natgillin/translations-raw huggingface dataset:
Econor 0.5% premix contains valnemulin in the form of valnemulin hydrochloride.
Zdravilne učinkovine:
Valnemulin hydrochloride equivalent to valnemulin base
Valnemulin v obliki valnemulinijevega klorida 5. 325 mg/ g kar ustreza
5.325 mg/ g 5 mg/ g
5 mg/ g valnemulinske baze
List of excipients:
Hipromeloza
Hypromellose and talc Colloidal anhydrous silica Isopropyl myristate Lactose
in puder; kloidni anhidrozni silicij; izopropilni miristat; laktoza
substance per kg feed with:
Dodajanje 75 mg učinkovine/ kg krme:
Econor 0.5% - 15 g/ kg feed
Econor 0. 5% - 15 g/ kg krme
43 This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
Te vrednosti so učinkovite pri zdravljenju kliničnih znakov bolezni; za popolno eliminacijo infekcije pa je potreben daljši čas zdravljenja in večje koncentracije zdravila.
Indication
42 Indikacije
disease disappear
Econor 0. 5% - 15 g / kg krme
minimum of 7 days and
- Driske pri prašičih - Kliničnih znakov
substance per kg feed with:
1. 0- 1. 5 mg/ kg t. m. / dan
up to 4 weeks
Najmanj 7 dni do 4 tednov
Econor 0.5% - 5 g/ kg feed
Econor 0. 5% - 5 g / kg krme
Dysentery Clinical signs of Porcine Colonic Spirochaetosis (colitis)
kolitisa pri prašičih, ki ga povzročajo spirohete
Mixing Instructions: mg Econor 0.5% premix/ kg feed = Dosage required (mg/ kg) x 200 x bodyweight (kg) / Daily feed intake (kg)
Navodilo za pripravo mešanice:
Aggressive pelleting conditions such as temperatures in excess of 80oC, and the use of abrasive substances for pre- mixture should be avoided.
mg Econor 0. 5% premiks/ kg krme = priporočen odmerek( mg/ kg) x 200 x telesna masa (kg) / količino dnevnega vnosa krme (kg) Pripravek je stabilen v procesu peletiranja pri 75° C. Izogibajte se pre agresivnemu postopku peletiranja kot sta temperatura nad 80° C in uporaba abrazivnih substanc.
3 years Shelf-life when incorporated into meal feed and protected from light and moisture:
3 leta Rok uporabnosti zdravila po dodajanju v mleto krmo in zaščiteno pred svetlobo in vlago:
EU/ 2/ 05/ 056/ 001
EU/ 2/ 05/ 056/ 00
Equilis Prequenza
1 Equilis Prequenza
Purified haemaglutinin from equine influenza viruses:
prečiščeni hemaglutinin iz virusov influence konj:
Intramuscular
intramuskularno
Vials (Type I glass) closed with a halogenobutyl
viale (steklo tipa I), zaprte z zamaški iz
Zero days
nič dni
A/ equine/ Prague/ 1/ 56 100 AU/ ml A/ equine/ Newmarket/ 1/ 9 3 50 AU/ ml
A/ konjski/ Prague/ 1/ 56 100 AU/ ml
rubber stopper and aluminium cap.
A/ konjski/ Newmarket/ 1/ 93 50 AU/ ml
A/ equine/ Newmarket/ 2/ 9 3 50 AU/ ml
A/ konjski/ Newmarket/ 2/ 93 50 AU/ ml
1 dose
napolnjene brizge 1 (steklo tipa I) z odmerek batom in nastavkom iz
10 pre-filled syringes
10 napolnjenih nič dni brizg
tip of halogenobutyl rubber
halogenobutilne gume
©EMEA 2006
Številka
EU Number
EU Izmišljeno ime
Pharmaceutical Form
Farmacevtska Ciljna
Target species
Način uporabe Ovojnina
Route of administration
Vsebina Velikost
Content
oblika
Package size
živalska vrsta zdravila
Withdrawal period
pakiranja
A/ equine/ Newmarket/ 2/ 9 3 50 AU/ ml
A/ konjski/ Newmarket/ 1/ 93 50 AU/ ml
EU/ 2/ 05/ 056/ 004
A/ konjski/ Newmarket/ 2/ 93 50 AU/ ml EU/ 2/ 05/ 056/ 004 Equilis Prequenza
5 pre-filled syringes
5 napolnjenih nič dni brizg
EU/ 2/ 05/ 057/ 001
EU/ 2/ 05/ 057/ 00
Vial (Type I glass) closed with a
viale (steklo tipa I), zaprte z zamaški iz
10 glass vials Zero days
10 steklenih vial
A/ equine/ Prague/ 1/ 56 100 AU/ ml
A/ konjski/ Prague/ 1/ 56 100 AU/ ml
halogenobutyl rubber stopper and aluminium
halogenobutilne gume in aluminijastimi
A/ equine/ Newmarket/ 1/ 93 50 AU/ ml
A/ konjski/ Newmarket/ 1/ 93 50 AU/ ml
cap.
