natgillin/translations-raw huggingface dataset:
A paediatric Phase 1 study examined the pharmacokinetics and pharmacodynamics of canagliflozin in children and adolescents ≥ 10 to < 18 years of age with type 2 diabetes mellitus.
V pediatrični študiji faze 1 so preučevali farmakokinetiko in farmakodinamiko kanagliflozina pri otrocih in mladostnikih s sladkorno boleznijo tipa 2, starih ≥ 10 do < 18 let.
The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
prekomernega uživanja alkohola, dehidracije, nenadnega zmanjšanja odmerka insulina ali povečane potrebe po insulinu zaradi večjega kirurškega posega ali resne bolezni.
Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse reactions in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
(vključno s podatki pri dolgotrajni uporabi) v kateri so ocenili neželene učinke, poročane v celotnem programu študij s kanagliflozinom (s placebom in aktivno nadzorovanih študij) (glejte preglednico 1) (glejte poglavji 4.2 in 4.4).
Canagliflozin is transported by P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).
P-glikoprotein (P-gp) in membranski transporterski protein (ABCG2 oz. BCRP - Breast Cancer Resistance Protein).
Dabigatran: The effect of concomitant administration of canagliflozin (a weak P-gp inhibitor) on dabigatran etexilate (a P-gp substrate) has not been studied.
Dabigatran: Učinka sočasne uporabe kanagliflozina (šibek zaviralec P-gp) na dabigatran eteksilat
Table 1: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studiesa and from postmarketing experience
Preglednica 1: Preglednica neželenih učinkov (po klasifikaciji MedDRA) iz s placebom nadzorovanih študija in neželenih učinkov poročanih v obdobju trženja zdravila
Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin Glimepiride (titrated) + metformin (N = 482)
V primerjavi z glimepiridom v okviru dvotirnega zdravljenja z metforminom (52 tednov) kanagliflozin + metformin glimepirid (s titracijo) + metformin (n = 482)
Excipient(s) with known effect Each tablet contains 39.2 mg lactose.
Ena tableta vsebuje 39,2 mg laktoze.
Invokana 300 mg film-coated tablets EU/1/13/884/005 (10 tablets)
Invokana 300 mg filmsko obložene tablete EU/1/13/884/005 (10 tablet)
Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (AUC)
Pri sočasni uporabi kanagliflozina z rifampicinom (ki je induktor številnih aktivnih prenašalcev in encimov, ki presnavljajo učinkovine) so opazili zmanjšanje sistemske izpostavljenosti (AUC) kanagliflozinu za 51% in zmanjšanje najvišje plazemske koncentracije (Cmax) za 28%.
In a 12-week clinical study, unstimulated LH did not increase in male patients treated with canagliflozin.
V 12-tedenski klinični študiji se pri bolnikih moškega spola, ki so prejemali kanagliflozin, koncentracija LH brez stimulacije ni zvečala.
Invokana 100 mg film-coated tablets EU/1/13/884/001 (10 tablets)
Invokana 100 mg filmsko obložene tablete EU/1/13/884/001 (10 tablet)
What Invokana contains
Kaj vsebuje zdravilo Invokana
• lower limb amputations (mainly of the toe) especially if you are at high risk of heart disease.
• ledvična odpoved (kot posledica prevelike izgube tekočine iz telesa) • amputacije na spodnjih okončinah (večinoma prstov na nogah), še posebej, če imate večje tveganje za bolezni srca
• If your doctor has prescribed canagliflozin along with any bile acid sequestrant such as cholestyramine (medicines for lowering cholesterol) you should take canagliflozin at least
• Če vam je zdravnik predpisal kanagliflozin skupaj z adsorbentom žolčnih kislin, kot je holestiramin (zdravilo za zniževanje holesterola v krvi), morate vzeti kanagliflozin vsaj 1 uro prej ali 4 do 6 ur po tem, ko ste vzeli adsorbent žolčnih kislin.
