natgillin/translations-raw huggingface dataset:
You may have a bowel movement within a few minutes to a few hours of the injection; therefore, it is recommended to have a toilet facility or bedpan near you.
Pražnjenje crijeva može nastupiti kroz nekoliko minuta do nekoliko sati nakon injekcije; stoga se preporučuje biti u blizini zahoda ili imati pri ruci noćnu posudu.
There was no evidence of a differential effect of gender on safety or efficacy.
Nije bilo dokaza koji bi upućivali na to da spol ima učinke na sigurnost ili djelotvornost.
The pre-filled syringe should NEVER be reused.
Napunjena štrcaljka ne smije se NIKADA ponovno upotrijebiti.
The steady-state volume of distribution (Vss) is approximately 1.1 L/kg.
Volumen distribucije u stanju dinamičke ravnoteže (Vss) iznosi oko 1,1 l/kg.
Hold the syringe at eye level so that you can see the dosing marks and make sure the tip of the needle is in the fluid all of the time.
Držite štrcaljku u razini oka, tako da možete vidjeti oznake za dozu i pazite da se vrh igle cijelo vrijeme nalazi u tekućini.
The terminal disposition half-life (t1/2) is approximately 8 hours.
Terminalno poluvrijeme uklanjanja (t1/2) iznosi oko 8 sati.
Not known: Gastrointestinal perforation (see section 4.4)
Nepoznato: gastrointestinalna perforacija (vidjeti dio 4.4)
The 8 mg pre-filled syringe will only be used to treat these patients if the dose needs to be decreased because of another medical problem.
Napunjena štrcaljka od 8 mg će se koristiti za liječenje ovih bolesnika isključivo ako je potrebno smanjiti dozu zbog nekog drugog zdravstvenog problema.
You may receive either a pack containing an inner carton with everything needed for the injection, or a single vial only.
Možete dobiti pakiranje koje sadrži unutarnju kutiju sa svim potrebnim za injekciju ili pakiranje u kojem se nalazi samo jedna bočica.
(≥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).
(≥ 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).
Push the full length of the needle into the skin at a slight angle (45 degrees) with a quick, short motion.
Gurnite iglu do kraja u kožu pod malim kutom (45 stupnjeva) brzim, kratkim pokretom.
Your doctor will tell you whether you should stop or continue taking your usual laxatives when you start using this medicine.
Vaš liječnik će Vam reći trebate li prekinuti ili nastaviti s uzimanjem uobičajenih laksativa kada počnete koristiti ovaj lijek.
Pack sizes of 1 vial,
Veličine pakiranja su 1 bočica,
Data from clinical trials suggest treatment with methylnaltrexone bromide can result in the rapid onset (within 30 to 60 minutes on average) of a bowel movement.
Podaci iz kliničkih studija upućuju na to da liječenje metilnaltreksonbromidom može dovesti do brzog pražnjenja crijeva (prosječno unutar 30 do 60 minuta).
This should be taken into account when prescribing methylnaltrexone bromide for such patients.
Ovo treba uzeti u obzir prilikom propisivanja metilnaltreksonbromida takvim bolesnicima.
In vitro metabolism studies suggest that methylnaltrexone bromide 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.
In vitro ispitivanja metabolizma pokazuju da metilnaltreksonbromid ne inhibira aktivnost CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 ili CYP3A4, dok je istovremeno slabi inhibitor metabolizma modela CYP2D6 supstrata.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
Methylnaltrexone sulphate is an inactive metabolite and present in plasma at a level of approximately 25 % of drug related materials.
Metilnaltrekson sulfat je inaktivni metabolit i prisutan je u plazmi na razini od oko 25 % tvari povezanih s lijekom.
If it is not, do not use the solution.
Ako to nije slučaj, nemojte upotrijebiti otopinu.
Patients had a history of chronic non-cancer pain and were taking opioids with stable doses of at least 50 mg of oral morphine equivalents per day.
Bolesnici su u anamnezi imali kroničnu nemalignu bol i uzimali su opioide u stabilnim dozama ekvivalentnim najmanje 50 mg oralnog morfina dnevno.
