natgillin/translations-raw huggingface dataset:
The reference medicine was Prednisolone 5 mg soluble tablets by Sovereign.
Referenčno zdravilo je bilo zdravilo Prednisolone 5 mg tablete za peroralno raztopino družbe Sovereign.
The grounds for the referral were that sufficient data had not been provided to show that Okrido produces comparable levels of the active substance in the body to Prednisolone 5 mg soluble tablets by Sovereign.
Razlog za napotitev je bilo dejstvo, da niso bili predloženi zadostni podatki, ki bi dokazovali, da zdravilo Okrido zagotovi podobne ravni zdravilne učinkovine v telesu kot zdravilo Prednisolone 5 mg tablete za peroralno raztopino družbe Sovereign.
The CHMP therefore concluded that the benefits of Okrido outweigh its risks, and therefore the marketing authorisation for Okrido should be granted in all concerned Member States.
CHMP je zato zaključil, da so koristi zdravila Okrido večje od z njim povezanih tveganj, in priporočil odobritev dovoljenja za promet z njim v vseh zadevnih državah članicah.
This summary was last updated in March 2018.
Povzetek je bil nazadnje posodobljen marca 2018.
Further information on Metacam can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Nadaljnje informacije o zdravilu Metacam so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
These side effects occur usually within the first week of treatment and are generally transient (temporary).
Običajno se ti učinki pojavijo v prvem tednu zdravljenja in so po navadi prehodni (začasni).
The European Medicines Agency decided that Metacam's benefits are greater than its risks and that it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Metacam večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Injections may be into a vein, muscles or under the skin.
Injekcije se dajejo v veno, mišico ali pod kožo.
In very rare cases, they may be serious or fatal.
V zelo redkih primerih so lahko resni ali povzročijo celo pogin.
Metacam received a marketing authorisation valid throughout the EU for Metacam on 7 January 1998.
Zdravilo Metacam je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 7. januarja 1998.
All sows also received antibiotics.
Vse svinje so dobile tudi antibiotik.
Why is Metacam approved in the EU?
Zakaj je bilo zdravilo Metacam odobreno v EU?
If the product is accidentally swallowed or self-injected by a person, the advice of a doctor should be sought immediately.
Če človek zdravilo nenamerno zaužije ali samoinjicira, se je treba nemudoma posvetovati z zdravnikom.
The study showed that the dogs receiving meloxicam injection followed by oral doses had the best results in improving mobility based on a standard scoring system.
Študija je pokazala, da so imeli psi, ki so prejeli injekcijo meloksikama, ki ji je sledilo peroralno jemanje zdravila, najboljše rezultate pri izboljšani gibljivosti na podlagi standardnega sistema točkovanja.
What are the risks associated with Metacam?
Kakšna tveganja so povezana z zdravilom Metacam?
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Metacam.
Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, se morajo izogibati stiku z zdravilom Metacam.
Other information about Metacam
Druge informacije o zdravilu Metacam
What is Metacam and what is it used for?
Kaj je zdravilo Metacam in za kaj se uporablja?
What benefits of Metacam have been shown in studies?
Kakšne koristi je zdravilo Metacam izkazalo v študijah?
The main measure of effectiveness was the assessment of pain score at various time points up to 20 hours post-surgery.
Glavno merilo učinkovitosti je bila ocena bolečine v različnih časovnih točkah do 20 ur po kirurškem posegu.
An overview of Metacam and why it is authorised in the EU
Pregled zdravila Metacam in zakaj je odobreno v EU
Metacam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs, cats and guinea pigs.
Metacam je protivnetno zdravilo, ki se uporablja za zdravljenje govedi, prašičev, konjev, psov, mačk in morskih prašičkov.
For the 20 mg/ml and 40 mg/ml solution for injection the meat withdrawal period is 5 days and for the 15 mg/ml oral suspension it is 3 days.
