natgillin/translations-raw huggingface dataset:
I de kliniske forsøg faldt den gennemsnitlige plasmaurinsyre (PUA) til 0,041 mmol/l (0,7 mg/dl) ca. 24 timer efter den første dosis af pegloticase hos patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, sammenholdt med en gennemsnitlig PUA på 0,48 mmol/l (8,2 mg/dl) hos placebobehandlede patienter.
In clinical trials, the mean plasma uric acid (PUA) levels fell to 0.7 mg/dl approximately 24 hours following the first dose of pegloticase in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with a mean PUA of 8.2 mg/dl in the placebo-treated patients.
Der var ingen indvirkning på fertiliteten at han- eller hunrotter.
There were no effects on the fertility of male or female rats.
Virknings- og sikkerhedsprofilen af pegloticase er den samme hos patienter med kreatininclearance under og over 50 ml/min.
Based on similar efficacy and safety profiles of pegloticase in patients with creatinine clearance below and above 50 ml/min, no dose adjustment is required for patients with renal impairment (see section 5.2).
Der er ikke udført formelle undersøgelser af virkningerne af leverinsufficiens.
No formal studies were conducted to examine the effects of hepatic impairment.
Efter markedsføring blev der indberettet et tilfælde, hvor indholdet af to hætteglas (16 mg) KRYSTEXXA blev administreret uden optræden af uønskede reaktioner.
The maximum dose that has been administered as a single intravenous dose during clinical studies was 12 mg. A post-marketing report documented administration of the contents of 2 vials (16 mg) without any adverse reaction related to KRYSTEXXA administration.
Andre svandt med støttende behandling med intravenøs væske, supplerende glukokortikoider eller antihistaminer eller efter ophør af infusionen samt med adrenalin mod anafylaktiske reaktioner.
fluids, additional glucocorticoids or antihistamines, or following discontinuation of the infusion and with epinephrine for anaphylactic reactions.
Hæmolyse og/eller methæmoglobinæmi
Haemolysis and/or Methemoglobinemia
De mest almindelige tegn og symptomer på lokale infusionsreaktioner var: rødme på injektionsstedet, kløe og udslæt.
The most common signs and symptoms of local infusion reactions were: redness at the injection site, itching, and rash.
Efter fortynding af KRYSTEXXA med 250 ml natriumkloridopløsning 4,5 mg/ml (0,45 %) eller 9 mg/ml (0,9 %) administreres det som en intravenøs infusion i løbet af mindst 2 timer med en infusionshastighed på ca. 2 ml/minut.
KRYSTEXXA, once diluted with 250 ml of sodium chloride solution, 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%), is administered as an intravenous infusion over no less than 2 hours, at a flow rate of approximately 2 ml/minute.
Denne indlægsseddel blev senest godkendt i {MM/ÅÅÅÅ\}.
This leaflet was last revised in {MM/YYYY} Other sources of information
KRYSTEXXA bør seponeres, hvis der to på hinanden følgende gange måles over 0,360 mmol/l
KRYSTEXXA should be discontinued if 2 consecutive levels above 6 mg/dl have been measured.
Før hver dosis vil lægen undersøge dit blod for indholdet af urinsyre for at sikre, at du skal fortsætte med at få KRYSTEXXA.
Your doctor will test your blood to measure uric acid levels before each dose to make sure that you should continue receiving KRYSTEXXA.
KRYSTEXXA, 8 mg, koncentrat til infusionsvæske, opløsning pegloticase
KRYSTEXXA 8 mg concentrate for solution for infusion pegloticase
Hos responderende patienter var PUA-værdien < 0,360 mmol/l (< 6 mg/dl) i hele den 6 måneders behandlingsperiode.
Responders maintained PUA values < 6 mg/dl throughout the 6-month treatment period.
KRYSTEXXA indeholder 4,2 mg natrium pr. dosis.
KRYSTEXXA contains 4.2 mg sodium per dose which means it is essentially sodium free.
I de efterfølgende tre måneder forekom akutte artritis urica-anfald hos 41 % og 67 % i de samme grupper, og hos patienter, der fik pegloticase, 8 mg hver 2. uge, i over et år, var sådanne anfald ikke almindelige.
This compared with flare rates of 41%and 67% in the same groups in the subsequent 3 months, and gout flares were infrequent in patients that received pegloticase 8 mg every 2 weeks for over one year.
