natgillin/translations-raw huggingface dataset:
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RESIDUE DATA FOR SURAMOX 15% LA AND ITS ASSOCIATED NAME STABOX 15% LA, SUBMITTED TO THE CVMP AS A FOLLOW-UP OF AN ARTICLE 35 REFERRAL, FOR LIFTING THE SUSPENSION OF THE MARKETING AUTHORISATIONS
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA PODATKOV O IZLOČANJU OSTANKOV ZA ZDRAVILO SURAMAX 15% IN Z NJIM POVEZANO IME STABOX 15% LA, PREDLOŽENO ODBORU ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI KOT NADALJEVANJE POSTOPKA NAPOTITVE V SKLADU S ČLENOM 35 ZA UMIK PREKLICA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Suramox 15% LA and its associated name Stabox 15% LA is presented as an injectable suspension containing amoxicillin, which is a β -lactam antibiotic, belonging to the group of penicillins intended for the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Zdravilo Suramox 15% LA in z njim povezano ime Stabox 15% LA sta na voljo v obliki raztopine za injiciranje, ki vsebujeta amoksicilin, ki je beta- laktamski antibiotik iz skupine penicilinov, namenjenih zdravljenju okužb dihal, ki jih povzročata Pasteurella multocida in Mannheimia haemolytica pri govedu, ter za zdravljenje okužb dihal, ki jih povzroča Pasteurella multocida pri prašičih.
In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/ kg bw (equivalent to 1 ml of Suramox 15% LA/ 10 kg bw) twice at 48 hours interval.
Pri obeh vrstah se zdravilo injicira intramuskularno z odmerkom 15 mg amoksicilina/ kg telesne mase (enakovredno 1 ml zdravila Suramox 15% LA/ 10 kg telesne mase) dvakrat v intervalu 48 ur.
Benzylpenicillin was considered by the Joint FAO/ WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990.
Na 36. seji Skupnega strokovnega odbora FAO/ WHO za aditive za živila (JECFA) leta 1990 je bil obravnavan benzilpenicilin.
In setting maximum residue limits (MRLs) for the penicillins, the CVMP adopted the same approach as the Joint FAO/ WHO Expert Committee on Food Additives (JECFA).
Pri določanju mejnih vrednosti ostankov zdravila za peniciline je Odbor za zdravila za uporabo v veterinarski medicini sprejel enak pristop kot Skupni strokovni odbor FAO/ WHO za aditive za živila (JECFA).
On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/ 90, in accordance with the following table:
2377/ 90 v skladu z naslednjo preglednico:
Pharmacologically
Farmakološka
Marker
Označevalec
Animal
Živalska
MRLs
Mejne
active substance
zdravilna
residue
ostanka
tissue
vrednosti
provisions
tkiva
Amoxicillin Amoxicillin
določbe
All food
učinkovina
50 µg/ kg
ostankov
Muscle
Amoksicilin Amoksicilin
producing species
Vse vrste za proizvodnjo živil
Fat Liver Kidney Milk
Mišična tkiva Maščobna tkiva Jetra Ledvica Mleko
EMEA/ CVMP/ 283947/ 2008-EN 2.
EMEA/ CVMP/ 283947/ 2008- SL 2.
In order to obtain the lifting of the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA, the marketing authorisation holder performed four new residue studies in cattle and five new residue studies in pigs.
Za odpravo preklica dovoljenja za promet z zdravilom Suramox 15% LA in z njim povezanega imena Stabox 15% LA je imetnik dovoljenja za promet z zdravilom izvedel štiri nove študije izločanja ostankov pri govedu in pet novih študij izločanja ostankov pri prašičih.
2.1 Residue studies in cattle
2. 1 Študije izločanja ostankov pri govedu
600 to 692 kg) were used (eight males and eight females).
Pri glavni študiji izločanja ostankov so uporabili težke živali (telesna masa 600 do 692 kilogramov) (osem samcev in osem samic).
The animals were given 15 mg amoxicillin/ kg bw corresponding to 1ml/ 10 kg bw which required 4 injections, three of which were the maximum volumes (20 ml) and the remaining given in the fourth injection.
Živali so prejele 15 mg amoksicilina/ kg telesne mase, kar ustreza 1 ml inj. raztopine/ 10 kg telesne mase; za to so bile potrebne štiri injekcije, tri od teh so bile največje možne količine (20 ml), preostala količina pa je bila injicirana s četrtim odmerkom.