Pri uporabi 20 in 40 mg/ml raztopine za injiciranje je karenca za meso pet dni, pri uporabi 15 mg/ml peroralne suspenzije pa tri dni.
In cattle, pigs and horses in very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Pri govedu, prašičih in konjih se lahko v zelo redkih primerih pojavijo anafilaktične reakcije, ki utegnejo biti zelo resne (celo smrtne) in jih je treba zdraviti simptomatsko.
A temporary swelling at the injection site can occur but resolves without intervention.
Lahko se pojavi prehodna oteklina na mestu injiciranja, vendar ta izzveni brez ukrepanja.
The withdrawal period is 15 days for meat and 5 days for milk.
Karenca je 15 dni za meso in pet dni za mleko.
The product is not authorised to use in horses producing milk for human consumption.
Zdravilo ni odobreno za uporabo pri konjih, katerih mleko je namenjeno prehrani ljudi.
For further information about using Metacam, see the package leaflet or contact your veterinarian or pharmacist.
Za več informacij o uporabi zdravila Metacam glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
These side effects resolve once treatment has stopped.
Ti neželeni učinki so izginili, kakor hitro se je zdravljenje zaključilo.
Another study in cattle involved 501 calves with diarrhoea.
Druga študija pri govedu je zajela 501 tele z drisko.
Metacam was effective in improving mobility and reducing pain from day 0-14 compared to the control group.
Zdravilo Metacam je bilo učinkovito pri izboljšanju gibljivosti in lajšanju bolečine 0-14 dni v primerjavi s kontrolno skupino.
The withdrawal period for meat is 5 days.
Karenca za meso je pet dni.
In very rare cases anaphylactoid reactions and elevated liver enzymes have been reported.
V zelo redkih primerih so poročali o anafilaktičnih reakcijah in povišanju jetrnih encimov.
46 cats received Metacam oral suspension for 28 days whilst 48 cats received placebo oral suspension.
46 mačk je 28 dni prejemalo zdravilo Metacam v obliki peroralne suspenzije, medtem ko je 48 mačk prejemalo peroralno suspenzijo brez zdravilne učinkovine.
Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Meloksikam deluje tako, da zavira encim, imenovan ciklooksigenaza, ki sodeluje pri tvorjenju prostaglandinov.
All calves were given oral rehydration therapy and antibiotics.
Vsa teleta so prejela zdravila za peroralno rehidracijo in antibiotike.
The main measure of effectiveness was blood levels of the stress hormone cortisol 30 minutes after surgery.
Glavno merilo učinkovitosti je bila raven stresnega hormona - kortizola v krvi 30 minut po kirurškem posegu.
The 40 mg/ml solution for injection should not be handled by pregnant women or women attempting to conceive as accidental self-injection may affect the development of the baby in the womb.
Z zdravilom v obliki 40 mg/ml raztopine za injiciranje naj ne rokujejo nosečnice ali ženske, ki bi rade zanosile, saj lahko vpliva na razvoj otroka v maternici.
Metacam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Zdravilo Metacam vsebuje meloksikam, ki spada v skupino zdravil, ki jim pravimo nesteroidna protivnetna zdravila (NSAID).
In one study three different meloxicam treatment schedules for acute locomotor disorders were compared.
V eni študiji so primerjali tri režime zdravljenja akutnih lokomotornih obolenj.
The main measure of effectiveness was based on clinical signs of diarrhoea and the animal's behaviour, feed intake, body temperature, respiratory rate, heart rate and general condition.
Glavno merilo učinkovitosti so bili klinični znaki driske in vedenje živali, ješčnost, telesna temperatura, hitrost dihanja in bitje srca ter splošno stanje živali.
The effectiveness of Metacam injection was studied in 209 pigs with non-infectious locomotor disorders.
Učinkovitost zdravila Metacam v obliki injekcije je bila proučena pri 209 prašičih z nenalezljivimi lokomotornimi obolenji.
