FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop taking Invokana and see a doctor as soon as possible if you have any of the following serious side effects:
Croatian: Prestanite uzimati lijek Invokana i što je prije moguće posjetite liječnika ako imate bilo koju od sljedećih ozbiljnih nuspojava:
English: How to store Invokana Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek Invokana Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Invokana is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Croatian: Invokana je indicirana u odraslih u dobi od 18 godina i starijih s dijabetesom tipa 2, za poboljšanje regulacije glikemije kao:
English: Canagliflozin as add-on therapy to insulin (with or without other glucose-lowering medicinal products).
Croatian: d Kanagliflozin kao dodatna terapija s inzulinom (sa ili bez drugih lijekova koji snižavaju glukozu).
English: 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).
Croatian: Primjena u bolesnika s rizikom pojave nuspojava povezanih s deplecijom volumena Zbog svog mehanizma djelovanja, kanagliflozin, povećavajući ekskreciju glukoze urinom (UGE) inducira osmotsku diurezu, što može reducirati intravaskularni volumen i smanjiti krvni tlak (vidjeti dio 5.1).
English: Lower limb amputations (mainly of the toe) especially in patients at high risk for heart disease
Croatian: Amputacije donjih udova (većinom nožnog prsta) naročito u bolesnika s visokim rizikom za bolesti srca
English: The primary assessment of safety and tolerability was conducted in a pooled analysis (n = 2,313) of four 26-week placebo-controlled clinical studies (monotherapy and add-on therapy with metformin, metformin and a sulphonylurea, and metformin and pioglitazone).
Croatian: Primarna procjena sigurnosti i podnošljivosti provedena analizom udruženih podataka (n = 2313) iz četiri 26-tjedna placebo kontrolirana klinička ispitivanja (monoterapija i dodatna terapija s metforminom, metforminom i sulfonilurejom, i metforminom i pioglitazonom).
English: A total of 10,285 patients with type 2 diabetes participated in nine double-blind, controlled clinical efficacy and safety studies conducted to evaluate the effects of Invokana on glycaemic control.
Croatian: Ukupno 10 285 bolesnika s dijabetesom tipa 2 sudjelovalo je u devet dvostruko slijepih, kontroliranih ispitivanja kliničke djelotvornosti i sigurnosti koje su provedene radi procjene djelotvornosti lijeka
English: • The other ingredients are: tablet core: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose film-coating: macrogol (3350), polyvinyl alcohol, talc, and titanium dioxide (E171).
Croatian: • Drugi sastojaci su: jezgra tablete: umrežena karmelozanatrij, hidroksipropilceluloza, laktoza, bezvodna; magnezijev stearat i mikrokristalična celuloza film ovojnica: makrogol (3350), poli(vinilni alkohol), talk i titanijev dioksid (E171).
English: 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)
Croatian: Nakon istovremene primjene kanagliflozina s rifampicinom (induktor različitih aktivnih transportera i enzima koji metaboliziraju lijekove), primijećeno je smanjenje sistemske izloženosti kanagliflozinu (AUC) i vršne koncentracije (Cmax) od 51% i 28%.
English: Because of how this medicine works, your urine will test positive for sugar (glucose) while you are on this medicine.
Croatian: Glukoza u mokraći Radi načina na koji ovaj lijek djeluje, Vaša će mokraća dati pozitivan rezultat na šećere (glukozu) za vrijeme uzimanja ovog lijeka.
English: Drug/Laboratory test interference
Croatian: Interferencija s lijekovima/laboratorijskim pretragama 1,5-AG testovi
English: Immune system disorders rare
Croatian: Poremećaj imunološkog sustava rijetko
English: h Balanitis or balanoposthitis includes the terms balanitis, balanoposthitis, balanitis candida, and genital infection fungal.
Croatian: h Balanitis ili balanopostitis uključuju termine balanitis, balanopostitis, kandidni balanitis i genitalna gljivična infekcija.
English: Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister.
Croatian: Polivinilklorid/aluminij (PVC/Al) perforirani blister djeljiv na jedinične doze.
English: Invokana 300 mg film-coated tablets EU/1/13/884/005 (10 tablets)
Croatian: Invokana 300 mg filmom obložene tablete EU/1/13/884/005 (10 tableta)
English: Excipient(s) with known effect Each tablet contains 39.2 mg lactose.
Croatian: Jedna tableta sadrži 39,2 mg laktoze.
