natgillin/translations-raw huggingface dataset:
However, cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have switched from immediate-release nicotinic acid to long-acting nicotinic acid at equivalent doses.
Vendar pa so se pri bolnikih, ki so z nikotinske kisline s takojšnjim sproščanjem prešli na njeno dolgodelujočo obliko v enakovrednem odmerku, pojavili primeri hudih toksičnih učinkov na jetra (vključno s fulminantno nekrozo jeter).
NAME OF THE MEDICINAL PRODUCT Tredaptive 1,000 mg/20 mg modified-release tablets.
Tredaptive 1.000 mg/20 mg tablete s prirejenim sproščanjem
For patients switching from immediate-release nicotinic acid to Tredaptive, therapy should be initiated at the 1,000 mg/20 mg dose and advanced to the 2,000 mg/40 mg maintenance dose after four weeks.
mora zdravljenje z zdravilom Tredaptive začeti z odmerkom 1.000 mg/20 mg in po 4 tednih preiti na vzdrževalni odmerek 2.000 mg/40 mg.
Switching from immediate-release (crystalline) nicotinic acid to Tredaptive has not been studied.
Učinki na jetra Prehod z nikotinske kisline s takojšnjim sproščanjem (kristalne nikotinske kisline) na zdravilo
Acute coronary syndrome
Pet-letna študija Coronary
It should be used with caution in patients with renal insufficiency, because nicotinic acid and its metabolites are primarily excreted by the kidneys (see sections 4.3, 4.4 and 5.2).
Previdno ga morate uporabljati pri bolnikih z ledvično insuficienco, kajti nikotinska kislina in njeni presnovki se izločajo predvsem skozi ledvice
Effect on lipids
Klinične študije Učinek na lipide
The apparent terminal half-life (t1/2) following a 40 mg dose of laropiprant administered as two modified-release tablets of nicotinic acid/laropiprant with food was approximately 17 hours.
uporabljenem v dveh tabletah laropipranta/nikotinske kisline s prilagojenim sproščanjem in s hrano, je bil približno 17 ur.
No adverse effects on fertility were observed in male or female rats given laropiprant prior to mating and throughout mating, at systemic exposure levels at least 289 times the human exposure based on the AUC of the recommended daily human dose.
Pri podganjih samcih in samicah niso opazili neželenih učinkov na plodnost, ko so živali dobivale laropiprant pred parjenjem in med parjenjem v sistemski izpostavljenosti, vsaj 289-krat tolikšni, kot je
LDL cholesterol, fatty substances called triglycerides and apo B (a part of LDL) in the blood;
Ta učinek zdravilo doseže tako, da v krvi zniža raven celotnega holesterola, LDL holesterola, maščobnih snovi, imenovanih trigliceridi, in apo B (ki je del
Those patients switching from 2,000 mg or more of prolonged-release nicotinic acid can initiate Tredaptive at the 2,000 mg/40 mg dose.
Če bolnik preide na zdravilo Tredaptive s pripravka nikotinske kisline s podaljšanim sproščanjem, ki ga je jemal v odmerku 2.000 mg ali več, lahko zdravilo Tredaptive začne jemati v odmerku
Effects of other medicinal products on nicotinic acid Bile acid sequestrants: Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Učinki drugih zdravil na nikotinsko kislino Izmenjevalci žolčnih kislin: Sočasna uporaba izmenjevalcev žolčnih kislin lahko zmanjša biološko uporabnost kislih zdravilnih učinkovin, kakršna je nikotinska kislina.
• a sudden serious allergic reaction (anaphylactic shock).
(samostojno in/ali skupaj z določenimi drugimi zdravili za zniževanje ravni holesterola) poročali o: • nenadni resni alergijski reakciji (anafilaktičnem šoku).
Patients who develop increased transaminase levels should be monitored until the abnormalities have resolved.
Če se transaminaze zvišajo, morate bolnika spremljati,
Similar treatment-related changes were observed in rabbit foetuses but in the presence of maternal toxicity at exposure levels approximately 629 times the human AUC of nicotinic acid at the recommended daily human dose.
Podobne, z zdravilom povezane spremembe, so pri izpostavljenostih, ki so bile približno 629-kratnik vrednosti
If you are not sure, talk to your doctor or pharmacist before taking Tredaptive.
Če ste negotovi, se, preden vzamete zdravilo Tredaptive, posvetujte z zdravnikom ali s farmacevtom.
Therefore, Tredaptive should be used with caution in patients with or predisposed to gout.
