FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not try to replace the cap on the retracted needle.
Slovenian: Ne skušajte ponovno namestiti pokrovčka, ko je igla že umaknjena v notranjost brizge.
English: Influenza like illness Peripheral swelling Injection site discolouration
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija mrazenje reakcije na mestu injiciranja periferni edem bolezen, podobna gripi periferno otekanje sprememba barve mesta injiciranja
English: Discontinuation of Inotersen should be considered in patients who develop liver transplant rejection during treatment.
Slovenian: Pri bolnikih, pri katerih med zdravljenjem pride do zavrnitve presajenih jeter, je treba razmisliti o prenehanju zdravljenja z inotersenom.
English: SC
Slovenian: TTR
English: This summary was last updated in December 2013.
Slovenian: Povzetek je bil nazadnje posodobljen decembra 2013.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Contacera on 6 December 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Contacera, veljavno po vsej Evropski uniji, izdala 6. decembra 2012.
English: Other information about Contacera:
Slovenian: Druge informacije o zdravilu Contacera:
English: Contacera meloxicam
Slovenian: Contacera meloksikam
English: Symptoms were reversible.
Slovenian: Simptomi so bili prehodne narave.
English: If someone accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately.
Slovenian: Če se zdravilo nenamerno injicira, se je treba takoj posvetovati z zdravnikom.
English: What benefit has Contacera shown during the studies?
Slovenian: Kakšne koristi je zdravilo Contacera izkazalo med študijami?
English: It is available as a solution for injection (20 mg/ml) and an oral suspension (15 mg/ml).
Slovenian: Na voljo je v obliki raztopine za injiciranje (20 mg/ml) in peroralne suspenzije (15 mg/ml).
English: In horses, a temporary swelling at the injection site can occur but resolves without intervention.
Slovenian: Pri konjih se lahko pojavi prehodna oteklina na mestu injiciranja, vendar uplahne brez ukrepanja.
English: What is the risk associated with Contacera?
Slovenian: Kakšna tveganja so povezana z zdravilom Contacera?
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.
Slovenian: Zdravilo se ne sme uporabljati pri konjih, mlajših od šest tednov, ali govedu, mlajšemu od enega tedna, kadar se ta uporablja za zdravljenje driske.
English: Contacera is a ‘generic', which means that Contacera is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Slovenian: Zdravilo Contacera je generično zdravilo, kar pomeni, da je podobno referenčnemu veterinarskemu zdravilu, ki je že odobreno v EU (zdravilu Metacam).
English: Why has Contacera been approved?
Slovenian: Zakaj je bilo zdravilo Contacera odobreno?
English: It must not be used in animals which are hypersensitive (allergic) to the active substance or to any of the other ingredients.
Slovenian: Ne sme se uporabljati pri živalih, ki so preobčutljive za (alergične na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
English: Consequently, Contacera's benefit is taken as being the same as that of the reference medicine.
Slovenian: Zato velja, da so njegove koristi enake kot pri referenčnem zdravilu.
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.
Slovenian: Zato je menil, da so njegove koristi tako kot pri zdravilu Metacam večje od z njim povezanih tveganj pri uporabi za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
English: For meat the withdrawal period is 15 days and for milk it is five days.
Slovenian: Karenca za meso je 15 dni, za mleko pa pet dni.
English: Contacera contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Slovenian: Zdravilo Contacera vsebuje meloksikam, ki spada v skupino zdravil, imenovanih nesteroidna protivnetna zdravila (NSAID).
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.
Slovenian: Po injiciranju se lahko v zelo redkih primerih pojavijo možne resne ali smrtne anafilaktične reakcije (podobne hudim alergijskim reakcijam), ki jih je treba zdraviti simptomatsko.
English: For meat the withdrawal period is five days.
Slovenian: Karenca za meso je pet dni.
English: It is also the time allowed after administration of the medicine before the milk can be used for human consumption.
Slovenian: Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
English: People who are hypersensitive to NSAIDs should avoid contact with Contacera.
Slovenian: Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom Contacera.
