natgillin/translations-raw huggingface dataset:
This compares with 4% of those given placebo and with 48% of patients given etanercept in 2 of the main studies.
To je primerljivo s 4 % bolnikov, ki so prejeli placebo, in 48 % bolnikov, ki so v dveh glavnih študijah prejeli etanercept.
After training, patients may inject Taltz if their doctor considers it appropriate.
Bolniki si lahko po opravljenem usposabljanju sami injicirajo zdravilo Taltz, če zdravnik meni, da je to primerno.
A risk management plan has been developed to ensure that Taltz is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Taltz je bil pripravljen načrt obvladovanja tveganj.
It is given as an injection under the skin.
Daje se s podkožno injekcijo.
What benefits of Taltz have been shown in studies?
Kakšne koristi je zdravilo Taltz izkazalo v študijah?
What are the risks associated with Taltz?
Kakšna tveganja so povezana z zdravilom Taltz?
Why is Taltz approved?
Zakaj je bilo zdravilo Taltz odobreno?
What is Taltz and what is it used for?
Kaj je zdravilo Taltz in za kaj se uporablja?
After further treatment with Taltz every 4 weeks for 48 weeks, 78% of patients had clear or nearly clear skin.
Po dodatnem zdravljenju z zdravilom Taltz vsake štiri tedne v obdobju 48 tednov je imelo čisto ali skoraj čisto kožo 78 % bolnikov.
It is not intended to provide practical advice on how to use Taltz.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For the full list of all side effects and restrictions with Taltz, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Taltz glejte navodilo za uporabo.
Also, 82% of patients given Taltz had clear or nearly clear skin after 12 weeks, compared with 4% of patients given placebo and 39% of patients given etanercept
Poleg tega je imelo 82 % bolnikov, ki so prejemali zdravilo Taltz, po 12 tednih čisto oziroma skoraj čisto kožo v primerjavi s 4 % bolnikov, ki so prejemali placebo, in 39 % bolnikov, ki so prejemali etanercept.
In 2 studies, treatment was continued in patients whose psoriasis improved with Taltz given every 2 weeks for 12 weeks.
V dveh študijah se je zdravljenje nadaljevalo pri bolnikih, pri katerih se je psoriaza izboljšala v 12 tednih ob prejemanju zdravila Taltz vsaka dva tedna.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Taltz, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The active substance in Taltz, ixekizumab, is a monoclonal antibody, a protein designed to attach to interleukin 17A, a messenger molecule in the body's immune system (the body's natural defences).
Zdravilna učinkovina zdravila Taltz, iksekizumab, je monoklonsko protitelo, tj. beljakovina, ki je bila zasnovana tako, da se veže na interlevkin 17A, signalno molekulo v imunskem sistemu telesa (naravni obrambni mehanizem telesa).
Studies show that Taltz is effective in treating plaque psoriasis in patients who required systemic treatment.
Študije so pokazale, da je zdravilo Taltz učinkovito pri zdravljenju psoriaze s plaki pri bolnikih, ki potrebujejo sistemsko zdravljenje.
Taltz can only be obtained with a prescription and it should be used under the supervision of a doctor experienced in diagnosing and treating psoriasis.
Izdaja zdravila Taltz je le na recept, zdravljenje pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze.
Taltz is available as an injection in pre-filled syringes and in pen injectors.
Zdravilo Taltz je na voljo v obliki injekcije v napolnjenih brizgah in injekcijskih peresnikih.
In 3 main studies involving over 3,800 patients with psoriasis, 89% of those treated every two weeks with Taltz attained a 75% reduction in PASI scores (a measure of disease severity and area of skin affected) after 12 weeks.
V treh glavnih študijah, v katere je bilo vključenih več kot 3 800 bolnikov s psoriazo, je po 12 tednih prišlo do 75-odstotnega znižanja ocene PASI (merilo za resnost bolezni in površino prizadete kože) pri 89 % bolnikov, zdravljenih z zdravilom Taltz vsaka dva tedna.
For practical information about using Taltz, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Taltz naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Interleukin 17A is involved in immune system effects, including inflammation, that cause psoriasis.
Interlevkin 17A je vpleten v delovanje imunskega sistema, vključno z vnetjem, ki povzroča psoriazo.
By attaching to interleukin 17A, ixekizumab blocks its action and reduces the activity of the immune system and thereby reduces the symptoms of psoriasis.
Iksekizumab z vezavo na interlevkin 17A zavira njegovo delovanje, zmanjša dejavnost imunskega sistema in s tem zmanjša simptome psoriaze.
