natgillin/translations-raw huggingface dataset:
Before REGRANEX you should wash your hands thoroughly.
Pred uporabo zdravila REGRANEX si temeljito umijte roke.
Before each application, the ulcer should be gently rinsed with saline or water to remove residual gel.
Pred vsakim nanosom gela razjedo previdno sperite s fiziološko raztopino ali vodo, da z nje odstranite preostali gel.
Apply REGRANEX as a continuous thin layer to the entire wound area(s) once daily using a clean application aid (e. g. a cotton swab or a tongue depressor).
Zdravilo REGRANEX nanesite na celotno površino rane v obliki tanke, neprekinjene plasti enkrat na dan z uporabo čistega pripomočka za nanašanje gela (npr. bombažni tampon ali palička za jezik).
Contact with other parts of the body should be avoided.
Izogibajte se stiku gela z drugimi deli telesa.
Once REGRANEX has been applied, cover the ulcer with a moist saline gauze dressing.
Vrh tube ne sme priti v stik z rano ali katerokoli drugo površino.
REGRANEX should only be applied
Pazite tudi, da preprečite vse druge možne oblike mikrobne kontaminacije ali kvarjenja gela med njegovo uporabo.
17 once daily even if you change your dressing more frequently.
17 Ko ste nanesli zdravilo REGRANEX, prekrijte razjedo z obkladkom iz gaze, namočene v fiziološko raztopino.
REGRANEX should not be used with occlusive dressings.
Zdravilo REGRANEX nanesite enkrat na dan, tudi če boste obkladke menjali pogosteje.
Your doctor will decide whether treatment should be continued.
Če po prvih 10 tednih neprekinjenega zdravljenja ni nikakršnih znakov celjenja, se posvetujte s svojim zdravnikom, ki bo določil, ali naj nadaljujete z zdravljenjem.
REGRANEX is not intended for repeated use.
Zdravilo REGRANEX ni namenjeno večkratni uporabi.
This medicinal product has been prescribed for you personally and you should not pass it on to others.
To zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
Any unfinished gel should be discarded after treatment is completed.
Morebitno neuporabljeno količino gela, ki vam preostane po zaključku zdravljenja, zavrzite.
If you use more REGRANEX than you should:
Če ste uporabili večji odmerek zdravila REGRANEX, kot bi smeli:
If you accidentally apply too much REGRANEX, it is unlikely to do you any harm.
Če ste pomotoma nanesli preveč zdravila REGRANEX, je malo verjetno, da bi vam to škodovalo.
However, always try to exactly follow the instructions for use.
Kljub temu pa skušajte vedno natančno upoštevati navodila za uporabo.
Like all medicines, REGRANEX can have side effects.
Kot vsa zdravila ima lahko tudi zdravilo REGRANEX neželene učinke.
The following conditions were reported during clinical trials of REGRANEX therapy: infection (including skin and bone infection), skin ulceration and skin disorders (including redness and pain).
V kliničnih preskušanjih z zdravilom REGRANEX so poročali o naslednjih stanjih: okužba (vključno z okužbo kože in kosti), kožne razjede in bolezni kože (vključno s pordelostjo in bolečino).
Blisters and swelling were reported rarely.
Redko so poročali o nastanku mehurjev in otekanju.
Cases of excessive production of tissue in the ulcer due to an exaggerated healing response have rarely been observed in patients receiving REGRANEX.
Pri bolnikih, ki so uporabljali zdravilo REGRANEX, so redko poročali o primerih prekomerne tvorbe tkiva v razjedi zaradi pretiranega zacelitvenega odziva.
If you start to feel unwell or notice any undesirable effects including effects not mentioned in this leaflet or if you are unsure about the effect of this product, do not hesitate to contact your doctor or pharmacist.
Če se začnete počutiti slabo ali opazite kakršnekoli neželene učinke, vključno z učinki, ki niso navedeni v tem navodilu ali če ste negotovi glede učinka tega zdravila, se brez odlašanja obrnite na svojega zdravnika ali farmacevta.
