natgillin/translations-raw huggingface dataset:
The likelihood of resistance development in these pathogens through exposure to tilmicosin when used for treatment of animals is expected to be negligible.
Pričakuje se, da je verjetnost razvoja odpornosti pri teh patogenih organizmih zaradi izpostavitve tilmikozinu pri zdravljenju živali, zanemarljiva.
• May cause sensitisation by skin contact.
• V stiku s kožo lahko povzroči senzibilizacijo.
• Do not work alone when using Micotil.
• Zdravila Micotil ne uporabljajte sami.
Eli Lilly Italia S.p.A Elanco Animal Health Via Gramsci, 733 Sesto Fiorentino, 50019 Firenze Italy
Eli Lilly Italia S.p.A Elanco Animal Health Via Gramsci, 733 Sesto Fiorentino, 50019 Firenze Italija
On the basis of a standard human body weight of 60 kg this would equate to 50-60 mg/kg bw.
Pri predpostavki standardne telesne mase človeka 60 kg, je to enakovredno 50-60 mg/kg TM.
Certain others (e.g. dobutamine) have partially countered cardiac effects of tilmicosin in animal experiments (pigs and dogs).
Določene druge snovi (npr. dobutamin) so delno zmanjšale kardiološke učinke tilmikozina v poskusih na živalih (prašičih in psih).
It noted that a lower strength product would firstly lead to an increase in the number of administrations necessary to achieve a therapeutic dose.
Upošteval je, da bi šibkejša oblika zdravila povzročila povečanje števila odmerjanj, ki bi bila potrebna za doseganje terapevtskega odmerka.
the CVMP recommends by a majority of 18 out of 27 votes that the warnings relative to user safety of the nationally granted Marketing Authorisations be harmonised and that the conditions of use be harmonised to ‘For use by veterinary surgeons only'; the revised aspects of the Summary of Product Characteristics are set out in Annex III and the conditions considered essential for the safe use of the product, as referred to in Article 36(4) of Directive 2001/82/EC as amended, are set out in Annex IV.
CVMP z večino 18 od 27 glasov priporoča, da se uskladijo opozorila v zvezi z varnostjo uporabnikov v nacionalnih dovoljenjih za promet in da se uskladijo pogoji uporabe z besedilom ‘Zdravilo lahko uporablja samo veterinar'; v Dodatku III so opredeljeni popravljeni vidiki Povzetka glavnih značilnosti zdravila in pogoji, v Dodatku IV pa so opredeljeni spremenjeni pogoji, ki so ključni za varno uporabo zdravila, iz člena 36(4) Direktive 2001/82/ES.
Young cattle (bovine) Not for use in cows producing milk for human consumption
Mlado govedo Ni za uporabo pri kravah za mleko za prehrano ljudi
A theoretical risk management option would be to maintain the status quo with respect to the divergence in the different EU Member States of user safety warnings, and additional safety measures, such as limitations of volume to be held per syringe, or restriction to use by veterinarians.
Teoretična možnost upravljanja s tveganjem bi bila vzdrževanje statusa quo glede razlik med posameznimi državami članicami EU v varnostnih opozorilih za uporabnike in dodatnih varnostnih ukrepih, kot so omejitve volumna na brizgo in omejitev uporabe na samo veterinarje.
This measure would additionally increase the stress to the treated animals by longer duration of restraint and multiple injections and reduce the benefits of the product in respect to a higher number of injection sites.
Ta ukrep bi dodatno povečal stres pri zdravljenih živalih zaradi časovno dolgotrajnejšega zadržanja, večkratnega injiciranja in zmanjšanja koristnih učinkov zdravila glede na večje število mest injiciranja.
The CVMP did not consider it necessary to recommend a limitation of the amount of Micotil to be held per syringe.
Po mnenju CVMP ni potrebe po priporočilu omejitve količine zdravila Micotil na brizgo.
When administered by injection, tilmicosin has been fatal in various species, including primates (in monkeys 30 mg/kg bw were shown to be fatal), mainly due to its cardio-toxic effects.