For more information about treatment with Taltz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Taltz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Plaque psoriasis improved to a greater extent in patients treated with Taltz than with placebo (a dummy treatment) or with etanercept, another medicine used to treat psoriasis.
Psoriaza s plaki se je pri bolnikih, ki so bili zdravljeni z zdravilom Taltz, izboljšala v primerjavi z bolniki, zdravljenimi s placebom (zdravilom brez zdravilne učinkovine) ali etanerceptom, tj. drugim zdravilom, ki se uporablja za zdravljenje psoriaze.
Taltz is a medicine used for treating moderate to severe plaque psoriasis, a disease causing red, scaly patches on the skin.
Zdravilo Taltz se uporablja za zdravljenje zmerne do hude psoriaze s plaki, tj. bolezni, ki povzroča rdeče, luskaste spremembe na koži.
The medicine has been shown to be effective in moderate to severe plaque psoriasis and its side effects are in line with other similar psoriasis medicines.
Zdravilo se je izkazalo za učinkovito pri zmerni do hudi psoriazi s plaki, njegovi neželeni učinki pa so v skladu z drugimi podobnimi zdravili za zdravljenje psoriaze.
How does Taltz work?
Kako zdravilo Taltz deluje?
How is Taltz used?
Kako se zdravilo Taltz uporablja?
Taltz contains the active substance ixekizumab.
Zdravilo vsebuje zdravilno učinkovino iksekizumab.
28 x 1tablets (unit dose) (calendar pack)
28x1 tableta (enoodmerni pretisni omoti) (koledarsko pakiranje)
A patient card shall be distributed to all patients, including:
Kartica za bolnika bo razdeljena vsem bolnikom, vključno z:
An education program to the health care professionals (HCP) (doctors-nurses-pharmacists) shall address,
Izobraževalni program za zdravstveno osebje (zdravnike-medicinske sestre-farmacevte) bo obsegal,
- Promote awareness of appropriate metabolic monitoring by distributing utilized published antipsychotic guidelines.
- Podpirati pomen ustreznega spremljanja presnove z razdeljevanjem koristnih, objavljenih antipsihotičnih smernic.
1) Description of post injection syndrome - Education about the 2 intramuscular formulations of olanzapine, including packaging differences - Description of reconstitution and proper administration technique - Recommendation for a 3-hour on-site observation period post injection - Recommendation that prior to giving the injection, the HCP should determine that the patient will clinical manifestation in post injection syndrome events - Recommendation for appropriate monitoring until the event resolves if an event should occur 2) Recommendations for monitoring of patients for glucose, lipids, and weight.
1) Opis sindroma po injiciranju - Izobraževanje glede 2 intramuskularnih oblik olanzapina, vključno z različnimi pakiranji - Opis rekonstitucije in pravilnih tehnik injiciranja - Priporočilo za 3-urno opazovanje na mestu po injiciranju - Priporočilo, da pred dajanjem injekcije zdravstveno osebje zagotovi, da bolnik ne bo sam odšel do svojega doma - Priporočilo o obvestilu bolnikom, da preostanek dneva po injiciranju ne vozijo in ne upravljajo s stroji, da morajo biti pozorni na znake in simptome sindroma po injiciranju ter da morajo imeti možnost po potrebi poiskati pomoč - Opis najpogostejših simptomov, ki so jih poročali pri prevelikem odmerjanju olanzapina in predstavljajo klinično izražene učinke pri sindromu po injiciranju - Priporočilo za ustrezno spremljanje bolnikov, dokler se, v primeru pojava učinkov, učinki ne izboljšajo 2) Priporočila za spremljanje bolnikov glede glukoze, lipidov in telesne mase.
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Država članica mora zagotoviti, da bodo vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, kot so opisani spodaj, izvedeni:
- Description of post injection syndrome - Recommendation for a 3-hour on-site observation period post injection - Recommendation that prior to giving the injection, the HCP should determine that the patient will clinical manifestation in post injection syndrome events - Recommendation for appropriate monitoring until the event resolves if an event should occur
- Opis sindroma po injiciranju - Priporočilo za 3-urno opazovanje na mestu po injiciranju - Priporočilo, da pred dajanjem injekcije zdravstveno osebje zagotovi, da bolnik ne bo sam odšel do svojega doma - Priporočilo o obvestilu bolnikom, da preostanek dneva po injiciranju ne vozijo in ne upravljajo s stroji, da morajo biti pozorni na znake in simptome sindroma po injiciranju ter da morajo imeti možnost po potrebi poiskati pomoč - Opis najpogostejših simptomov, ki so jih poročali pri prevelikem odmerjanju olanzapina in predstavljajo klinično izražene učinke pri sindromu po injiciranju - Priporočilo za ustrezno spremljanje bolnikov, dokler se, v primeru pojava učinkov, učinki ne izboljšajo
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI MORAJO BITI IZVEDENI V DRŽAVAH ČLANICAH
These reactions were generally mild in nature.
