FrancophonIA/ELRC3.0 huggingface dataset:
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su VMP-a bioekvivalenti, ako stvaraju iste razine djelatne tvari u tijelu.
English: Contacera must not be used in horses less than six weeks of age or in cattle less than one week of age when used in the treatment of diarrhoea.
Croatian: Contacera se ne smije primjenjivati u konja mlađih od šest tjedana ili u goveda mlađih od jednog tjedna starosti, ako se koristi za liječenje proljeva.
English: Why has Contacera been approved?
Croatian: Zašto je Contacera odobren?
English: The CVMP considered that, in accordance with European Union requirements, Contacera has been shown to be bioequivalent to Metacam.
Croatian: CVMP je zaključio da je, u skladu sa zahtjevima Europske unije, dokazano da je Contacera bioekvivalent VMP-u Metacam.
English: It is also the time allowed after administration of the medicine before the milk can be used for human consumption.
Croatian: To je također vrijeme koje mora proći od primjene lijeka prije nego što se mlijeko može iskoristiti za ljudsku uporabu.
English: Contacera is a ‘generic', which means that Contacera is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Croatian: Contacera je „generički” VMP, što znači da je Contacera sličan „referetnom veterinarsko-medicinskom lijeku” koji je već odobren na razini EU (Metacam).
English: If someone accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately.
Croatian: Ako si osoba slučajno ubrizga VMP, odmah potražiti pomoć liječnika.
English: Therefore the CVMP's view was that, as for Metacam, Contacera's benefits are greater than its risks when used for the approved indications and the Committee recommended that Contacera be given a marketing authorisation.
Croatian: Stoga, CVMP je mišljenja da, kao i u slučaju VMP-a Metacam, koristi od VMP-a Contacera nadmašuju s njim povezane rizike prilikom primjene za odobrene indikacije te je Povjerenstvo preporučilo da se za Contacera izda odobrenje za stavljanje VMP-a u promet.
English: In very rare cases, potentially serious or fatal anaphylactoid reactions (similar to severe allergic reactions) may occur following injection and should be treated symptomatically.
Croatian: U vrlo rijetkim slučajevima, nakon injekcije mogu potencijalno nastupiti ozbiljne ili smrtonosne anafilaktičke reakcije (slične ozbiljnim alergijskim reakcijama), te se iste moraju liječiti simptomatično.
English: It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients.
Croatian: Ne smije se primjenjivati u životinja koje su preosjetljive (alergične) na djelatnu tvar ili na bilo koju drugu pomoćnu tvar.
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis (inflammation of the lower part of the gut) have been reported.
Croatian: U vrlo rijetkim slučajevima prijavljeni su gubitak apetita, letargija, abdominalna bol i kolitis (upala u donjem dijelu crijeva).
English: For meat the withdrawal period is 15 days and for milk it is five days.
Croatian: Karencija za meso iznosi 15 dana, a za mlijeko pet dana.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Croatian: Budući da su prostaglandini tvari koje aktiviraju upalu, bol, eksudaciju (tekućinu koja curi iz krvnih žila tijekom upale) i groznicu, meloksikam smanjuje znakove ove bolesti.
English: Contacera must not be used in animals with liver, heart or kidney problems, bleeding disorders, or suffering from irritation or ulcers of the digestive tract.
Croatian: Contacera se ne smije primjenjivati u životinja s problemima s jetrom, srcem ili bubrezima, poremećajima krvarenja ili koje pate od iritacije ili čireva probavnog trakta.
English: For meat the withdrawal period with the 20 mg/ml solution for injection is five days and with the 15 mg/ml oral suspension it is three days.
Croatian: Karencija za meso u slučaju primjene 20 mg/ml otopine za injekciju iznosi pet dana, a u slučaju 15 mg/ml peroralne suspenzije iznosi tri dana.
English: What is Contacera?
Croatian: Što je Contacera?
English: For meat the withdrawal period is five days.
Croatian: Karencija za meso iznosi pet dana.
English: What is Contacera used for?
Croatian: Za što se Contacera koristi?
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Croatian: Meloksikam djeluje inhibirajući enzime naziva ciklooksigenaze koje su uključene u stvaranje prostaglandina.
English: Contacera contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Croatian: Contacera sadrži meloksikam, koji se ubraja u klasu veterinarsko-medicinskih lijekova naziva nesteroidni antiupalni lijekovi (NSAID-ovi).
