FrancophonIA/ELRC3.0 huggingface dataset:
English: CMDh agreed with the PRAC's conclusion that there is no level of cow's milk proteins that can be considered safe for these medicines when used to treat severe allergic reactions.
Slovenian: Skupina CMDh se je strinjala z zaključkom odbora PRAC, da ne obstaja raven beljakovin kravjega mleka, ki bi jo pri teh zdravilih lahko šteli za varno za zdravljenje hudih alergijskih reakcij.
English: The review of these medicines was triggered following reports of serious allergic reactions such as bronchospasm (excessive contraction of the airway muscles causing breathing difficulty) and anaphylaxis (sudden severe allergic reaction) with these medicines in patients allergic to cow's milk proteins.
Slovenian: Pregled teh zdravil je bil sprožen po poročilih o resnih alergijskih reakcijah, kot sta bronhospazem (čezmerno krčenje dihalnih mišic, ki povzroči težave z dihanjem) in anafilaksijo (nenadno hudo alergijsko reakcijo) pri bolnikih, alergičnih na beljakovine kravjega mleka.
English: Methylprednisolone injections are used to treat the symptoms of severe allergic reactions and other inflammatory conditions.
Slovenian: Injekcije metilprednizolona se uporabljajo za zdravljenje simptomov hudih alergijskih reakcij in drugih vnetnih bolezni.
English: The review covered certain injectable medicines which contain the corticosteroid methylprednisolone and are used to treat the symptoms of severe allergic reactions and other inflammatory conditions.
Slovenian: Pregled je zajel nekatera zdravila v obliki injekcije, ki vsebujejo kortikosteroid metilprednizolon in se uporabljajo za zdravljenje simptomov hudih alergijskih reakcij in drugih vnetnih bolezni.
English: • Lactose of bovine origin is used as an excipient in some injectable methylprednisolone-containing products.
Slovenian: • Laktoza govejega izvora se uporablja kot pomožna snov v nekaterih zdravilih v obliki injekcije, ki vsebujejo metilprednizolon.
English: It is considered that allergic conditions, such as asthma exacerbation, may increase susceptibility to allergic reactions to cow's milk proteins in methylprednisolone products containing lactose of bovine origin.
Slovenian: Velja, da lahko alergijske reakcije, kot so poslabšanja astme, povečajo dovzetnost za alergijske reakcije na beljakovine kravjega mleka v zdravilih z metilprednizolonom, ki vsebujejo laktozo govejega izvora.
English: • Patients being treated for an allergic reaction with these products should have their treatment stopped if their symptoms worsen or they develop new symptoms as these could be signs of an allergic reaction to cow's milk proteins.
Slovenian: • Če se pri bolnikih, ki se zdravijo zaradi alergijske reakcije, simptomi poslabšajo ali se pojavijo novi simptomi, je treba zdravljenje s temi zdravili prekiniti, saj bi lahko šlo za znake alergijske reakcije na beljakovine kravjega mleka.
English: Specifically, the review covered the strengths of injections that contain lactose (milk sugar) derived from cows' milk and hence can contain traces of cows' milk proteins.
Slovenian: Pregled je bil osredotočen zlasti na jakosti injekcij, ki vsebujejo laktozo (mlečni sladkor), pridobljeno iz kravjega mleka, in bi zato lahko vsebovale sledove beljakovin kravjega mleka.
English: The CMDh1 has endorsed the recommendation of EMA's Pharmacovigilance Risk Assessment Committee (PRAC) that methylprednisolone injections containing lactose (milk sugar), which potentially contain traces of cow's milk proteins, must not be used in patients with a known or suspected allergy to the proteins in cow's milk.
Slovenian: Skupina CMDh1 je podprla priporočila Odbora za ocenjevanje tveganja na področju farmakovigilance (PRAC) pri agenciji EMA, da se injekcije metilprednizolona, ki vsebujejo laktozo (mlečni sladkor), ki bi lahko vsebovale sledove beljakovin kravjega mleka, ne smejo uporabljati pri bolnikih, ki imajo znano alergijo na beljakovine kravjega mleka ali pri katerih se sumi nanjo.