All samples were analysed for amoxicillin concentrations using a validated HPLC-MS/ MS method with a limit of quantification of 25 µg/ kg for all tissues.
Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC- MS/ MS z mejo kvantifikacije 25 µg/ kg za vsa tkiva.
Residue levels in fat, liver, kidney and non-injection site muscle were below the limit of quantification from the first time point (7 days) with the exception of one kidney sample that contained residues at the level of the limit of quantification (25 µg/ kg).
Vrednosti koncentracije ostankov v maščobnih tkivih, jetrih, ledvicah in mišicah, v katere raztopine niso bile injicirane direktno, so bile pri prvi časovni točki (7 dni) pod mejno vrednostjo koncentracije ostankov, z izjemo enega vzorca ledvic, ki je vseboval mejno vrednost 25 µg/ kg.
Residues from the core injection site and its surrounding also remained below the limit of detection of muscle (2.1 µg/ kg) in all samples after 80 days and three samples after 90 days with remaining one being below the limit of quantification (25 µg/ kg).
Ostanki na mestu injiciranja in njegovi okolici so bili po 80 dneh pri vseh vzorcih pod ravnijo detekcije pri mišičnem tkivu (2, 1 µg/ kg), po 90 dneh pa pri treh vzorcih, z izjemo enega, pri katerem pa je bila vrednost ostanka pod določeno mejo kvantifikacije (25 µg/ kg).
2.2 Determination of meat withdrawal periods for cattle
2. 2 Izračun karence za meso govedi
Using the ‘ alternative approach’ as stated in CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/ CVMP/ 036/ 95) a withdrawal period of 8 days is obtained after adding 10% ‘ uncertainty factor’.
Pristop k usklajevanju karenc “ (EMEA/ CVMP/ 036/ 95), je dodana karenca v trajanju 8 dni zaradi dodanega 10% „ faktorja negotovosti “.
However, the actual withdrawal period for the product is to be based on the injection site residues.
Kljub temu pa se dejanska karenca določi na podlagi vrednosti koncentracije ostankov na mestu injiciranja.
The statistical approach, although preferred, could not be used for the calculation of the withdrawal period at the injection site given the non homogeneous nature of the studies as shown by the weight differences as well as the way residue levels were determined (3 samples versus just one), and therefore the ‘ alternative approach’ as set out in the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/ CVMP/ 036/ 95) was used.
„ Pristop k usklajevanju karenc “ (EMEA/ CVMP/ 036/ 95).
Considering that there is data at an additional time point (90 days) where residues were below the limit of quantification the addition of a 10% ‘ uncertainty factor’ was accepted.
Ob upoštevanju, da obstajajo podatki tudi za dodatno časovno točko (90 dni) ter da so bile tudi takrat vrednosti koncentracije ostankov pod mejnimi vrednostmi, je bil sprejet 10% dodatek „ faktorja negotovosti “.
A withdrawal period of 88 days is therefore established for cattle.
Za govedo je tako bila določena 88- dnevna karenca.
EMEA/ CVMP/ 283947/ 2008-EN 2.3 Residue studies in pigs
EMEA/ CVMP/ 283947/ 2008- SL 2. 3 Študije izločanja ostankov pri prašičih
66 - 84.5 kg) were used (eight male and eight female).
Pri glavni študiji izločanja ostankov so bile uporabljene težke živali (telesna masa 66– 84, 5 kg) (8 samcev in 8 samic).
The animals were given 15 mg amoxicillin/ kg bw corresponding to 1ml/ 10 kg/ bw which required 2 injections, one of which was the maximum volume (5 ml) and the remaining given in the second injection.
Živali so prejele 15 mg amoksicilina/ kg telesne mase, kar ustreza 1 ml inj. raztopine / 10 kg telesne mase; za to sta bili potrebni dve injekciji, ena od njiju največje možne količine (5 ml), preostala količina pa je bila injicirana z drugim odmerkom.
All samples were analysed for amoxicillin concentrations using a validated HPLC-MS/ MS method with a limit of quantification of 25 µg/ kg for all tissues.
Pri vseh vzorcih so koncentracije amoksicilina analizirali z metodo HPLC- MS/ MS z zahtevano mejo kvantifikacije 25 µg/ kg za vsa tkiva.
