FrancophonIA/ELRC3.0 huggingface dataset:
English: ELOCTA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU efmoroctocog alfa.
Slovenian: ELOCTA 1500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1500 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: Table 3: Pharmacokinetic parameters of ELOCTA using the one-stage clotting assay Pharmacokinetic parameters1
Slovenian: Preglednica 3: Farmakokinetični parametri zdravila ELOCTA, pridobljeni z enostopenjskim strjevalnim preskusom
English: The prepared solution will be clear to slightly opalescent and colourless.
Slovenian: Pripravljena raztopina mora biti bistra do rahlo motna in brezbarvna.
English: Table 6: Pharmacokinetic parameters of ELOCTA for paediatrics using the chromogenic assay Pharmacokinetic parameters1
Slovenian: Preglednica 6: Farmakokinetični parametri zdravila ELOCTA za pediatrično populacijo,
English: ELOCTA 5000 IU powder and solvent for solution for injection Each vial contains nominally 5000 IU efmoroctocog alfa.
Slovenian: ELOCTA 5000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 5000 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa recombinant coagulation factor VIII, Fc fusion protein
Slovenian: ELOCTA 250 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 500 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 750 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 1000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 1500 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 2000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 3000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 4000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 5000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 6000 i.e. prašek in vehikel za raztopino za injiciranje efmoroctocogum alfa rekombinantni koagulacijski faktor VIII, fuzijska beljakovina Fc
English: ELOCTA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU efmoroctocog alfa.
Slovenian: ELOCTA 3000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 3000 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: After reconstitution, each mL of solution for injection contains approximately 1000 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 1000 i.e. efmoroktokoga alfa.
English: After reconstitution, each mL of solution for injection contains approximately 500 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 500 i.e. efmoroktokoga alfa.
English: After reconstitution, each mL of solution for injection contains approximately 167 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 167 i.e. efmoroktokoga alfa.
English: Median annual factor consumption was 4700 IU/kg (min 3819, max 8230 IU/kg) in Study II and 4990 IU/kg (min 3856, max 9527) in Study III.
Slovenian: Profilaksa, starost od 6 do 12 let: Mediani interval odmerka je bil 3,49 dni v študiji II in 3,50 dni v študiji III. Mediana letna poraba faktorja je bila 4.700 i.e./kg (najmanj 3.819, največ 8.230 i.e./kg) v študiji II in 4.990 i.e./kg (najmanj 3.856, največ 9.527) v študiji III.
English: ELOCTA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU efmoroctocog alfa.
Slovenian: ELOCTA 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: ELOCTA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU efmoroctocog alfa.
Slovenian: ELOCTA 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: Headache Dizziness Dysgeusia
Slovenian: Bolezni živčevja glavobol omotica disgevzija občasni
English: ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa (recombinant coagulation factor VIII)
Slovenian: ELOCTA 750 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 1000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 1500 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 2000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 3000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 4000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 5000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 6000 i.e. prašek in vehikel za raztopino za injiciranje efmoroktokog alfa (efmoroctocogum alfa) (rekombinantni koagulacijski faktor VIII)
English: Repeat injection every 12 to 24 hours for 3-4 days or more until pain and acute disability are resolved.
Slovenian: do 24 ur ali več, dokler bolečina in akutna nezmožnost ne izzvenita.
English: ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection
Slovenian: ELOCTA 250 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 500 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 750 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 1000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 1500 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 2000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 3000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 4000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 5000 i.e. prašek in vehikel za raztopino za injiciranje ELOCTA 6000 i.e. prašek in vehikel za raztopino za injiciranje
English: Feeling hot
Slovenian: NALEPKA NA VIALI
English: Median annual factor consumption was 5146 IU/kg (min 3695, max 8474) in Study II and 5418 IU/kg (min 3435, max 9564) in Study III.
