natgillin/translations-raw huggingface dataset:
Mechanism of action and pharmacodynamic effects Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone.
Naloksegol je PEGiliran derivat antagonista mi-opioidnih receptorjev naloksona.
The 12.5 mg dose in the LIR subgroup also demonstrated shorter time to first post-dose SBM as compared to placebo in Kodiac 4 (p=0.002) and Kodiac 5 (p<0.001).
12,5 mg je bil čas do prvega spontanega iztrebljanja po odmerku v podskupini LIR krajši kot s placebom tako v Kodiac 4 (p = 0,002) kot v Kodiac 5 (p < 0,001).
Conditions with increased potential for gastrointestinal perforation Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases when naloxegol was used in patients who were at an increased risk of gastrointestinal (GI) perforation.
Bolezni in motnje, povezane z večjo možnostjo za perforacijo prebavil V obdobju trženja zdravila so poročali o primerih perforacije prebavil, vključno s smrtnimi primeri,
Naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in the gastrointestinal tract, thereby decreasing the constipating effects of opioids without impacting opioid-mediated analgesic effects on the central nervous system.
Tako zmanjša konstipacijski učinek opioidov, ne da bi poslabšal njihove analgetične učinke v osrednjem živčevju.
• The active substance is naloxegol.
• Učinkovina je naloksegol.
Co-administration of naloxegol and quinidine did not antagonize the morphine-induced miosis effect, suggesting that P-gp inhibition does not meaningfully change the capacity of naloxegol to cross the blood-brain barrier at therapeutic doses.
To kaže, da zavrtje P-gp pri terapevtskih odmerkih ne spremeni pomembno zmožnosti naloksegola za prehod skozi krvno-možgansko pregrado.
Naloxegol acts by binding to mu-opioid receptors in the GI tract targeting the underlying causes of OIC (i.e. reduced GI motility, hypertonicity and increased fluid absorption resulting from long-term opioid treatment).
zmanjšano motiliteto prebavil, hipertoničnost in večjo absorpcijo tekočine kot posledico dolgotrajnega zdravljenja z opioidi).
None of the metabolites were present in > 10% of the plasma concentrations of parent or total parent and metabolite related material.
plazemske koncentracije matične snovi ali celotne koncentracije matične spojine in s presnovki povezanih snovi.
Name and address of the manufacturers responsible for batch release
A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalcev, odgovornih za sproščanje serij
No dosage adjustment is required for patients with mild renal impairment.
Bolnikom z blago okvaro ledvic odmerka ni treba prilagoditi.
It is used when laxatives have not provided acceptable relief of constipation.
Uporabimo ga, če odvajala ne dosežejo ustreznega izboljšanja zaprtja.
Moventig 25 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol.
Moventig 25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 25 mg naloksegola v obliki naloksegolijevega oksalata.
The mixture can also be administered via a nasogastric tube (CH8 or greater), in this case the tablet can be crushed to a powder and mixed with water (120 ml).
V tem primeru lahko tableto zdrobite v prašek in zmešate z vodo (120 ml).
• if you take diltiazem or verapamil (for high blood pressure or angina) Your doctor may tell you to increase the dose to 25 mg depending on how you respond to the medicine.
• če jemljete diltiazem ali verapamil (za visok krvni tlak ali angino pektoris).
− Each Moventig 25 mg film-coated tablet (tablet) contains 25 mg naloxegol as naloxegol oxalate.
Ena filmsko obložena tableta (tableta) zdravila Moventig 25 mg vsebuje 25 mg naloksegola v obliki naloksegolijevega oksalata.
Moventig 12.5 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol.
Moventig 12,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 12,5 mg naloksegola v obliki naloksegolijevega oksalata.
In patients taking opioids with constipation, who have tried at least one laxative and had incomplete relief of constipation, Moventig has been shown in clinical trials to increase the number of bowel movements and improve symptoms of constipation caused by opioids.
Klinična preskušanja so pokazala, da zdravilo Moventig poveča število iztrebljanj in izboljša simptome zaprtja, ki jih povzročajo opioidi, pri bolnikih, ki jemljejo opioide, so zaprti ter so poskusili vsaj eno odvajalo, vendar z njim niso dosegli popolnega olajšanja zaprtja.