Pri injiciranju je bil tilmikozin usoden za različne živalske vrste, vključno s primati (pri opicah je bil smrtni odmerek 30 mg/kg TM), predvsem zaradi svojih kardiotoksičnih učinkov.
Concerns were raised concerning the adequacy of the existing safety warnings and conditions for use of the product in protecting users from self-injection and its potential serious consequences as well as the need to provide adequate information for medical action in case of such an occurrence or abuse of the product (suicide).
Predstavljeni so bili zadržki o ustreznosti sedanjih varnostnih opozoril in pogojev uporabe zdravila v smislu varovanja uporabnika pred samoinjiciranjem in potencialno hudimi posledicami; predstavljena je bila tudi potreba po zagotovitvi zadostnih podatkov za zdravniško oskrbo v primeru takšnih dogodkov ali zlorabe zdravila (samomor).
The blockade of this cardiac current is a possible mechanism for the negative inotropic effects that have been observed following the administration of the compound to conscious dogs.
Blokada tega srčnega električnega toka je možen mehanizem negativnih inotropnih učinkov, ki so jih opazili po dajanju te spojine psom pri zavesti.
Appropriate educational measures targeted at users (mainly the agricultural community) would be undertaken by the MAHs.
Ustrezne izobraževalne ukrepe za uporabnike (predvsem kmetijsko skupnost) bi izvedli imetniki dovoljenj za promet.
The CVMP is aware that educational measures are not likely to be 100% effective in reaching the intended target audience, the users, and will require repetition at regular intervals in order to achieve a high level of awareness.
CVMP se zaveda, da izobraževalni ukrepi verjetno ne bodo 100-odstotno učinkovito dosegli ciljnega občinstva, uporabnikov, in bodo za doseganje visoke stopnje zavesti potrebne ponovitve v rednih časovnih presledkih.
Furthermore the revised aspects of the Summary of Product Characteristics should be implemented in the labelling and product leaflet as set out below.
Poleg tega je treba spremembe Povzetka glavnih značilnosti zdravila uvesti tudi v označevanje zdravila in njegovo navodilo za uporabo, kakor je prikazano spodaj.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, NAČINA UPORABE, ŽIVALSKIH VRST IN IMETNIKOV DOVOLJENJ ZA PROMET Z ZDRAVILOM V ZADEVNIH DRŽAVAH ČLANICAH
Keep the syringe and needle separate at all other times.
Brizga in igla morata biti vedno ločeni.
The fact that the product is administered subcutaneously may also be considered as a benefit from the point of view of the quality of foodstuffs (muscle) when compared to certain so-called long acting formulations such as tetracyclines.
Dejstvo, da se zdravilo daje subkutano, se lahko z vidika kakovosti živil (mišic) v primerjavi s pripravki s podaljšanim delovanjem (npr. tetraciklini) smatra kot korist.
On the inside of the peel-back label
Notranja stran odlepljive nalepke
The representative of the MAHs further identified a report of accidental injection in humans where CaCl2 had been used as part of the emergency treatment of the patient.
Predstavnik imetnikov dovoljenj za promet z zdravili je nadalje predložil poročilo o nenamernem injiciranju pri ljudeh, kjer so uporabili CaCl2 kot del nujnega zdravljenja bolnika.
- The CVMP is aware that educational measures are not likely to be 100% effective in reaching all intended targets and will require repetition at regular intervals in order to achieve a high level of awareness.
- CVMP se zaveda, da izobraževalni ukrepi verjetno ne bodo 100-odstotno učinkovito dosegli celotnega ciljnega občinstva in bodo za doseganje visoke stopnje zavesti potrebne ponovitve v rednih časovnih presledkih.
- A residual risk remains that the veterinary surgeon may not fully comply with the recommended measures intended to ensure their personal safety (e.g. the user may fail to detach the needle from the syringe containing the product).
- Ostaja tveganje, da veterinarji morda ne bodo popolnoma upoštevali priporočenih ukrepov, ki so namenjeni njihovi osebni varnosti (tj. uporabniki morda ne bodo sneli igle iz brizge z zdravilom).
