natgillin/translations-raw huggingface dataset:
4) Restrain the calf and insert the nozzle of the metering pump into the calves mouth.
4) Poskrbite, da bo tele mirovalo, in mu šobo merilne črpalke vstavite v usta.
Use during pregnancy, lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti
To ensure a correct dosage, an appropriate metering pump for administration of ‘HALAGON' is included.
Zaradi natančnega odmerjanja je priložena ustrezna merilna črpalka za dajanje zdravila HALAGON.
• Reduction of diarrhoea due to diagnosed Cryptosporidium parvum infection.
• Ublažitev driske pri diagnozi okužbe s Cryptosporidium parvum.
Halofuginone (as lactate salt)
Halofuginon (v obliki laktata)
However, in order to make the HALAGON treatment easier, a simplified dosage scheme is proposed:
Za enostavnejše zdravljenje z zdravilom HALAGON lahko uporabimo naslednjo shemo odmerjanja:
• Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, in farms with history of cryptosporidiosis.
• Preprečevanje driske pri diagnozi okužbe s Cryptosporidium parvum na farmah, na katerih se je že v preteklosti pojavila kriptosporidioza.
Pull twice or three times, respectively, for administration of the desired volume (8 ml for calves of 35 - 45 kg and 12 ml for calves of 45 - 60 kg, respectively).
Da bi tele dobilo želeno količino, sprožilec potegnite dvakrat (tj. 8 ml za teleta, ki tehtajo 35 do 45 kg) oziroma trikrat (tj. 12 ml za teleta, ki tehtajo 45 do 60 kg).
For treatment of anorexic calves, the product should be administered in half a liter of an electrolyte solution.
Anoreksičnim teletom dajemo zdravilo v polovici litra elektrolitske raztopine.
Hankóczy Jenõ utca 21/A HU-1022 Budapest Tel.: +36 30 650 0 650
Magyarország Panon VetPharma Kft. Hankóczy Jenõ utca 21/A HU-1022 Budapest Tel.: +36 30 650 0 650
• 45 kg < calves < 60 kg: 12 ml of HALAGON once a day during 7 consecutive days
• 45 kg < teleta < 60 kg: 12 ml zdravila HALAGON, 1-krat na dan, 7 zaporednih dni
Once broached, use by …
Načeto zdravilo porabite do ...
Administer after colostrum feeding, or after milk or milk replacer feeding only.
Zdravilo dajemo le po hranjenju s kolostrumom, mlekom ali mlečnim nadomestkom.
Clear yellow oral solution.
Bistra rumena peroralna raztopina.
An appropriate device for oral administration is included.
Priložena je ustrezna naprava za peroralno dajanje.
• 35 kg < calves ≤ 45 kg: 8 ml of HALAGON once a day during 7 consecutive days
• 35 kg < teleta ≤ 45 kg: 8 ml zdravila HALAGON, 1-krat na dan, 7 zaporednih dni
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
PODATKI NA ZUNANJI OVOJNINI Zunanja kartonska ovojnina
The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Končna razpolovna doba izločanja je 11,7 ure po intravenskem dajanju in
Bovine 10 μg/kg 25 μg/kg
Halofuginon Halofuginon Govedo 10 µg/kg 25 µg/kg
Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to the active substance or any of the excipients should administer the veterinary medicinal product with caution.
Osebe z znano preobčutljivostjo za zdravilno učinkovino ali za katero koli pomožno snov naj bodo previdne pri dajanju veterinarskega zdravila.
The dosage is: 100 μg of halofuginone / kg bw / once a day for 7 consecutive days, i.e. 4 ml of HALAGON / 20 kg bw / once a day for 7 consecutive days.
Odmerjanje: 100 µg halofuginona/kg telesne mase, 1-krat na dan, 7 zaporednih dni, to je 4 ml zdravila HALAGON/20 kg telesne mase, 1-krat na dan, 7 zaporednih dni.
Cardboard box containing one bottle (high-density polyethylene) of 290 ml, 490 ml or 980 ml of the oral solution.
Kartonska škatla, ki vsebuje eno plastenko (iz polietilena visoke gostote) z 290 ml, 490 ml ali 980 ml peroralne raztopine.
Cardboard box with high density polyethylene bottles of 290 ml, 490 and 980 ml.
Kartonska škatla s plastenkami iz polietilena visoke gostote z 290 ml, 490 ml in 980 ml raztopine.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
6) Put the protector cap back on the nozzle.
