natgillin/translations-raw huggingface dataset:
Although skin contact with the veterinary medicinal product is unlikely, should this occur, wash the exposed area immediately, as GnRH analogues may be absorbed through the skin.
Čeprav stik kože z veterinarskim zdravilom ni verjeten, je treba, če do njega pride, nemudoma sprati izpostavljeni predel, ker se analogi GnRH lahko absorbirajo skozi kožo.
With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials more than 80 % of dogs administered one or more implants, returned to normal plasma testosterone levels (≥0.4 ng/ml) within 12 months of implantation.
Plazemska koncentracija testosterona (ki je uveljavljen nadomestni označevalec plodnosti) se je med kliničnimi preskusi pri več kot 80 % psov, ki so jim dali po enega ali več implantatov, v 12 mesecih po implantaciji vrnila na normalne vrednosti (≥0,4 ng/ml).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON
PODATKI NA ZUNANJI OVOJNINI KARTONASTA ŠKATLA
Data demonstrate that treatment with the veterinary medicinal product will reduce the libido of the dog.
Podatki kažejo, da bo dajanje zdravila za uporabo v veterinarski medicini zmanjšalo libido psa. Beli dihurji
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each implant contains Deslorelin (as deslorelin acetate) 4.7 mg
Vsak implantant vsebuje deslorelin (v obliki deslorelinijevega acetata) 4,7 mg
One out of 75 dogs treated with the veterinary medicinal product during clinical trials mated and tied with a bitch on heat within six months of implantation, but this did not result in pregnancy.
Eden od 75 psov, ki so prejeli zdravilo za uporabo v veterinarski medicini v kliničnih preskusih, se je v šestih mesecih po implantaciji uspešno sparil s psico, ki se je gonila, vendar temu ni sledila brejost.
Manufacturers responsible for the batch release: Virbac S.A.
Izdelovalec, odgovoren za sproščanje serij: Virbac S.A.
Do not use the veterinary medicinal product if the foil pouch is broken.
Ne uporabite zdravila za uporabo v veterinarski medicini, če je vrečka iz folije odprta ali poškodovana.
The veterinary medicinal product should be implanted subcutaneously in the loose skin on the back between the lower neck and the lumbar area.
Zdravilo za uporabo v veterinarski medicini implantirajte subkutano v ohlapno kožo na hrbtu med spodnjim delom vratu in ledvenim predelom.
Ninety-eight percent of dogs returned to normal plasma testosterone levels within 18 months of implantation.
Pri 98 odstotkih psov so se plazemske koncentracije testosterona v 18 mesecih po implantaciji vrnile na normalne vrednosti.
During clinical trials, most of the smaller size dogs (<10 kg bodyweight) maintained suppressed levels of testosterone for more than 12 months following implantation.
Med kliničnimi preskusi so se pri večini manjših psov (<10 kg telesne mase) vzdrževale znižane koncentracije testosterona več kot 12 mesecev po implantaciji.
It is recommended that the product should be administered under general anaesthesia in ferrets.
Pri belih dihurjih je priporočljivo, da implantat vsadite pod splošno anestezijo.
In certain cases, the implant may be lost from a treated ferret.
V nekaterih primerih lahko zdravljen dihur implantat izgubi.
The implant is supplied in a pre-loaded implanter.
Implantat je na voljo v napolnjenem implantatorju.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician, with a view to having the implant removed.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino, da vam bo implantat odstranil.
Select the implant site by locating the area of the back midway between the shoulder blades.
Izberite mesto implantacije v predelu hrbta sredi med lopaticama.
The use of Suprelorin in pre-pubertal dogs has not been investigated.
Uporabe Suprelorina pri psih pred puberteto niso raziskali.
Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega za sproščanje serije
See also “Special warnings”.
Glej tudi »Posebno(a) opozorilo(a)«.
The implant should be administered subcutaneously between the shoulder blades of the dog or ferret.
