natgillin/translations-raw huggingface dataset:
• twisted neck (spasmodic torticollis)
TWSTRS: Toronto Western Spasmodic Torticollis Rating Scale (lestvica za oceno spazmičnega tortikolisa Toronto Western)
Nervous system disorders Uncommon: dizziness, facial paralysis
omotica, obrazna paraliza
Eyelid spasm (blepharospasm)
Krči vek (blefarospazem)
Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins
Xeomin 100 enot LD50, prašek za raztopino za injiciranje nevrotoksin bakterije Clostridium Botulinum tipa A (150 kD), brez beljakovin, ki tvorijo komplekse
Dysphagia appears to be dose-dependent.
Videti je, da je odvisna od odmerka.
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains 100 LD50 units* of Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala vsebuje 100 enot LD50 nevrotoksina bakterije Clostridium Botulinum tipa A (150 kD), brez beljakovin, ki tvorijo komplekse.
dysphagia Uncommon: diarrhoea, dry mouth, vomiting, colitis
diareja, suha usta, bruhanje, kolitis Bolezni kože in podkožja Občasni:
Intubation and assisted ventilation will become necessary until improvement if paralysis of the respiratory muscles occurs.
Če pride do paralize dihalnih mišic, sta nujni intubacija in umetna ventilacija.
BEFORE YOU USE XEOMIN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO XEOMIN
Nervous system disorders Uncommon: headache, tremor
glavobol, tremor
General disorders and administration site conditions Uncommon: asthenia, injection site inflammation, injection site tenderness
astenija, vnetje na mestu injiciranja, občutljivost na mestu injiciranja
Medical supervision for up to several days and assisted ventilation may be necessary.
Morda bosta nujna nekajdnevni zdravniški nadzor in umetno dihanje.
Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150kD), free of complexing proteins For intramuscular use.
Xeomin 100 enot LD50 prašek za raztopino za injiciranje nevrotoksin bakterije Clostridium Botulinum tipa A (150 kD), brez beljakovin, ki tvorijo komplekse
PACKAGE LEAFLET
vzporedno preizkušanje
b) Distribution of the active substance in patients:
Splošne značilnosti zdravilne učinkovine:
This does not affect the safety or effectiveness of the medicine.
To ne vpliva na zdravje in učinkovitost zdravila.
The European Commission granted a marketing authorisation valid throughout the European Union for Stronghold on 25 November 1999.
Evropska komisija je dovoljenje za promet z zdravilom Stronghold, veljavno po vsej Evropski uniji, izdala 25. novembra 1999.
Shampooing or soaking the animal two hours or more after treatment did not affect the medicine's effectiveness.
Šamponiranje ali močenje dlake živali dve uri ali več po zdravljenju ni vplivalo na učinkovitost zdravila.
Other information about Stronghold:
Druge informacije o zdravilu Stronghold:
It must also not be used in cats that are suffering from another disease or that are weakened and underweight for their size and age.
Prav tako se ne sme uporabljati pri mačkah, ki imajo katero koli drugo bolezen ali so oslabljene oziroma podhranjene glede na svojo velikost in starost.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom to treat biting lice in cats and dogs,
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom zatiranje garij vrste Sarcoptes pri psih.
People with sensitive skin or known allergy to products of this type should handle Stronghold with caution.
Osebe z občutljivo kožo ali znano alergijo na tovrstna zdravila naj z zdravilom Stronghold ravnajo previdno.
On the day of treatment, children must not handle treated animals and the animals should not sleep with their owners, especially children.
Preprečiti je treba, da bi otroci na dan, ko je bilo zdravilo nanešeno, prišli v stik z živaljo, prav tako pa zdravljene živali ne smejo spati skupaj z lastniki, še zlasti ne z otroki.
It is available as a spot-on solution in 2 different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120, 240 and 360 mg).The concentration and the strength to use depends on the weight and species of the animal being treated.