Ikke kendt: hæmolyse
Not known: Haemolysis
Som vist i tabel 2 var responsandelen større hos patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, end i placebogruppen.
As shown in Table 2, a greater proportion of patients treated with KRYSTEXXA 8 mg every 2 weeks were responders as compared to patients receiving placebo.
• 1 ml KRYSTEXXA injiceres i en enkelt 250 ml pose med natriumklorid, 4,5 mg/ml (0,45 %) eller 9 mg/ml (0,9 %) injektionsvæske eller infusionsvæske.
• 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection or infusion.
Hvis du holder op med at få KRYSTEXXA og derefter genoptager behandlingen, kan der være øget risiko for infusionsreaktioner, herunder svære akutte overfølsomhedsreaktioner (anafylaksi).
If you stop taking KRYSTEXXA, and then are treated again, you may be at increased risk of infusion reactions, including severe acute allergic reactions (anaphylaxis) so your doctor will monitor you carefully when you restart treatment.
Dinatriumhydrogenphosphatdihydrat Natriumdihydrogenphosphatdihydrat Natriumklorid
Disodium hydrogen phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
KRYSTEXXA, 8 mg, koncentrat til infusionsvæske, opløsning
KRYSTEXXA 8 mg concentrate for solution for infusion
Følgende oplysninger er tiltænkt læger og sundhedspersonale:
The following information is intended for healthcare professionals only: KRYSTEXXA must be prepared as follows:
I de kliniske undersøgelser forekom akutte anfald af artritis urica i de første tre måneder hos 75 % af de patienter, der blev behandlet med KRYSTEXXA, 8 mg hver 2. uge, sammenholdt med 54 % af de placebobehandlede.
In clinical trials, the percentage of patients that had flares in the first 3 months was 75% in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with 54% in placebo-treated patients.
6.6 er KRYSTEXXA påvist at være fysisk og kemisk stabil ved fortynding i 250 ml natriumklorid, 4,5 mg/ml (0,45 %) og 9 mg/ml (0,9 %), gennem 4 timer ved 2 °C til 8 °C samt ved rumtemperatur (7 °C til 25 °C).
Physical and chemical stability of KRYSTEXXA diluted in 250 ml sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) has been demonstrated for 4 hours at 2°C to 8°C and at room temperature (20°C to 25°C), if the solution is prepared as described in section 6.6.
Behandlingen med KRYSTEXXA behøver ikke afbrydes ved akutte anfald af artritis urica.
KRYSTEXXA does not need to be discontinued because of a gout flare.
Hvordan KRYSTEXXA gives
How KRYSTEXXA is administered
Før behandlingen påbegyndes og især før kontrol af urinsyreniveauerne i serum, bør oral uratsænkende medicin være seponeret.
Before starting the treatment and especially before monitoring the serum uric acid levels, patients should discontinue oral urate-lowering medication and not institute therapy with oral urate-lowering medication while taking KRYSTEXXA (see section 4.4).
- Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre,
- If you get any side effects, talk to your doctor, pharmacist or nurse.
De ikke-kliniske undersøgelser viser, at pegloticase udskilles renalt.
From the nonclinical studies, the elimination of pegloticase is via renal/urinary excretion.
Akutte anfald af artritis urica
Acute gouty attacks (gout flare)
Brug ikke KRYSTEXXA, hvis den fortyndede opløsning indeholder partikler eller er misfarvet.
Do not use this medicine if you notice any particles or discolouration in the diluted solution.
Videnskabelige konklusioner og begrundelser, der anbefaler en ændring af betingelserne for
Annex IV Scientific conclusions and grounds recommending the variation to the terms of the Marketing Authorisation
Hvert hætteglas indeholder 8 mg pegloticase (koncentrat,
Each vial contains 8 mg of pegloticase (8 mg/ml concentrate)
Spørg lægen eller på apoteket eller sundhedspersonalet, hvis du er i tvivl om brugen af lægemidlet.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
I denne vægtgruppe var der desuden tendens til øget forekomst af høj titer af anti-pegloticase-antistoffer og infusionsrelaterede reaktioner (se pkt.
Also, high titres of anti-pegloticase antibodies and infusion-related reactions showed a tendency to occur in a greater proportion of patients in this weight group (see section 4.8).
