FrancophonIA/ELRC3.0 huggingface dataset:
English: Annual re-vaccination is required for canine parainfluenza and Leptospira components.
Slovenian: Vsaj eno leto po osnovnem cepljenju proti virusu pasje parainfluence in komponentam Leptospire.
English: − to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,
Slovenian: − za preprečevanje kliničnih znakov, okužbe in izločanja virusa z urinom, ki jih povzroča L.
English: The procedure started in November 2010.
Slovenian: Postopek se je začel novembra 2010.
English: Suppositories containing terpenic derivatives have been authorised through national procedures in Europe since the 1950s and are currently authorised and marketed in seven EU member states.
Slovenian: Svečke, ki vsebujejo derivate terpena, so bile v Evropi odobrene z nacionalnimi postopki v petdesetih letih prejšnjega stoletja, trenutno pa so odobrene in se tržijo v sedmih državah članicah EU.
English: Risk minimisation measures
Slovenian: Ukrepi za zmanjševanje tveganja
English: In most cases, medication errors involved the use of a child formulation instead of the infant formulation.
Slovenian: V večini primerov so napake pri uporabi zdravil vključevale uporabo formulacije za otroke namesto formulacije za dojenčke.
English: Limited clinically relevant efficacy has been demonstrated in the paediatric population.
Slovenian: Dokazana je bila omejena klinično pomembna učinkovitost pri pediatrični populaciji.
English: In children less than 30 months, no data on efficacy is available.
Slovenian: Za otroke, mlajše od 30 mesecev, podatki o učinkovitosti niso na voljo.
English: In particular, the minimum age recommendations varied from the neonatal period for some products, to 1 or even 6 months of age for others.
Slovenian: Razlikovala so se zlasti priporočila glede najnižje starosti, in sicer od neonatalnega obdobja za nekatera zdravila, do enega ali celo šest mesecev starosti za druga.
English: The main data was obtained from spontaneous reports, the literature and pre-clinical data.
Slovenian: Glavni podatki so bili pridobljeni iz spontanih poročil, literature in predkliničnih podatkov.
English: Changes to the product information (PI)
Slovenian: Spremembe informacij o zdravilu
English: Rectal lesions, including rectal burning, are of particular concern because of their severity and because they represent a limiting factor for treatment duration.
Slovenian: Rektalne lezije, vključno s pekočo bolečino v danki, so še posebej zaskrbljujoče zaradi svoje resnosti, in ker predstavljajo dejavnik, ki omejuje trajanje zdravljenja.
English: Overall conclusion
Slovenian: Splošni zaključki
English: The CHMP also took into account the 2010 safety review conducted by the French National Agency.
Slovenian: CHMP je upošteval tudi varnostni pregled, ki ga je leta 2010 izvedla francoska nacionalna agencija.
English: This is of particular concern in children and infants, who have little fatty mass, as these substances instead cross into the central nervous system (CNS), practically the only apolar structure at that age.
Slovenian: To je zlasti zaskrbljujoče pri otrocih in dojenčkih, ki imajo malo maščobne mase, saj te snovi zato prehajajo v osrednji živčni sistem, ki je praktično edina nepolarna struktura pri tej starosti.
English: Most clinical data are derived from open studies as well as data from clinical practice or expert opinions.
Slovenian: Večina kliničnih podatkov izhaja iz odprtih študij ter iz klinične prakse in strokovnih mnenj.
English: In order to address these divergences and taking into account the risk of medication error related to age, the CHMP decided to harmonise certain sections of the product information texts.
Slovenian: Da bi se uskladile te razlike in ob upoštevanju tveganja za napako pri uporabi zdravil zaradi starosti, je CHMP sklenil, da uskladi posamezna poglavja besedil informacij o zdravilu.
English: Overall summary of the scientific evaluation of suppositories containing terpenic derivatives (see Annex I).