Guinea pigs treated with Metacam had significantly higher frequency of feed intake (240 events) over three days, indicating that their pain was reduced, compared with guinea pigs given placebo (207 events).
Morski prašički, zdravljeni z zdravilom Metacam, so imeli v treh dneh bistveno večji vnos krme (240 dogodkov), kar kaže, da so v primerjavi z morskimi prašički, ki so dobili placebo (207 dogodkov), imeli manj bolečin.
37 cats received Metacam and 39 cats received carprofen (another NSAID) by subcutaneous (under the skin) injection immediately after receiving anaesthesia.
37 mačk je prejelo zdravilo Metacam, 39 pa karprofen (drugo nesteroidno protivnetno zdravilo) s podkožno injekcijo takoj po prejetju anestezije.
In addition to antibiotic therapy animals either received a single injection of Metacam or flunixin (another NSAID) for up to 5 days.
Poleg antibiotikov so živali do pet dni prejemale bodisi eno injekcijo zdravila Metacam ali fluniksin (drugo nesteroidno protivnetno zdravilo).
A laboratory study in 30 guinea pigs compared Metacam oral suspension with placebo given about 45 minutes before surgical castration and on each of the following two days.
V laboratorijski študiji na 30 morskih prašičkih so primerjali zdravilo Metacam v obliki peroralne suspenzije s placebom, danima 45 minut pred operativno kastracijo in dva naslednja dneva.
The main measure of effectiveness was based on their general condition, milk appearance and signs of udder inflammation.
Glavno merilo učinkovitosti je bilo splošno stanje živali, videz mleka in znaki vnetja vimena.
Metacam was comparable to flunixin in treating signs of infection and inflammation associated with puerperal septicaemia and toxaemia.
Zdravilo Metacam je bilo primerljivo s fluniksinom, kar zadeva zdravljenje znakov okužbe in vnetja, povezanih s puerperalno septikemijo in toksemijo.
Metacam treated piglets had significantly reduced blood cortisol levels (which indicates that they were exposed to lower levels of stress) 30 minutes after castration compared with the control group.
Pujski, ki so prejeli zdravilo Metacam, so imeli 30 minut po kastraciji v krvi občutno nižje ravni kortizola (kar kaže, da so bili izpostavljeni nižji ravni stresa) v primerjavi s kontrolno skupino.
The formulation and dose to use depends on the animal species, its bodyweight and the condition being treated.
Formulacija in višina odmerka sta odvisni od vrste živali, njene telesne mase in vrste bolezni, ki se zdravi.
The withdrawal period is the time allowed after administration of the medicine before an animal can be slaughtered and the meat used for human consumption.
Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso uporabi za prehrano ljudi.
In addition slight urticaria (itchy rash) and diarrhoea can occur which are both typical side effects of NSAIDs and which resolve by themselves.
Poleg tega se lahko pojavita rahla urtikarija (srbeč izpuščaj) in driska, ki sta tipična neželena učinka nesteroidnih protivnetnih zdravil in izzvenita sama od sebe.
The study showed Metacam to be effective in reducing pain associated with the dehorning procedure.
Študija je pokazala, da je zdravilo Metacam učinkovito za lajšanje bolečin, povezanih z odstranjevanjem rogov.
A study in 187 sows with puerperal septicaemia and toxaemia compared Metacam with flunixin (another NSAID).
V študiji pri 187 svinjah s puerperalno septikemijo in toksemijo so injekcijo zdravila Metacam primerjali s fluniksinom (drugim nesteroidnim protivnetnim zdravilom).
Metacam injection was studied in 60 calves with one group receiving Metacam and local anaesthetic and one group receiving a placebo injection and local anaesthetic prior to dehorning.
Zdravilo Metacam v obliki injekcije je bilo proučeno pri 60 teletih, pri čemer je ena skupina prejela zdravilo Metacam in lokalni anestetik, druga pa injekcijo brez zdravilne učinkovine in lokalni anestetik pred odstranjevanjem rogov.