Residue levels in fat+skin, liver and non injection site muscle were all below the limit of quantification from the first time point (7 days) with the exception of one kidney sample which had residues above the MRL at the first time point and another one above the Limit of quantification.
Vrednosti ostankov v maščobi, koži, jetrih in mišicah, v katere inj. raztopine niso bile injicirane, so bile pri prvi časovni točki (7 dni) pod mejno vrednostjo kvantifikacije, z izjemo enega vzorca ledvic, pri katerem je bila pri prvi časovni točki koncentracija ostankov nad mejno vrednostjo ostankov, ter drugega vzorca ledvic, ki je vseboval ostanke nad mejo kvantifikacije.
The other two kidney samples were below the limit of quantification (25 µg/ kg).
Druga dva vzorca ledvic sta bila pod mejo kvantifikacije (25 µg/ kg).
With the exception of one animal after 36 days which had high residues (core sample 339.4 µg/ kg), residue levels were below the MRL after 30, 38 and 46 days.
Z izjemo ene živali, pri katerih so bile 36 dni po zakolu vrednosti ostankov zelo visoke (osnovni vzorec 339, 4 µg/ kg), so bile pri vseh drugih vzorcih koncentracije ostankov po 30, 38 in 46 dneh pod mejno vrednostjo ostankov.
2.4 Determination of meat withdrawal periods for pigs
2. 4 Izračun karence za prašičje meso
Residue levels in skin+fat, liver and non-injection site muscle were below their respective MRLs from the first time point (7 days) tested and for kidneys from the second time point (14 days).
Koncentracije ostankov v maščobi in koži, jetrih in mišicah, v katere niso bile injicirane inj. raztopine, so bile pri prvi časovni točki (7 dni), pri vzorcih ledvic pa pri drugi časovni točki (14 dni), pod mejno vrednostjo ostankov.
Using the ‘ alternative approach’ as stated in CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/ CVMP/ 036/ 95) a withdrawal period of 16 days is obtained after adding 10% ‘ uncertainty factor’.
Pristop k usklajevanju karenc “ (EMEA/ CVMP/ 036/ 95), je dodana karenca v trajanju 16 dni zaradi dodanega 10% „ faktorja negotovosti “.
The statistical approach could not be used for the calculation of the withdrawal period as the test for log-linearity (F-test) was not met and therefore the ‘ alternative approach ’ as set out in the CVMP guideline (EMEA/ CVMP/ 036/ 95-Final) was used.
Statistični pristop se ni mogel uporabiti za izračun karence na mestu injiciranja, saj test logaritemske linearnosti (F- test) ni bil izpolnjen, tako da je bil uporabljen „ alternativni pristop “ v skladu z navodili Odbora za zdravila za uporabo v veterinarski medicini (EMEA/ CVMP/ 036/ 95- Končni).
A safety span of 30% was considered necessary in this case because at the previous time point, which was only 2 days earlier, one sample contained residues of nearly 7 times the MRL.
V tem primeru je bil zaradi enega vzorca, pri katerem je pri predhodni časovni točki, ki je bila le dva dni prej, izmerjena vrednost koncentracije ostankov presegla mejno vrednost ostankov za kar sedemkrat, določen 30% varnostni razpon.
This leads to a withdrawal period of 50 days.
To pomeni, da je karenca za prašičje meso 50 dni.
EMEA/ CVMP/ 283947/ 2008-EN 3.
EMEA/ CVMP/ 283947/ 2008- SL 3.