Slovenian: Splošni povzetek znanstvenega vrednotenja svečk, ki vsebujejo derivate terpena (glejte Prilogo I)
English: • The CHMP considered the totality of the available data, including the 2010 French safety review;
Slovenian: • CHMP je proučil skupne razpoložljive podatke, vključno s francoskim varnostnim pregledom iz leta 2010.
English: France subsequently submitted a notification on 27th October 2010, initiating a referral procedure under Article 31(2) of Directive 2001/83/EC, to assess the potential neurological risk and its impact on the benefit-risk of suppositories containing terpenic derivatives in children less than 30 months.
Slovenian: Francija je nato dne 27. oktobra 2010 predložila obvestilo, s katerim je sprožila napotitveni postopek v skladu s členom 31(2) Direktive 2001/83/ES, da bi se ovrednotila mogoča nevrološka tveganja in njihov vpliv na razmerje med tveganji in koristmi svečk, ki vsebujejo derivate terpena, pri otrocih, mlajših od 30 mesecev.
English: Camphor, menthol and eucalyptol are the most studied substances from a preclinical and clinical point of view.
Slovenian: Kafra, mentol in evkaliptol so najbolj raziskane snovi s predkliničnega in kliničnega vidika.
English: The products are typically indicated for supportive treatment for benign (mild) acute bronchial disorders, particularly productive and non productive cough.
Slovenian: Zdravila so običajno indicirana za podporno zdravljenje benignih (blagih) akutnih bronhialnih bolezni, zlasti produktivnega in neproduktivnega kašlja.
English: Thirty cases related to neurological disorders, and twenty-one serious cases with plausible relationship were reported.
Slovenian: Poročali so o 30 primerih, povezanih z nevrološkimi boleznimi, in 21 resnih primerih z verjetno povezavo.
English: The CHMP also reviewed the French safety assessment of the use of suppositories containing terpenic derivatives in children, completed in May 2010.
Slovenian: CHMP je pregledal tudi francosko oceno varnosti uporabe svečk, ki vsebujejo derivate terpena, pri otrocih, ki je bila zaključena maja 2010.
English: Efficacy is based mainly on traditional use of these products and supported by data regarding pharmacodynamic properties and by their effects as cough suppressants and anti-inflammatory drug in pre-clinical models.
Slovenian: Učinkovitost temelji predvsem na tradicionalni uporabi teh zdravil, podpirajo pa jo podatki o farmakodinamičnih lastnostih in njihovih učinkih pri uporabi za pomirjanje kašlja in proti vnetju v predkliničnih modelih.
English: From a mechanistic point of view, based on the pharmacological properties of terpenic derivatives, these substances are non-polar (or lipophilic) compounds which show an affinity for non-polar human body structures.
Slovenian: Z vidika mehanizma delovanja in na podlagi farmakoloških lastnosti derivatov terpena so te snovi nepolarne (ali lipofilne) spojine, ki kažejo afiniteto za nepolarne človeške telesne strukture.
English: In its assessment, the CHMP requested the MAHs to propose risk minimisation measures to address the identified risks.
Slovenian: V svoji oceni je CHMP od imetnikov dovoljenja za promet z zdravilom zahteval, da za ugotovljena tveganja predlagajo ukrepe za zmanjševanje tveganja.
English: These concerns are strengthened by the fact that no direct relationships could be established between the quantity of terpenic derivatives administered and the occurrence or severity of the adverse events.
Slovenian: Zadržke je okrepilo tudi dejstvo, da ni bila dokazana nobena neposredna povezava med količino uporabljenih derivatov terpena in pojavljanjem ali resnostjo neželenih učinkov.
English: However, there is no clinical data derived from comparative studies (randomized, double-blind and controlled studies), pooled analyses or meta-analyses comparing efficacy of terpenic derivatives used by rectal route and no studies focused on infants and children are available.
