FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore as a measure to mitigate this risk, the applicant proposed to downgrade dexamfetamine to second line use in ADHD and for children and adolescents of 6 to 17 years of age, if other medicinal and nonmedical treatment options have not achieved adequate results.
Slovenian: Zato je predlagatelj kot ukrep za zmanjšanje teh tveganj predlagal, da bi se deksamfetamin uporabljal le še kot zdravilo druge izbire pri zdravljenju ADHD ter pri otrocih in mladostnikih, starih od 6 do 17 let, kadar se z drugimi zdravili ali drugimi načini zdravljenja ne dosežejo ustrezni rezultati.
English: In addition to specific measures in the risk management plan, the committee recommended the monitoring of blood pressure and pulse rate in order to minimise these risks.
Slovenian: Odbor je za zmanjšanje teh tveganj poleg posebnih ukrepov v načrtu za obvladovanje tveganja priporočil še spremljanje krvnega tlaka in srčnega utripa.
English: Lisdexamfetamine and dexamfetamine can be regarded as pharmacodynamically identical, therefore to grant a marketing authorisation for dexamfetamine as second line ADHD treatment would be consistent with the recent approval of lisdexamfetamine for use in the same population.
Slovenian: Lisdeksamfetamin in deksamfetamin se lahko s farmakodinamičnega vidika obravnavata kot istovetna, zato bi bila izdaja dovoljenja za promet z deksamfetaminom kot zdravilom druge izbire pri zdravljenju ADHD skladna z nedavno odobritvijo lisdeksamfetamina za uporabo pri isti populaciji.
English: With regards to the risk of misuse and diversion within the ADHD population, a meta-analytic review by Lee et al. (2011) concluded that ADHD patients are at a considerably higher risk for substance abuse as compared to the (age-matched) general population.
Slovenian: Glede tveganja za napačno uporabo in uporabo za rekreativne namene pri populaciji bolnikov z ADHD so Lee in sodelavci v metaanalitičnem pregledu (2011) zaključili, da pri bolnikih z ADHD obstaja znatno večje tveganje za zlorabo snovi kot pri splošni (enako stari) populaciji.
English: • The Committee is of the opinion that dexamfetamine has a mechanism of action different from that of methylphenidate, and that the available data is supportive of the efficacy of dexamfetamine in treatment of ADHD.
Slovenian: • odbor je menil, da ima deksamfetamin drugačen mehanizem delovanja kot metilfenidat in da razpoložljivi podatki potrjujejo učinkovitost deksamfetamina pri zdravljenju ADHD;
English: The present application for Dexamed as second-line treatment of ADHD is a bibliographic (wellestablished use) application.
Slovenian: Predložena vloga za zdravilo Dexamed kot zdravilo druge izbire pri zdravljenju ADHD je bibliografska vloga (vloga na podlagi dobro uveljavljene uporabe).
English: • Whether sufficient scientific and clinical evidence exists to support the use of the product as second line treatment of ADHD.
Slovenian: • ali obstajajo zadostni znanstveni in klinični dokazi v podporo uporabi deksamfetamina kot zdravila druge izbire pri zdravljenju ADHD.
English: • The Committee reviewed all the data submitted by the applicant in support of the efficacy of dexamfetamine in second line treatment of ADHD, and the proposals for mitigation of the risk of misuse and diversion.
Slovenian: • odbor je proučil vse podatke, ki jih je predlagatelj predložil v podporo učinkovitosti deksamfetamina kot zdravila druge izbire pri zdravljenju ADHD, in predloge za zmanjšanje tveganja za napačno uporabo in uporabo za rekreativne namene;
English: The clinical data available, when taken together with clinical guidelines and the fact that the mechanism of action is different from that of other therapeutic options, supports the efficacy of dexamfetamine in second line treatment of ADHD.
Slovenian: Razpoložljivi klinični podatki, če so upoštevani skupaj s kliničnimi smernicami in dejstvom, da se mehanizem delovanja razlikuje od mehanizma pri drugih možnostih zdravljenja, potrjujejo učinkovitost deksamfetamina kot zdravila druge izbire pri zdravljenju ADHD.
English: The experts were of the opinion that there is currently little evidence to suggest that dexamfetamine is associated with a higher risk of dependence in the treated ADHD population than in those without ADHD.