Sådan virker KRYSTEXXA
How KRYSTEXXA works
Smertescore på en visuel analog skala var 44,2 ved baseline mod 28,4 i uge 25 for patienter behandlet med pegloticase, 8 mg hver 2. uge.
The Pain scores using a visual analogue scale were 44.2 at baseline vs. 28.4 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 53.9 vs. 57.2 in the placebo group (p≤0.001).
Ved enkeltdoser på 8 mg og 12 mg iagttoges et vedholdende (mere end 12 dage) fald i plasmaurinsyre til under opløseligheden på 0,360 mmol/l (6 mg/dl).
Sustained decrease in plasma uric acid below the solubility concentration of 6 mg/dl was observed for more than 12 days with single doses of 8 mg and 12 mg.
• 1 ml KRYSTEXXA injiceres i en enkelt 250 ml pose med natriumklorid, 4,5 mg/ml (0,45 %)
• 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection for infusion.
HAQ-PGA-scoren var 42,4 ved baseline mod 27,1 i uge 25 for patienter behandlet med pegloticase, 8 mg hver 2. uge.
The HAQ-PGA scores were 42.4 at baseline vs. 27.1 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 51.6 vs. 53.4 in the placebo group (p≤0.001).
Før hver infusion skal serumurinsyre måles.
Monitoring of serum uric acid level is required prior to each infusion.
• De øvrige indholdsstoffer er dinatriumhydrogenphosphatdihydrat,
• The other ingredients are disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride and water for injections.
HAQ-DI-scoren var 1,1 ved baseline mod 0,84 i uge 25 for patienter behandlet med KRYSTEXXA, 8 mg hver 2. uge.
The HAQ-DI scores were 1.1 at baseline vs. 0.84 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 1.2 vs. 1.3 in the placebo group (p≤0.01).
Almindelig: hævede led
Common: Vomiting
Ualmindelige bivirkninger (forekommer hos op til 1 ud af 100 behandlede): forværring af hjertesvigt med væskeophobning, hudinfektioner, forhøjet kaliumindhold i blodet.
Uncommon side effects: (may affect up to 1 in 100 people): worsening of a type of heart disease called congestive heart failure, skin infection, elevated potassium levels in the blood Frequency not known (cannot be estimated from available data): destruction of red blood cells If you get any side effects, talk to your doctor, pharmacist or nurse.
71 % af patienterne havde tophi ved baseline.
The mean PUA at baseline was 9.8 mg/dl. Seventy-one percent (71%) of patients had baseline tophi.
pværdi2
p-Value2
Meget almindelig: akutte anfald af artritis urica
Very common: Gout flare
Ikke almindelig: hyperkaliæmi
Metabolism and nutrition disorders Common: Hyperglycaemia Cardiac disorders
Mave-tarmkanalen
Breast-feeding
Injektionsvæske, pløsning
Solution for infusion
100 IE/ml
vials (glass)
EU/1/97/030/095 Insuman Rapid 100 IE/ml
EU/1/97/030/053 Insuman Infusat 100 IU/ml
EU/1/97/030/054 Insuman Infusat
EU/1/97/030/203 Insuman Implantable
Filamentøs hæmagglutinin, adsorberet 25 mikrogram Pertactin, adsorberet
Filamentous haemagglutinin, adsorbed 25 micrograms Pertactin, adsorbed
Pertussistoksoid, adsorberet
Pertussis toxoid, adsorbed
1 fyldt injektionssprøjte + 2 separate kanyler
1 pre-filled syringe + 2 separate needles
Rekombinant hepatitis B overfladeantigen (S protein), adsorberet
Recombinant Hepatitis B surface antigen (S protein), adsorbed Inactivated type 1 Poliovirus Inactivated type 2 Poliovirus Inactivated type 3 Poliovirus
Styrke Lægemiddelform Indgivelsesvej Emballage
Invented name Strength Pharmaceutical
Tetanustoksoid, adsorberet
Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed
1 fyldt injektionssprøjte + 1 separat kanyle
1 pre-filled syringe (glass) + 1 separate needle
r l g
Content
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Copalia den 16. januar 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Copalia on 16 January 2007.
Andre oplysninger om Copalia
Other information about Copalia
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Copalia.
This is a summary of the European public assessment report (EPAR) for Copalia.
Den fuldstændige EPAR for Copalia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Copalia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Copalia tages oralt som en tablet en gang dagligt med vand.
