natgillin/translations-raw huggingface dataset:
Pack of 4 boxes containing glass cartridges 50 x 1.7 ml.
Škatla s 50 samoaspiracijskimi steklenimi vložki po 1,7 ml. Pakiranje s 4 škatlami s 50 steklenimi vložki po 1,7 ml. Pakiranje z 8 škatlami s 50 steklenimi vložki po 1,7 ml.
o 1 ml of X contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).
o 1 ml zdravila X vsebuje 40 mg artikainijevega klorida in 5 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
• use other local anaesthetics, medicines that cause reversible loss of sensation (including volatile anaesthetics such as halothane);
• jemljete druge lokalne anestetike, zdravila, ki povzročajo povratno izgubo čutnih zaznav
Ptosis
Odmerjanje
However, accidental soft tissue injury was observed more frequently, especially in 3 to 7 year old children, due to the prolonged soft tissue anaesthesia.
7 let, zaradi podaljšanega trajanja anestezije mehkih tkiv.
Hyperacusis Tinnitus4
vključno z motnjami labirinta redki hiperakuza, tinitus4
This medicinal product must be used with special caution in patients with the following disorders and postponement of dental surgery should be considered if the condition is severe and/or unstable.
Če je stanje resno in/ali nestabilno, je treba razmisliti o odložitvi zobozdravstvene operacije.
Clinical efficacy and safety: {(Invented) name and associated names (see Annex I)} has an onset of 1.51.8 min for infiltration and 1.4-3.6 min for nerve block.
I)} se pojavi od 1,5 do 1,8 min po infiltraciji in od 1,4 do 3,6 min po živčnem bloku.
Uncommon side effects: may affect up to 1 in 100 people:
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): • pekoč občutek,
Drugs causing arrhythmias (e.g., antiarrhythmics like digitalis, quinidine): Dose of administration of this medicinal product should be reduced due to the increased risk of arrhythmia when both adrenaline and digital glucosides are administered concomitantly to patients.
Če se adrenalin in digitalisovi glikozidi uporabljajo sočasno, je zaradi večjega tveganja za aritmijo treba zmanjšati odmerek tega zdravila.
1 ml of solution for injection contains 40 mg of articaine hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).
1 ml raztopine za injiciranje vsebuje 40 mg artikainijevega klorida in 5 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
Nervousness / anxiety4 Not known Euphoric mood
neznana pogostnost evforično razpoloženje
NAME OF THE MEDICINAL PRODUCT {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
IME ZDRAVILA {(Izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 5 mikrogramov/ml raztopina za injiciranje artikainijev klorid/adrenalin
1 ml of solution for injection contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).
1 ml raztopine za injiciranje vsebuje 40 mg artikainijevega klorida in 10 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
NAME OF THE MEDICINAL PRODUCT {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
IME ZDRAVILA {(Izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 10 mikrogramov/ml raztopina za injiciranje artikainijev klorid/adrenalin
o 1 ml of Y contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).
o 1 ml zdravila Y vsebuje 40 mg artikainijevega klorida in 10 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
The lowest dose leading to effective anaesthesia should be used.
Uporabiti je treba najmanjši odmerek, ki zagotovi učinkovito anestezijo.
Each cartridge of 1.7 ml contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
Vsak vložek z 1,7 ml raztopine vsebuje 68 mg artikainijevega klorida in 17 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
Risk of biting trauma (lips, cheeks, mucosa, and tongue) exists, especially in children; the patient should be told to avoid chewing gum or eating until normal sensation is restored.
Bolniku je treba pojasniti, naj se izogiba žvečenju žvečilnega gumija ali uživanju hrane, dokler se ne povrne normalna čutna zaznava.
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva občasni bolečina v vratu redki trzanje mišic4
• swelling of tongue, lips and gums
• nizek krvni tlak, • otekanje jezika, ustnic in dlesni.
