FrancophonIA/ELRC3.0 huggingface dataset:
English: Hulio must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Slovenian: Zdravilo Hulio se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
English: What is Hulio and what is it used for?
Slovenian: Kaj je zdravilo Hulio in za kaj se uporablja?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hulio have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Hulio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: The active substance in Hulio, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Slovenian: Učinkovina v zdravilu Hulio, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanjo.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hulio is used to treat.
Slovenian: TNF sodeluje pri povzročanju vnetij in je prisoten v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Hulio uporablja.
English: Like other medicines of its class, Hulio may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Slovenian: Tako kot druga zdravila iz istega razreda lahko tudi zdravilo Hulio vpliva na obrambno sposobnost imunskega sistema proti okužbam in raku; pri bolnikih, ki prejemajo adalimumab, so bili namreč zabeleženi nekateri primeri resnih okužb in krvnega raka.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Slovenian: Drugi redki resni neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 1 000) so nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podobna obolenja (pri katerih imunski sistem napada bolnikova lastna tkiva, to pa povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (smrtno nevarno reakcijo z gripi podobnimi simptomi in bolečim izpuščajem, ki prizadene kožo, usta, oči in spolovila).
English: The reference medicine for Hulio is Humira.
Slovenian: Referenčno zdravilo za zdravilo Hulio je zdravilo Humira.
English: All these data were considered sufficient to conclude that Hulio will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Slovenian: Vsi ti podatki so bili ocenjeni kot zadostni za zaključek, da se bo zdravilo Hulio pri odobrenih uporabah z vidika učinkovitosti in varnosti vedlo enako kot zdravilo Humira.
English: For more information on the use of Hulio in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Hulio pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Slovenian: Najpogostejši neželeni učinki adalimumaba (opaženi pri več kot 1 bolniku od 10 so okužbe (vključno z okužbami nosu, grla in sinusov), reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
English: Hulio can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Hulio is used.
Slovenian: Predpisovanje in izdaja zdravila Hulio je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se zdravilo Hulio uporablja.
English: • non-infectious uveitis (inflammation of the layer beneath the white of the eyeball).
Slovenian: • neinfekcijskega uveitisa (vnetja sloja pod beločnico očesa).
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.
Slovenian: Zdravniki specialisti za očesne bolezni, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo adalimumaba.
English: Because Hulio is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hulio.
Slovenian: Zdravilo Hulio je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti adalimumaba, ki so že bile izvedene z zdravilom Humira, z zdravilom Hulio ni treba ponavljati.
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Slovenian: • aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), vključno z ankilozirajočim spondilitisom in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hulio has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Hulio po zgradbi, čistosti in biološkem delovanju primerljivo zdravilu Humira in da se po telesu enako prenaša.
English: Hulio contains the active substance adalimumab and is a ‘biosimilar medicine'.
Slovenian: Zdravilo Hulio vsebuje učinkovino adalimumab in je „podobno biološko zdravilo“.
English: For the full list of side effects and restrictions with Hulio, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Hulio glejte navodilo za uporabo.
English: For more information about using Hulio, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Hulio glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: In addition, a study in patients with rheumatoid arthritis has shown that the effects of the medicine are equivalent to those of Humira in this condition.
Slovenian: Poleg tega je študija pri bolnikih z revmatoidnim artritisom pokazala, da so učinki zdravila Hulio pri tej bolezni enakovredni učinkom zdravila Humira.
English: Therefore, the Agency's view was that, as for Humira, the benefit of Hulio outweighs the identified risk and it can be authorised.
Slovenian: Agencija je zato menila, da koristi zdravila Hulio enako kot pri zdravilu Humira odtehtajo znana tveganja in da se zdravilo lahko odobri.
English: Laboratory studies comparing Hulio with the reference medicine Humira have shown that the active substance in Hulio is highly similar to that in Humira in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Hulio primerjali z zdravilom Humira, so pokazale, da je učinkovina v zdravilu Hulio po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Humira.
