FrancophonIA/ELRC3.0 huggingface dataset:
English: * see section Description of selected adverse reactions below Description of selected adverse reactions Allergic reactions
Croatian: Opis odabranih nuspojava Alergijske reakcije
English: NAME OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Novo Nordisk A/S
English: In an interaction study with healthy volunteers, co-administration of deferasirox (30 mg/kg/day, 4 days), a moderate inhibitor of CYP2C8 and CYP3A4, and repaglinide (single dose, 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold (90% CI [2.03-2.63]) of control, a 1.6-fold (90% CI [1.42-1.84]) increase in Cmax, and a small, significant decrease in blood glucose values.
Croatian: U ispitivanju interakcija u zdravih dobrovoljaca, istodobna primjena deferasiroksa (30 mg/kg/dan, 4 dana), umjerenog inhibitora CYP2C8 i CYP3A4 i repaglinida (pojedinačna doza od 0,5 mg) rezultirala je povećanjem sistemske izloženosti repaglinidu (AUC) za 2,3 puta (90% CI [2,03-2,63]) u odnosu na kontrolnu skupinu, povećanjem Cmax za 1,6 puta (90% CI [1,42-1,84]) i malim, ali značajnim sniženjem razine glukoze u krvi.
English: • Deferasirox (used to reduce chronic iron overload)
Croatian: • deferasiroks (koristi se za snižavanje kroničnog preopterećenja željezom) • klopidogrel (sprječava zgrušavanje krvi)
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)
English: Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Denmark.
Croatian: Novo Allé, DK-2880 Bagsværd, Danska Ova uputa je zadnji puta revidirana u Drugi izvori informacija
English: • Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
Croatian: • fenitoin, karbamazepin, fenobarbital (koriste se za liječenje epilepsije) • gospina trava (biljni lijek).
English: Concomitant use of rifampicin and repaglinide might therefore induce a need for repaglinide dose adjustment which should be based on carefully monitored blood glucose concentrations at both initiation of rifampicin treatment (acute inhibition), following dosing (mixed inhibition and induction), withdrawal (induction alone) and up to approximately two weeks after withdrawal of rifampicin where the inductive effect of rifampicin is no longer present.
Croatian: Istodobna primjena rifampicina i repaglinida stoga može zahtijevati prilagodbu doze repaglinida, što treba činiti na osnovi pomnog praćenja koncentracije glukoze u krvi pri uvođenju terapije rifampicinom (akutna inhibicija),
English: INFORMATION IN BRAILLE prandin 0.5 mg
Croatian: prandin 0,5 mg
English: In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
Croatian: U ispitivanju provedenom na zdravim dobrovoljcima, istodobna primjena repaglinida (pojedinačna doza od 0,25 mg) i ciklosporina (ponovljena doza od 100 mg) povećala je AUC repaglinida otprilike 2,5 puta i Cmax otprilike 1,8 puta.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Oral use
Croatian: NAČIN I PUT PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: In an interaction study in healthy volunteers, coadministration of 250 mg clarithromycin, a potent mechanism-based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
Croatian: Istodobna primjena 250 mg klaritromicina, snažnog inhibitora CYP3A4, u ispitivanju interakcija provedenom na zdravim dobrovoljcima neznatno je povećala AUC repaglinida 1,4 puta i Cmax 1,7 puta te povećala srednju vrijednost AUC inzulina u serumu 1,5 puta i maksimalnu koncentraciju 1,6 puta.
English: MARKETING AUTHORISATION NUMBERS EU/1/00/162/009-11, EU/1/00/162/020
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/162/009-11, EU/1/00/162/020
English: A dose-dependent decrease in blood glucose was demonstrated in type 2 diabetic patients when administered in doses from 0.5 to 4 mg repaglinide.
Croatian: Klinička djelotvornost i sigurnost U bolesnika sa šećernom bolešću tipa 2, sniženje razine glukoze u krvi ovisno o dozi lijeka potvrđeno je pri dozama repaglinida od 0,5 do 4 mg.
English: • Have frequent hypos
Croatian: • imate česte hipoglikemije
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 1 mg of repaglinide
Croatian: NAVOĐENJE DJELATNE TVARI Svaka tableta sadrži 1 mg repaglinida.