English: Side effects that occurred with the oral suspension in horses included isolated cases of adverse reactions typically associated with NSAIDs (slight urticaria and diarrhoea).
Croatian: Nuspojave koje su nastupile prilikom primjene peroralne suspenzije u konja, uključuju izolirane slučajeve nuspojava koje se tipično povezuju s NSAID-ovima (blaga urtikarija i proljev).
English: What is the risk associated with Contacera?
Croatian: Koji su rizici povezani s VMP-om Contacera?
English: Since Contacera is a generic medicine, studies have been conducted to show that Contacera has the same characteristics as the reference medicine, Metacam.
Croatian: Budući da je Contacera generički veterinarsko-medicinski lijek, ispitivanja su provedena kako bi se dokazalo da Contacera ima iste karakteristike kao referentni veterinarsko-medicinski lijek, Metacam.
English: Contacera should not be used in pregnant or lactating mares but it can be used during pregnancy and lactation for cattle and pigs.
Croatian: Contacera se ne smije primjenjivati u gravidnih kobila ili kobila u laktaciji, no smije se primjenjivati u gravidnih goveda i svinja te goveda i svinja u laktaciji.
English: It can be used for diarrhoea in combination with oral re-hydration therapy (medicines given by mouth to restore water levels in the body) to reduce clinical signs of the disease in calves of over one week of age and young, non-lactating cattle.
Croatian: Može se primjenjivati u slučaju proljeva u kombinaciji s oralnom terapijom za rehidrataciju (VMP-ovi se primjenjuju peroralno kako bi se obnovile razine vode u tijelu) u svrhu smanjivanja kliničkih znakova bolesti u teladi u dobi od jednog tjedna i mlađih, te goveda u suhostaju.
English: Contacera is used in cattle, together with appropriate antibiotic therapy, to reduce clinical signs of disease in acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Croatian: Contacera se primjenjuje u goveda, zajedno s odgovarajućom antibiotskom terapijom u svrhu smanjivanja kliničkih znakova bolesti zbog akutne respiratorne infekcije (infekcije pluća i zračnih putova) te za liječenje akutnog mastitisa (upala vimeta).
English: It can be used for the relief of postoperative pain following dehorning in calves.
Croatian: Može se primjenjivati za ublažavanje boli nakon operativnog zahvata odrožnjavanja kod teladi.
English: In pigs, Contacera is used to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for supportive therapy together with appropriate antibiotic therapy in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Croatian: U svinja, Contacera se primjenjuje u neinfekcijskim poremećajima lokomotornog sustava (bolesti koje utječu na sposobnost kretanja) u svrhu smanjenja simptoma hromosti i upale, te za pomoćnu terapiju u liječenju bolesti koje nastupaju nakon prasenja (poroda) poput primjerice puerperalne septikemije i toksemije (sindrom mastitis-metritis-agalakcija) uz odgovarajuću antibiotsku terapiju.
English: What benefit has Contacera shown during the studies?
Croatian: Koje koristi VMP-a Contacera su utvrđene tijekom ispitivanja?
English: Based on the findings of the studies, Contacera was considered to be bioequivalent to the reference medicine.
Croatian: Na temelju nalaza ispitivanja, Contacera se smatra bioekvivaletnom referentnog veterinarskomedicinskog lijeka.
English: In horses, Contacera is used for the relief of pain associated with colic (abdominal pain) and for the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Croatian: U konja, Contacera se primjenjuje za ublažavanje bolova povezanih s kolikama, te za ublažavanje upale i olakšavanje bola u akutnim i kroničnim mišićno-koštanim poremećajima.
English: Information on the prescription status of this product may be found on the label of the carton.
Croatian: Informacije o tome je li za ovaj proizvod potreban veterinarski recept možete naći na etiketi/vanjskom dijelu pakiranja.
English: Contacera is a medicine that contains the active substance meloxicam.
Croatian: Contacera je veterinarsko-medicinski lijek koji sadrži djelatnu tvar meloksikam.
English: A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs.
Croatian: U goveda i svinja uočeno je blago privremeno oticanje u mjestu injekcije nakon injekcije ispod kože.
English: How has Contacera been studied?
Croatian: Kako se Contacera ispitivao?
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption.
Croatian: Karencija je razdoblje koje mora proći od primjene VMP-a do klanja životinje i korištenja mesa za ljudsku uporabu.
English: Consequently, Contacera's benefit is taken as being the same as that of the reference medicine.
