natgillin/translations-raw huggingface dataset:
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).
V1 0
16/ 18
V2 1
C1
5
C2
V3 6
C3
V6 42 months
42 meseci
Prequenza Prequenza Prequenza Te Te
Prequenza Prequenza Prequenza - Te - Te
Prequenza Te Prequenza
Prequenza- Te
15/ 17 In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (Primary vaccination course at 6 months of age and 4 weeks later)
Kadar je povečana ogroženost zaradi okužbe ali premajhen vnos kolostruma, lahko pri starosti 4 mesecev damo dodatni odmerek in nato izvedemo poln program cepljenja (osnovno cepljenje pri starosti 6 mesecev in 4 tedne pozneje).
Allow the vaccine to reach room temperature (15-25°C) before use.
Cepivo pred uporabo ogrejte na sobno temperaturo 15 °C – 25 °C.
Administer 1 ml of vaccine i. m..
Vbrizgajte 1 ml cepiva i. m.
Safety and efficacy of concurrent use with Tetanus-Serum from Intervet has been demonstrated.
Dokazani sta varnost in učinkovitost sočasne uporabe z Intervetovim Tetanus- Serumom (glejte poglavje 5. 8).
In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.
Če vam je bil ta izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
Equilis Prequenza is a vaccine for use in horses.
Zdravilo Equilis Prequenza je cepivo, ki se uporablja za konje.
The vaccine is available as a suspension for injection.
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 “) Cepivo je na voljo v obliki suspenzije za injiciranje.
Equilis Prequenza is used to vaccinate horses from six months of age against equine influenza.
Zdravilo Equilis Prequenza se uporablja za cepljenje konj, ki so starejši od šestih mesecev, proti influenci.
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 zelo pogosta pri konjih, vendar redko povzroči pogin.
This should be followed by a third vaccination five months later, and afterwards by yearly revaccinations.
Temu mora slediti tretje cepljenje pet mesecev pozneje, nato pa vsakoletna ponovna cepljenja.
Equilis Prequenza contains fragments (subunits) of the influenza virus against which the vaccine is indicated for.
Zdravilo Equilis Prequenza vsebuje delce (podenote) virusa influence, proti kateremu je cepivo indicirano.
When the product is given to horses, it helps the animals’ immune system to react more quickly when the animal is naturally exposed to the virus.
Ko konj prejme zdravilo, to pomaga njegovemu imunskemu sistemu, da hitreje reagira, kadar je naravno izpostavljen virusu.
This helps to protect against equine influenza.
S tem žival pomagamo zaščititi proti influenci konj.
The vaccine also contains an ‘ adjuvant’ to stimulate a better response.
Cepivo vsebuje tudi „ adjuvans “, ki spodbudi boljši odziv.
The safety of Equilis Prequenza 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 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.
Sklenili so, da zdravilo dobro prenašajo konji različnih starosti.
Equilis Prequenza was also studied in pregnant mares.
Zdravilo Equilis Prequenza so raziskovali tudi na brejih kobilah.
The effectiveness of Equilis Prequenza has been studied in several trials under laboratory and field conditions.
Učinkovitost zdravila Equilis Prequenza so raziskali v več preskušanjih, izvedenih v laboratorijskih in terenskih pogojih.
Most of the studies used Equilis Prequenza Te, a vaccine that protects against the three equine influenza strains (the same as Equilis Prequenza), as well as tetanus.
V večini študij so uporabili zdravilo Equilis Prequenza Te, cepivo, ki ščiti proti trem sevom virusov influence konj (tako kot Equilis Prequenza).
The main measure of effectiveness was the production of protective levels of antibodies against the influenza components.
Glavno merilo učinkovitosti 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.
V študijah so primerjali tudi klinične znake in izločanje virusa pri cepljenih in kontrolnih živalih, tj. tistih, ki niso prejele cepiva.
The studies showed that Equilis Prequenza is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, in horses from 6 months of age.
Študije so pokazale, da je zdravilo Equilis Prequenza učinkovito cepivo proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi pri konjih, starejših od šest mesecev.