zaporkami
A/ equine/ Newmarket/ 2/ 93 50 AU/ ml
A/ konjski/ Newmarket/ 2/ 93 50 AU/ ml
Tetanus toxoid ≥ 30 IU/ ml
toksoid tetanusa ≥ 30 i. e. / ml
1 dose
napolnjene brizge 1 (steklo tipa I) z odmerek batom in
10 pre-filled Zero days syringes
10 napolnjenih nič dni brizg
A/ equine/ Newmarket/ 1/ 93 50 AU/ ml
A/ konjski/ Prague/ 1/ 56 100 AU/ ml A/ konjski/ Newmarket/ 1/ 93 50 AU/ ml
halogenobutyl rubber
nastavkom iz halogenobutilne gume
©EMEA 2006
Številka EU
EU Number
Izmišljeno ime Jakost
Invented Name Strength
Farmacevtska oblika
EU/ 2/ 05/ 057/ 004
toksoid tetanusa ≥ 30 i. e. / ml EU/ 2/ 05/ 057/ 004
EMEA/ V/ C/ 095
EMEA/ V/ C/ 093
Equilis Prequenza Te is a vaccine for use in horses.
Zdravilo Equilis Prequenza Te je cepivo, ki se uporablja za konje.
It contains parts (subunits) of three equine influenza (flu) strains (‘ A/ equine-1/ Prague/ 1/ 56’, ‘ A/ equine-2/ Newmarket/ 1/ 93’ and ‘ A/ equine- 2/ Newmarket/ 2/ 93’) and tetanus toxoid (chemically inactivated toxin from the tetanus bacterium).
Vsebuje dele (podenote) treh sevov virusa influence konj (gripe) („ A/ konjski- 1/ Prague/ 1/ 56 “, „ A/ konjski- 2/ Newmarket/ 1/ 93 “ in „ A/ konjski- 2/ Newmarket/ 2/ 93 “) in toksoid tetanusa (kemično oslabljen toksin iz bakterije tetanusa).
Equilis Prequenza Te is used to vaccinate horses from six months of age against equine influenza and tetanus.
Zdravilo Equilis Prequenza Te se uporablja za cepljenje konj, ki so starejši od šestih mesecev, proti influenci konj in tetanusu.
The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.
Cepivo blaži klinične znake influence konj in izločanje virusa po okužbi.
Equine influenza is a highly contagious disease that is very common in horses but that rarely causes death.
Influenca konj je visoko nalezljiva bolezen, ki je pri konjih zelo pogosta, vendar redko povzroči pogin.
The vaccine also stimulates protection against tetanus to prevent mortality.
Cepivo tudi spodbuja zaščito proti tetanusu za preprečevanje umrljivosti.
To retain protection, horses need to be revaccinated.
Za ohranitev zaščite morajo biti konji ponovno cepljeni.
For protection against equine influenza, the first revaccination should be five months after primary vaccination, followed by yearly revaccinations.
Za zaščito proti influenci konj je treba izvesti prvo ponovno cepljenje pet mesecev po osnovnem cepljenju, čemur sledijo vsakoletna ponovna cepljenja.
For protection against tetanus, the first revaccination should be no later than 17 months after primary vaccination.
Za zaščito proti tetanusu je treba izvesti prvo ponovno cepljenje najpozneje v 17 mesecih po osnovnem cepljenju.
Equilis Prequenza Te contains fragments (subunits) of the influenza viruses against which the vaccine is indicated for.
Zdravilo Equilis Prequenza Te vsebuje delce (podenote) virusov influence, proti katerim je cepivo indicirano.