Slovenian: Profilaksa, starost < 6 let: Mediani interval odmerka je bil 3,50 dni v študiji II in študiji III. Mediana letna poraba faktorja je bila 5.146 i.e./kg (najmanj 3.695, največ 8.474) v študiji II in 5.418 i.e./kg (najmanj 3.435, največ 9.564) v študiji III.
English: Table 5: Pharmacokinetic parameters of ELOCTA for paediatrics using the one-stage clotting assay Pharmacokinetic parameters1
Slovenian: Preglednica 5: Farmakokinetični parametri zdravila ELOCTA za pediatrično populacijo,
English: Uncommon (PTPs)1 Very common (PUPs)1
Slovenian: Bolezni krvi in limfatičnega sistema zaviranje faktorja VIII občasni (PZB)1 zelo pogosti (PNB)1
English: Abdominal pain, lower Uncommon
Slovenian: Bolezni prebavil bolečina v spodnjem delu trebuha občasni
English: Do not remove the adapter from its protective cap. Do not touch the inside of the vial adapter package.
Slovenian: Ne dotikajte se notranjosti pakiranja nastavka za vialo.
English: General disorders and administration site conditions Malaise Chest pain
Slovenian: Splošne težave in spremembe na mestu aplikacije splošno slabo počutje bolečina v prsnem košu občutek hladu občutek vročine občasni
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija mialgija bolečina v hrbtu oteklost sklepov občasni
English: D.
Slovenian: SN:
English: Cardiac disorders
Slovenian: Srčne bolezni bradikardija občasni
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration and applicant in the Member States
Slovenian: Seznam imen zdravil, farmacevtskih oblik, jakosti, poti uporabe in predlagateljev držav članic
English: Annex I
Slovenian: Aneks I
English: 28 June 2013 EMA/385716/2013
Slovenian: 28. junij 2013 EMA/385716/2013
English: The review was initiated on 3 October 2012, at the request of the United Kingdom medicines agency under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled se je začel dne 3. oktobra 2012 na zahtevo agencije za zdravila Združenega kraljestva v skladu s členom 31 Direktive 2001/83/ES.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Slovenian: Tel. +44 (0)20 7418 8427 Elektronski naslov: press@ema.europa.eu
English: • Codeine should be used at the lowest effective dose for the shortest period of time.
Slovenian: • Kodein je treba uporabljati pri najmanjšem učinkovitem odmerku za najkrajši možni čas.
English: The CMDh agreed with the PRAC's conclusions and endorsed the following recommendations:
Slovenian: Skupina CMDh se je strinjala z zaključki odbora PRAC in podprla naslednja priporočila:
English: It is also used in the treatment of coughs, although this use in not covered by the current review.
Slovenian: Prav tako se uporablja za zdravljenje kašlja, vendar tovrstna uporaba ni bila obravnavana v tem pregledu.
English: • If you or your child are being treated with codeine and have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Slovenian: • Če vi ali vaš otrok jemljete kodein in imate kakršna koli vprašanja ali pomisleke v zvezi z zdravljenjem, se posvetujte z zdravnikom ali farmacevtom.
English: After discussions, on 31 October 2012 the scope of the review was extended from post-surgery pain relief in children to pain relief in children.
Slovenian: Po razpravah so dne 31. oktobra 2012 obseg pregleda razširili z lajšanja bolečine po operaciji pri otrocih na lajšanje bolečine pri otrocih.
English: • The pharmacokinetic profile of codeine has been studied in adults but limited information is available in children.
Slovenian: • farmakokinetični profil kodeina so preučevali pri odraslih, medtem ko so pri otrocih na voljo omejeni podatki.
English: In the European Union (EU), codeinecontaining medicines have been approved via national procedures, and are available either on prescription or over the counter in the different Member States.
Slovenian: V Evropski uniji (EU) so bila zdravila, ki vsebujejo kodein, odobrena po nacionalnih postopkih in so v različnih državah članicah na voljo bodisi le na recept bodisi v prosti prodaji.