Te reakcije so bile na splošno blage.
There is a low possibility of an allergic reaction in sensitised individuals.
Obstaja majhna možnost alergijske reakcije pri občutljivih osebah.
A U-40 syringe must be used.
Uporabiti je treba brizgo U-40.
*produced by recombinant DNA technology
*izdelano s tehnologijo rekombinantne DNK
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
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/).
Do not use for the acute management of diabetic ketoacidosis.
Ne uporabljajte za akutno zdravljenje diabetične ketoacidoze.
Stress and irregular exercise should be avoided.
Izogniti se je treba stresu in neredni fizični aktivnosti.
A white ring may be seen in the neck of some vials, but this does not affect the quality of the product.
V vratu nekaterih vial je lahko viden bel obroč, ki pa ne vpliva na kvaliteto zdravila.
Cloudy, white, aqueous suspension.
Motna, bela, vodna suspenzija.
One IU (International Unit) corresponds to 0.0347 mg of insulin human.
Ena i.e. (mednarodna enota) ustreza 0,0347 mg humanega insulina.
Therefore, close glucose monitoring and veterinary supervision is advised.
Zato se priporoča skrbno spremljanje glukoze in veterinarski nadzor.
Store upright in a refrigerator (2 °C - 8 °C).
Shranjujte pokončno v hladilniku (2 °C - 8 °C).
Cats and dogs
Mačke in psi
Re-evaluation of clinical signs and laboratory parameters should be performed as recommended by the attending veterinarian.
Ponovno oceno kliničnih znakov in laboratorijskih parametrov je treba opraviti v skladu s priporočili veterinarja.
Amendment of the periodic safety update report (PSUR) cycle is required, as detailed in the CVMP assessment report.
Potrebna je prilagoditev cikla poročila o varnosti zdravila (PSUR), kot je podrobno opisano v poročilu o oceni CVMP.
Store upright in a refrigerator.
Shranjujte pokončno v hladilniku.
In the majority of cats the glucose lowering effect lasted for a minimum of 9 hours after first insulin injection.
Pri večini mačk je trajal učinek nižanja ravni glukoze vsaj 9 ur po prvem injiciranju insulina.
For unused and broached vials:
Za neuporabljene in načete viale:
Dosing should be individualised and based on the clinical presentation of each patient.
Odmerjanje bi moralo biti individualno in določeno v skladu s klinično sliko vsakega pacienta.
Particular care should be taken with regard to the accuracy of dosing.
Posebno skrbno morate paziti na natančnost odmerjanja.
General guidance:
Splošne smernice:
EXP {month/year} Once broached use by ...
EXP {mesec/leto} Načeto zdravilo uporabite do …
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in viali po EXP.
Specific pharmacovigilance requirements:
Posebne farmakovigilančne zahteve:
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov proizvajalca odgovornega za sproščanje zadevne serije.
In the absence of compatibility studies, this product must not be mixed with other veterinary medicinal products.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
Avoid introduction of contamination during use.
Pazite, da med uporabo ne bo prišlo do kontaminacije.
The liver and the kidney are the two main organs which eliminate insulin from the circulation.
Jetra in ledvice sta dva glavna organa, ki insulin izločata iz obtoka.
In general, insulin requirements during pregnancy and lactation might be different due to a change in the metabolic state.
Na splošno so lahko potrebe po insulinu med brejostjo in laktacijo drugačne zaradi spremembe metaboličnega stanja.
ATCvet code: QA10AC01 Insulin (human).
Oznaka ATCvet: QA10AC01 insulin (humani).
The veterinarian should re-evaluate the animal at appropriate intervals and make adjustments to the treatment protocol, for instance dose and dosing regimen, until adequate glycaemic control has been attained.
Veterinar naj ponovno oceni žival v ustreznih intervalih in prilagodi protokol zdravljenja, na primer odmerek in shemo odmerjanja, dokler ni dosežen ustrezen glikemični nadzor.
Local injection site reactions were very rarely reported and resolved without cessation of therapy.
Zelo redko so poročali o lokalnih reakcijah na mestu injiciranja, ki so izginile brez prekinitve zdravljenja.