Implantat je treba subkutano aplicirati med lopatici psa ali belega dihurja.
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 prišlo takoj po implantaciji do prehodnega povečanega spolnega zanimanja, povečane velikosti mod in bolečin v modih.
Remove Luer Lock cap from the implanter.
Odstranite pokrovček z nastavkom po Luerju z implantatorja.
PHARMACEUTICAL FORM Implant
FARMACEVTSKA OBLIKA
In rare cases, 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).
Občasno je bilo pri psih zaznano pomanjkanje pričakovane učinkovitosti (v večini primerov je prišlo do premajhnega zmanjšanja velikosti mod in/ali paritve psice).
In very rare cases, a transient behavioural change has been reported with the development of aggression (see section 4.4).
V zelo redkih primerih je prišlo do prehodne spremembe obnašanja z razvojem agresije (glej poglavje
When administering the veterinary medicinal product, take care to avoid accidental self-injection by ensuring that animals are suitably restrained and the application needle is shielded until the moment of implantation.
Pri dajanju zdravila za uporabo v veterinarski medicini pazite, da bodo živali primerno imobilizirane in da bo igla za dajanje zdravila zaščitena s pokrovčkom vse do trenutka implantacije, da si zdravila ne bi nehote samoinjicirali.
Administer one implant only, irrespective of the size of the dog (see also “Special warnings”).
Dajajte samo po en implantat, ne glede na velikost psa (glej tudi »Posebna opozorila«).
Ferrets: There is no information available in ferrets concerning overdose.
Beli dihurji: Informacije za bele dihurje niso na voljo.
PACKAGE LEAFLET FOR: Suprelorin 4.7 mg implant for dogs
NAVODILO ZA UPORABO: Suprelorin 4,7 mg implantat za pse
Any mating that occurs more than 12 months after the administration of the veterinary medicinal product may result in pregnancy.
Vsako parjenje, do katerega pride več kot 12 mesecev po uporabi zdravila za uporabo v veterinarski medicini, lahko povzroči brejost.
In very rare cases, a testicle may be able to ascend the inguinal ring.
V zelo redkih primerih se lahko modo dvigne skozi dimeljski obroček.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Suprelorin is a white to pale yellow cylindrical implant containing 9.4 mg deslorelin (as deslorelin acetate).
Suprelorin je bel do svetlo rumen valjast implantat, ki vsebuje 9,4 mg deslorelina (v obliki deslorelinijevega acetata).
The recommended dose is one implant per dog, irrespective of the size of the dog (see also “Special warnings”).
Priporočeni odmerek je en implantat na psa, ne glede na njegovo velikost (glej tudi »Posebna opozorila«).
Dogs: No clinical adverse reactions other than those described in section 4.6 have been observed following subcutaneous administration of up to 6 times the recommended dose.
Psi: Pri subkutanem dajanju do 6-kratnega priporočenega odmerka niso opazili kliničnih neželenih učinkov, razen tistih, opisanih v poglavju 4.6.
Any mating that occurs more than 6 months after the administration of the veterinary medicinal product may result in pregnancy.
Vsako parjenje, do katerega pride več kot 6 mesecev po uporabi zdravila za uporabo v veterinarski medicini, lahko povzroči brejost.
Do not use if the foil pouch is broken.
Ne uporabite, če je vrečka iz folije odprta ali poškodovana.
It is therefore recommended that dogs should be allowed to reach puberty before treatment with the veterinary medicinal product is initiated.
Zato priporočamo, naj pred začetkom uporabe zdravila za uporabo v veterinarski medicini psi dosežejo puberteto.
The use of the veterinary medicinal product in pre-pubertal ferrets has not been investigated.
Uporaba zdravila za uporabo v veterinarski medicini pri pred pubertetnih belih dihurjih ni bila raziskana.
However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after 6 months, or repeated implantation, are limited.