Each cartridge of 1.7 ml contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
Vsak vložek z 1,7 ml raztopine vsebuje 68 mg artikainijevega klorida in 8,5 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
Somnolence (Drowsiness) Nystagmus
nevralgija (nevropatska bolečina),
Each cartridge of 1.7 ml of solution for injection contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
En vložek z 1,7 ml raztopine za injiciranje vsebuje 68 mg artikainijevega klorida in 17 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
The use of {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection over {(Invented) name and associated names (see Annex I)} 40 mg/ ml + 10 micrograms/ml, solution for injection should be considered on account of its lower adrenaline content of 5 micrograms/ml in:
Zaradi manjše vsebnosti adrenalina (5 mikrogramov/ml) morate razmisliti o uporabi zdravila {(izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 5 mikrogramov/ml raztopina za injiciranje namesto zdravila {(izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 10 mikrogramov/ml raztopina za injiciranje pri:
tranylcypromine, linezolide);
psevdoefedrin, oksimetazolin):
Each cartridge of 1.7 ml of solution for injection contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
En vložek z 1,7 ml raztopine za injiciranje vsebuje 68 mg artikainijevega klorida in 8,5 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
Dose and rate of administration of this medicinal product should be reduced due to an increased risk of severe hypertension.
Zaradi večjega tveganja za pojav hude hipertenzije je treba odmerek in hitrost aplikacije tega zdravila zmanjšati.
o Each cartridge of 1.7-ml of solution for injection of X contains 68 mg of articaine hydrochloride and 8.5 micrograms of adrenaline (as adrenaline tartrate).
o En vložek zdravila X z 1,7 ml raztopine za injiciranje vsebuje 68 mg artikainijevega klorida in 8,5 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {(Invented) name and associated names (see Annex I)} 40 mg/ml + 5 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
IME ZDRAVILA IN POT(I) UPORABE {(Izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 5 mikrogramov/ml raztopina za injiciranje artikainijev klorid/adrenalin dentalna uporaba
• rash, itching, swelling of the throat and difficulty breathing: this might be symptoms of an allergic
• izpuščaj, srbenje, otekanje žrela in težave pri dihanju.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION {(Invented) name and associated names (see Annex I)} 40 mg/ml + 10 micrograms/ml, solution for injection articaine hydrochloride/adrenaline
IME ZDRAVILA IN POT(I) UPORABE {(Izmišljeno) ime in povezana imena (glejte Prilogo I)} 40 mg/ml + 10 mikrogramov/ml raztopina za injiciranje artikainijev klorid/adrenalin dentalna uporaba
Swelling of tongue, lip, gums Uncommon Stomatitis, glossitis Nausea, vomiting, diarrhoea
Bolezni prebavil pogosti otekanje jezika, ustnic, dlesni občasni stomatitis, glositis, navzea, bruhanje, driska redki eksfoliacija (luščenje)/ulceracija dlesni/ustne sluznice neznana pogostnost disfagija, otekanje lic, glosodinija
What X / Y contains - The active substances are articaine hydrochloride and adrenaline tartrate.
- Učinkovini sta artikainijev klorid in adrenalinijev tartrat.
Respiratory, thoracic and mediastinal disorders
raztopina za injiciranje Bistra in brezbarvna raztopina.
o Each cartridge of 1.7-ml of solution for injection of Y contains 68 mg of articaine hydrochloride and 17 micrograms of adrenaline (as adrenaline tartrate).
o En vložek zdravila Y z 1,7 ml raztopine za injiciranje vsebuje 68 mg artikainijevega klorida in 17 mikrogramov adrenalina (v obliki adrenalinijevega tartrata).
Angioedema (face / tongue / lip / throat / larynx / periorbital oedema) Urticaria
srbenje redki angioedem (edem obraza/jezika/ustnic/žrela/grla/ periorbitalni edem), urtikarija neznana pogostnost rdečina,
Precautions to be taken before handling or administering the medicinal product
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
• Cardiac impulse formation and conduction disturbances (e.g. 2nd or 3rd degree atrioventricular block,
Najmanjši odmerek, ki zagotovi učinkovito anestezijo, je treba uporabiti v naslednjih primerih: • motnje nastanka in prevajanja srčnih impulzov (npr. atrioventrikularni blok druge ali tretje stopnje,
• sympathomimetic vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine,
• zdravila za zdravljenje napadov migrene (kot sta metizergid ali ergotamin), • simpatikomimetične vazopresorje (kot so kokain, amfetamini, fenilefrin, psevdoefedrin ali oksimetazolin), ki zvišujejo krvni tlak: če ste jih uporabili v zadnjih 24 urah, je načrtovani zobozdravstveni poseg treba odložiti;
Halogenated volatile anaesthetics (e.g., halothane):
Zaviralci COMT (zaviralci katehol O-metiltransferaze) (npr. entakapon, tolkapon):
10 DATE OF REVISION OF THE TEXT [To be completed nationally]
[Glejte Prilogo I - Izpolni država članica.]