Any dose adjustment (i.e. increase of dose) should be in general performed after several days (e.g. 1 week) since full action of insulin requires an equilibration phase.
Vsako prilagajanje odmerka (tj. večanje odmerka) je treba načeloma izvesti po nekaj dneh (npr. po 1 tednu), saj mora za razvoj polnega delovanja insulina preteči čas za vzpostavitev ravnovesja.
The safety and efficacy of ProZinc in breeding, pregnant and lactating animals has not been evaluated.
Varnost in učinkovitost zdravila ProZinc v obdobju razmnoževanja, brejosti in laktacije živali nista bili ugotovljeni.
The dose should be given concurrently with or immediately after a meal.
Odmerek je treba dati hkrati z obrokom ali takoj za njim.
The main effects of insulin are the reduction in circulating blood glucose concentrations and the storage of fat.
Glavna učinka insulina sta zmanjšanje koncentracij glukoze v krvnem obtoku in shranjevanja maščob.
Keep the vial in the outer carton in order to protect from light.
Vialo shranjujte v zunanji ovojnini za zaščito pred svetlobo.
If the animal owner is to administer the product, suitable training/advice should be provided by the prescribing veterinarian before using for the first time.
Če bo zdravilo dajal lastnik živali, mu mora veterinar, ki zdravilo predpiše, pred prvo uporabo zagotoviti ustrezno usposabljanje/svetovanje.
THE WORDS "FOR ANIMAL TREATMENT ONLY"
BESEDILO “SAMO ZA ŽIVALI”
Target tissue organs are i.e. liver, muscle and adipose tissue.
Tarčni tkivni organi so npr. jetra, mišice in maščobno tkivo.
The owner is advised to have glucose containing products (e.g. honey, dextrose gel) in the household.
Lastniku je treba svetovati, naj ima v gospodinjstvu izdelke, ki vsebujejo glukozo (npr. med, dekstrozni gel).
Very stressful events, inappetance, concomitant treatment with gestagens and corticosteroids or other concomitant diseases (e.g. gastro-intestinal, infectious or inflammatory or endocrine diseases), might influence insulin effectiveness and therefore the insulin dose may need to be adjusted.
Zelo stresni dogodki, pomanjkanje apetita, sočasno zdravljenje z gestageni in kortikosteroidi ali druge sočasne bolezni (npr. gastrointestinalne, kužne, vnetne ali endokrine bolezni) lahko vplivajo na učinkovitost insulina, zato bo morda treba odmerek insulina prilagoditi.
Overall insulin influences the regulation of the carbohydrate and fat metabolism.
Na splošno insulin vpliva na regulacijo presnove ogljikovih hidratov in maščob.
- Adjustments of insulin dose if required should usually be done between 0.5 to 1 IU insulin per injection.
- Prilagajanje odmerka insulina, če je potrebno, se običajno opravi med 0,5-1 i.e. insulina na injekcijo.
Adjustments of insulin dose on a once daily regimen, if required, should generally be done in a conservative and gradual manner, (e.g. up to 25% increase/decrease of the dose per injection).
Prilagoditve odmerka insulina na dajanje enkrat na dan, po potrebi, je treba na splošno izvajati konzervativno in postopno (npr. do 25% povečanje/zmanjšanje odmerka na injekcijo).
After the daily insulin dose is established, monitoring for diabetic control is recommended.
Po določitvi dnevnega odmerka insulina se priporoča spremljanje, ali je sladkorna bolezen pod nadzorom.
To achieve optimal control of diabetes mellitus, dose adjustments should primarily be based on clinical signs.
Za doseganje optimalnega nadzora sladkorne bolezni morajo prilagoditve odmerkov temeljiti predvsem na kliničnih znakih.
Fourty per cent of insulin is eliminated by the liver and 60% is eliminated by the kidney.
Jetra izločijo 40 % insulina in ledvice 60 %.
Insulin activates insulin receptors and therewith a complex cell signaling cascade which results in increased glucose uptake into the cells.
Insulin aktivira receptorje insulina in s tem kompleksno kaskado celičnega signaliziranja, kar povzroči povečan privzem glukoze v celicah.
Pharmacotherapeutic group: Insulins and analogues for injection, intermediate acting.
Farmakoterapevtska skupina: Insulini in analogi za injiciranje, s srednje dolgim delovanjem.
Dose reductions due to observed hypoglycaemia or suspected Somogyi effect (rebound hyperglycaemia) may be of 50% or higher (potentially including a temporary pause of insulin administration).
Odmerek se lahko zaradi opažene hipoglikemije ali suma na Somogyijev učinek (povratna hiperglikemija) zmanjša za 50 % ali več (lahko vključuje začasno prekinitev dajanja insulina).
