natgillin/translations-raw huggingface dataset:
The review of injectable medicines for acute allergic reaction that contain lactose from cows' milk was initiated on 1 December 2016 at the request of Croatia, under Article 31 of Directive 2001/83/EC.
Pregled zdravil v obliki injekcije za akutne alergijske reakcije, ki vsebujejo laktozo iz kravjega mleka, se je začel 1. decembra 2016 na zahtevo Hrvaške, v skladu s členom 31 Direktive 2001/83/ES.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj v zvezi z zdravili za uporabo v humani medicini, in podal več priporočil.
The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position.
Priporočila odbora PRAC so bila poslana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela stališče.
This may lead to additional doses being given which will further worsen the patient's condition.
To bi lahko privedlo do tega, da bi bolnik prejel dodatne odmerke, kar bi njegovo stanje še poslabšalo.
This is of particular concern in patients already being treated for an allergic reaction as they are more prone to developing new allergic reactions.
To je zlasti zaskrbljujoče pri bolnikih, ki se že zdravijo zaradi alergijske reakcije, saj so dovzetnejši za pojav novih alergijskih reakcij.
1 The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) is a medicines regulatory body representing the European Union (EU) Member States, as well as Iceland, Liechtenstein and Norway.
1 Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), Islandijo, Lihtenštajn in Norveško.
Current formulations containing lactose will be replaced with lactose-free formulations
Trenutne formulacije, ki vsebujejo laktozo, bodo nadomestile formulacije brez laktoze
• Companies have been asked to take steps by 2019 to replace current formulations containing lactose with lactose-free formulations.
• Družbe so bile zaprošene, da do leta 2019 izvedejo ukrepe za zamenjavo trenutnih formulacij, ki vsebujejo laktozo, s formulacijami brez laktoze.
Methylprednisolone-containing medicines have been authorised by national procedures for use by injection into a vein or muscle and have been available for many years in the EU under a variety of brand names including Solu-Medrol.
Zdravila, ki vsebujejo metilprednizolon, so bila po nacionalnih postopkih odobrena za injiciranje v veno ali mišico in so že mnogo let na voljo v EU pod različnimi tržnimi imeni, vključno z imenom Solu-Medrol.
Corticosteroids are anti-inflammatory medicines used to control the immune system (the body's natural defences) when it is overactive, as in allergic conditions.
Kortikosteroidi so protivnetna zdravila, ki se uporabljajo za nadzor imunskega sistema (naravne obrambe telesa), kadar je preveč dejaven, npr. pri alergijskih boleznih.
In this case it may be difficult to determine whether the patient's symptoms are due to a new allergic reaction caused by methylprednisolone products containing lactose or due to a worsening of the original condition.
V tem primeru bi lahko bilo težko ugotoviti, ali so se simptomi pri bolniku pojavili zaradi nove alergijske reakcije, ki so jo povzročila zdravila z metilprednizolonom, ki vsebujejo laktozo, ali zaradi poslabšanja prvotne bolezni.
Considering that methylprednisolone is used for the treatment of severe allergic reactions in an emergency setting where details of the patients' allergies may not always be known, the CMDh confirmed that the most effective way of minimising any risks is to remove cow's milk proteins from the preparation.
Ob upoštevanju, da se metilprednizolon uporablja za zdravljenje hudih alergijskih reakcij v nujnih primerih, kadar podatki o alergijah pri bolniku niso vedno znani, je skupina CMDh potrdila, da je najučinkovitejši način zmanjšanja tveganja odstranitev beljakovin kravjega mleka iz pripravka.
In some of the reported cases the adverse reaction was misinterpreted as a lack of therapeutic effect, leading to re-administration of methylprednisolone and subsequent worsening of the patient's clinical condition.
V nekaterih primerih, o katerih so poročali, so neželeni učinek zmotno razložili kot odsotnost terapevtskega učinka, kar je privedlo do ponovnega dajanja metilprednizolona in nadaljnjega poslabšanja kliničnega stanja bolnika.
CMDh further confirmed that patients being treated with methylprednisolone for an allergic reaction should have their treatment stopped if their symptoms worsen or they develop new symptoms.