English: 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
Croatian: Najčešće prijavljene nuspojave tijekom liječenja bile su hipoglikemija u kombinaciji s inzulinom ili sulfonilurejom, vulvovaginalna kandidijaza, infekcija mokraćnog sustava, poliurija ili polakizurija (npr. učestalo mokrenje).
English: Invokana 100 mg film-coated tablets EU/1/13/884/001 (10 tablets)
Croatian: Invokana 100 mg filmom obložene tablete EU/1/13/884/001 (10 tableta)
English: These symptoms could be a sign of “diabetic ketoacidosis” - a rare but serious, sometimes life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Croatian: rijetkog ali ozbiljnog, ponekad i po život opasnog problema koji se može javiti uz šećernu bolest zbog povišenih razina „ketonskih tijela“ u mokraći ili krvi, što je vidljivo u nalazima pretraga.
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Croatian: Ograničeni podaci iz kliničkih ispitivanja ukazuju da se DKA javlja s čestom učestalošću u bolesnika s dijabetesom tipa 1
English: ** See section 4.4. a Safety data profiles from individual pivotal studies (including studies in moderately renally impaired patients; older patients [≥ 55 years of age to ≤ 80 years of age]; patients with increased CV-risk) were generally consistent with the adverse reactions identified in this table.
Croatian: Profili sigurnosnih podataka iz individualnih pivotalnih ispitivanja (uključujući ispitivanja u bolesnika s blagim oštećenjem bubrega; u starijih bolesnika [≥ 55 godina starosti do ≤ 80 godina starosti]; u bolesnika s povećanim CV
English: Elderly patients may be at a greater risk for volume depletion, are more likely to be treated with diuretics, and to have impaired renal function.
Croatian: Stariji (≥ 65 godina starosti) Stariji bolesnici mogu imati veći rizik za depleciju volumena, obzirom na veću vjerojatnost da se liječe diureticima i da imaju oštećenu funkciju bubrega.
English: Excipient(s) with known effect Each tablet contains 117.78 mg lactose.
Croatian: Jedna tableta sadrži 117,78 mg laktoze.
English: • Invokana 300 mg film-coated tablets (tablets) are white, capsule-shaped, 17 mm long, with
Croatian: - Invokana 300 mg filmom obložene tablete (tablete) su bijele, oblika poput kapsule, dužine
English: • 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
Croatian: • Ako Vam je liječnik propisao kanagliflozin zajedno s bilo kojim od lijekova koji vežu žučnu kiselinu, poput kolestiramina (lijekovi za snižavanje kolesterola), kanagliflozin morate uzeti najmanje 1 sat prije ili 4 sata do 6 sati nakon lijeka koji veže žučnu kiselinu.
English: Therefore, 1,5-AG assays should not be used for assessment of glycemic control in patients on canagliflozin.
Croatian: testovi ne smiju koristiti u svrhu procjene kontrole glikemije u bolesnika na kanagliflozinu.
English: Increases in urinary glucose excretion with Invokana can falsely lower 1,5-anhydroglucitol (1,5-AG) levels and make measurements of 1,5-AG unreliable in assessing glycemic control.
Croatian: Povišenja ekskrecije glukoze urinom uz lijek Invokana mogu lažno sniziti razine 1,5-anhidroglucitola
English: Due to its mechanism of action, patients taking canagliflozin will test positive for glucose in their urine.
Croatian: Laboratorijski nalazi mokraće Zbog mehanizma djelovanja, bolesnici koji uzimaju kanagliflozin imati će pozitivan nalaz glukoze u mokraći.
English: 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).
Croatian: Oštećenje bubrega (eGFR < 60 mL/min/1,73 m2 ili CrCl < 60 mL/min) Bolesnici s početnom vrijednosti eGFR < 60 mL/min/1,73 m2 ili s CrCl < 60 mL/min imali su veću incidenciju nuspojava povezanih s deplecijom volumena (npr. posturalna omaglica, ortostatska hipotenzija, hipotenzija) uz kanagliflozin od 100 mg, kanagliflozin od 300 mg, odnosno placebo s incidencijama od 4,7%; 8,1% i 1,5% (vidjeti dijelove 4.2 i 4.4).
English: Possible signs of dehydration are: feeling light-headed or dizzy passing out (fainting) or feeling dizzy or faint when you stand up very dry or sticky mouth, feeling very thirsty feeling very weak or tired passing little or no urine fast heartbeat.