Metacam oral suspension was comparable to ketoprofen in improving lameness and pain.
Metacam v obliki peroralne suspenzije je bilo pri izboljšanju šepavosti in bolečine primerljivo s ketoprofenom.
A study was carried out in cats with acute musculo-skeletal disorders.
Opravljena je bila tudi študija pri mačkah z akutnimi kostno-mišičnimi obolenji.
The effectiveness of Metacam injection, in combination with antibiotic therapy, was studied in cattle with acute respiratory infection.
Učinkovitost injekcij zdravila Metacam v kombinaciji z antibiotiki je bila proučena pri govedu z akutno okužbo dihal.
Metacam significantly reduced lameness with 49% of the Metacam treated pigs with no lameness compared with 27% of the pigs which received the placebo treatment.
Pri prašičih je zdravilo Metacam občutno zmanjšalo šepavost, ki je izginila pri 49 % prašičev, v primerjavi s 27 % v skupini, ki je prejela injekcijo brez zdravilne učinkovine.
The studies with chronic locomotor disorders showed Metacam to be effective.
Študije pri psih s kroničnimi lokomotornimi obolenji so pokazale učinkovitost zdravila Metacam.
In pigs, Metacam is used in non-infectious locomotor disorders (diseases that affect the ability to move) to reduce lameness and inflammation, relieve post-operative pain associated with minor soft tissue surgery such as castration, and for supportive therapy together with antibiotics in the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome, a bacterial infection of the udder and/or the womb).
Pri prašičih se zdravilo Metacam uporablja za zdravljenje nenalezljivih lokomotornih obolenj (bolezni, ki prizadenejo gibalne sposobnosti živali) za zmanjševanje simptomov šepavosti in vnetja, za lajšanje bolečin po manjših kirurških posegih na mehkih tkivih, kot je npr. kastracija, ter kot podporna terapija v kombinaciji z antibiotiki pri zdravljenju bolezni po oprasitvi (kotitvi mladičev), kot so puerperalna septikemija in toksemija (sindrom mastitis-metritis-agalaktija, bakterijska okužba vimena in/ali maternice).
Metacam oral suspension was given for 5 days and compared with ketoprofen (another NSAID).
Zdravilo Metacam v obliki peroralne suspenzije so dajali pet dni in opravili primerjavo s ketoprofenom (drugim nesteroidnim protivnetnim zdravilom).
Metacam injection was studied in 76 cats undergoing ovariohysterectomy.
Zdravilo Metacam v obliki injekcije je bilo proučeno pri 76 mačkah po ovariohisterektomiji.
It can be used to relieve post-operative pain following dehorning in calves and as supportive therapy in the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Lahko se uporablja za lajšanje bolečin po kirurški odstranitvi rogov pri teletih in kot podporna terapija pri zdravljenju akutnega mastitisa (vnetja vimena) v kombinaciji z antibiotiki.
A study in 150 piglets was carried out to compare the effects of Metacam injection with placebo when given before castration.
Opravljena je bila tudi študija pri 150 pujskih za primerjavo učinkov injekcije zdravila Metacam in injekcije brez zdravilne učinkovine, preden se opravi kastracija.
As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Prostaglandini so snovi, ki sprožajo vnetje, bolečino in izcejanje tekočine (izcejanje tekočine iz krvnih žil med vnetnim procesom) ter povišano telesno temperaturo, meloksikam pa te bolezenske znake zmanjšuje.
Calves treated with Metacam showed a significant improvement in their signs of diarrhoea compared with the control group.
Pri teletih, zdravljenih z zdravilom Metacam, je bilo mogoče opaziti bistveno izboljšanje znakov driske v primerjavi s kontrolno skupino.
It can be used in 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.
Uporablja se lahko pri driski v kombinaciji s peroralno rehidracijo (zdravili, ki jih žival zaužije peroralno za vzpostavitev ustrezne ravni vode v telesu) za zmanjševanje kliničnih znakov bolezni pri teletih, starejših od enega tedna, in pri mladem govedu zunaj obdobja laktacije.