Skupina CMDh je poleg tega potrdila, da je treba zdravljenje bolnikov, pri katerih z metilprednizolonom zdravijo alergijsko reakcijo, prekiniti, če se njihovi simptomi poslabšajo ali se razvijejo novi simptomi.
In addition, the vial and packaging of these medicines will be clearly marked with a warning against use in patients with cow's milk allergy.
Poleg tega bo na viali in embalaži teh zdravil jasno označeno opozorilo o prepovedi uporabe pri bolnikih z alergijo na kravje mleko.
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.
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.
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.
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.
Methylprednisolone injections are used to treat the symptoms of severe allergic reactions and other inflammatory conditions.
Injekcije metilprednizolona se uporabljajo za zdravljenje simptomov hudih alergijskih reakcij in drugih vnetnih bolezni.
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.
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.
• Lactose of bovine origin is used as an excipient in some injectable methylprednisolone-containing products.
• Laktoza govejega izvora se uporablja kot pomožna snov v nekaterih zdravilih v obliki injekcije, ki vsebujejo metilprednizolon.
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.
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.
• 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.
• 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.
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.
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.
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.
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.
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.
Pregled je pokazal, da bi lahko injekcije metilprednizolona, ki vsebujejo laktozo, vsebovale tudi sledove beljakovin kravjega mleka, ki lahko sprožijo alergijske reakcije.
• Methylprednisolone injections containing lactose of bovine origin are now contraindicated in patients known or suspected to be allergic to cow's milk proteins.
• Injekcije metilprednizolona, ki vsebujejo laktozo govejega izvora, so pri bolnikih, ki imajo ali bi lahko imeli alergijo na beljakovine kravjega mleka, zdaj kontraindicirane.
• 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.
• Če ste alergični na beljakovine kravjega mleka in potrebujete metilprednizolon, bo zdravnik uporabil zdravilo z metilprednizolonom, ki ne vsebuje laktoze, ali drugo zdravilo.
• If you are allergic or suspected to be allergic to the proteins in cow's milk, you must not receive methylprednisolone injections containing lactose.
• Če ste alergični na beljakovine kravjega mleka ali sumite, da bi nanje lahko bili alergični, ne smete prejemati injekcij metilprednizolona, ki vsebujejo laktozo.
• If you are being treated for an allergic reaction with these products and your symptoms worsen,
• Če se ta zdravila uporabljajo za zdravljenje alergijske reakcije in bi se vaši simptomi poslabšali, bo zdravnik zdravljenje prekinil.
• For patients allergic to cow's milk protein who require methylprednisolone, consider preparations that do not contain lactose or use alternative treatments.
• Pri bolnikih, alergičnih na beljakovine kravjega mleka, ki potrebujejo metilprednizolon, premislite o pripravkih, ki ne vsebujejo laktoze, ali uporabite drugo vrsto zdravljenja.
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.
Ta zdravila bi namreč lahko vsebovala sledove beljakovin kravjega mleka, ki bi lahko pri bolnikih, alergičnih na kravje mleko, povzročile resne alergijske reakcije.
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.
Družbe so bile zaprošene, da predložijo podatke, ki omogočajo zamenjavo formulacij, ki vsebujejo laktozo iz kravjega mleka.
CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins
Skupina CMDh je potrdila, da se injekcije metilprednizolona, ki vsebujejo laktozo, ne smejo dajati bolnikom, alergičnim na beljakovine kravjega mleka
These products may also contain trace amounts of milk proteins, which can trigger an allergic reaction in patients allergic to cow's milk proteins.
Ta zdravila lahko vsebujejo tudi sledove mlečnih beljakovin, ki lahko pri bolnikih, alergičnih na kravje mleko, sprožijo alergijsko reakcijo.
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.
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.
• 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.
• 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.
• Tell your doctor if you have or suspect you have an allergy to cow's milk proteins.
• Če imate alergijo na beljakovine kravjega mleka ali sumite, da bi jo lahko imeli, to povejte zdravniku.
and is different from lactose intolerance where the body cannot easily digest lactose.
• 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.