Croatian: osjećaj ošamućenosti ili omaglice nesvjestica ili osjećaj omaglice ili gubitak svijesti pri ustajanju vrlo suha ili ljepljiva usta, snažan osjećaj žeđi osjećaj jake slabosti ili umora oslabljeno ili odsutno mokrenje brzi otkucaji srca.
English: • carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
Croatian: • karbamazepin, fenitoin ili fenobarbital (lijekovi koji se uzimaju za kontrolu napadaja) • efavirenz ili ritonavir (lijek koji se uzima za liječenje HIV infekcije)
English: In placebo-controlled studies, treatment with canagliflozin 100 mg and 300 mg resulted in mean reductions in systolic blood pressure of -3.9 mmHg and -5.3 mmHg, respectively, compared to placebo (-0.1 mmHg) and a smaller effect on diastolic blood pressure with mean changes for canagliflozin 100 mg and 300 mg of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg).
Croatian: Krvni tlak U placebo-kontroliranim ispitivanjima, liječenje kanagliflozinom od 100 mg i 300 mg dovelo je do smanjenja srednjih vrijednosti sistoličkog krvnog tlaka od -3,9 mmHg odnosno -5,3 mmHg, u usporedbi s placebom (-0,1 mmHg) i manjeg učinka na dijastolički krvni tlak sa promjene srednjih vrijednosti uz kanagliflozin od 100 mg i 300 mg od -2,1 mmHg odnosno -2,5 mmHg, u usporedbi s placebom (-0,3 mmHg).
English: Titanium dioxide (E171) Macrogol 3350
Croatian: Invokana 300 mg filmom obložene tablete poli(vinilni alkohol) titanijev dioksid (E171) makrogol 3350 talk
English: e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3%
Croatian: e Fraktura kostiju bila je prijavljena u 0,7% i 0,6% za kanagliflozin od 100 mg odnosno 300 mg, u usporedbi s 0,3% za placebo.
English: GR-151 21 Πεύκη, Αθήνα Tηλ: +30 210 80 90 000
Croatian: Tηλ: +30 210 80 90 000
English: A lower proportion of patients treated with canagliflozin 100 mg (5.6%) and canagliflozin 300 mg (4.9%) experienced at least one episode/event of hypoglycaemia over 52 weeks of treatment compared to the group treated with glimepiride (34.2%).
Croatian: Niži udio bolesnika liječenih kanagliflozinom od 100 mg (5,6%) i kanagliflozinom od 300 mg (4,9%) doživjelo je barem jednu epizodu/događaj hipoglikemije tijekom
English: g
Croatian: c
English: b b
Croatian: B.
English: 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.
Croatian: Čini se da su tumori bubrežnih tubula uzrokovani kanagliflozinom i feokromocitomi u štakora uzrokovani malapsorpcijom ugljikohidrata kao posljedicom inhibitornog djelovanja kanagliflozina na crijevni SGLT1 u crijevima štakora;
English: Invokana 300 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Croatian: Invokana 300 mg filmom obložene tablete Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 300 mg kanagliflozina.
English: l Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and
Croatian: l Srednje vrijednosti postotka promjene urea nitrata u krvi u odnosu na početnu bila je 17,1% i 18,0% za kanagliflozin od 100 mg odnosno 300 mg naspram 2,7% za placebo.
English: 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.
Croatian: 60 mL/min/1,73 m2 ili CrCl 60 mL/min, doza kanagliflozina mora se prilagoditi ili održavati na 100 mg jedanput dnevno.
English: In general, canagliflozin produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including HbA1c, the percentage of patients achieving HbA1c < 7%, change from baseline fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG).
Croatian: HbA1c, postotak bolesnika koji su postigli HbA1c < 7%, promjenu u odnosu na početnu vrijednost glukoze u plazmi natašte (FPG) i 2-satne postprandijalne glukoze (PPG).
English: 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).
Croatian: ≥ 60 mL/min, a potrebna im je stroža regulacija glikemije, doza se može povisiti na 300 mg jedanput dnevno peroralno (vidjeti ispod i dio 4.4).
English: Invokana 100 mg film-coated tablets Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Invokana 100 mg filmom obložene tablete Jedna tableta sadrži kanagliflozin hemihidrat, što odgovara 100 mg kanagliflozina.
