natgillin/translations-raw huggingface dataset:
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida and Mannheimia haemolytica.
Zdravljenje okužb dihal, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij Pasteurella multocida in Mannheimia haemolytica.
10 mg/kg bw, corresponding to 0.4 ml/kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
10 mg/kg telesne mase (kar ustreza 0,4 ml/kg telesne mase) enkrat na dan s subkutanim injiciranjem od 5 do 10 zaporednih dni.
Cattle, pigs, dogs, sheep, goats
govedo, prašiči, psi, ovce, koze
Cattle, pigs, dogs, cats
govedo, prašiči, psi, mačke
4.11 Withdrawal period(s)
Mednarodno nelastniško ime (INN)
Therefore PK/PD and resistance data were taken into account when considering the efficacy of enrofloxacin against Mycoplasma spp.
Pri presoji učinkovitosti enrofloksacina proti Mycoplasma spp.
Enrotron 50 mg roztwór do wstrzykiwań dla bydła, świń, psów i kotów
Enrotron 50 mg roztwór do wstrzykiwań dla bydła, świń, psów i kotów govedo, prašiči, psi, mačke
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Zdravljenje septikemije, ki jo povzročajo za enrofloksacin občutljivi sevi bakterije Escherichia coli.
Cattle, pigs, sheep, goats
govedo, prašiči, ovce, koze
2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by intramuscular injection for 3 days.
2,5 mg enrofloksacina/kg telesne mase (kar ustreza 0,5 ml/20 kg telesne mase) enkrat na dan z intramuskularnim injiciranjem 3 dni.
Cattle (100 mg/ml strength)
Govedo (jakost 100 mg/ml)
- Dosage: 5 mg/kg bw, once daily for 3 days by subcutaneous administration.
- Odmerjanje: 5 mg/kg telesne mase, enkrat na dan, 3 dni subkutano.
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of: Pasteurella multocida, Mycoplasma spp.
Zdravljenje okužb dihal, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij: Pasteurella multocida, Mycoplasma spp.
Cattle, dogs, pigs
govedo, psi, prašiči
ENROXIL Oplossing voor injectie 50 mg/ml voor kalveren, varkens en honden
ENROXIL Oplossing voor injectie 50 mg/ml voor kalveren, varkens en honden govedo, prašiči, psi
SC: Meat and offal: 12 days.
Subkutano: meso in organi: 12 dni.
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica, Mycoplasma spp.
Zdravljenje okužb dihal, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij Pasteurella multocida, Mannheimia haemolytica, Mycoplasma spp.
Enrotron 50mg/ml injekčný roztok pre hovädzí dobytok, ošípané, psy a mačky
Enrotron 50mg/ml injekčný roztok pre hovädzí dobytok, ošípané, psy a mačky govedo, prašiči, psi, mačke
ENROTRON 50 mg/ml, injekcinis tirpalas galvijams, kiaulėms, šunims ir katėms
ENROTRON 50 mg/ml, injekcinis tirpalas galvijams, kiaulėms, šunims ir katėms govedo, prašiči, psi, mačke
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by subcutaneous injection for 3 days.
5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/20 kg telesne mase) enkrat na dan s subkutanim injiciranjem 3 dni.
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.
Zdravljenje okužb dihal, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij Pasteurella multocida, Mannheimia haemolytica in Mycoplasma spp.
Cattle, sheep, pigs, dogs
govedo, ovce, prašiči, psi
Piglets (25 mg/ml strength)
Pujski (jakost 25 mg/ml)
Cattle, sheep, goats, pigs, dogs
govedo, ovce, koze, prašiči, psi
IV: Meat and offal: 5 days.
: meso in organi: 5 dni.
Powerflox Oplossing voor injectie 50 mg/ml voor runderen, varkens, honden en katten
Powerflox Oplossing voor injectie 50 mg/ml voor runderen, varkens, honden en katten govedo, prašiči, psi, mačke
Calves, pigs, poultry dogs, cats
teleta, prašiči, perutnina, psi, mačke
Thus, a withdrawal period of 4 days is recommended for sheep meat and offal for animals treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection.
Torej je priporočena karenca za meso in organe ovac, zdravljenih s priporočenim odmerkom 5 mg/kg telesne mase z jakostma 50 mg/ml ter 100 mg/ml, ki se dajeta s subkutanim injiciranjem, 4 dni.