GENERAL CLASSIFICATION FOR SUPPLY
Organski sistem Razvrstitev
How to store Moventig
Shranjevanje zdravila Moventig
Moventig contains the active substance naloxegol.
Zdravilo Moventig vsebuje zdravilno učinkovino naloksegol.
Patients with CV conditions
Bolniki s srčno-žilnimi boleznimi
Each film-coated tablet contains 25 mg naloxegol (as naloxegol oxalate).
Ena filmsko obložena tableta vsebuje 25 mg naloksegola (v obliki naloksegolijevega oksalata).
There was a statistically significant difference for the 25 mg dose versus placebo for the LIR subgroup responder rate in Kodiac 4 (p=0.002) and Kodiac 5 (p=0.014).
Delež odzivnih bolnikov v podskupini LIR se je med odmerkom 25 mg in placebom statistično značilno razlikoval tako v študiji Kodiac 4 (p = 0,002) kot Kodiac 5 (p = 0,014).
Interaction with strong CYP3A4 inhibitors
Medsebojno delovanje z močnimi zaviralci CYP3A4
Moventig 25 mg film-coated tablets naloxegol
Moventig 25 mg filmsko obložene tablete naloksegol
Package leaflet: Information for the patient Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets naloxegol
Navodilo za uporabo Moventig 12,5 mg filmsko obložene tablete Moventig 25 mg filmsko obložene tablete naloksegol
A possible treatment-related foetal skeletal malformation of fused arches was noted at highest dose tested in the rabbit embryo-foetal development study, in the absence of maternal toxicity.
V študiji embrio-fetalnega razvoja na kuncih so ob največjem testiranem odmerku (in v odsotnosti toksičnih učinkov za samice matere) opažali morebitno z zdravilom povezano malformacijo okostja pri plodu, in sicer zraščenih lokov.
− Each Moventig 12.5 mg film-coated tablet (tablet) contains 12.5 mg naloxegol as naloxegol oxalate.
Ena filmsko obložena tableta (tableta) zdravila Moventig 12,5 mg vsebuje 12,5 mg naloksegola v obliki naloksegolijevega oksalata.
In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of diltiazem on the single dose PK of naloxegol, co-administration of diltiazem and naloxegol resulted in a 3.4-fold (90% CI: 3.2-3.7) increase in naloxegol AUC and a 2.9fold increase in naloxegol Cmax (90% CI: 2.6-3.1), compared to when naloxegol was administered alone.
IZ: 3,2-3,7) zvišanje AUC naloksegola in 2,9-kratno (90 % IZ: 2,6-3,1) zvišanje Cmax naloksegola v primerjavi z uporabo naloksegola samega.
In Kodiac 4, placebo, 12.5 mg and 25 mg dose had median time to first post dose SBM of 43.4, 20.6, and 5.4 hours, respectively.
Mediani čas do prvega spontanega iztrebljanja po odmerku je bil v Kodiac 4 s placebom 43,4 ure, z 12,5 mg 20,6 ure in s 25 mg 5,4 ure.
Naloxegol 25 mg dose, compared with placebo, also resulted in greater improvement (change from baseline) of week 12 PAC-SYM rectal domain scores in both studies (p=0.004 and p<0.001, Kodiac 4 and 5, respectively) and for the stool domain scores in Kodiac 4 (p=0.031) and Kodiac 5 (p<0.001).
SYM (Kodiac 4 p = 0,004 in Kodiac 5 p < 0,001) in ocene domene blata (Kodiac 4 p = 0,031 in Kodiac 5 p < 0,001).
Nervous system disorders
Bolezni živčevja glavobol sindrom odtegnitve opioidov
Both studies were powered and stratified so that at least 50% of patients randomized to each treatment arm met baseline criteria to be categorized as a laxative inadequate responder (LIR).
bolnikov, randomiziranih v vsako terapevtsko skupino, izpolnjevalo merila za uvrstitev med bolnike z nezadostnim odzivom na odvajala.