Excipient(s) with known effect Each tablet contains 117.78 mg lactose.
Ena tableta vsebuje 117,78 mg laktoze.
Use in patients at risk for adverse reactions related to volume depletion Due to its mechanism of action, canagliflozin, by increasing urinary glucose excretion (UGE) induces an osmotic diuresis, which may reduce intravascular volume and decrease blood pressure (see section 5.1).
Kanagliflozin zaradi svojega mehanizma delovanja povečuje izločanje glukoze z urinom in tako povzroča osmotsko diurezo, ki lahko zmanjša znotrajžilni volumen in zniža krvni tlak (glejte poglavje 5.1).
Based on AUC exposure, the NOEL of 30 mg/kg/day for pheochromocytomas and renal tubular tumours is approximately 4.5 times the exposure at the daily clinical dose of 300 mg. Based on preclinical and clinical mechanistic studies, Leydig cell tumours, renal tubule tumours, and pheochromocytomas are considered to be rat-specific.
30 mg/kg/dan za feokromocitom in tumorje ledvičnih tubulov predstavljal približno 4,5-krat večjo izpostavljenost zdravilu kot klinični odmerek 300 mg. Na podlagi izsledkov predkliničnih in kliničnih mehanističnih študij velja, da so tumorji Leydigovih celic, tumorji ledvičnih tubulov in feokromocitomi specifični za podgane.
Adverse reactions related to volume depletion
Neželeni učinki, povezani s hipovolemijo
The hazard ratio for the composite primary endpoint (time to event of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and unstable angina requiring hospitalisation) for canagliflozin (both doses pooled) versus combined active and placebo comparators was 0.91 (95% CI: 0.68; 1.22); therefore, there was no evidence of an increase in cardiovascular risk with canagliflozin relative to comparators.
Razmerje ogroženosti za skupni primarni cilj opazovanja (čas do dogodka, ki je lahko kardiovaskularna smrt, možganska kap, ki jo bolnik preživi, miokardni infarkt, ki ga bolnik preživi, ali nestabilna angina pektoris, zaradi katere je treba bolnika sprejeti v bolnišnico) pri uporabi kanagliflozina (skupaj za oba odmerka) proti kombinirani vrednosti pri vseh primerjalnih zdravilih skupaj, vključno s placebom, je bilo 0,91 (95% IZ: 0,68; 1,22), kar pomeni, da ni nobenih dokazov, da bi bilo pri uporabi kanagliflozina tveganje za kardiovaskularne dogodke večje kot pri uporabi primerjalnih zdravil.
Titanium dioxide (E171) Macrogol 3350
Invokana 300 mg filmsko obložene tablete polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec
Renal failure (mainly in the context of volume depletion)
občasni levična odpoved (predvsem zaradi izgube tekočine)
Canagliflozin 100 mg and 300 mg as monotherapy and as dual or triple add-on therapy resulted in statistically significant reductions in the percentage of body weight at 26 weeks relative to placebo.
Telesna masa Kanagliflozin v monoterapiji ali kot dodatno zdravilo v okviru dvotirnega ali trotirnega zdravljenja je v odmerku 100 mg oziroma 300 mg po 26 tednih povzročil statistično značilno zmanjšanje telesne mase v primerjavi s placebom.
In patients tolerating canagliflozin 100 mg once daily who have an eGFR ≥ 60 mL/min/1.73 m2 or CrCl ≥ 60 mL/min and need tighter glycaemic control, the dose can be increased to 300 mg once daily orally (see below and section 4.4).
Pri bolnikih, ki odmerek 100 mg kanagliflozina enkrat na dan dobro prenašajo, imajo ocenjeno glomerulno filtracijo ≥ 60 ml/min/1,73 m2 ali očistek kreatinina ≥ 60 ml/min in potrebujejo boljši nadzor glikemije, se odmerek lahko poveča na 300 mg enkrat na dan, peroralno (glejte spodaj in poglavje 4.4).