Zato morate pri bolnikih, nagnjenih k protinu, zdravilo Tredaptive previdno uporabljati.
Laropiprant is metabolised primarily via acyl glucuronidation, with a smaller component of oxidative metabolism, followed by excretion of the glucuronide into faeces (via bile) and urine.
Laropiprant Laropiprant se presnovi predvsem z acilglukuronidacijo, z manjšim deležem oksidativne presnove;
Aluminium/Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.
Velikosti pakiranj: 14, 28, 56, 168 tablet s prirejenim sproščanjem ter 32 x 1 tableta s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
STATEMENT OF ACTIVE SUBSTANCE(S) Each modified-release tablet contains 1,000 mg of nicotinic acid and 20 mg of laropiprant.
Ena tableta s prirejenim sproščanjem vsebuje 1.000 mg nikotinske kisline in 20 mg laropipranta.
168 modified-release tablets
168 tablet s prirejenim sproščanjem 32 x 1 tableta s prirejenim sproščanjem
Tredaptive was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Tredaptive je bil enako učinkovit v vseh skupinah populacije bolnikov, ne glede na raso, spol,
• You should start by taking one tablet a day.
• Na začetku morate jemati po eno tableto na dan. • Po 4 tednih vam zdravnik lahko odmerek poveča na dve tableti na dan.
These signs resolved without treatment.
Ti simptomi so minili brez zdravljenja.
See also point 4.4.
Glejte poglavje 4.4.
Special warnings:
Posebna opozorila:
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.
Another GnRH analogue has been shown to be foetotoxic in laboratory animals.
Za neki drug analog GnRH so dokazali, da je pri laboratorijskih živalih fetotoksičen.
The biocompatible implant does not require removal.
Biokompatibilnega implantata ni treba odstraniti.
The actuator can be re-used.
Aktivator lahko uporabite večkrat.
The treated hobs may remain infertile up to four years.
Obravnavani samci, ki so prejeli implantat, lahko ostanejo neplodni do štiri leta.
2 implants preloaded in implanters + 1 actuator 5 implants preloaded in implanters + 1 actuator
2 implantata, napolnjena v implantatorja + 1 aktivator 5 implantatov, napolnjenih v implantatorje + 1 aktivator
Disinfection of the implantation site should be undertaken prior to implantation to avoid introduction of infection.
Pred implantacijo je treba dezinficirati mesto implantacije, da preprečimo vnos okužbe.
The metabolism of deslorelin is rapid.
Presnova deslorelina je hitra.
Dogs (male).
Psi (samci).
Implants may be located using ultrasound.
Implantate lahko poiščemo z ultrazvokom.
Examine the syringe and needle to ascertain that the implant has not remained within the syringe or needle, and that the spacer is visible.
Preglejte brizgo in iglo, da se boste prepričali, da implantat ni ostal v brizgi ali igli in da je distančnik viden.
Press the skin at the insertion site as the needle is withdrawn, and maintain pressure for 30 seconds.
Potem ko iglo izvlečete, pritisnite na kožo na mestu insercije in vzdržujte pritisk 30 sekund.
This suppression results in the failure of treated animals to synthesise and/or release follicle stimulating hormone (FSH) and luteinising hormone (LH), the hormones responsible for the maintenance of fertility.
To zaviranje tretiranim živalim prepreči, da bi sintetizirale in/ali sproščale folikle stimulirajoči hormon (FSH) in luteinizirajoči hormon (LH), ki sta odgovorna za vzdrževanje plodnosti.
Lift the loose skin between the shoulder blades.
Dvignite ohlapno kožo med lopaticama.
The veterinary medicinal product should therefore be used prudently in hobs intended for future reproduction.
Zdravilo za uporabo v veterinarski medicini je zato pri samcih, namenjenih za nadaljnje razmnoževanje, treba uporabljati previdno.
Therefore, the use of Suprelorin should be subject to a benefit/risk assessment performed by the responsible veterinarian.
Zato je uporaba Suprelorina odvisna od ocene razmerja med tveganjem in koristjo, ki jo opravi pristojni veterinar.
Hydrogenated palm oil Lecithin
Hidrogenirano palmovo olje Lecitin
Levels of testosterone remain below 0.1 ng/ml for at least 16 months.
Raven testosterona ostane pod 0,1 ng/ml za vsaj 16 mesecev.
Specific studies to evaluate the effect of deslorelin when administered during pregnancy have not been conducted.