The duration of protection was five months after primary vaccination and 12 months after the first revaccination.
Trajanje zaščite je bilo pet mesecev po osnovnem cepljenju in 12 mesecev po prvem ponovnem cepljenju.
What is the risk associated with Equilis Prequenza?
Kakšna tveganja so povezana z zdravilom Equilis Prequenza?
Swelling (max. diameter 5 cm) may occur, either as hard or soft swelling.
Lahko se pojavi trda ali mehka oteklina (premera največ 5 cm).
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza 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.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Equilis Prequenza pri imunizaciji konj, ki so starejši od 6 mesecev, proti influenci konj za zmanjšanje kliničnih znakov in izločanja virusa po okužbi večje od z njim povezanih tveganj.
The Committee recommended that Equilis Prequenza should be given a marketing authorisation.
Odbor je priporočil, da se za zdravilo Equilis Prequenza odobri dovoljenje za promet.
Page 2/ 3 ©EMEA 2008 Other information about Equilis Prequenza:
Stran 2/ 3 EMEA 2008 Druge informacije o zdravilu Equilis Prequenza:
The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza to Intervet International BV on 8 July 2005.
Evropska komisija je dovoljenje za promet z zdravilom Equilis Prequenza, 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 so navedeni na nalepki/ zunanji ovojnini zdravila.
Page 3/ 3 ©EMEA 2008
Stran 3/ 3 EMEA 2008
Active substances Purified haemagglutinin subunits from equine influenza viruses:
Zdravilne učinkovine 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
100 AU1 A/ konjski- 1 / Prague/ 1 / 56 A/ konjski- 2 / Newmarket/ 1/ 93 A/ konjski- 2 / Newmarket/ 2/ 93
375 micrograms 125 micrograms 62.5 micrograms
375 mikrogramov 125 mikrogramov 62, 5 mikrogramov
Excipient Thiomersal traces
Pomožna snov Tiomersal v sledeh
Suspension for injection
Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
4.1 Target species
Suspenzija za injiciranje
Influenza Onset of Duration
Influenca Razvoj imunosti:
immunity: of immunity:
Trajanje imunosti:
2/ 16 4.4 Special warnings
2/ 16 4. 4 Posebna opozorila
The first revaccination (third dose) is given 5 months after the primary vaccination course.
Prvo revakcinacijo (tretji odmerek) proti influenci konj opravimo 5 mesecev po osnovnem cepljenju.
This revaccination results in immunity to equine influenza lasting at least 12 months.
Drugo revakcinacijo opravimo 12 mesecev po prvi revakcinaciji.
The second revaccination is given 12 months after the first revaccination.
C 12
3/ 16 In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).
Kadar je povečana ogroženost zaradi okužbe ali premajhen vnos kolostruma, lahko pri starosti 4 mesecev damo dodatni odmerek in nato izvedemo poln program cepljenja (osnovno cepljenje pri starosti 6 mesecev in 4 tedne pozneje).
To stimulate active immunity against Equine influenza ATC-vet code:
Za vzbujanje aktivne imunosti proti influenci konj Oznaka ATC- vet:
Purified Saponin, Cholesterol, Phosphatidylcholine, Thiomersal traces
Prečiščeni saponin, holesterol, fosfatidilholin, tiomersal v sledovih
4/ 16 Package size:
Velikost pakiranja:
Cardboard box with 10 glass vials of 1 ml.
Zloženka z 10 steklenimi vialami po 1 ml
Cardboard box(es) with 1, 5 or 10 pre-filled syringes with needles.
4/ 16 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,.
5/ 16 ANNEX II
5/ 16 DODATEK II
7/ 16 ANNEX III
7/ 9 DODATEK III
9/ 16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 16 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).