• the new residue depletion studies in both cattle and pigs are of an acceptable standard and in large part in accordance with CVMP guideline on injection site residues (EMEA/ CVMP/ 542/ 03); • time points where residues at the injection sites were below the muscle MRL were identified for both cattle and pigs; • A meat withdrawal period can be set in both cattle and pigs using the ‘ Alternative approach’ as stated in the CVMP Note for guidance on the approach towards harmonisation of withdrawal periods (EMEA/ CVMP/ 036/ 95); • A meat withdrawal period of 88 days for cattle and 50 days for pigs can now be established;
Ob upoštevanju novih podatkov o izločanju ostankov, predloženih za umik preklica dovoljenja za promet z zdravilom Suramox 15% LA in z njim povezanega imena Stabox 15% LA v zvezi z določitvijo karence za govedo in prašiče je Odbor za zdravila za uporabo v veterinarski medicini zaključil, da: • so nove študije o izločanju ostankov pri govedu in prašičih sprejemljive kakovosti in večinoma v skladu z Navodili Odbora za zdravila za uporabo v veterinarski medicini Pristop k usklajevanju karenc (EMEA/ CVMP/ 542/ 03); • se lahko določijo časovne točke za govedo in prašiče, pri katerih je koncentracija ostankov v mišicah na mestu injiciranja pod mejno vrednostjo ostankov; • se lahko z uporabo „ alternativnega pristopa “ v skladu z Navodili Odbora za zdravila za uporabo v veterinarski medicini Pristop k usklajevanju karenc (EMEA/ CVMP/ 542/ 03) določi karenca za govedo in za prašiče; • se lahko za govedo tako določi karenca 88 dni, za prašiče pa karenca v trajanju 50 dni.
Therefore, the Committee for Medicinal Products for Veterinary Use recommends to lift the suspension of the marketing authorisations for Suramox 15% LA and its associated name Stabox 15% LA and to vary the marketing authorisations in order to set the withdrawal periods as stated above.
Odbor za zdravila za uporabo v veterinarski medicini zato priporoča, da se preklic dovoljenja za promet za zdravilo Suramox 15% LA in z njim povezano ime Stabox 15% LA umakne in ter da se dovoljenje za promet z zdravilom spremeni v skladu z zgoraj navedenima obdobjema karence.
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILA ZA UPORABO
Suramox 15% LA, suspension for injection
Suramox 15% LA, suspenzija za injiciranje
Active substance:
Zdravilna( e) učinkovina( e):
Micronised amoxicillin (as trihydrate)
Mikronizirani amoksicilin (kot trihidrat)
Excipient:
Pomožna( pomožne) snov( i):
Treatment of respiratory infections due to Pasteurella multocida and Mannheimia haemolytica.
Zdravljenje infekcij dihal zaradi Pasteurella multocida in Mannheimia haemolytica.
Treatment of respiratory infections due to Pasteurella multocida.
Zdravljenje infekcij dihal zaradi Pasteurella multocida.
Do not use in animals with known hypersensitivity to penicillin or other substances of the β -lactam group.
Ne uporabite pri živalih z znano preobčutljivostjo za penicilin ali druge snovi iz skupine beta - laktamov.
4.4 Special warnings for each target species
4. 4 Posebna opozorila za vsako ciljno vrsto
Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Za prvotno zdravljenje je treba uporabiti antibakterijsko terapijo ozkega spektra, kjer testiranje dovzetnosti predlaga verjetno uspešnost tega pristopa.
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.
Penicilini in cefalosporini lahko povzročijo preobčutljivost (alergijo) po injiciranju, vdihavanju, zaužitju ali stiku s kožo.
4.6 Adverse reactions (frequency and seriousness)
4.. 6 Neželeni učinki (pogostost in resnost)
Allergic reactions, skin reactions, anaphylaxis) may occur.
Pride lahko do pojava alergičnih reakcij, reakcij kože, anafilakse.
The safety of the product has not been assessed in pregnant and lactating targets species.
Varnost zdravila ni ocenjena pri ciljnih živalskih vrstah v obdobju brejosti in laktacije.
Use in such cases only according to the benefit/ risk assessment by the responsible veterinarian.
V takih primerih uporabite le v skladu z oceno koristi/ tveganja odgovornega veterinarja.
Administer 15 mg amoxicillin (as trihydrate) per kg bodyweight equivalent to 1 ml per 10 kg, twice at 48 hours interval.
Odmerite 15 mg amoksicilina (kot trihidrat) na kg telesne teže, enakovredno 1 ml na 10 kg, dvakrat v razmiku 48 ur.
June 2008
4. 11 Karenca
88 days - Pigs:
Meso in organi: – Govedo: – Prašiči:
50 days
88 dni 50 dni
- Milk:
– Mleko:
PHARMACOLOGICAL PROPERTIES
EMEA/ CVMP/ 283947/ 2008- SL 5.
Pharmacotherapeutic group:
Junij 2008
Penicillins with extended spectrum ATCVet code:
Farmakoterapevtska skupina: penicilini z razširjenim spektrom Oznaka ATCVet:
Amoxicillin belongs to β -lactams antibiotic family.