Specifičnih raziskav, s katerimi bi ocenili učinek dislorelina pri dajanju v nosečnosti, niso opravili.
Avoid injection of the implant into fat, as release of the active substance might be impaired in areas of low vascularisation.
Ne vbrizgajte implantata v maščevje, ker bo sproščanje aktivne učinkovine v predelih z majhno vaskularizacijo morda zmanjšano.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
Za vse morebitne nadaljnje informacije o tem zdravilu za uporabo v veterinarski medicini se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, Gonadotropinreleasing hormones (GnRH), ATCvet code: QH01CA93.
Farmakoterapevtska skupina: Hipofizni in hipotalamični hormoni ter sorodne učinkovine, gonadotropin sproščujoči hormoni (GnRH), oznaka ATC vet: QH01CA93.
Fully depress the actuator plunger and, at the same time, slowly withdraw the needle.
Do konca potisnite bat aktivatorja in hkrati počasi izvlecite iglo.
The reversibility of effects and ability of treated hobs to produce offspring subsequently has not been investigated.
Reverzibilnost učinkov in sposobnosti obravnavanih samcev, da zaplodijo potomce ni bila raziskana.
The GnRH agonist, deslorelin, acts by suppressing the function of the pituitary-gonadal axis when applied in a low, continuous dose.
Agonist GnRH deslorelin deluje tako, da zavira delovanje hipofizno-gonadne osi, če ga dajemo v majhnem, stalnem odmerku.
If the hair is long, a small area may be clipped, if required.
Če je dlaka dolga, je treba mogoče majhen predel postriči.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10/07/2007
Datum pridobitve dovoljenja za promet: 10/07/2007 Datum zadnjega podaljšanja dovoljenja za promet: 17/05/2017
Dogs and ferrets:
Psi in beli dihurji:
However, should it be necessary to end treatment, implants may be surgically removed by a veterinarian.
Če pa bi bilo treba prekiniti učinkovanje zdravila, lahko veterinar implantate kirurško odstrani.
It may be possible to palpate the implant in situ.
Mogoče boste lahko otipali implantat in situ.
Cardboard carton containing either two or five individually foil wrapped implanters that have been sterilised, together with an implanting device (actuator) that is not sterilised.
Kartonasta škatla, ki vsebuje bodisi dva bodisi pet implantatorjev, posamič zapakiranih v folijo in steriliziranih, skupaj s pripravo za implantacijo (aktivatorjem), ki ni sterilizirana.
In ferrets: Transient moderate swelling, pruritus and erythema at the implant site were commonly observed during clinical studies.
Pri belih dihurjih: Prehodno zmerno oteklino, srbenje in pordelost na mestu implantata so pogosto opazili med kliničnimi študijami.
Treatment in ferrets should be initiated at the beginning of the breeding season.
Pri belih dihurjih je z uporabo treba začeti na začetku paritvene sezone.
Surgical or medical castration might have unexpected consequences (i.e. improvement or worsening) on aggressive behaviour.
Kirurška ali kastracija z zadrilom lahko nepredvideno vpliva (t. j. izboljša ali poslabša) na agresivno obnašanje.
In 2 out of 30 dogs in the clinical trial infertility was not achieved until approximately 12 weeks after initial treatment, but in most cases these animals were not capable of successfully siring offspring.
Dva od 30 psov v kliničnih preskusih nista postala neplodna do približno 12 tednov po prvi uporabi zdravila, vendar v večini primerov te živali niso bile sposobne uspešno zaploditi zaroda.
Data demonstrate that treatment with the product will reduce the libido of the dog.
Podatki kažejo, da bo dajanje zdravila zmanjšalo libido psa.
The safety after repeated implantations with Suprelorin in ferrets has not been investigated.
Varnost po večkratni implantaciji s Suprelorinom pri belih dihurjih ni bila raziskana.
Only testosterone levels (i.e. an established surrogate marker of fertility) could definitely confirm a lack of efficacy of the treatment.
Pomanjkljivo učinkovitost postopka bi lahko z gotovostjo potrdila samo raven testosterona (t. j. določen nadomestni marker plodnosti).
In both of these circumstances a replacement implant should be administered.
V obeh primerih je treba uporabiti nadomestni implantat.
Surgical or medical castration might have unexpected consequences (i.e. improvement or worsening) on aggressiveness.
Kirurška ali kastracija z zdravilom lahko nepredvideno vpliva (t. j. izboljša ali poslabša) na agresivno obnašanje.