These fragments provoke a protective response of the immune system (the body ’ s natural defences) but cannot cause the disease.
Ti delci izzovejo zaščitni odziv imunskega sistema (naravni obrambni mehanizem telesa), vendar ne morejo povzročiti bolezni.
Vaccines work by ‘ teaching’ the immune system how to defend itself against diseases.
Cepiva delujejo tako, da imunski sistem „ naučijo “, kako naj se brani proti boleznim.
When the product is given to horses, it helps the animals’ immune system to react quicker when the animal is naturally exposed to the equine influenza virus and the Clostridium tetani bacterium.
Ko konj prejme zdravilo, pomaga imunskemu sistemu živali, da reagira hitreje, kadar je žival naravno izpostavljena virusu influence konj in bakteriji Clostridium tetani.
This helps to protect against equine influenza and tetanus.
S tem pomagamo zaščititi žival proti influenci konj in tetanusu.
The vaccine also contains an ‘ adjuvant’ to stimulate a better immune response.
Cepivo vsebuje tudi „ adjuvans “, ki spodbudi boljši imunski odziv.
The safety of Equilis Prequenza Te was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Varnost zdravila Equilis Prequenza Te so raziskovali v več študijah, izvedenih v laboratorijskih in terenskih pogojih na številnih konjih, starejših od 2 mesecev.
It was concluded that the product is well tolerated by horses of different ages.
Ugotovljeno je bilo, da konji različnih starosti dobro prenašajo zdravilo.
Equilis Prequenza Te was also studied in pregnant mares.
Zdravilo Equilis Prequenza Te so raziskovali tudi na brejih kobilah.
The effectiveness of Equilis Prequenza Te has been studied in several trials under laboratory and field conditions.
Učinkovitost zdravila Equilis Prequenza Te so raziskali v več preizkušanjih, izvedenih v laboratorijskih in terenskih pogojih.
The main measure of effectiveness of Equilis Prequenza Te against equine influenza was the production of protective levels of antibodies against the influenza components.
Glavno merilo učinkovitosti zdravila Equilis Prequenza Te proti influenci konj je bilo tvorjenje zaščitnih ravni protiteles proti influenci konj.
The studies also compared the clinical signs and virus excretion of a group of vaccinated animals with those of a control group, (i. e. which did not receive the vaccine or received a competitive product).
V študijah so primerjali tudi klinične znake in izločanje virusa pri cepljenih in kontrolnih živalih (tj. tistih, ki niso prejele cepiva ali so prejele konkurenčno cepivo).
Horses developed protective levels of antibodies two weeks after primary vaccination.
Konji so razvili zaščitne ravni protiteles dva tedna po osnovnem cepljenju.
The duration of protection was five months after primary vaccination and 12 months after the first revaccination for equine influenza and 17 months after primary vaccination and 24 months after the first revaccination for tetanus.
Trajanje zaščite je bilo pet mesecev po osnovnem cepljenju in 12 mesecev po prvem ponovnem cepljenje za influenco konj ter 17 mesecev po prvem cepljenju in 24 mesecev po prvem ponovnem cepljenju za tetanus.
What is the risk associated with Equilis Prequenza Te?
Kakšna tveganja so povezana z zdravilom Equilis Prequenza Te?
Swelling (max. diameter 5 cm) may occur at the injection site, either as a diffuse hard or soft swelling.
Lahko se pojavi neostro omejena trda ali mehka oteklina (premera največ 5 cm) na mestu dajanja.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
Če pride do nenamernega samoinjiciranja, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
Page 2/ 3 ©EMEA 2008 Why has Equilis Prequenza Te been approved?
Stran 2/ 3 ©EMEA 2008 Zakaj je bilo zdravilo Equilis Prequenza Te odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza Te exceeded the risks for the immunisation of horses from six months of age against equine influenza to reduce clinical signs and virus excretion after infection and against tetanus to prevent mortality.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Equilis Prequenza Te pri imunizaciji konj, ki so starejši od 6 mesecev, proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi ter proti tetanusu za preprečevanje umrljivosti večje od z njim povezanih tveganj.
The Committee recommended that Equilis Prequenza Te should be given a marketing authorisation.
Odbor je priporočil, da se za zdravilo Equilis Prequenza Te odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza Te to Intervet International BV on 8 July 2005.