English: 1,5-AG assay
Croatian: Stoga se 1,5-AG
English: Consideration may also be given to stopping treatment with canagliflozin in patients that develop events preceding amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Croatian: U bolesnika kod kojih se razviju događaji koji prethode amputaciji poput kožnog čira na donjim ektremitetima, infekcije, osteomijelitisa ili gangrene, u obzir se također može uzeti prekid liječenja kanagliflozinom.
English: 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
Croatian: U bolesnika s eGFR 60 mL/min/1,73 m do < 90 mL/min/1,73 m ili s CrCl 60 mL/min do
English: EU/1/13/884/007 (90 tablets)
Croatian: EU/1/13/884/007 (90 tableta)
English: EU/1/13/884/002 (30 tablets)
Croatian: EU/1/13/884/002 (30 tableta)
English: EU/1/13/884/006 (30 tablets)
Croatian: EU/1/13/884/006 (30 tableta)
English: EU/1/13/884/008 (100 tablets)
Croatian: EU/1/13/884/008 (100 tableta)
English: EU/1/13/884/004 (100 tablets)
Croatian: EU/1/13/884/004 (100 tableta)
English: EU/1/13/884/003 (90 tablets)
Croatian: EU/1/13/884/003 (90 tableta)
English: k Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg,
Croatian: k Srednje vrijednosti postotka promjene kreatinina u odnosu na početnu bila je 2,8% i 4,0% za kanagliflozin od 100 mg odnosno 300 mg naspram 1,5% za placebo.
English: Patients (%) achieving HbA1c < 7% 44.5b
Croatian: Bolesnici (%) koji su postigli HbA1c
English: Baseline (mean) in kg % change from baseline (adjusted mean)
Croatian: u kg % promjene od početne vrijednosti
English: c Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Croatian: Osip uključuje pojmove eritemni osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip,
English: to < 60 mL/min/1.73 m2, and patients ≥ 75 years of age had generally higher incidences of these adverse reactions.
Croatian: U ovoj udruženoj analizi, bolesnici na diureticima Henleove petlje, bolesnici s početnom vrijednosti eGFR 30 mL/min/1,73 m2 do < 60 mL/min/1,73 m2 i bolesnici starosti ≥ 75 godina imali su općenito veće incidencije ovih nuspojava.
English: m Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg,
Croatian: m Srednje vrijednosti postotka promjene kalija u krvi u odnosu na početnu bila je 0,5% i 1,0% za kanagliflozin od
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba) • osip ili crvena koža - koji može svrbiti i imati izbočine, curenje tekućine ili mjehure.
English: Patients with eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 In a pooled analysis of patients (N = 721) with a baseline eGFR 45 mL/min/1.73 m2 to
Croatian: U udruženoj analizi bolesnika (N = 721) s početnom vrijednosti eGFR 45 mL/min/1,73 m2 do
English: Content Pack size
Croatian: Sastav (koncentracija)
English: This will help to protect against the disease.
Croatian: Ovo pomaže u zaštiti od bolesti.
English: This summary was last updated in November 2014.
Croatian: Sažetak je posljednji put ažuriran u studenom 2014.
English: Coxevac was initially authorised under ‘exceptional circumstances'.
Croatian: Coxevac je prvotno odobren pod „iznimnim okolnostima“.
English: The reaction reduces and disappears without need for treatment.
Croatian: Reakcija se smanjuje i nestaje bez potrebe za liječenjem.
English: The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the efficacy of the vaccine.
Croatian: Europska agencija za lijekove (EMA) pregledala je dodatne informacije u skladu s usuglašenim rasporedom o djelotvornosti cjepiva.
English: The reaction gradually reduces and disappears without need for treatment.
Croatian: Reakcija se postepeno smanjuje i nestaje bez potrebe za liječenjem.
English: The withdrawal period for Coxevac for meat and milk is zero days.
Croatian: Razdoblje karencije za Coxevac za meso i mlijeko iznosi nula dana.
English: Nine months later, two additional injections should be given to cattle, again three weeks apart.
Croatian: Devet mjeseci kasnije, potrebno je primijeniti dvije dodatne injekcije u goveda, i to ponovno u razmaku od tri tjedna.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Coxevac on 30 September 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji za VMP Coxevac dana 30. rujna 2010.
English: The duration of protection was established to be 280 days in cattle and one year in goats.
Croatian: Utvrđeno je trajanje imunizacije od 280 dana u goveda i godine dana u koza.
English: Coxevac is available as a suspension for injection.
Croatian: Coxevac je dostupan kao suspenzija za injekciju.
