natgillin/translations-raw huggingface dataset:
5.1 Pharmacodynamic properties
13/ 19 5. 1 Farmakodinamične lastnosti
In vitro trimethoprim is generally bacteriostatic and has a broad spectrum of activity against both gram- positive and gram-negative bacteria.
In vitro je trimetoprim splošno bakteriostatičen in ima širok spekter delovanja proti gram- pozitivnim kot tudi proti gram- negativnim bakterijam.
The Cmax of sulfamethoxazole in pigs is approximately 6.2 µg/ g.
Cmax sulfametoksazola pri prašičih je približno 6, 2 µg/ g.
The Cmax of trimethoprim is 0.29 µg/ g.
Cmax trimetoprima je 0, 29 µg/ g.
The Cmax of sulfamethoxazole in chickens is approximately 9.0 µg/ g, whereas that of trimethoprim is 0.12 µg/ g.
Cmax sulfametoksazola pri piščancih je približno 9, 0 µg/ g, trimetoprima pa 0, 12 µg/ g.
Plasma elimination half-life for trimethoprim in poultry is less than 1 hour and that of sulfamethoxazole, approximately 1.5 hours.
Plazemski eliminacijski razpolovni čas za trimetoprim pri perutnini je manj kot 1 uro in za sulfametoksazol približno 1, 5 ure.
In pigs, elimination half-life for both substances is approximately 2.5 hours.
Pri prašičih je eliminacijski razpolovni čas za obe snovi približno 2, 5 uri.
Propylene glycol, Sodium hydroxide, Water, purified, N-methyl-pyrrolidone
Propilen glikol, natrijev hidroksid, prečiščena voda, N- metilpirolidon.
Solubility and stability of Methoxasol-T in drinking water are pH-dependent.
Topnost in obstojnost Methoxasola- T v pitni vodi sta odvisni od pH.
Shelf-life of the veterinary medicinal product as packaged for sale:
3 leta.
3 years After first opening the remaining shelf life is 12 months.
Rok uporabnosti po prvem odpiranju stične ovojnine je 12 mesecev.
Shelf-life after dilution or reconstitution according to directions:
Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili:
24 hours
24 ur.
14/ 19 6.5 Nature and composition of immediate packaging
6. 5 Vrsta ovojnine in vsebina
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
14/ 19 6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Handelsweg 25, P. O. Box 179, 5530 AD Bladel, The Netherlands
Handelsweg 25, P. O. Box 179, 5530 AD Bladel, Nizozemska
15/ 19 IMMEDIATE PACKAGING
15/ 19 STIČNA OVOJNINA
16/ 19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PRIMARNI OVOJNINI
Methoxasol, oral solution for pigs and broilers.
Methoxasol- T, peroralna raztopina za prašiče in piščance.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGIH SNOVI
Oral solution.
Peroralna raztopina
Pigs and broilers
Prašiči in piščanci.
Treatment and control of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Zdravljenje in preprečevanje okužb dihal, ki jih povzroča Actinobacillus pleuropneumoniae, dovzeten za trimetoprim in sulfametoksazol, kjer je dokazana bolezen v čredi.
Treatment and control of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Zdravljenje in preprečevanje okužb dihal, ki jih povzroča Escherichia coli, dovzetna za trimetoprim in sulfametoksazol, kjer je dokazana bolezen v jati.
17/ 19 7.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION, POSOLOGY
NAČIN IN POT( I) UPORABE
Methoxasol is intended for oral administration with drinking water:
Methoxasol- T je namenjen za peroralno dajanje s pitno vodo.
Broilers:
17/ 19 Piščanci:
33 mg/ kg bodyweight, corresponding to approximately 1 litre of the drug in 750 L drinking water, for 3-4 days.
33 mg/ kg telesne mase, kar ustreza približno 1 litru zdravila v 750 L pitne vode, 3- 4 dni.
In order to obtain the correct dosage the concentration of Methoxasol has to be adjusted accordingly.
Da dosežemo pravilno odmerjanje, je treba koncentracijo Methoxasola- T ustrezno prilagoditi.
5 days Broilers:
Piščanci:
6 days
5 dni 6 dni
Special precautions for use in animals Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for trimethoprim / sulfamethoxazole bacteriological sampling and susceptibility testing are recommended.
