FrancophonIA/ELRC3.0 huggingface dataset:
English: The withdrawal period for meat is five days for the 20 mg/ml solution for injection and three days for the granules in sachet and 15 mg/ml oral suspension.
Slovenian: Karenca za meso je pet dni pri uporabi raztopine za injiciranje v odmerku 20 mg/ml ter tri dni pri uporabi zrnc v vrečkah in peroralne suspenzije v odmerku 15 mg/ml.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Rheumocam has been shown to have comparable quality and to be bioequivalent to Metacam.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Rheumocam primerljivo raven kakovosti in je biološko enakovredno zdravilu Metacam.
English: Other information about Rheumocam
Slovenian: Druge informacije o zdravilu Rheumocam
English: This means that Rheumocam contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Slovenian: To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot referenčno zdravilo Metacam, ki je že odobreno v Evropski uniji (EU).
English: What is Rheumocam and what is it used for?
Slovenian: Kaj je zdravilo Rheumocam in za kaj se uporablja?
English: It can be used as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Slovenian: Lahko se uporablja kot podporna terapija pri zdravljenju akutnega mastitisa (vnetja vimena) v kombinaciji z antibiotiki.
English: For further information about using Rheumocam, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Rheumocam glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: Because Rheumocam is a generic and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Rheumocam generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: It is also the time required after administration of the medicine before milk may be used for human consumption.
Slovenian: Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Rheumocam, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: Rheumocam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Slovenian: Zdravilo Rheumocam vsebuje meloksikam, ki spada v skupino zdravil, ki jim pravimo nesteroidna protivnetna zdravila (NSAID).
English: The precautions are the same as for the reference medicine since Rheumocam is a generic medicine.
Slovenian: Previdnostni ukrepi so enaki kot pri referenčnem zdravilu, saj je zdravilo Rheumocam generično zdravilo.
English: The formulation to use depends on the animal and the condition being treated.
Slovenian: Uporabljena formulacija je odvisna od živali in vrste bolezni, ki se zdravi.
English: Moreover, it is used to lessen inflammation and pain in acute and chronic musculo-skeletal disorders.
Slovenian: Poleg tega se uporablja tudi za zmanjšanje vnetja in bolečin pri akutnih in kroničnih kostno-mišičnih obolenjih.
English: In cattle, Rheumocam is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways).
Slovenian: Pri govedu se zdravilo Rheumocam uporablja skupaj z ustreznim antibiotičnim zdravljenjem za zmanjšanje kliničnih znakov akutne okužbe dihal (okužbe pljuč in dihalnih poti).
English: Rheumocam contains the active substance meloxicam and is a generic medicine.
Slovenian: Zdravilo Rheumocam vsebuje učinkovino meloksikam in je generično zdravilo.
English: The withdrawal period is the time required after administration of the medicine before an 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: In pigs, Rheumocam is used to reduce lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move), for the relief of post-operative pain after minor soft tissue surgery such as castration, 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 Rheumocam uporablja za zmanjšanje šepavosti in vnetja pri neinfekcijskih lokomotornih motnjah (boleznih, ki prizadenejo gibalne sposobnosti živali), za lajšanje bolečin po manjših kirurških posegih na mehkih tkivih, kot je npr. kastracija, in kot podporna terapija v kombinaciji z ustreznimi antibiotiki pri zdravljenju bolezni po oprasitvi (kotitvi mladičev), kot so puerperalna septikemija in toksemija (sindrom mastitis-metritis-agalaktija).
English: Therefore the Agency's view was that, as for Metacam, the benefits of Rheumocam, outweigh the identified risks and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Rheumocam enako kot pri zdravilu Metacam odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: Since Rheumocam is a generic medicine, studies have been conducted to determine that it is bioequivalent to the reference medicine, Metacam.
Slovenian: Ker je zdravilo Rheumocam generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Metacam.
English: How has Rheumocam been studied?
Slovenian: Kako je bilo zdravilo Rheumocam raziskano?
English: In horses, Rheumocam is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Slovenian: Pri konjih se zdravilo Rheumocam uporablja za lajšanje bolečin, povezanih s koliko (trebušnih bolečin), ter zmanjšanje vnetja in lajšanje bolečin pri akutnih in kroničnih kostno-mišičnih obolenjih (obolenjih, ki prizadenejo mišice in kosti).
English: Rheumocam is available as granules, an oral (taken by mouth) suspension, chewable tablets and a solution for injection.
Slovenian: Zdravilo Rheumocam je na voljo v obliki zrnc, peroralne suspenzije, žvečljivih tablet in raztopine za injiciranje.
English: How does Rheumocam work?
Slovenian: Kako zdravilo Rheumocam deluje?
