natgillin/translations-raw huggingface dataset:
If any antibiotic is administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment has been completed.
Če dajemo antibiotik v enem tednu po cepljenju, je treba cepljenje po končanem antibiotičnem zdravljenju ponoviti.
Do not use after the expiry date which is stated on the label.
Cepiva ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
No data on the influence of maternal antibodies on the effect of vaccination with Nobivac Bb for cats are available.
Podatkov o vplivu maternalnih protiteles na učinkovitost cepljenja z Nobivacom Bb za mačke ni na voljo.
Dispose of waste material that has had contact with the active substance by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Odpadne snovi, ki so bile v stiku z zdravilno učinkovino, odstranite s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
Allow the solvent to reach room temperature.
Počakajte, da se vehikel ogreje na sobno temperaturo.
In cats that show more severe signs, appropriate antibiotic treatment may be indicated.
Pri mačkah, ki imajo resnejše znake, je včasih indicirano ustrezno antibiotično zdravljenje.
IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Immunologicals for felidae - cat - live bacterial vaccines.
Farmakoterapevtska skupina: imunološka sredstva za felidae - mačke - živa bakterijska cepiva.
The marketing authorisation holder must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v delu I vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
Shelf life after reconstitution: use within 4 hours.
Rok uporabnosti po rekonstituciji: porabite v 4 urah.
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use for special warnings for immunocompromised humans.
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pred uporabo preberite navodilo za uporabo in posebna opozorila za osebe z zmanjšano imunostjo.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega cepiva pred uporabo kateregakoli drugega zdravila za uporabo v veterinarski medicini ali po njej odločamo od primera do primera.
Manufacturers of the biological active substance
Izdelovalec biološke zdravilne učinkovine
Dogs, pigs and unvaccinated cats may react to the vaccine strain with mild and transient respiratory signs.
Pri psih, prašičih in necepljenih mačkah lahko cepni sev povzroči blage in prehodne respiratorne znake.
The import, sale, supply and/or use of Nobivac Bb for cats is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ali uporaba Nobivaca Bb za mačke je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni prisotna.
Withdraw 0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole contents of the syringe into one of the cat's nostrils.
Odvzemite 0,2 ml rekonstituiranega cepiva z 1- ali 2-mililitrsko brizgo, snemite iglo in mački vse cepivo v brizgi vbrizgajte v eno nosnico.
QUANTITY OF THE ACTIVE SUBSTANCE(S) 106.3- 108.3 CFU/dose B. bronchiseptica
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) 106.,3- 108.,3 CFU/odmerek B. bronchiseptica
SPECIAL STORAGE CONDITIONS Store at 2 - 8°C.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi 2 - 8°C.
In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
MANUFACTURER'S BATCH NUMBER Lot/Batch {number}
IZDELOVALČEVA ŠTEVILKA SERIJE Lot/serija {številka}
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
To stimulate active immunity against Bordetella bronchiseptica.
Spodbujanje aktivne imunosti proti bakteriji Bordetella bronchiseptica.
Box label:
Nalepka na škatli:
From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies.
Po podatkih v literaturi na imunsko reakcijo, ki jo spodbudi ta vrsta intranazalnega cepiva, ne vplivajo protitelesa, ki jih mladiči pridobijo od matere.
Vaccinated animals can spread the Bordetella bronchiseptica vaccine strain for six weeks; in individual cases for at least one year.
Cepljene živali lahko širijo bakterijski cepni sev Bordetella bronchiseptica šest tednov; posamezne najmanj eno leto.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
O varnosti in učinkovitosti sočasne uporabe cepiva z drugimi zdravili za uporabo v veterinarski medicini ni podatkov.
Solvent: Water for injection
Vehikel: voda za injekcije
After administration, occasionally sneezing, coughing, mild and transient discharge from the eyes or nose may occur.
Po dajanju se občasno lahko pojavi kihanje, kašelj, blag in prehoden izcedek iz oči ali nosu.
MARKETING AUTHORISATION NUMBER(S) EU/2/02/034/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/02/034/001
One 3 ml unit-dose vial (glass Type I) of lyophilisate sealed with a halogenobutyl rubber stopper and an aluminium cap, supplied with a vial (glass Type I) of 0.5 ml sterile solvent sealed with a halogenobutyl rubber stopper.
Ena viala po 3 ml (iz stekla tipa 1) liofilizata, zaprta z zamaškom iz sintetične gume in aluminijasto zaporko, in ena viala (iz stekla tipa 1) po 0,5 ml sterilnega vehikla, zaprta z zamaškom iz sintetične gume.
Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL - 5831 AN Boxmeer NIzozemska
For nasal use.
Za intranazalno uporabo
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sprostitev serije
4.2 Indications for use, specifying the target species For active immunisation of cats, of 1 month of age or older to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija mačk, starih 1 mesec ali starejših, za zmanjšanje kliničnih znakov obolenja zgornjih dihalnih poti, ki ga povzroča bakterija Bordetella bronchiseptica
Appropriate disinfection procedures should be used following use of this live bacterial vaccine.
Po uporabi tega živega bakterijskega cepiva je treba izvesti ustrezne postopke razkuževanja.
Lyophilisate:
Pakiranja:
Although the risk that immunocompromised humans become infected with Bordetella bronchiseptica is extremely low, such individuals should be aware that cats can shed the organism for up to 1 year after vaccination.
Čeprav je nevarnost, da bi se osebe z zmanjšano imunsko odpornostjo okužile z Bordetello bronchiseptico izjemno majhna, morajo vedeti, da jo lahko mačke izločajo do 1 leto po cepljenju.
CFU of live Bordetella bronchiseptica bacteria strain B-C2.
CFU živih bakterij Bordetella bronchiseptica, sev B-C2
Onset of immunity: Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Razvoj imunosti: Pri 8 mesecev starih mačkah se je imunost razvila že 72 ur po cepljenju.
Store at 2 - 8C.
Shranjujte pri temperaturi 2 do 8 ºC.
No adverse reactions other than those mentioned in section 4.6 were observed after the administration of an overdose of the vaccine.
Po dajanju prevelikega odmerka cepiva niso opazili nobenih drugih neželenih učinkov razen tistih, ki so navedeni v poglavju 4.6.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.
Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
The head of the cat should be held with its nose pointing upwards and its mouth closed, so that it is forced to breathe through its nostrils.
Mački držite glavo tako, da bosta nosnici obrnjeni navzgor in gobček zaprt in bo prisiljena dihati skozi nosnici.
Marketing authorisation holder and manufacturer: Intervet International B.V.
Imetnik dovoljenja za promet z zdravilom in izdelovalec Intervet International B.V.
Vaccination scheme: One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
En odmerek po 0,2 ml rekonstituiranega cepiva najmanj 72 ur pred obdobjem povečane nevarnosti okužbe.
The onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Pri 8 mesecev starih mačkah se je imunost razvila že 72 ur po cepljenju.
Sneezing by cats after administration does not adversely affect the efficacy of the veterinary medicinal product.
Kihanje po dajanju cepiva ne zmanjša njegove učinkovitosti.
Vaccinated animals can spread the vaccine strain of Bordetella bronchiseptica for six weeks, and there may be intermittent shedding for at least one year.
Cepljene živali lahko širijo cepni bakterijski sev Bordetella bronchiseptica šest tednov, s prekinitvami pa ga izločajo še najmanj eno leto.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS Each dose (0.2 ml) of reconstituted suspension contains:
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN Vsak odmerek po 0,2 ml rekonstituirane suspenzije vsebuje: Liofilizat:
For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Aktivna imunizacija mačk, starih 1 mesec ali starejših, za zmanjšanje kliničnih znakov obolenja zgornjih dihalnih poti, ki ga povzroča bakterija Bordetella bronchiseptica.
Water for injections.
Vehikel Voda za injekcije
Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided.
Aseptično rekonstituirajte liofilizirano cepivo z 0,3 ml priloženega sterilnega vehikla.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) of reconstituted suspension contains: Lyophilisate:
Vsak odmerek po 0,2 ml rekonstituirane suspenzije vsebuje: Liofilizat:
Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Aseptično rekonstituirajte liofilizat z 0,3 ml priloženega sterilnega vehikla.
INDICATION Live vaccine against feline upper respiratory tract disease caused by Bordetella bronchiseptica.
Živo cepivo proti bolezni zgornjih dihalnih poti pri mačkah, ki jo povzroča Bordetella bronchiseptica
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the product.
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen cepivu.
Lyophilisate: Off-white or cream-coloured pellet Solvent: clear colourless solution
Liofilizat; belkasta ali krem peleta Vehikel: bistra brezbarvna raztopina
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb for cats
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobivac Bb for cats
Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats that are in close contact with immunocompromised humans are not vaccinated with this vaccine.
Čeprav je nevarnost, da bi se osebe z zmanjšano imunsko odpornostjo okužile z Bordetello bronchiseptico izjemno majhna, ne priporočamo cepljenja mačk, ki so v tesnem stiku z njimi.
CONTRAINDICATIONS Do not use in pregnant or lactating queens.