It is recommended to move to a different site each time an injection is given.
Preporučuje se svaki put dati injekciju na drugom mjestu.
The safety and efficacy of methylnaltrexone bromide in children less than 18 years has not been established.
Sigurnost i djelotvornost metilnaltreksonbromida u djece u dobi do 18 godina nije ustanovljena.
During the first week (days 1, 3, 5, 7), patients received either methylnaltrexone bromide 0.15 mg/kg or placebo.
Tijekom prvog tjedna (dani 1, 3, 5, 7) bolesnici su primili ili metilnaltreksonbromid od 0,15 mg/kg ili placebo.
However, this resulted in a small reduction in total clearance (from 107 L/h to 95 L/h).
To je međutim dovelo do manjeg pada ukupnog klirensa (sa 107 l/h na 95 l/h).
The use of methylnaltrexone bromide for treating opioid-induced constipation beyond 48 weeks has not been evaluated in clinical trials.
Primjena metilnaltreksonbromida za liječenje konstipacije uzrokovane opioidima dulje od 48 tjedana nije ispitivana u kliničkim ispitivanjima.
In this study, the median patient age was 49 years (range 23-83); 60% were females.
U ovom ispitivanju medijan dobi bolesnika je iznosio 49 godina (raspon 23 - 83); 60% bolesnika bile su žene.
This may have an effect on your ability to drive and use machines.
To može utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
Use the other hand to gently pinch the cleaned area of skin and hold it firmly.
Drugom rukom nježno uzmite nabor kože u očišćenom području i čvrsto ga uhvatite.
Do not use Relistor - if you are allergic to methylnaltrexone bromide or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Relistor - Ako ste alergični na metilnaltreksonbromid ili neki drugi sastojak ovog lijeka (naveden u dijelu
The mechanism of this effect is unknown; however, the human cardiac potassium ion channel (hERG) appears not to be involved.
Mehanizam navedenog učinka nije poznat; međutim, čini se da ne uključuje kalijev ionski kanal kod ljudi (hERG).
Remove the protective plastic cap from the vial.
Skinite plastičnu zaštitnu kapicu s bočice.
For storage conditions of the medicinal product in the syringe, see section 6.3.
Uvjete čuvanja lijeka u štrcaljki, vidjeti u dijelu 6.3.
Do not attempt to administer an injection until you are sure that you understand how to prepare and give an injection.
Nemojte pokušavati dati injekciju dok niste sigurni da razumijete kako pripremiti i dati injekciju.
Patients may receive two consecutive doses 24 hours apart, only when there has been no response (bowel movement) to the dose on the preceding day.
Bolesnici mogu primiti dvije uzastopne doze u razmaku od 24 sata, samo u slučajevima kada nije bilo odgovora (stolice) na dozu od prethodnog dana.
This allows methylnaltrexone bromide to function as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system.
To omogućuje metilnaltreksonbromidu da djeluje kao periferni antagonist mu-opioidnih receptora u tkivima poput gastrointestinalnog trakta, a da ne utječe na analgetički učinak posredovan opioidima na središnji živčani sustav.
Release your thumb from the plunger to allow the protective sleeve to cover the needle.
Podignite palac s klipa da omogućite da zaštitni rukavac poklopi iglu.
Select a flat, clean, well-lit working surface where you can lay out the contents of your Relistor carton.
Odaberite ravnu, čistu, dobro osvijetljenu površinu na koju ćete složiti sadržaj pakiranja
In both studies, there was no evidence to suggest differential effects of age or gender on safety or efficacy.
U oba ispitivanja nije bilo dokaza koji bi upućivali na to da dob ili spol imaju učinke na djelotvornost ili sigurnost lijeka.
Pack containing 4, 7, 8 or 10 pre-filled syringes with a needle shield.
Pakiranje koje sadrži 4, 7, 8 ili 10 napunjenih štrcaljki sa štitnikom za iglu.
Relistor is indicated for the treatment of opioid-induced constipation when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older.
