natgillin/translations-raw huggingface dataset:
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and rabies virus.
Cepivo je namenjeno aktivni imunizaciji pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo virus pasje parainfluence, Leptospira interrogans serološka skupina Australis serovar Bratislava, Leptospira interrogans serološka skupina Canicola serovar Canicola, Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa in Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae in virus stekline.
The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies.
Učinkovitost komponente za steklino po enkratnem odmerku v starosti od 12 tednov je dokazana v laboratorijskih študijah.
Plastic box containing 25 vials (1 dose) of lyophilisate and 25 vials (1 ml) of suspension.
Plastična škatla s 25 vialami (s po 1 odmerkom) liofilizata in 25 vialami (po 1 ml) suspenzije.
Lyophilisate: spongy matter of white colour.
Liofilizat: gobasta snov bele barve.
Type 1 glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap.
Viala iz stekla tipa I, ki vsebuje 1 ml v suspenzije, zaprta z zamaškom iz klorobutilne gume in aluminijasto zaporko.
Plastic box containing 50 vials (1 dose) of lyophilisate and 50 vials (1 ml) of suspension.
Plastična škatla s 50 vialami (s po 1 odmerkom) liofilizata in 50 vialami (po 1 ml) suspenzije.
Name and address of the manufacturer of the biological active substances
Ime in naslov proizvajalca (proizvajalcev)biološke (bioloških) učinkovine (učinkovin)
Manufacturer responsible for batch release:
Proizvajalec, odgovoren za sproščanje serij:
− to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus,
− za preprečevanje kliničnih znakov (izcedek iz smrčka in oči) in zmanjšanje izločanja virusa, ki jih povzroča virus pasje parainfluence,
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
(European Medicines Agency) (http://www.ema.europa.eu/).
Adjuvant:
Videz:
At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components.
Vsaj eno leto po osnovnem cepljenju proti virusu pasje parainfluence in komponentov Leptospire.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila
Minimum Maximum Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10
Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
Lyophilisate (live attenuated):
Učinkovina(e): Liofilizat (živ, atenuiran):
Lyophilisate: Trometamol Edetic Acid Sucrose Dextran 70
Liofilizat: trometamol edetna kislina saharoza dekstran 70
ALR** titre ≥ 1:40
titer ALR** ≥ 1:40
Active substances:
Pomožna (pomožne) snovi:
VIAL (1 ML SUSPENSION)
VIALA (1 ML SUSPENZIJA) IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required.
Vsako leto je treba ponoviti cepljenje proti virusu parainfluence in komponentam Leptospire, za kar se lahko letno uporabi enkratni odmerek kompatibilnega cepiva Versican Plus Pi/L4 vsakoletno, če je potrebno.
In this case the second vaccination with Versican Plus Pi/L4R should not be given before 12 weeks.
Za prvo cepljenje se lahko uporabiti cepivo Versican Plus Pi/L4, vendar pa v tem primeru cepiva Versican plus Pi/L4R za drugo cepljenje ne smete uporabiti pred 12 tednom starosti.
ALR** titre ≥ 1:51
titer ALR** ≥ 1:51
ALR titre ≥ 1:51
titer ALR ≥ 1:51
6.5 Nature and composition of immediate packaging Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Viala iz stekla tipa I, ki vsebuje 1 odmerek liofilizata, zaprta z zamaškom iz brombutilne gume in aluminijasto zaporko.
PACKAGE LEAFLET: Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs
Versican Plus Pi/L4R liofilizat in suspenzija za suspenzijo za injiciranje za pse
L. kirschneri serovar Grippotyphosa
L. kirschneri, serološka skupina Grippotyphosa, serovar Grippotyphosa in
Disodium phosphate dodecahydrate
Suspenzija: natrijev klorid kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat voda za injekcije
Special warnings for each target species
POSEBNO(A) OPOZORILO(A) Posebna opozorila za vsako ciljno živalsko vrsto:
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi/L4R lyophilisate and suspension for suspension for injection for dogs
NAVODILO ZA UPORABO Versican Plus Pi/L4R liofilizat in v suspenzija za suspenzijo za injiciranje za pse
No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine.
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju 10-krat prevelikega odmerka cepiva ni bilo opaziti neželenih učinkov, razen tistih, navedenih v poglavju 4.6.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae
L. interrogans serovar Icterohaemorrhagiae,
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae,
L.interrogans, serološka skupina Canicola,serovar Canicola ter L. interrogans, serološka skupina Icterohaemorrhagiae, serovar Icterohaemorrhagiae,
STATEMENT OF THE MRLs Not applicable.
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
L. interrogans serovar Bratislava
interrogans serološka skupina Australis, serovar Bratislava,
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
Onset of immunity: - 2 weeks after a single vaccination from 12 weeks of age for rabies, - 3 weeks after completion of the primary course for CPiV and - 4 weeks after the completion of primary course for Leptospira components.
− 2 tedna po enkratnem cepljenju od 12 tedna starosti dalje proti steklini,
Annual re-vaccination is required for canine parainfluenza and Leptospira components.
Vsaj eno leto po osnovnem cepljenju proti virusu pasje parainfluence in komponentam Leptospire.
− to prevent clinical signs, infection and urinary excretion caused by L. interrogans serogroup Australis serovar Bratislava,
− za preprečevanje kliničnih znakov, okužbe in izločanja virusa z urinom, ki jih povzroča L.
The procedure started in November 2010.
Postopek se je začel novembra 2010.
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.
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.