English: The review found that methylprednisolone injections containing lactose derived from cow's milk may also contain traces of cow's milk proteins which can trigger allergic reactions.
Slovenian: Pregled je pokazal, da bi lahko injekcije metilprednizolona, ki vsebujejo laktozo, vsebovale tudi sledove beljakovin kravjega mleka, ki lahko sprožijo alergijske reakcije.
English: • Methylprednisolone injections containing lactose of bovine origin are now contraindicated in patients known or suspected to be allergic to cow's milk proteins.
Slovenian: • Injekcije metilprednizolona, ki vsebujejo laktozo govejega izvora, so pri bolnikih, ki imajo ali bi lahko imeli alergijo na beljakovine kravjega mleka, zdaj kontraindicirane.
English: • If you are allergic to cow's milk proteins and you require methylprednisolone, your doctor will use a methylprednisolone medicine that does not contain lactose or use an alternative medicine.
Slovenian: • Če ste alergični na beljakovine kravjega mleka in potrebujete metilprednizolon, bo zdravnik uporabil zdravilo z metilprednizolonom, ki ne vsebuje laktoze, ali drugo zdravilo.
English: • If you are allergic or suspected to be allergic to the proteins in cow's milk, you must not receive methylprednisolone injections containing lactose.
Slovenian: • Če ste alergični na beljakovine kravjega mleka ali sumite, da bi nanje lahko bili alergični, ne smete prejemati injekcij metilprednizolona, ki vsebujejo laktozo.
English: • If you are being treated for an allergic reaction with these products and your symptoms worsen,
Slovenian: • Če se ta zdravila uporabljajo za zdravljenje alergijske reakcije in bi se vaši simptomi poslabšali, bo zdravnik zdravljenje prekinil.
English: • For patients allergic to cow's milk protein who require methylprednisolone, consider preparations that do not contain lactose or use alternative treatments.
Slovenian: • Pri bolnikih, alergičnih na beljakovine kravjega mleka, ki potrebujejo metilprednizolon, premislite o pripravkih, ki ne vsebujejo laktoze, ali uporabite drugo vrsto zdravljenja.
English: This is because these products could contain traces of cow's milk proteins, which can cause serious allergic reactions in patients allergic to cow's milk.
Slovenian: Ta zdravila bi namreč lahko vsebovala sledove beljakovin kravjega mleka, ki bi lahko pri bolnikih, alergičnih na kravje mleko, povzročile resne alergijske reakcije.
English: Companies have been asked to provide data allowing the replacement of formulations containing lactose from cow's milk; this data should be provided by the middle of 2019.
Slovenian: Družbe so bile zaprošene, da predložijo podatke, ki omogočajo zamenjavo formulacij, ki vsebujejo laktozo iz kravjega mleka.
English: CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins
Slovenian: Skupina CMDh je potrdila, da se injekcije metilprednizolona, ki vsebujejo laktozo, ne smejo dajati bolnikom, alergičnim na beljakovine kravjega mleka
English: These products may also contain trace amounts of milk proteins, which can trigger an allergic reaction in patients allergic to cow's milk proteins.
Slovenian: Ta zdravila lahko vsebujejo tudi sledove mlečnih beljakovin, ki lahko pri bolnikih, alergičnih na kravje mleko, sprožijo alergijsko reakcijo.
English: In the meantime, the product information will be revised to reflect that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins.
Slovenian: Do takrat bodo informacije o zdravilih spremenjene, in sicer tako, da bo vanje vključeno, da se injekcije metilprednizolona ne smejo dajati bolnikom, alergičnim na beljakovine kravjega mleka.
English: • Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow's milk proteins who were treated for acute allergic conditions with these medicines.
Slovenian: • Pri bolnikih, alergičnih na beljakovine kravjega mleka, ki so se zaradi akutnih alergijskih reakcij zdravili s temi zdravili, so poročali o resnih alergijskih reakcijah, vključno z bronhospazmom in anafilaksijo.