Vendar so podatki, ki kažejo popolno reverzibilnost kliničnih učinkov (zmanjšana moda, zmanjšana količina ejakulata, zmanjšano število semenčic in zmanjšan libido), s plodnostjo vred, po 6 mesecih ali večkratnih implantacijah, omejeni.
However, data demonstrating the complete reversibility of clinical effects (reduced testicular size, reduced ejaculation volume, reduced sperm count and reduced libido) including fertility after 12 months, or repeated implantation, are limited.
Vendar so podatki, ki kažejo popolno reverzibilnost kliničnih učinkov (zmanjšana moda, zmanjšana količina ejakulata, zmanjšano število semenčic in zmanjšan libido), s plodnostjo vred, po 12 mesecih ali večkratnih implantacijah, omejeni.
Should a treated dog mate with a bitch between 8 and 12 weeks after treatment, appropriate measures should be taken to rule out the risk of pregnancy.
Če se pes, ki je dobil implantat, spari s samico v času od 8 do 12 tednov po implantaciji, je treba z ustreznimi ukrepi izključiti tveganje brejosti.
A short transient increase in plasma testosterone may be seen immediately after implantation.
Takoj po implantaciji se utegne pojaviti majhno prehodno zvišanje plazemske koncentracije testosterona.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Suprelorin is a white to pale yellow cylindrical implant containing 4.7 mg deslorelin (as deslorelin acetate).
Suprelorin je bel do svetlo rumen valjast implantat, ki vsebuje 4,7 mg deslorelina (v obliki deslorelinijevega acetata).
If loss of the first implant is suspected, then this can be confirmed by observing no reduction in testis size or plasma testosterone levels as both should reduce under correct implantation.
Če pride pri prvi implantaciji do suma izgube implantata, se to potrdi tako, da ni zaznanega zmanjšanja velikosti testisov ali ravni plazemskega testosterona, saj bi moralo pri pravilni implantaciji priti do njunega zmanjšanja.
Should a treated dog mate with a bitch between 6 weeks and 6 months after treatment, appropriate measures should be taken to rule out the risk of pregnancy.
Če se pes, ki je dobil implantat, spari s samico v času od 6 tednov do 6 mesecev po implantaciji, je treba z ustreznimi ukrepi izključiti tveganje brejosti.
Show the package leaflet or the label to the physician.
Zdravniku pokažite navodila za uporabo ali ovojnino.
Not all parameters of sexual activity have been tested specifically (seborrhoea, urine marking and aggressiveness).
(seboreja, označevanje z urinom in agresivnost) niso bili posebej testirani.
It is therefore recommended that ferrets should be allowed to reach puberty before treatment with the veterinary medicinal product is initiated.
Zato priporočamo, naj pred začetkom uporabe zdravila za uporabo v veterinarski medicini beli dihurji dosežejo puberteto.
If loss of the first implant is suspected, then this can be confirmed by observing no reduction in scrotal circumference or plasma testosterone levels after 6 weeks from the suspected date of loss, as both should reduce under correct implantation.
V kolikor obstaja sum izgube prvega implantata, potem to potrjuje neustrezno zmanjšanje obsega skrotuma ali ravni plazemskega testosterona po 6 tednih od domnevnega dneva izgube, saj bi po pravilni implantaciji moralo priti do zmanjšanja obeh.
During the treatment period, rare clinical effects have been reported: hair coat disorders (e.g. hair loss, alopecia, hair modification), urinary incontinence, down-regulation associated signs (e.g. decrease in testicle size, reduced activity).
Med obdobjem učinkovanja zdravila so poročali o redkih kliničnih učinkih: motnje v odlakanosti (npr. izgube dlake, alopecije, spremembe dlake), uhajanja seča, znakov povezanih z negativnim uravnavanjem (npr. zmanjšanje velikosti mod, zmanjšana aktivnost).
For the induction of temporary infertility in healthy, entire, sexually mature male dogs.
Za povzročitev začasne neplodnosti pri zdravih, neskopljenih, spolno zrelih psih samcih.