Posebni previdnostni ukrepi za uporabo pri živalih Zaradi verjetne variabilnosti (čas, geografske) pojavljanja odpornosti bakterij za trimetoprim/ sulfametoksazol priporočamo bakteriološko vzorčenje in preiskave dovzetnosti.
Overdose A 2 ½ fold overdose is well tolerated by pigs.
Preveliko odmerjanje Prašiči 2 ½- kratno preveliko odmerjanje dobro prenesjo.
18/ 19 In chicken an acute overdose will not occur because the birds will be reluctant to drink the strongly concentrated drinking water (too bitter taste if above 2 litres Methoxasol per 1000 litre drinking water).
Pri piščancih se akutno preveliko odmerjanje ne pojavi, ker ptice ne bodo hotele piti premočno koncentrirane pitne vode (pregrenkega okusa, če je več kot 2 litra Methoxasola- T na 1000 litrov pitne vode).
11.
18/ 19 11.
MARKETING AUTHORISATION NUMBER
ŠTEVILKA( E) DOVOLJENJ( A) ZA PROMET
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR SODIUM SALICYLATE
ODBOR ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI (CVMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 35 ZA ZDRAVILO NATRIJEV SALICILAT
On 27 November 2007, Ireland presented to the EMEA a referral under Article 35 of Directive 2001/ 82/ EC, as amended, concerning all oral soluble powders containing sodium salicylate which are indicated for calves and pigs.
Irska je dne 27. novembra 2007 pri Evropski agenciji za zdravila (EMEA) sprožila napotitveni postopek v skladu s členom 35 Direktive 2001/ 82/ ES, kot je bila spremenjena, glede vseh praškov za peroralne raztopine, ki vsebujejo natrijev salicilat in so indicirani za zdravljenje telet in prašičev.
As the procedure concerns a range of products, the assessment has been limited to specific parts of the authorisations in accordance with Article 35(2) of Directive 2001/ 82/ EC, as amended.
Ker napotitveni postopek zajema širok niz zdravil, je bilo ocenjevanje omejeno le na določene dele dovoljenj za promet v skladu s členom 35( 2) Direktive 2001/ 82/ ES, kot je bila spremenjena.
The Marketing Authorisation Holders and Applicant submitted written responses and the clock was re- started on 14 March 2008.
Ko so imetniki dovoljenja za promet in predlagatelj predložili pisne odgovore na vprašanja, se je odštevanje do izteka postopka nadaljevalo dne 14. marca 2008.
The dosage required for calves is however 40 mg/ kg bodyweight.
Priporočeni odmerek za teleta je 40 mg na kilogram telesne mase.
Reproduction is authorised provided the source is acknowledged. • The benefit/ risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age.
Reproduction is authorised provided the source is acknowledged. • Učinkovitost natrijevega salicilata kot pomožnega zdravljenja za teleta in prašiče je bila dokazana pri okužbah dihal, koristnost te spojine pa se je pokazala tudi pri zdravljenju vnetij v kombinaciji s sočasno terapijo z antibiotiki.
Pigs: to promote recovery of respiration and to reduce coughing in respiratory tract infections with concurrent antibiotic therapy.
Prašiči: za pospeševanje okrevanja pri obolenjih dihal in blažitev kašlja pri okužbah dihal v kombinaciji s sočasno terapijo z antibiotiki.
NA-Salicylaat, 100%, powder for solution for oral administration
NA- Salicylaat, 100%, prašek za peroralno raztopino
Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e. g. anti-infective) therapy if necessary.
Teleta: pomožno zdravljenje pireksije pri akutnih obolenjih dihal, po potrebi v kombinaciji z ustrezno terapijo (na primer z zdravili za zdravljenje okužb).
For the treatment of inflammation in combination with concurrent antibiotic therapy.
Prašiči: za zdravljenje vnetij v kombinaciji s sočasno terapijo z antibiotiki.
SOLACYL 100%, powder for oral solution for calves and pigs
SOLACYL 100%, prašek za peroralno raztopino za teleta in prašiče
The CVMP Opinion was adopted on 16 July 2008 and the subsequent Commission Decision adopted on 26 September 2008.
Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto 16. 07. 2008 odločba Komisije pa 26. 09. 2008.