Each film-coated tablet contains 12.5 mg naloxegol (as naloxegol oxalate).
Ena filmsko obložena tableta vsebuje 12,5 mg naloksegola (v obliki naloksegolijevega oksalata).
In an open-label, non-randomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of ketoconazole on the single dose PK of naloxegol, co-administration of ketoconazole and naloxegol resulted in a 12.9 fold (90% CI: 11.3-14.6) increase in naloxegol AUC and a 9.6-fold increase in naloxegol Cmax (90% CI: 8.1-11.3), compared to when naloxegol was administered alone.
(90 % IZ: 11,3-14,6) zvišanje AUC naloksegola in 9,6-kratno (90 % IZ: 8,1-11,3) zvišanje Cmax naloksegola v primerjavi z uporabo naloksegola samega.
Potential for interference with opioid-mediated analgesia There were no clinically relevant differences between naloxegol 12.5 mg, 25 mg, and placebo in average pain intensity, daily opioid dose or in opioid withdrawal scores over the 12-week study.
dnevnem odmerku opioidov ali oceni odtegnitve opioidov med 12,5 mg naloksegola, 25 mg naloksegola in placebom.
Grapefruit juice has been classified as a potent CYP3A4 inhibitor when consumed in large quantities.
Grenivkin sok, zaužit v veliki količini, se uvršča med močne zaviralce CYP3A4.
Time to first spontaneous bowel movement
Čas do prvega spontanega iztrebljanja blata Čas do prvega spontanega iztrebljanja je bil v podskupini LIR po uporabi prvega odmerka v skupini s
In the pooled data from Kodiac 4 and Kodiac 5, responder rates in the LIR subgroup were 30.1% for placebo, 42.5% for the 12.5 mg dose, and 47.7% for the 25 mg dose, with the relative risk (95% CI) for treatment effect versus placebo of 1.410(1.106, 1.797) and 1.584(1.253, 2.001) for the 12.5 mg and 25 mg groups, respectively.
12,5 mg 1,410 (1,106, 1,797) in med prejemniki 25 mg 1,584 (1,253, 2,001).
Talk to your doctor, pharmacist or nurse whilst taking Moventig:
Med jemanjem zdravila Moventig se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Talk to your doctor, pharmacist or nurse before taking Moventig:
Pred začetkom jemanja zdravila Moventig se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Interaction with CYP3A4 inhibitors and inducers
Medsebojno delovanje z zaviralci in induktorji CYP3A4
12.5 mg is well tolerated by the patient (see section 5.2).
12,5 mg (glejte poglavje 4.5).
In the LIR subgroup, the 25 mg dose increased the symptom responder rates in both studies as compared to placebo (Kodiac 4 p=0.001, Kodiac 5 p=0.005).
V podskupini LIR je odmerek 25 mg v primerjavi s placebom povečal delež odziva simptomov v obeh študijah (Kodiac 4
Moventig 12.5 mg film-coated tablets naloxegol
Moventig 12,5 mg filmsko obložene tablete naloksegol
Naloxegol is not recommended in patients who are taking strong CYP3A4 inducers (e.g. carbamazepine, rifampin, St. John's Wort) (see section 4.5).
Naloksegol ni priporočljiv za bolnike, ki jemljejo močne zaviralce CYP3A4 (npr. karbamazepin,
The dose can be increased to 25 mg if
Zdravnik vam bo morda naročil, da zvišate odmerek na 25 mg glede na to, kako se boste odzvali na zdravilo.
Oval, 13x7 mm, mauve tablet.
Moventig 25 mg filmsko obložena tableta (tableta) Ovalna, 13 x 7 mm velika tableta svetlo vijoličaste barve.
The time to first SBM in the LIR subgroup after taking the first dose was shorter for the 25 mg dose as compared to placebo in Kodiac 4 (p<0.001) and Kodiac 5 (p=0.002).
25 mg krajši kot s placebom tako v Kodiac 4 (p < 0,001) kot v Kodiac 5 (p = 0,002).
The glass should be rinsed with a further half glass of water (120 ml) and the contents drunk.