English: Inactivated Coxiella burnetii vaccine
Croatian: Cjepivo inaktivirane Coxiella burnetii
English: The vaccine is given to cattle and goats from three months of age.
Croatian: Cjepivo se primjenjuje u goveda i koza počevši od tri mjeseca starosti.
English: The effectiveness of Coxevac was investigated in both laboratory and field studies.
Croatian: Djelotvornost VMP-a Coxevac istražena je u laboratorijskim i terenskim ispitivanjima.
English: In the case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Croatian: Pri slučajnom samoinjiciranju potrebno je odmah potražiti liječnički savjet uz predočenje upute ili etikete liječniku.
English: Other information about Coxevac:
Croatian: Ostale informacije o VMP-u Coxevac:
English: The disease it causes is known as Q-fever.
Croatian: Bakterija uzrokuje bolest poznatu pod nazivom Q-groznica.
English: In 2014 the CVMP considered that the submitted data were adequate for the authorisation of Coxevac to convert to a normal status.
Croatian: 2014. godine, CVMP j zaključio da su dostavljeni podaci primjereni da se odobrenje za VMP Coxevac pretvori u normalni status.
English: Coxevac is a veterinary vaccine that contains inactivated (killed) Coxiella burnetii bacteria.
Croatian: Coxevac je veterinarsko-medicinsko cjepivo koje sadrži inaktiviranu (ubijenu) Coxiella burnetii bakteriju.
English: Coxevac is a bacterial vaccine.
Croatian: Coxevac je bakterijsko cjepivo.
English: In goats it is also very common to observe a slight increase of rectal temperature for 4 days post-vaccination without other general signs.
Croatian: Uobičajeno je da se u koza uoči neznatno povišenje rektalne temperature tijekom 4 dana nakon cijepljenja bez drugih općih znakova.
English: For goats, one injection should be given one year later.
Croatian: U slučaju koza dovoljno je primijeniti jednu injekciju jednom godišnje.
English: Coxiella burnetii is a bacterium that affects animals, including cattle and goats, and man.
Croatian: Coxiella burnetii je bakterija kojom se inficiraju životinje, uključujući goveda i koze, kao i čovjek.
English: This means that it was not possible to obtain complete information about Coxevac at the time of the initial authorisation.
Croatian: To znači da nije moguće dobiti potpune informacije o VMP-u Coxevac u trenutku početnog odobrenja za stavljanje VMP-a u promet.
English: 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.
Croatian: Uobičajeno je da se u goveda uoči otok maksimalnog promjera od 9 do 10 cm u mjestu injekcije, koji može trajati do 17 dana.
English: In cattle and goats Q-fever can cause abortions, still births and pneumonia.
Croatian: U goveda i koza, Q-groznica može prouzročiti pobačaje, mrtvorođenja i pneumoniju.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika dostupan je i u modulu znanstvene rasprave ovog EPAR-a.
English: The CVMP concluded that the benefits of Coxevac exceed the risks for the approved indication and recommended that Coxevac be given a marketing authorisation.
Croatian: CVMP je zaključio da VMP-a Coxevac nadmašuju rizike za odobrene indikacije i preporučio je da se VMP-u Coxevac izda odobrenje za stavljanje lijeka u promet.
English: Coxevac is used in cattle to lower the risk of spreading Coxiella burnetii infection and in goats to reduce abortions caused by the infection as well as reduce spreading the infection.
Croatian: Coxevac se koristi u goveda kako bi se smanjio rizik od širenja Coxiella burnetii infekcije, te u koza kako bi se smanjili pobačaji uzrokovani infekcijama kao i širenje infekcije.
English: The studies conducted in cattle and goats showed that Coxevac reduces bacteria shedding (which is a major factor in spreading the disease) in vaginal discharge and milk, whilst in goats Coxevac reduced bacteria shedding in faeces and the placenta as well.
Croatian: Ispitivanjima provedenima u goveda i koza utvrđeno je da VMP Coxevac smanjuje širenje bakterija (što je važan čimbenik u širenju bolesti) u vaginalnom iscjetku i mlijeku, dok u koza VMP Coxevac smanjuje širenje bakterija u izmetu i placenti.
English: In goats it is very common to see a palpable reaction of 3 to 4 cm diameter at the injection site which may last for 6 days.
Croatian: Uobičajeno je da se u koza uoči opipljiva reakcija promjera 3 do 4 cm u mjestu injekcije, koja može trajati do 6 dana.