English: • Gemfibrozil (used to treat high blood fats)
Croatian: • gemfibrozil (koristi se za snižavanje povišenih masnoća u krvi)
English: INFORMATION IN BRAILLE prandin 2 mg
Croatian: prandin 2 mg
English: • ACE-inhibitors (used to treat heart conditions)
Croatian: • ACE inhibitore (koriste se za liječenje bolesti srca)
English: Poloxamer
Croatian: Polakrilinkalij
English: Elderly No clinical studies have been conducted in patients >75 years of age.
Croatian: Nisu provedena klinička ispitivanja u bolesnika u dobi
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg of repaglinide.
Croatian: Svaka tableta sadrži 0,5 mg repaglinida.
English: How to store Prandin
Croatian: Moguće nuspojave Kako čuvati Prandin
English: EU/1/00/162/009 30 tablets EU/1/00/162/010 90 tablets EU/1/00/162/011 120 tablets EU/1/00/162/020 270 tablets
Croatian: EU/1/00/162/009 30 tableta EU/1/00/162/010 90 tableta EU/1/00/162/011 120 tableta EU/1/00/162/020 270 tableta
English: INFORMATION IN BRAILLE prandin 1 mg
Croatian: prandin 1 mg
English: Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Croatian: Istodobna primjena gemfibrozila (600 mg dva puta dnevno), inhibitora CYP2C8 i repaglinida (pojedinačna doza od 0,25 mg) u zdravih dobrovoljaca povećava AUC repaglinida 8,1 puta i Cmax 2,4 puta.
English: MARKETING AUTHORISATION NUMBERS EU/1/00/162/015-17, EU/1/00/162/019
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/162/015-17, EU/1/00/162/019
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: MARKETING AUTHORISATION NUMBERS EU/1/00/162/003-005, EU/1/00/162/021
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/162/003-005, EU/1/00/162/021
English: • If you have kidney problems.
Croatian: • Ako imate problema s bubrezima.
English: They include: increased urination; feeling thirsty; dry skin and dry mouth.
Croatian: Znakovi koji upozoravaju na visoku razinu šećera u krvi javljaju se postupno, a uključuju: povećano mokrenje, osjećaj žeđi, suhu kožu i suha usta.
English: Meglumine
Croatian: Mučnina
English: EU/1/00/162/015 30 tablets EU/1/00/162/016 90 tablets EU/1/00/162/017 120 tablets EU/1/00/162/019 270 tablets
Croatian: EU/1/00/162/015 30 tableta EU/1/00/162/016 90 tableta EU/1/00/162/017 120 tableta EU/1/00/162/019 270 tableta
English: Magnesium stearate
Croatian: Magnezijev stearat Meglumin Poloksamer
English: Pharmaco-therapeutic group: Drugs used in diabetes, other blood glucose lowering drugs, excl. insulins, ATC code: A10BX02
Croatian: Farmakoterapijska skupina: lijekovi za liječenje šećerne bolesti, drugi lijekovi za snižavanje razine glukoze u krvi, osim inzulina.
English: Prandin 0.5 mg tablets Prandin 1 mg tablets Prandin 2 mg tablets
Croatian: Uputa o lijeku: Informacije za korisnika Prandin 0,5 mg tablete Prandin 1 mg tablete Prandin 2 mg tablete repaglinid
English: NAME OF THE MEDICINAL PRODUCT Prandin 0.5 mg tablets
Croatian: Prandin 0,5 mg tablete
English: Concomitant use
Croatian: Istodobna primjena
English: EU/1/00/162/003 30 tablets EU/1/00/162/004 90 tablets EU/1/00/162/005 120 tablets EU/1/00/162/021 270 tablets
Croatian: EU/1/00/162/004 90 tableta EU/1/00/162/005 120 tableta EU/1/00/162/021 270 tableta
English: Prandin 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: Abdominal pain, diarrhoea Common Vomiting, constipation Very rare Nausea
Croatian: Poremećaji probavnog sustava Bol u abdomenu, proljev
English: N/A
Croatian: A.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of repaglinide.
Croatian: Svaka tableta sadrži 2 mg repaglinida.
English: NAME OF THE MEDICINAL PRODUCT Prandin 2 mg tablets
Croatian: Prandin 2 mg tablete
English: Clinical data in healthy volunteers support CYP2C8 as being the most important enzyme involved in repaglinide metabolism with CYP3A4 playing a minor role, but the relative contribution of CYP3A4
Croatian: Klinički podaci u zdravih dobrovoljaca ukazuju da je CYP2C8 najvažniji enzim metabolizma repaglinida.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of repaglinide.