English: In dogs, Rheumocam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Slovenian: Pri psih se zdravilo Rheumocam uporablja za lajšanje pooperativne bolečine in vnetja po ortopedskih kirurških posegih (npr. kirurškem posegu zaradi zloma kosti) in kirurških posegih na mehkih tkivih.
English: In cats, Rheumocam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery.
Slovenian: Pri mačkah se zdravilo Rheumocam uporablja za lajšanje pooperativne bolečine in vnetja po ovariohisterektomiji (odstranitvi rodil), ortopedskih kirurških posegih in kirurških posegih na mehkih tkivih.
English: How is Rheumocam used?
Slovenian: Kako se zdravilo Rheumocam uporablja?
English: Rheumocam can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: This summary was last updated in: 04-2013.
Slovenian: Ta povzetek je bil nazadnje posodobljen: 04-2013.
English: Specific interactions were not investigated.
Slovenian: Posameznih medsebojnih učinkovanj niso preiskovali.
English: The product can be administered with or without food for up to 12 months.
Slovenian: Zdravilo lahko dajete z ali brez hrane do 12 mesecev.
English: Dirlotapide
Slovenian: Dirlotapid
English: It is available in three pack sizes; 20 ml, 50 ml and 150 ml and supplied with appropriate dosing devices.
Slovenian: Na razpolago je v treh vrstah pakiranja; po 20 ml, 50 ml in 150 ml, in vključuje ustrezen pripomoček za odmerjanje.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Slentrol on 13.04.2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Slentrol, veljavno po vsej Evropski uniji, odobrila dne 13.04.2007.
English: Slentrol has been studied in a large number of dogs in both laboratory and field trials for up to one year.
Slovenian: Zdravilo Slentrol so raziskali pri velikemu številu psov tako v laboratorijskih kot terenskih preizkušanjih v trajanju do enega leta.
English: Other information about Slentrol:
Slovenian: Druge informacije o zdravilu Slentrol:
English: This veterinary medicine has been developed especially for dogs and is not for use in humans.
Slovenian: To veterinarsko zdravilo je namenjeno samo za pse in ni za uporabo pri ljudeh.
English: The dogs also received other medicines during the study as required, such as anti-inflammatory drugs (including NSAIDs), antimicrobials, parasiticides, vaccines, dietary supplements, vitamins, hormones and cardiovascular drugs.
Slovenian: Psi so med študijo po potrebi prejemali tudi druga zdravila, kakršna so protivnetna zdravila (vključno z NSAID), protimikrobna zdravila, sredstva proti parazitom, cepiva, dodatke k prehrani, vitamine, hormone ter zdravila za srce in ožilje.
English: The medicine is administered to the dog for 2 weeks, and after the first 2 weeks the veterinarian will double the initial dose for a further 2 weeks.
Slovenian: Zdravilo se daje psom 2 tedna, nato pa veterinar začetni odmerek podvoji in uporabo podaljša še za nadaljnja 2 tedna.
English: Information on the prescription status of this product may be found on the label/outer package.
Slovenian: Podatke o predpisovanju tega zdravila najdete na notranji/zunanji ovojnini.
English: If accidental skin or eye contact occurs, flush immediately with lots of water.
Slovenian: Če pride do nenamernega stika s kožo ali očmi, nemudoma izperite z obilico vode.
English: What benefit has Slentrol shown during the studies?
Slovenian: Kakšne koristi je zdravilo Slentrol izkazalo med raziskavami?
English: The weight lowering effect was up to 20 % after 6 months of therapy in the initial weight loss phase of treatment.
Slovenian: Učinek nižanja telesne teže je po šestih mesecih v začetni fazi zdravljenja prekomerne telesne teže znašal do 20 %.
English: The active substance in Slentrol, dirlotapide, works in the gut by blocking a protein (the microsomal triglyceride transfer protein).
Slovenian: Zdravilna učinkovina v zdravilu Slentrol, dirlotapid, deluje v črevesju, kjer blokira določeno beljakovino (mikrosomske prenašalne beljakovine za trigliceride).
English: If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Slovenian: Če nenamerno zaužijete to zdravilo, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko.
English: It is to be used as part of an overall weight management programme which also includes appropriate dietary changes and exercise practice.
Slovenian: Zdravilo se uporablja kot del celotnega programa uravnavanja telesne teže, ki vključuje tudi ustrezne spremembe prehranjevalnih navad in razgibavanje.
English: What is the risk associated with Slentrol?
Slovenian: Kakšna tveganja so povezana z zdravilom Slentrol?
English: Some dogs received Slentrol while the remainder received the medicine with the active substance removed (control group).
