natgillin/translations-raw huggingface dataset:
Only use this medicine if the solution is clear, colourless to pale yellow, and does not contain flakes or particles.
Ovaj lijek koristite jedino ako je otopina bistra, bezbojna do blijedožuta i ne sadrži pahuljice ili čestice.
The renal clearance of methylnaltrexone bromide was reduced following multiple-dose administration of cimetidine (from 31 L/h to 18 L/h).
Bubrežni klirens metilnaltreksonbromida bio je smanjen nakon višestrukog doziranja cimetidina (s 31 l/h na 18 l/h).
INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR
UPUTE ZA PRIPREMU I PRIMIJENU INJEKCIJE RELISTORA
If unsure, please contact your doctor, nurse or pharmacist.
Ako niste sigurni, molimo obratite se Vašem liječniku, medicinskoj sestri ili ljekarniku.
Dizziness is a common side effect of this medicine.
Omaglica je česta nuspojava ovog lijeka.
Patients had opioid-induced constipation (< 3 rescue medication-free bowel movements per week during the screening period).
Bolesnici su imali konstipaciju uzrokovanu opioidima (< 3 pražnjenja crijeva tjedno tijekom razdoblja probira bez primjene dodatnog laksativa).
Pick up the syringe from your work surface.
Podignite štrcaljku s radne površine.
Insert the needle straight down into the centre of the vial stopper.
Uvedite iglu ravno nadolje u središte čepa bočice.
Areas with scars or stretch marks should be avoided.
Treba izbjegavati mjesta s ožiljcima ili strijama.
Slowly pull the plunger down to the 0.4 mL or 0.6 mL mark on the syringe or as advised, depending on the dose prescribed by your doctor, nurse or pharmacist.
Polako vucite klip prema dolje do oznake na štrcaljki od 0,4 ml ili 0,6 ml ili do oznake doze koja Vam je propisana od Vašeg liječnika, medicinske sestre ili ljekarnika.
The 4-week, double-blind period was followed by an 8-week, open-label period during which methylnaltrexone bromide was to be used as needed, but no more frequently than once daily.
Nakon 4tjednog, dvostruko slijepog razdoblja slijedilo je 8-tjedno, otvoreno razdoblje tijekom kojeg je metilnaltreksonbromid primjenjivan po potrebi, ali ne češće od jedanput dnevno.
Remove the syringe and needle from the vial.
Izvadite štrcaljku i iglu iz bočice.
NEVER recap the needle.
NIKADA nemojte vraćati pokrov na iglu.
Step 1: Preparing for an injection
Korak 1: Priprema za injekciju
Animal studies have shown excretion of methylnaltrexone bromide in breast milk.
Ispitivanja na životinjama pokazala su izlučivanje metilnaltreksonbromida u mlijeko životinja.
Severity and worsening symptoms Patients should be advised to promptly report severe, persistent, and/or worsening symptoms.
Bolesnike se mora uputiti da bez odlaganja prijave teške simptome, simptome koji traju i/ili se pogoršavaju.
In a study comparing single and multiple-dose pharmacokinetic profiles of intravenous methylnaltrexone bromide at a dose of 24 mg between healthy, young (18 to 45 years of age n = 10) and elderly (65 years of age and over n = 10) subjects, the effect of age on exposure to methylnaltrexone bromide was found to be minor.
U ispitivanju u kojemu je uspoređen farmakokinetički profil metilnaltreksonbromida nakon jednokratne i višekratne intravenske doze od 24 mg kod zdravih, mladih (18 do 45 godina, n=10) i starijih ispitanika (u dobi od 65 godina i stariji n=10), bilo je utvrđeno da je učinak dobi na izloženost metilnaltreksonbromidu zanemariv.
Your doctor will decide if you can use Relistor if you are pregnant.
Relistor ukoliko ste trudni.
The adverse reactions are classified as: 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) and not known (cannot be estimated from the available data).
Učestalost nuspojava je klasificirana kao: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
In a study of volunteers with varying degrees of renal impairment receiving a single dose of 0.30 mg/kg methylnaltrexone bromide, renal impairment had a marked effect on the renal excretion of methylnaltrexone bromide.