Croatian: Svaka tableta sadrži 1 mg repaglinida.
English: Repaglinide tablets are yellow, round and convex and engraved with Novo Nordisk logo (Apis bull).
Croatian: Tablete repaglinida su žute boje, okrugle i konveksne s utisnutim zaštitnim znakom tvrtke Novo Nordisk (Apis bik).
English: Repaglinide tablets are white, round and convex and engraved with Novo Nordisk logo (Apis bull).
Croatian: Tablete repaglinida su bijele boje, okrugle i konveksne s utisnutim zaštitnim znakom tvrtke Novo Nordisk (Apis bik).
English: Since the safety profile of this combination has not been established with dosages higher than 0.25 mg for repaglinide and 320 mg for trimethoprim, the concomitant use of trimethoprim with repaglinide should be avoided.
Croatian: 320 mg trimetoprima, istodobnu primjenu trimetoprima s repaglinidom treba izbjegavati.
English: Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided.
Croatian: 0,25 mg, istodobnu primjenu ciklosporina i repaglinida treba izbjegavati.
English: Rare (may affect up to 1 in 1,000 patients) • Acute coronary syndrome (but it may not be due to the medicine).
Croatian: • akutni koronarni sindrom (možda nije uzrokovan lijekom).
English: Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull).
Croatian: Tablete repaglinida su boje breskve, okrugle i konveksne s utisnutim zaštitnim znakom tvrtke Novo Nordisk (Apis bik).
English: Prandin tablets are round and convex and engraved with the Novo Nordisk logo (Apis bull).
Croatian: Prandin tablete su okrugle i ispupčene s utisnutim zaštitnim znakom tvrtke Novo Nordisk (Apis bik).
English: Common (may affect up to 1 in 10 patients)
Croatian: Druge nuspojave Često (mogu se javiti u do 1 na 10 bolesnika)
English: • Danazol (used to treat breast cysts and endometriosis)
Croatian: • danazol (koristi se za liječenje cista na dojci i endometrioze) • hormone štitnjače (koriste se za liječenje niske razine hormona štitnjače)
English: Repaglinide
Croatian: Doziranje
English: NAME OF THE MEDICINAL PRODUCT Prandin 1 mg tablets
Croatian: Prandin 1 mg tablete
English: What Prandin is and what it is used for What you need to know before you take Prandin How to take Prandin
Croatian: Što morate znati prije nego počnete uzimati Prandin Nemojte uzimati Prandin
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Prevalence %
Croatian: Prevalencija %
English: Estimates indicate that up to 7% of the Caucasian population may have this deficiency.
Croatian: Procjene ukazuju da do 7% bjelačke populacije može imati ovaj nedostatak.
English: “Children with compromised respiratory function
Croatian: “Djeca s kompromitiranom respiratornom funkcijom
English: African/Ethiopian African American
Croatian: afrička/etiopska afroamerička azijska bjelačka grčka mađarska sjevernoeuropska
English: “Paediatric population:
Croatian: “Pedijatrijska populacija:
English: These factors may worsen symptoms of morphine toxicity.”
Croatian: Ti čimbenici mogu pogoršati simptome toksičnosti morfina."
English: Some people have a variation of this enzyme and this can affect people in different ways.
Croatian: Neke osobe imaju varijaciju ovog enzima, što na različite načine može utjecati na njih.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Informacije o lijeku mogu se naknadno ažurirati od strane nadležnih tijela država članica, u suradnji s referentnom državom članicom, na odgovarajući način, te u skladu s postupcima opisanim u Poglavlju 4 Dijela III Direktive 2001/83/EC.
English: If a patient has a deficiency or is completely lacking this enzyme an adequate therapeutic effect will not be obtained.
Croatian: Ako bolesnik ima nedostatak ili mu u potpunosti manjka ovaj enzim, neće biti moguće postići odgovarajući terapijski učinak.
English: Section 2 - What you need to know before you <take> <use> <product name>
Croatian: Dio 2 - Što morate znati prije nego počnete <uzimati> <primjenjivati> <zaštićeni naziv>
English: Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:
Croatian: Procjene prevalencije vrlo brzih metabolizatora u različitim populacijama sažete su u nastavku:
English: Codeine and morphine passes into breast milk.”