• dabigatran (blood thinner medicine that lowers the risk of blood clot formation).
• dabigatran (zdravilo za redčenje krvi, ki zmanjšuje nastajanje krvnih strdkov) Nosečnost in dojenje
In the dedicated cardiovascular study, where patients were generally older with a higher rate of diabetes complications, the incidences of adverse reactions related to volume depletion were 2.8% with canagliflozin 100 mg, 4.6% with canagliflozin 300 mg, and 1.9% with placebo.
V posebni kardiovaskularni študiji, v katero so bili vključeni večinoma starejši bolniki z večjo pogostnostjo zapletov sladkorne bolezni, je bila pogostnost neželenih učinkov, povezanih s hipovolemijo, 2,8% pri uporabi 100 mg kanagliflozina, 4,6% pri uporabi 300 mg kanagliflozina in 1,9% pri uporabi placeba.
• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing).
Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) • hude alergijske reakcije (lahko vključujejo otekanje obraza, ustnic, ust, jezika, grla, zaradi česar je lahko oteženo dihanje ali požiranje).
Urinary tract infections were more frequently reported for canagliflozin 100 mg and 300 mg (5.9% versus 4.3%, respectively) compared to 4.0% with placebo.
Okužbe sečil O okužbah sečil so pogosteje poročali pri bolnikih, ki so prejemali 100 mg oziroma 300 mg kanagliflozina (5,9% oziroma 4,3%) v primerjavi s 4,0% pri tistih, ki so prejemali placebo.
• if you are allergic to canagliflozin or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste vzeli zdravilo Invokana Ne jemljite zdravila Invokana - če ste alergični na kanagliflozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Add-on therapy with insulind (18 weeks) Canagliflozin + insulin
Dodatno zdravljenje pri zdravljenju z insulinomd (18 tednov) kanagliflozin + insulin placebo + insulin (n = 565)
The most commonly reported adverse reactions during treatment were hypoglycaemia in combination with insulin or a sulphonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria
so bili hipoglikemija pri kombinaciji z insulinom ali s sulfonilsečnino, vulvovaginalna kandidoza, okužba sečil in poliurija ali polakisurija (torej pogosto uriniranje).
A substudy of patients with baseline HbA1c > 10% to ≤ 12% with canagliflozin as monotherapy resulted in reductions from baseline in HbA1c (not placebo-adjusted) of -2.13% and -2.56% for canagliflozin 100 mg and 300 mg, respectively.
V podštudiji z bolniki z izhodiščno ravnijo HbA1c od > 10% do ≤ 12% je v monoterapiji s kanagliflozinom prišlo do znižanja od izhodiščne vrednosti HbA1c (ni bila prirejena glede na placebo) za -2,13% pri uporabi odmerka 100 mg in za -2,56% pri uporabi odmerka 300 mg.
i Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and
i Povprečni odstotek povečanja glede na začetno vrednost za 100 mg kanagliflozina in 300 mg kanagliflozina v primerjavi s placebom je bil za celokupni holesterol 3,4% in 5,2% v primerjavi z 0,9%; HDL-holesterol 9,4% in 10,3% v primerjavi s 4,0%; LDL-holesterol 5,7% in 9,3% v primerjavi z 1,3%; ne-HDL-holesterol 2,2% in 4,4% v primerjavi z 0,7%; trigliceride 2,4% in 0,0% v primerjavi z 7,6%.
Renal impairment (eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min) Patients with a baseline eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min had a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) with incidences of 4.7%, 8.1%, and 1.5% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.4).
Pri bolnikih z izhodiščno vrednostjo ocenjene glomerulne filtracije < 60 ml/min/1,73 m2 ali z očistkom kreatinina < 60 ml/min so opazili večjo pogostnost neželenih učinkov, povezanih s hipovolemijo (kot so položajna omotica, ortostatska hipotenzija in hipotenzija), in sicer 4,7% pri 100 mg kanagliflozina in 8,1% pri 300 mg kanagliflozina ter 1,5% pri placebu (glejte poglavji 4.2 in 4.4).
Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Trotirno zdravljenje z metforminom in s sulfonilsečnino (26 tednov) kanagliflozin + metformin in sulfonilsečnina placebo + metformin in sulfonilsečnina
Sitagliptin 100 mg + metformin and sulphonylurea (N = 378)
sitagliptin 100 mg + metformin in sulfonilsečnina
For patients receiving canagliflozin, in case of intercurrent conditions that may lead to volume depletion (such as a gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including renal function tests), and serum electrolytes is recommended.
(na primer s telesnim pregledom, z meritvami krvnega tlaka, z laboratorijskimi preiskavami vključno s testi delovanja ledvic) in določanje koncentracije elektrolitov v serumu.
In the dedicated cardiovascular study and the larger pooled analysis, discontinuations due to adverse reactions related to volume depletion and serious adverse reactions related to volume depletion were not increased with canagliflozin.
V posebni kardiovaskularni študiji in po podatkih združene analize pogostnost prekinitve zdravljenja zaradi neželenega učinka, povezanega s hipovolemijo, in pogostnost resnih neželenih učinkov,
Elderly (≥ 65 years old) Renal function and risk of volume depletion should be taken into account (see section 4.4).
Upoštevati je treba stanje ledvic in tveganje za pojav hipovolemije (glejte poglavje 4.4).
Invokana 100 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Invokana 100 mg filmsko obložene tablete Ena tableta vsebuje kanagliflozinijev hemihidrat v količini, ki ustreza 100 mg kanagliflozina.
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
povečane koncentracije “ketonskih teles” v urinu in krvi hitra izguba telesne mase slabost ali bruhanje bolečine v trebuhu huda žeja hitro in globoko dihanje zmedenost nenavadna zaspanost ali utrujenost sladkast zadah, sladek ali kovinski okus v ustih ali spremenjen vonj seča ali znoja
After single-dose oral administration of 100 mg and 300 mg in healthy subjects, canagliflozin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 hour to 2 hours post-dose.
Pri zdravih osebah je po enkratnem peroralnem odmerku 100 mg oziroma 300 mg prišlo do hitre absorpcije kanagliflozina, pri čemer je do največje koncentracije v plazmi prišlo
Approximately 33% of the administered radioactive dose was excreted in urine, mainly as O-glucuronide metabolites (30.5%).
Približno 33% danega radioaktivno označenega odmerka se je izločilo z urinom, največ v obliki
Monotherapy (26 weeks) Canagliflozin
Monoterapija (26 tednov) kanagliflozin placebo (n = 192)
Patients (%) achieving HbA1c < 7% Body weight
N/Ac bolniki (%), ki so dosegli raven HbA1c
Canagliflozin-induced renal tubule tumours and pheochromocytomas in rats appear to be caused by carbohydrate malabsorption as a consequence of intestinal SGLT1 inhibitory activity of canagliflozin in the gut of rats; mechanistic clinical studies have not demonstrated carbohydrate malabsorption in humans at canagliflozin doses of up to 2-times the maximum recommended clinical dose.
ki jih pri podganah povzroča kanagliflozin, prihaja zaradi malabsorpcije ogljikovih hidratov, do katere pride zaradi zaviralnega delovanja kanagliflozina na črevesni prenašalec SGLT1 v črevesju podgan.
Relative to subjects with normal hepatic function, the geometric mean ratios for Cmax and AUC∞ of canagliflozin were 107% and 110%, respectively, in subjects with Child-Pugh class A (mild hepatic impairment) and 96% and 111%, respectively, in subjects with Child-Pugh class B (moderate) hepatic impairment following administration of a single 300 mg dose of canagliflozin.