Relistor je indiciran za liječenje konstipacije uzrokovane opioidima kada odgovor na terapiju laksativima nije dovoljan u odraslih bolesnika, u dobi od 18 godina i starijih.
It is not recommended to inject into areas where the skin is tender, bruised, red, or hard.
Ne preporučuje se davanje injekcije na mjestima gdje je koža osjetljiva, natučena, crvena ili tvrda.
Data from 133 (62 methylnaltrexone bromide, 71 placebo) patients were analysed.
Analizirani su podaci 133 bolesnika (62 metilnaltreksonbromid, 71 placebo).
• Risk Management Plan
LIJEKA • Plan upravljanja rizikom (RMP)
In the second week, a patient's assigned dose could be increased to 0.30 mg/kg if the patient had 2 or fewer rescue-free laxations up to day 8.
Tijekom drugog tjedna doza koju su bolesnici primali mogla se povisiti na 0,30 mg/kg ako je bolesnik imao 2 ili manje laksacija bez primjene dodatnog laksativa do 8. dana.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN DOHVATA I POGLEDA DJECE
In both studies, patients had advanced terminal illness and limited life expectancy, with the majority having a primary diagnosis of incurable cancer; other primary diagnoses included end-stage COPD/emphysema, cardiovascular disease/heart failure, Alzheimer's disease/dementia, HIV/AIDS, or other advanced illnesses.
U oba ispitivanja bolesnici su imali uznapredovalu terminalnu bolest s ograničenim očekivanjem trajanja života, a većina je bila s primarnom dijagnozom neizlječivog raka; ostale primarne dijagnoze uključivale su terminalni stadij KOPB/emfizema, kardiovaskularnu bolest/zatajenje srca, Alzheimerovu bolest/demenciju, HIV/AIDS ili druge uznapredovale bolesti.
The capped syringe or syringe and needle should NEVER be reused.
Štrcaljka s pokrovom ili štrcaljka s iglom se NIKADA ne smiju ponovno upotrijebiti.
Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor.
Metilnaltreksonbromid je selektivni antagonist vezivanja opioida na mu-receptor.
Patient weight in kg Fill syringe to mL level (dose) Less than 38 kg
Težina bolesnika u kg Štrcaljku napuniti do oznake ml (doza) Manje od 38 kg
Women using this medicine should not breast-feed, since it is not known if methylnaltrexone bromide passes into human breast milk.
Žene koje uzimaju ovaj lijek ne smiju dojiti budući da nije poznato izlučuje li se metilnaltreksonbromid u majčino mlijeko.
Opioid-induced constipation in adult patients with advanced illness Methylnaltrexone bromide treatment has not been studied in adult patients with advanced illness in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.1).
Konstipacija uzrokovana opioidima u odraslih bolesnika s uznapredovalom bolešću Liječenje metilnaltreksonbromidom nije ispitivano u odraslih bolesnika s uznapredovalom bolešću u kliničkim ispitivanjima duže od 4 mjeseca te ga stoga treba primjenjivati samo u ograničenom razdoblju (vidjeti dio 5.1).
Pack sizes of 4, 7, 8 and 10 pre-filled syringes.
Veličine pakiranja: 4, 7, 8, i 10 napunjenih štrcaljki.
Paediatric population No studies have been performed in the paediatric population (see section 4.2).
Na pedijatrijskoj populaciji nisu provedena ispitivanja (vidjeti dio 4.2).
Following intravenous injection of methylnaltrexone bromide, juvenile rats were found to be more sensitive than adult rats to methylnaltrexone-related toxicity.
Nakon primanja intravenske injekcije metilnaltreksonbromida, utvrđeno je da su mladi štakori osjetljiviji od odraslih štakora na toksičnost povezanu s metilnaltreksonbromidom.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with methylnaltrexone bromide should be made, taking into account the benefit of breast-feeding to the child and the benefit of methylnaltrexone bromide therapy to the woman.