6) Zaščitni pokrovček nataknite nazaj na šobo.
The active substance in HALAGON is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Za pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije
In new-born calves:
Novorojena teleta:
PHARMACEUTICAL PARTICULARS 6.1.
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
STATEMENT OF ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Shelf-life after first opening the immediate packaging: 6 months.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 6 months.
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Antiparasitic agents/Agents acting against protozoa
Antiparazitiki/Ant iprotozoiki
EU/2/16/201/001 (290 ml) EU/2/16/201/002 (490 ml) EU/2/16/201/003(980 ml)
EU/2/16/201/002 (490 ml)
HALAGON 0.5 mg/ml oral solution halofuginone
HALAGON 0,5 mg/ml, peroralna raztopina Halofuginon
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Izdelovalec, odgovoren za sproščanje serij:
HALAGON 0.5 mg/ml oral solution for calves halofuginone (as lactate salt)
HALAGON 0,5 mg/ml, peroralna raztopina za teleta halofuginon (v obliki laktata)
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE AMTERIALS, IF ANY
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
MARKETING AUTHORISATION NUMBER(S)
IMETNIK DOVOLJENJ(A) ZA PROMET
Panon VetPharma Kft.
Peroralna raztopina.
HALAGON 0.5mg/ml oral solution for calves.
HALAGON 0,5 mg/ml, peroralna raztopina za teleta.
Polska
Belgija
Target species
Živalska vrsta
Special warnings
12 POSEBNA OPOZORILA
DATE OF REVISION OF THE TEXT
DATUM REVIZIJE BESEDILA DD. mesec LLLL
2) Remove the protector cap from the nozzle.
2) S šobe odstranite zaščitni pokrovček.
Target tissues
Peroralna raztopina
Oral solution.
Za peroralno uporabo.
Oral Solution
NAVEDBA UČINKOVINE
SPECIAL WARNING(S)
4.4 Posebna opozorila
Manufacturer responsible for batch release: Divasa-Farmavic, S.A.
Imetnik dovoljenja za promet z zdravilom: EMDOKA bvba
It is taken morning and evening.
Jemlje se zjutraj in zvečer.
Further information on Stayveer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Stayveer so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Stayveer?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Stayveer?
This medicine is the same as Tracleer, which is already authorised in the EU.
To zdravilo je enako zdravilu Tracleer, ki je že odobreno v Evropski uniji (EU).
What benefits of Stayveer have been shown in studies?
Kakšne koristi zdravila Stayveer so se pokazale v študijah?
In adults, the starting dose is 62.5 mg twice a day for four weeks, which is increased to the usual dose of 125 mg twice a day.
Pri odraslih je začetni odmerek 62,5 mg dvakrat na dan štiri tedne, kar se poveča na običajni odmerek 125 mg dvakrat na dan.
What is Stayveer and what is it used for?
Kaj je zdravilo Stayveer in za kaj se uporablja?
Stayveer is available as film-coated tablets (62.5 mg and 125 mg).
Na voljo je v obliki filmsko obloženih tablet (62,5 mg in 125 mg).
‘Class II' involves slight limitation of physical activity.
funkcijski razred pomeni rahlo omejitev telesne dejavnosti.
Stayveer received a marketing authorisation valid throughout the EU on 24 June 2013.
Za zdravilo Stayveer je bilo 24. junija 2013 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that Stayveer's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Stayveer večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
As for all medicines, data on the use of Stayveer are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Stayveer stalno spremljajo.
An overview of Stayveer and why it is authorised in the EU
Pregled zdravila Stayveer in zakaj je odobreno v EU
What are the risks associated with Stayveer?
Kakšna tveganja so povezana z zdravilom Stayveer?
Other information about Stayveer
Druge informacije o zdravilu Stayveer
By expanding these blood vessels, pressure is reduced and symptoms are improved.
Z razširitvijo krvnih žil se tlak zniža in simptomi izboljšajo.
The second study which also looked at the effect of Stayveer on digital ulcer healing in 190 patients did not find any effect.
V drugi študiji, v kateri so prav tako proučevali učinek zdravila Stayveer na celjenje razjed prstov pri 190 bolnikih, se ni pokazal nikakršen učinek.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stayveer have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Stayveer upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about using Stayveer, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Stayveer glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Stayveer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin (a medicine that acts on the immune system).
