicom i neprozirnim bijelim tijelom te oznakom „GR 6“ otisnutom crnom tintom na tijelu kapsule.
English: - visual impairment.
Croatian: - ako imate poremećaj vida.
English: Reagila 6 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Croatian: Reagila 6 mg tvrde kapsule: prethodno geliran škrob (kukuruzni), magnezijev stearat, boja brilliant blue FCF (E 133), boja allura red AC (E 129), titanijev dioksid (E 171), želatina, crna tinta (šelak, crni željezov oksid (E 172), propilenglikol, kalijev hidroksid).
English: Reagila 3 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).
Croatian: Reagila 3 mg tvrde kapsule: prethodno geliran škrob (kukuruzni), magnezijev stearat, boja allura red AC (E 129), boja brilliant blue FCF (E 133), titanijev dioksid (E 171), žuti željezov oksid (E 172), želatina, crna tinta (šelak, crni željezov oksid (E 172), propilenglikol, kalijev hidroksid).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 3 mg kariprazina u obliku kariprazinklorida.
English: What Reagila contains
Croatian: Sadržaj pakiranja i druge informacije Što Reagila sadrži
English: Gedeon Richter România S.A. Tel: +40-265-257 011
Croatian: Gedeon Richter Plc. atstovybė Lietuvoje Tel: +370 5 261 01 54
English: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink.
Croatian: Tvrda želatinska kapsula veličine „4“ (približne duljine 14,3 mm) s neprozirnom zelenom kapicom i neprozirnim bijelim tijelom te oznakom „GR 3“ otisnutom crnom tintom na tijelu kapsule.
English: Titanium dioxide (E 171) Gelatin
Croatian: Ovojnica kapsule (kapsula od 1,5 mg) titanijev dioksid (E 171) želatina
English: Blood thyroid stimulating hormone decreased
Croatian: Endokrini poremećaji snižena vrijednost tireostimuliraj ućeg hormona u krvi hipotireoza
English: Reagila 1.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
Croatian: Tvrda želatinska kapsula veličine „4“ (približne duljine 14,3 mm) s neprozirnom bijelom kapicom i neprozirnim bijelim tijelom te oznakom „GR 1.5“ otisnutom crnom tintom na tijelu kapsule.
English: Reagila 4.5 mg hard capsules ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Croatian: Tvrda želatinska kapsula veličine „4“ (približne duljine 14,3 mm) s neprozirnom zelenom kapicom i neprozirnim zelenim tijelom te oznakom „GR 4.5“ otisnutom bijelom tintom na tijelu kapsule.
English: België/Belgique/Belgien Recordati BVBA Tél/Tel: +32 2 46101 36
Croatian: Tél/Tel: +32 2 46101 36
English: Pregnancy, puerperium and perinatal conditions
Croatian: Stanja vezana za trudnoću, babinje i perinatalno razdoblje sindrom ustezanja od lijeka u novorođenčadi
English: Reagila 6 mg hard capsules ‘Size 3' (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink.
Croatian: Tvrda želatinska kapsula veličine „3“ (približne duljine 15,9 mm) s neprozirnom ljubičastom kapicom i neprozirnim bijelim tijelom te oznakom „GR 6“ otisnutom crnom tintom na tijelu kapsule.
English: Baseline Mean ± SD
Croatian: ± SD
English: This means that the effects of these components in Odefsey should be similar to their effects in other medicines.
Croatian: To znači da bi učinci tih komponenti u lijeku Odefsey trebali biti slični njihovim učincima u drugim lijekovima.
English: The full EPAR for Odefsey can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Odefsey nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Odefsey contains three active substances.
Croatian: Lijek Odefsey sadrži tri djelatne tvari.
English: Other information about Odefsey
Croatian: Ostale informacije o lijeku Odefsey
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje treba započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: This is a summary of the European public assessment report (EPAR) for Odefsey.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Odefsey.
English: It is not intended to provide practical advice on how to use Odefsey.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Odefsey.
English: Odefsey does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Lijek Odefsey ne liječi infekciju virusom HIV-1 ni AIDS, no može odgoditi oštećenje imunološkog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: What measures are being taken to ensure the safe and effective use of Odefsey?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Odefsey?