Some form of documentation would be required to note the dispensing veterinary surgeon's decision to consider a person suitably qualified, where the suitably qualified person also acknowledges understanding of the risks afforded by the product, the implications with respect to personal safety and regarding safe storage.
Potrebna je dokumentacija, kjer bo zabeležena odločitev veterinarja, ki je izdaja zdravilo, o primerni usposobljenosti posamezne osebe in kjer bo primerno usposobljena oseba potrdila, da razume tveganja, povezana z zdravilom, posledice v zvezi z osebno varnostjo in varnim shranjevanjem.
The primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotrophy).
Primarni kardiološki učinki so zvišana srčna frekvenca (tahikardija) in zmanjšana krčljivost (negativna inotropija).
The risk of failure of the proposed measure is considered as very real; - The users of the products, though a number may be highly qualified and experienced in handling farm animals, are likely to be very divergent in respect to experience in handling and administration of medicines of high toxic potential.
Pričakuje se realno tveganje neuspeha predlaganega ukrepa; - Čeprav so lahko nekateri uporabniki zdravila visoko usposobljeni in izkušeni pri ravnanju z domačimi živalmi, se ostali verjetno zelo razlikujejo med seboj v izkušenosti pri ravnanju z zdravili in dajanjem zdravil z visokim potencialom toksičnosti.
The use of the product would be restricted to veterinary surgeons only.
Uporaba zdravila bi bila omejena samo na veterinarje.
The results of an additional study with administration of epinephrine as a treatment for combating intravenous tilmicosin toxicity in swine strongly suggest that intravenous administration of epinephrine may be contraindicated due to the rate of deaths in the treated group.
Rezultati dodatne raziskave z dajanjem epinefrina za zdravljenje intravenske toksičnosti tilmikozina pri prašičih močno nakazuje, da je morda intravensko dajanje epinefrina kontraindicirano zaradi visoke smrtnosti v skupini, ki je prejemala zdravljenje.
Qualitative risk assessment
Kvalitativno vrednotenje tveganja
Before attempting a quantitative risk assessment for human adverse reactions to Micotil, it must be pointed out that any calculations of incidences of reactions in veterinary pharmacovigilance can only be regarded as rough estimates that are influenced by many variables, not the least uncertainties regarding actual doses used in order to estimate the number of animal treatments, and under reporting of actual occurrences of adverse reactions.
Pred poskusom kvantitativnega vrednotenja tveganja neželenih reakcij na Micotil pri človeku, je treba izpostaviti, da se lahko vse izračune pojavnosti reakcij v veterinarski farmakovigilanci jemlje kot grobe ocene, na katere vplivajo številne spremenljivke, med drugim tudi negotovost dejansko uporabljenih odmerkov, na podlagi katerih bi ocenili število epizod zdravljenj živali, in podcenjeno dejansko poročanje o neželenih učinkih.
Considering the recommendation of the Committee to restrict use to veterinary surgeons only, restriction of maximum pack size is not relevant, as the product will remain in the care of the veterinary surgeon.
V okviru priporočila Odbora o omejitvi uporabe na samo veterinarje omejitev največjega pakiranja ni smiselna, ker bo zdravilo v presoji veterinarja.
In particular, therapeutic levels of the antibacterial tilmicosin are reported to occur in the lung within one hour of administration of Micotil in animals.
Zlasti zato, ker protibakterijska učinkovina tilmikozin v pljučih doseže terapevtske ravniže v eni uri po dajanju zdravila Micotil pri živalih.
Appropriate educational measures for veterinary surgeons in practice would be required of the MAH to ensure awareness of veterinary surgeons to the changed evaluation of the product.
Z ustreznimi izobraževalnimi ukrepi za veterinarje v praksi bi moral imetnik dovoljenja za promet (MAH) zagotoviti zavedanje veterinarjev o spremenjeni oceni zdravila.
• Never carry a syringe loaded with Micotil 300 with the needle attached.