The suspension should be mixed by gently rolling the vial prior to withdrawing each dose from the vial.
Zdravilo je treba nežno premešati z vrtenjem viale, preden iz viale potegnete odmerek.
In cases where hypoglycaemia is suspected, blood glucose measurements should be taken at the time of occurrence (if possible) as well as shortly prior to the next feeding/injection (where applicable).
V primerih, kjer obstaja sum hipoglikemije, je treba meritve glukoze v krvi opraviti ob pojavu le-te (če je mogoče) in malo pred naslednjim hranjenjem/ injiciranjem (kjer je to primerno).
In case of accidental self-injection seek medical advice immediately and show the package leaflet to the physician.
V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo.
After subcutaneous injection, proteolytic tissue enzymes degrade protamine to permit the absorption of insulin.
Po subkutani injekciji proteolitični tkivni encimi razkrojijo protamin in omogočijo absorpcijo insulina.
Protamine zinc recombinant human insulin is an insulin whose absorption and onset of action is delayed by the addition of protamine and zinc leading to crystal formation.
Rekombinantni humani protamin-cink-insulin je insulin, katerega absorpcija in začetek delovanja se zamakneta z dodajanjem protamina in cinka, kar povzroči nastajanje kristalov.
In this case immediate administration of a glucose containing solution or gel and/or food is required.
V tem primeru je potrebna takojšnja uporaba raztopine, ki vsebuje glukozo ali gela in/ali hrane.
In those cases sufficient endogenous insulin production will be regained and the exogenous insulin dose will need to be adjusted or ceased.
V teh primerih bo zadostna endogena proizvodnja insulina ponovno dosežena in odmerek eksogenega insulina je treba prilagoditi ali ga prenehati dajati.
For newly diagnosed diabetic dogs, a starting dose of 0.5 IU insulin/kg once daily is recommended.
Za novo diagnosticirane diabetične pse je priporočljiv začetni odmerek 0,5 i.e. insulina/kg enkrat dnevno.
- Switching to twice daily dosing: In such cases, it is recommended to reduce the dose per injection by one third (e.g. 12 kg dog being treated once daily with 12 IU insulin/injection may be switched to 8 IU insulin/injection administered twice daily).
- Prehod na odmerjanje dvakrat na dan: v takih primerih je priporočljivo zmanjšati odmerek na injekcijo za tretjino (npr. za 12 kg psa, ki se zdravi enkrat dnevno z 12 i.e. insulina/injekcijo se lahko naredi prehod na 8 i.e. insulina/injekcijo, ki se daje dvakrat na dan).
Following the binding of insulin with the insulin receptor and the subsequent action, insulin is released back into the extracellular environment.
Po vezavi insulina z receptorji insulina in po dogodkih, ki sledijo, se insulin sprosti nazaj v ekstracelularno okolje.
The product should be administered in the morning and in the evening, approx. 12 hours apart.
Zdravilo je treba dajati zjutraj in zvečer, pribl.
If insufficient improvement in diabetic control is observed after an adequate dose adjustment period of 4 to 6 weeks on once daily treatment, the following options may be considered: - Further adjustments of insulin dose on once daily treatment may be necessary; in particular if dogs undertake increased physical activity, have a change of their usual diet or during concomitant illness.
Če po ustreznem prilagajanju odmerka od 4 do 6 tednov pri enkratnem dnevnem zdravljenju ni zadostnega izboljšanja diabetičnega nadzora, se lahko upoštevajo naslednje možnosti: - Morda bodo potrebne dodatne prilagoditve odmerka insulina enkrat na dan; zlasti, če imajo psi povečano fizično aktivnost, če se jim spremeni njihova običajna prehrana ali med sočasno drugo boleznijo.
Insulin administration should be temporarily stopped and the next dose of insulin adjusted appropriately.
Dajanje insulina je treba začasno ustaviti in naslednji odmerek insulina ustrezno prilagoditi.
- For cats previously controlled on insulin, a higher starting dose up to 0.7 IU insulin/kg bodyweight may be appropriate.
- Za mačke, ki so bile predhodno nadzorovane z insulinom, je morda ustrezen višji začetni odmerek do 0,7 i.e. insulina/kg telesne mase.
Active substance: Insulin human*
Učinkovina: insulin, humani *
Similarly, changing the diet may alter insulin requirements and necessitate a change of insulin dose.
Podobno lahko sprememba diete spremeni potrebo po insulinu in zahteva spremembo odmerka insulina.