English: • dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) except when used as a single dose treatment;
Croatian: • deksametazon (kortikosteroidni lijek koji se koristi za liječenje upala i suprimiranje imunološkog sustava), osim kod liječenja primjenom jednokratne doze;
English: Why is Odefsey approved?
Croatian: Zašto je Odefsey odobren?
English: • rifabutin, rifampicin, rifapentine (antibiotics);
Croatian: • rifabutin, rifampicin i rifapentin (antibiotici);
English: Odefsey must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Odefsey:
Croatian: Lijek Odefsey ne smije se koristiti sa sljedećim lijekovima jer oni mogu uzrokovati smanjenje koncentracije rilpivirina u krvi te tako smanjiti i djelotvornost lijeka Odefsey:
English: What is Odefsey and what is it used for?
Croatian: Što je Odefsey i za što se koristi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Odefsey is an alternative treatment option to Eviplera with similar effectiveness.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je lijek Odefsey alternativno rješenje za liječenje lijekom Eviplera koji je slične djelotvornosti.
English: The CHMP therefore decided that Odefsey's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je CHMP odlučio da koristi od lijeka Odefsey nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: Odefsey is an antiviral medicine used to treat adults and adolescents (aged over 12 years and weighing at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Odefsey je antivirusni lijek koji se koristi za liječenje odraslih osoba i adolescenata (starijih od 12 godina čija tjelesna težina iznosi najmanje 35 kg) zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Odefsey have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza koje zdravstveni djelatnici i bolesnici trebaju poštovati radi sigurne i učinkovite uporabe lijeka Odefsey nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: All three active substances block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected.
Croatian: Sve tri djelatne tvari onemogućuju djelovanje reverzne transkriptaze, virusnog enzima koji omogućuje replikaciju virusa HIV-1 u zaraženim stanicama.
English: Very common side effects with rilpivirine also include increased cholesterol levels (total cholesterol and LDL-cholesterol), insomnia (difficulty sleeping) and increased liver and pancreas enzymes.
Croatian: Vrlo česte nuspojave rilpivirina također su povišena razina kolesterola (ukupni kolesterol i LDL-kolesterol), nesanica (teškoće sa spavanjem) i povišene razine enzima jetre i gušterače.
English: It is only used in patients where the virus has not developed resistance to a class of HIV medicines called nonnucleoside reverse transcriptase inhibitors, tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Croatian: Koristi se samo u bolesnika kod kojih virus nije razvio rezistenciju na klasu lijekova za HIV koji se nazivaju inhibitori nenukleozidne reverzne transkriptaze, tenofovir ili emtricitabin, i kod kojih razina HIV-a u krvi (virusno opterećenje) nije veće od 100 000 HIV-1 RNK kopija/ml.
English: Odefsey is available as tablets, each containing 200 mg emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide.
Croatian: Lijek Odefsey dostupan je u obliku tableta koje sadrže 200 mg emtricitabina, 25 mg rilpivirina i 25 mg tenofoviralafenamida.
English: By blocking this enzyme, Odefsey reduces the amount of HIV-1 in the blood and keeps it at a low level.
Croatian: Onemogućivanjem djelovanja reverzne transkriptaze, lijek Odefsey smanjuje količinu virusa HIV-1 u krvi i održava je na niskoj razini.
English: For more information about treatment with Odefsey, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Odefsey pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: To support the use of tenofovir alafenamide, the company provided data from studies showing that combination medicines containing tenofovir alafenamide are as effective in reducing the amount of HIV-1 in the blood as those containing tenofovir disoproxil.
Croatian: Kako bi se dokazale koristi od primjene tenofoviralafenamida, tvrtka je dostavila podatke iz ispitivanja koja pokazuju da su kombinacije lijekova koje sadrže tenofoviralafenamid jednako djelotvorne u smanjivanju količine virusa HIV-1 u krvi kao i one koje sadrže tenofovirdizoproksil.
English: What are the risks associated with Odefsey?
Croatian: Koji su rizici povezani s lijekom Odefsey?
English: In terms of safety, tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil and may lead to reduced side effects in the kidneys and bones.
Croatian: U pogledu sigurnosti, tenofoviralafenamid je učinkovit pri manjoj dozi u odnosu na tenofovirdizoproksil i mogao bi imati blaže nuspojave povezane s bubrezima i kostima.