• Nikoli ne prenašajte brizge napolnjene z zdravilom Micotil 300 in nameščeno iglo.
However, serious adverse reactions after accidental injection have been reported.
Vendar so bila poročila o hudih neželenih reakcijah po nenamernem injiciranju.
Following oral or parenteral administration of tilmicosin the main target organ for toxicity is the heart.
Pri peroralni ali parenteralni uporabi je srce poglavitni ciljni organ toksičnih učinkov tilmikozina.
No accidental fatalities due to accidental injection of Micotil have been reported in the EU.
V EU ni zabeleženih nezgodnih smrti zaradi nenamernega injiciranja zdravila Micotil.
NOTE TO THE PHYSICIAN
OPOMBA ZA ZDRAVNIKA
If a group of animals is to be treated, leave the needle in the vial as a draw-off needle for subsequent doses.
Če zdravite skupino živali, pustite iglo v viali za odmerjanje naslednjih odmerkov.
Subsequent studies were conducted to determine if intravenous calcium chloride administration reduces or diminishes this toxic cardiovascular effect of tilmicosin.
S kasnejšimi raziskavami so ugotavljali, ali intravensko dajanje CaCl2 zmanjša ali odpravi ta toksični kardiovaskularni učinek tilmikozina.
Product trade name
Lastniško ime izdelka
NOTE TO THE PHYSICIAN: Please see inside part of label or package leaflet for details.
OPOMBA ZA ZDRAVNIKA: Za podrobnosti glejte notranji del nalepke ali navodilo za uporabo.
Exposure assessment
Vrednotenje izpostavitve
Calculation of number of administrations (doses) based on a 10 mg/kg BW dose, 90% in cattle (250 kg BW) and 10% in sheep (30 kg BW) for the USA.
Izračun števila odmerjanj (odmerkov) je za ZDA temeljilo na odmerku 10 mg/kg TM, 90 % pri govedu (250 kg TM) in 10 % pri ovcah (30 kg TM).
However, it is possible that if the lay use of the product were to continue, any improvements in medical advice and hospital care might be of academic use as the appropriate medical intervention could be too late.
Če pa bi bila uporaba zdravila s strani laikov še naprej možna, bi bila vsa izboljšanja nasvetov in bolnišnične oskrbe nepraktična, saj bi bila ustrezna zdravniška oskrba prepozna.
Cattle (not to be used in lactating cows)
Govedo (ni za uporabo pri kravah v obdobju laktacije)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON -ALL AUTHORISED PACK SIZES
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLICA - VSA ODOBRENA PAKIRANJA
Although the actual role of CaCl2 infusion following tilmicosin exposure in humans is inconclusive because of the limited data available, it is suggested that CaCl2 infusion may help to reverse the induced changes in blood pressure and heart rate in humans.
Čeprav dejanska vloga infundiranja CaCl2 po izpostavitvi tilmikozinu pri ljudeh ni dokončna zaradi omejene količine podatkov, ki so na voljo, izgleda, da infundiranje CaCl2 pri ljudeh lahko pripomore k spremembi induciranih sprememb krvnega tlaka in srčne frekvence.
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
NAČIN UPORABE IN DAJANJA Pred uporabo preberite navodila za uporabo.
Two fatalities following accidental injection of Micotil were reported in the United States but no accidental human fatality has ever been reported in Europe since the introduction of Micotil.
Iz Združenih držav Amerike poročajo o dveh smrtnih primerih po nenamernem injiciranju zdravila Micotil, vendar v Evropi od uvedbe zdravila Micotil nikoli ni bilo poročil o nezgodnih smrtnih primerih pri ljudeh.
Cardiovascular toxicity may be due to calcium channel blockade.
Kardiovaskularna toksičnost je lahko posledica blokiranja kalcijevih kanalčkov.