Na voljo je v obliki raztopine za kožni nanos v dveh različnih koncentracijah (6 % in 12 %) ter v tubah različnih jakosti (15, 30, 45, 60, 120, 240 in 360 mg).
Stronghold must not be used in animals under six weeks of age.
Zdravilo Stronghold se ne sme uporabljati pri živalih do šestega tedna starosti.
Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Selamektin aktivira posebne beljakovine, imenovane kloridni kanalčki na površini živčnih in mišičnih celic zajedavcev, kar kloridnim delcem omogoča, da vstopijo v živčne celice in ohromijo njihovo običajno električno dejavnost.
What is the risk associated with Stronghold?
Kakšna tveganja so povezana z zdravilom Stronghold?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Stronghold exceed the risks for the approved indications and recommended that Stronghold be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Stronghold večje od z njim povezanih tveganj, kadar se uporablja za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
If Stronghold comes into contact with the eyes, they should be flushed immediately with water and medical attention sought.
Če pride zdravilo Stronghold v stik z očmi, jih je treba nemudoma sprati z obilo vode in poiskati medicinsko pomoč.
What benefit has Stronghold shown during the studies?
Kakšne koristi je zdravilo Stronghold izkazalo med študijami?
Stronghold treatment was found to be effective after a single administration or repeated treatments at monthly intervals, depending on the type of infestation it was being used to treat or prevent.
Zdravljenje z zdravilom Stronghold se je izkazalo za učinkovito po enkratnem odmerku ali ponavljajočih se zdravljenjih v mesečnih intervalih, odvisno od vrste infestacije, ki se zdravi ali preprečuje.
The effectiveness was then confirmed in field studies in cats and dogs by looking at the number of live parasites at various times after treatment.
Nato so jo potrdili s terenskimi študijami pri mačkah in psih, v katerih so beležili število živih zajedavcev v različnih časovnih obdobjih po zdravljenju.
Stronghold
Stronghold selamektin
Stronghold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Zdravilo Stronghold vsebuje selamektin, tj. antiparazitsko zdravilo iz razreda avermektinov.
In the treatment of sarcoptic mange in dogs, two treatments given 30 days apart were required to completely eliminate the mites in dogs.
Pri zatiranju garij vrste Sarcoptes pri psih sta bili za popolno odstranitev garij potrebni dve zdravljenji v razmiku 30 dni.
In field studies, it reduced the flea comb counts by up to 98% in cats and 99% in dogs 90 days after treatment, as well as preventing flea eggs from hatching, and killing and preventing the development of flea larvae.
V terenskih študijah je zdravilo 90 dni po zdravljenju zmanjšalo število izčesanih bolh za do 98 % pri mačkah in 99 % pri psih, prav tako pa je preprečilo izleganje jajčec bolh ter uničilo ličinke bolh in preprečilo njihov razvoj.
Why has Stronghold been approved?
Zakaj je bilo zdravilo Stronghold odobreno?
The effectiveness of Stronghold against the specified parasites was investigated in laboratory studies in cats and dogs.
Učinkovitost zdravila proti navedenim zajedavcem je bila proučena z laboratorijskimi študijami pri mačkah in psih.
Stronghold causes temporary alopecia (hair loss) at the application site in less than 1 in 1,000 cats.
Zdravilo Stronghold povzroča začasno izpadanje dlake na mestu nanosa pri manj kot 1 od 1 000 mačk.
How has Stronghold been studied?
Kako je bilo zdravilo Stronghold raziskano?
Used applicators should be disposed of immediately and not left within sight or reach of children.
Uporabljene kapalke za nanos zdravila je treba nemudoma zavreči in morajo vselej biti izven pogleda in dosega otrok.
Field studies also showed that Stronghold was 100% effective in preventing heartworm disease in dogs and cats.
Terenske študije so pokazale tudi, da je bilo zdravilo Stronghold 100-odstotno učinkovito pri preprečevanju obolenj zaradi infestacij s srčnimi glistami pri psih in mačkah.