A/ konjski- 1/ Prague 56 (100 AU), A/ konjski- 2/ Newmarket/ 1/ 93 (50 AU), A/ konjski- 2/ Newmarket/ 2/ 93 (50 AU)
1, 5 or 10 x 1 dose
1, 5 ali 10 x 1 odmerek
METHODS AND ROUTE OF ADMINISTRATION
NAČIN UPORABE IN DAJANJA
{month/ year}
EXP {mesec/ leto}
THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO "SAMO ZA ŽIVALI" IN POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET, KAR ZADEVA OSKRBO IN UPORABO
For animal treatment only Veterinary medicinal product subject to prescription.
Uporablja se le na osnovi recepta veterinarja.
Keep out of reach and sight of children
Zdravilo shranjujte izven dosega in pogleda otrok.
EU/ 2/ 05/ 056/ 001-004
EU/ 2/ 05/ 057/ 001- 004
11/ 16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
11/ 16 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ROUTE OF ADMINISTRATION
NAČIN UPORABE ZDRAVILA
13/ 16 PACKAGE LEAFLET FOR:
13/ 16 NAVODILO ZA UPORABO
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGIH SESTAVIN
Active substance Purified haemagglutinin subunits from equine influenza viruses:
Zdravilne učinkovine 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
100 AU3 A/ konjski- 1 / Prague/ 1 / 56 A/ konjski- 2 / Newmarket/ 1/ 93 A/ konjski- 2 / Newmarket/ 2/ 93
375 micrograms 125 micrograms 62.5micrograms
375 µg 125 µg 62, 5 µg
2 weeks after the primaryvaccination course 5 months after the primaryvaccination course 12 months after the first revaccination
2 tedna po osnovnem cepljenju 5 mesecev po osnovnem cepljenju 12 mesecev po prvi revakcinaciji
2 Antigenic units
________________________________ 2 antigenske enote
14/ 16 6.
14/ 16 5.
In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, for up to 3 days in exceptional circumstances.
V zelo redkih primerih se lahko pojavi vročina, včasih z letargijo in neješčnostjo, ki traja 1 dan, izjemoma 3 dni.
In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later).
C
9.
C 5
ADVICE ON CORRECT ADMINISTRATION
C5 30 meseci
The highly contagious and common disease caused by this bacterium is commonly called ‘ strangles’.
Visoko nalezljiva in pogosta bolezen, ki jo povzroča ta bakterija, je običajno znana pod imenom „ smolika “.
When a horse is given the vaccine, the immune system recognises the bacteria as ‘ foreign’ and makes antibodies against them.
Ko konj prejme cepivo, imunski sistem prepozna bakterije kot „ tujke “ in proti njim razvije protitelesa.
The bacterium strain included in Equilis StrepE has had some genes removed, so that it grows less well inside the horse’ s body and is less likely to cause disease.
Sevu bakterije, ki ga vsebuje zdravilo Equilis StrepE, so bili odstranjeni nekateri geni, zato v telesu konja slabše raste in obstaja manjša verjetnost, da bi povzročil bolezen.
The vaccine is given as a 0.2-ml injection into the inside of the upper lip.
Cepivo se daje z 0, 2 ml injekcijo v notranjo stran zgornje ustnice.
The results of the safety trials demonstrate that Equilis StrepE is safe for horses from four months of age onwards, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Rezultati študij varnosti zdravila so pokazali, da je Equilis StrepE varen za uporabo pri konjih, starejših od štirih 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged as the local and systemic reactions observed after single, repeated dose and overdose treatment were considered acceptable.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged mesecev, saj so bile reakcije na mestu injiciranja in reakcije telesa, ugotovljene po enkratnem in večkratnem cepljenju ter cepljenju s prevelikim odmerkom, ocenjene kot sprejemljive.
The swelling should disappear within three weeks and should have no effect on the horse’ s appetite, nor cause it any discomfort.
Oteklina običajno izgine v treh tednih in ne vpliva na apetit cepljenega konja, niti mu ne povzroča nelagodja.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis StrepE exceed the risks for immunisation of horses against S. equi to reduce clinical signs and occurrence of lymph node abscesses, and recommended that Equilis StrepE be given a marketing authorisation.
Zato je priporočil, da se za zdravilo Equilis StrepE odobri dovoljenje za promet z zdravilom.