English: • Tell your doctor if you have or suspect you have an allergy to cow's milk proteins.
Slovenian: • Če imate alergijo na beljakovine kravjega mleka ali sumite, da bi jo lahko imeli, to povejte zdravniku.
English: and is different from lactose intolerance where the body cannot easily digest lactose.
Slovenian: • Alergija na beljakovine kravjega mleka prizadene majhen odstotek prebivalstva (do 3 osebe od 100) in se razlikuje od laktozne intolerance, pri kateri telo laktoze ne more zlahka prebaviti.
English: Tube (Alu) 60 g (0.1%)
Slovenian: 60g (0.1%)
English: EU number Invented name Strength Pharmaceutical formRoute of administration Packaging Content (concentration) Package size EU/1/00/149/001 Panretin
Slovenian: Ovojnina Vsebina (koncentracija) Velikost pakiranja
English: Cutaneous use
Slovenian: Panretin
English: Inactivated porcine parvovirus, strain NADL-2: RP* > 1.15, Inactivated Erysipelothrix rhusiopathiae, strain R32E11: ELISA > 3.34 IE50%**.
Slovenian: 125 odmer ki (250 ml).
English: Packaging Content Package size Withdrawal period
Slovenian: 1 stekleno vialo z 10 odmerki (20 ml)
English: * Relative potency (ELISA).
Slovenian: 10 odmerkov (20 ml)
English: In cattle, seven main studies were carried out.
Slovenian: Pri govedu so izvedli sedem glavnih študij.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Dicural on 16 January 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Dicural, veljavno po vsej Evropski uniji, odobrila dne 16. januarja 1998.
English: It is only used in calves and young cattle.
Slovenian: Uporablja se samo pri teletih in mlademu govedu.
English: These tend to disappear within one or two days and do not require additional treatment.
Slovenian: Neželeni učinki navadno izginejo v enem ali dveh dneh in ne potrebujejo dodatnega zdravljenja.
English: The itching tends to disappear within a few minutes and the swelling within a few days.
Slovenian: Srbenje navadno izgine v nekaj minutah, oteklina pa v nekaj dneh.
English: This includes small- and medium-sized breeds up to and including eight months of age, large breeds up to one year of age and giant breeds up to 18 months of age.
Slovenian: To vključuje majhne in srednje velike pasme do konca osmega meseca starosti, velike pasme do enega leta starosti in izredno velike pasme do 18 mesecev starosti.
English: It is available as an oral solution for chickens and turkeys (100 mg/ml), as tablets for dogs (15 mg, 50 mg, 100 mg and 150 mg), and as a solution for injection for cattle and dogs (50 mg/ml).
Slovenian: Na voljo je v obliki peroralne raztopine za piščance in purane (100 mg/ml), v obliki tablet za pse (15 mg, 50 mg, 100 mg in 150 mg) in kot raztopina za injiciranje za govedo in pse (50 mg/ml).
English: What benefit has Dicural shown during the studies?
Slovenian: Kakšne koristi je zdravilo Dicural izkazalo med študijami?
English: For both chickens and turkeys it is given in the drinking water for five days;
Slovenian: Tako piščancem kot puranom se daje v pitni vodi pet dni.
English: Dicural was as effective as or slightly more effective than the comparator antibiotics.
Slovenian: Zdravilo Dicural je bilo enako učinkovito ali malce učinkovitejše od primerjalnih antibiotikov.
English: What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Slovenian: Koliko časa mora preteči, preden se lahko žival zakolje in meso porabi za prehrano ljudi (obdobje karence)?
English: In all species, Dicural was effective in reducing the number of infected animals or reducing the severity of infection.
Slovenian: Zdravilo Dicural je bilo pri vseh živalskih vrstah učinkovito pri zniževanju števila okuženih živali ali pri zniževanju resnosti okužbe.