The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite.
Uporabljena jakost in število odmerkov sta odvisna od mase zdravljene živali, živalske vrste, ki ji žival pripada, ter od vrste zajedavca.
Stronghold is an antiparasitic medicine that contains the active substance selamectin.
Stronghold je zdravilo proti zajedavcem, ki vsebuje zdravilno učinkovino selamektin.
Treated animals must not be touched until the application area is dry.
Izogibati se je treba dotikanja živali, na katere je bilo nanešeno zdravilo, dokler se mesto nanosa ne posuši.
Stronghold is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.
Zdravilo je treba hraniti v varni razdalji od virov vročine, isker, odprtega ognja ali drugih virov vžiga.
Stronghold may produce clumping of the hair at the application site or the appearance of a small quantity of a white powder in less than 1 in 1,000 cats.
Pri manj kot 1 od 1 000 mačk lahko povzroči zlepljanje dlake na mestu nanosa ali pojav manjših količin belega prahu.
What is Stronghold used for?
Za kaj se zdravilo Stronghold uporablja?
The user must not smoke, eat or drink while handling Stronghold.
Med uporabo zdravila Stronghold ni dovoljeno kaditi, jesti ali piti.
Stronghold was also effective in the treatment of adult intestinal hookworms in cats, adult intestinal roundworms in cats and dogs, and biting lice in dogs and cats.
Zdravilo Stronghold je bilo učinkovito tudi pri zdravljenju odraslih črevesnih trakulj pri mačkah, odraslih črevesnih glist pri mačkah in psih ter infestacij s krvosesimi ušmi pri psih in mačkah.
Stronghold is used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body.
Zdravilo Stronghold se uporablja za zdravljenje in preprečevanje infestacij z zajedavci, ki živijo na koži ali v dlaki mačk in psov, npr. z bolhami in garjami, ter za zatiranje črvastih zajedavcev, ki živijo v telesu.
It is also effective in treating ear mites in cats and dogs.
Učinkovito je bilo tudi pri zatiranju ušesnih garij pri mačkah in psih.
The contents of the tube are squeezed onto the skin after parting the fur between the shoulder blades.
Živali razmaknemo dlako med lopaticama, da se prikaže koža, in na to mesto stisnemo vsebino tube.
How does Stronghold work?
Kako zdravilo Stronghold deluje?
What is Stronghold?
Kaj je zdravilo Stronghold?
It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs,
preprečevanje obolenj pri mačkah in psih, ki jih povzroča srčna glista; zatiranje ušesnih garij pri mačkah in psih; zatiranje odraslih črevesnih glist in črevesnih trakulj pri mačkah; zatiranje odraslih črevesnih glist pri psih; zatiranje krvosesih uši pri mačkah in psih;
There is no alternative available for this purpose in the EU at present.
Za ta namen v EU trenutno ni na voljo nobena alternativa.
Member State EU/EEA
Država članica EU/EEP
Quality, target animal safety, user safety and residues were not assessed in this referral procedure.
Kakovost, varnost tarčnih živalskih vrst, varnost uporabnikov in ostanki se v tem napotitvenem postopku niso ocenjevali.
Thus, the PECsoil, and hence PECsurfacewater, could be conservatively reduced by 85% and not only by 69%.
Tako bi lahko vrednost PECtla in z njo vrednost PECpovršinska voda konservativno znižali za 85 % in ne le za 69 %.
This value is used for the calculation of the initial PECsurfacewater value.
Ta vrednost se uporablja pri izračunu začetne vrednosti
Therefore on 21 March 2013 Germany initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing altrenogest to be administered orally to pigs and horses.
Zato je Nemčija 21. marca 2013 sprožila postopek v skladu s členom 35 Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest za peroralno dajanje prašičem in konjem.
Consequently, the benefit-risk balance is considered positive.