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
Slovenian: • obolenja hidradenitis suppurativa (acne inversa), tj. dolgotrajnega obolenja kože, ki povzroča vozliče, abscese (gnojne tvorbe) in kožne brazgotine;
English: Studies have also shown that giving Hulio produces similar levels of the active substance in the body to giving Humira.
Slovenian: Študije so pokazale tudi, da zdravilo Hulio vzpostavi podobne ravni učinkovine v telesu kot zdravilo Humira.
English: • Crohn's disease (a disease causing inflammation of the gut);
Slovenian: • Crohnove bolezni (bolezni, ki povzroča vnetje črevesja);
English: In addition, Hulio was as effective as Humira in a study involving 730 patients with rheumatoid arthritis that was not adequately controlled with the medicine methotrexate.
Slovenian: Poleg tega je bilo v študiji, ki je vključevala 730 bolnikov z revmatoidnim artritisom, ki z metotreksatom ni bil dovolj nadzorovan, zdravilo Hulio enako učinkovito kot zdravilo Humira.
English: How is Hulio used?
Slovenian: Kako se zdravilo Hulio uporablja?
English: How does Hulio work?
Slovenian: Kako zdravilo Hulio deluje?
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
Slovenian: • poliartikularnega juvenilnega idiopatskega artritisa in aktivnega artritisa, povezanega z entezitisom
English: • plaque psoriasis (a disease causing red, scaly patches on the skin);
Slovenian: • psoriaze v plakih (bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži);
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Slovenian: • ulceroznega kolitisa (bolezni, ki povzroča vnetje in razjede v črevesni sluznici);
English: • rheumatoid arthritis (a disease causing inflammation of the joints);
Slovenian: • revmatoidnega artritisa (bolezni, ki povzroča vnetje sklepov);
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Slovenian: • psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži in vnetje sklepov);
English: 2 (Pediatrics Vol. 79 No. 4 April 1987)(2)
Slovenian: 79, št. 4, april 1987)(2)
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of l Directive 2001/83/EC.
Slovenian: • Odbor je preučil obvestilo o napotitvenem postopku, ki ga je sprožilo Združeno kraljestvo v skladu s členom 29(4) Direktive 2001/83/ES;
English: Chronic under-dosing has consequences to normal brain development of children.
Slovenian: Kronično premajhno odmerjanje pa ima posledice za normalen razvoj možganov pri otrocih.
English: Overall summary of the scientific evaluation of Levothyroxine Alapis and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Levothyroxine Alapis in povezanih imen (glej Prilogo I)
English: Harmful for those suffering from alcoholism.
Slovenian: Škoduje ljudem, ki imajo težave zaradi alkoholizma.
English: Propylene glycol
Slovenian: Propilen glikol
English: There was a significant difference in the occurrence of clinical seizures (P = .021).
Slovenian: Razlika v pojavu kliničnih napadov je bila statistično pomembna (P = 0,021).
English: • The Committee reviewed all the data that was available to address the potential serious risk to public health, in particular with regard to the safety of Levothyroxine Alapis 100 microgram/ml oral drops solution.
Slovenian: • Odbor je pregledal vse razpoložljive podatke, da bi obravnaval morebitno resno tveganje za javno zdravje, zlasti glede varnosti raztopine Levothyroxine Alapis 100 mikrogramov/ml v obliki peroralnih kapljic;
English: Deviation from a vertical position is more likely in situations where the patient / carer is attempting to manage / slow the drop rate to enable a relatively high number of drops to be counted.
Slovenian: Odklon od navpičnega položaja je bolj verjeten, kadar bolnik/negovalec poskuša obvladati/upočasniti hitrost kapljic, da bi lahko preštel sorazmerno veliko število kapljic.
English: Therefore the risk of medication error was considered to be a potential serious risk to public health.