Pregnant women should not administer the veterinary medicinal product.
Nosečnice zdravila za uporabo v veterinarski medicini ne smejo dajati.
In very rare cases the temporary infertility may last more than 18 months.
V zelo redkih primerih lahko začasna neplodnost traja več kot 18 mesecev.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton.
Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leti
In rare cases (>0.01 % to < 0.1%), suspected lack of expected efficacy has been reported (in the majority of cases a lack of reduction of testicle size was reported and/or a bitch was mated).
V redkih primerih (>0,01 % do < 0,1%) je prišlo do suma pomanjkljive učinkovitosti (v večini primerov je prišlo do premajhnega zmanjšanja velikosti mod in/ali paritve psice).
Infertility is achieved from 6 weeks up to at least 6 months after initial treatment.
Neplodnost se doseže za čas od 6 tednov do najmanj 6 mesecev po začetni uporabi.
Thus dogs with sociopathic disorders and showing episodes of intra-specific (dog to dog) and/or inter-specific (dog to another species) aggressions should not be castrated either surgically or with the implant.
Zato psov s sociopatskimi motnjami ali z epizodami intra-specifičnih (psa na psa) in/ali inter-specifičnih (psa na drugo vrsto) agresij ni dovoljeno kastrirati tako kirurško kot z implantatom.
Administer one implant only, irrespective of the size of the ferret.
Dajte samo en implantat, ne glede na velikost belega dihurja.
If lack of treatment efficacy is suspected, then the dog's implant (e.g. presence) should be checked.
V primeru pomanjkljive učinkovitosti postopka je treba preveriti pasji implantat (t. j. prisotnost).
Special precautions for use in animals
Posebni previdnostni ukrepi za uporabo pri živalih Psi
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).
The recommended dose is one implant per dog, irrespective of the size of the dog (see also point 4.4).
Priporočeni odmerek je en implantat na psa ne glede na velikost psa (glej tudi poglavje 4.4).
Each pre-loaded implanter is packaged in a sealed foil pouch, which is subsequently sterilised.
Vsak napolnjen implantator je zapakiran v neprodušno zaprto vrečko iz folije in je, nato steriliziran.
It has been shown that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin.
Koncentracija deslorelina v plazmi je najvišja 7 do 35 dni po vsaditvi implantata, ki vsebuje 5 mg radioaktivno označenega deslorelina.
During clinical trials with Suprelorin 4.7 mg, the mean duration of testosterone suppression was 1.5 times longer among smaller size dogs (<10 kg) compared with all larger dogs.
Med kliničnimi preskusi s Suprelorinom 4,7 g, je bilo povprečje znižane koncentracije testosterona 1,5-krat daljše pri manjših psih (<10 kg) kot pri vseh večjih psih.
Dogs (male) and ferrets (male).
Psi (samci) in beli dihurji (samci).
The use of the veterinary medicinal product in dogs of less than 10 kg or more than 40 kg bodyweight, therefore, should be subject to a risk/benefit assessment performed by the veterinarian.
Pri uporabi zdravila za uporabo v veterinarski medicini pri psih s telesno težo, manjšo od 10 kg ali večjo od 40 kg, je zato potrebna ocena razmerja med tveganjem in koristjo, ki jo opravi veterinar.
Measurement of plasma concentrations of testosterone has demonstrated the persistent pharmacological effect of the continuing presence of deslorelin in the circulation for at least 12 months following administration of the veterinary medicinal product.
Meritve plazemskih koncentracij testosterona so pokazale trajen farmakološki učinek stalne prisotnosti deslorelina v krvnem obtoku vsaj 12 mesecev po vsaditvi zdravila.
Do not use after the expiry date which is stated on the carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
Measurement of plasma concentrations of testosterone has demonstrated the persistent pharmacological effect of the continuing presence of deslorelin in the circulation for at least six months following administration of the veterinary medicinal product.
Meritve plazemskih koncentracij testosterona so pokazale trajen farmakološki učinek stalne prisotnosti deslorelina v krvnem obtoku vsaj šest mesecev po vsaditvi zdravila.
Tissue glue can be used to close the site of administration if required.
Priporočljivo je uporabiti lepilo za tkivo, da zaprete mesto implantacije, če je to potrebno.
During clinical trials, most of the smaller size dogs (<10 kg) maintained suppressed levels of testosterone for more than 12 months following implantation.
Med kliničnimi preskusi je večina manjših psov (<10 kg) vzdrževala znižane koncentracije testosterona več kot 12 mesecev po implantaciji.