Zato je razmerje med tveganji in koristmi pozitivno.
The CVMP noted that measures are already in place to reduce runoff based on European and national legislation.
Odbor CVMP je ugotovil, da so ukrepi za zmanjšanje površinskega odtoka že uveljavljeni na podlagi evropske in nacionalne zakonodaje.
Altrenogest is a synthetic steroidal hormone, an orally active progestogen.
Altrenogest je sintetični steroidni hormon, peroralno aktiven progestogen.
Strength Pharmaceutical form
Farmacevt-ska oblika
Animal species
Žival-ska vrsta
The results from STEP 4 ranged from 16 pg/l (R1) to 219 pg/l (R3).
Rezultati 4. koraka so znašali od 16 pg/l (R1) do 219 pg/l (R3).
The shift in sex ratio towards males clearly underlines the androgenic potential of the substance.
Zaradi premika deleža po spolu k samcem je jasno poudarjen androgeni potencial snovi.
A survey of the national legislation in relation to Directive 91/676/EEC revealed that countries with a minimum distance of 1 and 2 m from the water body represent almost two-thirds of the total pig production in Europe.
Pregled nacionalne zakonodaje v povezavi z Direktivo 91/676/EGS je pokazal, da države z najmanj metrsko in dvometrsko oddaljenostjo od vodnega telesa predstavljajo skoraj dve tretjini celotne prašičereje v Evropi.
Extrapolation of EC10 values was not possible, in line with the recommendations of the OECD 54 guideline on Current Approaches in the Statistical Analysis of Ecotoxicity Data: A Guidance to Application (2006)5.
Ekstrapolacija vrednosti EC10 ni bila mogoča v skladu s priporočili smernice OECD št. 54 „Trenutni pristopi k statistični analizi podatkov o ekotoksičnosti: navodila za uporabo“ (2006)5.
Exposure studies
Študije o izpostavljenosti
However, the CVMP considered that the assumption of 60% of the total dose being excreted via urine as an overly conservative value.
Kljub temu je odbor CVMP menil, da je predpostavka, da bo 60 % celotnega odmerka izločenega z urinom, pretirano konservativna.
However, it is for the treatment of individual mares, i.e. not for the treatment of the entire herd for the synchronisation of ovulation.
Vendar odobritev velja za zdravljenje posameznih kobil, torej ne za zdravljenje celotne črede za sinhronizacijo ovulacije.
Ecotoxicity data
Podatki o ekotoksičnosti
Results show that the dissipation time (DT50) of altrenogest in manure was 6.0 days (20±2 °C).
Rezultati kažejo, da je bil čas razkrajanja (DT50) altrenogesta v gnoju 6,0 dneva (20 ± 2 °C).
These results are considered to be in line with existing literature data for progestagens and also with residue concentrations found in liver and kidney of pigs.
Za te rezultate velja, da so v skladu z obstoječimi podatki iz literature o progestogenih in tudi s koncentracijami ostankov v jetrih in ledvicah prašičev.
The aerobic transformation of altrenogest was investigated in four different soils (OECD Test Guideline 3074 (21.1 ± 0.1 °C for 21 days)).
Aerobno pretvorbo altrenogesta so preučevali v štirih različnih tleh (smernica OECD za testiranje št. 3074 (21,1 ± 0,1 °C v obdobju 21 dni)).
Risks to the environment
Tveganje za okolje
Mineralisation was negligible over the period of 100 days and non-extractable residues were formed during the incubation period and accounted for 26.5% of the applied radioactivity on day 45.
V obdobju 100 dni je bila mineralizacija zanemarljiva in med inkubacijsko dobo so nastali neizločljivi ostanki, ki so 45. dan predstavljali 26,5 % uporabljene radioaktivnosti.
STEP 1 resulted in a PECgroundwater being below the threshold value (0.1 µg/l), anticipating that a risk for groundwater could in principle be excluded.