U ispitivanju na dobrovoljcima s različitim stupnjevima oštećenja bubrega koji su primili jednokratnu dozu od 0,30 mg/kg metilnaltreksonbromida, oštećenje bubrega imalo je značajan učinak na izlučivanje metilnaltreksonbromida bubrezima.
An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone bromide mg/kg dose-adjusted exposure increased as body weight increased.
Integrirana analiza farmakokinetičkih podataka kod zdravih ispitanika upućuje na to da se s povećanjem tjelesne težine povećava izloženost metilnaltreksonbromidu s rastućom dozom mg/kg.
• Flatulence (passing wind)
Nadutost (vjetrovi)
Results showed no meaningful effect of hepatic impairment on the AUC or Cmax of methylnaltrexone bromide.
Rezultati nisu pokazali značajni učinak oštećenja jetre na AUC ili Cmax metilnaltreksonbromida.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 July 2008
Datum prvog odobrenja: 02. srpnja 2008.
Very common: Abdominal pain, nausea, diarrhoea, flatulence Skin and subcutaneous tissue disorders
Vrlo često: abdominalna bol, mučnina, proljev, flatulencija Poremećaji kože i potkožnog tkiva
Step 2: Preparing the injection syringe
Korak 2: Priprema injekcijske štrcaljke
Carefully pull back the plunger on the syringe to either the 0.4 mL mark for 8 mg of Relistor or the 0.6 mL mark for 12 mg Relistor.
Oprezno izvucite klip štrcaljke ili do oznake za 0,4 ml za dozu od 8 mg Relistora, ili do oznake za 0,6
Methylnaltrexone bromide is eliminated primarily as the unchanged active substance.
Metilnaltreksonbromid se u prvom redu eliminira kao nepromijenjena djelatna tvar.
Packs of more than one vial contain inner cartons consisting of: one vial, one 1 mL injection syringe with retractable injection needle, and two alcohol swabs.
Pakiranja s više od jedne bočice sadrže unutarnje kutije u kojima su: jedna bočica, jedna štrcaljka za injekciju od 1 ml s iglom za injekciju na uvlačenje i dva alkoholom natopljena jastučića.
Prior to screening, patients had opioid-induced constipation defined as either <3 bowel movements in the preceding week or no bowel movement for >2 days.
Prije probira kod bolesnika je inducirana konstipacija opioidima, definirana ili kao < 3 stolice tijekom proteklog tjedna ili kao izostanak stolice tijekom > 2 dana.
If you get a stomach ache that is either severe or will not go away, stop taking this medicine and call your doctor straight away.
Ukoliko osjetite bol u trbuhu koja je ili teška ili ne prolazi, prestanite uzimati ovaj lijek i odmah se obratite liječniku.
Pre-filled syringe of clear type I glass with stainless-steel needle, plastic plunger, and polypropylene rigid needle cover.
Napunjena štrcaljka od prozirnog stakla tip I s iglom od nehrđajućeg čelika, plastičnim klipom i krutim polipropilenskim pokrovom za iglu.
Gently tap the syringe to make any air bubbles rise to the top of the syringe; be sure that you still hold onto the vial and syringe.
Lagano lupkajte po štrcaljki kako bi se mjehurići zraka podigli do vrha štrcaljke; svakako čvrsto držite bočicu i štrcaljku.
If needed, you may cover the injection site with a plaster.
Po potrebi, pokrijte ubodno mjesto flasterom.
Contact your pharmacist, nurse or doctor for assistance.
Obratite se za pomoć Vašem ljekarniku, medicinskoj sestri ili liječniku.
If you are using the supplied injection syringe with retractable injection needle, DO NOT PUSH THE PLUNGER DOWN COMPLETELY.
Koristite li isporučenu injekcijsku štrcaljku s iglom za injekciju na uvlačenje, NEMOJTE
These include the Relistor vial, a 1 mL injection syringe (with or without retractable needle), 2 alcohol swabs, and a cotton ball or gauze.
To uključuje bočicu Relistora, injekcijsku štrcaljku od 1 ml (s ili bez igle za injekciju na uvlačenje), 2 alkoholom natopljena jastučića i pamučni tupfer ili gazu.
The effects of methylnaltrexone bromide in pregnant women are not known.
Učinci metilnaltreksonbromida kod trudnica nisu poznati.