EU number Invented name Strength Pharmaceutical formRoute of administration Packaging Content (concentration) Package size EU/1/00/149/001 Panretin
Ovojnina Vsebina (koncentracija) Velikost pakiranja
Inactivated porcine parvovirus, strain NADL-2: RP* > 1.15, Inactivated Erysipelothrix rhusiopathiae, strain R32E11: ELISA > 3.34 IE50%**.
125 odmer ki (250 ml).
Packaging Content Package size Withdrawal period
1 stekleno vialo z 10 odmerki (20 ml)
* Relative potency (ELISA).
10 odmerkov (20 ml)
In cattle, seven main studies were carried out.
Pri govedu so izvedli sedem glavnih študij.
The European Commission granted a marketing authorisation valid throughout the European Union, for Dicural on 16 January 1998.
Evropska komisija je dovoljenje za promet z zdravilom Dicural, veljavno po vsej Evropski uniji, odobrila dne 16. januarja 1998.
It is only used in calves and young cattle.
Uporablja se samo pri teletih in mlademu govedu.
These tend to disappear within one or two days and do not require additional treatment.
Neželeni učinki navadno izginejo v enem ali dveh dneh in ne potrebujejo dodatnega zdravljenja.
The itching tends to disappear within a few minutes and the swelling within a few days.
Srbenje navadno izgine v nekaj minutah, oteklina pa v nekaj dneh.
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.
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.
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).
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).
What benefit has Dicural shown during the studies?
Kakšne koristi je zdravilo Dicural izkazalo med študijami?
For both chickens and turkeys it is given in the drinking water for five days;
Tako piščancem kot puranom se daje v pitni vodi pet dni.
Dicural was as effective as or slightly more effective than the comparator antibiotics.
Zdravilo Dicural je bilo enako učinkovito ali malce učinkovitejše od primerjalnih antibiotikov.
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Koliko časa mora preteči, preden se lahko žival zakolje in meso porabi za prehrano ljudi (obdobje karence)?
In all species, Dicural was effective in reducing the number of infected animals or reducing the severity of infection.
Zdravilo Dicural je bilo pri vseh živalskih vrstah učinkovito pri zniževanju števila okuženih živali ali pri zniževanju resnosti okužbe.
As for other fluoroquinolones, difloxacin should not be used in dogs that are growing quickly because it can affect the cartilage of some joints.
Od drugih fluorokinolonov se difloksacin ne sme uporabljati pri psih, ki hitro rastejo, ker lahko vpliva na hrustanec nekaterih sklepov.
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.
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.
Other information about Dicural:
Druge informacije o zdravilu Dicural:
Dicural is used to treat infections caused by bacteria:
Zdravilo Dicural se uporablja za zdravljenje okužb, ki jih povzročajo bakterije:
For full details, see the Summary of Product Characteristics (SPC, also part of the EPAR).
Za vse podrobnosti glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
In chickens and turkeys, nine main trials have been carried out in birds with respiratory system infections.
Pri piščancih in puranih so izvedli devet glavnih preskušanj, ki so vključevala ptice z okužbami dihal.
What is the risk associated with Dicural?
Kakšna tveganja so povezana z zdravilom Dicural?
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.
Po zadnjem danem odmerku zdravila Dicural se piščancev in puranov ne sme zaklati 24 ur, goveda pa 46 dni.
It is given as tablets by mouth once a day for at least five days until the infection has been cured.
Daje se v obliki tablet enkrat dnevno najmanj pet dni, dokler se okužba ne pozdravi.
On the first day of treatment, it can be given by injection under the skin before switching to the tablets;
Prvi dan zdravljenja se zdravilo lahko injicira pod kožo, preden se preide na uporabo tablet.
People who are hypersensitive (allergic) to quinolones (a group of antibiotics that includes the fluoroquinolones) should avoid any contact with Dicural.
Osebe, ki so preobčutljive za (alergične na) kinolone (skupino antibiotikov, ki vključuje fluorokinolone), naj se izogibajo vsakršnemu stiku z zdravilom Dicural.
What is Dicural used for?
Za kaj se zdravilo Dicural uporablja?
Difloxacin works by blocking an enzyme called ‘DNA gyrase', which is important in allowing bacteria to make copies of their DNA.