PACKAGE LEAFLET FOR: Suprelorin 9.4 mg implant for dogs and ferrets
NAVODILO ZA UPORABO: Suprelorin 9,4 mg implantat za pse in bele dihurje
Repeat treatment every 16 months to maintain efficacy.
Za ohranjanje učinkovanja zdravljenje ponovite vsakih 16 mesecev.
With respect to testosterone levels (an established surrogate marker of fertility), during clinical trials 68 % of dogs administered one implant, returned to fertility within 2 years of implantation.
se je med kliničnimi preskusi 68 % psov, ki so jim dali po en implantat, v 2 letih po implantaciji vrnila plodnost.
It has been shown in dogs that plasma deslorelin levels peak 7 to 35 days following administration of an implant containing 5 mg radiolabelled deslorelin.
Koncentracija deslorelina v plazmi je pri psih najvišja 7 do 35 dni po vsaditvi implantata, ki vsebuje
C. STATEMENT OF THE MRLs Not applicable.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
The product should be implanted subcutaneously in the loose skin on the back in the intrascapular space.
Zdravilo implantirajte podkožno v ohlapno kožo na hrbtu, v področje med lopaticami.
Do not use the product if the foil pouch is broken.
Ne uporabite zdravila, če je vrečka iz folije odprta ali poškodovana.
For the induction of temporary infertility in healthy, entire, sexually mature male dogs and ferrets.
Za povzročitev začasne neplodnosti pri zdravih, neskopljenih, spolno zrelih psih in belih dihurjih samcih.
In dogs: Moderate swelling at the implant site was commonly observed for 14 days during safety/efficacy studies.
Pri psih: Zmerno otekanje mesta implantacije je bilo pogosto opaženo v trajanju 14 dni med študijami o varnosti/učinkovitosti.
Deslorelin (as deslorelin acetate)
Deslorelin (v obliki deslorelinijevega acetata) 4,7 mg
One implant should be administered subcutaneously between the shoulder blades of the dog.
En implantat dajte psu subkutano med lopaticama.
Repeat administration every 12 months to maintain efficacy.
Ponavljajte uporabo vsakih 12 mesecev, da se bo učinkovitost vzdrževala.
If loss of the implant is suspected following reimplantation, then a progressive increase will be seen in testis size and/or plasma testosterone levels.
Če pride do suma izgube implantata po ponovni implantaciji, bo prišlo do postopnega povečanja testisov in/ali ravni plazemskega testosterona.
Insert the entire length of the needle subcutaneously.
Potisnite iglo do konca subkutano.
Treated ferrets should therefore still be kept away from jills on heat within the first weeks after initial treatment.
Zato moramo bele dihurje, ki so prejeli implantat, v prvih tednih po začetni uporabi še vedno imeti ločene od samic, ki se gonijo.
NAME OF THE VETERINARY MEDICINAL PRODUCT Suprelorin 9.4 mg implant for dogs and ferrets.
Suprelorin 9,4 mg implantat za pse in bele dihurje
If loss of the implant is suspected following re-implantation after 12 months, a progressive increase will be seen in scrotal circumference and/or plasma testosterone levels.
Če pride do suma izgube implantata po ponovni implantaciji po 12 mesecih, bo prišlo do postopnega naraščanja skrotalnega obsega in/ali plazemske koncentracije testosterona.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE Veterinary medicinal product subject to prescription.
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
NAME OF THE VETERINARY MEDICINAL PRODUCT Suprelorin 4.7 mg implant for dogs
Suprelorin 4,7 mg implantat za pse
Moderate swelling at the implant site was observed observed for 14 days during safety/efficacy studies.
Zmerno otekanje mesta implantacije je bilo pogosto opaženo v trajanju 14 dni med študijami varnosti/učinkovitosti.
Histologically, mild local reactions with chronic inflammation of the connective tissue and some capsule formation and collagen deposition have been seen at 3 months after administration following simultaneous subcutaneous administration of up to 10 times the recommended dose.