Croatian: Stoga, se smatra da je korist od VMP-a Contacera jednaka koristi od referentnog VMP-a.
English: How does Contacera work?
Croatian: Na koji način Contacera djeluje?
English: The treatment will be repeated every 3 weeks.
Croatian: Liječenje će se ponoviti svaka 3 tjedna.
English: The possibility of genetic counselling should be considered.
Croatian: Treba razmotriti mogućnost genetskog savjetovanja.
English: The following information is intended for medical or healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo medicinskim ili zdravstvenim djelatnicima:
English: You should also drink water and eat high fibre foods.
Croatian: Također biste trebali piti vodu i jesti namirnice s visokim udjelom vlakana.
English: It is most unlikely that you will be asked to store this medicine yourself.
Croatian: Malo je vjerojatno da ćete morati sami pohraniti ovaj lijek.
English: Recent (within 2 weeks) or current severe infection.
Croatian: Nedavna (unutar 2 tjedna) ili trenutačna teška infekcija.
English: Javlor with food and drink
Croatian: Javlor s hranom i pićem
English: This is considered the most relevant population for the efficacy analysis, as it most closely reflects the population intended for treatment.
Croatian: Ovo se smatra najrelevantnijom populacijom za analizu djelotvornosti jer najbolje odražava populaciju namijenjenu za liječenje.
English: Genetic counselling is also recommended for patients wishing to have children after therapy.
Croatian: Genetsko savjetovanje preporučuje se i za bolesnice koje žele imati djecu nakon terapije.
English: Therefore, risks of clinically significant interactions should be unlikely.
Croatian: Zbog toga bi rizici klinički značajnih interakcija trebali biti malo vjerojatni.
English: Fatal if given by other routes.
Croatian: Smrtonosan ako se primjenjuje drugim putem.
English: However, this combination was associated with a particularly high risk of haematological toxicity.
Croatian: Međutim, ta je kombinacija bila povezana s osobito visokim rizikom od hematološke toksičnosti.
English: To avoid extravasations it is important to be sure that the needle is correctly introduced before starting the infusion.
Croatian: Da bi se izbjegle ekstravazacije, važno je biti siguran da je igla ispravno uvedena prije početka infuzije.
English: What Javlor is and what it is used for
Croatian: Što je Javlor i za što se koristi
English: First Event
Croatian: Prvi događaj
English: Javlor is not intended for use in children and adolescents.
Croatian: Javlor nije namijenjen za primjenu u djece i adolescenata.
English: Each pack contains 1 or 10 vials.
Croatian: Svako pakiranje sadrži 1 ili 10 bočica.
English: Date of first authorisation: 21 September 2009 Date of the latest renewal: 16 May 2014
Croatian: Datum posljednje obnove: 16. svibnja 2014
English: All resolved during the study.
Croatian: Svi slučajevi su se razriješili tijekom ispitivanja.
English: You should tell your doctor if you are drinking grapefruit juice since it may increase the effect of Javlor.
Croatian: Obavijestite liječnika ako pijete sok od grejpa jer on može pojačati učinak Javlora.
English: Used in children and adolescents
Croatian: Djeca i adolescenti
English: Overall 8 patients (0.6% of the treated population) died from infection as a complication occurring during neutropenia.
Croatian: Ukupno 8 bolesnika (0,6% liječene populacije) umrlo je od infekcije kao komplikacije koja se pojavila tijekom neutropenije.
English: All cases resolved rapidly without treatment discontinuation.
Croatian: Svi slučajevi brzo su nestali bez prekida liječenja.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before starting your therapy.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije početka terapije.
English: Other medicines and Javlor
Croatian: Drugi lijekovi i Javlor
English: Do not drive or use machines if you experience side effects that affect your ability to concentrate and react.
Croatian: Nemojte upravljati vozilima ili raditi sa strojevima ako primijetite nuspojave koje utječu na Vašu sposobnost koncentracije i reagiranja.
English: Vinflunine did not induce peripheral neuropathy in animals.
Croatian: Vinflunin nije inducirao perifernu neuropatiju u životinja.
English: You should not be given Javlor if you are pregnant, unless it is absolutely necessary.
Croatian: Ne biste trebali primati Javlor ako ste trudni, osim ako je to neophodno.
English: If pregnancy occurs during treatment, the patient should be informed about the risk for the unborn child and be monitored carefully.
