natgillin/translations-raw huggingface dataset:
EU/1/01/174/015 12 film-coated tablets EU/1/01/174/016 24 film-coated tablets EU/1/01/174/017 30 film-coated tablets EU/1/01/174/018 60 film-coated tablets EU/1/01/174/019 84 film-coated tablets EU/1/01/174/020 120 film-coated tablets EU/1/01/174/021 360 film-coated tablets
EU/1/01/174/015 12 filmsko obloženih tablet EU/1/01/174/016 24 filmsko obloženih tablet EU/1/01/174/017 30 filmsko obloženih tablet EU/1/01/174/018 60 filmsko obloženih tablet EU/1/01/174/019 84 filmsko obloženih tablet EU/1/01/174/020 120 filmsko obloženih tablet EU/1/01/174/021 360 filmsko obloženih tablet
EU/1/01/174/001 12 film-coated tablets EU/1/01/174/002 24 film-coated tablets EU/1/01/174/003 30 film-coated tablets EU/1/01/174/004 60 film-coated tablets EU/1/01/174/005 84 film-coated tablets EU/1/01/174/006 120 film-coated tablets EU/1/01/174/007 360 film-coated tablets
EU/1/01/174/001 12 filmsko obloženih tablet EU/1/01/174/002 24 filmsko obloženih tablet EU/1/01/174/003 30 filmsko obloženih tablet EU/1/01/174/004 60 filmsko obloženih tablet EU/1/01/174/005 84 filmsko obloženih tablet EU/1/01/174/006 120 filmsko obloženih tablet EU/1/01/174/007 360 filmsko obloženih tablet
How to take Starlix
Kako jemati zdravilo Starlix
Talk to your doctor before taking Starlix - if you know that you have a liver problem.
Pred začetkom jemanja zdravila Starlix se posvetujte z zdravnikom, - če veste, da imate težave z jetri, - če imate hude težave z ledvicami, - če imate težave s presnavljanjem zdravil, - če boste morali biti operirani, - če ste imeli pred kratkim zvišano telesno temperaturo, nezgodo ali okužbo.
EU/1/01/174/008 12 film-coated tablets EU/1/01/174/009 24 film-coated tablets EU/1/01/174/010 30 film-coated tablets EU/1/01/174/011 60 film-coated tablets EU/1/01/174/012 84 film-coated tablets EU/1/01/174/013 120 film-coated tablets EU/1/01/174/014 360 film-coated tablets
EU/1/01/174/008 12 filmsko obloženih tablet EU/1/01/174/009 24 filmsko obloženih tablet EU/1/01/174/010 30 filmsko obloženih tablet EU/1/01/174/011 60 filmsko obloženih tablet EU/1/01/174/012 84 filmsko obloženih tablet EU/1/01/174/013 120 filmsko obloženih tablet EU/1/01/174/014 360 filmsko obloženih tablet
You should ask for doctor advice on driving if you have frequent episodes of hypoglycaemia or if you are not aware of the first signs of hypoglycaemia.
Če imate pogoste hipoglikemije ali ne zaznavate prvih znakov hipoglikemije, se morate glede vožnje posvetovati z zdravnikom.
The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.
Priporočeni največji dnevni odmerek je 180 mg, ki ga bolnik vzame pred tremi glavnimi obroki.
Other events
Drugi učinki
Each film-coated tablet contains 180 mg nateglinide.
Ena filmsko obložena tableta vsebuje 180 mg nateglinida.
Starlix contains lactose monohydrate.
Zdravilo Starlix vsebuje laktozo monohidrat.
Each film-coated tablet contains 120 mg nateglinide.
Ena filmsko obložena tableta vsebuje 120 mg nateglinida.
Its effect may be delayed if it is taken during or after meals.
Če bi ga jemali v vmesnem času ali po obrokih, bi delovalo počasneje.
Take Starlix before meals (see section 3, “How to take Starlix”); its effect may be delayed if it is taken during or after meals.
Zdravilo Starlix skupaj s hrano, pijačo in alkoholom Zdravilo Starlix jemljite pred obroki (glejte poglavje 3 "Kako jemati zdravilo Starlix").
Discontinuation should be considered in patients with severe renal impairment who present with potentiation of the hypoglycaemic effect.