English: Contacera is a medicine that contains the active substance meloxicam.
Slovenian: Contacera je zdravilo, ki vsebuje zdravilno učinkovino meloksikam.
English: The product is not authorised for use in horses producing milk for human consumption.
Slovenian: Zdravilo ni odobreno za uporabo pri konjih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
English: The CVMP considered that, in accordance with European Union requirements, Contacera has been shown to be bioequivalent to Metacam.
Slovenian: CVMP je menil, da je bilo dokazano, da je zdravilo Contacera v skladu z zahtevami Evropske unije biološko enakovredno zdravilu Metacam.
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.
Slovenian: Pri uporabi raztopine za injiciranje 20 mg/ml je karenca za meso pet dni, pri uporabi peroralne suspenzije 15 mg/ml pa tri dni.
English: Information on the prescription status of this product may be found on the label of the carton.
Slovenian: Podatki o predpisovanju tega zdravila so navedeni na nalepki na zunanji ovojnini.
English: How has Contacera been studied?
Slovenian: Kako je bilo zdravilo Contacera raziskano?
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.
Slovenian: Zdravilo Contacera se ne sme uporabljati pri živalih, ki imajo težave z jetri, srcem ali ledvicami, motnje strjevanja krvi, razdražena prebavila ali razjede v prebavilih.
English: It can be used for the relief of postoperative pain following dehorning in calves.
Slovenian: Lahko se uporablja tudi za lajšanje bolečin po kirurški odstranitvi rogov pri teletih.
English: What is Contacera used for?
Slovenian: Za kaj se zdravilo Contacera uporablja?
English: Contacera should not be used in pregnant or lactating mares but it can be used during pregnancy and lactation for cattle and pigs.
Slovenian: Zdravilo Contacera se ne sme uporabljati pri brejih ali doječih kobilah, lahko pa se v obdobju brejosti uporablja pri govedu in prašičih.
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.
Slovenian: Karenca je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
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.
Slovenian: Uporablja se lahko tudi pri driski v kombinaciji s peroralno rehidracijo (zdravili, ki jih žival zaužije za vzpostavitev ustrezne ravni vode v telesu) za zmanjševanje kliničnih znakov bolezni pri teletih, starejših od enega tedna, ter pri mladem govedu zunaj obdobja laktacije.
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).
Slovenian: Pri prašičih se zdravilo Contacera uporablja za ublažitev simptomov šepavosti in vnetij pri neinfekcijskih boleznih gibal (boleznih, ki vplivajo na zmožnost gibanja) ter pri zdravljenju bolezni po oprasitvi, kot sta puerperalna septikemija in toksemija (sindrom mastitis-metritis-agalactia), skupaj z ustreznim antibiotičnim zdravljenjem.
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).
Slovenian: Zdravilo Contacera se pri govedu uporablja skupaj z ustreznim antibiotičnim zdravljenjem za zmanjšanje kliničnih bolezenskih znakov pri akutni okužbi dihal (okužbi pljuč in dihalnih poti) in za zdravljenje mastitisa (vnetja vimena).
English: Based on the findings of the studies, Contacera was considered to be bioequivalent to the reference medicine.
Slovenian: V študijah je bilo ugotovljeno, da je zdravilo Contacera biološko enakovredno referenčnemu zdravilu.
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.
Slovenian: Pri konjih se zdravilo Contacera uporablja za lajšanje bolečin, povezanih s kolikami (trebušnimi bolečinami) ter vnetja in bolečin pri akutnih in kroničnih kostno-mišičnih obolenjih.
English: Since Contacera is a generic medicine, studies have been conducted to show that Contacera has the same characteristics as the reference medicine, Metacam.
Slovenian: Ker je zdravilo Contacera generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Metacam.
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).
Slovenian: Pri dajanju peroralne suspenzije konjem so se pojavili neželeni učinki, ki so značilni za nesteroidna protivnetna zdravila (blažja urtikarija, driska).
English: What is Contacera?
Slovenian: Kaj je zdravilo Contacera?