EMEA/ 436209/ 2008 Page 2/ 2
EMEA/ 436209/ 2008- SL Page 2/ 2
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER / APPLICANT
IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, POTI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET / PREDLAGATELJ
1/ 9 Member State / Marketing Authorisation Number
1/ 9 Država članica / Številka dovoljenja za promet
Austria (8-00694)
Avstrija (8- 00694)
NA-SALICYLAAT, 100%, powder for solution for oral administration
NA- SALICYLAAT, 100%, prašek za peroralno raztopino
2/ 9 ANNEX II
2/ 9 DODATEK II
3/ 9 SCIENTIFIC CONCLUSIONS
3/ 9 ZNANSTVENI ZAKLJUČKI
2.1 Questions put to the Marketing Authorisation Holder
2. 1 Vprašanja za imetnike dovoljenj za promet
2 Plasma concentrations of sodium salicylate in nursery pigs treated orally.
2 Plasma concentrations of sodium salicylate in nursery pigs treated orally..
The MAHs should discuss the benefit/ risk balance of the product, with special regard to: • the merits of using sodium salicylate as an oral medication for mass administration in cattle and pigs when individual treatment with parenteral NSAIDs may offer more precise therapy; • the use for analgesic and antipyretic effects under field condition, bearing in mind that the use in young animals which are suffering disease stress may lead to a potentiation of the undesirable effects of salicylate toxicity.
Imetniki dovoljenj za promet naj izvedejo razpravo o razmerju med koristmi in tveganji zdravila s posebnim poudarkom na: • prednostih uporabe natrijevega salicilata kot peroralnega zdravila za masovno uporabo pri govedu in prašičih, če lahko individualno zdravljenje s parenteralnimi nesteroidnimi protivnetnimi zdravili zagotovi natančnejšo terapijo; • smislu uporabe zdravila za dosego analgetičnih in antipiretičnih učinkov v terenskih pogojih, upoštevajoč, da uporaba zdravila pri mladih živalih, pri katerih se pojavlja stres zaradi bolezni, lahko vodi k povečanju neželenih učinkov toksičnosti salicilata.
2.2 Documentation provided
2. 2 Predložena dokumentacija
Chevita Ges m. b. H. submitted all requested parts of the dossier (Part I and Part IV) as well as a dose determination study, which was not included in Part IV of the application dossier.
Družba Chevita Ges m. b. H. je predložila vse zahtevane module dosjeja (modul I in modul IV) kot tudi študijo o določitvi odmerka, ki ni bila vključena v modul IV predloženega dosjeja.
NA-Salicylaat, 100%, powder for solution for oral administration and NA-Salicylaat, 80% WSP
NA- Salicylaat, 100%, prašek za peroralno raztopino in NA- Salicylaat, 80% WSP
Solacyl 100%, powder for oral solution for calves and pigs
Solacyl 100%, prašek za peroralno raztopino za teleta in prašiče
Eurovet referred to the originator product from Dopharma, Na-salicylaat 100%, REG NL 8913.
Družba Eurovet se je oprla na originatorsko zdravilo družbe Dopharma, Na- salicylaat 100%, REG NL 8913.
It was recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Sprejeto je bilo priporočilo, da naj za Solacyl 100% prašek za peroralno raztopino za teleta in prašiče, veljajo priporočila napotitve Skupnosti v skladu s členom 35( 2) za praške za peroralno raztopino, ki vsebujejo natrijev salicilat.
• The benefit/ risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age
5/ 9 • Razmerje med koristmi in tveganji se je pokazalo kot pozitivno, kljub temu pa je v povzetku glavnih značilnosti zdravila za uporabo pri mladih živalih potrebno navesti, da zdravilo ni namenjeno uporabi pri komaj skotenih ali zelo mladih teletih, starih manj kot dva tedna, ter pri pujskih, starih manj kot štiri tedne.
5/ 9 The following indications have been justified:
Potrjene so bile naslednje indikacije:
6/ 9 ANNEX III
6/ 9 DODATEK III
7/ 9 Amendments to be included in the relevant sections of the SPC:
7/ 9 Spremembe, ki se vključijo v ustrezna poglavja povzetka glavnih značilnosti zdravila:
In calves, the dose administered should be amended to read 40 mg/ kg once daily.
Priporočeni odmerek za teleta naj se spremeni v 40 mg/ kg enkrat dnevno.