Slovenian: Nekateri psi so prejemali zdravilo Slentrol, preostali pa so prejemali zdravilo brez zdravilne učinkovine (kontrolna skupina).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Slentrol excede the risks for the management of overweight and obesity in adult dogs and recommended that Slentrol be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila Slentrol pri uravnavanju prekomerne telesne teže in debelosti psov večje od tveganj, zato priporoča odobritev dovoljenja za promet z zdravilom Slentrol.
English: Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once every 20 days on average).
Slovenian: Pri nekaterih psih (manj kot 10 %) je prišlo do večkratnega bruhanja (t.j.
English: Slentrol at the recommended dose of 5 mg/ml and using the recommended treatment schedule reduced body weight in obese dogs when compared to the control group.
Slovenian: Zdravilo Slentrol je pri priporočenem odmerku velikosti 5 mg/ml in ob upoštevanju priporočenega urnika zdravljenja znižalo telesno težo prekomerno težkih psov v primerjavi s kontrolno skupino.
English: Slentrol is an oral solution, colourless to pale yellow in colour.
Slovenian: Zdravilo Slentrol je brezbarvna do bledo rumena peroralna raztopina.
English: Following these initial 4 weeks of therapy, dogs should be weighed monthly during treatment with the product and dose adjustments are made monthly according to the weight loss achieved.
Slovenian: Po končanih začetnih 4 tednih bi morali pse med zdravljenjem s tem zdravilom tehtati vsak mesec in v skladu z ugotovljeno telesno težo vsak mesec tudi prilagoditi odmerek zdravila.
English: How has Slentrol been studied?
Slovenian: Kako je bilo zdravilo Slentrol raziskano?
English: Slentrol contains the active substance dirlotapide which helps to reduce weight in dogs.
Slovenian: Zdravilo Slentrol vsebuje zdravilno učinkovino dirlotapid, ki pripomore k zniževanju telesne teže psov.
English: For a full list of all side-effects reported with Slentrol, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Slentrol, glejte Navodilo za uporabo.
English: The treatment is an initial measure in an obesity management programme; it has to be combined with changes in diet, which must be continued after treatment is finished.
Slovenian: Zdravilo je treba kombinirati s spremembo prehranjevalnih navad, s tem pa je treba nadaljevati tudi po zaključku zdravljenja.
English: Two large field trials were conducted, one in Europe and one in the USA, in healthy dogs which had a bodyweight higher than recommended.
Slovenian: Na zdravih psih, katerih telesna teža je bila višja od priporočene, so opravili dve veliki preizkušanji na terenu, enega v Evropi, drugega pa v ZDA.
English: Certain medications, e.g. drugs that lower serum cholesterol or other serum lipids, or drugs that affect appetite and/or body weight, e.g. long-acting glucorticoids, were not permitted for use during the study.
Slovenian: Med študijo ni bila dovoljena uporaba nekaterih zdravil, npr. tistih, ki nižajo serumski holesterol oziroma druge serumske maščobe ali zdravila, ki vplivajo na tek in/ali telesno maso, kakršni so npr. dolgotrajno delujoči glukokortikoidi.
English: What is Slentrol used for?
Slovenian: Za kaj se zdravilo Slentrol uporablja?
English: Vomiting, sometimes accompanied by signs of lethargy, diarrhoea or softened faeces may occur during treatment.
Slovenian: Med zdravljenjem lahko pride do bruhanja, ki ga včasih spremljajo znaki zaspanosti, driska ali mehko blato.
English: This protein is normally involved in the absorption of fats from the diet. By blocking the protein Slentrol decreases the absorption of fats from the gut and this change in fat absorption has an appetite suppressant effect.
Slovenian: Z zaviranjem beljakovine zdravilo Slentrol zniža absorpcijo maščob iz črevesja, ta sprememba pa potlači tek.
English: What is Slentrol?
Slovenian: Kaj je zdravilo Slentrol?
English: Rebound weight gain was seen after treatment was completed.
Slovenian: Po koncu zdravljenja so opazili ponovno večanje telesne teže.
English: Slentrol is used in adult dogs that are overweight or obese, to help them lose weight.
Slovenian: Zdravilo Slentrol se uporablja za zniževanje telesne teže odraslih psov, ki imajo prekomerno telesno težo oziroma so debeli.
English: The majority of the weight loss occurs as a result of appetite suppression.
Slovenian: Zaradi potlačenega teka psi izgubijo največji del telesne teže.
English: It is available as capsules (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).
Slovenian: Na voljo je v obliki kapsul (5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg).
English: The name of the medicine was changed to Temozolomide Accord on 27 May 2015.
Slovenian: Ime zdravila je bilo spremenjeno v Temozolomide Accord 27. maja 2015.