Relistor is a solution for injection.
Relistor je otopina za injekciju.
• Do not use a Relistor pre-filled syringe more than one time, even if there is medicine in the syringe.
Uvijek upotrijebite napunjenu štrcaljku Relistora samo jedan put, čak i kad u štrcaljki ostane lijeka.
As a quaternary amine, the ability of methylnaltrexone bromide to cross the blood-brain barrier is restricted.
Sposobnost prolaska metilnaltreksonbromida, kao kvarternog amina, kroz krvno-moždanu barijeru je ograničena.
Czech republic
Češka Republika
The three areas of the body recommended for injection of Relistor are upper legs, abdomen, and upper arms.
Tri tjelesne regije koje se preporučuju za davanje injekcije Relistora su natkoljenice, trbuh i nadlaktice.
• If you have severe stomach symptoms which continue or get worse, contact your doctor immediately because these could be symptoms of a hole developing in the bowel wall (intestinal perforation).
● Ako imate teške simptome u području trbuha koji ne prestaju ili se pogoršavaju, odmah se javite liječniku, jer bi to mogli biti simptomi puknuća crijeva (intestinalne perforacije).
Quickly pull the needle out of the skin, being careful to keep it at the same angle as it was inserted.
Brzim pokretom izvucite iglu iz kože i pri tom pazite da ju držite pod istim kutom pod kojim ste ju umetnuli.
The organic cation transporter (OCT)-related drug-drug interaction potential between methylnaltrexone bromide and an OCT inhibitor was studied in 18 healthy subjects by comparing the single-dose pharmacokinetic profiles of methylnaltrexone bromide before and after multiple 400 mg doses of cimetidine.
Mogućnost interakcija lijek-lijek povezana s organskim kationskim transporterom (OTC) između metilnaltreksonbromida i OCT inhibitora ispitivana je kod 18 zdravih ispitanika uspoređivanjem farmakokinetskih profila pojedinačne doze metilnaltreksonbromida prije i poslije višekratnih doza 400 mg cimetidina.
Important information about some of the ingredients of Relistor This medicine contains less than 1 mmol sodium (23 mg) per dose i.e., essentially “sodium free.”
Važne informacije o nekim sastojcima Relistora Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. u osnovi je "bez natrija”
Dispose of the capped syringe or needle and syringe in a closable puncture-resistant container as instructed by your doctor, nurse or pharmacist.
Štrcaljku s pokrovom ili štrcaljku s iglom odbacite u neprobojni spremnik koji možete zatvoriti, u skladu s uputama Vašeg liječnika, medicinske sestre ili ljekarnika.
Stool consistency was not meaningfully improved in patients who had soft stool at baseline.
Konzistencija stolice nije značajno poboljšana kod bolesnika koji su na početku imali mekanu stolicu.
The difference between methylnaltrexone bromide 12 mg once daily and placebo of 1.6 RFBMs per week is statistically significant (p < 0.001) and clinically meaningful.
Razlika između metilnaltreksonbromida u dozi od 12 mg jedanput dnevno i placeba u iznosu od 1,6 pražnjenja crijeva bez primjene dodatnog laksativa tjedno statistički je značajna (p<0,001) i klinički bitna.
• This medicine should not be used for treatment of patients with constipation which is not related to opioid use.
• Ovaj lijek se ne smije koristiti za liječenje zatvora kod bolesnika kod kojih zatvor nije povezan s primjenom opioida.
The adverse reactions are classified as: very common (≥1/10); common (≥1/100 to <1/10); uncommon
Učestalost nuspojava je klasificirana kao: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često
INFORMATION IN BRAILLE RELISTOR 8 mg
PODACI NA BRAILLEOVOM PISMU Relistor 8 mg
You will be instructed by your doctor, nurse or pharmacist on the techniques of self-injection.
Vaš liječnik, medicinska sestra ili ljekarnik objasnit će Vam tehniku samoinjiciranja.
If you push solution back into the vial, slowly pull back the plunger to draw the correct amount of solution back into the syringe.
Ako istisnete otopinu natrag u bočicu, polagano povucite klip natrag, kako biste uvukli ispravnu količinu tekućine u štrcaljku.