8/ 9 4.3 Contraindications
8/ 9 4. 3 Kontraindikacije
London, May 2008 EMEA/ 209536/ 2008
London, maj 2008 EMEA/ 209536/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP) OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL AS AMENDED FOR SOLACYL
ODBOR ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI (CVMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33( 4), KAKOR JE BIL SPREMENJEN, ZA ZDRAVILO SOLACYL
Solacyl 100% powder for oral solution for calves and pigs is indicated in calves for supportive treatment for reduction of pyrexia in acute respiratory disease, in combination with appropriate (e. g. anti-infective) therapy if necessary and in pigs for the supportive treatment for relief of pain in musculoskeletal disorders in combination with appropriate (e. g. anti-infective) therapy if necessary.
Zdravilo Solacyl 100% prašek za peroralno raztopino za teleta in prašiče je indicirano kot podporno zdravljenje, če je potrebno, pri teletih za znižanje pireksije pri akutnih boleznih dihal v kombinaciji z ustrezno (npr. protivirusno) terapijo in kot podporno zdravljenje, če je potrebno, pri prašičih za lajšanje bolečin pri kostno- mišičnih obolenjih v kombinaciji z ustrezno (npr. protivirusno) terapijo.
In August 2006 a Decentralised Procedure started with The Netherlands as Reference Member State and thirteen Concerned Member States.
Decentraliziran postopek se je na Nizozemskem kot referenčni državi članici in trinajstih zadevnih državah članicah začel avgusta 2006.
Ireland considered that, due to the absence of efficacy documentation it could not be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Irska je bila mnenja, da zaradi pomanjkljive dokumentacije glede učinkovitosti ni mogoče sklepati, da je zdravilo učinkovito, in da kot tako predstavlja morebitno resno tveganje za zdravje živali.
The Netherlands notified the EMEA in November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution and the matter was referred to the CVMP.
Nizozemska je novembra 2007 obvestila EMEA, da usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirane postopke CMD( v) ni dosegla dogovora glede zdravila Solacyl 100% prašek za peroralno raztopino, zato je bila zadeva napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands).
Zdravilo Solacyl 100% prašek za peroralno raztopino je generik zdravila Natrium salicylaat (odobrenega na Nizozemskem).
CVMP started the referral procedure on 11 December 2007 and agreed on a 37 day time frame.
CVMP je pričel z napotitvenim postopkom 11. decembra 2007 in soglasno sprejel 37- dnevni rok.
On the basis of the grounds for referral, CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Na podlagi vzrokov za napotitveni postopek je CVMP obravnaval razlike med zdravilom Solacyl 100% prašek in referenčnim zdravilom, ki bi lahko upravičile različne zaključke o učinkovitosti zdravil.
Solacyl 100% powder for oral solution proved to be essentially similar to the reference product, Natrium salicylaat 100%.
Zdravilo Solacyl 100% prašek za peroralno raztopino je dokazano bistveno podobno referenčnemu zdravilu Natrium salicylaat 100%.
The objections raised by Ireland should not prevent the granting of a marketing authorisation for Solacyl 100% powder for oral solution for calves and pigs.
Zadržki, ki jih je podala Irska, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom Solacyl 100% prašek za peroralno raztopino za teleta in prašiče.
It is recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Priporočljivo je, da se za zdravilo Solacyl 100% prašek za peroralno raztopino za teleta in prašiče upošteva izid napotitvenega postopka Skupnosti v skladu s členom 35( 2) za peroralne topne praške, ki vsebujejo natrijev salicilat.
The CVMP Opinion was adopted on 13 February 2008 and the subsequent Commission Decision adopted on 17 April 2008.
Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto 13. februarja 2008 odločba Komisije pa 17. aprila 2008.
EMEA/ 209536/ 2008
EMEA/ 209536/ 2008- SL
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, POTI UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET
1/ 7 Applicant or Marketing Authorisation Holder
1/ 7 Živalska Predlagatelj ali
Product invented name
Izmišljeno
Animal Frequency and species route of administration
imetnik dovoljenja za promet z zdravilom
Recommended dose
pot uporabe zdravila
Solacyl 100% powder for oral solution
Solacyl 100% prašek za peroralno raztopino
powder
prašek
Calves oral and pigs
teleta in prašiči
20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.
20 mg natrijevega salicilata na kg telesne mase dvakrat dnevno 1 do 3 dni.
35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.
35 mg natrijevega salicilata na kg telesne mase enkrat dnevno 3 do 5 dni.