STORING REGRANEX
SHRANJEVANJE ZDRAVILA REGRANEX
Do not use your medicine after the expiry date (MM/ YY) as indicated on the tube and the outer carton.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti (MM/ LL), ki je naveden na tubi in na zunanji škatli.
Esteve, S. A.
Esteve, S. A Avda.
Relistor is a medicine that contains the active substance methylnaltrexone bromide.
Relistor je zdravilo, ki vsebuje zdravilno učinkovino metilnaltrekson bromid.
It is available as a solution for injection containing 12 mg methylnaltrexone bromide in 0.6 ml.
Na voljo je kot raztopina za injiciranje, ki v 0, 6 ml vsebuje 12 mg metilnaltrekson bromida.
Relistor is used to treat the constipation caused by opioids (painkillers that are related to morphine) in adults who are very ill and are receiving palliative care (treatment of the symptoms of a disease that is not intended to lead to cure).
Zdravilo Relistor se uporablja za zdravljenje zaprtosti zaradi opioidov (zdravil proti bolečinam, ki so povezana z morfijem) pri odraslih, ki so zelo bolni in prejemajo paliativno oskrbo (zdravljenje simptomov bolezni, ki pa ne vodi k ozdravitvi).
It is used when the response to the usual laxative medicines has not been sufficient.
Uporablja se v primerih, kadar običajno zdravljenje z odvajalnimi zdravili ne zadostuje.
Relistor is given as an injection under the skin, once every two days.
Zdravilo Relistor se injicira v podkožje vsak drugi dan.
The dose depends on the patient’ s body weight, and should be reduced in patients who have severe problems with their kidneys.
Odmerek je odvisen od bolnikove telesne mase in ga je treba pri bolnikih z resnimi ledvičnimi težavami ustrezno zmanjšati.
It is not recommended for patients who have very severe problems with their kidneys that requires dialysis or severe liver problems.
Ne priporoča se za bolnike z resnimi ledvičnimi težavami, ki potrebujejo dializo, ali imajo resne težave z jetri.
Opioids relieve pain by attaching to ‘ opioid receptors ’ in the brain and spinal cord.
Opioidi lajšajo bolečine tako, da se vežejo na receptorje opioidov v možganih in hrbtenjači.
The active substance in Relistor, methylnaltrexone bromide, is a mu-opioid receptor antagonist.
Zdravilna učinkovina v zdravilu Relistor, metilnaltrekson bromid, je antagonist mu- opioidnih receptorjev.
This means that it blocks a specific type of opioid receptor called the ‘ mu-opioid receptor’.
To pomeni, da blokira posebno vrsto opioidnih receptorjev, imenovanih mu- opioidni receptorji.
Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Metilnaltrekson bromid se pridobiva iz naltreksona, dobro znane učinkovine, ki se uporablja za blokiranje delovanja opioidov.
In contrast to naltrexone, methylnatrexone bromide is less able to enter the brain, meaning that it blocks the mu-opioid receptors in the gut but not in the brain.
V nasprotju z naltreksonom, ima metilnaltrekson bromid slabšo sposobnost prehajanja v možgane, kar pomeni, da blokira mu- opioidne receptorje v črevesju, ne pa tudi v možganih.
By blocking these receptors, Relistor reduces the constipation due to opioids, but does not interfere with their painkilling effects.
Z blokiranjem teh receptorjev zdravilo Relistor zmanjšuje zaprtost nastalo zaradi opioidov, vendar ne vpliva na njihovo protibolečinsko učinkovanje.
Relistor was studied in two main studies in a total of 288 patients with an advanced illness and constipation caused by opioids.
Zdravilo Relistor so raziskali v dveh glavnih študijah, pri katerih je sodelovalo skupaj 228 bolnikov v naprednih stadijih bolezni in zaprtosti zaradi opioidov.