English: Odefsey emtricitabine / rilpivirine / tenofovir alafenamide
Croatian: Odefsey emtricitabin/rilpivirin/tenofoviralafenamid
English: The combination of active substances in Odefsey (emtricitabine, rilpivirine and tenofovir) is already approved in the EU as Eviplera to treat HIV-1 infection, although in Eviplera tenofovir is present as tenofovir disoproxil whereas in Odefsey it is present as tenofovir alafenamide.
Croatian: Kombinacija djelatnih tvari u lijeku Odefsey (emtricitabin, rilpivirin i tenofovir) već je odobrena u EU-u pod nazivom Eviplera za liječenje infekcije virusom HIV-1, iako je tenofovir u lijeku Eviplera prisutan kao tenofovirdizoproksil, a u lijeku Odefsey kao tenofoviralafenamid.
English: In addition, to support its application, the company performed a ‘bioequivalence' study comparing Odefsey with two other HIV medicines: Edurant (rilpivirine) and Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide).
Croatian: Kako bi poduprla svoj zahtjev, tvrtka je, osim toga, provela ispitivanje „bioekvivalencije” u kojem je usporedila lijek Odefsey s drugim dvama lijekovima za liječenje HIV-a, lijekom Edurant (rilpivirin) i lijekom Genvoya (elvitegravir, kobicistatom, emtricitabin i tenofoviralafenamid).
English: Rilpivirine is an antiviral agent called non-nucleoside reverse transcriptase inhibitor.
Croatian: Rilpivirin je antivirusni agens koji se naziva inhibitor nenukleozidne reverzne transkriptaze.
English: The most common side effects seen with the active substance rilpivirine and with the combination of emtricitabine and tenofovir alafenamide (which may affect more than 1 in 10 people) are headache, dizziness and nausea (feeling sick).
Croatian: Najčešće su zabilježene nuspojave djelatne tvari rilpivirina i kombinacije s emtricitabinom i tenofoviralafenamidom (mogu se javiti u više od 1 na 10 osoba) glavobolja, omaglica i mučnina (osjećaj slabosti).
English: • omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole (medicines for reducing stomach acid);
Croatian: • omeprazol, esomeprazol, dekslanzoprazol, lanzoprazol, pantoprazol, rabeprazol (lijekovi za smanjenje želučane kiseline);
English: • St John's wort (a herbal preparation used for depression and anxiety).
Croatian: • gospina trava (biljni pripravak za liječenje depresije i anksioznosti).
English: This study showed that Odefsey produces the same levels of rilpivirine in the body as Edurant, and the same levels of emtricitabine and tenofovir alafenamide as Genvoya.
Croatian: U tom je ispitivanje utvrđeno da lijek Odefsey proizvodi istu razinu rilpivirina u tijelu kao i lijek Edurnat te iste razine emtricitabina i tenofoviralafenamida kao lijek Genvoya.
English: For practical information about using Odefsey, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Odefsey pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How does Odefsey work?
Croatian: Kako djeluje Odefsey?
English: What benefits of Odefsey have been shown in studies?
Croatian: Koje su koristi lijeka Odefsey utvrđene u ispitivanjima?
English: How is Odefsey used?
Croatian: Kako se Odefsey koristi?
English: Odefsey contains the active substances emtricitabine, rilpivirine and tenofovir alafenamide.
Croatian: Lijek Odefsey sadrži djelatne tvari emtricitabin, rilpivirin, tenofovir i alafenamid.
English: Invented name Strength
Croatian: Broj EU odobrenja Zaštićeno ime
English: Bottle (glass type III)
Croatian: U vodi za piće Bočica ( stakle tipa III)
English: 4 litres 1 bottle Meat and offal: 14 days
Croatian: 1 bočica Meso i iznutrice: 14 dana
English: 1 litre
Croatian: 1 litra 1 bočica
English: This may happen:
Croatian: To se može dogoditi:
English: Date of last renewal: 23 July 2008
Croatian: Datum posljednje obnove: 23. srpnja 2008.
English: • If you are under 18 or over 75 years of age.
Croatian: • Ako ste mlađi od 18 ili stariji od 75 godina.
English: Please ask your doctor whether you can drive a car if you:
Croatian: Upitajte svog liječnika smijete li upravljati vozilom ako:
English: Prandin may not be suitable for you.
Croatian: Prandin Vam možda neće odgovarati.