Croatian: Ako tijekom liječenja dođe do trudnoće, bolesnicu treba informirati o riziku za nerođeno dijete i pažljivo je nadzirati.
English: Javlor must not be given intrathecally (into the spine).
Croatian: Javlor se ne smije davati intratekalno (u kralježnicu).
English: Javlor is for single use only.
Croatian: Javlor je samo za jednokratnu uporabu.
English: Vinflunine (mg/m²)
Croatian: Vinflunin (mg/m²)
English: What Javlor looks like and contents of the pack
Croatian: Kako Javlor izgleda i sadržaj pakiranja
English: 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 dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije uporabe odgovornost su korisnika i normalno ne bi trebali biti duži od 24 sata na temperaturi od 2°C do 8°C, osim ako se postupak razrjeđivanja nije proveo u kontroliranim i validiranim aseptičkim uvjetima.
English: However a statistically significant effect was seen on progression-free survival.
Croatian: Međutim, uočen je statistički značajan učinak na preživljenje bez progresije bolesti.
English: Storage conditions are detailed in the section intended for medicinal or heathcare professionals.
Croatian: Uvjeti čuvanja detaljno su opisani u dijelu namijenjenom medicinskim ili zdravstvenim djelatnicima.
English: Radiological signs are white matter abnormalities in the posterior regions of the brain.
Croatian: Radiološki znakovi su abnormalnosti bijele tvari u stražnjim dijelovima mozga.
English: Organ toxicity: moderate, severe or life threatening
Croatian: Toksičnost za organe: umjerena, teška ili opasna po život
English: The veins of the hand dorsum and those close to joints should be avoided.
Croatian: Treba izbjegavati vene nadlanice i one blizu zglobova.
English: - The other ingredient is water for injections.
Croatian: - Drugi sastojak je voda za injekcije.
English: During treatment, your doctor may reduce the dose of Javlor, delay or interrupt the treatment if you experience certain side effects.
Croatian: Tijekom liječenja liječnik može smanjiti dozu Javlora, odgoditi ili prekinuti liječenje ako ćete imati određene nuspojave.
English: On the basis of the results of animal studies and the pharmacological action of the medicinal product, there is a potential risk of embryonic and foetal abnormalities.
Croatian: Na temelju rezultata ispitivanja na životinjama i farmakološkog djelovanja lijeka postoji potencijalni rizik od abnormalnosti embrija i fetusa.
English: These toxic effects were dose-related and fully or-partially reversible following a 1-month recovery period.
Croatian: Ti toksični učinci bili su ovisni o dozi i potpuno ili djelomično reverzibilni nakon jednomjesečnog razdoblja oporavka.
English: Content of the pack and other information What Javlor contains
Croatian: Sadržaj pakiranja i druge informacije Što Javlor sadrži
English: Therefore, caution should be excercised when this type of combination is used.
Croatian: Stoga je potreban oprez prilikom primjene ove kombinacije.
English: EU/1/09/550/001 (box of 1 vial of 2 mL with grey stopper) EU/1/09/550/002 (box of 10 vials of 2 mL with grey stopper) EU/1/09/550/003 (box of 1 vial of 4 mL with grey stopper) EU/1/09/550/004 (box of 10 vials of 4 mL with grey stopper) EU/1/09/550/005 (box of 1 vial of 10 mL with grey stopper) EU/1/09/550/006 (box of 10 vials of 10 mL with grey stopper) EU/1/09/550/007 (box of 1 vial of 2 mL with black stopper) EU/1/09/550/008 (box of 10 vials of 2 mL with black stopper) EU/1/09/550/009 (box of 1 vial of 4 mL with black stopper) EU/1/09/550/010 (box of 10 vials of 4 mL with black stopper) EU/1/09/550/011 (box of 1 vial of 10 mL with black stopper) EU/1/09/550/012 (box of 10 vials of 10 mL with black stopper)
Croatian: EU/1/09/550/004 (kutija s 10 bočica od 4 mL sa sivim čepom) EU/1/09/550/005 (kutija s 1 bočicom od 10 mL sa sivim čepom) EU/1/09/550/006 (kutija s 10 bočica od 10 mL sa sivim čepom) EU/1/09/550/007 (kutija s 1 bočicom od 2 mL s crnim čepom) EU/1/09/550/008 (kutija s 10 bočica od 2 mL s crnim čepom) EU/1/09/550/009 (kutija s 1 bočicom od 4 mL s crnim čepom) EU/1/09/550/010 (kutija s 10 bočica od 4 mL s crnim čepom) EU/1/09/550/011 (kutija s 1 bočicom od 10 mL s crnim čepom) EU/1/09/550/012 (kutija s 10 bočica od 10 mL s crnim čepom)
English: One patient died after myocardial infarction and another one due to a cardiopulmonary arrest.