Both studies compared the effectiveness of Relistor with that of placebo (a dummy treatment) in stimulating the bowel to open.
Obe študiji sta primerjali učinkovitost zdravila Relistor v primerjavi s placebom (zdravilom brez zdravilne učinkovine) pri spodbujanju delovanja črevesja.
The main measure of effectiveness in both studies was the number of patients whose bowel opened within four hours of the first dose.
Glavno merilo učinkovitosti pri obeh študijah je bilo število bolnikov, ki so odvajali blato v roku štirih ur po prvem odmerku.
The second study also looked at the number of patients whose bowels opened at least twice within four hours of the first four doses.
Druga študija je upoštevala tudi bolnike, pri katerih je do odvajanja blata prišlo vsaj dvakrat v roku štirih ur po prvih štirih odmerkih.
Relistor was more effective than placebo in stimulating the bowels to open.
Zdravilo Relistor je bil pri spodbujanju odvajanja bolj učinkovito kot placebo.
In the two studies taken together, 55% of the patients receiving Relistor opened their bowels within four hours after first injection (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123).
Rezultati obeh študij kažejo, da je 55% bolnikov, ki so prejeli zdravilo Relistor, odvajalo blato v roku štirih ur po prvem injiciranju (91 od 165) v primerjavi s 15% bolnikov, ki so prejeli placebo (18 od 123).
In the second study, 52% of the patients receiving Relistor opened their bowels at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71).
Pri drugi študiji je 52% bolnikov, ki so prejeli zdravilo Relistor, odvajalo blato vsaj dvakrat v roku štirih ur po prvih štirih odmerkih (32 od 62) v primerjavi z 8% bolnikov, ki so prejeli placebo (6 od 71).
The most common side effects with Relistor (seen in more than 1 patient in 10) are abdominal (tummy) pain, nausea (feeling sick), flatulence (wind) and diarrhoea.
Najpogostejši neželeni učinki zdravila Relistor (opaženi pri več kot 1 bolniku izmed 10) so abdominalne (trebušne) bolečine, navzeja (občutek slabosti), napenjanje (vetrovi) in driska.
For the full list of all side effects reported with Relistor, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Relistor, glejte navodilo za uporabo.
Relistor should not be used in people who may be hypersensitive (allergic) to methylnaltrexone bromide or any of the other ingredients.
Zdravila Relistor ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) metilnaltrekson bromid ali katero koli drugo sestavino zdravila.
It should also not be used in patients whose bowel is blocked or who have a condition that needs immediate bowel surgery.
Prav tako ga ne smejo uporabljati bolniki z zaprtim črevesjem ali katerih stanje zahteva takojšnjo operacijo črevesja.
The Committee for Medicinal Products for Human Use (CHMP) decided that Relistor’ s benefits are greater than its risks for the treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Relistor pri zdravljenju zaprtja zaradi opioidov pri bolnikih v naprednih stadijih bolezni, ki prejemajo paliativno oskrbo, kadar zdravljenje z običajnimi odvajali ni zadostno, večje od z njim povezanih tveganj.
The Committee recommended that Relistor be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Relistor odobri dovoljenje za promet.
Other information about Relistor:
Druge informacije o zdravilu Relistor:
The European Commission granted a marketing authorisation valid throughout the European Union for Relistor to Wyeth Europa Limited on 02 July 2008.
Evropska komisija je dovoljenje za promet z zdravilom Relistor, veljavno po vsej Evropski uniji, odobrila družbi Wyeth Europa Limited dne 02. julija 2008.
The full EPAR for Relistor can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Relistor je na voljo tukaj.
EU Procedure number Invented name Strength
Številka postopka EU
Subcutaneous use Vial (glass)
subkutana uporaba viala (steklena)
RELISTOR 12 mg / 0.6 ml solution for injection.
RELISTOR 12 mg/ 0, 6 ml raztopina za injiciranje.
Each vial of 0.6 ml contains 12 mg methylnaltrexone bromide.