Slovenian: Vendar pa ni bilo na voljo nobenih podatkov, ki bi bili pridobljeni iz primerjalnih študij (randomiziranih, dvojno slepih in nadzorovanih), združenih analiz ali metaanaliz, pri katerih bi primerjali učinkovitost derivatov terpena, ki se uporabljajo rektalno, prav tako pa ne iz študij s poudarkom na dojenčkih in otrocih.
English: The CHMP considered this to be of concern, especially when considering cases where children were exposed to an inadequate dosage or suppository formulation, for example due to parents using suppositories dispensed for older children in other younger children or infants in the family.
Slovenian: CHMP je menil, da je to zaskrbljujoče, zlasti ob upoštevanju primerov, v katerih so bili otroci izpostavljeni neustreznemu odmerjanju ali formulaciji svečke, na primer kadar so starši pri mlajših otrocih ali dojenčkih uporabili svečke, predpisane starejšim otrokom v družini.
English: In addition, limited clinically relevant efficacy has been demonstrated in the paediatric population and no data on efficacy is available in children less than 30 months.
Slovenian: Nadalje je bila dokazana omejena klinično pomembna učinkovitost pri pediatrični populaciji, podatki o učinkovitosti pri otrocih, mlajših od 30 mesecev, pa niso na voljo.
English: The MAHs and the CHMP also agreed on the wording of a ‘Direct healthcare professional' communication, to inform prescribers on the above agreed contraindications to be sent to relevant health care professionals, including pharmacists.
Slovenian: Imetniki dovoljenja za promet z zdravilom in CHMP so potrdili besedilo „neposrednega obvestila zdravstvenim delavcem“, s katerim so zdravniki, ki predpisujejo zdravilo, obveščeni o navedenih dogovorjenih kontraindikacijah in ki ga je treba poslati zadevnemu zdravstvenemu osebju, vključno s farmacevti.
English: Benefit-risk balance
Slovenian: Razmerje med tveganji in koristmi
English: The CHMP also noted that the limited available data made it impossible to establish whether a direct relationship exists between the administered dose and the ADRs observed.
Slovenian: CHMP je tudi ocenil, da je zaradi omejenih razpoložljivih podatkov nemogoče ugotoviti, ali obstaja neposredna povezava med uporabljenim odmerkom in opaženimi neželenimi učinki.
English: Other disorders including skin disorders and respiratory disorders were also identified.
Slovenian: Druge bolezni vključujejo bolezni kože in bolezni dihal.
English: The CHMP reviewed a number of publications confirming that terpenic derivatives can induce convulsions in humans.
Slovenian: CHMP je pregledal več publikacij, ki so potrjevale, da lahko derivati terpena pri ljudeh povzročajo krče.
English: In member states where they are authorised, suppositories containing terpenic derivatives have been used for decades as treatment for benign acute bronchial disorders or oropharynx congestive states, particularly for non productive cough.
Slovenian: V državah članicah, v katerih so svečke, ki vsebujejo derivate terpena, odobrene, se uporabljajo že desetletja kot zdravilo za benigne akutne bronhialne bolezni ali kongestivne orofaringealne bolezni, zlasti pri neproduktivnem kašlju.
English: Six cases of local irritation and one case of rectorrhagia with favourable outcome were notified, together with 12 cases of cutaneous ADRs and 2 cases of respiratory ADRs.
Slovenian: Poročali so o šestih primerih lokalnega draženja in enem primeru krvavitve iz danke s pozitivnim izidom, skupaj z dvanajstimi primeri kožnih neželenih učinkov in dveh primerih dihalnih neželenih učinkov.
English: For the cases where time to onset was reported, the neurological ADRs occurred on the day of treatment initiation.
Slovenian: V primerih, pri katerih so poročali tudi o času do pojava neželenih učinkov, so pokazali, da so se nevrološki neželeni učinki pojavili na dan začetka zdravljenja.