How is Metacam used?
Kako se zdravilo Metacam uporablja?
Metacam injection in combination with antibiotic therapy was investigated in a study involving 240 cattle with acute mastitis.
Zdravilo Metacam v obliki injekcije v kombinaciji z antibiotiki je bilo raziskano v študiji z 240 glavami goveda z akutnim mastitisom.
Metacam 5 mg/ml solution for injection was comparable to carprofen in reducing post-operative pain in cats following ovariohysterectomy.
Zdravilo Metacam 5 mg/ml v obliki raztopine za injiciranje je bilo za lajšanje bolečine po kirurškem posegu pri mačkah po ovariohisterektomiji primerljivo s karprofenom.
326 cattle received Metacam given as an injection together with antibiotic therapy whilst 326 cattle received a placebo (dummy) injection and antibiotic therapy.
326 živali je prejelo zdravilo Metacam v obliki injekcije skupaj z antibiotiki, medtem ko je drugih 326 živali prejelo injekcijo brez zdravilne učinkovine skupaj z antibiotiki.
In very rare cases, in dogs, haemorrhagic diarrhoea (bloody diarrhoea), haematemesis (vomiting blood) or gastrointestinal ulceration (ulcer in the gut) have been reported.
Pri psih so v zelo redkih primerih poročali o hemoragični diareji (driski s krvjo v blatu), hematemezi (bruhanju krvi) ali gastrointestinalnih razjedah (razjedah v črevesju).
In cattle, Metacam is used together with antibiotics, to reduce clinical signs such as fever and inflammation in acute (short-term) respiratory infection (infection of the lungs and airways).
Pri govedu se zdravilo Metacam uporablja skupaj z antibiotiki za zmanjšanje kliničnih znakov povišane telesne temperature in akutne (kratkotrajne) okužbe dihal (okužbe pljuč in dihalnih poti).
Metacam was comparable to the control product in providing supportive treatment of acute mastitis in cattle.
Zdravilo Metacam je bilo pri podpornem zdravljenju akutnega mastitisa pri govedu primerljivo s kontrolnim zdravilom.
In dogs and cats, occasional side effects of Metacam are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, apathy (lack of vitality) and kidney failure.
Pri psih in mačkah so občasni neželeni učinki zdravila Metacam enaki tistim, ki so značilni za nesteroidna protivnetna zdravila, kot so zmanjšan tek, bruhanje, driska, kri v blatu, apatija (pomanjkanje vitalnosti) in ledvična odpoved.
In very rare cases loss of appetite, lethargy, abdominal pain and colitis (inflammation of the lower part of the gut) have been reported.
V zelo redkih primerih se lahko pojavijo izguba teka, letargija, trebušne bolečine in kolitis (vnetje spodnjega dela črevesja).
Both medicines were comparable in reducing pain associated with equine colic.
Obe zdravili sta bili primerljivi za lajšanje bolečine, povezane s koliko.
Metacam oral suspension was studied for treatment of musculoskeletal disorders associated with lameness in two studies and compared to treatment with vedaprofen.
Zdravilo Metacam v obliki peroralne suspenzije je bilo v dveh študijah proučeno za zdravljenje kostnomišičnih obolenj, povezanih s šepavostjo, in primerjano z zdravljenjem z vedaprofenom.
Metacam contains the active substance meloxicam.
Vsebuje učinkovino meloksikam.
Metacam improved lameness in horses at day 14 and at the final follow-up examination 2-4 days later than the vedaprofen treated group whilst the second study showed Metacam to be comparable to vedaprofen.
Z zdravilom Metacam je bila šepavost pri konjih občutno manjša 14. dan in pri končnem naknadnem pregledu dva do štiri dni pozneje, kot v skupini, ki je prejela vedaprofen.
Moreover, it is used to alleviate pain and inflammation in acute and chronic musculo-skeletal disorders.