English: As for other fluoroquinolones, difloxacin should not be used in dogs that are growing quickly because it can affect the cartilage of some joints.
Slovenian: Od drugih fluorokinolonov se difloksacin ne sme uporabljati pri psih, ki hitro rastejo, ker lahko vpliva na hrustanec nekaterih sklepov.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Dicural are greater than the risks for the treatment and recommended that Dicural be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Dicural pri zdravljenju večje od z njim povezanih tveganj, in priporočil da se za zdravilo Dicural odobri dovoljenje za promet.
English: Other information about Dicural:
Slovenian: Druge informacije o zdravilu Dicural:
English: Dicural is used to treat infections caused by bacteria:
Slovenian: Zdravilo Dicural se uporablja za zdravljenje okužb, ki jih povzročajo bakterije:
English: For full details, see the Summary of Product Characteristics (SPC, also part of the EPAR).
Slovenian: Za vse podrobnosti glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: In chickens and turkeys, nine main trials have been carried out in birds with respiratory system infections.
Slovenian: Pri piščancih in puranih so izvedli devet glavnih preskušanj, ki so vključevala ptice z okužbami dihal.
English: What is the risk associated with Dicural?
Slovenian: Kakšna tveganja so povezana z zdravilom Dicural?
English: After the last administration of Dicural, chickens and turkeys should not be slaughtered for 24 hours and cattle should not be slaughtered for 46 days.
Slovenian: Po zadnjem danem odmerku zdravila Dicural se piščancev in puranov ne sme zaklati 24 ur, goveda pa 46 dni.
English: It is given as tablets by mouth once a day for at least five days until the infection has been cured.
Slovenian: Daje se v obliki tablet enkrat dnevno najmanj pet dni, dokler se okužba ne pozdravi.
English: On the first day of treatment, it can be given by injection under the skin before switching to the tablets;
Slovenian: Prvi dan zdravljenja se zdravilo lahko injicira pod kožo, preden se preide na uporabo tablet.
English: People who are hypersensitive (allergic) to quinolones (a group of antibiotics that includes the fluoroquinolones) should avoid any contact with Dicural.
Slovenian: Osebe, ki so preobčutljive za (alergične na) kinolone (skupino antibiotikov, ki vključuje fluorokinolone), naj se izogibajo vsakršnemu stiku z zdravilom Dicural.
English: What is Dicural used for?
Slovenian: Za kaj se zdravilo Dicural uporablja?
English: Difloxacin works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Slovenian: Difloksacin deluje tako, da zavira encim „DNK giraza“, ki je pomemben, ker bakterijam omogoča, da kopirajo svojo DNK.
English: Dicural must not be used in birds producing eggs for human consumption or within four weeks before the onset of the laying period.
Slovenian: Zdravilo Dicural se ne sme uporabiti pri pticah v obdobju nesnosti, katerih jajca so namenjena prehrani ljudi, ali štiri tedne pred začetkom obdobja nesnosti.
English: In dogs, side effects from Dicural are rare, but include loss of appetite, vomiting, diarrhoea and anal irritation.
Slovenian: Pri psih so neželeni učinki zdravila Dicural redki, vendar vključujejo zmanjšanje apetita, bruhanje, drisko in iritacijo anusa.
English: Injection of Dicural solution for injection under the skin may result in some itching, local swelling and slight pain.
Slovenian: Injiciranje zdravila Dicural v obliki raztopine za injiciranje pod kožo lahko povzroči nekaj srbenja, lokalnega otekanja in rahlo bolečino.
English: Why has Dicural been approved?
Slovenian: Zakaj je bilo zdravilo Dicural odobreno?
English: However, since no studies have been performed in lame birds, Dicural must not be used in birds with existing leg weakness or osteoporosis (brittle bones).
Slovenian: Ker pa študij niso izvajali pri šepavih pticah, se zdravilo Dicural ne sme uporabljati pri pticah z obolenjem nog ali osteoporozo (krhke kosti).