English: Be aware that the desired effect is not achieved if you stop taking Prandin.
Croatian: Imajte na umu da željeni učinak nije postignut ako prestanete uzimati Prandin.
English: Possible interactions should therefore be taken into account by the physician:
Croatian: Stoga liječnik mora uzeti u obzir moguće interakcije:
English: • If you have an infection or a fever
Croatian: • ako imate infekciju ili vrućicu
English: What Prandin is and what it is used for
Croatian: Što je Prandin i za što se koristi
English: Four blister pack sizes are available.
Croatian: Dostupne su četiri veličine blister pakiranja.
English: If you miss a dose, take the next dose as usual - do not double the dose.
Croatian: Ako zaboravite uzeti dozu, uzmite sljedeću dozu kao obično - nemojte uzeti dvostruku dozu.
English: Prandin with alcohol
Croatian: Prandin s alkoholom
English: Your body's response to Prandin may change if you take other medicines, especially these:
Croatian: Reakcija tijela na Prandin može se promijeniti ako uzimate druge lijekove, posebice ove:
English: • If you are about to have major surgery or you have recently suffered a severe illness or infection.
Croatian: • Ako se spremate na veći operativni zahvat ili ste nedavno preboljeli ozbiljniju bolest ili infekciju.
English: Warnings and precautions Talk to your doctor before taking Prandin:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego uzmete Prandin:
English: Do not take more Prandin than your doctor has recommended.
Croatian: Nemojte uzeti više lijeka Prandin nego što Vam je preporučio liječnik.
English: They must not give you any food or drink.
Croatian: Oni Vam ne smiju davati nikakvu hranu ni piće jer biste se mogli ugušiti.
English: The safety and efficacy of repaglinide in children below 18 years have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost repaglinida u djece mlađe od 18 godina nisu još ustanovljene.
English: • Diabetes mellitus type 1, C-peptide negative.
Croatian: • Šećerna bolest tipa 1, C-peptid negativan.
English: Repaglinide should be taken before main meals (i.e. preprandially).
Croatian: Repaglinid je potrebno uzimati prije glavnih obroka (tj. preprandijalno).
English: Paediatric population No data are available.
Croatian: Pedijatrijska populacija Nema dostupnih podataka.
English: • If you exercise less than usual.
Croatian: • ako vježbate manje nego obično.
English: Other medicines and Prandin
Croatian: Drugi lijekovi i Prandin
English: Tell people you have diabetes and that if you pass out (become unconscious) due to a hypo, they must turn you on your side and get medical help straight away.
Croatian: Recite ljudima da imate šećernu bolest i da Vas, ako se onesvijestite (izgubite svijest) zbog hipoglikemije, moraju okrenuti na bok i odmah zatražiti medicinsku pomoć.
English: • If you take other medicines or suffer from liver or kidney problems (see other sections of 2.
Croatian: • ako uzimate druge lijekove ili imate problema s jetrom ili bubrezima (vidjeti ostale odjeljke dijela 2.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known
Croatian: Učestalost je definirana kao: često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti na temelju dostupnih podataka).
English: Prandin should not be taken if you have a severe liver disease (see Do not take Prandin).
Croatian: Prandin ne smijete uzimati ako imate tešku bolest jetre (vidjeti Nemojte uzimati
English: • If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent)
Croatian: • Ako se teška hipoglikemija ne liječi, ona može uzrokovati oštećenje mozga (privremeno ili trajno) pa čak i smrt.
English: What Prandin looks like and contents of the pack
Croatian: Kako Prandin izgleda i sadržaj pakiranja
English: • If you are allergic to repaglinide or any of the other ingredients in this medicine (listed in section 6).
Croatian: • ako ste alergični na repaglinid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Prandin has no direct influence on the ability to drive and use machines but may cause hypoglycaemia.
Croatian: Prandin nema izravnog učinka na sposobnost upravljanja vozilima i rada sa strojevima, ali može uzrokovati hipoglikemiju.
English: 30 tablets 90 tablets 120 tablets 270 tablets
Croatian: 30 tableta 90 tableta 120 tableta 270 tableta
English: • If you eat more than usual
Croatian: • ako jedete više nego obično
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 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti lijeka Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: Your doctor will work out your dose.
Croatian: Liječnik će Vam odrediti dozu.