Kozarec morajo nato splakniti z dodatnega pol kozarca vode
Patients taking a minimum of 30 morphine equivalent units (meu) of opioids per day for at least 4 weeks before enrolment and self-reported OIC were eligible.
Za vključitev so bili primerni bolniki, ki so pred vključitvijo vsaj 4 tedne jemali najmanj 30
The tablets need to be taken with food and drink.
Tablete se vzamejo s hrano in pijačo.
It is available as white tablets (625 mg).
Na voljo je v obliki tablet bele barve (625 mg).
This document is a summary of the European Public Assessment Report (EPAR) for Cholestagel.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cholestagel.
They can either be taken all at once, or split into two doses during the day.
Vzamejo se bodisi naenkrat ali v dveh odmerkih na dan.
Lowering cholesterol, especially LDL cholesterol, can reduce the risk of heart disease.
Znižanje holesterola, zlasti LDL-holesterola, lahko zmanjša tveganje za srčno obolenje.
Cholestagel is used in the following ways:
Zdravilo Cholestagel se uporablja na naslednje načine:
Other information about Cholestagel:
Druge informacije o zdravilu Cholestagel:
In comparison, the patients taking placebo had no changes in LDL-cholesterol levels.
V primerjavi s tem pri bolnikih, ki so jemali placebo, ni bilo nobenih sprememb ravni LDL-holesterola.
For more information about treatment with Cholestagel, read the Package Leaflet (also part of the EPAR).
Za več informacij o zdravljenju z zdravilom Cholestagel preberite navodilo za uporabo (ki je prav tako del EPAR).
This combination can also be used in patients who have familial hypercholesterolaemia (primary hypercholesterolaemia that runs in the family).
Ta kombinacija se lahko uporabi tudi pri bolnikih z družinsko hiperholesterolemijo (primarno hiperholesterolemijo, ki je prisotna v družini).
‘Primary' means that there is no disease causing the high cholesterol levels.
„Primarna“ pomeni, da visokih ravni holesterola ne povzroča nobena bolezen.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cholestagel.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Cholestagel, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Cholestagel shown during the studies?
Kakšne koristi je zdravilo Cholestagel izkazalo med študijami?
Patients should start a cholesterol-lowering diet before treatment and continue it throughout treatment.
Bolniki morajo dieto za zniževanje ravni holesterola začeti pred zdravljenjem in jo nadaljevati med njim.
The European Commission granted a marketing authorisation valid throughout the European Union for Cholestagel to Genzyme Europe B.V. on 10 March 2004.
Evropska komisija je dovoljenje za promet z zdravilom Cholestagel, veljavno po vsej Evropski uniji, odobrila družbi Genzyme Europe B.V.
• together with ezetimibe (another cholesterol-lowering medicine), with or without a statin.
• skupaj z ezetimibom (drugim zdravilom za zniževanje rani holesterola) s statinom ali brez njega.
The maximum dose is seven tablets a day when it is taken on its own, and six tablets a day when it is taken with other medicines.
Največji odmerek je sedem tablet na dan, če se jemljejo samostojno, in šest tablet na dan, če se jemljejo z drugimi zdravili.
The CHMP concluded that Cholestagel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Cholestagel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Cholestagel should not be used in people who may be hypersensitive (allergic) to colesevelam or any of the other ingredients.
Zdravila Cholestagel ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) kolesevelam ali katero koli drugo sestavino zdravila.
The main measure of effectiveness was the decrease in LDL-cholesterol levels after four to six weeks, except for one of the studies looking at Cholestagel taken on its own, which measured the cholesterol levels after six months.
Glavno merilo učinkovitosti je bilo znižanje ravni LDLholesterola po štirih do šestih tednih, razen v študiji, v katerih so proučevali samostojno jemanje zdravila Cholestagel in so raven holesterola izmerili po šestih mesecih.
Three of these studies looked at Cholestagel taken in combination with a statin (lovastatin, simvastatin or atorvastatin) in 491 patients, two looked at Cholestagel taken on its own in 592 patients, and one looked at Cholestagel in combination with ezetimibe in 86 patients.