Slovenian: Izvedenci so menili, da je trenutno malo dokazov, ki bi kazali na to, da je deksamfetamin pri populaciji zdravljenih bolnikov z ADHD povezan z večjim tveganjem za odvisnost kot pri tistih brez ADHD.
English: Amfetamines increase levels of catecholamine in the synaptic cleft by blocking reuptake of noradrenaline and dopamine by presynaptic neurons, by releasing dopamine and noradrenaline from dopaminergic neurons, and possibly by inhibiting monoamine oxidase.
Slovenian: Amfetamini zvišajo ravni kateholaminov v sinaptični reži, tako da preprečijo ponovni privzem noradrenalina in dopamina v presinaptične nevrone, sproščajo dopamin in noradrenalin iz dopaminergičnih nevronov ter verjetno tudi zavirajo monoaminooksidazo.
English: Methylphenidate reversibly binds to the presynaptic transporter protein with resultant inhibition of catecholamines re-uptake into the presynaptic neuron (Volkow et al., 2002), increases the release of dopamine from presynaptic cytoplasmic storage vesicles and blocks the uptake of dopamine into neuronal cytoplasmic storage vesicles, making dopamine more available in the presynaptic cytoplasm for release into the synaptic cleft (Sulzer et al., 2005).
Slovenian: Metilfenidat se reverzibilno veže na presinaptično prenašalno beljakovino in s tem zavira ponovni privzem kateholaminov v presinaptični nevron (Volkow in sod., 2002), poveča sproščanje dopamina iz skladiščnih mešičkov v presinaptični citoplazmi in prepreči privzem dopamina v živčne citoplazemske skladiščne mešičke, tako da je v presinaptični citoplazmi na voljo več dopamina, ki se lahko sprosti v sinaptično režo (Sulzer in sod.,
English: Furthermore the Committee requested that a PASS will be conducted to evaluate the long-term safety profile of dexamfetamine in children with ADHD, specifically targeting key issues such as cardiovascular events, growth and psychiatric related adverse events.
Slovenian: Prav tako je odbor zahteval, da se izvede študija PASS za ovrednotenje profila dolgoročne varnosti deksamfetamina pri otrocih z ADHD, s posebnim poudarkom na ključnih problemih, kot so srčno-žilni dogodki, rast in psihiatrični neželeni dogodki.
English: The objecting Member State considered that, based on the pharmacodynamics and pharmacokinetics of dexamfetamine, the potential risk for dependence and abuse associated to this product is higher than that of other treatment options for ADHD.
Slovenian: Država članica, ki je izrazila pomisleke, je menila, da je glede na farmakodinamiko in farmakokinetiko deksamfetamina možno tveganje za odvisnost in zlorabo, povezano s tem zdravilom, večje kot pri drugih načinih zdravljenja ADHD.
English: Even though no single study can be taken as pivotal evidence, the publications submitted within the application, which include not just published studies but also therapeutic guidelines and textbooks, are supportive of the efficacy in second line treatment of ADHD.
Slovenian: Čeprav nobene posamezne študije ni mogoče šteti za ključni dokaz, publikacije, predložene v okviru vloge, med katerimi so poleg objavljenih študij tudi terapevtske smernice in učbeniki, potrjujejo učinkovitost deksamfetamina kot zdravila druge izbire pri zdravljenju ADHD.
English: Its use as second line treatment only, despite its proven efficacy, is a measure introduced in order to mitigate this concern.
Slovenian: Uporaba deksamfetamina izključno kot zdravila druge izbire, kljub dokazani učinkovitosti, je ukrep, ki je bil sprejet za zmanjšanje tega tveganja.
English: • Conduct a PASS to evaluate the long-term safety profile of dexamfetamine in children with ADHD, specifically targeting key issues such as cardiovascular events, growth and psychiatric related adverse events.
Slovenian: • izvesti je treba študijo PASS za ovrednotenje profila dolgoročne varnosti deksamfetamina pri otrocih z ADHD, s posebnim poudarkom na ključnih problemih, kot so srčno-žilni dogodki, rast in psihiatrični neželeni dogodki.
English: However, the Committee also considered that the risk minimisation measures proposed are appropriate to mitigate the risk.
Slovenian: Vendar je prav tako menil, da so predlagani ukrepi za zmanjšanje tveganja primerni za zmanjšanje tveganja.
English: Indeed short acting treatments are less likely to affect sleep pattern and appetite compared to long-acting products.