Infertility is achieved from 8 weeks up to at least 12 months after initial treatment.
Neplodnost se doseže za čas od 8 tednov do 12 mesecev po začetni uporabi.
In very rare cases, there has been transitory increased sexual interest, increased testicle size and testicular pain immediately after implantation.
V zelo redkih primerih je takoj po implantaciji prišlo do prehodnega povečanega spolnega zanimanja, povečane velikosti mod in bolečin v modih.
Due to limited data, the use of Suprelorin in dogs of less than 10 kg or more than 40 kg bodyweight should be subject to a risk/benefit assessment performed by the veterinarian.
Zaradi omejenih podatkov je uporaba Suprelorina pri psih, lažjih od 10 kg in težjih od 40 kg, odvisna od ocene razmerja med tveganjem in koristjo, ki jo opravi veterinar.
The need for subsequent implantations should be based on the increase in testis size and/or increase in plasma testosterone concentrations and return to sexual activity.
Potreba po naslednji implantaciji mora temeljiti na povečanju velikosti testisov in/ali povečanju plazemske koncentracije testosterona ter vrnitvi spolne aktivnosti.
For very large dogs (>40 kg), data are limited but duration of testosterone suppression was comparable to that seen in medium and large dogs.
Za zelo velike pse (>40 kg) so podatki omejeni, vendar je bilo trajanje supresije testosterona primerljivo s trajanjem, ugotovljenim pri srednjih in velikih psih.
06516 Carros France
06516 Carros FRANCIJA
In certain cases, the implant may be lost from a treated dog.
V nekaterih primerih lahko zdravljen pes izgubi implantat.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Hydrogenated palm oil Lecithin
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
White to pale yellow cylindrical implant.
Implantat Bel do svetlo rumen valjast implantat.
The recommended dose is one implant per ferret, irrespective of the size of the ferret.
Priporočeni odmerek je en implantat na belega dihurja, ne glede na njegovo velikost.
Infertility (suppression of spermatogenesis, reduced testis size, levels of testosterone below 0.1 ng/ml, and suppression of musky odor) is achieved between 5 weeks and 14 weeks after initial treatment under laboratory conditions.
Neplodnost (zavrtje spermatogeneze, zmanjšana velikost testisov, raven testosterona pod 0,1 ng/ml, in zavrtje vonja mošusa) se v laboratorijskih pogojih doseže v času od 5 do 14 tednov po začetni uporabi.
For very large dogs (>40 kg bodyweight), data are limited but duration of testosterone suppression was comparable to that seen in medium and large dogs.
Za zelo velike pse (>40 kg telesne mase) so podatki omejeni, vendar je bilo trajanje supresije testosterona primerljivo s trajanjem, ugotovljenim pri srednjih in velikih psih.
In very rare cases, a transient behavioural change has been reported with the development of aggression (see “Special warnings”).
V zelo redkih primerih je prišlo do prehodne spremembe obnašanja z razvojem agresije (glej »Posebna opozorila«).
The substance can be directly measured in the plasma up to approximately 2.5 months post implantation.
Učinkovino lahko neposredno merimo v plazmi še približno poltretji mesec po implantaciji.
The ability of dogs to sire offspring following their return to normal plasma testosterone levels, after the administration of the veterinary medicinal product, has not been investigated.
Sposobnosti psov, da zaplodijo potomstvo, potem ko se jim po uporabi zdravila za uporabo v veterinarski medicini plazemska koncentracija testosterona vrne na normalno vrednost, niso raziskovali.
95% of dogs had returned to normal plasma testosterone levels within 2.5 years of implantation.
Pri 95 % psov so se plazemske koncentracije testosterona v 2,5 letih po implantaciji vrnile na normalne vrednosti.
The actuator is attached to the implanter using the Luer Lock connection.
Aktivator pritrdite na implantator s konektorjem z nastavkom po Luerju.
Overdose (symptoms, emergency procedures, antidotes):
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
In case of accidental self-injection, seek medical advice immediately, with a view to having the implant removed.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom, da vam bo implantat odstranil.
The continuous low dose of deslorelin will reduce the functionality of the male reproductive organs, libido and spermatogenesis and lower the plasma testosterone levels, from 4-6 weeks after implantation.
Stalen majhen odmerek deslorelina bo 4-6 tednov po implantaciji zmanjšal funkcionalnost moških reprodukcijskih organov, libido in spermatogenezo in znižal plazemsko koncentracijo testosterona.