English: • No dose-ADR relationship could be established and the observed risk of neurological adverse events could not be adequately addressed by measures other than contraindications in this population;
Slovenian: • Dokazana ni bila nobena povezava med velikostjo odmerka in neželenimi učinki; opaženega tveganja za nevrološke neželene učinke pa ukrepi, razen kontraindikacije za to populacijo, ne morejo ustrezno rešiti.
English: A total of 92 cases of ADRs were identified in the national pharmacovigilance database and the periodic safety update reports, with about 82% (76/92) of these cases occurring in children less than 30 months.
Slovenian: V nacionalni farmakovigilančni zbirki podatkov in v z zadnjimi podatki dopolnjenih rednih poročilih o varnosti zdravila je bilo skupno 92 primerov neželenih učinkov, pri čemer se je okoli 82 % (76 od 92) neželenih učinkov pojavilo pri otrocih, mlajših od 30 mesecev.
English: A number of adverse drug reactions, including serious nervous system disorders were reported in paediatric patients, including convulsions, agitation, somnolence, hypersomnia, hypotonia, disorientation, and hallucination.
Slovenian: Pri pediatričnih bolnikih so poročali o številnih neželenih učinkih zdravila, vključno s hudimi boleznimi živčnega sistema, krči, vznemirjenostjo, zaspanostjo, hipersomnijo, hipotonijo, zmedenostjo in halucinacijami.
English: In addition, the duration of use was limited to 3 days, due to risks related to terpenic derivatives storage in tissues and brain and the risk of rectal burning.
Slovenian: Poleg tega je bil čas uporabe zdravila omejen na tri dni zaradi tveganja, povezanega s kopičenjem derivatov terpena v tkivih in možganih ter tveganja za pekočo bolečino v danki.
English: In particular, the CHMP looked at data on suppositories containing camphor, cineole (eucalyptol) and menthol, niaouli, thymus vulgaris and cineole, citral, cineole (eucapyptol), pine essential oil and guaiacol, turpentine and pine essence.
Slovenian: CHMP je zlasti proučil podatke o svečkah, ki vsebujejo kafro, cineol (evkaliptol) in mentol, niaouli, vrtni timijan (thymus vulgaris) in cineol, citral, cineol (evkaliptol), eterično olje bora in guaiakol, terpentin in izvleček bora.
English: The CHMP concluded that the data confirms the concerns that suppositories containing terpenic derivatives can induce neurological disorders, especially convulsions, in children less than 30 months.
Slovenian: CHMP je sklenil, da podatki potrjujejo pomisleke, da lahko svečke, ki vsebujejo derivate terpena, povzročajo nevrološke bolezni, zlasti krče, pri otrocih, mlajših od 30 mesecev.
English: Whereas
Slovenian: Koristi
English: Medication errors included 5 neurological ADRs.
Slovenian: Zaradi napak pri uporabi zdravil se je pojavilo pet nevroloških neželenih učinkov.
English: Finally, dispensing or administration errors were also identified with cases where the administered/prescribed suppository was not suitable for the age or weight of the child.
Slovenian: Ugotovljene pa so bile tudi napake pri izdajanju oziroma uporabi, saj so obstajali primeri, kjer uporabljena/predpisana svečka ni bila primerna za starost ali telesno maso otroka.
English: The risk minimisation measures proposed by the MAHs were considered insufficient to reduce the neurological risk to an acceptable level in children less than 30 months.
Slovenian: Ocenjeno je bilo, da so ukrepi za zmanjševanje tveganja, ki so jih predložili imetniki dovoljenja za promet z zdravilom, nezadostni, da bi nevrološko tveganje pri otrocih, mlajših od 30 mesecev, zmanjšali na sprejemljivo raven.
English: Moreover, suppositories are known to distribute systemically, due to product absorption through the rectal mucous membrane which is particularly vascularised.
Slovenian: Poleg tega je znano, da se svečke zaradi absorpcije skozi rektalno sluznico, ki je še posebno močno prekrvavljena, porazdeljujejo sistemsko.
English: The CHMP also noted that terpenic derivatives administered by other route of administration (cutaneous and inhaled) are associated with risks of neurological, skin, and local toxicity.