Enrotron 50, 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde
Enrotron 50, 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde govedo (teleta), prašiči, psi
Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Enrofloxacin
Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Enrofloxacin mačke, govedo, psi, prašiči
5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/10 kg bw, once daily for 3-5 days.
5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/10 kg telesne mase) enkrat na dan 3-5 dni.
ENROCILL 50mg/ml solución inyectable para bovino, porcino y perros
ENROCILL 50mg/ml solución inyectable para bovino, porcino y perros govedo, prašiči, psi
Cattle (calves), pigs, dog
govedo (teleta), prašiči, psi
Enrotron 25 mg/ml roztwór do wstrzykiwań dla psów, kotów i zwierząt egzotycznych
Enrotron 25 mg/ml roztwór do wstrzykiwań dla psów, kotów i zwierząt egzotycznych psi, mačke, eksotične živali
Calves (50 mg/ml strength)
Teleta (jakost 50 mg/ml)
Enrotron 25 mg/ml injekčný roztok pre psy , mačky a exotické živočíchy
Enrotron 25 mg/ml injekčný roztok pre psy , mačky a exotické živočíchy psi, mačke, eksotične živali
Germany SP Veterinaria SA Ctra.
Portugalska SP Veterinaria SA Ctra.
Enroxil 50 mg/ml Injektionslösung für Kälber, Schweine und Hunde
Enroxil 50 mg/ml Injektionslösung für Kälber, Schweine und Hunde teleta, prašiči, psi
5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/20 kg bw, once daily for 3-5 days.
5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/20 kg telesne mase) enkrat na dan 3-5 dni.
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mycoplasma spp.
Zdravljenje okužb dihal, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij Pasteurella multocida, Mycoplasma spp.
Dogs, cattle, poultry, cats, pigs
Enroxil psi, govedo, perutnina, mačke, prašiči
2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/10 kg bw, once daily by intramuscular injection for 3 days.
2,5 mg enrofloksacina/kg telesne mase (kar ustreza 0,5 ml/10 kg telesne mase) enkrat na dan z intramuskularnim injiciranjem 3 dni.
Germany Chanelle Pharmaceuticals Manufacturing Ltd.
Portugalska Chanelle Pharmaceuticals Manufacturing Ltd.
Enroxil 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde
Enroxil 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde govedo (teleta), prašiči, psi
Cattle, pigs, dogs
govedo, prašiči, psi
Enrotron 50 mg/ml injekční roztok pro skot, prasata, psy a kočky
Enrotron 50 mg/ml injekční roztok pro skot, prasata, psy a kočky govedo, prašiči, psi, mačke
Goats (50 mg/ml and 100 mg/ml strengths)
Koze (jakosti 50 mg/ml in 100 mg/ml)
5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/5 kg bw, once daily by subcutaneous injection for up to 5 days.
5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/5 kg telesne mase) enkrat na dan s subkutanim injiciranjem največ 5 dni.
Floxadil 50mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten
Floxadil 50mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten govedo, prašiči, psi, mačke
Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1.0 ml/20 kg bw, once daily by intramuscular injection for 3 days.
Okužba prebavil ali septikemija, ki jo povzroči bakterija Escherichia coli: 5 mg enrofloksacina/kg telesne mase (kar ustreza 1,0 ml/20 kg telesne mase) enkrat na dan z intramuskularnim injiciranjem 3 dni.
Enrotron 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten
Enrotron 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten govedo, prašiči, psi, mačke
Belgium SP Veterinaria SA Ctra.
Romunija SP Veterinaria SA Ctra.
- Dosage: 5 mg/kg bw, once daily for 5 days
- Odmerjanje: 5 mg/kg telesne mase, enkrat na dan 5 dni.
Fenoflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen
Fenoflox 50 mg/ml Injektionslösung für Tiere govedo, prašiči, psi, mačke
Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.
Zdravljenje okužb prebavil, ki jih povzročajo za enrofloksacin občutljivi sevi bakterije Escherichia coli.
aureus, together with a bacteriological cure of 66.67%.
aureus, bakteriološko ozdravitev pa pri
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by subcutaneous injection for 3 days.
5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/10 kg telesne mase) enkrat na dan s subkutanim injiciranjem 3 dni.
Pigs, rabbits, dogs, cats
prašiči, kunci, psi, mačke
Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of, e.g.: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Zdravljenje okužb prebavil, dihal in urogenitalnega trakta (dodatno antibiotično zdravljenje piometre) ter okužb kože in ran, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij, kot so na primer: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Germany Krka d.d.
