natgillin/translations-raw huggingface dataset:
As for every medicine, the company provided studies on the quality of Pregabalin Accord.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Pregabalin Accord.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Accord has been shown to have comparable quality and to be bioequivalent to Lyrica.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pregabalin Accord primerljivo raven kakovosti kot zdravilo Lyrica ter da mu je biološko enakovredno.
The active substance in Pregabalin Accord, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Zdravilna učinkovina v zdravilu Pregabalin Accord, pregabalin, ima podobno strukturo kot telesu lastni „živčni prenašalec“ gama-aminomaslena kislina (GABA), vendar ima bistveno drugačne biološke učinke.
This means that Pregabalin Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Lyrica.
What are the benefits and risks of Pregabalin Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Pregabalin Accord?
For more information about treatment with Pregabalin Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pregabalin Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
For practical information about using Pregabalin Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pregabalin Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about Pregabalin Accord
Druge informacije o zdravilu Pregabalin Accord
Pregabalin Accord is a ‘generic medicine'.
Zdravilo Pregabalin Accord je „generično zdravilo“.
It is not intended to provide practical advice on how to use Pregabalin Accord.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Opravila je tudi študije, ki so pokazale, da je zdravilo Pregabalin Accord biološko enakovredno referenčnemu zdravilu.
After one week, the dose can be increased to 300 mg per day.
Po enem tednu se lahko odmerek poveča na 300 mg na dan. Odmerki se lahko še povečajo, dokler ni dosežen najučinkovitejši odmerek.
Why is Pregabalin Accord approved?
Zakaj je bilo zdravilo Pregabalin Accord odobreno?
• neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
kot se pojavlja pri bolnikih z diabetesom ali pasovcem, in centralno nevropatsko bolečino, kot se pojavlja pri bolnikih s poškodbo hrbtenjače;
How has Pregabalin Accord been studied?
Kako je bilo zdravilo Pregabalin Accord raziskano?
How is Pregabalin Accord used?
Kako se zdravilo Pregabalin Accord uporablja?
How does Pregabalin Accord work?
Kako zdravilo Pregabalin Accord deluje?
Pregabalin Accord contains the active substance pregabalin.
Zdravilo Pregabalin Accord vsebuje zdravilno učinkovino pregabalin.
56 capsules + 1 inhaler
56 kapsul + 1 inhalator
Strength Pharmaceutical Form Route of Administration
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
448 (8x 56) capsules +10 inhalers (2 x monthly multipack)
448 (8x 56) kapsul +10 inhalatorjev (2 x mesečno skupno pakiranje)
224 (4x 56) capsules + 5 inhalers (monthly multipack)
224 (4x 56) kapsul + 5 inhalatorjev (mesečno skupno pakiranje)
ATC vet code: QP54AA05.
Oznaka ATC vet: QP54AA05.
Interaction with other medicinal products and other forms of interaction: None known.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Niso poznane.
Used applicators should be disposed of immediately and not left within the sight or reach of children.
Uporabljene aplikatorje je treba takoj odstraniti in jih ne puščati na dosegu otrok.
The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Zdravilo ne sme priti v vodotoke, ker je lahko nevaren za ribe in druge vodne organizme.
Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
Ne uporabite pri mačkah obolelih zaradi sočasnih bolezni ali pri mačkah, ki so močno oslabljene in podhranjene (glede na velikost in starost).
This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods leading to their paralysis and/or death.
To inhibira električno aktivnost živčnih celic nematodov in mišičnih celic artropodov kar vodi k njihovi paralizi in/ali smrti.
None known
Niso znane.
On the day of treatment, children must not handle treated animals and the animals should not be permitted to sleep with their owners, especially children.
Na dan, ko živalim dajete zdravilo, se morajo otroci izogibati stiku z živalmi in živali ne smejo spati skupaj s svojimi lastniki, še posebej z otroki.
Colourless to yellow solution.
Brezbarvna do rumena raztopina.
Squeeze the pipette firmly to empty the contents in one spot.
Trdno stisnite merilno kapalko, da se vsebina izprazni na enem mestu.