Potrebno je odlučiti da li nastaviti/prekinuti dojenje ili nastaviti/prekinuti liječenje metilnaltreksonbromidom uzimajući u obzir korist dojenja za dijete i korist liječenja metilnaltreksonbromidom za ženu.
- If you or your doctor know that your bowels were or are obstructed or your bowels are in a state where there is an immediate need for surgical intervention (which has to be diagnosed by your doctor).
- Ako Vi ili Vaš liječnik znate da su Vaša crijeva bila ili su začepljena ili da su Vaša crijeva u stanju u kojem postoji hitna potreba za kirurškim zahvatom (takvo stanje mora dijagnosticirati
Severe renal impairment decreased the renal clearance of methylnaltrexone bromide by 8- to 9-fold; however, this resulted in only a 2-fold increase in total methylnaltrexone bromide exposure (AUC).
Teško oštećenje bubrega dovelo je do smanjenja renalnog klirensa metilnaltreksonbromida za 8 do 9 puta; međutim, ovo je dovelo do samo dvostrukog povećanja ukupne izloženosti metilnaltreksonbromidu (AUC).
Patients with severe renal impairment whose weight falls outside the 62 to 114 kg range (see section 5.2) need to reduce their mg/kg dose by 50 %.
Bolesnicima s teškim oštećenjem bubrega čija je težina izvan raspona od 62 do 114 kg (vidjeti dio 5.2), potrebno je smanjiti dozu u mg/kg za 50%.
If you experience any of these side effects, which are either severe or will not go away, you should talk to your doctor:
Ukoliko doživite bilo koju od tih nuspojava koje su teške ili ne prolaze, morate se obratiti svom liječniku:
These patients should use Relistor vials and not the pre-filled syringe.
Ovi bolesnici moraju koristiti bočice Relistora, a ne napunjenu štrcaljku.
Assemble the supplies you will need for your injection.
Složite sve predmete koji su Vam potrebni za injekciju.
If you forget a dose, talk to your doctor or pharmacist as soon as possible.
Ako zaboravite uzeti jednu dozu, što prije se obratite svojem liječniku ili ljekarniku.
Relistor is given as a subcutaneous injection.
Relistor se daje kao supkutana injekcija.
If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with methylnaltrexone bromide and consult their physician.
Pojavi li se tijekom liječenja težak ili trajan proljev, bolesnicima treba savjetovati da ne nastavljaju liječenje metilnaltreksonbromidom te da se posavjetuju sa svojim liječnikom.
Do not attempt to administer an injection until you are sure that you understand how to give the injection.
Nemojte pokušavati dati injekciju dok niste sigurni da razumijete kako dati injekciju.
In palliative care patients, Relistor is added to usual laxative treatment (see section 5.1).
U bolesnika koji primaju palijativnu skrb, Relistor se dodaje liječenju uobičajenim laksativima (vidjeti dio 5.1).
For patients with long-term pain (except patients receiving supportive care for advanced illness), fill the syringe to the 0.6 mL mark for 12 mg of Relistor.
Za bolesnike s dugoročnom boli (osim bolesnika koji primaju suportivnu skrb za uznapredovalu bolest) napunite štrcaljku do oznake od 0,6 ml za 12 mg lijeka Relistor.
The most common adverse reactions in all patients exposed to methylnaltrexone bromide during all phases of placebo-controlled studies were abdominal pain, nausea, diarrhoea and flatulence.
Najčešće nuspojave kod svih bolesnika koji su primali metilnaltreksonbromid tijekom svih faza placebom kontroliranih ispitivanja bile su abdominalna bol, mučnina, proljev i flatulencija.
The following instructions explain how to prepare and give an injection of Relistor when using a prefilled syringe.
Slijedeće upute opisuju kako pripremiti i dati injekciju Relistora kada se koristi napunjena štrcaljka.
If you forget to use Relistor
Ako ste zaboravili uzeti Relistor
A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus.
U ispitivanju na zdravim dragovoljcima opažena je ortostatska hipotenzija povezana s dozom od 0,64 mg/kg, koja je davana kao intravenski bolus.
Do not insert it at an angle as the needle may bend or break.