Risk minimisation measures
Ukrepi za zmanjševanje tveganja
In most cases, medication errors involved the use of a child formulation instead of the infant formulation.
V večini primerov so napake pri uporabi zdravil vključevale uporabo formulacije za otroke namesto formulacije za dojenčke.
Limited clinically relevant efficacy has been demonstrated in the paediatric population.
Dokazana je bila omejena klinično pomembna učinkovitost pri pediatrični populaciji.
In children less than 30 months, no data on efficacy is available.
Za otroke, mlajše od 30 mesecev, podatki o učinkovitosti niso na voljo.
In particular, the minimum age recommendations varied from the neonatal period for some products, to 1 or even 6 months of age for others.
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.
The main data was obtained from spontaneous reports, the literature and pre-clinical data.
Glavni podatki so bili pridobljeni iz spontanih poročil, literature in predkliničnih podatkov.
Changes to the product information (PI)
Spremembe informacij o zdravilu
Rectal lesions, including rectal burning, are of particular concern because of their severity and because they represent a limiting factor for treatment duration.
Rektalne lezije, vključno s pekočo bolečino v danki, so še posebej zaskrbljujoče zaradi svoje resnosti, in ker predstavljajo dejavnik, ki omejuje trajanje zdravljenja.
Overall conclusion
Splošni zaključki
The CHMP also took into account the 2010 safety review conducted by the French National Agency.
CHMP je upošteval tudi varnostni pregled, ki ga je leta 2010 izvedla francoska nacionalna agencija.
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.
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.
Most clinical data are derived from open studies as well as data from clinical practice or expert opinions.
Večina kliničnih podatkov izhaja iz odprtih študij ter iz klinične prakse in strokovnih mnenj.
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.
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.
Overall summary of the scientific evaluation of suppositories containing terpenic derivatives (see Annex I).
Splošni povzetek znanstvenega vrednotenja svečk, ki vsebujejo derivate terpena (glejte Prilogo I)
• The CHMP considered the totality of the available data, including the 2010 French safety review;
• CHMP je proučil skupne razpoložljive podatke, vključno s francoskim varnostnim pregledom iz leta 2010.
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.
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.
Camphor, menthol and eucalyptol are the most studied substances from a preclinical and clinical point of view.
Kafra, mentol in evkaliptol so najbolj raziskane snovi s predkliničnega in kliničnega vidika.
The products are typically indicated for supportive treatment for benign (mild) acute bronchial disorders, particularly productive and non productive cough.
Zdravila so običajno indicirana za podporno zdravljenje benignih (blagih) akutnih bronhialnih bolezni, zlasti produktivnega in neproduktivnega kašlja.
Thirty cases related to neurological disorders, and twenty-one serious cases with plausible relationship were reported.
Poročali so o 30 primerih, povezanih z nevrološkimi boleznimi, in 21 resnih primerih z verjetno povezavo.
The CHMP also reviewed the French safety assessment of the use of suppositories containing terpenic derivatives in children, completed in May 2010.
CHMP je pregledal tudi francosko oceno varnosti uporabe svečk, ki vsebujejo derivate terpena, pri otrocih, ki je bila zaključena maja 2010.
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.
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.
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.
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.
In its assessment, the CHMP requested the MAHs to propose risk minimisation measures to address the identified risks.
V svoji oceni je CHMP od imetnikov dovoljenja za promet z zdravilom zahteval, da za ugotovljena tveganja predlagajo ukrepe za zmanjševanje tveganja.
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.
Zadržke je okrepilo tudi dejstvo, da ni bila dokazana nobena neposredna povezava med količino uporabljenih derivatov terpena in pojavljanjem ali resnostjo neželenih učinkov.
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.
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.
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.
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.
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.
Nadalje je bila dokazana omejena klinično pomembna učinkovitost pri pediatrični populaciji, podatki o učinkovitosti pri otrocih, mlajših od 30 mesecev, pa niso na voljo.
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.
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.
Benefit-risk balance
Razmerje med tveganji in koristmi
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.
CHMP je tudi ocenil, da je zaradi omejenih razpoložljivih podatkov nemogoče ugotoviti, ali obstaja neposredna povezava med uporabljenim odmerkom in opaženimi neželenimi učinki.
Other disorders including skin disorders and respiratory disorders were also identified.
Druge bolezni vključujejo bolezni kože in bolezni dihal.
The CHMP reviewed a number of publications confirming that terpenic derivatives can induce convulsions in humans.
CHMP je pregledal več publikacij, ki so potrjevale, da lahko derivati terpena pri ljudeh povzročajo krče.
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.
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.
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.
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.
For the cases where time to onset was reported, the neurological ADRs occurred on the day of treatment initiation.
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.
• 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;
• 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.
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.
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.
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.
Pri pediatričnih bolnikih so poročali o številnih neželenih učinkih zdravila, vključno s hudimi boleznimi živčnega sistema, krči, vznemirjenostjo, zaspanostjo, hipersomnijo, hipotonijo, zmedenostjo in halucinacijami.
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.
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.
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.
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.
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.
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.
Whereas
Koristi
Medication errors included 5 neurological ADRs.
Zaradi napak pri uporabi zdravil se je pojavilo pet nevroloških neželenih učinkov.
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.
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.
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.
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.
Moreover, suppositories are known to distribute systemically, due to product absorption through the rectal mucous membrane which is particularly vascularised.
Poleg tega je znano, da se svečke zaradi absorpcije skozi rektalno sluznico, ki je še posebno močno prekrvavljena, porazdeljujejo sistemsko.
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.
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.
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.
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.
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.
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.