Zdravilo Stayveer se ne sme uporabljati pri bolnikih, ki imajo določene težave z jetri, bolnicah, ki so noseče ali bi lahko zanosile in ki ne uporabljajo zanesljivih metod preprečevanja zanositve, ter bolnikih, ki jemljejo ciklosporin (zdravilo, ki učinkuje na imunski sistem).
The company that makes Stayveer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.
Podjetje, ki izdeluje zdravilo Stayveer, bo zagotovilo opozorilno kartico za bolnike glede nujnega izvajanja rednih krvnih preiskav delovanja jeter in uporabo učinkovitega kontracepcijskega sredstva za preprečitev nosečnosti.
Side effects reported with Stayveer are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Stayveer, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The company that makes Tracleer has agreed that its scientific data can be used for Stayveer (‘informed consent').
Podjetje, ki proizvaja zdravilo Tracleer, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Stayveer („uporaba dokumentacije s soglasjem“).
The most common side effects with Stayveer (which may affect more than 1 in 10 people) are headache, fluid retention, anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body) and abnormal results of blood tests to check the liver.
Najpogostejši neželeni učinki zdravila Stayveer (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so glavobol, zastajanje tekočine, anemija (nizke ravni hemoglobina, beljakovine v rdečih krvnih celicah, ki po telesu prenaša kisik) in nenormalni izvidi krvnih preiskav delovanja jeter.
Why is Stayveer authorised in the EU?
Zakaj je bilo zdravilo Stayveer odobreno v EU?
Stayveer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms.
Zdravilo Stayveer se uporablja za zdravljenje bolnikov s pljučno arterijsko hipertenzijo (PAH) III. funkcijskega razreda za izboljšanje fizične zmogljivosti (sposobnosti izvajanja telesne dejavnosti) in zmanjševanje simptomov.
The active substance in Stayveer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Učinkovina v zdravilu Stayveer, bosentan, zavira naravno prisoten hormon, imenovan endotelin-1 (ET-1), ki povzroča zožitev krvnih žil.
• caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
• posledica skleroderme (imenovane tudi sistemska skleroza, tj. bolezen, pri kateri se nenormalno razrašča vezivno tkivo, ki daje oporo koži in drugim organom);
In the first study, patients taking Stayveer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo.
V prvi študiji so imeli bolniki, ki so jemali zdravilo Stayveer, po 16 tednih zdravljenja povprečno 1,4 nove razjede prstov, bolniki, ki so jemali placebo, pa 2,7 nove razjede.
Stayveer can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Predpisovanje in izdaja zdravila Stayveer je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem pljučne arterijske hipertenzije ali sistemske skleroze.
The ‘class' reflects the severity of the disease: ‘class III' PAH involves marked limitation of physical activity.
Funkcijski razred odraža resnost bolezni: pljučna arterijska hipertenzija III. funkcijskega razreda vključuje izrazito omejitev telesne dejavnosti.
Stayveer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes).
Zdravilo Stayveer se lahko uporablja tudi pri odraslih s sistemsko sklerozo, pri katerih je slab pretok krvi zaradi bolezni povzročil nastanek razjed prstov (razjed na prstih rok in nog).
However, Stayveer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.
Zdravilo Stayveer pa je po šestih mesecih zdravljenja zmanjšalo upor krvnih žil za 23 %, kar kaže na razširitev krvnih žil v primerjavi s placebom.
Some improvement with Stayveer can also occur in patients with class II PAH.
Zdravilo Stayveer lahko nekoliko izboljša stanje tudi pri bolnikih s pljučno arterijsko hipertenzijo II.
In PAH, Stayveer added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.
Pri pljučni arterijski hipertenziji je bilo zdravilo Stayveer kot dodatek k bolnikovemu trenutnemu zdravljenju po 16 tednih zdravljenja učinkovitejše od placeba (zdravila brez učinkovine) pri povečanju razdalje, ki jo bolniki lahko prehodijo v šestih minutah (način merjenja fizične zmogljivosti).
How is Stayveer used?
Kako se zdravilo Stayveer uporablja?
How does Stayveer work?
Kako zdravilo Stayveer deluje?
Stayveer is given to reduce the number of new digital ulcers.
Daje se za zmanjševanje števila novih razjed prstov.
Stayveer contains the active substance bosentan.
Zdravilo Stayveer vsebuje učinkovino bosentan.
Stayveer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults.
Zdravilo Stayveer je bilo v dveh študijah pri skupno 312 odraslih učinkovitejše od placeba pri zaviranju nastajanja novih razjed prstov.