Amoksicilin spada v skupino beta- laktamskih antibiotikov.
Its structure contains the β -lactam ring and thiazolidine ring common to all penicillins.
Njegova struktura vsebuje beta- laktamski obroč in tiazolidinski obroč, ki sta skupna vsem penicilinom.
β -lactam antibiotics prevent the bacterial cell wall synthesis by interfering with the final stage of peptidoglycan synthesis.
Beta- laktamski antibiotiki preprečujejo sintezo bakterijske celične stene, pri čemer onemogočajo končno stopnjo sinteze peptidoglikana.
They inhibit the activity of transpeptidase enzymes which catalyse cross- linkage of the glycopeptide polymer units that form the cell wall.
Preprečujejo delovanje encimov transpeptidaze, ki katalizirajo navzkrižno povezovanje enot glikopeptidnega polimera, ki oblikujejo celično steno.
Amoxicillin is susceptible to breakdown by ß-lactamases produced by some bacterial strains.
Amoksicilin je dovzeten na razdelitev beta- laktamaz, ki jih proizvajajo nekateri bakterijski sevi.
Another possible mode of resistance to β -lactam antibiotics can be associated with chromosomal mutations in bacteria resulting either in modification of the penicillin binding proteins (PBPs) or in modification of the cellular permeability to β -lactams.
Drugi možen način odpornosti na beta- laktamske antibiotike je lahko povezan s kromosomskimi mutacijami bakterij, kar povzroča modifikacijo proteinov, ki vežejo peniciline (PBP), ali pa modifikacijo celične prepustnosti beta- laktamov.
After a single intramuscular administration of the product at 15 mg/ kg to pigs, mean amoxicillin plasma peak concentration of 3.78 µg/ ml is reached 0.77 hours after dosing.
Po posameznem intramuskularnem dajanju zdravila v količini 15 mg/ kg pri prašičih je povprečna največja koncentracija3, 78 µg/ ml amoksicilina v plazmi dosežena v 0, 77 ure.
After a single intramuscular administration of the product at 15 mg/ kg to cattle, mean amoxicillin plasma peak concentration of 2.93 µg/ ml is reached 1.64 hours after dosing.
Po posameznem intramuskularnem dajanju zdravila v količini 15 mg/ kg pri govedu povprečna največja koncentracija 2, 93 µg/ ml amoksicilina v plazmi doseženav 1, 64 ure.
Benzyl alcohol Stearic acid Aluminium stearate Propylene glycol dicaprylate/ dicaprate
Benzil alkohol Stearinska kislina Aluminijev stearat Propilen glikol dikaprilat/ dikaprat
EMEA/ CVMP/ 283947/ 2008-EN 6.2 Incompatibilities
6. 2 Inkompatibilnosti
Shelf-life after first opening the container:
Rok uporabnosti po prvem odpiranju stične ovojnine:
6.4.
EMEA/ CVMP/ 283947/ 2008- SL 6. 4.
This veterinary medicinal product does not require any special storage conditions required.
Junij 2008
Polyethylene terephtalate (PET) bottles with rubber closures and aluminium capsules
Steklenice iz polietilen tereftalata (PET) z gumijastim pokrovom in aluminijevimi kapsulami.
Product presentations:
Pakiranje zdravila:
Box of 125 ml bottle Box of 250 ml bottle Box of 500 ml bottle
Škatla s steklenico s 125 ml Škatla s steklenico z250 ml Škatla s steklenico s 500 ml
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Posebni varnosti ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
{MM/ YYYY} or< month YYYY >
{MM/ LLLL} ali < mesec LLLL >
EMEA/ CVMP/ 283947/ 2008-EN
EMEA/ CVMP/ 283947/ 2008- SL PODATKI NA ZUNANJI OVOJNINI
BOX of 125, 250 or 500 ml
ŠKATLA 125, 250 ALI 500 ml
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Zdravilna( e) učinkovina( e):
Micronised amoxicillin (as trihydrate) 150.0 mg/ ml Excipient:
Mikronizirani amoksicilin (kot trihidrat) Pomožna snov: benzil alkohol 35, 0 mg/ ml
Benzyl alcohol 35.0 mg/ ml
150, 0 mg/ ml
Box of 125 ml bottle Box of 250 ml bottle Box of 500 ml bottle
Škatla s steklenico 125 ml Škatla s steklenico 250 ml Škatla s steklenico 500 ml
Administer 15 mg amoxicillin (as trihydrate) per kg bodyweight equivalent to 1 ml per 10 kg, twice at 48 hours interval.