Pri bolnikih z blago okvaro jeter (Child-Pugh razreda A) oziroma z zmerno okvaro jeter (Child-Pugh razreda B) so po enkratnem odmerku 300 mg kanagliflozina vrednosti geometričnega povprečja Cmax kanagliflozina znašale 107% oziroma 96% teh vrednosti pri osebah z normalno jetrno funkcijo,
EU/1/13/884/007 (90 tablets)
EU/1/13/884/007 (90 tablet)
EU/1/13/884/002 (30 tablets)
EU/1/13/884/002 (30 tablet)
EU/1/13/884/008 (100 tablets)
EU/1/13/884/008 (100 tablet)
EU/1/13/884/003 (90 tablets)
EU/1/13/884/003 (90 tablet)
EU/1/13/884/004 (100 tablets)
EU/1/13/884/004 (100 tablet)
EU/1/13/884/006 (30 tablets)
EU/1/13/884/006 (30 tablet)
Elimination Following administration of a single oral [14C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and
Po odmerjanju enkratnega s [14C] označenega peroralnega odmerka kanagliflozina zdravim osebam so 41,5% danega radioaktivnega odmerka prestregli v blatu v obliki kanagliflozina, 7,0% v obliki hidroksiliranega metabolita in 3,2% v obliki O-glukuronidnega presnovka.
In two 52-week active-controlled studies comparing canagliflozin to glimepiride and sitagliptin, sustained and statistically significant mean reductions in the percentage of body weight for canagliflozin as add-on therapy to metformin were -4.2% and -4.7% for canagliflozin 100 mg and 300 mg, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5% for canagliflozin 300 mg in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%).
V dveh 52-tedenskih aktivno nadzorovanih študijah, v katerih so kanagliflozin primerjali z glimepiridom oziroma s sitagliptinom, je 100 mg oziroma 300 mg kanagliflozina kot dodatno zdravilo pri zdravljenju z metforminom povzročilo trajno in statistično značilno zmanjšanje telesne mase s povprečno spremembo odstotka telesne mase -4,2% oziroma
Pregnancy
Izločanje
Renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to
Pri bolnikih z ocenjeno glomerulno filtracijo 60 ml/min/1,73 m2 do < 90 ml/min/1,73 m2 ali z očistkom kreatinina 60 ml/min do < 90 ml/min ni potrebno prilagajati odmerka.
Stop taking Invokana and see a doctor as soon as possible if you have any of the following serious side effects:
Če se pri vas pojavi kateri od naslednjih resnih neželenih učinkov, prenehajte jemati zdravilo in čimprej poiščite zdravnika:
• constipation
• zaprtje
Therefore, the canagliflozin dose should be limited to 100 mg once daily in patients with eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min and canagliflozin should not be used in patients with an eGFR < 45 mL/min/1.73 m2 or CrCl < 45 mL/min (see section 4.2).
Zato je treba dnevni odmerek kanagliflozina pri bolnikih z ocenjeno glomerulno filtracijo < 60 ml/min/1,73 m2 ali očistkom kreatinina < 60 ml/min omejiti na 100 mg.
Baseline (mean) in kg % change from baseline (adjusted mean)
24,7b telesna masa izhodiščna (povprečna) vrednost v kg % spremembe od izhodiščne vrednosti (prilagojena povprečna vrednost)
Hypoglycaemia in combination with insulin or sulphonylurea uncommon
Presnovne in prehranske motnje zelo pogosti hipoglikemija pri uporabi v kombinaciji z insulinom in sulfonilsečnino občasni dehidracija*
However, dilatation of the renal pelvis was noticed with a No Observed Effect Level (NOEL) at exposures 2.4 times and 0.6 times the clinical exposures at 100 mg and 300 mg doses, respectively, and did not fully reverse within the approximately 1-month recovery period.
Pri izpostavljenostih, ki so 2,4-krat in 0,6-krat presegale klinične izpostavljenosti pri odmerkih 100 mg in
Canagliflozin 300 mg + metformin and sulphonylurea (N = 377)
kanagliflozin 300 mg +
b b
PRILOGA I
In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m or CrCl 60 mL/min, the dose of canagliflozin should be adjusted to or maintained at 100 mg once daily.