In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Stayveer and placebo groups.
funkcijskega razreda je bila razdalja, ki jo bolniki lahko prehodijo v šestih minutah, med skupinama, zdravljenima z zdravilom Stayveer oziroma placebom, podobna.
Stayveer therefore prevents blood vessels from narrowing.
Zdravilo Stayveer torej preprečuje zožitev krvnih žil.
For the full list of side effects of Stayveer, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Stayveer, glejte navodilo za uporabo.
<Do not use in ….>
<Ne uporabite v ...>
ANNEX II[Not applicable for MRP/DCP]
PRILOGA II[Not applicable for MRP/DCP]
OTHER INFORMATION>
DRUGE INFORMACIJE>
<Use only accordingly to the benefit-risk assessment by the responsible veterinarian.>
<Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.>
ATC vet code: {lowest available level (e.g. subgroup for chemical substance)}.
Oznaka ATC vet: {najnižja razpoložljiva raven (npr. podskupina za kemijsko snov)}.
<Accidental injection is dangerous.>
<Nenamerno injiciranje je nevarno.>
<Dispose of waste material in accordance with local requirements.>
<Odpadne snovi odstranite v skladu z lokalnimi zahtevami.>
<This being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
<Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 39(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
<The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.>[Only applicable, if justified after authorisation.]
<Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju naslednjih dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih.> [Only applicable, if justified after authorisation.]
Pharmacotherapeutic group: {group}.
Farmakoterapevtska skupina: {skupina}.
<Official control authority batch release is required for this product.> [only for those immunological veterinary medicinal products which are listed for HYPERLINK "https://www.edqm.eu/en/Veterinary-OCABR-Guidelines-1531.html" \l "PSG"Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
<Za to zdravilo je potreben postopek uradne kontrole in sproščanja.> [only for those immunological veterinary medicinal products which are listed for HYPERLINK "https://www.edqm.eu/en/Veterinary-OCABR-Guidelines-1531.html" \l "PSG"Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
<Specific pharmacovigilance requirements:>
<Posebne farmakovigilančne zahteve:>
<The long-term effects of the veterinary medicinal product on the population dynamics of dung beetles have not been investigated.
<Dolgoročni učinki tega zdravila na dinamiko populacije govnačev niso raziskani.
<According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
<Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
Personnel involved in attending vaccinated {species} should follow general hygiene principles (changing clothes, wearing gloves, cleaning and disinfection of boots) and take particular care in handling animal waste and bedding materials from recently vaccinated {species}.>
Osebje, ki oskrbuje cepljene {živalske vrste} morajo upoštevati splošna higienska načela (menjava obleke, uporaba rokavic, čiščenje in razkuževanje čevljev) in mora še posebej paziti pri ravnanju z izločki in nastiljem {živalskih vrst}, ki so bile pred kratkim cepljene.>
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (HYPERLINK "http://www.ema.europa.eu/"http://www.ema.europa.eu/).
<Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) ( HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/).>
<To the user:
<Namenjeno uporabniku:
b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.>
b) bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.>
<Not for use in birds producing or intended to produce eggs for human consumption.>
<Ni za uporabo pri pticah,ki proizvajajo ali so namenjene proizvodnji jajc za prehrano ljudi..>
<Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.>
<Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo , se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.>
<Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.>
<Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.>
<PHARMACOLOGICAL><IMMUNOLOGICAL> PROPERTIES
<FARMAKOLOŠKE> <IMUNOLOŠKE> LASTNOSTI
<Do not use in breeding animals.>
<Ne uporabite pri vzrejnih živalih.>
· <SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES>
<SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH>
<No data available.>
<Ni podatkov.>
Pharmaco-logically active substanceMarker residueAnimal speciesMRLsTarget tissuesOther provisionsTherapeutic classification
Farmakološko aktivna snovMarker ostanekŽivalska vrstaMRLCiljna tkivaDruge določbeTerapevtske indikacije
<{DD month YYYY}>
<{DD mesec LLLL}>
<{X} degree days.>
<{X} dnevnih stopinj.>
<For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
<Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.>
The active substance being a principle of biological origin intended to <produce> <active><passive><diagnose a state of> immunity is not within the scope of Regulation (EC) No 470/2009.
Učinkovina, ki je v osnovi biološkega izvora namenjena <vzbujanju> <aktivne> <pasivne> <diagnosticiranju> imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
<The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.>
<V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov proizvajalca, odgovornega za sproščanje zadevne serije.>