Croatian: Kodein i morfin prolaze u majčino mlijeko."
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Croatian: Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti <liječnika> <ili> <,> <ljekarnika> < ili medicinsku sestru>.
English: SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA (SmPC) [Za sve lijekove u Dodatku I, izmijenit će se postojeće informacije o lijeku (umetanje, zamjena ili brisanje teksta, na odgovarajući način) kako bi dogovoreni tekst bio naveden kao u nastavku]
English: Section 4 - Possible side effects
Croatian: Dio 4 - Moguće nuspojave
English: In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.
Croatian: U teškim slučajevima to može uključivati simptome cirkulatorne i respiratorne depresije koje mogu ugrožavati život i u vrlo rijetkim slučajevima biti smrtonosne.
English: • “In children below the age of 12 years due to an increased risk of developing serious and lifethreatening adverse reactions.
Croatian: • “U djece mlađe od 12 godina zbog povećanog rizika od razvoja ozbiljnih i po život opasnih nuspojava.
English: Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
Croatian: Primjena kodeina se ne preporučuje u djece u koje postoji mogućnost kompromitirane respiratorne funkcije uključujući neuromuskularne poremećaje, teška srčana ili respiratorna stanja, infekcije gornjih dišnih putova ili pluća, višestruke traume ili opsežne kirurške zahvate.
English: Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite.
Croatian: Kodein se metabolizira putem jetrenog enzima CYP2D6 u morfin, njegov aktivni metabolit.
English: However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses.
Croatian: Međutim, ako je bolesnik brzi ili vrlo brzi metabolizator, postoji povećani rizik od razvoja nuspojava toksičnosti opioida čak i kod uobičajeno propisivanih doza.
English: At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
Croatian: Pri normalnim terapijskim dozama, kodein i njegov aktivni metabolit mogu biti prisutni u majčinom mlijeku pri vrlo niskim dozama te se ne smatra vjerojatnim da imaju štetan učinak na dojenčad.
English: Do not <take> <use> <product name>: “If you are under 12 years old” “If you know that you metabolise very rapidly codeine into morphine” “If you are breastfeeding”
Croatian: Nemojte <uzimati> <primjenjivati> <zaštićeni naziv>: “Ako ste mlađi od 12 godina” “Ako vam je poznato da vrlo brzo metabolizirate kodein u morfin” “Ako dojite”
English: If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
Croatian: Ako primijetite neku od sljedećih nuspojava, morate prestati uzimati ovaj lijek i odmah potražiti liječničku pomoć: sporo ili plitko disanje, smetenost, pospanost, sužene zjenice, mučnina ili povraćanje, zatvor, pomanjkanje apetita.
English: These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
Croatian: Ti bolesnici brzo pretvaraju kodein u morfin, što rezultira višim vrijednostima morfina u serumu od očekivanih.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V*.
English: “CYP2D6 metabolism
Croatian: “Metabolizam putem CYP2D6
English: • “In women during breastfeeding (see section 4.6)”
Croatian: • “U dojilja (vidjeti dio 4.6)”
English: Other people are more likely to get serious side effects because a very high amount of morphine is produced.
Croatian: Druge osobe sklonije su ozbiljnim nuspojavama zbog velike količine nastalog morfina.
English: PACKAGE LEAFLET (PL) [The following wording should be included in the package leaflet of the marketing authorisations:]
Croatian: UPUTA O LIJEKU (PL) [Potrebno je uključiti sljedeći tekst u uputu o lijeku odobrenja za stavljanje lijeka u promet:]
English: General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite.
Croatian: Opći simptomi toksičnosti opioida uključuju konfuziju, somnolenciju, plitko disanje, sužene zjenice, mučninu, povraćanje, zatvor i gubitak apetita.
English: In some people, morphine is not produced or produced in very small quantities, and it will not have an effect on their cough symptoms.
Croatian: U pojedinaca morfin se ne stvara ili se stvara u vrlo malim količinama, i to neće utjecati na njihove simptome kašlja.
English: However, if the patient is an ultrarapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.”
Croatian: Međutim, ako je bolesnica vrlo brzi metabolizator enzima CYP2D6, u majčinom mlijeku mogu biti prisutne više razine aktivnog metabolita morfina te u vrlo rijetkim slučajevima mogu rezultirati simptomima toksičnosti opioida u dojenčadi, što može biti smrtonosno."