Odmerite 15 mg amoksicilina (kot trihidrat) na kg telesne teže, enakovredno 1 ml na 10 kg, dvakrat na 48- urne intervale.
- Milk:
EMEA/ CVMP/ 283947/ 2008- SL 8.
2.5 days
KARENCA:
Read the package leaflet before use.
POSEBNO( A) OPOZORILO( A), ČE JE/ SO POTREBNO( A)
< EXP {month/year} > Shelf-life after first opening the container:
< EXP {mesec/ leto} > Načeto/ odprto zdravilo uporabite do:
This veterinary medicinal product does not require any special storage conditions required.
Za shranjevanje ni posebnih navodil.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO “ SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
< Batch > < Lot > < BN > {number}
< Serija > < lot > < številka serije > {številka}
EMEA/ CVMP/ 283947/ 2008-EN PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
EMEA/ CVMP/ 283947/ 2008- SL
Bottle of 125, 250 or 500 ml
Steklenica 125, 250 ali 500 ml
Micronised amoxicillin (as trihydrate) 150.0 mg/ ml
Mikronizirani amoksicilin (kot trihidrat)
Bottle of 125, 250 or 500 ml.
Steklenica 125, 250 ali 500 ml.
ROUTE(S) OF ADMINISTRATION
NAČIN IN POT( I) UPORABE
WITHDRAWAL PERIOD
KARENCA:
Meat and offal: - Cattle: - Pigs:
Meso in drobovina: – Govedo: – Prašiči:
88 days 50 days
88 dni 50 dni
< EXP {month/year} > Shelf-life after first opening the container:
< EXP {mesec/ leto} > Rok uporabnosti po prvem odpiranju ovojnine:
EMEA/ CVMP/ 283947/ 2008-EN
EMEA/ CVMP/ 283947/ 2008- SL 10.
June 2008 PACKAGE LEAFLET
Junij 2008 NAVODILO ZA UPORABO
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGE( IH) SESTAVIN( E)
Do not use in rabbits, guinea pigs, hamsters or gerbils.
Ne uporabite pri zajcih, morskih prašičkih, hrčkih ali peščenih podganah.
Do not use in case of known resistance to amoxicillin
Ne uporabite v primeru znane odpornosti na amoksicilin.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
EMEA/ CVMP/ 283947/ 2008- SL
Intramuscular injection (cattle, pigs).
Junij 2008
Cattle and pigs:
8.
Administer 15 mg amoxicillin (as trihydrate) per kg bodyweight equivalent to 1 ml per 10 kg, twice at 48 hours interval.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT( I) IN NAČIN UPORABE ZDRAVILA
EMEA/ CVMP/ 283947/ 2008-EN 9.
Intramuskularno injiciranje (govedo, prašiči).
ADVICE ON CORRECT ADMINISTRATION
Govedo in prašiči:
June 2008
9.
EMEA/ CVMP/ 283947/ 2008-EN Use during pregnancy or lactation
EMEA/ CVMP/ 283947/ 2008- SL Uporaba med brejostjo ali laktacijo
London, 5 September 2008 EMEA/ 344321/ 2008
London, 5. september 2008 EMEA/ 344321/ 2008
Amoxicillin
DODATNO MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA Suramox 15% LA in z njim povezano ime Stabox 15% LA Mednarodno nelastniško ime (INN): amoksicilin
Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic belonging to the penicillin group.
Zdravilo Suramox 15% LA je suspenzija za injiciranje, ki vsebuje amoksicilin, t. j. beta- laktamski antibiotik iz skupine penicilinov.
In both species the product is administered intramuscularly at a dose of 15 mg amoxicillin/ kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice with a 48 hour interval between doses.
Pri obeh živalskih vrstah se zdravilo daje dvakrat v 48- urnem razmaku med obema injiciranjima, in sicer intramuskularno v odmerku 15 mg amoksicilina/ 1 kg telesne mase (kar je enakovredno 1 ml zdravila Suramox 15% LA/ 10 kg telesne mase).