KONTRAINDIKACIJE Cepiva ne uporabite pri brejih ali doječih samicah.
TARGET SPECIES Cats
CILJNE ŽIVALSKE VRSTE
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC(CI) BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Not all presentations may be marketed.
Ni nujno, da so v prometu vsa navedena pakiranja
Place the syringe in front of one of the nostrils and carefully administer the whole contents of the syringe into the nasal cavity via this nostril.
Brizgo držite pred nosnico in njeno vsebino previdno vbrizgajte skozi nosnico v nosno votlino.
Carton box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent Not all presentations may be marketed.
Zloženka s 5 vialami s po 1 odmerkom liofilizata in 5 vialami z vehiklom Plastična škatla s 5 vialami z 1 odmerkom liofilizata in 5 vialami z vehiklom Ni nujno, da so v prometu vsa navedena pakiranja
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment
BESEDILO “SAMO ZA ŽIVALI” Samo za živali
Sorbitol
KARENCA
PACKAGE LEAFLET FOR Nobivac Bb lyophilisate and solvent for suspension for cats
NAVODILO ZA UPORABO Nobivac Bb liofilizat in vehikel za suspenzijo za mačke
The vaccine is administered directly from the tip of the syringe onto the opening of the nostril and enters the nasal cavity during inhalation.
Cepivo je treba vbrizgati neposredno s konice brizge na nosno odprtino, od koder med vdihom steče v nosno votlino.
Shake well after addition of the solvent.
Po dodajanju vehikla dobro pretresite.
Do not use in pregnant or lactating queens.
Cepiva ne uporabljajte pri brejih ali doječih samicah.
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb lyophilisate and solvent for suspension for cats
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Nobivac Bb liofilizat in vehikel za suspenzijo za mačke
Do not administer during antibiotic treatment or in conjunction with any other intranasal veterinary medicinal products.
Cepiva ne smemo dajati med zdravljenjem z antibiotiki ali hkrati z drugimi zdravili za uporabo v veterinarski medicini za intranazalno dajanje.
Do not administer during antibiotic treatment, or in conjunction with any other intranasal veterinary medicinal product.
Cepiva ne smemo dajati med zdravljenjem z antibiotiki ali hkrati z drugimi zdravili za uporabo v veterinarski medicine za intranazalno dajanje.
C. STATEMENT OF THE MRLs Not applicable
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED Detailed information on this product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani
Veterinary medicinal product subject to prescription.
Izdaja zdravila je le na veterinarski recept.
Lyohpilisate:
Shema cepljenja:
METHOD AND ROUTE OF ADMINISTRATION For nasal use.
NAČIN IN POT(I) UPORABE Za intranazalno uporabo Pred uporabo preberite navodilo za uporabo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for the solvent vial:
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent.
Zloženka s 5 vialami z 1 odmerkom liofilizata in 5 vialami z vehiklom Plastična škatla s 5 vialami z 1 odmerkom liofilizata in 5 vialami z vehiklom
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Pred uporabo preberite navodilo za uporabo.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 0.5 ml
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Vehikel za Nobivac Bb KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) 1 odmerek VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 0,5 ml
Nasal use.
Intranazalna uporaba
106.3-108.3 colony forming units (CFU) of live Bordetella bronchiseptica strain B-C2 Solvent:
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Odmerek po 0,2 ml vsebuje: ≥ 106,3- ≤ 108,3 CFU živih bakterij Bordetella bronchiseptica, sev B-C2
ROUTE(S) OF ADMINISTRATION Nasal use.
POT(I) UPORABE ZDRAVILA Glejte navodilo za uporabo.
4.5 Special precautions for use
4.5 Posebni previdnostni ukrep(i)
Phosphate buffers.
Liofilizat: želatina sorbitol fosfatni pufri
Carton box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent.
FARMACEVTSKA OBLIKA Liofilizat in vehikel za suspenzijo VELIKOST PAKIRANJA 5 vial s po 1 odmerkom liofilizata in 5 vial z vehiklom, CILJNE ŽIVALSKE VRSTE
QUANTITY OF THE ACTIVE SUBSTANCE(S) 1 dose
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for the vaccine vial:
Nalepka za vialo s cepivom:
16 March 2015
16. marec 2015
The referral started on 4 June 2014.
Napotitveni postopek se je začel 4. junija 2014.
The final opinion was converted into a Decision by the European Commission on 16 March 2015.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 16. marca 2015.
The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Odbor je imenoval C. Ibrahim za poročevalko in M. Holzhauser-Albertija za soporočevalca.