Nemojte umetati iglu pod kutom jer bi se mogla savinuti ili slomiti.
Do not inject into areas where the skin is tender, bruised, red, or hard.
Nemojte injicirati na mjestu gdje je kože osjetljiva, oštećena, crvena ili tvrda.
Subcutaneous injections of Relistor at 150 mg/kg/day decreased fertility in rats.
Supkutane injekcije Relistora u dozi od 150 mg/kg/dan smanjile su plodnost kod štakora.
Subcutaneous use (SC)
Potkožna primjena (s.c.)
If you have used more this medicine than you should (either by injecting too much on a single occasion or by using more than one injection in 24 hours), you may feel dizzy when standing up, so talk to a doctor or pharmacist immediately.
Ako uzmete više ovog lijeka nego što ste trebali (bilo da ste injicirali preveliku količinu odjednom, bilo da ste koristili više od jedne injekcije tijekom 24 sata), može se dogoditi da osjećate omaglicu pri ustajanju pa se odmah se obratite liječniku ili ljekarniku.
This section contains important questions that you will need to answer before you take Relistor, and during treatment with Relistor.
U ovom odlomku navedena su važna pitanja na koja morate odgovoriti prije i tijekom liječenja
Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (Cmax) achieved at approximately 0.5 hours following subcutaneous administration.
Metilnaltreksonbromid se brzo apsorbira, pri čemu se vršne koncentracije (Cmax) postižu otprilike 0,5 sati nakon supkutane primjene.
What Relistor contains - The active substance is methylnaltrexone bromide.
Što Relistor sadrži - Djelatna tvar je metilnaltreksonbromid.
In adult and juvenile dogs given methylnaltrexone bromide at 20 mg/kg/day, clinical signs indicative of CNS toxicity and prolongation of QTc interval were observed.
Kod odraslih i mladih pasa koji su dobivali dozu metilnaltreksonbromida od 20 mg/kg/dan, opaženi su klinički znaci koji ukazuju na toksičnost na CNS i produljenje QTc intervala.
Methylnaltrexone bromide does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes.
Metilnaltreksonbromid ne utječe na farmakokinetiku lijekova koji se metaboliziraju putem izoenzima citokroma P450 (CYP).
Therefore, Relistor should not be used for treatment of patients with constipation not related to opioid use.
Stoga se Relistor ne smije koristiti za liječenje bolesnika s konstipacijom koja nije povezana s primjenom opioida.
It treats constipation that is caused by medicines for moderate to severe pain called opioids (for example morphine or codeine).
Ovaj lijek služi za liječenje zatvora koji uzrokuju lijekovi za umjerenu i jaku bol koji se nazivaju opioidi (na primjer morfin ili kodein).
The 8 mg pre-filled syringe presentation of Relistor should only be used to treat these patients when existing medical conditions require the dose to be decreased to 8 mg (0.4 mL of solution), see Special Populations.
Napunjenu štrcaljku s 8 mg lijeka Relistor treba koristiti isključivo za liječenje ovih bolesnika kada postojeća medicinska stanja zahtijevaju smanjenje doze na 8 mg (0,4 ml otopine), vidjeti dio Posebne populacije.
• If you have severe liver or kidney disease.
● Ako imate tešku bolest jetre ili bubrega.
N-demethylation of methylnaltrexone bromide to produce naltrexone is not significant, accounting for 0.06 % of the administered dose.
N-demetilacija metilnaltreksonbromida kojom nastaje naltrekson nije značajna, a odgovara za 0,06% primijenjene doze.
Each of the methyl-6-naltrexol isomers has somewhat less antagonist activity than parent compound, and a low exposure in plasma of approximately 8 % of the drug-related materials.
Svaki od izomera metil-6-naltreksola posjeduje nešto slabiju antagonističku aktivnost od ishodišnog lijeka te nisku izloženost u plazmi od oko 8% od tvari povezanih s lijekom.
In a clinical drug interaction study in healthy adult male subjects, a subcutaneous dose of 0.3 mg/kg of methylnaltrexone bromide did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.