The CVMP concurs with the representative of the MAHs that ‘the risk of fatal outcome as a result of an accidental injection/self-injection can be related to the following factors: dose, unrestrained animals, unprotected needles attached to a loaded syringe, working in isolation, the lack of accessible product information for emergency or health care professional to determine suitable treatments'.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) se strinja s predstavnikom imetnikov dovoljenj za promet, da je „tveganje smrtnega izida kot posledice nenamernega injiciranja/samoinjiciranja povezano z naslednjimi dejavniki: odmerek, nezadržane živali, nezaščitene igle na napolnjeni brizgi, delo brez spremljevalcev, nedostopnost podatkov o zdravilu za osebje nujne medicinske pomoči in zdravstveno osebje, na podlagi katerih bi se lahko izbralo primerno zdravljenje“.
In pigs, intramuscular injection of 10 mg tilmicosin/kg caused increased respiration, emesis and convulsions; 20 mg/kg resulted in mortality in 3 of 4 pigs, and 30 mg/kg caused the death of all 4 pigs tested.
Pri prašičih je intramuskularno injiciranje 10 mg tilmikozina/kg povzročilo pospešeno dihanje, bruhanje in krče; odmerek 20 mg/kg je povzročil smrt pri 3 od 4 prašičev, odmerek 30 mg/kg pa je povzročil smrt pri vseh 4 preskušanih prašičih.
Under paragraph 4.9 “Amounts to be administered and administration route”
Pod točko 4.9 „Odmerjanje in način uporabe“
Restrain the animal and insert a separate needle subcutaneously into the injection site.
Zadržite žival in subkutano uvedite drugo iglo na mesto injiciranja.
• Never carry a syringe loaded with Micotil with the needle attached.
• Nikoli ne prenašajte brizge napolnjene z zdravilom Micotil in nameščeno iglo.
Injection in a fold of skin over the rib cage behind the shoulder is suggested.
Priporoča se kožna guba nad rebri za pleči.
Netherlands Eli Lilly Nederland B.V. Postbus 379
Nizozemska Eli Lilly Nederland B.V.
The needle should be connected to the syringe only when filling the syringe or administering the injection.
Iglo namestite na brizgo samo pri polnjenju brizge ali injiciranju.
Other aspects relevant to the risk assessment include the fact that the use in cattle probably carries a higher risk of serious adverse effects in humans than would be the case in sheep due to the fact that adult cattle may be more physically threatening and the volumes used are higher.
Pomemben vidik vrednotenja tveganja je dejstvo, da je z govedom povezano večje tveganje za hude neželene učinke pri človeku kot z ovcami, ker je odraslo govedo fizično bolj ogrožajoče in ker se za govedo uporabljajo večji volumni zdravila.
A number of risk management options considered by the CVMP are detailed below.
V spodnjem besedilu so podrobno predstavljene možnosti upravljanja s tveganjem, o katerih je razpravljal CVMP.
Physicians treating patients exposed to this compound are advised to discuss clinical management with the National Poisons Information Service on: (indicate here the telephone number of the centre).
Zdravnikom, ki zdravijo bolnike izpostavljene tej spojini, svetujemo, da se o kliničnem postopanju posvetujejo s Centrom za zastrupitve na: (telefonska številka Centra).
The use of a 2 ml or smaller syringe will facilitate accurate dosing.
Natančnejše odmerjanje bo lažje z 2-mililitrsko ali manjšo brizgo.
- Clear warning that injection of the product in human beings has been associated with fatalities; - Instructions for safe use of the product (use different needles for loading a syringe and injecting into an animal, always uncouple syringe from needle during transport); - Instructions to properly restrain animals (the one treated and others in the vicinity); - Instructions never to work alone; - Recommendation to provide the physician with the vial or the package leaflet in case of accidental injection; - Note to the physician in the package leaflet and SPC detailing the known effects of Micotil in human beings, treatments to be avoided and substances that may partially counter certain effects of Micotil, including telephone numbers of national poison centres.