Evropska komisija je dovoljenje za promet z zdravilom Equilis Prequenza Te, veljavno po vsej Evropski uniji, odobrila družbi Intervet International BV dne 8. julija 2005.
Information on the prescription status of this product may be found on the label/ outer package.
Podatki o predpisovanju tega zdravila se nahajajo na nalepki/ zunanji ovojnini zdravila.
This summary was last updated in October 2008.
Ta povzetek je bil nazadnje posodobljen 10- 2008.
Page 3/ 3 ©EMEA 2008
Stran 3/ 3 ©EMEA 2008
Equilis Prequenza Te, suspension for injection, for horses
Equilis Prequenza Te, suspenzija za injiciranje, za konje
Active substances Tetanus toxoid and purified haemagglutinin subunits from equine influenza viruses:
Zdravilne učinkovine Toksoid tetanusa in podenote prečiščenega hemaglutinina iz virusov influence konj:
A/ equine-1/ Prague/ 1/ 56 A/ equine-2/ Newmarket/ 1/ 93 A/ equine-2/ Newmarket/ 2/ 93 Tetanus toxoid
100 AU1 A/ konjski- 1 / Prague/ 1 / 56 A/ konjski- 2 / Newmarket/ 1/ 93 A/ konjski- 2 / Newmarket/ 2/ 93 Toksoid tetanusa
Purified Saponin Cholesterol Phosphatidylcholine
Prečiščeni saponin Holesterol Fosfatidilholin
375 micrograms 125 micrograms 62.5 micrograms
375 mikrogramov 125 mikrogramov 62, 5 milrogramov
Excipient Thiomersal traces Formaldehyde traces
Pomožna snov Tiomersal v sledeh Formaldehid v sledeh
4.1 Target species
KLINIČNI PODATKI
Tetanus
4. 1 Ciljne živalske vrste
2 weeks after the primary vaccination course 5 months after the primary vaccination course 12 months after the first revaccination
Aktivna imunizacija konj po šestem mesecu starosti proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi in aktivna imunizacija proti tetanusu za preprečevanje smrtnosti
Onset of immunity:
Influenca Razvoj imunosti:
2 weeks after the primary vaccination course 17 months after the primary vaccination course 24 months after the first revaccination
2 tedna po osnovnem cepljenju 5 mesecev po osnovnem cepljenju 12 mesecev po prvi revakcinaciji
1 Antigenic units 2 Flocculation equivalents; corresponds with ≥ 30 IU/ ml guinea pig serum in the Ph. Eur. potency test
Eur.
2/ 17 4.3 Contraindications
2/ 18 Tetanus Razvoj imunosti:
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
Če pride do nenamernega samoinjiciranja, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
Can be used during pregnancy and lactation.
Lahko se uporablja v obdobju brejosti.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other vaccine.
O varnosti in učinkovitosti sočasne uporabe cepiva z drugimi cepivi ni podatkov.
Safety and efficacy of concurrent use with Tetanus-Serum from Intervet (see section 4.9) has been demonstrated.
Dokazani sta varnost in učinkovitost sočasne uporabe z Intervetovim Tetanus- Serumom (glejte poglavje 4. 9).
It is therefore recommended that no other vaccines should be administered concurrently or simultaneously.
Zato sočasnega ali hkratnega dajanja z drugimi cepivi ne priporočamo.
3/ 17 Revaccination Influenza
3/ 18 Revakcinacija Influenca
The alternate use, at 12 months interval, of a suitable vaccine against equine influenza, containing the strains A/ equi 1/ Prague 56, A/ equi 2/ Newmarket-1/ 93 and A/ equi 2/ Newmarket-2/ 93, is recommended to maintain immunity levels for the influenza component (see scheme).
Za ohranjanje ravni imunosti proti influenci konjev priporočamo izmenično uporabo, v razmikih po 12 mesecev, ustreznega cepiva proti influenci konj, ki vsebuje seve A/ konjski 1/ Prague 56, A/ konjski 2/ Newmarket- 1/ 93 in A/ konjski 2/ Newmarket- 2/ 93 (glejte shemo).
Tetanus The first revaccination is given not later than 17 months after the primary vaccination course.
Tetanus Prvo revakcinacijo opravimo najpozneje 5 ali 17 mesecev po osnovnem cepljenju.