Ena 0, 6- mililitrska viala vsebuje 12 mg metilnaltreksonijevega bromida.
One ml of solution contains 20 mg methylnaltrexone bromide.
En ml raztopine vsebuje 20 mg metilnaltreksonijevega bromida.
Sterile, clear solution, colourless to pale-yellow, essentially free from visible particulates.
Sterilna bistra raztopina, brezbarvna do svetlo rumena, praktično brez vidnih delcev.
Treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Zdravljenje z opioidi povzročene konstipacije pri bolnikih z napredovalo boleznijo, ki prejemajo paliativno zdravljenje, kadar je odziv na običajno odvajalno zdravljenje nezadosten.
For adults only.
Samo za odrasle.
RELISTOR should be added to induce prompt bowel movements when response to usual laxative therapy has been insufficient.
Zdravilo RELISTOR naj se doda, da bo povzročilo takojšnje iztrebljanje, kadar je odziv na običajno zdravljenje z odvajali nezadosten.
The recommended dose of methylnaltrexone bromide is 8 mg (0.4 ml RELISTOR) (for patients weighing 38-61 kg) or 12 mg (0.6 ml RELISTOR) (for patients weighing 62-114 kg).
Priporočeni odmerek metilnaltreksonijevega bromida je 8 mg (0, 4 ml zdravila RELISTOR) (za bolnike, ki tehtajo 38- 61 kg) ali 12 mg (0, 6 ml zdravila RELISTOR) (za bolnike, ki tehtajo 62- 114 kg).
Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/ kg.
Bolniki, katerih telesna teža je zunaj navedenih meja, naj prejmejo po 0, 15 mg/ kg.
The injection volume for these patients should be calculated:
Injekcijski volumen za te bolnike izračunamo takole:
Dose (ml) = patient weight (kg) x 0.0075
odmerek (ml) = bolnikova telesna teža (kg) x 0, 0075
Renal patients In patients with severe renal impairment (creatinine clearance less than 30 ml/ min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 ml RELISTOR) for those weighing 62 to 114 kg, or from 0.15 mg/ kg to 0.075 mg/ kg for those whose weight falls outside the 62 to 114 kg range (see section 5.2).
Ledvični bolniki Pri bolnikih s težkimi ledvičnimi okvarami (očistek kreatinina manjši od 30 ml/ min) moramo odmerek metilnaltreksonijevega bromida zmanjšati z 12 mg na 8 mg (0, 4 ml zdravila RELISTOR) pri bolnikih, ki tehtajo
There are no data available from patients with end-stage renal impairment on dialysis, and RELISTOR is not recommended in these patients (see section 4.4).
Podatkov o bolnikih z ledvično okvaro v končnem stadiju na dializi ni na voljo in zdravilo RELISTOR pri teh bolnikih ni priporočljivo (glejte poglavje 4. 4).
2 Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see section 5.2).
Okvare jeter Pri bolnikih z blagimi do zmernimi okvarami jeter ni potrebno prilagajanje odmerka (glejte poglavje 5. 2).
There are no data available from patients with severe hepatic impairment (Child-Pugh Class C), and RELISTOR is not recommended in these patients (see section 4.4).
Podatkov o bolnikih s težkimi okvarami jeter (razred C po Child- Pughovi lestvici) ni na voljo in zdravilo RELISTOR pri teh bolnikih ni priporočljivo (glejte poglavje 4. 4).
Paediatric patients There is no experience in children under the age of 18 (see section 5.2).
Pediatrični bolniki Izkušenj pri otrocih, mlajših od 18 let, ni (glejte poglavje 5. 2).
Therefore, methylnaltrexone should not be used in the paediatric age group until further data become available.
Zato metilnaltreksonija pri otrocih ne smemo uporabljati, dokler ne bo na voljo več podatkov.
Elderly patients No dose adjustment is recommended based on age (see section 5.2).
Starejši bolniki Na podlagi starosti ne priporočajo nikakršnega prilagajanja odmerjanja (glejte poglavje 5. 2).