Slovaška Krka d.d.
2.5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular injection for 3 days.
2,5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/10 kg telesne mase) enkrat na dan z intramuskularnim injiciranjem 3 dni.
Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by intramuscular injection for 3 days.
Okužba prebavil ali septikemija, ki jo povzroči bakterija Escherichia coli: 5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/20 kg telesne mase) enkrat na dan z intramuskularnim injiciranjem 3 dni.
Floxibac 50 mg/ml solução injetável para bovinos, suínos, cães e gatos
Floxibac 50 mg/ml solução injetável para bovinos, suínos, cães e gatos govedo, prašiči, psi, mačke
Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg of bw, corresponding to 2 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Okužba prebavil ali septikemija, ki jo povzroči bakterija Escherichia coli: 5 mg enrofloksacina/kg telesne mase (kar ustreza 2 ml/10 kg telesne mase) enkrat na dan z intramuskularnim injiciranjem 3 dni.
Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Zdravljenje okužb prebavil, dihal in urogenitalnega trakta (vključno z zdravljenjem prostatitisa in dodatnim antibiotičnim zdravljenjem piometre), okužb kože in ran ter vnetja ušesa (zunanjega sluhovoda/srednjega ušesa), ki jih povzročajo za enrofloksacin občutljivi sevi bakterij Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Calves, pigs, dogs
teleta, prašički, psi
Enrotron 50 mg/ml Solução injectável para bovinos, suínos, cães e gatos
Enrotron 50 mg/ml Solução injectável para bovinos, suínos, cães e gatos govedo, prašiči, psi, mačke
Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Zdravljenje okužb prebavil, dihal in urogenitalnega trakta (vključno z zdravljenjem prostatitisa in dodatnim antibiotičnim zdravljenjem piometre), okužb kože in ran ter vnetja ušesa (zunanjega sluhovoda/srednjega ušesa), ki jih povzročajo za enrofloksacin občutljivi sevi bakterij: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Zdravljenje okužb prebavil, dihal in urogenitalnega trakta (dodatno antibiotično zdravljenje piometre) ter okužb kože in ran, ki jih povzročajo za enrofloksacin občutljivi sevi bakterij: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Okužba prebavil ali septikemija, ki jo povzroči bakterija Escherichia coli: 5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/10 kg telesne mase) enkrat na dan z intramuskularnim injiciranjem 3 dni.
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily by subcutaneous injection for up to 5 days.
5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/10 kg telesne mase) enkrat na dan s subkutanim injiciranjem največ 5 dni.
Enroxil 50 mg/ml solution for injection for calves, pigs and dogs
Enroxil 50 mg/ml solution for injection for calves, pigs and dogs govedo, prašiči, psi
Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen
Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen govedo, prašiči, psi, mačke
Ganadexil Enrofloxacina 5% Enrofloxacin 50 mg/ml
Ganadexil Enrofloxacina 5% Enrofloxacin 50 mg/ml govedo (teleta), prašiči, psi
Enrofloxacin was administered at 2.5 and 5 mg/kg bw/day intramuscularly for 3 days and by oral route.
Uporabili so intramuskularno in peroralno odmerjanje enrofloksacina, in sicer 2,5 in 5 mg/kg telesne mase/dan 3 dni.
Floxadil 50mg/ml Injektionslösung fürRinder, Schweine, Hunde und Katzen
Floxadil 50mg/ml Injektionslösung fürRinder, Schweine, Hunde und Katzen govedo, prašiči nad 25 kg, psi, mačke
Thus a withdrawal period of 72 hours (3 days) is recommended for milk from cattle treated at the recommended dose of 5 mg/kg bw/day with the 100 mg/ml strength intravenously.
Torej je za mleko govedi, zdravljene s priporočenim odmerkom 5 mg/kg telesne mase/dan z jakostjo 100 mg/ml, ki se daje intravensko, priporočil karenco 72 ur (3 dni).
Rabbits (25 mg/ml strength)
Kunci (jakost 25 mg/ml)
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, daily by subcutaneous injection for up to 5 days.
5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/10 kg telesne mase) na dan s subkutanim injiciranjem največ 5 dni.
In view of above the CVMP considered that these indications can be accepted.
Na podlagi zgornjih podatkov je odbor CVMP menil, da so te indikacije sprejemljive.