Slovenian: Dejansko kratkodelujoča zdravila manj pogosto vplivajo na vzorec spanja in tek v primerjavi z dolgodelujočimi zdravili.
English: While there is no information about the sequence of treatments, mainly due to its cross-over design the results are convincing.
Slovenian: Čeprav predvsem zaradi navzkrižnega eksperimentalnega načrta ni podatkov o vrstnem redu zdravljenj, so rezultati prepričljivi.
English: During the assessment of the marketing authorisation application for Dexamed, concerns were raised regarding the potential for abuse and dependence of dexamfetamine.
Slovenian: Med ocenjevanjem vloge za pridobitev dovoljenja za promet z zdravilom Dexamed se je pojavila zaskrbljenost glede možnosti za zlorabo deksamfetamina in odvisnost od njega.
English: • Undertake a DUS to follow the use of prescribed dexamfetamine in the European Union using multiple data sources.
Slovenian: • izvesti je treba študijo o uporabi zdravila, namenjeno spremljanju uporabe predpisanega deksamfetamina v Evropski uniji s pomočjo različnih virov podatkov.
English: A drug utilisation study to follow the use of prescribed dexamfetamine in the European using multiple data sources was also required.
Slovenian: Poleg tega je treba izvesti študijo o uporabi zdravila, namenjeno spremljanju uporabe predpisanega deksamfetamina v Evropski uniji s pomočjo različnih virov podatkov.
English: • Whether downgrading the product to second line treatment and the proposed RMP measures are sufficient to mitigate concerns relating to the perceived potential for misuse and diversion.
Slovenian: • ali omejitev uporabe zdravila na zdravljenje druge izbire in predlagani ukrepi v načrtu za obvladovanje tveganja zadoščajo za zmanjšanje skrbi, povezanih z ugotovljeno možnostjo napačne uporabe in uporabe za rekreativne namene;
English: The risk management plan for the product includes educational material for both prescribers and patients/carers, as well as a drug utilisation study that has been expanded to collect information specifically on abuse and misuse.
Slovenian: Načrt za obvladovanje tveganja za zdravilo vključuje izobraževalno gradivo za zdravstvene delavce, ki bodo predpisovali zdravilo, in bolnike/negovalce ter tudi študijo o uporabi zdravila, ki je bila razširjena, tako da bo omogočila pridobitev specifičnih podatkov o zlorabi in napačni uporabi.
English: The indication has been restricted to second line, the risk management plan for the product includes educational material for both prescribers and patients/carers, as well as a drug utilisation study that has been expanded to collect information specifically on abuse and misuse.
Slovenian: Indikacija je bila omejena na zdravljenje druge izbire, načrt za obvladovanje tveganja za zdravilo pa vključuje izobraževalno gradivo za zdravstvene delavce, ki bodo predpisovali zdravilo, in bolnike/negovalce ter tudi študijo o uporabi zdravila, ki je bila razširjena, tako da bo omogočila pridobitev specifičnih podatkov o zlorabi in napačni uporabi.
English: Having considered the data submitted by the applicant, the CHMP considered that there is sufficient evidence to conclude that non-responders to methylphenidate may benefit from dexamfetamine.
Slovenian: Potem ko je proučil podatke, ki jih je predložil predlagatelj, je odbor CHMP menil, da so na voljo zadostni dokazi za zaključek, da bi deksamfetamin lahko koristil bolnikom, ki se ne odzovejo na metilfenidat.
English: The study by Elia et al. (1991) concluded that there is a need to try both stimulants because there is individual variability in response.
Slovenian: da je treba preskusiti oba stimulanta, ker obstaja individualna variabilnost odziva.
English: Taking into account all the available data, the Committee accepted that dexamfetamine has potential for misuse, diversion and also dependence.
Slovenian: Ob upoštevanju vseh razpoložljivih podatkov se je odbor strinjal, da pri deksamfetaminu obstaja možnost za napačno uporabo, uporabo za rekreativne namene in tudi odvisnost.
English: Methylphenidate is more selective for the dopamine transporter, while dexamfetamine also has a number of other actions including direct actions on receptors and modulating other modes of dopamine uptake as well as effect on other catecholamines.
Slovenian: Metilfenidat je bolj selektiven za prenašalec dopamin, medtem ko deksamfetamin deluje še na številne druge načinemed drugim neposredno deluje na receptorje in vpliva na druge načine privzema dopamina, poleg tega pa ima tudi učinek na druge kateholamine.