V treh študijah so proučevali jemanje zdravila Cholestagel v kombinaciji s statinom (lovastatinom, simvastatinom ali atorvastatinom) pri 491 bolnikih, v dveh študijah so proučevali samostojno jemanje zdravila Cholestagel pri 592 bolnikih, v eni študiji pa so proučevali jemanje zdravil Cholestagel v kombinaciji z ezetimibom pri 86 bolnikih.
The final study looked at Cholestagel as an add-on to ezetimibe and a statin in 86 adults with familial hypercholesterolaemia.
V končni študiji so zdravilo Cholestagel proučevali kot dopolnilo k ezetimibinu in statinu pri 86 odraslih z družinsko hiperholesterolemijo.
What is the risk associated with Cholestagel?
Kakšna tveganja so povezana z zdravilom Cholestagel?
Because the bile acids are prevented from being absorbed into the bloodstream, the liver is forced to make more bile acids.
Absorpcija žolčnih kislin v krvni obtok je tako preprečena, zato morajo jetra tvoriti več žolčnih kislin.
As the liver uses cholesterol to make bile acids, this reduces cholesterol levels in the blood.
Ker jetra porabijo holesterol za tvorjenje žolčnih kislin, se zmanjšajo ravni holesterola v krvi.
Cholestagel is used to lower cholesterol levels in adults with primary hypercholesterolaemia (high blood cholesterol levels).
Zdravilo Cholestagel se uporablja za zmanjšanje ravni holesterola pri odraslih s primarno hiperholesterolemijo (visokimi ravnmi holesterola v krvi).
The recommended dose of Cholestagel is six tablets a day when it is taken on its own, and four to six tablets a day when it is taken in combination with other medicines.
Priporočeni odmerek zdravila Cholestagel je šest tablet na dan, kadar se vzame samostojno, in štiri do šest tablet na dan, kadar se vzame v kombinaciji z drugimi zdravili.
The active substance in Cholestagel, colesevelam, is not absorbed by the body, but stays in the gut, where it attaches to substances called bile acids and carries them out of the body in the faeces.
Zdravilne učinkovine zdravila Cholestagel, kolesevelama, telo ne absorbira, ampak ostane v prebavnem sistemu, kjer se veže na snovi, imenovane žolčne kisline, ki se z blatom izločijo iz telesa.
For the full list of all side effects reported with Cholestagel, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cholestagel, glejte navodilo za uporabo.
In studies, the most common side effects with Cholestagel (seen in more than 1 patient in 10) were flatulence (gas) and constipation.
V študijah sta bila najpogostejša neželena učinka (opažena pri več kot 1 bolniku izmed 10) napenjanje (vetrovi) in zaprtje.
Cholestagel has been compared with placebo (a dummy treatment) in seven main studies involving adults with primary hypercholesterolaemia.
Zdravilo Cholestagel so primerjali s placebom (zdravilom brez zdravilne učinkovine) v sedmih glavnih študijah, v katere so bili vključeni odrasli s primarno hiperholesterolemijo.
Why has Cholestagel been approved?
Zakaj je bilo zdravilo Cholestagel odobreno?
• as an add-on to a statin (another cholesterol-lowering medicine) and a cholesterol-lowering diet, to further reduce ‘low-density-lipoprotein' (LDL or ‘bad') cholesterol levels in patients who are not adequately controlled with a statin alone;
• kot dopolnilo statinu (drugemu zdravilu za zniževanje ravni holesterola) in dieti za zniževanje ravni holesterola za nadaljnje znižanje ravni holesterola „lipoprotein nizke gostote“ (LDL ali „slabega“ holesterola) pri bolnikih, ki jih samo s statinom ni mogoče ustrezno nadzorovati;
• as an add-on to a cholesterol-lowering diet, to reduce total-cholesterol and LDL-cholesterol levels in patients who cannot take statins;
• kot dopolnilo k dieti za zniževanje ravni holesterola za znižanje ravni celotnega holesterola in ravni holesterola „lipoprotein nizke gostote“ pri bolnikih, ki ne morejo prejemati statina;
When added to ezetimibe and a statin, Cholestagel caused a reduction of 11% in LDL-cholesterol levels after six weeks in patients with familial hypercholesterolaemia, compared with a rise of 7% when adding placebo.