English: The full EPAR for Temozolomide Accord can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Temozolomide Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Temozolomide Accord is used first with radiotherapy and then on its own;
Slovenian: Zdravilo Temozolomide Accord se najprej uporabi skupaj z radioterapijo, nato pa samostojno;
English: The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Hospira on 15 March 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Temozolomide Hospira, veljavno po vsej Evropski uniji, izdala 15. marca 2010.
English: This means that Temozolomide Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Temodal.
English: For more information about treatment with Temozolomide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Temozolomide Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Temozolomide Accord.
English: Temozolomide Accord is a ‘generic medicine'.
Slovenian: Temozolomide Accord je „generično zdravilo“.
English: Temozolomide Accord should be taken without food.
Slovenian: Zdravilo Temozolomide Accord je treba jemati brez hrane.
English: Temozolomide Accord is used to treat malignant glioma (brain tumours) in the following groups of patients:
Slovenian: Zdravilo Temozolomide Accord se uporablja za zdravljenje malignih gliomov (možganskih tumorjev) pri naslednjih skupinah bolnikov:
English: 1 Previously known as Temozolomide Hospira.
Slovenian: 1 Prej znano kot Temozolomide Hospira.
English: Treatment with Temozolomide Accord should be prescribed by a doctor with experience in the treatment of brain tumours.
Slovenian: Zdravljenje z zdravilom Temozolomide Accord mora predpisati zdravnik, ki ima izkušnje z zdravljenjem možganskih tumorjev.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Temozolomide Accord.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Temozolomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Temozolomide Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Accord has been shown to have comparable quality and to be bioequivalent to Temodal.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Temozolomide Accord primerljivo raven kakovosti kot zdravilo Temodal ter mu je biološko enakovredno.
English: Other information about Temozolomide Accord:
Slovenian: Druge informacije o zdravilu Temozolomide Accord:
English: Temozolomide Accord temozolomide
Slovenian: Temozolomide Accord temozolomid
English: What are the benefit and risk of Temozolomide Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Temozolomide Accord?
English: Because Temozolomide Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Slovenian: Ker je zdravilo Temozolomide Accord generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Temodal.
English: Temozolomide Accord is used on its own in these patients.
Slovenian: Pri teh bolnikih se zdravilo Temozolomide Accord uporablja samostojno.
English: The active substance in Temozolomide Accord, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Slovenian: Zdravilna učinkovina zdravila Temozolomide Accord, temozolomid, spada v skupino zdravil proti raku, imenovanih alkilirajoči citostatiki.
English: Temozolomide Accord is a cancer medicine that contains the active substance temozolomide.
Slovenian: Temozolomide Accord je zdravilo proti raku, ki vsebuje zdravilno učinkovino temozolomid.
English: The dose of Temozolomide Accord depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Slovenian: Odmerek zdravila Temozolomide Accord je odvisen od telesne površine (izračunane glede na telesno višino in maso bolnika) in sega od 75 do 200 mg na kvadratni meter, enkrat na dan. Odmerek in število odmerkov sta odvisna od vrste zdravljenega tumorja ter od tega, ali je bil bolnik že zdravljen, ali se zdravilo Temozolomide Accord uporablja samostojno ali skupaj z drugimi zdravljenji in kako se bolnik odziva na zdravljenje.
English: Why has Temozolomide Accord been approved?
Slovenian: Zakaj je bilo zdravilo Temozolomide Accord odobreno?
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Accord.
Slovenian: Preden bo bolnik vzel zdravilo Temozolomide Accord, bo morda potreboval tudi zdravilo za preprečevanje bruhanja.
English: How has Temozolomide Accord been studied?
Slovenian: Kako je bilo zdravilo Temozolomide Accord raziskano?
English: What is Temozolomide Accord used for?
Slovenian: Za kaj se zdravilo Temozolomide Accord uporablja?
English: What is Temozolomide Accord?
Slovenian: Kaj je zdravilo Temozolomide Accord?
English: How does Temozolomide Accord work?
Slovenian: Kako zdravilo Temozolomide Accord deluje?
English: How is Temozolomide Accord used?
Slovenian: Kako se zdravilo Temozolomide Accord uporablja?
English: The Committee recommended that Temozolomide Accord be given marketing authorisation.
Slovenian: Zato je menil, da tako kot pri zdravilu Temodal koristi odtehtajo znana tveganja in priporočil, da se za zdravilo Temozolomide Accord izda dovoljenje za promet.
English: Date of first authorisation: 15 January 2015 Date of latest renewal: 03 September 2019
Slovenian: Datum prve odobritve: 15. januar 2015 Datum zadnjega podaljšanja: 03. september 2019
English: You may see a small air bubble, which is normal.
Slovenian: Morda lahko vidite majhen zračni mehurček, kar je normalno.
English: Your doctor will decide if and when you may restart the treatment.
Slovenian: Zdravnik bo določil če in kdaj lahko ponovno začnete z zdravljenjem.