The European Commission granted a marketing authorisation valid throughout the European Union for Equilis StrepE to Intervet International B. V. on 7 May 2004.
Evropska komisija je dovoljenje za promet z zdravilom Equilis StrepE, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B. V. dne 7. maja 2004.
This summary was last updated in September 2007.
Ta povzetek je bil nazadnje posodobljen 09- 2007.
109.0 to 109.4 cfu of live
Živi delecijski mutant seva
Lyophilisate and solvent for suspension for
Liofilizirani prašek za
Submucosal injection
Submukozno injiciranje
Lyophilisate: vial (glass) Solvent: vial (glass)
Liofilizirani viala (steklo)
1 dose Solvent:
Prašek:
0.5 ml
0, 5 ml 10 vial vehikla
10 vials powder Zero days 10 vials solvent
Streptococcus equi TW928 109. 0 do 109. 4 CFU
deletion mutant Streptococc us equi strain TW928
suspenzijo za injiciranje
injection
Vehikel: viala (steklo)
10 applicators 10 syringes with needle
10 applikatorjev 10 brizg z iglo
Per dose of 0.2 ml vaccine:
V odmerku po 0, 2 ml cepiva:
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu1
Živi delecijski mutant seva Streptococcus equi TW928 109, 0 do 109, 4 CFU1
The onset of immunity is established as 2 weeks after basic vaccination.
Imunost se razvije 2 tedna po osnovnem cepljenju.
The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e. g. stables with horses that travel to shows and/ or competitions in such areas, or stables that obtain or have livery horses from such areas.
Cepivo je namenjeno za uporabo pri konjih, pri katerih je nevarnost okužbe s Streptococcusom equi jasno razpoznana, ker so bili v stiku s konji iz območij, za katera je znano, da je na njih prisoten ta povzročitelj, npr. hlevi s konji, ki jih vozijo na razstave ali tekmovanja na takšna območja, ali hlevi, kjer sprejemajo ali imajo v oskrbi konje s takšnih območij.
1 Colony forming units
1 Colony forming units – kolonijske enote
2/ 23 From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection.
Iz literature je znano, da se lahko pri zelo majhnem številu konjev razvije hemoragična purpura, če jih cepimo kmalu po okužbi.
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
Posebna previdnost je potrebna pri nameščanju aplikatorja na iglo, da bi se izognili poškodbam zaradi vboda z iglo.
In case of accidental self injection, seek medical advice immediately and show the package insert or the label to the physician.
V primeru nenamernega samo- injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Accidental self injection may result in an inflammatory reaction with severe pain and swelling.
Nenamerno samoinjiciranje lahko povzroči vnetno reakcijo s hudo bolečino in oteklino.
If you are accidentally injected with this product seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Če vam je bil ta proizvod nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le zelo majhna količina, in mu pokažite navodilo za uporabo.
Antiinflammatory therapy is indicated even if only a very small amount of the product in injected.
Čeprav je bila injicirana le zelo majhna količina proizvoda, je indicirana protivnetna terapija.
The sensitivity of the vaccine strain to antibiotics is listed below (SPC under section 4.8)
Občutljivost cepnega seva za antibiotike je navedena spodaj (v poglavju 4. 8).
Further, an increase in rectal temperature up to 2°C may occur on the day of vaccination.
Na dan cepljenja se lahko za največ 2 °C poveča rektalna temperatura.
In rare cases, inappetance, fever and shivering may be observed.
Redko lahko opazimo anoreksijo, vročino in tresenje.
3/ 23 4.7 Use during pregnancy, lactation or lay
3/ 23 4. 7 Uporaba v obdobju brejosti, laktacije ali nesnosti
Limited information is available on the safety and efficacy from the use of this vaccine with any other.
Na voljo je malo podatkov o varnosti in učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim cepivom.
It is therefore recommended that no other vaccines should be administered concurrently or simultaneously.
Zato odsvetujemo sočasno ali hkratno uporabo katerega koli cepiva.
The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine, and trimetroprim-sulfa combinations.