English: A slight temporary swelling at the injection site following injection under the skin was observed in cattle and pigs.
Slovenian: Pri govedu in prašičih so opazili blago prehodno oteklino na mestu injiciranja v podkožje.
English: How does Contacera work?
Slovenian: Kako zdravilo Contacera deluje?
English: The treatment will be repeated every 3 weeks.
Slovenian: Zdravljenje se ponovi vsake 3 tedne.
English: Therefore, risks of clinically significant interactions should be unlikely.
Slovenian: Zato tveganje klinično pomembnih interakcij ni verjetno.
English: Unopened vial 3 years.
Slovenian: Neodprta viala 3 leta.
English: Recent (within 2 weeks) or current severe infection.
Slovenian: Nedavna (v zadnjih 2 tednih) ali potekajoča huda okužba.
English: The use of gloves, goggles and protective clothing is recommended.
Slovenian: Priporočamo uporabo zaščitnih rokavic, zaščitnih očal in zaščitnih oblačil.
English: All cases resolved rapidly without treatment discontinuation.
Slovenian: Vsi primeri so izzveneli hitro brez prekinitve zdravljenja.
English: First Event
Slovenian: Prvi dogodek
English: This is considered the most relevant population for the efficacy analysis, as it most closely reflects the population intended for treatment.
Slovenian: Ta se šteje za najbolj pomembno populacijo za analizo učinkovitosti, saj najbolj odraža populacijo, ki se lahko zdravi.
English: Therefore, caution should be excercised when this type of combination is used.
Slovenian: Zato je pri uporabi tovrstnih kombinacij potrebna previdnost.
English: Date of first authorisation: 21 September 2009 Date of the latest renewal: 16 May 2014
Slovenian: Datum prve odobritve: 09/2009 Datum zadnjega podaljšanja: 05/2014
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
English: Genetic counselling is also recommended for patients wishing to have children after therapy.
Slovenian: Genetsko posvetovanje je priporočljivo za bolnike, ki želijo imeti otroke po zdravljenju.
English: The carcinogenic potential of vinflunine has not been studied.
Slovenian: Karcinogeni potencial vinflunina ni bil preučen.
English: Used in children and adolescents
Slovenian: Uporaba pri otrocih in mladostnikih
English: Javlor with food and drink
Slovenian: Zdravilo Javlor skupaj s hrano in pijačo
English: Store in a refrigerator.
Slovenian: Zdravilo shranjujte v hladilniku.
English: Other appropriate measures should be taken, such as blood transfusions, administration of antibiotics and growth factors.
Slovenian: Uvesti je treba druge ustrezne ukrepe, kot so transfuzije krvi, dajanje antibiotikov in rastnih faktorjev.
English: You should tell your doctor if you are drinking grapefruit juice since it may increase the effect of Javlor.
Slovenian: Zdravniku povejte, če pijete sok grenivk, ker lahko poveča učinek zdravila Javlor
English: You should also drink water and eat high fibre foods.
Slovenian: Piti morate vodo in uživati živila z visoko vsebnostjo vlaknin.
English: Procedure for proper handling and disposal of anticancer medicinal products should be considered.
Slovenian: Upoštevati morate postopek za pravilno ravnanje in odstranjevanje zdravil proti raku.
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)
Slovenian: EU/1/09/550/001 (škatla z 1 vialo z 2 ml s sivim zamaškom) EU/1/09/550/002 (škatla z 10 vialami po 2 ml s sivim zamaškom) EU/1/09/550/003 (škatla z 1 vialo s 4 ml s sivim zamaškom) EU/1/09/550/004 (škatla z 10 vialami po 4 ml s sivim zamaškom) EU/1/09/550/005 (škatla z 1 vialo z 10 ml s sivim zamaškom) EU/1/09/550/006 (škatla z 10 vialami po 10 ml s sivim zamaškom) EU/1/09/550/007 (škatla z 1 vialo z 2 ml s črnim zamaškom) EU/1/09/550/008 (škatla z 10 vialami po 2 ml s črnim zamaškom) EU/1/09/550/009 (škatla z 1 vialo s 4 ml s črnim zamaškom) EU/1/09/550/010 (škatla z 10 vialami po 4 ml s črnim zamaškom) EU/1/09/550/011 (škatla z 1 vialo z 10 ml s črnim zamaškom) EU/1/09/550/012 (škatla z 10 vialami po 10 ml s črnim zamaškom)
English: All resolved during the study.