Croatian: Jedan je bolesnik umro nakon infarkta miokrada, a drugi zbog kardiopulmonarnog zastoja.
English: Store in a refrigerator (2°C-8°C).
Croatian: Čuvati u hladnjaku (2°C- 8°C).
English: Intrathecal administration of Javlor may be fatal.
Croatian: Intratekalna primjena Javlora može biti smrtonosna.
English: General precautions for preparation and administration.
Croatian: Opće mjere opreza za pripremu i primjenu.
English: In case of small or sclerosed veins, lymphoedema or recent venipuncture of the same vein, the use of a central catheter may be preferred.
Croatian: U slučaju malih ili sklerotičnih vena, limfedema ili nedavne venepunkcije iste vene, može se preferirati uporaba centralnog katetera.
English: The terminal volume of distribution is large, 2422±676 litres (about 35 l/kg) suggesting extensive distribution into tissues.
Croatian: Terminalni volumen distribucije je velik, 2422±676 litara (oko 35 l/kg), što upućuje na opsežnu distribuciju u tkiva.
English: If the solution comes into contact with the skin, this should be washed immediately and thoroughly with soap and water.
Croatian: Ako otopina dođe u doticaj s kožom, kožu treba odmah temeljito oprati sapunom i vodom.
English: Myocardial infarction or ischaemia were experienced by 0.5% of the patients and most of them had a pre-existing cardiovascular disease or risk factors.
Croatian: Infarkt miokarda ili ishemiju doživjelo je 0,5% bolesnika, a većina ih je prethodno imala kardiovaskularnu bolest ili faktore rizika.
English: In case of overdose, the patient should be kept in a specialised unit and vital functions should be closely monitored.
Croatian: U slučaju predoziranja bolesnika treba zadržati u specijaliziranoj jedinici i pomno nadzirati njegove vitalne funkcije.
English: No specific clinical studies of vinflunine in combination with these compounds have been carried out yet.
Croatian: Još nisu provedena specifična klinička ispitivanja vinflunina u kombinaciji s tim spojevima.
English: From a microbiological point of view, the product should be used immediately after dilution.
Croatian: S mikrobiološkog gledišta, lijek treba primijeniti odmah nakon razrjeđivanja.
English: Your blood cell counts will be checked regularly before and during your treatment, since low counts of blood cells is a very common side effect with Javlor.
Croatian: Vaša krvna slika redovito će se provjeravati prije i tijekom liječenja jer je niska razina krvnih stanica vrlo česta nuspojava primjene Javlora.
English: Javlor should be administered by a 20-minute intravenous infusion and NOT be given by rapid intravenous bolus.
Croatian: Javlor je potrebno primijeniti 20-minutnom intravenskom infuzijom, a NE ga davati kao brzi intravenski bolus.
English: The concomitant use of opioids could enhance the risk of constipation.
Croatian: Istodobna uporaba opioida mogla bi povećati rizik konstipacije.
English: The carcinogenic potential of vinflunine has not been studied.
Croatian: Karcinogeni potencijal vinflunina nije ispitivan.
English: This effect may lead to an increased risk of ventricular arrhythmias although no ventricular arrhythmias were observed with vinflunine.
Croatian: Ovaj učinak može dovesti do povećanog rizika od ventrikularnih aritmija iako kod primjene vinflunina nisu primijećene nikakve ventrikularne aritmije.
English: According to an in vitro study, such changes could be related to adsorption of vinflunine on the liposomes and a modified blood distribution of both compounds.
Croatian: Prema jednom in vitro ispitivanju, takve promjene mogu se povezati s adsorpcijom vinflunina na liposome i promijenjenom distribucijom obaju spojeva u krvi.
English: Clinical and radiological features usually resolved rapidly without sequelae after treatment discontinuation.
Croatian: Klinički i radiološki znakovi obično bi brzo nestali bez posljedica nakon prekida liječenja.
English: What you need to know before you use Javlor Do not use Javlor
Croatian: Što morate znati prije nego počnete primjenjivati Javlor
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja za stavljanje lijeka u promet će podnositi periodička izvješća o neškodljivosti za ovaj lijek u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.