English: In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief or relieve their cough.
Croatian: U pojedinaca morfin se ne stvara ili se stvara u vrlo malim količinama te neće osigurati dovoljno ublažavanje boli ili kašlja.
English: These amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are the outcome of the referral procedure.
Croatian: Ove izmjene odgovarajućih dijelova sažetka opisa svojstava lijeka i upute o lijeku ishod su arbitražnog postupka.
English: Morphine is the substance that produces the effects of codeine and relieves pain and symptoms of cough.
Croatian: Morfin je tvar odgovorna za učinke kodeina te ublažava bol i simptome kašlja.
English: “Codeine is transformed to morphine in the liver by an enzyme.
Croatian: “Kodein se putem enzima u jetri pretvara u morfin.
English: • “In women during breastfeeding (see section 4.6)” • “In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers”
Croatian: • “U dojilja (vidjeti dio 4.6)” • “U bolesnika za koje je poznato da su vrlo brzi metabolizatori CYP2D6”
English: “Do not take <codeine><Product name (if a combination product)> while you are breastfeeding.
Croatian: “Nemojte uzimati <kodein><Naziv lijeka (ako je kombinirani lijek)> tijekom razdoblja dojenja.
English: Morphine is the substance that produces the effects of codeine.
Croatian: Morfin je tvar odgovorna za učinke kodeina.
English: Annex III Amendments to relevant sections of the product information
Croatian: Izmjene određenih dijelova informacija o lijeku
English: Section 4.2 - Posology and method of administration [Note: For products authorised in the cough and/or cold indication only:]
Croatian: Dio 4.2 - Doziranje i način primjene [Napomena: Za lijekove odobrene samo u indikaciji kašlja i/ili prehlade:]
English: “<Codeine><Product name (if a combination product)> is contraindicated in women during breastfeeding (see section 4.3).
Croatian: “<Kodein><Naziv lijeka (ako je kombinirani lijek)> je kontraindiciran u žena tijekom razdoblja dojenja (vidjeti dio 4.3).
English: [Note: For products authorised in the cough and/or cold and pain indications:]
Croatian: [Napomena: Za lijekove odobrene u indikacijama kašlja i/ili prehlade i boli:]
English: • “In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers”
Croatian: • “U bolesnika za koje je poznato da su vrlo brzi metabolizatori CYP2D6” [Napomena: Za lijekove odobrene u indikacijama kašlja i/ili prehlade i boli:]
English: Children aged less than 12 years: <Codeine><product name (if a combination products)> is contraindicated in children below the age of 12 years (see sections 4.3).
Croatian: Djeca mlađa od 12 godina: <Kodein><Naziv lijeka (ako je kombinirani lijek)> je kontraindiciran u djece mlađe od 12 godina (vidjeti dio 4.3).
English: Adolescents older than 12 years of age <Codeine><Product name (if a combination product)> is not recommended in adolescents with compromised respiratory function for the treatment of <cough><and/or><cold>1.
Croatian: Adolescenti stariji od 12 godina <Kodein><Naziv lijeka (ako je kombinirani lijek)> se ne preporučuje u adolescenata s kompromitiranom respiratornom funkcijom za liječenje <kašlja><i/ili><prehlade>1.
English: “Reporting of suspected adverse reactions
Croatian: „Prijavljivanje nuspojava
English: Children aged 12 years to 18 years <Codeine><Product name (if a combination product)> is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of <cough><and/or><cold>1 (see section 4.4).”
Croatian: Djeca u dobi od 12 do 18 godina <Kodein> < Naziv lijeka (ako je kombinirani lijek)> se ne preporučuje za primjenu u djece od 12 do 18 godina s kompromitiranom respiratornom funkcijom za simptomatsko liječenje <kašlja><i/ili><prehlade>1 (vidjeti dio 4.4).”
English: “Reporting of side effects
Croatian: “Prijavljivanje nuspojava
English: Children aged less than 12 years: <Codeine><Product name (if a combination product)> is contraindicated in children below the age of 12 years for the symptomatic treatment of <cough><and/or><cold>1see sections 4.3).
Croatian: Djeca mlađa od 12 godina: <Kodein> < Naziv lijeka (ako je kombinirani lijek)> je kontraindiciran u djece mlađe od 12 godina za simptomatsko liječenje <kašlja><i/ili><prehlade>4 vidjeti dio 4.3).