natgillin/translations-raw huggingface dataset:
Study Endpoints
Opazovani dogodki v študiji
VFEND contains the active substance voriconazole.
Zdravilo VFEND vsebuje zdravilno učinkovino vorikonazol.
Please see instructions below before using VFEND suspension.
Preden uporabite zdravilo VFEND suspenzija, preberite spodnja navodila:
What VFEND looks like and contents of the pack VFEND powder and solvent for solution for infusion is presented as an administration kit containing:
VFEND prašek in vehikel za raztopino za infundiranje je na voljo v kompletu za aplikacijo, ki vsebuje:
Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below
podkožnega tkiva, sluznice in podsluzničnih tkiv, srbeča ali boleča območja debele rdeče kože s srebrnkastimi luskami, draženje kože in sluznic, življenjsko nevarno kožno stanje, pri katerem se veliki deli povrhnjice, najbolj zunanje plasti kože, odluščijo od spodaj ležečih plasti kože - majhni, suhi, luskasti predeli kože, včasih odebeljeni in s koničastimi izrastki ali ''rogovi''
Contact your doctor immediately if you become pregnant while being treated with VFEND.
Če med zdravljenjem z zdravilom VFEND zanosite, se takoj posvetujte z zdravnikom.
Patients 40 kg and above*
intravensko peroralno bolniki s telesno maso 40 kg in več*
VFEND 200 mg powder and solvent for solution for infusion
VFEND 200 mg prašek in vehikel za raztopino za infundiranje
Detailed information on this medicinal product is available on the website of the European Medicines Agency.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Elevated liver enzymes
• Eksfoliacijske kožne rakcije
You may experience abnormal intolerance to light as a result of taking more VFEND than you should.
Če vzamete večji odmerek zdravila VFEND, kot bi smeli, se pri vas lahko pojavi nenormalna preobčutljivost na svetlobo.
IFI to day 100
100. dneva
SLOWLY push down the plunger of the oral syringe.
POČASI potiskajte bat brizge.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, so čas in pogoji shranjevanja pred uporabo odgovornost uporabnika in običajno ne smejo biti daljši od 24 ur pri 2 °C do 8 °C, razen če je rekonstitucija potekala v nadzorovanih in preverjenih aseptičnih pogojih.
Frequent monitoring for adverse reactions and toxicity related to methadone, including QTc prolongation, is recommended when coadministered with voriconazole since methadone levels increased following coadministration of voriconazole.
Ker se raven metadona ob sočasni uporabi z vorikonazolom poveča, je priporočljivo pogosto nadziranje neželenih učinkov in toksičnosti metadona, vključno s podaljšanjem QTc.
VFEND contains lactose
Zdravilo VFEND vsebuje laktozo
A disorder in which the body's immune system attacks part of the peripheral nervous system Heart rhythm or conduction problems (sometimes life threatening) Life threatening allergic reaction
- čezmerno dejavna ščitnica - poslabšanje delovanja možganov, ki je resen zaplet bolezni jeter - izguba večine vlaken vidnega živca, zamotnitev roženice, nehotni gibi očesa - preobčutljivost na svetlobo, ki se kaže z mehurji na koži - bolezen, pri kateri imunski sistem v telesu napade del perifernega živčevja - težave s srčnim ritmom ali prevajanjem (včasih življenjsko nevarne) - življenjsko nevarna alergijska reakcija - motnja v strjevanju krvi - alergijske kožne reakcije (včasih hude), vključno s hitrim otekanjem (edemom) usnjice,
Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
- rak kože, - vnetje tkiva, ki obdaja kost, - rdeča luskasta območja ali obročaste kožne lezije, ki so lahko simptom avtoimunske bolezni,
VFEND 200 mg powder and solvent for solution for infusion Voriconazole
VFEND 200 mg prašek in vehikel za raztopino za infundiranje vorikonazol
Hepatic impairment
Očesne bolezni okvare vida
• A sterile, single use, syringe.
• sterilno brizgo za enkratno uporabo.