Slovenian: CHMP je tudi ugotovil, da je uporaba derivatov terpena na drug način (nanos na kožo in z vdihavanjem) povezana s tveganjem za nevrološko, kožno in lokalno toksičnost.
English: The clinical evidence shows that children less than 30 months are more prone to neurological disorders due to immaturity of the central nervous system, which results in a higher susceptibility to neurological toxicity.
Slovenian: Klinični dokazi kažejo, da so otroci, mlajši od 30 mesecev, bolj nagnjeni k nevrološkim boleznim zaradi nezrelosti osrednjega živčnega sistema, zaradi česar so občutljivejši za nevrološko toksičnost.
English: While acknowledging that direct comparisons of suppositories containing terpenic derivatives regarding these aspects are lacking and that suppositories could be a therapeutic alternative in children who do not tolerate treatment with ointments, the CHMP was of the opinion that the available data confirms that the safety profile of terpenic derivatives used by rectal route in infants and children is of concern.
Slovenian: Ob upoštevanju, da v zvezi s tem ni neposrednih primerjav svečk, ki vsebujejo derivate terpena, ter da bi bile svečke lahko nadomestno zdravljenje za otroke, ki ne prenašajo zdravljenja z mazili, je CHMP menil, da razpoložljivi podatki potrjujejo, da je varnostni profil derivatov terpena, ki se uporabljajo rektalno pri dojenčkih in otrocih, zaskrbljujoč.
English: In reaching its opinion, the CHMP took into account the totality of the available data on the safety of suppositories containing terpenic derivatives in paediatric populations, noting the limited efficacy data in the paediatric population, the absence of data on efficacy in children less than 30 months, the known neurological toxicity of terpenic derivatives, the risk of potentially severe neurological and local lesions and the risk of medication errors arising from the mistaken use of children formulations in infants.
Slovenian: Pri oblikovanju mnenja je CHMP upošteval skupne razpoložljive podatke o varnosti svečk, ki vsebujejo derivate terpena, pri pediatrični populaciji, pri čemer je izpostavil omejene podatke o učinkovitosti pri pediatrični populaciji, pomanjkanje podatkov o učinkovitosti pri otrocih, mlajših od 30 mesecev, znano nevrološko toksičnost derivatov terpena, tveganje za potencialno hude nevrološke in lokalne lezije ter tveganje za napake pri uporabi zdravila, ki izhajajo iz napačne uporabe formulacij za otroke pri dojenčkih.
English: The CHMP also considered it necessary to restrict the duration of treatment in the remaining approved paediatric population to 3 days, due to risk of rectal burning and to the risks related to storage of terpenic derivatives in tissues and brain (the rate of metabolism and elimination is unknown, as a consequence of their lipophilic properties) which can lead to neuropsychological disorders.
Slovenian: CHMP je prav tako menil, da je treba trajanje zdravljenja pri preostali odobreni pediatrični populaciji omejiti na 3 dni zaradi tveganja za pekočo bolečino v danki in zaradi tveganj, povezanih s kopičenjem derivatov terpena v tkivih in možganih (hitrost presnove in izločanja ni znana zaradi njihovih lipofilnih lastnosti), kar lahko privede do nevropsiholoških obolenj.
English: The CHMP assessed the totality of the data submitted by the Marketing Authorisation Holders (MAHs).
Slovenian: CHMP je ocenil skupne podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom.
English: Following a safety review completed in May 2010 by the French National Agency to investigate potential neurological risks, mainly represented by convulsions, suppositories containing terpenic derivatives (including camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needle, eucalyptus and turpentine) were contraindicated in France in children less than 30 months and in children with history of febrile convulsion or epilepsy.