Pri bolnikih s hudo okvaro ledvic, pri katerih prihaja do močnejšega hipoglikemičnega učinka, je treba razmisliti o prekinitvi odmerjanja zdravila.
- if you have another medical condition that may cause low blood sugar (e.g. an under-active pituitary or adrenal gland).
Previdnost je potrebna, - če ste starejši od 65 let, - če ste podhranjeni, - če imate drugo bolezen, ki utegne povzročati nizek krvni sladkor (npr. premalo dejavno hipofizo ali nadledvično žlezo).
Starlix 60 mg film-coated tablets Starlix 120 mg film-coated tablets Starlix 180 mg film-coated tablets nateglinide
Starlix 60 mg filmsko obložene tablete Starlix 120 mg filmsko obložene tablete Starlix 180 mg filmsko obložene tablete nateglinid
STARLIX 60 mg film-coated tablets STARLIX 120 mg film-coated tablets STARLIX 180 mg film-coated tablets
STARLIX 60 mg filmsko obložene tablete STARLIX 120 mg filmsko obložene tablete STARLIX 180 mg filmsko obložene tablete
60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on one side and “60” on the other.
60 mg rožnate, okrogle tablete z zaobljenimi robovi in oznako “STARLIX” na eni ter “60” na drugi strani.
It is especially important that you tell your doctor, pharmacist or nurse if you are taking: - Non-steroidal anti-inflammatory agents (used, for example, to treat muscle and joint pain).
Zelo pomembno je, da obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete: - nesteroidna protivnetna zdravila (ki jih uporabljamo na primer pri bolečinah v mišicah in sklepih); - salicilate, kot je na primer Aspirin (uporabljamo jih za lajšanje bolečin); - zaviralce monoamin oksidaze (uporabljamo jih za zdravljenje depresije); - zaviralce adrenergičnih receptorjev beta ali zaviralce ACE (zaviralce angiotenzinske konvertaze) (ki se uporabljajo na primer za zdravljenje visokega krvnega tlaka in nekaterih bolezni srca); - diuretike (uporabljajo se za zdravljenje visokega krvnega tlaka); - kortikosteroide, na primer prednizon in kortizon (uporabljajo se za zdravljenje vnetnih bolezni); - zaviralce presnove zdravil, na primer flukonazol (uporablja se za zdravljenje glivičnih okužb),
Starlix 180 mg film-coated tablets are red, ovaloid tablets with “STARLIX” marked on one side and “180” on the other.
Starlix 180 mg filmsko obložene tablete so rdeče, ovalne tablete z oznako “STARLIX” na eni ter “180” na drugi strani.
Starlix 120 mg film-coated tablets are yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other.
Starlix 120 mg filmsko obložene tablete so rumene, ovalne tablete z oznako “STARLIX” na eni ter “120” na drugi strani.
Talk to your doctor, pharmacist or nurse before taking Starlix.
Pred začetkom jemanja zdravila Starlix se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
STARLIX 60 mg film-coated tablets
STARLIX 60 mg filmsko obložene tablete
Your ability to concentrate or react may be reduced if you have low blood sugar (hypoglycaemia).
V primeru nizkega krvnega sladkorja (hipoglikemije) so vaše zmožnosti za zbrano vožnjo in ustrezno reagiranje zmanjšane.
Starlix 180 mg film-coated tablets nateglinide
Starlix 180 mg filmsko obložene tablete nateglinid
Croscarmellose sodium Magnesium stearate Yellow iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc
STARLIX 120 mg filmsko obložene tablete laktoza monohidrat mikrokristalna celuloza povidon premrežen natrijev karmelozat magnezijev stearat rumeni železov oksid (E172) hipromeloza titanov dioksid (E171) smukec makrogol brezvoden koloidni silicijev dioksid
Starlix 120 mg film-coated tablets nateglinide
Starlix 120 mg filmsko obložene tablete nateglinid
Starlix 60 mg film-coated tablets nateglinide
Starlix 60 mg filmsko obložene tablete nateglinid
Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc
STARLIX 180 mg filmsko obložene tablete laktoza monohidrat mikrokristalna celuloza povidon premrežen natrijev karmelozat magnezijev stearat rdeči železov oksid (E172) hipromeloza titanov dioksid (E171) smukec makrogol brezvoden koloidni silicijev dioksid
• dizziness
Obsegajo:
What Starlix looks like and contents of the pack Starlix 60 mg film-coated tablets are pink, round tablets with “STARLIX” marked on one side and “60” on the other.