English: When handling Dicural oral solution for chickens and turkeys, use gloves and a face-protecting device to avoid irritation of the skin or eyes.
Slovenian: Pri ravnanju z zdravilom Dicural v obliki peroralne raztopine za piščance in purane je treba uporabljati rokavice ter zaščitno obrazno masko, da bi se izognili draženju kože ali oči.
English: Dicural must not be used in epileptic dogs.
Slovenian: Zdravilo Dicural se ne sme uporabljati pri psih, ki imajo epilepsijo.
English: In dogs, four main trials looked at the effects of Dicural in treating bladder infections.
Slovenian: Pri psih so v štirih glavnih preskušanjih opazovali učinke zdravila Dicural na zdravljenje okužb sečnega mehurja.
English: Dicural contains the active substance difloxacin, which is an antibiotic.
Slovenian: Zdravilo Dicural vsebuje zdravilno učinkovino difloksacin, ki je antibiotik.
English: Two of these studies compared Dicural with enrofloxacin and one compared it with the combination of amoxicillin and clavulanic acid (used together as an antibiotic).
Slovenian: V dveh od teh študij so primerjali zdravilo Dicural z enrofloksacinom, v eni pa so zdravilo primerjali s kombinacijo amoksicilina in klavulanske kisline (skupaj sta se uporabljala kot antibiotik).
English: In chickens and turkeys, no side effects from Dicural are known.
Slovenian: Pri piščancih in puranih ni znanih neželenih učinkov zdravila Dicural.
English: Dicural is given once a day for up to five days as an injection under the skin.
Slovenian: Zdravilo Dicural se daje enkrat dnevno do pet dni z injiciranjem pod kožo.
English: The active substance in Dicural, difloxacin, belongs to a group of antibiotics called ‘fluoroquinolones'.
Slovenian: Zdravilna učinkovina zdravila Dicural je difloksacin, ki spada v skupino antibiotikov, imenovanih „fluorokinoloni“.
English: In cattle, injection of Dicural solution for injection under the skin may result in some temporary swelling at the site of the injection.
Slovenian: Pri govedu lahko injiciranje zdravila Dicural v obliki raztopine za injiciranje pod kožo začasno povzroči otekanje na mestu injiciranja.
English: • in cattle, Dicural is used to treat infections affecting the lungs and breathing (shipping fever and calf pneumonia).
Slovenian: • Pri govedu se zdravilo Dicural uporablja za zdravljenje okužb, ki vplivajo na pljuča in dihanje (transportna mrzlica in pljučnica pri teletih).
English: One of these trials compared Dicural-treated birds with untreated birds, and another compared Dicural with enrofloxacin (another veterinary fluoroquinolone).
Slovenian: V enem od teh preizkušanj so ptice, zdravljene z zdravilom Dicural, primerjali z nezdravljenimi pticami, v drugi pa so zdravilo Dicural primerjali z enrofloksacinom (drugim fluorokinolonom, ki se uporablja v veterinarski medicini).
English: All seven studies compared Dicural with enrofloxacin in calves.
Slovenian: V vseh sedmih študijah so primerjali zdravilo Dicural z enrofloksacinom pri teletih.
English: By blocking the production of DNA, difloxacin stops the bacteria that are causing an infection from growing and multiplying.
Slovenian: Difloksacin z zavrtjem tvorjenja DNK zaustavi rast in razmnoževanje bakterij, ki povzročajo okužbo.
English: A further three trials looked at its effects in treating pyoderma: two compared it with enrofloxacin and one compared it with amoxicillin and clavulanic acid.
Slovenian: V ostalih treh preskušanjih so opazovali učinke zdravila pri zdravljenju pioderme: v dveh preskušanjih so zdravilo primerjali z enrofloksacinom, v enem pa so ga primerjali z amoksicilinom in klavulansko kislino.
English: • in dogs, Dicural is used to treat acute (short-lived) infections of the bladder and to treat pyoderma (a skin infection with a rash and raised lumps).