English: • A physician's guide to prescribing including direction for diagnosis according to DSM/ICD guidelines and for recognition and exclusion of patients with a history of abuse misuse diversion and dependency;
Slovenian: • priročnik za predpisovanje za zdravnike, ki vsebuje navodila za diagnosticiranje v skladu s smernicami DSM/MKB in za prepoznavanje ter izključitev bolnikov, ki so že kdaj zlorabljali ali napačno uporabljali zdravila, jih uporabljali za rekreativne namene ali bili od njih odvisni;
English: Taking into account all the available data, the Committee considered that there is sufficient evidence to conclude that non-responders to methylphenidate may benefit from dexamfetamine.
Slovenian: Ob upoštevanju vseh razpoložljivih podatkov je odbor menil, da so na voljo zadostni dokazi za zaključek, da bi deksamfetamin lahko koristil bolnikom, ki se ne odzovejo na metilfenidat.
English: However there are perceived risks of diversion and abuse associated with this medication.
Slovenian: Vendar pa so bila v povezavi s tem zdravilom ugotovljena tveganja za zlorabo in uporabo za rekreativne namene.
English: • The Committee is also of the opinion that the proposed risk minimisation measures are appropriate to mitigate the risks of misuse and diversion.
Slovenian: • odbor je prav tako menil, da so predlagani ukrepi za zmanjšanje tveganja primerni za zmanjšanje tveganj za napačno uporabo in uporabo za rekreativne namene.
English: It concludes that methylphenidate is more selective for dopamine transporter, while dexamfetamine also has a number of other actions including direct actions on receptors and modulating other modes of dopamine uptake as well as effect on other catecholamines.
Slovenian: Zaključek je bil, da je metilfenidat bolj selektiven za prenašalec dopamin, medtem ko deksamfetamin deluje še na številne druge načine - med drugim neposredno deluje na receptorje in vpliva na druge načine privzema dopamina, poleg tega pa ima tudi učinek na druge kateholamine.
English: Efficacy in second line treatment of ADHD
Slovenian: Učinkovitost deksamfetamina kot zdravila druge izbire pri zdravljenju ADHD
English: Indeed it is agreed that stimulants, including dexamfetamine, have potential for misuse, diversion and dependence.
Slovenian: Dejansko je znano, da pri stimulantih, vključno z deksamfetaminom, obstaja možnost napačne uporabe, uporabe za rekreativne namene in odvisnosti.
English: It is accepted that dexamfetamine has potential for misuse, diversion and also dependence.
Slovenian: Potrjeno je bilo, da pri deksamfetaminu obstaja možnost za napačno uporabo, uporabo za rekreativne namene in tudi odvisnost.
English: In the current application, the use of dexamfetamine as second line treatment of ADHD is a measure introduced to mitigate this concern.
Slovenian: V obravnavani vlogi je kot ukrep za zmanjšanje tega tveganja predlagana uporaba deksamfetamina kot zdravila druge izbire pri zdravljenju ADHD.
English: --1 Live recombinant E2 gene deleted bovine viral diarrhoea virus containing classical swine fever E2 (CP7_E2alf) 104.8 to 106.5 TCID50* * Tissue culture infectious dose 50%
Slovenian: --1 Živi rekombinatni virus goveje virusne driske z izbrisanim genom E2, ki vsebuje gen E2 klasične prašičje kuge (CP7_E2alf) 104,8* do 106,5 TCID*50 * infektivni odmerek za tkivno kulturo
English: Local reactions resolve within two to five days without treatment.
Slovenian: Lokalne reakcije izginejo v dveh do petih dneh brez zdravljenja.
English: from the beginning of the gestational period.
Slovenian: od začetka obdobja gestacije.
English: An elevation in the body temperature after vaccination is common which resolves spontaneously within 24 to 48 hours.
Slovenian: Povišana telesna temperatura po cepljenju je pogosta in se spontano razreši v 24 do 48 urah.
English: The second dose being given at least 3 weeks before mating.
Slovenian: Drugi odmerek se daje vsaj 3 tedne pred parjenjem.
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Slovenian: Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivnem imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
English: Primary vaccination scheme:
Slovenian: Shema primarnega cepljenja:
English: Avoid introduction of contamination during use.