English: As the CMDh position was adopted by consensus, it will be directly implemented by the Member States.
Slovenian: Ker je skupina CMDh soglasno sprejela sklep, ga bodo neposredno izvajale države članice.
English: There also seems to be a particular risk in those paediatric patients who might already have compromised airways and who require pain relief following tonsillectomy and/or adenoidectomy.
Slovenian: Prav tako se zdi, da so še posebej ogroženi tisti pediatrični bolniki, ki morda že imajo prizadete dihalne poti in ki potrebujejo zdravilo proti bolečinam po tonzilektomiji in/ali adenoidektomiji;
English: The product information for codeine should also include general information for healthcare professionals, patients and carers on the risk of morphine side effects with codeine, and how to recognise their symptoms.
Slovenian: Prav tako bi bilo treba v informacije o zdravilih, ki vsebujejo kodein, vključiti splošne informacije za zdravstvene delavce, bolnike in skrbnike o tveganjih za neželene učinke morfina, povezanih z uporabo kodeina, in o tem, kako lahko prepoznajo njihove simptome.
English: The risk of side effects with codeine may also apply to adults.
Slovenian: Tveganje za neželene učinke pri uporabi kodeina obstaja tudi pri odraslih.
English: As codeine-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Slovenian: Ker so vsa zdravila, ki vsebujejo kodein, odobrena na nacionalni ravni, so bila priporočila odbora PRAC posredovana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončen sklep.
English: Nevertheless, it is considered that codeine still has a place in the treatment of acute pain in the paediatric population and given the concerns about its risks, it should only be used in line with the updated indication, contraindications, warnings and other changes to the product information described above.
Slovenian: Kljub temu velja, da je kodein še vedno primeren za zdravljenje akutne bolečine pri pediatrični populaciji, vendar se ga lahko zaradi zadržkov glede z njim povezanih tveganj uporablja samo ob upoštevanju posodobljene indikacije, kontraindikacij, opozoril in drugih sprememb informacij o zdravilu, opisanih zgoraj.
English: These recommendations follow a review of available safety and efficacy data on codeine when used for pain relief in children, including pharmacokinetic data, clinical studies, post-marketing data in Europe and other published literature:
Slovenian: Ta priporočila so bila sprejeta po preučitvi razpoložljivih podatkov o varnosti in učinkovitosti kodeina za lajšanje bolečine pri otrocih, vključno s farmakokinetičnimi podatki, kliničnimi študijami, podatki iz obdobja trženja v Evropi in drugo objavljeno literaturo:
English: • The product information of these medicines should carry a warning that children with conditions associated with breathing problems should not use codeine.
Slovenian: • v informacije o zdravilu za ta zdravila je treba vključiti opozorilo, da otroci z boleznimi, ki so povezane s težavami z dihanjem, ne smejo uporabljati kodeina.
English: Codeine is converted into morphine in the body by an enzyme called CYP2D6.
Slovenian: Kodein se v telesu pretvarja v morfin s pomočjo encima, imenovanega CYP2D6.
English: As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by all Member States, according to an agreed timetable.
Slovenian: Ker je skupina CMDh soglasno podprla priporočilo odbora PRAC, ga bodo odslej neposredno izvajale vse države članice v skladu z dogovorjenim časovnim razporedom.
English: Codeine is marketed as a singleingredient medicine or in combination with other substances such as aspirin or paracetamol.
Slovenian: Kodein se trži kot zdravilo z eno učinkovino ali v kombinaciji z drugimi učinkovinami, kot sta aspirin ali paracetamol.
English: The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by consensus a series of risk minimisation measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMDh) je soglasno podprla vrsto ukrepov za zmanjšanje tveganja, namenjenih odpravi zadržkov v zvezi z varnostjo zdravil, ki vsebujejo kodein in se uporabljajo za obvladovanje bolečine pri otrocih.