RELISTOR is given as a subcutaneous injection.
Zdravilo RELISTOR dajemo v obliki subkutane injekcije.
The three areas of the body recommended for injection of RELISTOR are upper legs, abdomen, and upper arms.
Trije predeli telesa, ki jih priporočamo za injiciranje zdravila RELISTOR, so stegno, trebuh in nadlaket.
RELISTOR can be injected without regard to food.
Zdravilo Relistor lahko injiciramo ne glede na obroke hrane.
Therefore, RELISTOR should not be used for treatment of patients with constipation not related to opioid use.
Zato zdravila RELISTOR ne bi smeli uporabljati za zdravljenje bolnikov s konstipacijo, ki ni povezana z uporabo opioidov.
If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with RELISTOR and consult their physician.
Če se med zdravljenjem pojavi težka ali trdovratna driska, moramo bolnikom svetovati, naj ne nadaljujejo zdravljenja z zdravilom RELISTOR in naj se posvetujejo s svojim zdravnikom.
Methylnaltrexone bromide treatment has not been studied in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.2).
Zdravljenja z metilnaltreksonijevim bromidom niso proučevali v kliničnih preskušanjih, daljših od 4 mesecev, zato ga smemo uporabljati le krajši čas (glejte poglavje 5. 2).
RELISTOR should only be used in patients who are receiving palliative care.
RELISTOR je dovoljeno uporabljati le pri bolnikih, ki prejemajo paliativno zdravljenje.
It is added to usual laxative treatment.
Dodajamo ga običajnemu odvajalnemu zdravljenju.
RELISTOR is not recommended in patients with severe hepatic impairment or with end-stage renal impairment requiring dialysis (see section 4.2).
3 Zdravilo RELISTOR ni priporočljivo za bolnike s težkimi okvarami jeter ali z okvarami ledvic v končnem stadiju, pri katerih je potrebna dializa (glejte poglavje 4. 2).
Therefore, RELISTOR should only be administered with caution in these patients.
Zato moramo zdravilo RELISTOR pri teh bolnikih uporabljati zelo previdno.
3 This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e., essentially sodium- free).
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘ brez natrija ’
Methylnaltrexone does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes.
Metilnaltreksonij ne vpliva na farmakokinetiko zdravil, ki jih presnavljajo izocimi s citokromom P450 (CYP).
Methylnaltrexone is minimally metabolised by CYP isozymes.
Izocimi s CYP minimalno presnavljajo metilnaltreksonij.
In vitro metabolism studies suggest that methylnaltrexone does not inhibit the activity of CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of the metabolism of a model CYP2D6 substrate.
Študije presnove in vitro kažejo, da metilnaltreksonij ne inhibira aktivnosti CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 in CYP3A4, je pa šibak inhibitor presnove modelnega substrata CYP2D6.
In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.3 mg/ kg of methylnaltrexone did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.
V klinični študiji medsebojnega delovanja zdravil pri zdravih odraslih moških subkutan odmerek 0, 3 mg/ kg metilnaltreksonija ni signifikantno vplival na presnovo dekstrometorfana, ki je substrat CYP2D6.
The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone and an OCT inhibitor was studied in 18 healthy subjects by comparing the single- dose pharmacokinetic profiles of methylnaltrexone before and after multiple 400 mg doses of cimetidine.
Pri 18 zdravih preiskovancih so proučevali možnost medsebojnega delovanja med zdraviloma, povezanega s prenašalcem organskih kationov (OCT), med metilnaltreksonijem in zaviralcem OCT, tako da so primerjali farmakokinetični profil enkratnega odmerka metilnaltreksonija pred več zaporednimi 400- miligramskimi odmerki cimetidina in po njih.
The renal clearance of methylnaltrexone was reduced following multiple-dose administration of cimetidine (from 31 l/ h to 18 L/ h).