Po 1. koraku je bila vrednost PECpodzemna voda pod mejno vrednostjo (0,1 µg/l), kar pomeni, da bi bilo tveganje za podzemno vodo načeloma mogoče izključiti.
The CVMP acknowledges that buffer zones may be useful measures to reduce the release of altrenogest into surface water via run-off.
Odbor CVMP meni, da so varovalni pasovi lahko koristni ukrepi za zmanjšanje izpusta altrenogesta v površinsko vodo s površinskim odtokom.
Following normalisation from the 21.1 °C study temperature to standard 20°C laboratory conditions using the Arrhenius equation (equivalent to a correction factor of 1.11), the DT50 proposed for use in modelling is 6.5 days.
Po normalizaciji temperature z 21,1 °C v času študije na standardnih 20 °C v laboratorijskih pogojih je z uporabo Arrheniusove enačbe (enako korekcijskemu faktorju 1,11) vrednost DT50, predlagana za uporabo pri modeliranju, 6,5 dneva.
A PECsoil refined of 0.013 µg/kg was determined accordingly, resulting on an application rate of 0.000094 kg/ha.
V skladu s tem je bila določena izboljšana vrednost PECtla v višini 0,013 µg/kg in s tem odmerek 0,000094 kg/ha.
• the CVMP considered that at present in the EU there is no alternative available for oestrus synchronisation of gilts;
• odbor CVMP je upošteval, da trenutno v EU ni na voljo nobena alternativa za sinhronizacijo estrusa pri svinjah mladicah;
Consequently, based on metabolism studies the Committee concluded that the PECsoil can be more realistically refined considering the total excretion altrenogest-equivalents being 5% to 16.5% of the dose.
Na podlagi študij o presnovi je zato odbor zaključil, da je vrednost PECtla mogoče bolj realno izboljšati z upoštevanjem, da je celotna količina izločenih ekvivalentov altrenogesta od 5 % do 16,5 % odmerka.
Yet, the results from the fish study indicate a potential environmental risk due to the endocrine disrupting properties of the substance below 0.4 µg/l.
Rezultati študije z ribami pa kažejo na morebitno okoljsko tveganje, ker ima snov pri vrednostih pod 0,4 µg/l lastnosti endokrinega motilca.
Although efficacy has not been assessed specifically in this referral procedure, altrenogest is a wellestablished hormone widely used as standard treatment for the synchronisation of oestrus in sexually mature gilts.
Čeprav se učinkovitost v tem napotitvenem postopku ni posebej ocenjevala, je altrenogest uveljavljen hormon, ki se pogosto uporablja kot običajno zdravljenje za sinhronizacijo estrusa pri spolno zrelih svinjah mladicah.
The active substance altrenogest is a potent synthetic hormone which was demonstrated to affect reproduction in fish at very low concentrations.
Zdravilna učinkovina altrenogest je močan sintetični hormon, ki v zelo nizkih koncentracijah dokazano vpliva na razmnoževanje rib.
However, the RQs calculated for the R3 scenario were above the threshold, i.e. 1.67 (1 m), >1.36 (3 m), >1.24 (5 m), and >1.04 (10 m), thus, indicating a risk for the aquatic environment for this scenario.
Kljub temu so bili količniki tveganja za scenarij R3 nad pragom, tj. 1,67 (1 m), > 1,36 (3 m), > 1,24 (5 m) in > 1,04 (10 m), kar kaže na tveganje za vodno okolje pri tem scenariju.
As a result, PECgroundwater was further refined with the Metamodel (STEP 2) and FOCUS PEARL model, both confirming that PECgroundwater being < 0.000001 μg/l.
Zaradi tega je bila vrednost PECpodzemna voda dodatno izboljšana s pomočjo metamodela (2. korak) in modela FOCUS PEARL, ki sta potrdila, da je vrednost PECpodzemna voda < 0,000001 μg/l.