60/120 Appropriate combination of pipettes
60/120 Ustrezna kombinacija merilnih kapalk
Potency (mg/ml)
Jakost (mg/ml)
It is important to apply the dose as indicated to minimise the quantity that the animal can lick off.
Pomembno je, da odmerek nanesete točno po navodilih, da s tem najbolj zmanjšate količino, ki bi jo žival lahko polizala.
Containers and residual contents should be disposed of along with collected domestic refuse to avoid contamination of any water courses.
Vsebniki in ostanki vsebine se morajo odlagati v sistemu zbiranja gospodinjskih odpadkov, da se izognete onesnaženju vseh vodnih virov.
However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.
Vseeno, šamponiranje in močenje dlake 2 uri ali več po nanosu ne zmanjša učinkovitosti proizvoda.
Avoid contact between the product and your fingers.
Izogibajte se stiku prstov z zdravilom.
Butylated hydroxytoluene 0.8 mg/ml.
Butilhidroksitoluen 0,8 mg/ml.
This is normal and will disappear typically within 24 hours of treatment administration and does not affect either the safety or efficacy of the veterinary medicinal product.
Pojav je običajen in tipično izgine v roku 24 urah po nanosu in ne vpliva na varnost ali učinkovitost tega zdravila za uporabo v veterinarski medicini.
Do not smoke, eat or drink while handling the product.
Med uporabo zdravila ni dovoljeno kaditi, jesti ali piti.
Selamectin paralyses and/or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission.
Selamektin paralizira in/ali ubije širok spekter parazitov nevretenčarjev z oviranjem prevodnosti kloridnih kanalov, kar povzroči motnje v normalni nevrotransmisiji.
Date of first authorisation: 19 July 2019
Datum pridobitve dovoljenja za promet: 19/07/2019
Selamectin is a semi-synthetic compound of the avermectin class.
Selamektin je polsintetična spojina iz skupine avermektinov.
This veterinary medicinal product is to be applied to the skin surface only.
To zdravilo za uporabo v veterinarski medicini nanašajte le na površino kože.
Method and route of administration:
Način in pot uporabe:
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Priporoča se, da veterinar 30 dni po zdravljenju žival ponovno pregleda, ker je pri nekaterih živalih potreben še drugi odmerek.
Store in the unopened sachet in a dry place to protect from light and moisture.
Shranjujte v neodprti vrečki na suhem mestu da zaščitite pred svetlobo in vlago.
This veterinary medicinal product does not require any special temperature storage conditions.
Za shranjevanje tega zdravila ni posebnih temperaturnih omejitev.
Local temporary clumping of the hair at the application site and/or an occasional appearance of a small quantity of a white powder has been reported rarely.
Lokalno začasno zlepljenje dlake na mestu nanosa in/ali občasen pojav manjših količin belega prahu je bilo poročano redko.
Cats and/or dogs.
Mačke in/ali psi.
Administer in accordance with the following table:
Odmerjanje se določi po naslednji tabeli:
The appropriate length of the treatment period for individual parasites is specified below.
Ustrezen čas zdravljenja za posamezne parazite je določen v spodnji tabeli.
Butylhydroxytoluene Dipropylene glycol methyl ether Isopropyl alcohol
Butilhidroksitoluen Dipropilen glikol metil eter Izopropilalkohol
Selamectin may adversely affect fish or certain water-borne organisms on which they feed.
Selamektin je lahko nevaren za ribe in druge vodne organizme s katerimi se prehranjujejo.
This product is not effective against adult D. immitis.
Zdravilo ne deluje na odrasle oblike D. immitis.
People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Osebe z občutljivo kožo ali znano alergijo na tovrstna zdravila za uporabo v veterinarski medicini naj s tem zdravilom ravnajo previdno.
Butylhydroxytoluene 0.8 mg/ml For the full list of excipients, see section 6.1.
Butilhidroksitoluen 0,8 mg/ml Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
This product is highly flammable; keep away from heat, sparks, open flames or other sources of ignition.
To zdravilo je lahko vnetljivo, zato ga hranite zaščitenega pred vročino, iskrami, odprtim plamenom ali drugimi vnetljivimi viri.
Each single-dose (pipette) delivers:
Vsak enkratni odmerek (merilna kapalka) vsebuje:
3 - Part the hair at the base of your animal's neck in front of the shoulder blades to expose a small area of skin.
3 - Razmaknite dlako na zatilju živali pred robom lopatic, da se razkrije manjša površina kože.
Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
Zdravljene živali naj se ne zadržujejo v bližini ognja ali drugih vnetljivih virov najmanj 30 minut ali dokler dlaka ni suha.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
The veterinary medicinal product may be administered year-round or at least within one month of the animal's first exposure to mosquitoes and monthly thereafter until the end of the mosquito season.
Zdravilo za uporabo v veterinarski medicini se lahko daje vse leto ali vsaj znotraj obdobja enega meseca po prvi izpostavitvi živali komarjem, nato pa vsak mesec, dokler traja sezona komarjev.
The systemic persistence of selamectin in plasma and the lack of extensive metabolism provide effective concentrations of selamectin for the duration of the inter-dosing interval (30 days).
Sistemska vztrajnost selamektina v plazmi in pomanjkanje obsežnega metabolizma zagotavljata učinkovite koncentracije selamektina za celotno obdobje med dvema nanosoma (30 dni).
• Treatment of biting lice infestations (Felicola subrostratus)
• Zatiranje infestacij z ušmi, ki grizejo (Felicola subrostratus)
For use as part of a treatment strategy for flea allergy dermatitis the veterinary medicinal product should be administered at monthly intervals.
Za uporabo kot del strategije zdravljenja alergijskega dermatitisa se zdravilo za uporabo v veterinarski medicini daje v mesečnih intervalih.
When concurrent infestations or infections in the same animal are to be treated with the veterinary medicinal product, only one application of the recommended 6 mg/kg dose should be administered at any one time.
Kadar je treba z zdravilom za uporabo v veterinarski medicini zdraviti hkratne infestacije ali infekcije pri isti živali, se daje priporočen odmerek 6 mg/kg le enkrat v priporočenem enkratnem odmerku.
If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
V primeru znatnejšega lizanja se lahko pri mačkah redko opazi kratko obdobje močnejšega slinjenja.
For ear mite treatment, do not apply directly in the ear canal.
Za zdravljenje ušesnih garij zdravila ne nanašajte neposredno v ušesni kanal.
Selamectin was also administered at 3 times the recommended dose to breeding male and female cats and dogs, including pregnant and lactating females nursing their litters and at 5 times the recommended dose to ivermectin-sensitive Collies, and no undesirable effects were observed.
Selamektin se je v trikratnem priporočenem odmerku uporabil pri mačjih in pasjih samcih in samicah za vzrejo, vključno pri brejih in doječih živalih, ki so imele leglo z mladiči in v petkratnem priporočenem odmerku pri kolijih, občutljivih na ivermektin, vendar ni bilo opaženih nobenih neželenih učinkov.
The veterinary medicinal product is in polypropylene single-dose pipettes in an aluminium sachet overwrap.
Zdravilo za uporabo v veterinarski medicini se nahaja v polipropilenski enoodmerni merilni kapalki, ki je zavita v aluminijasto vrečko.
If accidental eye exposure occurs, flush the eyes immediately with water and seek medical advice immediately and show the package leaflet or the label to the physician.
Če pride zdravilo pomotoma v oči, jih takoj izperite z veliko količino vode in se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
The prolonged persistence and slow elimination of selamectin from plasma is reflected in the terminal elimination half-life values of 8 and 11 days in cats and dogs respectively.
Podaljšano vztrajanje in počasno izločanje selamektina iz plazme se odraža v končnem razpolovnem času izločanja v trajanju 8 dni pri mačkah, oziroma 11 dni pri psih.
Mild transient alopecia at the site of application has been reported rarely after use of the veterinary medicinal product in cats.
Blaga prehodna alopecija na mestu dajanja je bila redko poročana po uporabi tega zdravila za uporabo v veterinarski medicini pri mačkah.
Push the cap down to break the applicator seal.
Pritisnite pokrovček navzdol, da predrete zaporo na aplikatorju.
Treatment of ear mites (Otodectes cynotis).
• Zdravljenje ušesnih garij (Otodectes cynotis).
Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC
Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: VIRBAC
The final dose must be given within one month after the last exposure to mosquitoes.
Zadnji odmerek je potrebno dati znotraj enega meseca po zadnjem stiku živali s komarji.
Cat, dog
Mačke, psi
Transient focal irritation may also be observed very rarely.
Prehodno točkovno vzdraženje se lahko opazi zelo redko.
Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.
Zdravljenim živalim se najmanj dve uri po zdravljenju ne sme dovoliti kopanje v vodnih virih.
How to apply : Remove the product pipette from its protective package.
Kako se zdravilo nanese: Merilno kapalko z zdravilom vzemite iz zaščitnega ovoja.
Therefore, it effectively breaks the flea life cycle by killing adults (on the animal), preventing the hatching of eggs (on the animal and in its environment) and by killing larvae (environment only).
Razvojni krog bolhe prekine tako, da ubije odrasle bolhe (na živali), prepreči izleganje jajčec (na živali in v njeni okolici) in ubije ličinke (samo v okolju).
The alopecia and irritation are normally self-resolving, but symptomatic therapy may be applicable in some circumstances.
Alopecija in vzdražena koža se običajno umirita spontano, v nekaterih primerih pa je potrebno simptomatsko zdravljenje.
• Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
• Preprečevanje obolenj s srčno glisto, ki jih povzroča Dirofilaria immitis z mesečnim nanosom.
Apply the tip of the pipette directly to the skin without massaging.
Konico merilne kapalke namestite neposredno na kožo in ne masirate.
Activity has also been demonstrated against heartworm larvae.
Dokazana je bila tudi učinkovitost proti larvam srčne gliste.
Dogs (kg) Product
Psi (kg) Zdravilo
If a dose is missed and a monthly interval between dosing is exceeded then immediate administration of the veterinary medicinal product and resumption of monthly dosing will minimise the opportunity for the development of adult heartworms.
Če se kakšen odmerek izpusti in se mesečni presledek med dvema odmerkoma prekorači, se s takojšnjim dajanjem zdravila za uporabo v veterinarski medicini in ponovnim mesečnim odmerjanjem možnost razvoja odraslih oblik parazita zmanjša na najmanjšo možno mero.
Animals may be bathed 2 hours after treatment without loss of efficacy.
Živali lahko kopate 2 uri po nanosu, učinkovitost zdravila se s tem ne zmanjša.
As with other macrocyclic lactones, reversible neurological signs, including seizures, have been very rarely observed after use of the veterinary medicinal product in both dogs and cats.
Kot pri drugih makrocikličnih laktonih, so tudi po uporabi tega zdravila za uporabo v veterinarski medicini v zelo redkih primerih pri psih in mačkah opazili reverzibilne nevrološke znake vključno z epileptičnimi napadi.
Loose debris should be gently removed from the external ear canal at the time of treatment.
V času zdravljenja je treba nežno odstraniti odluščeno skorjico iz zunanjega ušesnega kanala.
The product is available in packs of one, four and twenty-four (all pipette sizes).
Proizvod je dobavljiv v pakiranju po ena, štiri ali štiri in dvajset merilnih kapalk (vse velikosti merilnih kapalk).
Debris from selamectintreated pets kills flea eggs and larvae not previously exposed to selamectin and thus may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Ostružki z živali tretiranih s selamektinom ubijejo jajčeca in ličinke bolh, ki še niso bile izpostavljene selamektinu kar lahko pripomore pri obvladovanju obstoječe infestacije okolja z bolhami na področjih, ki so dostopna živalim.
Treatment and prevention of flea infestations caused by Ctenocephalides spp.
Mačke in psi: • Zdravljenje in preprečevanje infestacij z bolhami, ki jih povzročajo vrste Ctenocephalides spp.
Selamectin has adulticidal, ovicidal and larvicidal activity against fleas.
Selamektin ima adulticidno, ovicidno in larvicidno delovanje na bolhe.
1 - Holding the pipette upright, remove the cap.
1 - Merilno kapalko držite pokončno, odstranite pokrovček.
Cat
Mačke
The product is ovicidal for 3 weeks after administration.
Zdravilo deluje ovicidno 3 tedne po dajanju.
Apply to the skin at the base of the neck in front of the shoulder blades.
Nanesite na kožo na zatilju pred robom lopatic.
This product is a skin and eye irritant.
Zdravilo draži kožo in oči.
Do not apply when the animal's hair coat is wet.
Zdravila ne nanašajte na mokro dlako živali.
• Treatment of sarcoptic mange (caused by Sarcoptes scabiei)
• Zatiranje garij vrste Sarcoptes (Sarcoptes scabiei)
Selamectin was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed.
Pri dajanju trikratnega priporočenega odmerka selamektina mačkam in psom inficiranim z odraslo obliko srčne gliste ni bilo opaženih nobenih neželenih učinkov.
The product may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with the product.
Kljub temu se v skladu z dobro veterinarsko prakso priporoča, da se vse živali stare 6 mesecev ali več, ki živijo v državah, kjer obstaja prenašalec mikrofilarij, pred pričetkom zdravljenja s tem zdravilom testirajo na prisotnost infestacije z odraslimi oblikami mikrofilarij.
Treatment of sarcoptic mange (dogs)
Zdravljenje garij vrste Sarcoptes (psi)
Do not use this veterinary medicinal product after the expiry date which is stated on the pipette, sachet and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na merilni kapalki,
When replacing another heartworm preventive veterinary medicinal product in a heartworm disease prevention programme, the first dose of the veterinary medicinal product must be given within a month of the last dose of the former medication.
Kadar s tem zdravilom za uporabo v veterinarski medicini nadomestimo druga zdravila za uporabo v veterinarski medicini v programih za preprečevanje infestacij s srčnimi glistami, je treba prvi odmerek tega zdravila dati znotraj obdobja enega meseca po zadnjem odmerjanju prejšnjega zdravila.
A single dose of the veterinary medicinal product should be administered.
Aplicirajte enkraten odmerek zdravila za uporabo v veterinarski medicini.
No undesirable effects were observed after the administration of 10 times the recommended dose of selamectin.
Pri dajanju selamektina v desetkratnem priporočenem odmerku ni bilo opaženih nobenih neželenih učinkov.
This breaks the flea life cycle and prevents flea infestations.
Življenjski krog bolh je tako prekinjen in zagotovljena je preventiva pred infestacijo z bolhami.
The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Zdravilo se lahko uporabi kot pomoč pri zdravljenju alergijskega dermatititsa, ki ga povzročajo bolhe, zaradi svojega ovicidnega in larvicidnega delovanja pa lahko pomaga pri kontroli že obstoječe infestacije okolja z bolhami na področjih, ki so dostopna živalim.
Specific pharmacovigilance requirements: PSUR submissions shall be synchronised with those for the reference product.
Oddaja rednih posodobljenih poročil o varnosti zdravila (PSUR) se sinhronizira z oddajo kot pri referenčnem zdravilu.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON, 15 MG (1, 4 AND 24 PIPETTES)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA, 15 MG (1, 4 IN 24 MERILNIH KAPALK)
The product should be administered as a single application of a single dose delivering a minimum of 6 mg/kg selamectin.
To zdravilo dajemo enkrat v enkratnem odmerku, ki zagotavlja najmanj 6 mg selamektina na kilogram telesne mase.
2 - Invert the cap and place other end back onto applicator tip.
2 - Obrnite pokrovček in ga z nasprotnim koncem namestite nazaj na vrh merilne kapalke.
It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when the product has been administered monthly.
V okviru strategije preprečevanja dirofilarioze se priporoča periodično testiranje psov na morebitno okužbo z odraslo obliko dirofilarije, tudi takrat, ko se zdravilo uporablja mesečno.
Following absorption from the skin selamectin distributes systemically and is slowly eliminated from plasma as manifested in detectable plasma concentrations in dogs and cats 30 days after administration of a single topical dose at 6 mg/kg.
Z detekcijo koncentracije selamektina v plazmi pri mačkah in psih so ugotovili, da se selamektin po resorbciji iz kože sistemsko porazdeli in se nato počasi izloča iz plazme še 30 dni po nanosu enkratnega odmerka (6 mg/kg) na kožo.