Ledvični očistek metilnaltreksonija se je po uporabi večkratnih odmerkov cimetidina zmanjšal (z 31 l/ uro na 18 l/ uro).
However, this resulted in a small reduction in total clearance (from 107 L/ h to 95 l/ h).
Vendar je to le malo zmanjšalo celotni očistek (s 107 l/ uro na 95 l/ uro).
Consequently, no meaningful change in AUC of methylnaltrexone, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
Zato niso pred uporabo večkratnih odmerkov cimetidina in po njej opazili nobene pomembne spremembe AUC metilnaltreksonija, prav tako ne Cmax.
Pregnancy There are no adequate data with the use of methylnaltrexone bromide in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi metilnaltreksonijevega bromida pri nosečnicah.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Študije na živalih so pokazale vpliv velikih odmerkov na sposobnost razmnoževanja (glejte poglavje 5. 3).
RELISTOR should not be used during pregnancy unless clearly necessary.
Zdravila RELISTOR ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Lactation It is unknown whether methylnaltrexone bromide is excreted in human breast milk.
Dojenje Ni znano, ali se metilnaltreksonijev bromid pri ljudeh izloča v materino mleko.
Animal studies have shown excretion of methylnaltrexone bromide in breast milk.
Raziskave na živalih so pokazale izločanje metilnaltreksonijevega bromida v mleko.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with RELISTOR should be made, taking into account the benefit of breast-feeding to the child and the benefit of RELISTOR therapy to the woman.
Sprejeti je treba odločitev o nadaljevanju ali prekinitvi dojenja in nadaljevanju ali prekinitvi zdravljenja z zdravilom RELISTOR in pri tem upoštevati korist dojenja za otroka in korist zdravljenja z zdravilom RELISTOR za žensko.
However, as a pure peripherally restricted opioid antagonist, the likelihood that methylnaltrexone will affect such activities is low.
Ker pa je metilnaltreksonij opioiden antagonist, omejen samo na periferijo, je verjetnost, da bo vplival na takšne dejavnosti, majhna.
Dizziness may occur, and this may have an effect on driving and use of machines (see section 4.8).
Lahko se pojavi vrtoglavost, ta pa utegne vplivati na sposobnost vožnje in upravljanja s stroji (glejte poglavje 4. 8).
The most common drug-related adverse reactions in all patients exposed to methylnaltrexone bromide during all phases of placebo-controlled studies were abdominal pain, nausea, diarrhoea and flatulence.
Najpogostejše neželene reakcije, povezane z zdravilom, pri vseh bolnikih, ki so bili izpostavljeni metilnaltreksonijevemu bromidu med vsemi fazami s placebom kontroliranih študij, so bile bolečine v trebuhu, navzea, driska in vetrovi.
Very common (≥ 1/ 10); Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very rare (< 1/ 10,000), unknown (cannot be estimated from the available data).
4 Neželeni učinki so razvrščeni kot: zelo pogosti (≥1/ 10); pogosti (≥1/ 100 do < 1/ 10); občasni (≥1/ 1. 000 do < 1/ 100); redki (≥1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti:
4 Gastrointestinal disorders Very common:
Bolezni prebavil
Abdominal pain, nausea, flatulence, diarrhoea
bolečine v trebuhu, navzea, vetrovi, driska
Injection site reactions (e. g. stinging, burning, pain, redness, oedema)
reakcije na mestu injiciranja (npr. zbadanje, pekoč občutek, bolečina, rdečica, edem).
No case of overdose has been reported during clinical trials.
Ni poročil o primerih prevelikega odmerjanja med kliničnimi preskušanji.
A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/ kg administered as an intravenous bolus.
V študiji na zdravih prostovoljcih so ugotovili ortostatsko hipotenzijo, povezano z odmerkom 0, 64 mg/ kg, danim v obliki intravenskega bolusa.
Pharmacotherapeutic group: not yet assigned, ATC code: not yet assigned.
Farmakoterapevtska skupina: še ni dodeljena, oznaka ATC: še ni dodeljena.