It was to be available as tablets (0.5, 1 and 2 mg).
Na voljo naj bi bilo v obliki tablet (0,5, 1 in 2 mg).
The letter from the company notifying the Agency of the withdrawal of the application is available here.
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo tukaj.
The company had not yet responded to the last round of questions at the time of the withdrawal.
Družba se ob umiku vloge še ni odzvala na zadnji sklop vprašanj.
This means that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
To pomeni, da je CHMP takrat ocenjeval dokumentacijo, ki jo je predložila družba, in pripravil sezname vprašanj.
The CHMP was concerned about an impurity in the medicine and about the way the company had analysed the results of the bioequivalence study.
CHMP je izrazil zadržke v zvezi z nečistoto v zdravilu in v zvezi s tem, kako je družba analizirala rezultate študije biološke enakovrednosti.
On 23 March 2010, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Repaglinide Sun for the treatment of type 2 diabetes.
je dne 23. marca 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Repaglinide Sun, namenjeno zdravljenju sladkorne bolezni tipa 2.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Repaglinide Sun could not have been approved.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih zastavil CHMP, je Odbor v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Repaglinide Sun ni mogoče odobriti.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Repaglinide Sun did not outweigh its risks.
Zato je CHMP v času umika vloge menil, da koristi zdravila Repaglinide Sun ne odtehtajo tveganj, povezanih z njim.
This means that Repaglinide Sun was intended to be similar to a ‘reference medicine' already authorised in the European Union called NovoNorm.
To pomeni, da je zdravilo Repaglinide Sun podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu NovoNorm.
Repaglinide Sun was developed as a ‘generic medicine'.
Zdravilo Repaglinide Sun je bilo razvito kot „generično zdravilo“.
Because Repaglinide Sun was developed as a generic medicine, the company presented the results of a study carried out to investigate whether it is ‘bioequivalent' to the reference medicine or not.
Ker je bilo zdravilo Repaglinide Sun razvito kot generično zdravilo, je družba predložila rezultate študije, ki je bila opravljena za proučitev, ali je zdravilo biološko enakovredno referenčnemu zdravilu.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za vzdrževanje primerne ravni glukoze v krvi ali pri kateri telo ne more učinkovito izrabljati insulina.
Repaglinide Sun is a medicine that contains the active substance repaglinide.
Repaglinide Sun je zdravilo, ki vsebuje zdravilno učinkovino repaglinid.
Repaglinide Sun was expected to be used in patients who have type 2 diabetes.
Zdravilo Repaglinide Sun naj bi se uporabljalo za zdravljenje bolnikov s sladkorno boleznijo tipa 2.
Repaglinide Sun was to be used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) could not be controlled by diet, weight reduction and exercise.
Zdravilo Repaglinide Sun naj bi se uporabljalo skupaj z dieto in telesno dejavnostjo za znižanje glukoze (sladkorja) v krvi pri bolnikih, pri katerih hiperglikemije (visokih ravni glukoze v krvi) ni več mogoče nadzorovati z dieto, zmanjšanjem telesne mase in telesno dejavnostjo.
What is Repaglinide Sun?
Kaj je zdravilo Repaglinide Sun?
Repaglinide Sun was also to be used together with metformin (another antidiabetes medicine) in type 2 diabetes patients whose blood glucose levels were not satisfactorily controlled on metformin alone.
Zdravilo Repaglinide Sun naj bi se uporabljalo tudi skupaj z metforminom (drugim zdravilom proti sladkorni bolezni) pri bolnikih s sladkorno boleznijo tipa 2, pri katerih samo z metforminom ni možno zadovoljivo nadzorovati ravni glukoze v krvi.
Repaglinide Sun is expected to work in the same way as the reference medicine, NovoNorm, by helping the pancreas to produce more insulin at mealtimes.