Slovenian: V vseh primerih je stanje izzvenelo med študijo.
English: Vinflunine did not induce peripheral neuropathy in animals.
Slovenian: Vinflunin ni induciral periferne nevropatije pri živalih.
English: Each pack contains 1 or 10 vials.
Slovenian: Pakiranje vsebuje 1 ali 10 vial.
English: Radiological signs are white matter abnormalities in the posterior regions of the brain.
Slovenian: Radiološki znaki so nepravilnosti v beli možganovini zadnjih regij možganov.
English: To avoid extravasations it is important to be sure that the needle is correctly introduced before starting the infusion.
Slovenian: Za preprečevanje ekstravazacij je pomembno, da se pred začetkom infundiranja prepričate, ali je igla pravilno vstavljena.
English: No specific clinical studies of vinflunine in combination with these compounds have been carried out yet.
Slovenian: Specifične klinične študije vinflunina v kombinaciji s tema spojinama niso bile opravljene.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP.
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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: There are no data available on the use of vinflunine in pregnant women.
Slovenian: Nosečnost Ni podatkov o uporabi vinflunina pri nosečnicah.
English: These toxic effects were dose-related and fully or-partially reversible following a 1-month recovery period.
Slovenian: Ti toksični učinki so bili odvisni od odmerka ter popolnoma ali delno reverzibilni po enomesečnem obdobju okrevanja.
English: Vinflunine should therefore not be used during pregnancy, unless it is strictly necessary.
Slovenian: Zato vinflunina ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: If the solution comes into contact with the skin, this should be washed immediately and thoroughly with soap and water.
Slovenian: Če raztopina pride v stik s kožo, morate ta predel kože nemudoma in temeljito umiti z milom in vodo.
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.
Slovenian: Na osnovi rezultatov študij na živalih in farmakološkega delovanja zdravila obstaja potencialno tveganje nenormalnosti zarodka in plodu.
English: In case of overdose, the patient should be kept in a specialised unit and vital functions should be closely monitored.
Slovenian: V primeru prevelikega odmerjanja mora biti bolnik v specializirani enoti z natančnim spremljanjem življenjskih funkcij.
English: The terminal volume of distribution is large, 2422±676 litres (about 35 l/kg) suggesting extensive distribution into tissues.
Slovenian: Terminalni volumen porazdelitve je velik, tj. 2422±676 litrov (približno 35 l/kg), kar nakazuje obsežno porazdelitev v tkivih.
English: Javlor must not be given intrathecally (into the spine).
Slovenian: Zdravilo Javlor se ne sme dajati intratekalno (v hrbtenico).
English: Efficacy and safety of vinflunine have not been studied in patients with performance status ≥ 2.
Slovenian: Učinkovitost in varnost vinflunina nista bili preučeni pri bolnikih s telesno zmogljivostjo ≥ 2.
English: Studies in animals have shown embryotoxicity and teratogenicity (see section 5.3).
Slovenian: Študije na živalih so pokazale embriotoksičnost in teratogenost (glejte poglavje 5.3).
English: Organ toxicity: moderate, severe or life threatening
Slovenian: Na posamezen organ usmerjena toksičnost: zmerna, huda, življenjsko nevarna
English: Javlor is not intended for use in children and adolescents.
Slovenian: Zdravilo Javlor ni namenjeno zdravljenju otrok in mladostnikov.
English: One patient died after myocardial infarction and another one due to a cardiopulmonary arrest.
Slovenian: En bolnik je umrl po miokardnem infarktu, en bolnik pa zaradi kardiopulmonalnega zastoja.