V1
C1
V2
C2
V4 12 V5 12
C6
V6
42 meseci
42 months
Prequenza - Te
Prequenza Te
Prequenza Prequenza - Te
Prequenza Prequenza Prequenza Prequenza Te Prequenza
Prequenza- Te
Prequenza Te
Prequenza
Te Te
Prequenza- Te
Concurrent active and passive immunisation (emergency vaccination) The vaccine can be used together with Tetanus-Serum from Intervet for treatment of injured horses that have not been immunised against tetanus.
Sočasna aktivna in pasivna imunizacija (cepljenje v nujnih situacijah) Cepivo lahko uporabljamo hkrati z Intervetovim Tetanus- Serumom za zdravljenje konj s poškodbami, ki niso bili imunizirani proti tetanusu.
In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum from Intervet at a separate injection site, using separate syringes and needles.
V tem primeru lahko damo prvi odmerek (V1) za osnovno cepljenje sočasno z ustreznim profilaktičnim odmerkom Intervetovega Tetanus- Seruma, na drugo mesto in s posebnimi brizgami in iglami.
The second dose of the vaccine (V2) should be administered 4 weeks later.
Drugi odmerek cepiva (V2) moramo dati 4 tedne pozneje, kot je opisano zgoraj.
A third vaccination with Equilis Prequenza Te should be repeated at least four weeks later.
Tretje cepljenje z Equilisom Prequenca Te in Tetanus- Serumom moramo ponoviti najmanj štiri tedne pozneje.
Concurrent use of Equilis Prequenza Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Prequenza Te in the absence of tetanus antitoxin serum.
Sočasna uporaba Equilisa Prequenca Te in Intervetovega Tetanus- Seruma lahko zmanjša aktivno imunost proti tetanusu v primerjavi s konji, cepljenimi z Equilisom Prequenza Te, ki niso prejeli seruma z antitoksinom tetanusa.
Following the administration of a double dose of vaccine, no side-effects other than those described under 4.6 have been observed except for some depression at the day of vaccination
Dvojni odmerek cepiva ni povzročil neželenih učinkov, ki bi se razlikovali od tistih, opisanih v 4. 6, razen blage depresivnosti na dan cepljenja.
To stimulate active immunity against Equine influenza and tetanus ATC-vet code:
Za vzbujanje aktivne imunosti proti influenci konj in tetanusu Oznaka ATC- vet:
Purified Saponin, Cholesterol, Phosphatidylcholine, Thiomersal traces, Formaldehyde traces
Prečiščeni saponin, holesterol, fosfatidilholin, tiomersal v sledeh, formaldehid v sledeh
4/ 17 6.2 Incompatibilities
6. 2 Inkompatibilnosti
Do not mix with any other vaccine or immunological product.
Ne mešajte z nobenim drugim cepivom ali imunološkim zdravilom.
Store at 2-8°C, protected from light.
Shranjujte pri 2- 8 °C, zaščiteno pred svetlobo.
6.5 Nature and composition of immediate packaging
6. 5 Vrsta ovojnine in vsebine
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
Zloženka z 10 steklenimi vialami po 1 ml Zloženka( e) z 1, 5 ali 10 napolnjenimi brizgami z iglami.
6.6 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
Wim de Körverstraat 35 NL-5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL- 5831 AN Boxmeer Nizozemska
5/ 17 ANNEX II
6/ 18 DODATEK II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE
POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET, KAR ZADEVA OSKRBO IN UPORABO
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET, KAR ZADEVA VARNO IN UČINKOVITO UPORABO
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin)
45 Poplar Road Parkville VIC 3052 Australia
45 Poplar Road Parkville VIC 3052 Avstralija
Poligono El Montalvo 37080 Salamanca Spain
Poligono El Montalvo 37080 Salamanca Španija
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE
POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM, KAR ZADEVA OSKRBO IN UPORABO
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET, KAR ZADEVA VARNO IN UČINKOVITO UPORABO
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Council Regulation (EEC) 2377/ 90.
Zdravilna učinkovina je učinkovina biološkega izvora, namenjena za vzbujanje aktivne imunosti, in ni zajeta v Uredbi Sveta (EGS) 2377/ 90.