U kliničkom ispitivanju interakcije lijekova na odraslim zdravim muškim ispitanicima, supkutana doza od 0,3 mg/kg metilnaltreksonbromida nije značajno utjecala na metabolizam dekstrometorfana, supstrata CYP2D6.
Keep the needle attached to the syringe.
Ostavite iglu pričvršćenu na štrcaljku.
• If you feel sick, vomit, shiver, sweat, have belly pain and/or feel a fast heart beat shortly after taking Relistor talk to your doctor
● Ako osjećate mučninu, povraćate, drhtite, znojite se, imate bol u trbuhu i/ili osjećate ubrzane otkucaje srca kratko nakon uzimanja Relistora obratite se svom liječniku
Do not touch this area again before giving the injection.
Nemojte ponovno dodirivati ovo mjesto prije davanja injekcije.
• Safely throw away the Relistor pre-filled syringe after use (Step 4).
Nakon upotrebe bacite napunjenu štrcaljku Relistora na sigurno mjesto (Korak 4).
There are no adequate data with the use of methylnaltrexone bromide in pregnant women.
Ne postoje adekvatni podaci o primjeni metilnaltreksonbromida kod trudnica.
Step 1: Preparing for an injection Step 2: Choosing and preparing an injection site Step 3: Injecting Relistor pre-filled syringe Step 4: Disposing of supplies
Korak 1: Priprema za injekciju Korak 2: Odabir i priprema ubodnog mjesta Korak 3: Injiciranje Relistora napunjenom štrcaljkom Korak 4: Zbrinjavanje neupotrijebljenog lijeka
In vitro studies have shown methylnaltrexone bromide to be a mu-opioid receptor antagonist (inhibition constant [Ki] = 28 nM), with 8-fold less potency for kappa opioid receptors (Ki = 230 nM) and much reduced affinity for delta opioid receptors.
In vitro ispitivanja su pokazala da je metilnaltreksonbromid antagonist mu-opioidnog receptora (konstanta inhibicije [Ki] = 28 nM), s 8 puta slabijim afinitetom za kappa opioidne receptore (Ki = 230 nM) i značajno smanjenim afinitetom za delta opioidne receptore.
Allow the injection site to air-dry before injecting.
Ostavite ubodno mjesto da se osuši na zraku prije davanja injekcije.
Clean the injection site with an alcohol swab and let it dry.
3. Očistite ubodno mjesto jastučićem natopljenim alkoholom i pustite da se osuši.
Methylnaltrexone bromide has minor influence on the ability to drive and use machines.
Metilnaltreksonbromid malo utječe na sposobnost upravljanja vozilima i rada na strojevima.
Patients should be monitored for severe, persistent, or worsening abdominal pain; methylnaltrexone bromide should be discontinued if this symptom occurs.
Bolesnici trebaju biti nadzirani zbog moguće pojave teške, perzistirajuće boli ili pogoršanja boli u abdomenu; treba obustaviti primjenu metilnaltreksonbromida pri pojavi ovih simptoma.
The mean steady-state Cmax and AUC for the elderly were 545 ng/mL and 412 ng•h/mL, approximately 8.1 % and 20 %, respectively, greater than those for young subjects.
Srednje vrijednosti Cmax i AUC u stanju dinamičke ravnoteže kod starijih osoba bile su 545 ng/ml i 412 ng•h/ml, odnosno oko 8,1% i 20% veće od istih vrijednosti kod mlađih ispitanika.
Elderly population No dose adjustment is recommended based on age (see section 5.2).
Ne preporučuje se prilagodba doze u skladu s dobi (vidjeti dio 5.2).
Durability of response was demonstrated in Study 302, in which the laxation response rate was consistent from dose 1 through dose 7 over the course of the 2-week, double-blind period.
Trajanje učinaka pokazano je u ispitivanju 302, u kojem je stopa odgovora s laksacijom bila stalno prisutna od 1. do 7. doze lijeka tijekom dvostruko slijepog razdoblja od 2 tjedna.