English: Other medicines and Javlor
Slovenian: Druga zdravila in zdravilo Javlor
English: - No dose adjustment is necessary in patients:
Slovenian: - Prilagoditev odmerka ni potrebna:
English: If pregnancy occurs during treatment, the patient should be informed about the risk for the unborn child and be monitored carefully.
Slovenian: Če med zdravljenjem bolnica zanosi, jo je treba obvestiti o tveganju za nerojenega otroka in natančno spremljati.
English: What Javlor is and what it is used for What you need to know before you use Javlor How to use Javlor
Slovenian: Kaj je zdravilo Javlor in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Javlor Kako uporabljati zdravilo Javlor
English: Hematological toxicity
Slovenian: Hematološka toksičnost
English: In vitro studies showed that vinflunine had neither inducing effects on CYP1A2, CYP2B6 or CYP3A4 activity nor inhibition effects on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Slovenian: V študijah in vitro so ugotovili, da vinflunin ne inducira aktivnosti CYP1A2, CYP2B6 ali CYP3A4, niti ne zavira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4.
English: The possibility of genetic counselling should be considered.
Slovenian: Lahko se opravi tudi genetsko posvetovanje.
English: - The other ingredient is water for injections.
Slovenian: - Pomožna snov je voda za injekcije.
English: This effect may lead to an increased risk of ventricular arrhythmias although no ventricular arrhythmias were observed with vinflunine.
Slovenian: Ta učinek lahko povzroči večje tveganje ventrikularnih aritmij, čeprav pri uporabi vinflunina teh niso opazili.
English: These medicines affect cancer cell growth by stopping cell division, leading to cell death (cytotoxicity).
Slovenian: Ta zdravila vplivajo na rast rakastih celic s prekinitvijo delitve celic, kar povzroči uničenje celic (citotoksičnost).
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.
Slovenian: V študiji in vitro so ugotovili, da so takšne spremembe morda povezane z adsorpcijo vinflunina na liposome in z modificiranim porazdeljevanjem obeh spojin v krvi.
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.
Slovenian: V primerih majhnih ali sklerotičnih ven, limfedema ali nedavne venipunkcije v isti veni je priporočena uporaba centralnega katetra.
English: Respiratory, thoracic and mediastinal disorders Dyspnoea occurred in 3.2% of the patients but was rarely severe (Grade 3/4: 1.2%).
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Pri 3,2 % bolnikov se je pojavila dispneja, ki pa je bila v redkih primerih huda (stopnja 3/4: 1,2 %).
English: Javlor will be given to you by a qualified healthcare professional as an intravenous infusion (drip into your vein) lasting 20 minutes.
Slovenian: Zdravilo Javlor vam bo dal usposobljen zdravstveni delavec v obliki intravenske infuzije (zdravilo gre direktno v veno), ki traja 20 minut.
English: Storage conditions are detailed in the section intended for medicinal or heathcare professionals.
Slovenian: Pogoji shranjevanja so podrobno opisani v poglavju, namenjenem zdravstvenemu osebju.
English: According to the population pharmacokinetic analysis, neither gender nor performance status (ECOG score) had an impact on vinflunine clearance which is directly proportional to body surface area.
Slovenian: V populacijski farmakokinetični analizi so ugotovili, da niti spol niti zmogljivost (rezultat po lestvici ECOG) ne vplivata na očistek vinflunina, ki je neposredno sorazmeren s površino telesa.
English: The concomitant use of opioids could enhance the risk of constipation.
Slovenian: Sočasna uporaba opioidov lahko poveča tveganje zaprtosti.
English: Men and women with reproductive potential must use an effective method of contraception during the treatment and up to 3 months after the last vinflunine administration (see section 4.6).
Slovenian: Moški in ženske v reproduktivni dobi morajo med zdravljenjem uporabljati učinkovito metodo kontracepcije in do 3 mesece po zadnjem odmerku vinflunina (glejte poglavje 4.6).
English: Pregnant staff should not handle Javlor.
Slovenian: Nosečnice ne smejo delati z zdravilom Javlor.