Overall summary of the scientific evaluation of veterinary medicinal products containing altrenogest to be administered orally to pigs and horses (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo altrenogest za peroralno dajanje prašičem in konjem (glejte Prilogo I)
The anaerobic and aerobic degradation of altrenogest were investigated for altrenogest in manure and soil, respectively.
Anaerobno in aerobno razgradnjo altrenogesta so preučevali pri altrenogestu v gnoju oziroma tleh.
The CVMP considered that after administration of altrenogest at a daily oral dose of 20 mg/pig for 18 days, only 25% of the total dose of altrenogest was excreted in urine as altrenogest or altrenogest conjugates, and the remainder in bile.
Odbor CVMP je upošteval, da je bilo po 18 dneh dajanja altrenogesta v dnevnih odmerkih 20 mg/prašiča samo 25 % celotnega odmerka altrenogesta izločenega z urinom kot altrenogest ali konjugati altrenogesta, preostanek pa z žolčem.
It was concluded that for R1 and R4 scenarios there is no risk for contamination of surface water with altrenogest after spreading manure from treated animals onto cropland, while a risk cannot be excluded for R3-scenario.
Ugotovili so, da pri scenarijih R1 in R4 ni tveganja za kontaminacijo površinske vode z altrenogestom po nanosu gnoja zdravljenih živali na njivske površine, pri scenariju R3 pa tveganja ni mogoče izključiti.
It is included in veterinary medicinal products currently authorised in the European Union for gilts and mares for zootechnical purposes (oestrus synchronisation).
Vsebujejo ga zdravila za uporabo v veterinarski medicini, ki so trenutno odobrena v Evropski uniji za svinje mladice in kobile v zootehnične namene (sinhronizacijo estrusa).
Germany expressed concerns that veterinary medicinal products containing altrenogest may present a potential serious risk for the environment as the active substance is a steroid hormone and data from publicly available literature show a high risk to aquatic organisms arising from other steroids with a similar molecular structure.
Nemčija je izrazila pomisleke, da bi zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest, lahko pomenila morebitno resno tveganje za okolje, ker je njihova zdravilna učinkovina steroidni hormon, podatki iz javno dostopne literature pa kažejo na visoko tveganje za vodne organizme zaradi drugih steroidov s podobno molekulsko strukturo.
After 45 days, altrenogest and its transformation products (the latter at or above 10%) were not detected in the manure using high performance liquid chromatography- radiochromatography (HPLC-RAM) and liquid chromatography tandem mass spectrometry (LC/MS-MS) (mean of two replicates).
Po 45 dneh altrenogesta in njegovih produktov pretvorbe (teh je bilo vsaj 10 %) niso odkrili v gnoju s pomočjo tekočinske kromatografije visoke ločljivosti - radiokromatografije (HPLC-RAM) in tekočinske kromatografije s tandemsko masno spektrometrijo (LC/MS-MS) (srednja vrednost dveh ponovitev).
To determine PECsurfacewater, the FOCUS STEP 4 approach is the highest tier exposure scenario, in which all relevant and representative R scenarios (R1, R3 and R4) were considered by the CVMP.
Za določitev vrednosti PECpovršinska voda je pristop v 4. koraku modela FOCUS scenarij z najvišjo stopnjo izpostavljenosti, pri katerem je odbor CVMP upošteval vse ustrezne in reprezentativne scenarije R (R1, R3 in R4).
Based on this more realistic approach, and considering metabolism of up to 85% (release factor 0.15), no risk could be identified for R1 and R4 scenarios (in line with the MAHs calculation considering 69% metabolism, release factor 0.31).
Na podlagi tega bolj realističnega pristopa in ob upoštevanju presnove do 85 % (faktor sproščanja 0,15) ni bilo mogoče ugotoviti tveganja za scenarija R1 in R4 (v skladu z izračunom imetnikov dovoljenja za promet z zdravilom, pri katerem so upoštevali 69-odstotno presnovo in faktor sproščanja 0,31).