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/5 kg bw, daily by subcutaneous injection for up to 5 days.
5 mg enrofloksacina/kg telesne mase (kar ustreza 1 ml/5 kg telesne mase) na dan s subkutanim injiciranjem največ 5 dni.
Fenoflox 50 mg / ml solução injectável para bovinos, suínos, cães e gatos
Fenoflox 50 mg/ml Oplossing voor injectie govedo, prašiči, psi, mačke
- Dosage for rodents: 10 mg/kg bw, once daily by subcutaneous injection for 5-10 consecutive days
- Odmerjanje za glodavce: 10 mg/kg telesne mase, enkrat na dan s subkutanim injiciranjem od
Belgium Chanelle Pharmaceuticals Manufacturing Ltd.
Madžarska Chanelle Pharmaceuticals Manufacturing Ltd.
Fenoflox 50mg/ml solution injectable pour bovins, porcins, chiens et chats
Fenoflox 50mg/ml solution injectable pour bovins, porcins, chiens et chats govedo, prašiči, psi, mačke
Enrotron 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats
Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats govedo, prašiči, psi, mačke
Basle,
Basel,
Member State/EEA
Država članica/EGP
DK-2100 Köpenhamn Ö DENMARK
DK-2100 Köbenhavn DANSKA
The target animals are:
Ciljne živali so:
None known
Niso znane
If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.
Če to ni mogoče, mora terapija temeljiti na lokalnih (na ravni regije, kmetije) epidemioloških podatkih o občutljivosti ciljnih bakterij.
40, 81379 München GERMANY
40, 81379 München NEMČIJA
c/De la Marina, 206 08013 Barcelona SPAIN
c/De la Marina, 206 08013 Barcelona ŠPANIJA
The prevention strategy should include efforts to eliminate the infection from the parent generation.
Strategija preprečevanja mora vključevati prizadevanja za odpravo okužbe iz starševske generacije.
Largo Umberto Boccioni, 1 21040 Origlio (Varese) ITALY
Largo Umberto Boccioni, 1 21040 Origlio (Varese) ITALIJA
Biochemiestrasse 10, 6250 Kundl AUSTRIA
Biochemiestrasse 10, 6250 Kundl AVSTRIJA
Due to the divergent national decisions taken by Member States concerning the authorisation of these products, the issue was referred to CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SPC) across the European Union.
Zaradi razhajajočih se nacionalnih odločitev držav članic glede odobritve teh zdravil je bila zadeva v skladu s členom 34(1) Direktive 2001/82/ES napotena na CVMP, da bi se razrešile razlike med nacionalno odobrenimi povzetki glavnih značilnosti zdravila v Evropski uniji.
antibacterial for systemic use
protibakterijska zdravila za sistemsko uporabo
Premixes with tiamulin are marketed in 20 European Member States under a variety of invented names (see Annex I).
Predmešanice tiamulina so v prometu v 20 evropskih državah članicah pod številnimi izmišljenimi imeni (glejte Dodatek I).
Mesogion Av 198, 15561 Holargos GREECE
Mesogion Av 198, 15561 Holargos GRČIJA
The Marketing Authorisation Holders were requested:
Imetniki dovoljenja za promet z zdravilom so bili pozvani:
Severe growth depression or death may result.
Lahko povzroči hud zastoj rasti ali smrt.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TIAMUTIN PREMIX AND ASSOCIATED NAMES (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA TIAMUTIN PREMIX IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
• 10% and
• 10 % in
In turkeys serum levels of tiamulin are similar to chickens.
Pri puranih so serumske ravni tiamulina podobne tistim pri kokoših.
1. to provide an exhaustive list of differences between the SPCs of the product authorised in the Member States; 2. to review all sections of the SPCs and to suggest appropriate changes in the text where divergences exist and to propose a harmonised Product Information (SPC and labelling), taking into account the latest guidance; 3. to provide available relevant data, in particular substantiating such proposed harmonised Product Information in relation to the discrepancies identified above.
1. da predložijo izčrpen seznam razlik med povzetki glavnih značilnosti zdravila, ki je odobreno v državah članicah; 2. da pregledajo vsa poglavja povzetkov glavnih značilnosti zdravila in predlagajo ustrezne spremembe besedila, kjer obstajajo razlike, ter predlagajo usklajene informacije o zdravilu (povzetek glavnih značilnosti zdravila in označevanje) ob upoštevanju najnovejših smernic; 3. da predložijo razpoložljive ustrezne podatke, zlasti za utemeljitev takšnih predlaganih usklajenih informacij o zdravilu glede na zgodaj navedena razhajanja.
Conclusion: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holders, the CVMP concluded as follows:
Zaključek: CVMP je po proučitvi podlage za napotitev in odgovorov, ki so jih predložili imetniki dovoljenja za promet z zdravilom, zaključil naslednje:
Resistance to tiamulin may be associated with decreased susceptibility to other pleuromutilins.
Odpornost proti tiamulinu je mogoče povezati z zmanjšano občutljivostjo na druge plevromutiline.
The intake of medicated feed depends on the clinical condition of the animals.
Vnos zdravilne krmne mešanice je odvisen od kliničnega stanja živali.
Novartis Sante Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE
Novartis Sante Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCIJA
The main sections of disharmony of the existing SPCs were:
Poglavitna poglavja neskladnosti med obstoječimi povzetki glavnih značilnosti zdravila so bila:
It appears to inhibit microbial protein production by producing biochemical inactive initiation complexes, which prevent elongation of the polypeptide chain.
Kaže, da proizvodnjo mikrobnih beljakovin zavira s proizvajanjem biokemično neaktivnih iniciacijskih kompleksov, ki preprečujejo podaljševanje polipeptidne verige.
The variation in posology amongst the nationally authorised Summary of Product Characteristics (SPC) meant that this issue also needed to be addressed in this referral procedure.
Razlika v odmerjanju med nacionalno odobrenimi povzetki glavnih značilnosti zdravila je pomenila, da je treba tudi to vprašanje obravnavati v tem postopku napotitve.
Concerning withdrawal periods the very wide variation in currently approved withdrawal periods was noted (e.g. ranging from 1 day to 20 days in pigs, 3 to 8 days in chickens and turkeys, 0 days in rabbits).
Z vidika karence je bilo opaziti zelo veliko razhajanje med trenutno odobrenimi karencami (npr. od 1 dne do 20 dni pri prašičih, od 3 do 8 dni pri piščancih in puranih ter 0 dni pri kuncih).
Clinically relevant resistance to tiamulin requires combinations of mutations around the tiamulin binding site.
Klinično pomembna odpornost proti tiamulinu zahteva kombinacije mutacij okrog veznega mesta za tiamulin.
Hoge Mauw 900, 2370 Arendonk BELGIUM
Leo Aerden Hoge Mauw 900, 2370 Arendonk BELGIJA
Notably although emergence of antimicrobial resistance against M. hyopneumoniae does not seem to be of immediate concern there is a need to consider resistance also against other microbes present in swine herds such as B. hyodysenteriae.
Čeprav nastop protimikrobne odpornosti proti M. hyopneumoniae ni neposreden vzrok za zaskrbljenost, je treba upoštevati tudi odpornost proti drugim mikrobom, ki so prisotni v prašičjih čredah, npr. proti B. hyodysenteriae.
Treatment should be administered until 2 - 3 days after clinical signs has resolved.
Zdravljenje je treba izvajati še 2 do 3 dni po tem, ko klinični znaki izginejo.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi)
As regards harmonisation of indications and based on the efficacy data provided it is agreed to harmonise the indications as follows:
V zvezi z usklajevanjem indikacij je bil na podlagi predloženih podatkov o učinkovitosti dogovorjen naslednji način usklajevanja indikacij:
When mixing the veterinary medicinal product and handling the medicated feed, direct contact with eyes, skin and mucous membranes should be avoided.
Pri mešanju zdravila za uporabo v veterinarski medicini in ravnanju z zdravilno krmno mešanico se je treba izogibati neposrednemu stiku z očmi, kožo in sluzničnimi membranami.
ATCvet code:
Oznaka ATCvet:
People with known hypersensitivity to tiamulin should administer the product with caution.
Osebe z znano preobčutljivostjo na tiamulin naj bodo previdne pri dajanju izdelka.
Rabbits There are no pharmacokinetic data available for rabbits.
Kunci Farmakokinetični podatki za kunce niso na voljo.
Acute cases and severely diseased animals with reduced feed intake should be treated with a product of suitable formulation such as an injectable or water solution.
Akutne primere in hudo bolne živali z zmanjšanim vnosom krme je treba zdraviti z izdelkom v ustrezni obliki, npr. z injekcijsko ali vodno raztopino.