International non-proprietary name (INN): colistin
Mednarodno nelastniško ime (INN): kolistin
Committee for Medicinal Products for Veterinary Use (CVMP)
Odbor za zdravila za uporabo v veterinarski medicini (CVMP)
Colistin sulfate belongs to the polymyxin group of antibiotics.
Kolistinijev sulfat spada v skupino antibiotikov polimiksinov.
The most common target species are pigs followed by chicken and cattle then other poultry species (e.g. turkeys), horses, rabbits, sheep and goats.
Najpogostejša ciljna vrsta so prašiči, ki jim sledijo piščanci in govedo ter druge perutninske vrste (npr. purani), konji, kunci, ovce in koze.
This group of antibiotics has a polypeptide structure, with mainly bactericidal activity and a medium antibacterial spectrum, which covers Gram-negative microorganisms only.
Ta skupina antibiotikov ima polipeptidno zgradbo, pri čemer imajo predvsem baktericidno delovanje in srednje širok protibakterijski spekter, ki zajema le gramnegativne mikroorganizme.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Seznam zadevnih imen zdravil je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v Prilogi III.
Veterinary medicinal products containing colistin as a sole active substance for oral administration in food producing animals are widely used in almost all EU Member States.
Zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin kot edino zdravilno učinkovino in se uporabljajo peroralno pri živalih za proizvodnjo živil, so splošno razširjena zdravila v skoraj vseh državah članicah EU.
Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP menil, da je splošno razmerje med tveganji in koristmi za ta zdravila še vedno pozitivno, če se upoštevajo spremembe informacij o zdravilu.
Oral colistin formulations including powder, solution, premix, tablets and paste have been authorised, mainly for group and flock treatment for the treatment and prevention of different specified gastrointestinal diseases caused by sensitive Enterobacteriacea species (e.g. Salmonella and Escherichia coli), but marketing authorisations without more specific indications do also exist.
Za peroralne oblike kolistina, vključno s praškom, raztopino, predmešanico, tabletami in pasto, so bila izdana dovoljenja za promet, zlasti za zdravljenje skupin ali jat, in sicer za zdravljenje in preprečevanje različnih določenih bolezni prebavil, ki jih povzročajo občutljive bakterije družine Enterobacteriacea (npr. Salmonella in Escherichia coli), vendar obstajajo tudi dovoljenja za promet z zdravili z manj podrobnimi indikacijami.
On 12 May 2014, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing colistin to be administered orally.
Evropska komisija je dne 12. maja 2014 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2011/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin in se uporabljajo peroralno.
No written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders.
Predlagatelji in imetniki dovoljenja za promet z zdravilom niso podali pisnih pripomb na priporočila in predlagane spremembe informacij o zdravilu.
Therefore, on 11 December 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing colistin to be administered orally.
Odbor je zato 11. decembra 2014 soglasno sprejel pozitivno mnenje ter priporočil spremembo pogojev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin in se uporabljajo peroralno.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf
2 Spremenjene smernice odbora CVMP o povzetku glavnih značilnosti zdravila za protimikrobna zdravila (EMEA/CVMP/SAGAM/383441/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf
Opinion following an Article 351 referral for veterinary medicinal products containing colistin to be administered orally
Mnenje v zvezi z napotitvijo v skladu s členom 351 za zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin in se uporabljajo peroralno
The CVMP was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) 2.
Odbor CVMP je bil naprošen, da poda mnenje o ukrepih, ki bi jih morali sprejeti, da bi zagotovili preudarno uporabo kolistina pri živalih za proizvodnjo živil po vsej EU in čim bolj zmanjšali morebitna tveganja, povezana z uporabo opredeljenih zdravil, ter med drugim mnenje o tem, ali je treba v informacije o zdravilu vključiti ustrezne indikacije in opozorila o preudarni uporabi
1 Article 35 of Directive 2001/82/EC, as amended 2 CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom in/ali omejiti indikacije opredeljenih zdravil ob upoštevanju spremenjenih smernic odbora CVMP o povzetku glavnih značilnosti zdravila za protimikrobna zdravila (EMEA/CVMP/SAGAM/383441/2005) 2.
MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Številka (EU) dovoljenja za promet
suspension: 2.5 ml; emulsion: 2.5 ml
suspenzija: 2,5 ml ; emulzija: 2,5 ml
Intramuscular use suspension (H1N1): vial (glass); emulsion (adjuvant): vial (glass)
suspenzija in emulzija za emulzijo za injiciranje intramuskularna uporaba suspenzija (H1N1): viala (steklo); emulzija (adjuvans): viala (steklo)