Study 301 compared methylnaltrexone bromide given as a single, double-blind, subcutaneous dose of 0.15 mg/kg, or 0.3 mg/kg versus placebo.
U ispitivanju 301 uspoređen je metilnaltreksonbromid, davan kao jednokratna, dvostruko slijepa supkutana doza od 0,15 mg/kg ili 0,3 mg/kg, s placebom.
If there are bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe.
Ako ima mjehurića, lagano lupkajte prstom po štrcaljki kako bi se mjehurići zraka podigli do vrha štrcaljke.
Patients whose weight falls outside of the ranges should be dosed at 0.15 mg/kg.
Bolesnici čija je težina izvan navedenog raspona trebaju primiti dozu od 0,15 mg/kg.
This medicine is given by an injection under the skin (by subcutaneous injection) in either (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (if not self-injecting).
Ovaj lijek se daje injekcijom pod kožu (supkutanom injekcijom) ili u (1) natkoljenice (bedra), (2) abdomen (trbuh) ili (3) nadlakticu (ako ne injicirate sami). (Pogledajte UPUTE ZA PRIPREMU I PRIMJENU INJEKCIJE RELISTOR-a na kraju ove upute).
Do not use this medicine after the expiry date which is stated on the carton, tray lid and syringe label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake „EXP“.
Relistor contains an active substance called methylnaltrexone bromide which acts by blocking the side effects of opioid pain medicines that affect the bowel.
Relistor sadrži djelatnu tvar pod nazivom metilnaltreksonbromid koja sprječava nuspojave koje opioidni lijekovi za ublažavanje bolova imaju na probavni sustav.
In order to get the air out of the syringe, gently push the plunger down to inject the air into the vial.
Da biste iz štrcaljke izbacili zrak, lagano gurajte klip prema dolje, kako biste injicirali zrak u bočicu.
Make sure you have set aside a proper amount of time to complete the injection.
Odvojite dovoljno vremena za davanje injekcije.
Opioid-induced constipation in adult patients with chronic pain (except palliative care patients with advanced illness)
Konstipacija uzrokovana opioidima u odraslih bolesnika s kroničnom boli (osim bolesnika s uznapredovalom bolešću koji primaju palijativnu skrb)
Methylnaltrexone bromide is metabolised to a modest extent in humans based on the amount of methylnaltrexone bromide metabolites recovered from excreta.
Metilnaltreksonbromid se kod ljudi metabolizira u umjerenom opsegu, kako je utvrđeno na temelju metabolita metilnaltreksonbromida koji su nađeni u izlučevinama.
Therefore, Relistor should only be administered with caution in these patients.
Stoga se kod ovih bolesnika Relistor smije primjenjivati samo uz povećani oprez.
The following instructions explain how to inject Relistor.
Uvod Sljedeće upute opisuju kako dati injekciju Relistora.
The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone bromide has not been studied.
Učinak teškog oštećenja jetre na farmakokinetiku metilnaltreksonbromida nije ispitan.
Ask your doctor, nurse or pharmacist for instructions on the right way to throw away (dispose of) the container.
Obratite se Vašem liječniku, medicinskoj sestri ili ljekarniku glede uputa kako da na pravi način bacite
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.
Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. praktički ne sadrži natrij.
Study 302 compared double-blind, subcutaneous doses of methylnaltrexone bromide given every other day for 2 weeks versus placebo.
U ispitivanju 302 uspoređene su dvostruko slijepe supkutane doze metilnaltreksonbromida koji je davan svaki drugi dan tijekom 2 tjedna, s placebom.
The mean methylnaltrexone bromide exposure at 0.15 mg/kg over a weight range of 38 to 114 kg was 179 (range = 139-240) ng•h/mL.
Srednja vrijednost izloženosti metilnaltreksonbromidu u dozi od 0,15 mg/kg, pri rasponu tjelesne težine od 38 do 114 kg, iznosila je 179 ng•h/ml (raspon= 139 - 240).
The Cmax and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/kg to 0.5 mg/kg in a doseproportional manner.
Cmax i površina ispod krivulje odnosa između koncentracije u plazmi i vremena (AUC) povećavaju se s povećavanjem doze od 0,15 mg/kg na 0,50 mg/kg.