English: • Parents and caregivers who notice any of the following symptoms in a patient given codeine should stop giving the medicine and seek medical attention immediately: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation and lack of appetite.
Slovenian: • Starši in skrbniki, ki pri bolniku, ki je prejel kodein, opazijo katerega koli od naslednjih simptomov, morajo prenehati dajati zdravilo in nemudoma poiskati zdravniško pomoč: počasno ali plitko dihanje, zmedenost, zaspanost, zožene zenice, slabost ali bruhanje, zaprtje in zmanjšanje teka.
English: This follows a review of these medicines by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which investigated reports of serious and fatal respiratory depression in children after taking codeine for pain relief.
Slovenian: Podlaga je bil pregled teh zdravil, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila in v katerem so preučili poročila o resni in smrtni depresiji dihanja pri otrocih po uporabi kodeina za lajšanje bolečine.
English: The PRAC concluded that a number of risk minimisation measures are necessary to ensure that only children for whom the benefits are greater than the risks are given the medicine for pain relief.
Slovenian: PRAC je zaključil, da je potrebnih več ukrepov za zmanjšanje tveganja, s katerimi bi zagotovili, da bi se zdravilo za lajšanje bolečin uporabljalo samo pri otrocih, pri katerih so koristi večje od tveganj.
English: Codeine is an opioid that is authorised as a painkiller in adults and children.
Slovenian: Kodein je opioid, ki je odobren kot zdravilo proti bolečinam za odrasle in otroke.
English: • Codeine is not recommended for use in children in whom respiratory function might be compromised as this may worsen the symptoms of morphine toxicity.
Slovenian: • Kodein se ne priporoča za uporabo pri otrocih, pri katerih je delovanje dihal morda oslabljeno, saj so lahko zaradi tega simptomi toksičnosti morfina hujši.
English: • Mothers who are breastfeeding should not take codeine because codeine can pass to the baby through breast milk.
Slovenian: • Matere, ki dojijo, ne smejo jemati kodeina, ker se ta lahko prenese na otroka z materinim mlekom.
English: More about the medicine
Slovenian: Več informacij o zdravilu
English: Codeine should therefore not be used in people of any age who are known to be ultra-rapid metabolisers nor in breastfeeding mothers (because codeine can pass to the baby through breast milk).
Slovenian: Kodein se zato ne sme uporabljati pri osebah vseh starosti, za katere je znano, da imajo izredno hitro presnovo, in pri ženskah, ki dojijo (ker se kodein lahko prenese na otroka z materinim mlekom).
English: The effect of codeine on pain is due to its conversion into morphine in the patient's body.
Slovenian: Učinek kodeina na bolečino je posledica njegove pretvorbe v morfin v telesu bolnika.
English: In addition, a published case report described a case of respiratory depression resulting in death in a breastfed infant whose codeine-using mother was a CYP2D6 ultra-rapid metaboliser.
Slovenian: Poleg tega je bila v objavljenem kliničnem primeru opisana depresija dihanja, ki se je končala s smrtjo pri dojenem otroku, katerega mati je jemala kodein in je imela izredno hitro presnovo s CYP2D6;
English: • Patients who are known to be ‘ultra-rapid metabolisers', which means that they are more at risk of serious side effects with codeine, should not use codeine as pain relief.
Slovenian: • Bolniki, za katere je znano, da imajo „izredno hitro presnovo, kar pomeni, da pri njih obstaja večje tveganje za resne neželene učinke kodeina, ne smejo uporabljati kodeina za lajšanje bolečine.
English: • Codeine is now contraindicated: in all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome and in patients of any age who are known to be CYP2D6 ultra-rapid metabolisers (up to approximately 10% of Caucasians are CYP2D6 ultra-rapid metabolisers, but prevalence differs according to racial and ethnic group), due to an increased risk of developing serious and life-threatening adverse reactions; and in women who are breastfeeding.