Slovenian: Zato se je štelo, da tveganje za napako pri uporabi zdravila lahko pomeni resno tveganje za javno zdravje;
English: It is also noted that the proposed package leaflet (PL) recommends that the drops are not administered directly to the patient, but should first be delivered to a spoon.
Slovenian: Navedeno je tudi, da predlagano navodilo za uporabo vsebuje priporočilo, da se kapljice ne dajejo neposredno bolniku, temveč jih je najprej treba odmeriti na žlico.
English: Levothyroxine Alapis contains 200mg/ml of ethanol per dose.
Slovenian: Zdravilo Levothyroxine Alapis vsebuje 200 mg/ml etanola na odmerek.
English: More seizures occurred with the higher dose of propylene glycol, where 33% of the infants had seizures, vs only 14% of infants who received the lower dose of propylene glycol.
Slovenian: Pri višjih odmerkih propilen glikola je bilo napadov več: imelo jih je 33 % dojenčkov, medtem ko jih je imelo samo 14 % dojenčkov, ki so prejemali nižje odmerke propilen glikola.
English: To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.'
Slovenian: To je treba upoštevati pri nosečnicah in ženskah, ki dojijo, otrocih in skupinah z visokim tveganjem, kot so bolniki z obolenjem jeter ali epilepsijo.“
English: Based on the above, the CHMP considers that the safety concerns relating to Levothyroxine Alapis that were raised during the decentralised procedure and the CMDh referral procedure have not been sufficiently addressed.
Slovenian: CHMP na podlagi zgoraj navedenega meni, da pomisleki v zvezi z varnostjo zdravila Levothyroxine Alapis, ki so bili izraženi med decentraliziranim postopkom in napotitvenim postopkom CMDh, niso bili dovolj obravnavani.
English: Despite the shortcomings of this study the data suggest a dose-dependent trend towards a higher incidence of seizures with higher doses of propylene glycol.
Slovenian: Čeprav ima študija nekaj pomanjkljivosti, podatki kažejo na od odmerkov odvisno nagnjenost k večji pojavnosti napadov z višjimi odmerki propilen glikola.
English: • The Committee was of the opinion that there was an unacceptable risk of medication error due to the dropper insert, where the inappropriate orientation of the dropper insert would result in inaccurate and variable drop volume.
Slovenian: • Odbor je menil, da zaradi kapalnega vložka obstaja nesprejemljivo tveganje za napako pri uporabi zdravila, da bi lahko neprimerna usmeritev kapalnega vložka pripeljala do nepravilnega in spremenljivega volumna kapljic.
English: However this was not accepted due to the risk of dosing errors.
Slovenian: Predlog pa ni bil sprejet zaradi tveganja za napake pri odmerjanju zdravila.
English: The proposed patient populations are: adults, children over 12 years (in the treatment of diffuse non-toxic goitre), and neonates and infants (with congenital hypothyroidism).
Slovenian: Predlagane skupine bolnikov so: odrasli, otroci, starejši od 12 let (pri zdravljenju difuzne netoksične golše), ter novorojenčki in dojenčki (s prirojenim hipotiroidizmom).
English: The guidance “Guideline on the excipients in the label and the package leaflet of medicinal products for human use” states that if the content of ethanol is 100 mg - 3g per dose, the following should be stated in the PL: ‘This medicinal product contains < > vol % ethanol (alcohol), i.e. up to < > mg per dose, equivalent to < > ml beer, < > ml wine per dose.
Slovenian: V navodilu „Smernice v zvezi s pomožnimi snovmi na nalepki in navodilu za uporabo zdravil v humani medicini“ je navedeno, da je treba v primerih, kadar vsebnost etanola znaša od 100 mg do 3 g na odmerek, v navodilu za uporabo navesti: „To zdravilo vsebuje <> vol % etanola (alkohola), tj. do <> mg na odmerek, kar ustreza <> ml piva, <> vina na odmerek.
English: Newborn infants, and children are not able to metabolize ethanol as efficiently as adults; as a consequence, they may be at higher risk of both acute and chronic alcohol-related toxicities.