Difloksacin deluje tako, da zavira encim „DNK giraza“, ki je pomemben, ker bakterijam omogoča, da kopirajo svojo DNK.
Dicural must not be used in birds producing eggs for human consumption or within four weeks before the onset of the laying period.
Zdravilo Dicural se ne sme uporabiti pri pticah v obdobju nesnosti, katerih jajca so namenjena prehrani ljudi, ali štiri tedne pred začetkom obdobja nesnosti.
In dogs, side effects from Dicural are rare, but include loss of appetite, vomiting, diarrhoea and anal irritation.
Pri psih so neželeni učinki zdravila Dicural redki, vendar vključujejo zmanjšanje apetita, bruhanje, drisko in iritacijo anusa.
Injection of Dicural solution for injection under the skin may result in some itching, local swelling and slight pain.
Injiciranje zdravila Dicural v obliki raztopine za injiciranje pod kožo lahko povzroči nekaj srbenja, lokalnega otekanja in rahlo bolečino.
Why has Dicural been approved?
Zakaj je bilo zdravilo Dicural odobreno?
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).
Ker pa študij niso izvajali pri šepavih pticah, se zdravilo Dicural ne sme uporabljati pri pticah z obolenjem nog ali osteoporozo (krhke kosti).
When handling Dicural oral solution for chickens and turkeys, use gloves and a face-protecting device to avoid irritation of the skin or eyes.
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.
Dicural must not be used in epileptic dogs.
Zdravilo Dicural se ne sme uporabljati pri psih, ki imajo epilepsijo.
In dogs, four main trials looked at the effects of Dicural in treating bladder infections.
Pri psih so v štirih glavnih preskušanjih opazovali učinke zdravila Dicural na zdravljenje okužb sečnega mehurja.
Dicural contains the active substance difloxacin, which is an antibiotic.
Zdravilo Dicural vsebuje zdravilno učinkovino difloksacin, ki je antibiotik.
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).
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).
In chickens and turkeys, no side effects from Dicural are known.
Pri piščancih in puranih ni znanih neželenih učinkov zdravila Dicural.
Dicural is given once a day for up to five days as an injection under the skin.
Zdravilo Dicural se daje enkrat dnevno do pet dni z injiciranjem pod kožo.
The active substance in Dicural, difloxacin, belongs to a group of antibiotics called ‘fluoroquinolones'.
Zdravilna učinkovina zdravila Dicural je difloksacin, ki spada v skupino antibiotikov, imenovanih „fluorokinoloni“.
In cattle, injection of Dicural solution for injection under the skin may result in some temporary swelling at the site of the injection.
Pri govedu lahko injiciranje zdravila Dicural v obliki raztopine za injiciranje pod kožo začasno povzroči otekanje na mestu injiciranja.
• in cattle, Dicural is used to treat infections affecting the lungs and breathing (shipping fever and calf pneumonia).
• Pri govedu se zdravilo Dicural uporablja za zdravljenje okužb, ki vplivajo na pljuča in dihanje (transportna mrzlica in pljučnica pri teletih).
One of these trials compared Dicural-treated birds with untreated birds, and another compared Dicural with enrofloxacin (another veterinary fluoroquinolone).
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).
All seven studies compared Dicural with enrofloxacin in calves.
V vseh sedmih študijah so primerjali zdravilo Dicural z enrofloksacinom pri teletih.
By blocking the production of DNA, difloxacin stops the bacteria that are causing an infection from growing and multiplying.
Difloksacin z zavrtjem tvorjenja DNK zaustavi rast in razmnoževanje bakterij, ki povzročajo okužbo.
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.
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.
• 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).
• Pri psih se zdravilo Dicural uporablja za zdravljenje akutnih (kratkotrajnih) okužb sečnega mehurja in za zdravljenje pioderme (okužba kože z izpuščajem in dvignjenimi bulicami).
How does Dicural work?
Kako zdravilo Dicural deluje?
How has Dicural been studied?
Kako je bilo zdravilo Dicural raziskano?
The full list of bacteria against which Dicural is active can be found in the SPC.
Za celoten seznam bakterij, proti katerim deluje zdravilo Dicural, glejte povzetek glavnih značilnosti zdravila.