Zdravilo Repaglinide Sun naj bi delovalo enako kot referenčno zdravilo NovoNorm, in sicer naj bi spodbujalo trebušno slinavko, da med obroki tvori več insulina.
What was Repaglinide Sun expected to be used for?
Za kaj naj bi se zdravilo Repaglinide Sun uporabljalo?
How is Repaglinide Sun expected to work?
Kako naj bi zdravilo Repaglinide Sun delovalo?
Name Strength Pharmaceutical Form
Ime Jakost Farmacevtska oblika Pot uporabe
Package size bottle (HDPE)
100 Tablet EU/1/11/739/008 Dasselta 5 mg Filmsko obložena tableta Peroralna uporaba vsebnik za tablete (HDPE) 250 Tablet
The effect is generally time-dependent.
Delovanje je na splošno odvisno od časa.
Do not use in automatically powered syringes which have no additional protection system.
Ne uporabljajte v avtomatskih brizgah, ki nimajo dodatnega varovalnega sistema.
These swellings resolved within 1 to 6 days.
Te otekline so splahnele v 1 do 6 dneh.
ATCvet code: QJ01FA96.
Oznaka ATC vet: QJ01FA96
The mean terminal half-life is 4.4 days.
Povprečni končni razpolovni čas je 4,4 dni.
Bovine respiratory disease
Goveja respiratorna bolezen
Data were collected on zoonotic bacteria and commensals.
Podatki so bili zbrani na zoonotskih bakterijah in komenzalih.
Otherwise, the use of a multiple-dose syringe is recommended.
Sicer pa se priporoča uporaba brizge za večkratno odmerjanje.
S: susceptible; I: intermediate; R: resistant
O: občutljiv; S: srednji; R: rezistenten
Piglet, newborn Piglet, 3-4 weeks Growing
Pujski, novorojeni Pujski, stari 3-4 tedne
The antimicrobial activity spectrum of tildipirosin includes:
Spekter antimikrobnega delovanja tildipirozina vključuje:
Disk content
Vsebnost diska
MIC values for Salmonella were reported to be in the range of 4-16 µg/ml, and all strains were wild type.
Vrednosti MIK za Salmonella so bile v razponu od 4-16 µg/ml in vsi sevi so bili divji.
Swellings persisted for up to 3 days.
Otekline so trajale do 3 dni.
Therapeutic classification
Terapevtska klasifikacija
Injection should be given in a horizontal direction and a 90° angle to the body axis.
Injekcijo je treba dati v vodoravni smeri in v kotu 90° na os telesa.
Mortality was observed at doses of 25 mg/kg body weight and higher.
Smrtnost so opazili pri odmerkih 25 mg/kg telesne teže in večjih.
Macrolides are characterised by their extensive partitioning into tissues.
Za makrolide je značilna njihova obsežna porazdelitev v tkiva.
Macrolides in general are bacteriostatic antibiotics but for certain pathogens can be bactericidal.
Makrolidi na splošno so bakteriostatični antibiotiki, za nekatere patogene pa so lahko baktericidni.
The excipients 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.
Pomožne snovi, navedene v poglavju 6.1 Povzetka glavnih značilnosti zdravila, so bodisi dovoljene snovi, za katere je v tabeli 1priloge Uredbe Komisije (EU) št. 37/2010 navedeno, da MRL niso potrebni ali pa velja mnenje, da ne spadajo v okvir Uredb (ES) št. 470/2009, kadar se uporabljajo tako kot v tem zdravilu za uporabo v veterinarski medicini.
Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.
Kadar je le mogoče, uporabljajte zdravilo za uporabo v veterinarski medicini samo na podlagi testiranja občutljivosti.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Uradno, državno in lokalno antimikrobno politiko je treba upoštevati vedno, kadar uporabljate zdravilo za uporabo v veterinarski medicini.
The injection volume should not exceed 5 ml per injection site.
Volumen injiciranega zdravila naj ne preseže 5 ml na mesto injiciranja.
The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.
Prisotnost bolezni v čredi mora biti potrjena, preden se začne z metafilakso.
They inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA and act by blocking the prolongation of the peptide chain.
Preprečujejo biosintezo esencielnih beljakovin s selektivno vezavo na bakterijsko ribosomsko RNK in delujejo tako, da blokirajo podaljšanje peptidne verige.