Slovenian: • Pri psih se zdravilo Dicural uporablja za zdravljenje akutnih (kratkotrajnih) okužb sečnega mehurja in za zdravljenje pioderme (okužba kože z izpuščajem in dvignjenimi bulicami).
English: How does Dicural work?
Slovenian: Kako zdravilo Dicural deluje?
English: How has Dicural been studied?
Slovenian: Kako je bilo zdravilo Dicural raziskano?
English: The full list of bacteria against which Dicural is active can be found in the SPC.
Slovenian: Za celoten seznam bakterij, proti katerim deluje zdravilo Dicural, glejte povzetek glavnih značilnosti zdravila.
English: • in chickens and turkeys, Dicural is used to treat certain infections affecting the respiratory system (lungs and air sacs).
Slovenian: • Pri piščancih in puranih se zdravilo Dicural uporablja za zdravljenje nekaterih okužb, ki vplivajo na dihala (pljuča in pljučne mešičke), zdravilo Dicural se uporablja samo pri mladih puranih do 2 kg telesne mase.
English: What is Dicural?
Slovenian: Kaj je zdravilo Dicural?
English: Small bubbles may still be visible.
Slovenian: Majhni mehurčki bodo morda še vedno vidni.
English: There may be new information.
Slovenian: Morda bodo vsebovala nove informacije.
English: • properly labelled to warn of hazardous waste inside the container.
Slovenian: • ki je ustrezno označen, da opozarja na nevarne odpadke v vsebniku.
English: • 2 alcohol wipes
Slovenian: • 2 alkoholna robčka
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: Use a new pen instead.
Slovenian: Namesto tega uporabite nov peresnik.
English: Do not throw it away.
Slovenian: Ne zavrzite ga.
English: This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).
Slovenian: To je lahko nevarno v okoliščinah, v katerih sta ti zmožnosti posebno pomembni (npr. pri vožnji avtomobila ali upravljanju strojev).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {DD month YYYY}
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: <{DD. mesec LLLL}
English: Store in a refrigerator (2°C-8°C).
Slovenian: Shranjujte v hladilniku (2°C-8°C).
English: Do not use it after this time period.
Slovenian: Po tem času jih ne uporabljajte več.
English: The safety and efficacy of Semglee have not been established.
Slovenian: Varnost in učinkovitost zdravila Semglee nista raziskani.
English: Most minor reactions to insulins usually disappear in a few days to a few weeks.
Slovenian: Večina manjših reakcij na insuline po navadi izgine v nekaj dneh do nekaj tednih.
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Slovenian: Nekatera zdravila povzročijo spremembe koncentracije krvnega sladkorja (znižanje ali zvišanje ali oboje, odvisno od okoliščin).
English: • Do not try to fix an unusable or damaged pen.
Slovenian: • Ne poskušajte popraviti neuporabnega ali poškodovanega injekcijskega peresnika.
English: F - Repeat steps 3B through 3E up to three more times until you see drops of insulin at the tip of the needle.
Slovenian: F - Ponovite korake od 3B do 3E še do trikrat, dokler ne zagledate kapljic insulina na konici igle.
English: You need one injection of Semglee every day, at the same time of the day.
Slovenian: Vsak dan potrebujete eno injekcijo zdravila Semglee ob istem času dneva.
English: United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 This leaflet was last revised in {month YYYY}.
Slovenian: United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 Navodilo je bilo nazadnje revidirano dne {mesec LLLL}.
English: Do not apply lubricants such as oil.
Slovenian: Ne nanašajte maziv, kot je olje.
English: Required supplies:
Slovenian: Potrebni pripomočki:
English: The following graph shows the results from a study in patients: Activity profile in patients with type 1 diabetes
Slovenian: Spodnji graf prikazuje rezultate študije pri bolnikih: Potek delovanja pri bolnikih z diabetesom tipa 1
English: Your doctor will show you in which area of the skin you should inject Semglee.
Slovenian: Zdravnik vam bo pokazal, v kateri predel kože injicirajte zdravilo Semglee.