Pri bolnikih, ki dobro prenašajo kanagliflozin, pri katerih se ocenjena glomerulna filtracija zmanjša in ostane pod 60 ml/min/1,73 m ali očistek kreatinina pod
for placebo.
razlika v primerjavi s placebom
In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2
Rezultati te združene analize so pokazali večinoma večjo pogostnost teh neželenih učinkov pri bolnikih, ki so jemali diuretike Henleyeve zanke, pri bolnikih z izhodiščno vrednostjo ocenjene glomerulne filtracije od 30 ml/min/1,73 m2 do < 60 ml/min/1,73 m2 in pri bolnikih, ki so bili stari ≥ 75 let.
Content Pack size
Pot uporabe Stična ovojnina Vsebina
This summary was last updated in November 2014.
Povzetek je bil nazadnje posodobljen novembra 2014.
This document cannot replace a face-to-face discussion with your veterinarian.
Dokument ne more nadomestiti osebnega pogovora z veterinarjem.
The European Commission granted a marketing authorisation valid throughout the European Union, for Coxevac on 30 September 2010.
Evropska komisija je dovoljenje za promet z zdravilom Coxevac, veljavno po vsej Evropski uniji, izdala 30. septembra 2010.
The duration of protection was established to be 280 days in cattle and one year in goats.
Ugotovljeno trajanje zaščite pri govedu je 280 dni in eno leto pri kozah.
Coxevac was initially authorised under ‘exceptional circumstances'.
Zdravilo Coxevac je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Other information about Coxevac:
Druge informacije o zdravilu Coxevac:
The effectiveness of Coxevac was investigated in both laboratory and field studies.
Učinkovitost zdravila Coxevac so proučevali v laboratorijskih in terenskih študijah.
In 2014 the CVMP considered that the submitted data were adequate for the authorisation of Coxevac to convert to a normal status.
Leta 2014 je odbor CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet s cepivom Coxevac spremeni v običajno dovoljenje.
The vaccine is given to cattle and goats from three months of age.
Cepivo se govedu in kozam daje od starosti treh mesecev dalje.
In goats it is also very common to observe a slight increase of rectal temperature for 4 days post-vaccination without other general signs.
Pri kozah se zelo pogosto pojavi tudi rahel dvig rektalne temperature do štiri dni po cepljenju brez drugih splošnih znakov.
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or the milk used for human consumption.
Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
Nine months later, two additional injections should be given to cattle, again three weeks apart.
Po devetih mesecih je treba govedu ponovno injicirati dva odmerka, tudi tokrat v tritedenskem razmiku.
The withdrawal period for Coxevac for meat and milk is zero days.
Karenca za cepivo Coxevac za meso in mleko je nič dni.
In cattle it is very common to see a swelling of maximum diameter of 9 to 10 cm at the injection site, which may last for 17 days.
Pri govedu se zelo pogosto pojavi oteklina premera največ 9 do 10 cm na mestu vboda, ki lahko traja 17 dni.
Coxevac is a bacterial vaccine.
Zdravilo Coxevac je bakterijsko cepivo.
What benefit has Coxevac shown during the studies?
Kakšne koristi je zdravilo Coxevac izkazalo med študijami?
Coxiella burnetii is a bacterium that affects animals, including cattle and goats, and man.
Coxiella burnetii je bakterija, ki napade živali, med drugim govedo in koze, ter človeka.
The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the efficacy of the vaccine.
Evropska agencija za zdravila (EMA) je pregledala vse nove podatke o učinkovitosti cepiva, ki so bili predloženi po dogovorjenem časovnem razporedu.
The vaccine is given as two injections under the skin, three weeks apart.
Injicira se dvakrat pod kožo v razmiku treh tednov.