Ko je bilo zdravilo Cholestagel dodano ezetimibu in statinu, so se ravni LDL-holesterola pri bolnikih z družinsko hiperholesterolemijo po šestih tednih znižale za 11 % v primerjavi s povečanjem za 7 %, ko so zdravilo dodali placebu.
Looking at the results of the three studies in which Cholestagel was used with a statin, there was an 8% reduction in LDL-cholesterol levels with 2.3 g Cholestagel (about four tablets) after six weeks, as compared to placebo.
Glede na rezultate treh študij, v katerih je bilo zdravilo Cholestagel uporabljeno s statinom, so se ravni LDL-holesterola pri jemanju 2,3 g zdravila Cholestagel (približno štirih tablet) v primerjavi s placebom po šestih tednih zmanjšale za 8 %.
The combination of Cholestagel and ezetimibe was more effective than ezetimibe taken with placebo: there was a fall of 32% in LDL-cholesterol levels in the patients taking Cholestagel and a fall of 21% in those taking placebo.
Zdravilo Cholestagel je bilo enako učinkovito, če so ga bolniki jemali zjutraj, zvečer ali dvakrat na dan. Kombinacija zdravila Cholestagel in ezetimiba je bila učinkovitejša od ezetimiba vzetega s placebom: ravni LDL-holesterola so se znižale za 32 % pri bolnikih, ki so jemali zdravilo Cholestagel, in za 21 % pri tistih, ki so jemali placebo.
In the longer study, the decrease seen at six weeks with 3.8 g Cholestagel (about six tablets) was maintained for six months.
V študiji, ki je trajala dalj časa, se je zmanjšanje, opaženo po šestih tednih zdravljenja s 3,8 g zdravila Cholestagel (približno šest tablet), ohranilo šest mesecev.
Blood cholesterol levels should also be measured before and during treatment to check the patient's response.
Za preverjanje bolnikovega odziva bi morali pred zdravljenjem in med njim meriti tudi ravni holesterola v krvi.
Cholestagel is a medicine that contains the active substance colesevelam.
Cholestagel je zdravilo, ki vsebuje zdravilno učinkovino kolesevelam.
The full EPAR for Cholestagel can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Cholestagel je na voljo tukaj.
How has Cholestagel been studied?
Kako je bilo zdravilo Cholestagel raziskano?
What is Cholestagel?
Kaj je zdravilo Cholestagel?
What is Cholestagel used for?
Za kaj se zdravilo Cholestagel uporablja?
There was a 16% reduction with 3.8 g Cholestagel (about six tablets).
Pri jemanju 3,8 g zdravila Cholestagel (približno šest tablet) je znižanje znašalo 16 %.
In the studies looking at Cholestagel taken on its own, more than half of the patients receiving 3.8 or 4.5 g Cholestagel (about six to seven tablets) had a decrease in LDL-cholesterol level of 15 to 18% after six weeks.
V študijah, s katerimi so proučevali samostojno jemanje zdravila Cholestagel, se je raven LDLholesterola po šestih tednih pri več kot polovici bolnikov, ki so prejemali 3,8 ali 4,5 g zdravila Cholestagel, zmanjšala za 15 do 18 %.
How does Cholestagel work?
Kako zdravilo Cholestagel deluje?
How is Cholestagel used?
Kako se zdravilo Cholestagel uporablja?
It must not be used in patients whose gut or bile duct is blocked.
Ne sme se uporabljati pri osebah z zaprtjem žolčnega kanala.
Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Znanstveni zaključki, podlaga za spremembo pogojev dovoljenj za promet z zdravilom ter podrobna obrazložitev znanstvenih razlogov za odstopanja od priporočila odbora PRAC
The applicant requested a re-examination of the opinion.
Vlagatelj je zahteval ponovno presojo mnenja.
QUESTIONS AND ANSWERS ON THE RECOMMENDATION FOR REFUSAL OF A MARKETING AUTHORISATION APPLICATION for VERAFLOX
VPRAŠANJA IN ODGOVORI GLEDE PRIPOROČILA ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo VERAFLOX