Slovenian: Novorojenčki in otroci ne morejo tako učinkovito presnavljati etanola kot odrasli, zaradi česar so lahko izpostavljeni višjemu tveganju za akutno in kronično toksičnost, povezano z alkoholom.
English: The decentralised marketing authorisation application for the medicinal product Levothyroxine is a well-established use application according to Article 10(a) of Directive 2001/83/EC.
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom po decentraliziranem postopku temelji na dejstvu, da je raba zdravila Levothyroxine že dobro uveljavljena v skladu s členom 10(a) Direktive 2001/83/ES.
English: As there is limited information on safe ethanol concentrations in paediatric formulations intended for chronic use, there are concerns with regard to chronic use of Levothyroxine Alapis in neonates/children, as ethanol represents an additional insult to brain development that is already compromised by congenital hypothyroidism.
Slovenian: Ker ni na voljo dovolj informacij o varnih koncentracijah etanola v pediatričnih pripravkih, namenjenih za kronično uporabo, se pojavljajo pomisleki v zvezi s kronično uporabo zdravila Levothyroxine Alapis pri novorojenčkih/otrocih, saj je etanol še dodatna ovira za razvoj možganov, ki je že tako ogrožen zaradi prirojenega hipotiroidizma.
English: The proposed indications for Levothyroxine Alapis are for: the treatment of hypothyroidism (congenital or acquired, including diffuse non-toxic goiter), hypothyroidism forms of Hashimoto's thyroiditis and thyroid carcinoma.
Slovenian: Predlagane indikacije zdravila Levothyroxine Alapis so: zdravljenje hipotiroidizma (prirojenega ali pridobljenega, vključno z difuzno netoksično golšo), hipotirotičnih oblik Hashimotovega tiroiditisa in karcinoma ščitnice.
English: The absence of robust user testing with representative members of the general public provides no reassurance that this dropper device will prove manageable and accurate in practice.
Slovenian: Ker ni bilo izvedeno neposredno preverjanje uporabnosti med tipičnimi predstavniki splošne javnosti, ni zagotovila, da se bo kapalka v praksi izkazala za obvladljivo in natančno.
English: The dosing errors due to the difficulty in accurately counting a large number of drops per dose (up to 20 drops) of Levothyroxine Alapis solution also remain a concern.
Slovenian: Zaskrbljenost vzbujajo tudi napake, ki nastanejo, ker je težko natančno prešteti veliko kapljic v enem odmerku (do 20 kapljic) raztopine zdravila Levothyroxine Alapis.
English: In light of the Applicant's failure to provide responses to the CHMP list of questions during the Article 29(4) referral procedure, the assessment was carried out on the data made available during the decentralised procedure and the CMDh referral procedure.
Slovenian: Ker predlagatelj med napotitvenim postopkom iz člena 29(4) ni predložil odgovorov na seznam vprašanj CHMP, je bila ocena izvedena na podlagi podatkov, ki so bili pridobljeni med decentraliziranim postopkom in napotitvenim postopkom skupine CMDh.
English: Two groups of infants were treated with two doses of propylene glycol; 0.3 g/day and 3 g/day in an IV multivitamin solution, during two consecutive 19month periods in a retrospective design.
Slovenian: V retrospektivno načrtovani študiji sta dve skupini dojenčkov prejeli različna odmerka propilen glikola, in sicer 0,3 g/dan in 3 g/dan v IV multivitaminski raztopini ter v dveh zaporednih 19-mesečnih obdobjih.
English: • The Committee was of the opinion that the chronic co-administration of the proposed quantities of the excipients ethanol and propylene glycol in children remains a safety concern.
Slovenian: • Odbor je menil, da kronično sočasna uporaba predlaganih količin pomožnih snovi etanola in propilen glikola pri otrocih še vedno vzbuja pomisleke v zvezi z varnostjo.