Starlix 60 mg filmsko obložene tablete so rožnate, okrogle tablete z oznako “STARLIX” na eni ter “60” na drugi strani.
How to store Starlix
Shranjevanje zdravila Starlix
EU/1/01/174/001-007
STARLIX 60 mg filmsko obložene tablete EU/1/01/174/001-007
EU/1/01/174/015-021
STARLIX 180 mg filmsko obložene tablete EU/1/01/174/015-021
EU/1/01/174/008-014
STARLIX 120 mg filmsko obložene tablete EU/1/01/174/008-014
120 mg yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other.
STARLIX 120 mg filmsko obložene tablete 120 mg rumene, ovalne tablete z oznako “STARLIX” na eni ter “120” na drugi strani.
Doctors and patients must be aware of this possibility.
Zdravniki in bolnice se morajo te možnosti zavedati.
It is used to treat the following groups:
Uporablja se za zdravljenje naslednjih skupin bolnikov:
The European Commission granted a marketing authorisation valid throughout the European Union for Ovaleap on 27 September 2013.
Evropska komisija je dovoljenje za promet z zdravilom Ovaleap, veljavno po vsej Evropski uniji, odobrila dne 27. septembra 2013.
The main measure of effectiveness was the number of oocytes (immature eggs) collected.
Glavno merilo učinkovitosti je bilo število zbranih oocitov (nezrelih jajčec).
What measures are being taken to ensure the safe and effective use of Ovaleap?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ovaleap?
The full EPAR for Ovaleap can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ovaleap je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
• men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
• moških, ki imajo hipogonadotropni hipogonadizem (redko bolezen pomanjkanja hormonov).
This is a summary of the European public assessment report (EPAR) for Ovaleap.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ovaleap.
The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems.
Izdaja zdravila je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem težav s plodnostjo.
This is called ‘ovarian hyperstimulation syndrome'.
To imenujemo „sindrom hiperstimulacije jajčnikov“.
The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Najpogostejši neželeni učinki zdravila Ovaleap (ki lahko prizadenejo več kot 1 osebo od 10) so reakcije na mestu injiciranja (bolečina, rdečina, modrice, oteklina ali razdraženost).
After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice.
Po prvem injiciranju si lahko bolnik zdravilo injicira sam ali s pomočjo partnerja, če sta dovolj motivirana, če sta bila za to ustrezno usposobljena in če imata na voljo strokovno svetovanje.
It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons.
Prav tako se ne sme uporabljati, kadar se bolnik ne more učinkovito odzvati na zdravljenje, na primer pri bolnikih, katerih jajčniki ali moda ne delujejo, ali pri ženskah, ki ne smejo zanositi iz zdravstvenih razlogov.
This means that Ovaleap is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Ovaleap and the reference medicine contain the same active substance.
To pomeni, da je podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU), in da vsebuje isto zdravilno učinkovino kot referenčno zdravilo.
Ovaleap has been compared with GONAL-f in one main study involving 299 women undergoing fertility treatment.
Zdravilo Ovaleap so primerjali z zdravilom GONAL-f v eni glavni študiji, v katero je bilo vključenih 299 žensk, ki so se zdravile zaradi neplodnosti.
The average number of oocytes collected was 12.2 in the Ovaleap group, compared with 12.0 in the GONAL-f group.
Povprečno število zbranih oocitov v skupini, ki je jemala zdravilo Ovaleap, je znašalo 12,2, v skupini, ki je jemala zdravilo GONAL-f, pa 12,0.
A risk management plan has been developed to ensure that Ovaleap is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Ovaleap je bil pripravljen načrt obvladovanja tveganj.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ovaleap, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Ovaleap vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
• women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
• žensk s hudim pomanjkanjem (zelo nizkimi ravnmi) luteinizirajočega hormona (LH) in folikle stimulirajočega hormona (FSH).
What are the risks associated with Ovaleap?
Kakšna tveganja so povezana z zdravilom Ovaleap?
What benefits of Ovaleap have been shown in studies?
Kakšne koristi je zdravilo Ovaleap izkazalo v študijah?
The reference medicine for Ovaleap is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here.