Copalia is taken by mouth as one tablet once a day with some water.
Copalia amlodipin/valsartan
Copalia amlodipine / valsartan
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Copalia skal anvendes.
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 Copalia.
Hvis du ønsker yderligere oplysninger om behandling med Copalia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Copalia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
CHMP besluttede, at fordelene ved Copalia opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Copalia.
The CHMP decided that Copalia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvilken risiko er der forbundet med Copalia?
What is the risk associated with Copalia?
De hyppigste bivirkninger ved Copalia (sm optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, betændelse i næse og hals (nasopharyngitis), influenza, lavt kaliumindhold i blodet (hypokaliæmi), forskellige former for hævelser (ødemer), træthed, rødmen, kraftesløshed (asteni) og hedeture.
The most common side effects with Copalia (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Virksomheden fremlagde desuden dokumentation for, at blodets indhold af amlodipin og valsartan er den samme hos personer, der får Copalia, som hos dem, der får lægemidlerne hver for sig.
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Copalia and people taking the separate medicines.
Den fuldstændige liste over indberettede bivirkninger ved Copalia fremgår af indlægssedlen.
For the full list of all side effects reported with Copalia, see the package leaflet.
Copalia må ikke anvendes til patienter med svær lever- eller galdeblæresygdom, patienter med visse hjerteproblemer eller patienter med svær hypotension (lavt blodtryk).
Copalia must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Copalia må heller ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension), hos patienter med type 2-diabetes eller patienter med moderat eller svær nyresygdom.
Copalia must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Den dosis Copalia, der skal anvendes, afhænger af, hvilken dosis amlodipin eller valsartan patienten fik tidligere.
The dose of Copalia to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Hvorfor blev Copalia godkendt?
Why has Copalia been approved?
Copalia må ikke anvendes til patienter, der er overfølsomme (allergiske) over for amlodipin eller andre lægemidler i gruppen af "dihydropyridinderivater", valsartan eller andre af indholdsstofferne.
Copalia must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Hvad er Copalia?
What is Copalia?
Copalia indeholder to aktive stoffer, amlodipin og valsartan.
Copalia contains two active substances, amlodipine and valsartan.
Copalia anvendes til patienter med essentiel hypertension (forhøjet blodtryk), når blodtrykket ikke kan kontrolleres tilstrækkeligt med amlodipin eller valsartan alene.
Copalia is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Copalia er et lægemiddel, der indeholder de to aktive stoffer amlodipin og valsartan.
Copalia is a medicine that contains two active substances, amlodipine and valsartan.
Hos de patienter, der fik amlodipin alene, faldt blodtrykket med 10,0 mmHg, sammenlignet med 11,8 mmHg hos dem, der desuden fik 160 mg valsartan.
Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.
Hvad anvendes Copalia til?
What is Copalia used for?
Hvordan blev Copalia undersøgt?
How has Copalia been studied?
Hvilken fordel viser undersøgelserne, at der er ved Copalia?
What benefit has Copalia shown during the studies?
Hvordan anvendes Copalia?
How is Copalia used?
Hvordan virker Copalia?
How does Copalia work?
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Storbritannien Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road
Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road
Oxycodonhydrochlorid / Naloxonhydrochlorid
Oxycodone hydrochloride/ Naloxone hydrochloride
Norpharma A/S Slotsmarken 15, Hørsholm
Norpharma A/S Slotsmarken 15, Horsholm
13, Othellos Street, Dhali Industrial Zone, Nicosia Cypern
Mundipharma Pharmaceuticals Ltd. 13, Othellos Street, Dhali Industrial Zone, Nicosia Cyprus
Via G. Serbelloni 4, Milano
Mundipharma Pharmaceuticals Srl Via G. Serbelloni 4, Milano
Millbank House, Arkle Road Sandyford, Dublin 18 Irland
Mundipharma Pharmaceuticals Ltd. Millbank House, Arkle Road Sandyford, Dublin 18 Ireland
Luxemborg Mundipharma Comm. VA Blarenberglaan 3C Mechelen
Luxembourg Mundipharma Comm. VA Blarenberglaan 3C
Norpharma A/S Slotsmarken 15 Hørsholm 2970 Danmark
Denmark Norpharma A/S Slotsmarken 15, Horsholm
Luxemborg Mundipharma Comm. VA Blarenberglaan 3C, Mechelen
Luxembourg Mundipharma Comm. VA Blarenberglaan 3C,
Yderligere information om Rizmoic findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/rizmoic
Further information on Rizmoic can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rizmoic
Den anbefalede dosis er én tablet én gang dagligt, som patienten kan tage med eller uden afføringsmiddel.