Slovenian: Med uporabo se izogibajte kontaminaciji.
English: ReproCyc PRRS EU (lyophilisate)
Slovenian: ReproCyc PRRS EU (liofilizat)
English: Each bottle is closed with a rubber stopper and an aluminium cap.
Slovenian: Vsaka plastenka je zaprta z gumijastim zamaškom in aluminijasto zaporko.
English: Transient redness or swelling (up to 4 cm) caused by the injection procedure is very common.
Slovenian: Prehodna rdečina ali oteklina (do 4 cm), ki jo povzroča postopek injiciranja, je zelo pogosta.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: For pigs previously non-vaccinated against porcine parvovirus: Two intramuscular injections of one dose, 3 weeks apart.
Slovenian: Za prašiče, predhodno necepljene proti prašičjemu parvovirusu: Dve intramuskularni injekciji enega odmerka, 3 tedne narazen.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated , including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Date of first authorisation: 26/04/2019
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 26/04/2019
English: Keep the bottle in the outer carton in order to protect from light.
Slovenian: Plastenko shranjujte v zunanji ovojnini za zaščito pred svetlobo.
English: Overdose (symptoms, emergency procedures, antidotes): No data available.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Na voljo ni podatkov.
English: The following corresponding presentations (doses) can be mixed:
Slovenian: Razredčiti je možno naslednje ustrezne predstavitve (odmerke):
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli po “EXP”.
English: EXP {month/year} Once broached use within 8 hours.
Slovenian: EXP {mesec/leto} Načeto zdravilo uporabite v 8 urah.
English: 4.7 Use during pregnancy, lactation and lay
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen z omenjenim.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with ReproCyc PRRS EU and administered at one injection site.
Slovenian: Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da je to cepivo mogoče razredčiti z zdravilom ReproCyc PRRS EU in ga dajati na enem mestu injiciranja.
English: Ensure that the lyophilisate is completely reconstituted before use.
Slovenian: Prepričajte se, da je pred uporabo liofilizat popolnoma rekonstituiran.
English: Store and transport refrigerated (2 °C - 8 C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: Do not mix with any other veterinary medicinal product, except with ReproCyc PRRS EU.
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z ReproCyc PRRS EU.
English: This vaccine is designed to stimulate the development of an active immune response in pigs to porcine parvovirus.
Slovenian: To cepivo je namenjeno spodbujanju razvoja aktivnega imunskega odziva pri prašičih na prašičji parvovirus.
English: Shelf life after first opening of the bottle: use within 8 hours.
Slovenian: Rok uporabnosti po prvem odpiranju plastenke: uporabite v 8 urah.
English: 6.6 Special precautions for the disposal of unused medicinal product or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
English: The full content of one vial of ReproCyc ParvoFLEX should be used to reconstitute the lyophilisate of one vial of ReproCyc PRRS EU.
Slovenian: Celotno vsebino ene viale zdravila ReproCyc ParvoFLEX je treba uporabiti za rekonstitucijo liofilizata ene viale zdravila ReproCyc PRRS EU.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Na voljo ni podatkov.
English: ReproCyc ParvoFLEX hereby replaces the solvent of ReproCyc PRRS EU.
Slovenian: ReproCyc ParvoFLEX tako nadomesti topilo zdravila ReproCyc PRRS EU.
English: Adjuvant: Carbomer 2 mg.
Slovenian: Karbomer 2 mg.
English: Each dose (2 ml) contains:
Slovenian: Vsak odmerek (2 ml) vsebuje:
English: One intramuscular injection of one dose at least every six months is recommended in a whole herd programme (see section “Indications”).
Slovenian: Shema ponovnega cepljenja: Ena intramuskularna injekcija enega odmerka vsaj vsakih 6 mesecev (glejte razdelek “Indikacije”).
English: Store and transport refrigerated (2 C-8 C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
English: One dose (2 ml): Porcine Parvovirus VP2 subunit antigen Carbomer
Slovenian: En odmerek (2 ml): Podenota antigena VP2 prašičjega parvovirusa Karbomer
English: One intramuscular injection of one dose at least every 6 months is recommended in a whole herd programme (see section 4.2).
Slovenian: Shema ponovnega cepljenja: Ena intramuskularna injekcija enega odmerka vsaj vsakih 6 mesecev (glejte tudi poglavje 4.2).