Referenčno zdravilo za zdravilo Ovaleap je zdravilo GONAL-f. Za več informacij o podobnih bioloških zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
Therefore, the CHMP's view was that, as for GONAL-f, Ovaleap's benefits are greater than its risks and recommended that it be approved for use in the EU.
Zato je menil, da so koristi zdravila Ovaleap tako kot pri zdravilu GONAL-f večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Ovaleap
Druge informacije o zdravilu Ovaleap
• women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation.
• žensk, ki se zdravijo s postopki asistirane reprodukcije, kot je in vitro oploditev (zdravljenje neplodnosti).
It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Ne sme se uporabljati pri bolnikih s tumorji hipofize ali hipotalamusa ali z rakom na prsih, maternici ali jajčnikih.
Ovaleap is given to stimulate the ovaries to produce more than one egg at a time;
Zdravilo Ovaleap se daje za spodbujanje jajčnikov k proizvodnji več kot enega jajčeca naenkrat;
The follitropin alfa in Ovaleap, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce human FSH.
Folitropin alfa v zdravilu Ovaleap in tudi v zdravilu GONAL-f se pridobiva z metodo, imenovano „tehnologija rekombinantne DNA“, pri kateri je v celice vstavljen gen (DNK), s katerim lahko tvorijo humani FSH.
Ovaleap must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Zdravila Ovaleap ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) folitropin alfa, FSH ali katero koli drugo sestavino zdravila.
It is not intended to provide practical advice on how to use Ovaleap.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Ovaleap, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ovaleap preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Ovaleap has been shown to have a comparable quality, safety and efficacy profile to GONAL-f.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo dokazano, da so kakovost, varnost in učinkovitost zdravila Ovaleap in zdravila GONAL-f primerljive.
The active substance in Ovaleap, follitropin alfa, is a copy of the natural hormone FSH.
Zdravilna učinkovina zdravila Ovaleap, folitropin alfa, je kopija naravnega hormona FSH.
In women, Ovaleap must not be used when there is enlargement or a cyst of the ovary caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina.
Pri ženskah se zdravilo Ovaleap ne sme uporabljati ob povečanih jajčnikih ali prisotnosti cist, ki niso posledica policističnega obolenja jajčnikov, ali pri nepojasnjenem krvavenju iz nožnice.
Ovaleap is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.
Zdravilo Ovaleap se uporablja skupaj s humanim horionskim gonadotropinom (hCG) za spodbujanje nastanka sperme.
For practical information about using Ovaleap, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Ovaleap naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What is Ovaleap and what is it used for?
Kaj je zdravilo Ovaleap in za kaj se uporablja?
Ovaleap is a medicine that contains the active substance follitropin alfa.
Ovaleap je zdravilo, ki vsebuje zdravilno učinkovino folitropin alfa.
Ovaleap has been shown to be comparable to the reference medicine, GONAL-f.
Izkazalo se je, da je zdravilo Ovaleap primerljivo z referenčnim zdravilom GONAL-f.
Why is Ovaleap approved?
Zakaj je bilo zdravilo Ovaleap odobreno?
For the full list of all side effects reported with Ovaleap, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ovaleap, glejte navodilo za uporabo.
Ovaleap is available as a solution for injection.
Zdravilo Ovaleap je na voljo v obliki raztopine za injiciranje.
• women who do not produce eggs and do not respond to treatment with clomiphene citrate
• žensk, ki ne proizvajajo jajčec in se ne odzivajo na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja jajčnike, da proizvajajo jajčeca);
Ovaleap is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
Zdravilo Ovaleap se daje skupaj z zdravili, ki vsebujejo LH, kar spodbudi jajčeca, da dozorijo v jajčnikih;
The dose of Ovaleap and how often it is given depend on why it is being used and on the patient's response to treatment.
Zdravilo Ovaleap se daje z injekcijo pod kožo enkrat na dan. Odmerek zdravila Ovaleap in pogostost odmerjanja sta odvisna od razloga za uporabo in od bolnikovega odziva na zdravljenje.
In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10.
Pri več kot 1 bolnici od 10 so opazili tudi nastanek ovarijskih cist (vrečic s tekočino v jajčnikih) in glavobol.
How is Ovaleap used?
Kako se zdravilo Ovaleap uporablja?