The recommended dose is one tablet once daily, which the patient can take with or without a laxative.
Som for alle lægemidler bliver data vedrørende brug af Rizmoic løbende overvåget.
As for all medicines, data on the use of Rizmoic are continuously monitored.
Det indeholder det aktive stof naldemedin.
It contains the active substance naldemedine.
De fleste af bivirkningerne hos patienter med eller uden kræft var milde til moderate.
The majority of side effects in patients with or without cancer were mild to moderate.
Patienten skal holde op med at tage Rizmoic, når der ikke længere tages et opioid.
The patient must stop taking Rizmoic when they are no longer taking an opioid.
For mere information om brug af Rizmoic, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Rizmoic, see the package leaflet or contact your doctor or pharmacist.
Rizmoic fås som 200-mikrogram-tabletter.
Rizmoic is available as 200 microgram tablets.
Andre oplysninger om Rizmoic
Other information about Rizmoic
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Rizmoic opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency therefore decided that Rizmoic's benefits are greater than its risks and it can be authorised for use in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rizmoic?
What measures are being taken to ensure the safe and effective use of Rizmoic?
Desuden var bivirkningerne ved Rizmoic, som hovedsagelig påvirkede tarmen, for det meste milde eller moderate.
Furthermore, the side effects of Rizmoic, which mainly affected the gut, were mostly mild or moderate.
Bivirkninger rapporteret for Rizmoic vurderes omhyggeligt, og der tages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Rizmoic are carefully evaluated and any necessary action taken to protect patients.
Forstoppelse er den hyppigste bivirkning ved smertestillende opioide lægemidler, og mange almindelige afføringsmidler er ikke effektive til behandling af tilstanden.
Constipation is the most common side effect of opioid pain medicines and many standard laxatives are not effective in treating the condition.
En oversigt over Rizmoic, og hvorfor det er godkendt i EU
An overview of Rizmoic and why it is authorised in the EU
Rizmoic udleveres kun efter recept.
Rizmoic can only be obtained with a prescription.
Fordi molekylerne i naldemedin er designet til ikke at komme ind i hjernen, blokerer lægemidlet ikke opioidernes virkning på smertereceptorerne i hjernen og hindrer derfor ikke smertelindring.
Because molecules of naldemedine were designed not be able to enter into the brain, the medicine does not block opioids from working on pain receptors in the brain and therefore does not interfere with pain relief.
Rizmoic må ikke anvendes hos patienter med blokeret eller perforeret tarm eller patienter med høj risiko for blokering af tarmen.
Rizmoic must not be used in patients with a blocked or perforated bowel or patients at high risk of bowel blockage.
I studierne blev Rizmoic sammenlignet med placebo (en uvirksom behandling) for at se, om behandlingen konsekvent ville øge antallet af patienter, der havde afføring, og give dem afføring mindst tre gange om ugen under behandlingen.
The studies compared Rizmoic with placebo (a dummy treatment) to see if treatment would consistently increase the number of patients who can pass stools and allow them to do so at least 3 times a week during treatment.
Hvad er Rizmoic, og hvad anvendes det til?
What is Rizmoic and what is it used for?
I to andre studier, der omfattede 307 patienter, som tog opioider for kræftsmerter, opnåede 74 % af de patienter, der tog Rizmoic i to uger, det ønskede resultat sammenlignet med 36 % af de patienter, der tog placebo.
In two other studies, involving 307 patients taking opioids for cancer pain, 74% of patients taking Rizmoic for two weeks achieved the desired outcome compared with 36% of patients taking placebo.
Hvorfor blev Rizmoic godkendt i EU?
Why is Rizmoic authorised in the EU?
Det aktive stof i Rizmoic, naldemedin, virker ved at binde til og blokere receptorerne i tarmen (mu-, delta- og kappaopioidreceptorerne), hvorigennem opioidlægemidler forårsager forstoppelse.
The active substance in Rizmoic, naldemedine, works by attaching to and blocking receptors in the gut (mu-, delta- and kappa-opioid receptors), through which opioid medicines cause constipation.