Slovenian: • Kodein je po novem kontraindiciran: pri vseh pediatričnih bolnikih (starih od 0-18 let), ki so imeli tonzilektomijo in/ali adenoidektomijo zaradi obstruktivne apneje med spanjem, in pri bolnikih vseh starosti, za katere je znano, da imajo izredno hitro presnovo s CYP2D6 (izredno hitro presnovo s CYP2D6 ima približno do 10 % belcev, prevalenca pa je različna glede na rasno in etnično skupino), saj pri njih obstaja povečano tveganje za razvoj resnih in življenjsko nevarnih neželenih učinkov; ter pri ženskah, ki dojijo.
English: The effect of codeine on pain is due to its conversion into morphine.
Slovenian: Učinek kodeina na bolečino je posledica njegove pretvorbe v morfin.
English: • The available efficacy data on codeine for pain relief in children suggest that the analgesic effect of codeine on pain is not superior to that of other analgesics, such as non-steroidal anti-inflammatory drugs and non-opioid analgesics.
Slovenian: • razpoložljivi podatki o učinkovitosti kodeina pri lajšanju bolečine pri otrocih kažejo, da analgetični učinek kodeina na bolečino ni večji od učinka drugih analgetikov, kot so nesteroidna protivnetna zdravila in neopioidni analgetiki.
English: The available data suggest that there is a reduced ability to metabolise codeine in younger children but that the enzyme system responsible for the metabolism of codeine can be considered to be fully matured by the age of 12.
Slovenian: Razpoložljivi podatki kažejo, da imajo mlajši otroci zmanjšano zmožnost presnove kodeina in da se encimski sistem, ki je odgovoren za presnovo kodeina, popolnoma razvije pri 12. letih;
English: Most of the cases occurred after surgical removal of the tonsils or adenoids for obstructive sleep apnoea (frequent interruption of breathing during sleep).
Slovenian: Večina primerov se je zgodila po kirurški odstranitvi tonzil ali žrelnic zaradi obstruktivne apneje med spanjem (pogoste prekinitve dihanja med spanjem).
English: • Six cases (including 3 with a fatal outcome) of respiratory depression in children treated with codeine at recommended doses after undergoing tonsillectomy for obstructive sleep apnoea were reviewed.
Slovenian: • pregledanih je bilo šest primerov (vključno 3 s smrtnim izidom) depresije dihanja pri otrocih, zdravljenih s kodeinom v priporočenih odmerkih, ki so prestali tonzilektomijo zaradi obstruktivne apneje med spanjem.
English: In these patients, codeine is converted into morphine in the body at a faster rate than normal, resulting in high levels of morphine in the blood that can cause toxic effects such as respiratory depression.
Slovenian: Pri teh bolnikih se kodein v telesu hitreje pretvori v morfin kot običajno, zaradi česar se pojavijo visoke ravni morfina v krvi, ki lahko povzročijo toksične učinke, kot je depresija dihanja.
English: In these patients, codeine is converted into morphine in the body at a faster rate than normal, resulting in high levels of morphine in the blood that can cause toxic effects such as breathing difficulties.
Slovenian: Pri teh bolnikih se kodein v telesu hitreje pretvori v morfin kot običajno, zaradi česar se pojavijo visoke ravni morfina v krvi, ki lahko povzročijo toksične učinke, na primer težave z dihanjem.
English: Codeine is a widely used opioid medicine for pain relief.
Slovenian: Kodein je opioid, ki se splošno uporablja za lajšanje bolečine.
English: • Although morphine-induced side effects may occur at all ages, the current evidence suggests that children below 12 years are at special risk of life-threatening respiratory depression with codeine.
Slovenian: • čeprav se neželeni učinki zaradi morfina lahko pojavijo pri osebah vseh starosti, trenutni podatki kažejo, da je tveganje za življenjsko nevarno depresijo dihanja pri uporabi kodeina še zlasti veliko pri otrocih, mlajših od 12 let.