Wipe the vial's rubber stopper with an alcohol swab and place it on your flat work surface.
Jastučićem natopljenim alkoholom obrišite gumeni čep na bočici i postavite ju na ravnu radnu plohu.
Methylnaltrexone bromide is excreted via the milk of lactating rats.
Metilnaltreksonbromid se izlučuje u mlijeku štakora.
When the syringe is empty, quickly pull the needle out of the skin, being careful to keep it at the same angle as inserted.
Kada je štrcaljka prazna, brzim pokretom izvucite iglu iz kože pazeći pri tom da je držite pod istim kutom pod kojim ste je umetnuli.
It is unknown whether methylnaltrexone bromide is excreted in human breast milk.
Nije poznato izlučuje li se metilnaltreksonbromid u majčino mlijeko u ljudi.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, vomiting, abdominal pain, palpitations, and blushing have occurred in patients treated with methylnaltrexone bromide.
Simptomi povezani s ustezanjem od opioida, uključujući hiperhidrozu, zimicu, povraćanje, bol u abdomenu, palpitacije, i crvenilo pojavili su se kod bolesnika koji su liječeni metilnaltreksonbromidom.
The double-blind dose was followed by an open-label, 4-week dosing period, where methylnaltrexone bromide could be used as needed, no more frequently than 1 dose in a 24-hour period.
Nakon dvostruko slijepe doze slijedilo je otvoreno razdoblje doziranja od 4 tjedna u kojem je metilnaltreksonbromid primjenjivan po potrebi, ne češće od jedne doze tijekom 24 sata.
Methylnaltrexone bromide-treated patients had a significantly higher rate of laxation within 4 hours of the double-blind dose (62 % for 0.15 mg/kg and 58 % for 0.3 mg/kg) than placebo-treated patients (14 %); p<0.0001 for each dose versus placebo.
Bolesnici liječeni metilnaltreksonbromidom imali su značajno veću stopu laksacije unutar 4 sata nakon dvostruko slijepe doze (62% za 0,15 mg/kg i 58% za 0,3 mg/kg) od bolesnika koji su primili placebo (14%); p<0,0001 za svaku dozu u odnosu na placebo.
Relistor can be injected without regard to food.
Relistor se može injicirati neovisno o obrocima.
In juvenile rats administered intravenous methylnaltrexone bromide for 13 weeks, adverse clinical signs (incidences of convulsions and labored breathing) occurred at dosages (≥ 3 mg/kg/day) and exposures (5.4 times the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg) that were lower than those that caused similar toxicity in adult rats (20 mg/kg/day).
Kod mladih štakora kojima je metilnaltreksonbromid davan intravenski tijekom 13 tjedana, nastupili su štetni klinički znakovi (pojave konvulzija i teškog disanja) i to pri dozama (≥ 3 mg/kg/dan) i izloženostima (5,4 puta veća izloženost {AUC} nego kod odraslih ljudi pri supkutanoj dozi od 0,15 mg/kg) koje su bile niže od onih koje su prouzrokovale sličnu toksičnost kod odraslih štakora (20 mg/kg/dan).
• It is important to be near a toilet with assistance available if necessary, since bowel movement may happen within 30 minutes after injection of the medicine.
• Važno je biti u blizini zahoda, po potrebi uz pomoć, budući da se stolica može pojaviti kroz 30
INFORMATION IN BRAILLE RELISTOR 12 mg/0.6 mL
PODACI NA BRAILLEOVOM PISMU Relistor 12 mg/0,6 ml
SPECIAL STORAGE CONDITIONS Store below 30°C.
POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 30° C.
Hydrochloric acid (to adjust pH)
Kloridna kiselina (za podešavanje pH)
To prepare the area of skin where Relistor is to be injected, wipe the injection site with an alcohol swab.
3. Da biste pripremili mjesto injiciranja Relistora, očistite ubodno mjesto jastučićem natopljenim alkoholom.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Nuspojave su unutar svake skupine učestalosti prikazane redosljedom u padajućem nizu prema ozbiljnosti:
The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone bromide has been studied in 8 subjects each, with Child-Pugh Class A and B, compared to healthy subjects.