Do not administer intravenously.
Ne dajajte intravensko.
For treatment of cattle over 450 kg body weight, divide the dose so that no more than 10 ml are injected at one site.
Pri zdravljenju goveda nad 450 kg telesne teže razdelite odmerek tako, da ne boste injicirali več kot 10 ml na eno mesto injiciranja.
Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer NIZOZEMSKA
The product has a long duration of action; however, the exact clinical effect duration after a single injection is unknown.
Zdravilo ima dolgotrajno delovanje, vendar pa točno trajanje kliničnega delovanja po enkratnem odmerku ni znano.
Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Ker ni študij kompatibilnosti, tega zdravila za uporabo v veterinarski medicini ne smete mešati z drugimi zdravili za uporabo v veterinarski medicini.
Following metaphylactic use, approximately 86% of the healthy animals remained free of clinical signs of disease (as compared to approximately 65% of animals in the untreated control group).
Po metafilaktični uporabi je približno 86 % zdravih živali ostalo brez kliničnih znakov bolezni (v primerjavi s približno 65 % živali v nezdravljeni kontrolni skupini).
Three amine substituents at the macrocyclic lactone ring result in a tri-basic character of the molecule.
Zaradi treh substituentov amina na makrocikličnem laktonskem obroču ima molekula tri-bazični značaj.
In line with responsible use principles, metaphylactic use of Zuprevo is only indicated in severe outbreaks of SRD caused by the indicated pathogens.
V skladu z načeli za odgovorno uporabo je metafilaktična uporaba zdravila Zuprevo indicirana samo v hudih izbruhih prašičje respiratorne bolezni, ki jo povzročijo indicirani patogeni.
180 mg. For the full list of excipients, see section 6.1.
180 mg Za celoten seznam pomožnih snovi glejte poglavje 6.1.
The mean terminal half-life is approximately 9 days.
Povprečna končna razpolovna doba je 9 dni.
Special attention should be paid to using the appropriate injection site and to use the appropriate needle size and length (adjusted to the size and weight of animal) according to Good Veterinary Practice.
Posebno je treba paziti, da izberete primerno mesto za injiciranje in da uporabite primerno velikost in dolžino igle (glede na velikost in težo živali) v skladu z dobro veterinarsko prakso.
However, there was no evidence for any selective developmental or reproductive effects in any of the laboratory studies.
Z laboratorijskimi študijami niso bili dokazani selektivni razvojni ali reproduktivni učinki.
4.7 Use during pregnancy and lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
Minimum inhibitory concentration (MIC) data for the target pathogens (wild type distribution) are presented in the table below.
Podatki o minimalni inhibitorni koncentraciji (MIK) za ciljne patogene (distribucija divjega tipa) so prikazani na spodnji preglednici.
Carton Box
Kartonska škatla
5831 AN Boxmeer The NETHERLANDS
5831 AN Boxmeer NIZOZEMSKA
Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Ne uporabite pri brejih živalih, katerih mleko je namenjeno prehrani ljudi, v obdobju 2 mesecev pred pričakovano telitvijo.
The recommended injection site is the location just behind the ear at the highest point of the base of the ear, at the transition from bald to hairy skin.
Priporočeno mesto injiciranja je mesto za ušesom na najvišji točki korena ušesa, na prehodu z gole na dlakasto kožo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 6 May 2011.
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobritve dovoljenja: 6. maj 2011
The rubber stopper of the vial may be safely punctured up to 20 times.
Gumijasti zamašek viale lahko varno prebodete do 20-krat.
Generally, cross-resistance between tildipirosin and other macrolides, lincosamides or streptogramins is to be expected.
Na splošno se pričakuje navzkrižna rezistenca med tildipirozinom in drugimi makrolidi, linkozamidi ali streptogramini.
The active substance in Zuprevo is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina v zdravilu Zuprevo je dovoljena učinkovina, kot je navedeno v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
In very rare cases, anaphylactic reactions, with a potentially fatal outcome, might occur.
V zelo redkih primerih se lahko pojavi anafilaktična reakcija z možnim poginom.
In very rare cases, transient lethargy in piglets has been observed.
V zelo redkih primerih so pri pujskih opazili prehodno letargijo.