Poleg tega se pri njih uporablja za lajšanje vnetja in bolečin pri akutnih in kroničnih kostno-mišičnih obolenjih.
Metacam is available as an oral (taken by mouth) suspension, a solution for injection and chewable tablets.
Zdravilo Metacam je na voljo v obliki peroralne suspenzije, raztopine za injiciranje in žvečljivih tablet.
In guinea pigs, Metacam is used to reduce post-operative pain after soft tissue surgery such as castration.
Pri morskih prašičkih se zdravilo Metacam uporablja za lajšanje bolečin pri kirurških posegih na mehkih tkivih, kot je na primer kastracija.
How does Metacam work?
Kako zdravilo Metacam deluje?
In horses, Metacam is used to relieve pain associated with colic (abdominal pain) and to alleviate inflammation and pain in both acute and chronic (long-term) musculo-skeletal disorders (disorders affecting the muscles and bones).
Pri konjih se zdravilo Metacam uporablja za lajšanje kolike (trebušnih bolečin) ter vnetja in bolečin pri akutnih in kroničnih (dolgotrajnih) kostno-mišičnih obolenjih.
A number of studies were conducted in dogs with acute and chronic locomotor disorders with both oral and injectable Metacam.
Pri psih z akutnimi ali kroničnimi lokomotornimi obolenji je bilo izvedenih več študij z uporabo peroralnega ali injiciranega zdravila Metacam.
Metacam injection in cattle significantly improved clinical signs of respiratory infection and reduced fever compared with antibiotics alone.
Zdravilo Metacam v obliki injekcije je pri govedu v primerjavi z uporabo samo antibiotikov občutno izboljšalo klinične znake okužb dihal in zmanjšalo povišano telesno temperaturo.
Animals received either Metacam injection or a placebo injection.
Živali so prejele bodisi injekcijo zdravila Metacam ali injekcijo brez zdravilne učinkovine.
Metacam injection was compared with vedaprofen (another NSAID) for pain relief associated with equine colic in 269 horses.
Zdravilo Metacam v obliki injekcije so pri 269 konjih primerjali z vedaprofenom (drugim nesteroidnim protivnetnim zdravilom) za lajšanje bolečine, povezane s koliko.
In dogs, Metacam is used to reduce post-operative pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Pri psih se zdravilo Metacam uporablja za lajšanje pooperativne bolečine in vnetja po ortopedskih kirurških posegih (npr. kirurškem posegu zaradi zloma kosti) in kirurških posegih na mehkih tkivih.
In cats, Metacam is used to reduce post-operative pain and inflammation after ovariohysterectomy (spay operation), orthopaedic and minor soft tissue surgery.
Pri mačkah se zdravilo Metacam uporablja za lajšanje pooperativne bolečine in vnetja po ovariohisterektomiji (odstranitvi rodil), ortopedskih kirurških posegih in manjših kirurških posegih na mehkih tkivih.
Metacam can only be obtained with a prescription.
Predpisovanje in izdaja zdravila je le na recept.
Pigs either received Metacam or a placebo injection.
Prašiči so prejeli bodisi injekcijo zdravila Metacam ali injekcijo brez zdravilne učinkovine.
In cattle and pigs, Metacam is well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in most cattle studied in laboratory conditions.
Pri večini goveda, zdravljenega v laboratorijskih pogojih, so opazili le blago, prehodno oteklino na mestu injiciranja zdravila v podkožje.
On behalf of the Management Board, therefore, I would like to extend a warm welcome to them in advance.
Zato bi jim rad v imenu upravnega odbora vnaprej izrekel toplo dobrodošlico.
Such questions usually arise during the research and development phase.
Taka vprašanja se običajno pojavijo med fazo raziskovanja in razvoja.
It is available in all official EU languages.
Na voljo je v vseh uradnih jezikih EU.
One PMF was finalised.
En PMF je bil dokončan.