Study endpoints
Mejne vrednosti
Children aged 2 to less than 12 years and teenagers aged 12 to 14 years weighing less than 50 kg
tablete otroci, stari od 2 do manj kot 12 let, in najstniki, stari od 12 do 14 let, s telesno maso manj kot 50 kg najstniki, stari od 12 do 14 let, s telesno maso več kot 50 kg, in vsi najstniki, starejši od 14 let odmerek v prvih 24 urah (polnilni odmerek)
If not used immediately, in-use storage times and conditions of the reconstituted vial prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Če ni uporabljeno takoj, so čas shranjevanja in pogoji pred uporabo rekonstituirane viale odgovornost uporabnika, vendar čas običajno ne sme presegati 24 ur pri temperaturi med 2 °C in 8 °C, razen če ni priprava opravljena v nadzorovanih in preverjenih aseptičnih pogojih.
Turn the bottle upside down while holding the oral syringe in place.
Medtem ko držite brizgo, obrnite plastenko na glavo.
400 mg (10 ml) every 12 200 mg (5 ml) every 12
6 mg/kg vsakih 12 ur 400 mg (10ml) vsakih 12 ur
Blood cholesterol increased, blood urea increased Allergic skin reactions (sometimes severe), including life-threatening skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth, inflammation of the skin, hives, sunburn or severe skin reaction following exposure to light or sun, skin redness and irritation, red or purple discoloration of the skin which may be caused by low platelet count, eczema
sončne opekline ali hude kožne reakcije po izpostavljanju svetlobi ali soncu, rdečica in draženje kože, rdeče ali vijoličasto obarvanje kože, ki ga lahko povzroči nizko število krvnih ploščic, ekcem - reakcije na mestu infundiranja - alergijske reakcije ali pretiran imunski odziv
Constipation, indigestion, inflammation of the lips Jaundice, inflammation of the liver and liver injury Skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat, red area on the skin that is covered with small confluent bumps, redness of the skin Itchiness
zastajanje tekočine v pljučih - zaprtje, prebavne težave, vnetje ustnic - zlatenica, vnetje jeter in poškodbe jeter - kožni izpuščaji, ki lahko povzročijo hude mehurje in luščenje kože, za katere je značilna ravna rdeča površina kože, prekrita z majhnimi zlivajočimi izboklinami, pordelost kože - srbenje - izguba las - bolečine v hrbtu - odpoved ledvic, kri v urinu, spremembe izidov preiskav za spremljanje delovanja ledvic
Voriconazole Cmax  4% Voriconazole AUC  32%
v primerjavi z 200 mg vorikonazola BID, vorikonazol Cmax  4 % vorikonazol AUC  32 %
Critical Instructions for safe and effective use of infusion kit Aseptic procedures will be followed during kit preparation Bag must be inverted when the reconstituted Voriconazole is added
Pomembna navodila za varno in učinkovito uporabo infuzijskega kompleta
IFI to day 180
180. dneva
Infusion-related reactions, predominantly flushing and nausea, have been observed during administration of the intravenous formulation of voriconazole.
Med intravensko uporabo pripravkov vorikonazola so opažali z infundiranjem povezane reakcije, predvsem zardevanje in navzeo.
Each ml of oral suspension contains 40 mg of voriconazole when reconstituted with water.
1 mililiter peroralne suspenzije po pripravi z vodo vsebuje 40 mg/ml vorikonazola.
Package Size
velikost pakiranja
EU Number
Vsebina (koncentracija)
EU/1/97/045/003 Helicobacter Test INFAI for children of the age 3-11
EU/1/97/045/003 Test Helicobacter INFAI za otroke v starosti 3-11 let
50 jars
50 plastenkami
50 jars, as part of a multicomponent kit with breath bags
50 plastenkami, 50 vrečke za vzorce izdihanega zraka
Invented name Strength Pharmaceutical form Route of administration
Številka EU Izmišljeno ime Jakost
1 jar, as part of a multicomponent kit with breath bags
1plastenka, 2 vrečke za vzorce izdihanega zraka
12 x (1 vial + 1 prefilled syringe + 1 vial adapter with needle + 2 alcohol wipes) (Titration pack)
12 x (1 viala + 1 napolnjena injekcijska brizga + 1 adapter za vialo z iglo + 2 alkoholni blazinici) (set za titriranje)
MA (EU) number (Invented) name
(Izmišlje no) ime
Other information about Ifirmasta:
Druge informacije o zdravilu Ifirmasta:
The name of the medicine was changed to Ifirmasta on 24 September
Ime zdravila je bilo 24. septembra 2009 spremenjeno v Ifirmasta.
What are the benefit and risk of Ifirmasta?
Kakšne so koristi in tveganja, povezana z zdravilom Ifirmasta?