Histološko so 3 mesece po subkutanem dajanju do 10-kratnega priporočenega odmerka ugotovili blage lokalne reakcije s kroničnim vnetjem veznega tkiva, nastankom kapsule in odlaganjem kolagena
Repeat administration every 6 months to maintain efficacy.
Ponavljajte uporabo vsakih 6 mesecev, da se bo učinkovitost vzdrževala.
However, it is not necessary to keep bitches away from treated dogs following subsequent implantations, provided that the veterinary medicinal product is administered every 6 months.
Pod pogojem, da se zdravilo za uporabo v veterinarski medicini uporabi vsakih 6 mesecev, po poznejših implantacijah psic ni treba več ločevati od tretiranih psov.
If loss of the implant is suspected in connection with the first implantation, this can be confirmed by observing no reduction in scrotal circumference or plasma testosterone levels after 8 weeks from the suspected date of loss, as both should reduce under correct implantation.
Če pride pri prvi implantaciji do suma izgube implantata, se lahko to po osmih tednih od dneva domnevne izgube potrdi tako, da ni zaznanega zmanjšanja skrotalnega obsega ali plazemske koncentracije testosterona, saj bi moralo pri pravilni implantaciji priti do njunega zmanjšanja.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS FOIL POUCH
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Histologically, mild local reactions with chronic inflammation of the connective tissue and some capsule formation and collagen deposition have been seen at 3 months after administration following simultaneous subcutaneous administration of up to 6 times the recommended dose.
Histološko so 3 mesece po subkutanem dajanju do 6-kratnega priporočenega odmerka ugotovili blage lokalne reakcije s kroničnim vnetjem veznega tkiva, nastankom kapsule in odlaganjem kolagena.
Any mating that occurs more than 16 months after the administration of the product may result in pregnancy.
Vsako parjenje, do katerega pride po več kot 16 mesecih po implantaciji, lahko vodi do brejosti.
Marketing authorisation holder: VIRBAC S.A.
Imetnik dovoljenja za promet z zdravilom: VIRBAC S.A.
The use of the veterinary medicinal product in pre-pubertal dogs has not been investigated.
Uporabe tega zdravila pri psih pred puberteto niso raziskali.
However, it is not necessary to keep bitches away from treated dogs following subsequent implantations for the initial 8 week period, provided that the veterinary medicinal product is administered every 12 months.
Pod pogojem, da se zdravilo za uporabo v veterinarski medicini uporabi vsakih 12 mesecev, po poznejših implantacijah v obdobju 8 tednov po dajanju zdravila, psic ni treba več ločevati od tretiranih psov.
No clinical adverse reactions other than those described in the section “Adverse reactions” have been observed following subcutaneous administration of up to 10 times the recommended dose.
Po sočasnem subkutanem dajanju do 10-kratnega priporočenega odmerka niso opazili neželenih kliničnih učinkov, razen tistih, opisanih v poglavju »Neželeni učinki«.
If loss of the implant is suspected following re-implantation after 6 months, then a progressive increase will be seen in scrotal circumference and/or plasma testosterone levels.
V kolikor obstaja sum izgube implantata po ponovni implantaciji po 6 mesecih, potem bo opazno ponovno povečanje obsega skrotuma ali ravni plazemskega testosterona.
Treated dogs should therefore still be kept away from bitches on heat within the first 8 weeks after initial treatment.
Zato moramo pse, ki so prejeli implantat, prvih osem tednov po začetni uporabi še vedno imeti ločene od psic, ki se gonijo.
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Izdelovalec, odgovoren za sproščanje serij:
Treated dogs should therefore still be kept away from bitches on heat within the first 6 weeks after initial treatment.
Zato moramo pse, ki so prejeli implantat, prvih 6 tednov po začetni uporabi še vedno imeti ločene od psic, ki se gonijo.