English: Nunn et al; Journal of Clinical Pharmacy and Therapeutics (2004) 29, 521-529
Slovenian: An assessment of dose-uniformity of samples delivered from paediatric oral droppers (Ocena o enotnosti odmerkov vzorcev iz pediatričnih kapalk za peroralno dajanje), A. J. Nunn et al; Journal of Clinical Pharmacy and Therapeutics, (2004)29, 521-529.
English: The possible medication errors caused by the dropper insert were discussed by the CHMP:
Slovenian: CHMP je obravnaval možne napake pri uporabi zdravila zaradi uporabe priloženega kapalnega vložka:
English: In addition there are also concerns in patients with hepatic impairment, epilepsy and in vulnerable adults such as those suffering from alcoholism.
Slovenian: Obstajajo tudi pomisleki pri bolnikih z okvaro jeter, epilepsijo in ranljivih populacijah odraslih, na primer alkoholikih.
English: Although propylene glycol is widely used as an excipient in oral and injectable medicines, literature data on its safety in children when administered chronically is sparse.
Slovenian: Čeprav se propilen glikol obsežno uporablja kot pomožna snov v zdravilih za peroralno dajanje in injiciranje, je v literaturi malo podatkov o njegovi varnosti za otroke pri kroničnem dajanju.
English: The study by MacDonald et al2, seems relevant as daily doses of propylene glycol similar to what can be expected from Levothyroxine Alapis were studied in one of the study arms.
Slovenian: Pri tem se zdi pomembna študija MacDonald et al2, saj so odmerki propilen glikola, ki so jih preučevali pri eni skupini bolnikov, podobni odmerkom, ki jih je mogoče pričakovati pri dajanju zdravila Levothyroxine Alapis.
English: In light of the failure to provide responses to the CHMP list of questions, , the available information was not considered to be sufficient to address the safety concerns of the chronic use of ethanol and the propylene glycol, in particular in the paediatric population.
Slovenian: Ker CHMP ni dobil odgovorov na svoj seznam vprašanj, informacije, ki so bile na voljo, niso štele za zadostne za odpravo pomislekov glede varnosti pri kronični rabi etanola in propilen glikola, zlasti pri pediatrični populaciji.
English: In conclusion given that Levothyroxine Alapis is a highly concentrated solution containing 100 mcg/ml the dropper device is considered to be unsuitable due to inaccuracies resulting from improper dropper orientation and miscounting, especially for paediatric initial doses less than 25 mcg.
Slovenian: Ker je zdravilo Levothyroxine Alapis visoko koncentrirana raztopina, ki vsebuje 100 mcg/ml, je bilo ugotovljeno, da kapalke ni mogoče šteti za primerne zaradi napak, ki nastanejo zaradi nepravilne usmerjenosti kapalke in napačnega štetja, kar zlasti velja za začetne odmerke v pediatriji, manjše od 25 mcg.
English: Medication errors caused by the administration device (dropper insert) Initially two different dropper inserts resulting in different drop sizes that would count up to 40 drops was proposed by the Applicant.
Slovenian: Napake pri uporabi zdravila zaradi pripomočka za dajanje (kapalni vložek) Predlagatelj je na začetku predlagal dva različna kapalna vložka, kar pomeni razliko v velikosti kapljic, ki lahko znaša tudi do 40 kapljic.
English: Combination of ethanol and propylene glycol
Slovenian: Kombinacija etanola in propilen glikola
English: This is a bibliographic application that refers to literature concerning several levothyroxin tablet formulations and solutions and thus no reference is made to a single unique formulation.
Slovenian: Vloga je bibliografska in se sklicuje na literaturo, ki se nanaša na več pripravkov v obliki tablet in raztopin levotiroksina, zaradi česar ni sklicevanja na posamično farmacevtsko obliko.
English: Inaccuracies due to miscounting
Slovenian: Napake zaradi napačnega štetja
English: Inaccuracies due to improper dropper orientation
Slovenian: Napake zaradi nepravilne usmerjenosti kapalke