Učinak blagog i umjerenog oštećenja jetre na sistemsku izloženost metilnaltreksonbromidu ispitan je na po 8 ispitanika (8 za blago i 8 za umjereno oštećenje), s Child-Pugh stadijem A i B, u usporedbi sa zdravim ispitanicima.
Subcutaneous injections of Relistor at 150/100 mg/kg/day to rats resulted in decreased offspring weights; doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) had no effect on labour, delivery, or offspring survival and growth.
150/100 mg/kg/dan kod štakora dovele su do smanjene težine potomstva; doze do 25 mg/kg/dan (18 puta veća izloženost [AUC] nego kod ljudi pri supkutanoj dozi od 0,3 mg/kg) nisu utjecale na trudove, porod ili preživljavanje i rast potomstva.
Methylnaltrexone bromide is minimally metabolised by CYP isozymes.
Metilnaltreksonbromid se u vrlo maloj mjeri metabolizira djelovanjem CYP izoenzima.
Step 4a: Injecting Relistor using a pack containing injection syringe with retractable injection needle
Korak 4a: Injiciranje Relistora kod upotrebe pakiranja koje sadrži štrcaljku za injekciju s iglom za injekciju na uvlačenje
Conversion to methyl-6-naltrexol isomers and methylnaltrexone sulphate appears to be the primary pathway to metabolism.
Čini se da je glavni metabolički put konverzija u izomere metil-6-naltreksola i metilnaltrekson sulfat.
Dispose of the pre-filled syringe as instructed by your doctor, nurse or pharmacist.
Zbrinite napunjenu štrcaljku prema uputama svojeg liječnika, medicinske sestre ili ljekarnika.
Methylnaltrexone bromide-treated patients also had significantly higher rates of laxation within 4 hours after at least 2 of the first 4 doses (52 %) than did placebo-treated patients (9 %); p<0.0001.
Bolesnici liječeni metilnaltreksonbromidom također su imali značajno veću stopu laksacije unutar 4 sata nakon davanja najmanje 2 od prve 4 doze lijeka (52%) od bolesnika koji su primili placebo (9%); p=0,0001.
Step 4b: Injecting Relistor using a standard injection syringe and injection needle
Korak 4b: Injiciranje Relistora kod upotrebe standardne injekcijske štrcaljke i injekcijske igle
A total of 154 patients (methylnaltrexone bromide 0.15 mg/kg, n = 47; methylnaltrexone bromide 0.3 mg/kg, n = 55, placebo, n = 52) were treated in the double-blind period.
(metilnaltreksonbromid 0,15 mg/kg, n = 47; metilnaltreksonbromid 0,3 mg/kg, n = 55; placebo, n = 52).
sweating, hair standing on end, blushing, fast heart beat)
drhtanje, curenje iz nosa, znojenje, naježena koža, crvenilo, ubrzani otkucaji srca)
Make sure that the dose prescribed by your doctor matches the dose on the pre-filled syringe label.
Provjerite odgovara li doza na naljepnici napunjene štrcaljke dozi koju je propisao Vaš liječnik
Do not touch the needle or allow the needle to touch any surface.
NEMOJTE dodirivati iglu i pazite da igla ne dotakne bilo koju drugu površinu.
Tel. +36 1 998 99 47 e-mail: mail.hu@sobi.com
+36 1 998 99 47 e-mail: mail.hu@sobi.com
Clear solution, colourless to pale-yellow, essentially free from visible particulates.
Bistra, bezbojna do blijedo žuta otopina, uglavnom bez vidljivih čestica.
The activity of methylnaltrexone bromide has been studied in patients with constipation induced by opioids.
Aktivnost metilnaltreksonbromida ispitivana je kod bolesnika s konstipacijom uzrokovanom opioidima.
• Diarrhoea (passing of frequent watery stools)
Mučnina Proljev (česte vodenaste stolice)
Sodium hydroxide (to adjust pH)
Natrijev hidroksid (za podešavanje pH)
No adverse effects occurred in either juvenile or adult dogs at a dose of 5 mg/kg/day (44 times the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg).
Niti kod mladih niti kod odraslih pasa nisu nastupili štetni učinci pri dozi od 5 mg/kg/dan (44 puta veća izloženost {AUC} nego kod odraslih ljudi pri supkutanoj dozi od 0,15 mg/kg).