Ovaleap is a ‘biosimilar' medicine.
Zdravilo Ovaleap je „podobno biološko“ zdravilo.
How does Ovaleap work?
Kako zdravilo Ovaleap deluje?
ATCvet code: QI02AD02.
Oznaka ATC vet: QI02AD02.
This should be considered in case of herd vaccination.
To moramo upoštevati v primeru cepljenja črede.
Date of first authorisation: 22.12.2014 Date of last renewal:
Datum pridobitve dovoljenja za promet: 22.12.2014 Datum zadnjega podaljšanja:
Avoid multiple broaching.
Izogibajte se večkratnemu prebadanju.
Can be used during lactation.
Lahko se uporablja v obdobju laktacije.
The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Učinkovina, ki je v osnovi biološkega izvora, namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
A definitive diagnosis of persistent infection can only be established upon re-testing in blood after an interval of at least 3 weeks.
Dokončno diagnozo trajne okužbe je mogoče postaviti samo pri ponovnem testiranju v krvi po presledku, ki traja vsaj 3 tedne.
Hypersensitivity reactions, including anaphylactic-type reactions, have been reported very rarely (post-marketing safety experience).
O preobčutljivih reakcijah, vključno z reakcijami anafilaktičnega tipa, so poročali zelo redko (izkušnje z varnostjo po trženju).
Duration of immunity: 1 year after immunisation.
Trajanje imunosti: 1 leto po imunizaciji.
The reconstituted vaccine is transparent and colourless.
Rekonstituirano cepivo je prozorno in brezbarvno.
Interaction with other medical products and other forms of interaction:
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:
If you notice any side effects, even those not already listed in this package leaflet or think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilno ni delovalo, obvestite svojega veterinarja.
Revaccination is recommended after 1 year.
Ponovno cepljenje je priporočeno čez 1 leto.
Specific pharmacovigilance requirements: Periodic safety update reports are required at yearly intervals.
Posebne farmakovigilančne zahteve: Redna posodobljena poročila o varnosti zdravila (PSUR) je treba redno posodabljati v letnih obdobjih.
12 months after primary vaccination most studied animals still had antibody titres at plateau while some animals had lower titres.
Dvanajst mesecev po primarnem cepljenju je imela večina proučevanih živali titre protiteles še vedno v višini platoja, nekatere živali pa so imele nižje titre.
To ensure the protection of animals introduced to the herd where BVDV is circulating, vaccination has to be completed 3 weeks before introduction.
Da zagotovimo zaščito živali, ki jih vključujemo v čredo, v kateri kroži BVDV, mora biti cepljenje končano 3 tedne pred vključevanjem.
Shedding of the vaccine virus by body fluids cannot be excluded.
Razsoja virusa cepiva s telesnimi tekočinami ni mogoče izključiti.
* Bovine viral diarrhoea virus ** Tissue culture infectious dose 50%
* virus bovine virusne driske ** infektivni odmerek na tkivni kulturi 50 %
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
SPC so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe(ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
The field studies to investigate the efficacy of the vaccine were done in herds where persistently infected animals had been removed.
Terenske študije za prikaz učinkovitosti cepiva so opravili v čredah, iz katerih so bile trajno okužene živali odstranjene.
Ensure that the lyophilisate is completely reconstituted before use.
Prepričajte se, da je liofilizat pred uporabo popolnoma rekonstituiran.
Animals which are vaccinated later than 3 weeks before gestation or during the early gestation may not be protected against foetal infection.
Živali, ki so cepljene pozneje kot 3 tedne pred kotitvijo ali med zgodnjo brejostjo, mogoče ne bodo zaščitene pred virusno okužbo.
Studies have shown that vaccine virus may be excreted in milk up to 23 days after vaccination at low amounts (~ 10 TCID50/ml), although when such milk was fed to calves, no seroconversion occurred in those calves.
Študije so pokazale, da se virus cepiva lahko v majhnih količinah (~ 10 TCID50/ml) izloča v mleku do 23 dni po cepljenju, čeprav po tistem, ko so tako mleko dali uživati teletom, pri teh teletih ni prišlo do serokonverzije.
Preparation of vaccine for use (reconstitution):
Priprava cepiva za uporabo (rekonstitucija):
Recommended re-vaccination programme:
Priporočeni program ponovnih cepljenj: