natgillin/translations-raw huggingface dataset:
For practical information about using Onglyza, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Onglyza naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
These hormones are released after a meal and stimulate the pancreas to produce insulin.
Ti hormoni se sproščajo po zaužitju hrane in spodbujajo trebušno slinavko k tvorbi insulina.
Saxagliptin does not work when the blood glucose is low.
Saksagliptin ni učinkovit, kadar je raven glukoze v krvi nizka.
In type 2 diabetes, the pancreas does not make enough insulin to control the level of glucose in the blood or the body is unable to use insulin effectively.
Pri sladkorni bolezni tipa 2 trebušna slinavka ne proizvaja dovolj insulina za vzdrževanje primerne ravni glukoze v krvi ali ga telo ne more učinkovito izrabiti.
Why is Onglyza approved?
Zakaj je bilo zdravilo Onglyza odobreno?
For the full list of all side effects reported with Onglyza, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Onglyza, glejte navodilo za uporabo.
A further study compared saxagliptin with metformin in patients who had not previously received substantial treatment with diabetes medicines.
V dodatni študiji so primerjali saksagliptin z metforminom pri bolnikih, ki predhodno niso bili zadostno zdravljeni z zdravili za zdravljenje sladkorne bolezni.
It is not intended to provide practical advice on how to use Onglyza.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
In these studies saxagliptin was used as an ‘add-on' to other diabetes medicines in patients in whom previous treatment had failed.
V teh študijah je bil saksagliptin uporabljen kot dodatek drugim zdravilom za sladkorno bolezen pri bolnikih, pri katerih predhodno zdravljenje ni bilo učinkovito.
Onglyza is a diabetes medicine used with diet and exercise to treat adults with type 2 diabetes to control their blood glucose (sugar) level.
Onglyza je zdravilo za zdravljenje sladkorne bolezni, ki se skupaj z dieto in telesno vadbo uporablja za zdravljenje odraslih s sladkorno boleznijo tipa 2 za uravnavanje ravni glukoze (sladkorja) v krvi.
The dose of Onglyza should be reduced to 2.5 mg once a day in patients with moderate or severe kidney problems.
Priporočeni odmerek je 5 mg enkrat na dan. Odmerek zdravila Onglyza je treba pri bolnikih z zmerno ali hudo okvaro ledvic zmanjšati na 2,5 mg enkrat na dan.
Saxagliptin given on its own has also been shown to be more effective than placebo at controlling blood glucose in four studies: in patients given saxagliptin HbA1c levels fell by around 0.5 percentage points more than in patients given placebo.
Saksagliptin se je tudi kot samostojno zdravilo v štirih študijah izkazal za učinkovitejšega kot placebo pri nadzorovanju glukoze v krvi: pri bolnikih, ki so ga prejemali, se je raven HbA1c znižala za približno 0,5 odstotne točke bolj kot pri bolnikih, ki so prejemali placebo.
By increasing levels of incretin hormones in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Saksagliptin s povečanjem ravni inkretinskih hormonov v krvi spodbudi trebušno slinavko k tvorjenju večjih količin insulina, kadar je raven glukoze v krvi visoka.
Onglyza has been shown to be effective at controlling blood glucose levels both on its own and as addon to other diabetes medicines.
Zdravilo Onglyza se je izkazalo za učinkovito pri uravnavanju ravni glukoze tako kot samostojno zdravilo kot kot dodatek drugim zdravilom za sladkorno bolezen.
This gives an indication of how well the blood glucose is controlled.
To je pokazatelj, kako dobro je uravnana raven glukoze v krvi.
Saxagliptin, the active substance in Onglyza, has been shown to be more effective than placebo (a dummy treatment) at controlling blood glucose in 8 main studies in over 3,900 patients.
Zdravilna učinkovina v zdravilu Onglyza, saksagliptin, se je v osmih glavnih študijah pri 3 900 bolnikih izkazala za učinkovitejšo od placeba (zdravila brez zdravilne učinkovine) pri nadzorovanju glukoze v krvi.
How does Onglyza work?
Kako zdravilo Onglyza deluje?
How is Onglyza used?
Kako se zdravilo Onglyza uporablja?
• In 565 patients not satisfactorily controlled on a thiazolidinedione (diabetes medicines such as pioglitazone and rosiglitazone), HbA1c levels fell by around 0.9 percentage points in patients adding saxagliptin compared with a fall of around 0.3 percentage points in patients who added placebo.
• Pri 565 bolnikih, katerih bolezen ni bila zadovoljivo uravnana s tiazolidinedionom (zdravili za sladkorno bolezen, kot sta pioglitazon in rosiglitazon), so ravni HbA1c padle za približno 0,9 odstotne točke pri bolnikih, ki so dodatno prejemali saksagliptin, v primerjavi z dvigom za približno 0,3 odstotne točke pri tistih, ki so dodatno prejemali placebo.
• In 534 patients not satisfactorily controlled with metformin alone, adding saxagliptin reduced HbA1c levels by around 0.9 percentage points and adding saxagliptin and dapagliflozin reduced HbA1c levels by 1.5 percentage points.
• Pri 534 bolnikih, pri katerih bolezen ni bila zadovoljivo uravnana samo z metforminom, je dodajanje saksagliptina zmanjšalo ravni HbA1c za približno 0,9 odstotne točke, dodajanje saksagliptina in dapaglifozina pa za 1,5 odstotne točke.
• In 315 patients not satisfactorily controlled with metformin and dapagliflozin, adding saxagliptin to treatment with dapagliflozin and metformin reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo was added to dapagliflozin and metformin.
• Pri 315 bolnikih, pri katerih bolezen ni bila zadovoljivo uravnana z metforminom in saksagliptinom, se je po dodajanju saksagliptina zdravljenju s dapaglifozinom in metforminom raven HbA1c znižala za 0,5 odstotne točke, v primerjavi z znižanjem za 0,2 odstotne točke, ko so zdravljenju s dapaglifozinom in metforminom dodajali placebo.
• In 768 patients not satisfactorily controlled on a sulphonylurea, HbA1c levels fell by around 0.6 percentage points in patients adding saxagliptin compared with a rise of around 0.1 percentage points in patients who added placebo.
• Pri 768 bolnikih, katerih bolezen ni bila zadovoljivo uravnana s sulfonilsečnino, so ravni HbA1c padle za približno 0,6 odstotne točke pri bolnikih, ki so dodatno prejemali saksagliptin, v primerjavi z dvigom za približno 0,1 odstotne točke pri tistih, ki so dodatno prejemali placebo.
• In 743 patients not satisfactorily controlled on metformin alone, HbA1c levels fell by around 0.7 percentage points (from around 8.1% to around 7.4%) in patients adding saxagliptin compared with a rise of around 0.1 percentage points in patients adding placebo.
• Pri 743 bolnikih, katerih bolezen ni bila zadovoljivo uravnana samo z metforminom, so ravni HbA1c padle za približno 0,7 odstotne točke (s približno 8,1 na približno 7,4 %) pri bolnikih, ki so dodatno prejemali saksagliptin, v primerjavi z dvigom za približno 0,1 odstotne točke pri tistih, ki so dodatno prejemali placebo.
• In 257 patients who took saxagliptin with metformin and a sulphonylurea, HbA1c levels fell by around 0.7 percentage points, compared with a fall of 0.1 percentage points in patients who were given placebo in place of saxagliptin.
• Pri 257 bolnikih, ki so prejemali saksagliptin z metforminom in sulfonilsečnino, so ravni HbA1c padle za približno 0,7 odstotne točke v primerjavi z upadom za približno 0,1 odstotne točke pri tistih, ki so dodatno prejemali placebo namesto saksagliptina.
• In 457 patients not satisfactorily controlled on insulin (with or without metformin), HbA1c levels fell by around 0.7 percentage points in patients adding saxagliptin compared with a fall of around 0.3 percentage points in patients adding placebo.
• Pri 457 bolnikih, katerih bolezen ni bila zadovoljivo uravnana z insulinom (z metforminom ali brez njega), so ravni HbA1c padle za približno 0,7 odstotne točke pri bolnikih, ki so dodatno prejemali saksagliptin, v primerjavi z dvigom za približno 0,3 odstotne točke pri tistih, ki so dodatno prejemali placebo.
Onglyza contains the active substance saxagliptin.
Zdravilo Onglyza vsebuje zdravilno učinkovino saksagliptin.
• In 320 patients not controlled with metformin and saxagliptin, adding dapagliflozin to saxagliptin and metformin reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.
• Še ena študija, ki je vključevala bolnike, pri katerih bolezen z metforminom in saksagliptinom ni bila uravnana, je pokazala, da se je po dodajanju dapagliflozina zdravljenju s saksagliptinom in metforminom v obdobju 24 tednov raven HbA1c znižala za 0,8 odstotne točke, v primerjavi z znižanjem za 0,1 odstotne točke, ko so zdravljenju s saksagliptinom in metforminom dodajali placebo.
These measures should help to protect the environment.
Na ta način pomagate varovati okolje.
Where necessary, cats can be re-treated at 12-week intervals.
Če je potrebno, je treba mačke zdraviti v 12-tedenskih razmikih.
EXP: {month/year}
EXP: {mesec/leto}
Weight of cat (kg)
Teža mačke (kg)
The period between treatment and return from the endemic areas should not exceed 60 days.
Obdobje med zdravljenjem in vrnitvijo na neendemično področje ne sme presegati 60 dni.
It takes up to 48 hours for the application site to become dry but it will be noticeable for longer.
Da se mesto aplikacije posuši traja do 48 ur, opazno pa je še dlje časa.
If you notice any side effects, even those not already listed in this package leaflet or you think the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
Date of first authorisation: 08/05/2018
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 08/05/2018
Each cardboard box contains 1 or 2 pipettes.
Vsaka kartonska škatla vsebuje 1 ali 2 merilni kapalki.
Intervet UK Limited Walton Manor Walton
Intervet UK Limited Walton Manor
Parasite control is recommended throughout the period of potential infestation risk.
Kontrola parazitov se priporoča skozi celotno obdobje, ko obstaja možno tveganje za infestacijo/infekcijo.
Fluralaner is an acaricide and insecticide.
Fluralaner je akaricid in insekticid.
Intervet Productions Rue de Lyons 27460 Igoville FRANCE
Intervet Productions Rue de Lyons 27460 Igoville FRANCIJA
Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
UNITED KINGDOM
ZDRUŽENO KRALJEVSTVO
Do not use directly on skin lesions.
Ne dajajte neposredno na poškodovano kožo.
This includes cuddling the animal and sharing a bed with the animal.
To vključuje ljubkovanje in spanje z živaljo v isti postelji.
Make sure that your animal's application site is no longer noticeable before resuming contact with the site of application.
Prepričajte se, da mesto apliciranja na vaši živali ni več opazno, preden imate nadaljnje stike z mestom aplikacije.
An in vitro study also demonstrated that very low concentrations of fluralaner stop the production of viable eggs by fleas.
In vitro študija je tudi dokazala, da zelo nizke koncentracije fluralanerja ustavijo proizvodnjo za življenje sposobnih jajčec pri bolhah.
In some cases, soap and water is not sufficient to remove the product spilled on the fingers, therefore gloves must be used.
V nekaterih primerih milo in voda ne zadoščata za odstranitev zdravila, ki se je razlilo po prstih, zato je treba uporabiti rokavice.
Contact may occur either directly, when handling the product, or when handling the treated animal.
Do stika z zdravilom lahko pride neposredno, bodisi pri ravnanju z zdravilom ali pri ravnanju z zdravljeno živaljo.
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
To zdravilo se lahko uporablja kot del strategije zdravljenja dermatitisa zaradi alergije na bolhe (FAD).
Pregnancy, lactation and fertility:
Brejost, laktacija in plodnost:
In the absence of available data, treatment of kittens less than 9 weeks of age and cats less than 1.2 kg bodyweight is not recommended.
Ker ni ustreznih podatkov zdravljenje s tem zdravilom ni priporočljivo za mladiče, mlajše od 9 tednov starosti in za mačke, ki tehtajo manj kot 1,2 kg.
Manufacturer responsible for batch release: Intervet Productions
Proizvajalec, odgovoren za sproščanje serij: Intervet Productions
Do not allow the product to enter water courses as this may be dangerous for fish and other aquatic organisms.
Zdravilo ne sme priti v vodotoke, ker je to lahko nevarno za ribe in druge vodne organizme.
Apply to skin.
Nanesite na kožo.
Do not allow recently treated animals to groom each other.
Ne dovolite ravnokar zdravljenim mačkam, da negujejo druga drugo.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class under specific circumstances.
Odpornost na parazite za katerikoli razred anthelmintikov se lahko razvije po pogosti, ponavljani uporabi anthelmintikov tega razreda v specifičnih okoliščinah.
Intervet UK Limited Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ United Kingdom
Intervet UK Limited Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ Združeno kraljestvo
The use of this veterinary medicinal product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Uporaba tega zdravila naj temelji na oceni vsakega posameznega primera in na lokalni epidemiološki situaciji trenutne občutljivosti ciljne živalske vrste, da bi omejili možnost prihodnje izbire za odpornost.
Care should be taken to avoid contact with the eyes of the animal.
Paziti je treba, da zdravilo ne pride v oči živali.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
For the prevention of heartworm disease caused by Dirofilaria immitis for 8 weeks.
Za preprečevanje bolezni srčne gliste, ki jih povzroča Dirofilaria immitis skozi 8 tednov.
This leads to an increased membrane permeability of nematode and arthropod nerve and/or muscle cells for chloride ions and results in hyperpolarization, paralysis and death of the parasites.
To vodi k povečani prepustnosti membrane nematodnega in artropodnega živca in / ali mišičnih celic za kloridne ione in povzroči hiperpolarizacijo, paralizo in smrt parazitov.
Treatment of male breeding animals is not recommended.
Zdravljenje moških plemenskih živali ni priporočljivo.
A used pipette should immediately be disposed of.
Uporabljeno kapalko je treba takoj zavreči.
Newly emerged fleas on a cat are killed before viable eggs are produced.
Bolhe, ki se na novo pojavijo na mačkah, so ubite, preden proizvedejo za življenje sposobna jajčeca.
No therapeutic effect against adult Dirofilaria immitis has been established.
Terapevtskega delovanja proti odraslim Dirofilaria immitis niso ugotovili.
The flea life cycle is broken due to the rapid onset of action and long lasting efficacy against adult fleas on the animal and the absence of viable egg production.
Življenjski cikel bolhe je prekinjen zaradi hitrega začetka delovanja in dolgo trajajočega učinkovanja proti odraslim bolham na živali in ker bolhe ne proizvajajo več za življenje sposobnih jajčec.
Milbemycins and avermectins have a common mode of action that is based on the binding of ligandgated chloride channels (glutamate-R and GABA-R).
Milbemicini in avermektini imajo skupen način delovanja, ki temelji na vezavi kloridnih kanalov z ligandom (glutamat-R in GABA-R).
Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested.
Izogibajte se pogostemu kopanju in šamponiranju živali, ker vzdrževanje učinkovitosti zdravila v teh primerih ni bilo preizkušano.
Do not allow treated animals to come into contact with untreated animals until the application site is dry.
Ne dovolite, da pridejo zdravljene živali v stik z nezdravljenimi, dokler se mesto nanosa ne posuši.
In case of spillage onto, for example table or floor surfaces, remove excess product using paper tissue and clean the area with detergent.
V primeru razlitja, na primer po mizi ali po tleh, poberite odvečno zdravilo s papirnato brisačo in očistite površino z detergentom.
It is therefore recommended, in accordance with good veterinary practice, that animals of 6 months of age or older and living in areas where a vector exists, should be tested for existing adult heartworm infections before application of the veterinary medicinal product for the prevention of heartworm disease.
Zato je v skladu z dobro veterinarsko prakso priporočljivo, da so mačke, stare 6 mesecev ali starejše in živijo na področjih, kjer obstaja vektor, testirane glede obstoja infekcij z odraslimi srčnimi glistami, preden apliciramo zdravila za uporabo v veterinarski medicini za preprečevanje bolezni srčne gliste.
Clear colourless to yellow solution.
Bistra brezbarvna do rumena raztopina.
This product is for topical use and should not be administered orally.
To zdravilo je za topikalno uporabo in se ne sme dajati peroralno.
It is important to apply the dose as indicated to prevent the animal from licking and ingesting the product.
Pomembno je, da nanesete odmerek, kot je navedeno, da žival ne more lizati in zaužiti zdravila.
Binding of glutamate-gated chloride channels, which are specific to invertebrates and do not exist in mammals, is considered the main mechanism for the anthelmintic and insecticidal activity.
Vezava z glutamati nadzorovanih kloridnih kanalov, ki so specifične za nevretenčarje in ne obstajajo pri sesalcih, velja za glavni mehanizem antihelmintične in insekticidne dejavnosti.
The effect on Dirofilaria immitis larvae has been shown to last over a period of 60 days after treatment with the product.
Učinek na ličinke Dirofilaria immitis dokazano traja preko 60 dni po zdravljenju z zdravilom.
Moxidectin, a semisynthetic derivative of nemadectin, belongs to the milbemycin group of macrocyclic lactones (avermectins being the other) and has parasiticidal activity against a range of internal and external parasites (including ear mites (Otodectes cynotis)).
Moksidektin, semisintetičen derivat nemadektina, spada v skupino milbemicina makrocikličnih laktonov (avermektini so druga skupina) in ima paraziticidno delovanje proti vrsti notranjih in zunanjih parazitov (vključno z ušesnimi garjami (Otodectes cynotis)).
Fluralaner has a high potency against ticks and fleas by exposure via feeding, i.e. it is systemically active on target parasites.
Fluralaner ima veliko moč proti klopom in bolham, če so mu izpostavljeni preko hranjenja, to pomeni, da je sistemsko aktiven na ciljne parazite.
In molecular on-target studies on insect GABA receptors of flea and fly, fluralaner is not affected by dieldrin resistance.
V molekularnih ciljanih študijah na GABA receptorjih bolhe in muhe, fluralanerja ne prizadene odpornost na dieldrin.
If skin contact does occur, wash the affected area immediately with soap and water.
Če pride do stika s kožo, prizadeto območje takoj sperite z milom in vodo.
Moxidectin lacks substantial efficacy against fleas and ticks.
Moksidektin nima bistvene učinkovitosti proti bolham in klopom.
The veterinary medicinal product is exclusively indicated when use against ticks or fleas and one or more of the other target parasites is indicated at the same time.
Zdravilo za uporabo v veterinarski medicini je indicirano izključno tedaj, kadar je indicirana uporaba proti klopom in bolham in proti enemu ali več drugim ciljnim parazitom istočasno.
The pipette is open and ready for application when the breaking of the seal is felt.
Kapalka je odprta in pripravljena za uporabo, ko začutite da je tesnilo počilo.
People with a sensitive skin or known allergy in general e.g. to other veterinary medicinal products of this type should handle the veterinary medicinal product as well as treated animals with caution.
Ljudje z občutljivo kožo ali znano alergijo na splošno, npr. na druga zdravila za uporabo v veterinarski medicini tega tipa, morajo z zdravili za uporabo v veterinarski medicini in z zdravljenimi živalmi ravnati previdno.
If skin reactions occur, consult a physician and show them the product packaging.
Če pride do kožnih reakcij, se posvetujte z zdravnikom in mu pokažite ovojnino zdravila.
This veterinary medicinal product does not require any special temperature storage conditions.
Za shranjevanje zdravila ni posebnih temperaturnih omejitev.
Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein.
Ugotovljeno je, da so makrociklični laktoni, ki vključujejo moksidektin, substrati za p-glikoprotein.
The onset of effect (killing effect) for ticks (I. ricinus) and fleas (C. felis) is within 48 hours after treatment.
Nastop učinka (ubijanje) za klope (I. ricinus) in bolhe (C. felis) se začne v 48 urah po zdravljenju.
This product can cause eye irritation.
Zdravilo lahko povzroči draženje oči.
The cap will stay on the pipette; it is not possible to remove it.
Pokrovček bo ostal na kapalki; ni ga mogoče odstraniti.
The sachets should only be opened immediateley prior to use.
Vrečice odprite le neposredno pred uporabo.
The need for and frequency of retreatment should be in accordance with the advice of the prescribing veterinarian and take into account the local epidemiological situation.
Potrebo za ponovno in pogosto zdravljenje mora svetovati veterinar, ki zdravljenje predpiše, upoštevati pa je treba tudi lokalno epidemiološko situacijo.
Step 3: Squeeze the pipette gently and apply the entire contents directly to the cat's skin.
Tretji korak: Narahlo stiskajte kapalko in nanesite njeno celotno vsebino neposredno na kožo.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
Moxidectin is only active on larvae (L3 and L4) of Dirofilaria immitis and not on adult worms.
Moksidektin deluje samo na ličinke (L3 in L4) Dirofilaria immitis in ne na odrasle parazite.
The safety of the veterinary medicinal product has not been established in pregnant or lactating animals and therefore use in such animals is not recommended.
Varnost zdravila za uporabo v veterinarski medicini v dobi brejosti in laktacije ni bila dokazana, zato uporaba pri teh živalih ni priporočljiva.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Bolhe in klopi se morajo pritrditi na gostitelja in se začeti hraniti, da bi bili izpostavljeni zdravilni učinkovini.