The full EPAR for Ifirmasta 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 Ifirmasta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This means that Ifirmasta is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aprovel.
The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Krka on 1 December 2008.
Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Krka, veljavno po vsej Evropski uniji, izdala 1. decembra 2008.
For more information about treatment with Ifirmasta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ifirmasta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Ifirmasta is a ‘generic medicine'.
Zdravilo Ifirmasta je „generično zdravilo“.
Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Zdravljenje se začne z odmerkom 150 mg enkrat dnevno, ki se običajno poveča na 300 mg enkrat dnevno.
This document is a summary of the European public assessment report (EPAR) for Ifirmasta.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ifirmasta.
The usual recommended dose of Ifirmasta is 150 mg once a day.
Običajni priporočeni odmerek zdravila Ifirmasta znaša 150 mg enkrat dnevno.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ifirmasta.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Zaradi tega se krvni tlak zniža, kar posledično zmanjša tveganje, ki ga povzroča visok krvni tlak, kot je denimo kap.
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dve zdravili sta biološko enakovredni, ko dosegata enake ravni zdravilne učinkovine v telesu.
Why has Ifirmasta been approved?
Zakaj je bilo zdravilo Ifirmasta odobreno?
Ifirmasta is used in adults who have essential hypertension (high blood pressure).
Zdravilo Ifirmasta se uporablja pri odraslih bolnikih z esencialno hipertenzijo (visokim krvnim tlakom).
Because Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je zdravilo Ifirmasta generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
Ifirmasta is a medicine that contains the active substance irbesartan.
Ifirmasta je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
The active substance in Ifirmasta, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Zdravilna učinkovina zdravila Ifirmasta, irbesartan, je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu prepreči delovanje hormona, imenovanega angiotenzin II.
The Committee recommended that Ifirmasta be given marketing authorisation.
Priporočil je, da se za zdravilo Ifirmasta izda dovoljenje za promet.
Because Ifirmasta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine.
Ker je zdravilo Ifirmasta generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnemu zdravilu.
By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Irbesartan z blokiranjem receptorjev, na katere se angiotenzin II običajno veže, zavira delovanje tega hormona, kar omogoči razširitev krvnih žil.
The CHMP concluded that, in accordance with EU requirements, Ifirmasta has been shown to have comparable quality and to be bioequivalent to Aprovel.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ifirmasta primerljivo raven kakovosti kot zdravilo Aprovel ter da mu je biološko enakovredno.
In patients with hypertension and type 2 diabetes, Ifirmasta is added to some other treatments for hypertension.
Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Ifirmasta uvede poleg drugih načinov zdravljenja hipertenzije.
Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk.
Zato je menil, da koristi, tako kot pri zdravilu Aprovel, odtehtajo znana tveganja.
Ifirmasta is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Zdravilo Ifirmasta se uporablja tudi za zdravljenje ledvičnega obolenja pri odraslih z visokim krvnim tlakom in sladkorno boleznijo tipa 2.
How has Ifirmasta been studied?
Kako je bilo zdravilo Ifirmasta raziskano?
What is Ifirmasta used for?
Za kaj se zdravilo Ifirmasta uporablja?
What is Ifirmasta?
Kaj je zdravilo Ifirmasta?
How is Ifirmasta used?
Kako se zdravilo Ifirmasta uporablja?
How does Ifirmasta work?
Kako zdravilo Ifirmasta deluje?
Previously known as Irbesartan Krka.
Prej znano kot zdravilo Irbesartan Krka.
The current annual reporting cycle for periodic safety update reports (PSURs) should be maintained.
Potrebno je ohraniti letni cikel rednih posodobljenih poročil o varnosti zdravila (PSUR).
Date of first authorisation: 14/04/2011 Date of last renewal: 15/03/2016
Datum pridobitve: 14/04/2011 Datum podaljšanja dovoljenja za promet: 15/03/2016
Each ml of vaccine contains:
En ml cepiva vsebuje:
a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control and/or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
1 dose per year.
1 odmerek letno.
Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Občasno lahko prisotnost maternalnih protiteles pri ovcah minimalne priporočene starosti vpliva na zaščito, ki jo zagotavlja cepivo.
Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/).
Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Vsak program ponovnega cepljenja mora odobriti pristojni organ ali odgovorni veterinar ob upoštevanju lokalnih epidemioloških razmer.
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 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.
ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Oznake ATC vet: QI04AA02 (ovce) in QI02AA08 (govedo).
Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Vsako neuporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo pri teh zdravilih, je treba odstraniti v skladu z lokalnimi zahtevami.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ni podatkov o varnosti ter učinkovitosti uporabe tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na plastenki/kartonski škatli.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/).
OTHER INFORMATION Immunological properties
DRUGE INFORMACIJE Imunološke lastnosti
The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle).
Varnost in učinkovitost cepiva nista bili ugotovljeni pri plemenskih samcih (ovce in govedo).
In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National competent authorities on the current vaccination policies against bluetongue virus (BTV).
Pri tej kategoriji živali lahko cepivo uporabimo le na podlagi ocene razmerja korist-tveganje odgovornega veterinarja in/ali pristojnega nacionalnega organa, odvisno od veljavne politike cepljenja proti virusu bolezni modrikastega jezika (BTV).
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Ob uporabi cepiva pri drugih domačih in divjih vrstah prežvekovalcev, ki jih ogroža okužba, je potrebna previdnost; pred množičnim cepljenjem je priporočljivo testno cepljenje manjšega števila živali.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
Special warnings for each target species: Vaccinate healthy animals only.
Posebna opozorila za vsako živalsko vrsto Cepite samo zdrave živali.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity:
*(ciklična vrednost (Ct) ≥ 36 pri potrjeni metodi RT-PCR, kar kaže, da virusni genom ni prisoten) Nastop imunosti:
It lasts not longer than 24 to 48 hours.
Povišana telesna temperatura traja od 24 do 48 ur.
Temporary local reactions can occur very rarely at the injection site in the form of a nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful.
Zelo redko se pojavijo začasne lokalne reakcije na mestu injiciranja v obliki bule premera 0,5 do 1 cm pri ovcah in 0,5 do 3 cm pri govedu, ki pa izgine najkasneje v 14 dneh in ki je lahko boleča.
Tel.: + 34 986 33 04 00 Fax: + 34 986 33 65 77 czv@czveterinaria.com
Tel: + 34 986 33 04 00 Faks: + 34 986 33 65 77 czv@czveterinaria.com
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
*(ciklična vrednost (Ct) ≥ 36 pri potrjeni metodi RT-PCR, kar kaže, da virusni genom ni prisoten)
EU/2/11/122/001 bottle of 52 ml EU/2/11/122/002 bottle of 100 ml EU/2/11/122/003 bottle of 252 ml
EU/2/11/122/001 plastenka z 52 ml EU/2/11/122/002 plastenka s 100 ml EU/2/11/122/003 plastenka z 252 ml
Occasionally a slight increase of the temperature (0.5 ºC - 1.0 ºC) is observed for 24-48 hours after the administration of a double dose of the vaccine.
Občasno je mogoče opaziti blago povišanje telesne temperature (0,5 ºC-1,0 ºC), ki traja 24-48 ur po dajanju dvojnega odmerka cepiva.
No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Na voljo ni nobenih informacij o uporabi cepiva pri seropozitivnem govedu niti pri govedu z maternalnimi protitelesi.
BLUEVAC BTV8 suspension for injection for cattle and sheep
BLUEVAC BTV8 suspenzija za injiciranje za ovce in govedo
Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections)
tiomersal fosfatna pufrska fiziološka raztopina (natrijev klorid, dinatrijev fosfat in kalijev fosfat, voda za injekcije)
Each ml of vaccine contains: BTV8 antigen 106.5 CCID50
En ml cepiva vsebuje: antigen BTV8 106,5 CCID50
4.2 Indications for use, specifying the target species Sheep
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Ovce
(*) equivalent to titre prior to inactivation (log10)
(*)enakovredno titru pred inaktivacijo (log 10)
(*)equivalent to titre prior to inactivation (log10)
(*) enakovredno titru pred inaktivacijo (log 10)
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,
An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle.
NEŽELENI UČINKI Povprečno povišanje telesne temperature, ki variira med 0,5 in 1,0 °C, je pogosta reakcija pri ovcah in govedu.
1 year after the second dose.
1 leto po drugem odmerku.
Suspension for injection White or pinkish-white.
Bela ali rožnato-bela.
31 days after the second dose.
31 dni po drugem odmerku.
Loss of appetite can occur in very rare cases.
V zelo redkih primerih lahko pride tudi do izgube teka.
20 days after the second dose.
20 dni po drugem odmerku.