Half of the calculated total daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed.
Zmešamo polovico izračunane celokupne dnevne količine praška in 5– 10 litrov čiste vode.
This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily.
To raztopino nato ob mešanju dodamo v količino pitne vode, ki se porabi v približno 3– 4 urah, ter jo damo dvakrat dnevno.
The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 26 November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution.
Nizozemska, referenčna država članica v decentraliziranem postopku, je 26. novembra 2007 obvestila EMEA, da v Koordinacijski skupini za postopke medsebojnega priznavanja in decentralizirane postopke – zdravila za veterinarsko uporabo (CMD( v)) ni bilo doseženo soglasje o zdravilu Solacyl 100% prašek za peroralno raztopino.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter was referred to the CVMP.
Zadeva je bila v skladu s členom 33( 4) Direktive Sveta 2001/ 82/ ES, kakor je bila spremenjena, napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
CVMP noted that Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands) and that the concerns raised by Ireland could only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
CVMP je opozoril, da je Solacyl 100% prašek za peroralno raztopino generična različica zdravila Natrium salicylaat (ki je odobreno na Nizozemskem) in da se lahko zadržki Irske obravnavajo le v okviru tega postopka, če bi se ugotovilo, da razlike med zdraviloma omogočajo različne zaključke o varnosti in učinkovitosti.
On the basis of the grounds for referral CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Na podlagi vzrokov za napotitveni postopek je CVMP obravnaval razlike med zdravilom Solacyl 100% prašek in referenčnim zdravilom, ki bi lahko upravičile različne zaključke o učinkovitosti zdravil.
The application dossier and any data added to it up to Day 60 of the referral procedure in CMD(v) to be provided to all CVMP Members and the EMEA.
1. dokumentacija predlagatelja in vsi podatki, ki so bili vanjo dodani do 60. dne napotitvenega postopka v CMD( v), se pošljejo vsem članicam CVMP in EMEA;
To indicate and to substantiate where necessary, any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
2. prikazati in po potrebi utemeljiti vse razlike med zdravilom Solacyl 100% prašek in referenčnim zdravilom, ki bi lahko upravičile različne zaključke o učinkovitosti zdravil.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
V zvezi s 1. vprašanjem je predlagatelj predložil kopijo izvirne dokumentacije, ki je bila predložena kot utemeljitev vloge za decentralizirani postopek, in dodatne podatke, ki so bili predloženi med decentraliziranim postopkom kot odgovor na vrednotenje I. in II. faze ter nato med napotitvenim postopkom v CMD( v).
In response to question 2, the applicant answered that Solacyl 100% powder for oral solution is identical to the reference product and that there is no reason to reach different conclusions on the efficacy of the two products.
V zvezi z 2. vprašanjem je predlagatelj odgovoril, da je zdravilo Solacyl 100% prašek za peroralno raztopino identično referenčnemu zdravilu in da ni razloga za različne zaključke o učinkovitosti zdravil.
6/ 7 The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except Ireland) at day 210 of the decentralised procedure.
6/ 7 Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so različice, s katerimi se strinjajo referenčna država članica in zadevne države članice (z izjemo Irske) na 210. dan decentraliziranega postopka.
EMEA/ CVMP/ 283947/ 2008-EN
EMEA/ CVMP/ 283947/ 2008- SL
Member
Država
Marketing
Imetnik dovoljenja
Frequency and
Pogostost in
State
članica
Authorisation
za promet z zdravilom
name
ime izdelka
route of
način uporabe zdravila
administration
Češka republika
Cattle, pigs
govedo, prašiči
15 mg amoxicillin/ kg bw (equivalent to 1ml/ 10 kg)
15 mg amoksicilina/ kg tt (enakovredno 1ml/ 10 kg)
Cattle:
Meso in drobovina: govedo:
58 days Pigs:
58 dni prašiči:
35 days Milk:
35 dni Mleko:
2.5 days
2, 5 dni
France2
Francija2
Suramox 15% LA
Suramox 15
Two intramuscular injections at 48 hours interval
z vmesnim intervalom 48 ur
Cattle:
prašiči:
1 Marketing Authorisation not granted 2 Reference Member State for the Mutual recognition Procedure
1 Brez dovoljenja za promet 2 Referenčna država članica za postopek medsebojnega priznavanja