Cepni sev je odporen proti aminoglikozidom, sulfonamidom, flumekvinu in kombinacijam trimetoprima in sulfametoksazola.
Submucosal vaccination with 0.2 ml of reconstituted product.
Submukozno cepljenje z 0, 2 ml rekonstituiranega cepiva.
Allow the solvent to reach room temperature (15 - 25°C).
Počakajte, da se vehikel ogreje na sobno temperaturo (15– 25 °C).
Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Liofilizat aseptično rekonstituirajte z 0, 3 ml priloženega sterilnega vehikla.
Do NOT shake and wait 1 minute after addition of the solvent.
NE stresajte in po dodajanju vehikla počakajte 1 minuto.
Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided (see Figure 1) and connect the applicator to the needle (see Figure 2).
S priloženo brizgo odvzemite 0, 2 ml rekonstituiranega cepiva (glejte sliko 1) in na iglo namestite aplikator (glejte sliko 2).
Restrain the animal’ s head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip.
Konju zadržite glavo, dvignite zgornjo ustnico in iglo vbodite na notranji strani zgornje ustnice tako globoko, da se aplikator dotakne njene površine.
Figure 3
4/ 23 Slika 3
4/ 23 Vaccination scheme:
Osnovno cepljenje:
Basic vaccination: horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Konje po 4. mesecu starosti cepimo dvakrat s po enim odmerkom cepiva v razmaku 4 tednov.
In addition to the clinical signs given under section 4.6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Poleg kliničnih znakov, ki so opisani v poglavju 4. 6, lahko cepljenje z 10- krat prevelikim odmerkom povzroči tudi absces submandibularnega limfnega vozla.
Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination.
Na dan cepljenja se lahko za največ 2, 5 °C poveča rektalna temperatura.
QI05AE live bacterial vaccine
QI05AE živo bakterijsko cepivo
In the challenge studies performed by Intervet, insufficient protection was seen in approximately one quarter of horses vaccinated with the recommended dose.
V provokacijskih preskusih, ki jih je izvedlo podjetje Intervet, so nezadostno zaščito zasledili pri približno eni četrtini konjev, ki so bili cepljeni s priporočenim odmerkom.
6.1 List of excipients
stabilizator NAO- 1
NAO-1 stabiliser Water for injections
5/ 23 voda za injekcije
Lyophilisate and solvent:
Liofilizat in vehikel:
5/ 23 Reconstituted vaccine should be used within 4 hours.
Rekonstituirano cepivo je treba uporabiti v 4 urah.
Store refrigerated (2°C – 8°C).
Shranjujte v hladilniku (2 °C– 8 °C).
Each package of Equilis StrepE contains:
Eno pakiranje Equilisa StrepE vsebuje:
10 vials with lyophilisate and 10 vials of 0.5 ml solvent, each in 3 ml Type I glass vials closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap, 10 applicators, 10 syringes with needle.
10 vial z liofilizatom in 10 vial z 0, 5 ml vehikla v 3 - mililitrskih vialah iz stekla tipa I, zaprtih z zamaški iz umetne gume in tesnili iz aluminija s šifro; 10 aplikatorjev in 10 brizg z iglo.
6/ 23 ANNEX II
6/ 23 DODATEK II
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION HOLDER REGARDING SUPPLY OR USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE ALI UPORABE
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION HOLDER WITH REGARD TO SAFE AND EFFECTIVE USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
Substance
Učinkovina
Streptococcus equi strain
Sev Streptococcus equi
Not within the scope of Council Regulation (EC) 2377/ 90
Ne spada na področje Uredbe Sveta (ES) 2377/ 90
Active principles of biological origin intended to produce active or passive immunity are not within the scope of the Regulation
Zdravilna učinkovina biološkega izvora, ki ustvarja aktivno ali pasivno imunost, ne spada na področje Uredbe.
8/ 23 ANNEX III
8/ 23 DODATEK III
10/ 23 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 23 PODATKI NA ZUNANJI OVOJNINI
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Živi delecijski mutant seva Streptococcus equi TW928 109, 0 do 109, 4 CFU