4.11 Withdrawal period
4.9 Odmerjanje in pot uporabe
No clinical adverse reactions other than those described in section 4.6 have been observed following simultaneous subcutaneous administration of up to 10 times the recommended dose.
Po sočasnem subkutanem dajanju do 10-kratnega priporočenega odmerka niso opazili neželenih kliničnih učinkov, razen tistih, opisanih v poglavju 4.6.
Repeat treatment every 12 months to maintain efficacy.
Zdravilo dajte vsakih 12 mesecev, da se bo učinkovitost vzdrževala.
Attach the actuator to the implanter using the Luer Lock connection.
S konektorjem z nastavkom po Luerju pritrdite aktivator na implantator.
Repeat treatment every 6 months to maintain efficacy.
Zdravilo dajte vsakih šest mesecev, da se bo učinkovitost vzdrževala.
Sodium acetate anhydrous 6.2 Major incompatibilities
Natrijev acetat, brezvodni
ROUTE(S) OF ADMINISTRATION Subcutaneous route
NAČIN IN POT(I) UPORABE
Dogs: No adverse reactions other than those described in section “Adverse effects” have been observed following subcutaneous administration of up to 6 times the recommended dose.
Psi: Pri subkutanem dajanju do 6-kratnega priporočenega odmerka, niso opazili neželenih učinkov,
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES One implant preloaded in one implanter
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Psi: Subkutana uporaba.
Package size
Ovojnina Velikost pakiranja
Fatal cases have also been reported.
Poročali so tudi o smrtnih primerih.
Patients should not exceed the recommended dose and/or the recommended duration of treatment.
Bolniki ne smejo preseči priporočenega odmerka in/ali priporočenega trajanja zdravljenja.
Adopted at the 6-9 March 2017 PRAC
Sprejeto na seji odbora PRAC med 6. in 9. marcem 2017
Some cases had a fatal outcome (see section 4.9).
Nekateri primeri so se končali s smrtjo (glejte poglavje 4.9).
Do not take this product for anything other than its intended use (see section 1) and never take more than the recommended amount (see section 3).
To zdravilo uporabljajte samo za predvideni namen (glejte poglavje 1) in ga nikoli ne vzemite več, kot je priporočeno (glejte poglavje 3).
If a child takes too much or shows any of the above symptoms, call a doctor immediately.
Če otrok zaužije preveč zdravila ali če ima katerega od zgornjih simptomov, takoj pokličite zdravnika.
3 - If you take more <brand name> than you should If you have taken too many <brand name>, immediately contact a doctor or hospital for advice.
3 - Če ste vzeli večji odmerek zdravila <lastniško ime>, kot bi smeli Če ste vzeli preveč zdravila <lastniško ime>, se za nasvet takoj obrnite na zdravnika ali bolnišnico.
Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.
Simptomi lahko vključujejo: pospešen srčni utrip, nereden srčni utrip, spremembe srčnega utripa (ti simptomi imajo lahko potencialno resne, življenje ogrožajoče posledice), togost mišic, nekoordinirane gibe, zaspanost, težave z uriniranjem ali oslabljeno dihanje.
2 - What you need to know before you use OPDIVO Warnings and precautions
2 - Kaj morate vedeti, preden boste uporabili zdravilo OPDIVO Opozorila in previdnostni ukrepi
Children react more strongly to large amounts of <brand name> than adults.
Otroci na večje količine zdravila <lastniško ime> reagirajo močneje.
2 - What you need to know before you take <brand name>
2 - Kaj morate vedeti, preden boste vzeli zdravilo <lastniško ime>
Nivolumab; pembrolizumab - Transplant rejection (EPITT no 18781)
Nivolumab; pembrolizumab - zavrnitev presadka (št. EPITT 18781)
Loperamide - Serious cardiac events with high doses of loperamide from abuse and misuse (EPITT no 18339)
Loperamid - resni srčni dogodki pri velikih odmerkih loperamida zaradi zlorabe in napačne uporabe (št. EPITT 18339)