The MRL status of the excipients is as follows:
Status pomožnih snovi glede na MRL:
Substance Saponin
saponin
MRL status Annex II for all food producing species (under Quillaia saponins)
za proizvodnjo živil (pod saponini Quillaia)
Sodium phosphate (Na2HPO4)
natrijev fosfat (Na2HPO4)
Covered by Annex II entry for authorised food additives with an E number (E339)
Ureja vnos v Dodatku II za dovoljene aditive za živila s številko E (E339)
Potassium phosphate (KH2PO4)
kalijev fosfat (KH2PO4)
Annex II for all food producing species (approved as food additives with an E number (E340))
Dodatek II za vse živali, namenjene za proizvodnjo živil (odobrene kot aditive za živila s številko E (E340))
Commission Regulation (EEC) No 2034/ 96
2034/ 96 Uredba Komisije (EGS) št.
Sodium chloride (NaCl)
natrijev klorid (NaCl)
Annex II for all food producing species
Dodatek II za vse živali, namenjene za proizvodnjo živil
Commission Regulation (EEC) No 2796/ 95
2796/ 95 Uredba Komisije (EGS) št.
Magnesium chloride (MgCl2) Calcium chloride (CaCl2)
magnezijev klorid (MgCl2)
Annex II for all food producing species Annex II for all food producing species
Dodatek II za vse živali, namenjene za proizvodnjo živil
7/ 17 ANNEX III
8/ 10 DODATEK III
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 18 PODATKI NA ZUNANJI OVOJNINI
A/ equine-1/ Prague 56 (100 AU), A/ equine-2/ Newmarket/ 1/ 93 (50 AU), A/ equine-2/ Newmarket/ 2/ 93 (50 AU), Tetanus toxoid 40 Lf.
A/ konjski- 1/ Prague 56 (100 AU), A/ konjski- 2/ Newmarket/ 1/ 93 (50 AU), A/ konjski- 2/ Newmarket/ 2/ 93 (50 AU), toksoid tetanusa 40 Lf
1, 5 or 10 50 x 1 dose
1, 5 ali 10 x 1 odmerek
Store at 2-8 °C, protected from light.
Shranjujte pri 2- 8 °C, zaščiteno pred svetlobo.
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO "SAMO ZA ŽIVALI"
For animal treatment only Veterinary medicinal product subject to prescription
Uporablja se le na osnovi recepta veterinarja.
THE WORDS "KEEP OUT OF REACH AND SIGHT OF CHILDREN"
BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROK''
Keep out of the reach and sight of children
Zdravilo shranjujte izven dosega in pogleda otrok.
< Batch > < Lot > < BN > {number}
< Serija > {številka}
11/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 18 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
{batch no.}
{št. serije}
13/ 17 PACKAGE LEAFLET FOR:
14/ 18 NAVODILO ZA UPORABO
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGIH SESTAVIN( E)
A/ equine-1/ Prague/ 1/ 56 A/ equine-2/ Newmarket/ 1/ 93 A/ equine-2/ Newmarket/ 2/ 93 Tetanus toxoid
100 AU3 A/ konjski- 1 / Prague/ 1 / 56 A/ konjski- 2 / Newmarket/ 1/ 93 A/ konjski- 2 / Newmarket/ 2/ 93 Toksoid tetanusa
AU3 AU AU Lf4
50 AU 50 AU 40 Lf4
Purified saponin Cholesterol Phosphatidylcholine
Prečiščeni saponin Holesterol Fosfatidilholin
375 micrograms 125 micrograms 62.5 micrograms
375 µg 125 µg 62, 5 µg
2 weeks after the primary vaccination course 5 months after the primary vaccination course 12 months after the first revaccination
2 tedna po osnovnem cepljenju 5 mesecev po osnovnem cepljenju 12 mesecev po prvi revakcinaciji
3 Antigenic units 4 Flocculation equivalents; corresponds with ≥ 30 IU/ ml guinea pig serum in the Ph. Eur. potency test
Eur.
14/ 17 Duration of immunity:
15/ 18 Tetanus Razvoj imunosti:
17 months after the primary vaccination course 24 months after the first revaccination
2 tedna po osnovnem cepljenju 17 mesecev po osnovnem cepljenju 24 mesecev po prvi revakcinaciji
Revaccination Influenza
Revakcinacija Influenca
This revaccination results in immunity to equine influenza lasting at least 12 months.
Revakcinacija z Equilisom Prequenza Te ali Equilisom Prequenza vzbudi imunost proti influenci konj, ki traja najmanj 12 mesecev.