- Jasno opozorilo, da je injiciranje tega zdravila v človeka povezano s smrtnimi primeri; - Navodila za varno uporabo zdravila (uporaba različnih igel za polnjenje brizge in injiciranje v žival, vedno sneti brizgo z igle med prenašanjem); - Navodila za ustrezno zadržanje živali (zdravljene živali in živali v bližini); - Navodilo, da mora biti pri dajanju zdravila prisotnih več oseb; - Priporočilo, da se zdravniku v primeru nenamernega injiciranja pokaže viala ali navodilo za uporabo; - Opomba zdravniku v navodilu za uporabo in SPC s podrobnostmi o znanih učinkih zdravila Micotil pri človeku, postopkih zdravljenja, katerim se je treba izogniti, in snoveh, ki delno zmanjšajo določene učinke zdravila Micotil, ter telefonskimi številkami nacionalnih centrov za zastrupitve.
The incidence of accidental injection or accidental self-injection of Micotil has also been estimated by the representative of the MAHs as 1.6 per million administrations, with an overall incidence of accidental exposure of a human being of 3 exposures per million administrations.
Pojavnost nenamernega injiciranja ali nenamernega samoinjiciranja zdravila Micotil je ocenil tudi predstavnik imetnikov dovoljenj za promet na podlagi 1,6 milijona odmerjanj, pri čemer je bila ugotovljena skupna pojavnost nenamerne izpostavitve človeka 3 na milijon odmerjanj.
Such a volume restriction would necessitate additional administrations to the same animal.
Zaradi takšne omejitve volumna bi bilo potrebno isti živali zdravilo dati večkrat.
- the Committee, having considered the referral question whether the wording with regard to the safety of users of the Micotil product literature should be harmonised in respect of a restriction to use by veterinary surgeons only, by majority considered that the condition of use be harmonised to ‘For use by veterinary surgeons only'; this condition was considered essential for the safe use of the veterinary medicinal product;
- Odbor je po preučitvi vprašanja v napotitvi, ali naj se besedilo v zvezi z varnostjo uporabnikov v literaturi zdravila Micotil uskladi z omejitvijo uporabe na samo veterinarje, z večino ugotovil, da se pogoj za uporabo uskladi z besedilom ‘Zdravilo lahko uporablja samo veterinar'; ta pogoj se smatra kot ključen za varno uporabo zdravila za veterinarsko uporabo;
Pre-clinical data and an isolated clinical report suggest that calcium chloride infusion may help to reverse tilmicosin induced changes in blood pressure and heart rate in humans.
Predklinični podatki in osamljeno klinično poročilo kažejo, da infundiranje kalcijevega klorida pri ljudeh lahko pripomore k spremembi induciranih sprememb krvnega tlaka in srčne frekvence.
Tilmicosin can cause fatalities in human beings following injection of high doses of the substance.
Tilmikozin lahko pri človeku ob injiciranju velikih odmerkov povzroči smrt.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS:
PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA:
Appropriate educational measure targeted at users (veterinary surgeons and the agricultural community) would be undertaken by the MAHs.
Ustrezne izobraževalne ukrepe za uporabnike (veterinarje in kmetijsko skupnost) bi jih izvedli imetniki dovoljenj za promet.
- the Committee, having considered the referral question whether the wording of the Micotil product literature should be harmonised with regard to the volume to deliver per syringe with regard to the safety of users, unanimously did not consider such a restriction to be an appropriate measure in order to ensure appropriate user safety throughout the EU;
- Odbor je po preučitvi vprašanja v napotitvi, ali naj se besedilo v zvezi z varnostjo uporabnikov v literaturi zdravila Micotil uskladi glede volumna za injiciranje na brizgo, soglasno ugotovil, da takšna omejitev ni ustrezen ukrep za zagotovitev ustrezne varnost uporabnikov po EU;
By contrast it seems probable that the risk of non-fatal effects in humans following use in sheep would be higher than in cattle due to the fact that sheep require a lower dose and the product may be widely used in such animals.
Zaradi tega se zdi, da je pri uporabi pri ovcah lahko večje tveganje nesmrtnih učinkov kot pri govedu, ker se za ovce uporabljajo manjši odmerki in ker je zdravilo široko uporabljeno za zdravljenje teh živali.