Slovenian: Po varnostnem pregledu, ki ga je francoska nacionalna agencija zaključila maja 2010 in v katerem je proučevala mogoča nevrološka tveganja, ki so jih predstavljali predvsem krči, so bile svečke, ki vsebujejo derivate terpena (vključno s kafro, cineolom, niaoulijem, divjim timijanom, terpineolom, terpinom, citralom, mentolom ter eteričnimi olji iz evkaliptusa, iglic bora in terpentina), v Franciji kontraindicirane pri otrocih, mlajših od 30 mesecev, in pri otrocih z anamnezo vročinskih krčev ali epilepsije.
English: As a consequence, taking into account the risk of neurological toxicity and other adverse events in the paediatric population, the CHMP considered that the benefit-risk of suppositories containing terpenic derivatives in children less than 30 months is not positive under normal conditions of use.
Slovenian: Posledično je CHMP ob upoštevanju tveganja za nevrološko toksičnost in druge neželene učinke pri pediatrični populaciji, menil, da razmerje med tveganji in koristmi svečk, ki vsebujejo derivate terpena, pri otrocih, mlajših od 30 mesecev, pod normalnimi pogoji uporabe ni pozitivno.
English: The CHMP was of the opinion that marketing authorisations with a wide approved age range should be varied to contraindicate use in children less than 30 months while marketing authorisations where the only approved age range is children less than 30 months should be revoked.
Slovenian: CHMP je menil, da je treba dovoljenja za promet z zdravilom z velikim starostnim razponom spremeniti, tako da bo uporaba pri otrocih, mlajših od 30 mesecev, kontraindicirana; dovoljenja za promet z zdravili, za katera je edini odobreni starostni razpon do 30 mesecev, pa je treba preklicati.
English: Having assessed the proposals submitted by the MAHs (including the introduction of special warnings, a lower weight limit, limiting treatment duration, a contra-indication in case of history of convulsions or epilepsy and highlighting the risk of interaction with other products containing terpenic which could result in an increased risk of neurological side effects), the CHMP considered that in addition to the measures proposed, a contraindication in children less than 30 months was necessary to adequately manage the risk profile of suppositories containing terpenic derivatives.
Slovenian: Po proučitvi predlogov, ki so jih predložili imetniki dovoljenja za promet z zdravilom (vključno z vključitvijo posebnih opozoril, nižjo mejo telesne mase, omejenim trajanjem zdravljenja, kontraindiciranjem v primeru anamneze krčev ali epilepsije in poudarjanjem tveganja za medsebojno delovanje z drugimi zdravili, ki vsebujejo derivate terpena, kar bi lahko povzročilo povečano tveganje za pojavljanje nevroloških neželenih učinkov), je CHMP menil, da je poleg predloženih ukrepov treba vključiti tudi kontraindikacijo pri otrocih, mlajših od 30 mesecev, za ustrezno obvladovanje profila tveganja svečk, ki vsebujejo derivate terpena.
English: When taking into account all system organ classes, the reported adverse drug reactions (ADRs) were mainly nervous system disorders.
Slovenian: Pri upoštevanju vseh organskih sistemov se je pokazalo, da so neželeni učinki, o katerih so poročali, predvsem bolezni živčnega sistema.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REVOCATION OR THE AMENDMENTS OF THE RELEVANT SECTIONS OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMA, AS APPLICABLE TAKING INTO CONSIDERATION THE AGE RANGE OF THE APPROVED POPULATION
Slovenian: ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA RAZVELJAVITEV ALI DOPOLNITVE USTREZNIH POGLAVIJ POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA, KAKOR VELJAJO OB UPOŠTEVANJU STAROSTNEGA RAZPONA ODOBRENE POPULACIJE
English: • The biological plausibility of increased neurological toxicity in children less than 30 months was considered to be established due to the to immaturity of the central nervous system which results in a higher susceptibility;
Slovenian: • Šteje se, da je biološka verjetnost povečane nevrološke toksičnosti pri otrocih, mlajših od 30 mesecev, dokazana zaradi nezrelosti osrednjega živčnega sistema, ki povzroča večjo občutljivost.