natgillin/translations-raw huggingface dataset:
Patients received INCIVO at a dosage of 750 mg every 8 hours, except for patients on an efavirenz-based regimen who received INCIVO at a dosage of 1,125 mg every 8 hours.
Na probiru, zahtjev za bolesnike je bio HIV-1 RNK < 50 kopija/ml i broj CD4 > 300 stanica/mm Bolesnici su primili dozu od 750 mg INCIVA svakih 8 sati, osim bolesnika na režimu temeljenom na efavirenzu koji su primili dozu od 1125 mg INCIVA svakih 8 sati.
ADRs to INCIVO are presented in table 3.
Tablični sažeti prikaz nuspojava Nuspojave lijeka INCIVO prikazane su u Tablici 3.
It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with telaprevir.
Kad se varfarin primjenjuje istodobno s telaprevirom preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
)/PR: INCIVO 1,125 mg twice daily for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; T12(q8h)/PR: INCIVO 750 mg every 8 hours for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks
T12(b.i.d.)/PR: INCIVO 1125 mg dva puta na dan tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 24 ili 48 tjedana; T12(q8h)/PR: INCIVO 750 mg svakih 8 sati tijekom 12 tjedna s peginterferonom alfa-2a i ribavirinomtijekom 24 ili 48 tjedana
Table 10 shows SVR rates by extent of liver fibrosis at baseline.
Tablica 10 pokazuje stope SVR prema opsegu fibroze jetre na početku ispitivanja.
HORMONAL CONTRACEPTIVES/OESTROGEN ethinylestradiol* norethindrone*
HORMONSKI KONTRACEPTIVI/ESTROGEN
If you notice the missed dose after 4 hours, then skip the intake and take the next doses as usual.
Ako primijetite da ste propustili uzeti dozu lijeka, a prošlo je više od 4 sata, preskočite uzimanje te doze i sljedeće doze uzmite prema uobičajenom rasporedu.
T12/PR48: INCIVO for 12 weeks followed by placebo for 4 weeks, in combination with peginterferon alfa-2a and ribavirin for 48 weeks;
T12/PR48: INCIVO tijekom 12 tjedana nakon čega je slijedio placebo tijekom 4 tjedna, u kombinaciji s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana;
Renal impairment
Linearnost/nelinearnost
PDE-5 INHIBITORS sildenafil tadalafil vardenafil
INHIBITORI FOSFODIESTERAZE, TIP 5 (PDE-5)
Bridging fibrosis Cirrhosis
Premoštavajuća fibroza
45 to ≤ 65 years of age Black
45 do ≤ 65 godina starosti Ispitanici crne rase Hispano-latino porijeklo Indeks tjelesne mase ≥ 30 kg/m
T12/PR24: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 weeks; T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
T12/PR24: INCIVO tijekom 12 tjedana uz peginterferon alfa-2a i ribavirin tijekom 24 tjedna; T12/PR48: INCIVO tijekom 12 tjedana uz peginterferon alfa-2a i ribavirin tijekom 48 tjedana
The frequency rate of the side effects associated with INCIVO is given below.
Učestalost nuspojava povezanih s INCIVOM navedena je u daljnjem tekstu.
HCV RNA levels should be monitored at weeks 4 and 12 to determine treatment duration.
Da bi se odredilo trajanje liječenja potrebno je u 4. i 12. tjednu odrediti koncentraciju HCV RNK.
INCIVO must be administered with peginterferon alfa and ribavirin.
INCIVO se mora primjenjivati s peginterferonom alfa i ribavirinom.
Caution is warranted and clinical monitoring of patients is recommended.
Nalaže se oprez i preporučuje kliničko praćenje bolesnika.
Patients in these studies, 108, 111 and C216, had compensated liver disease, detectable HCV RNA, and liver histopathology consistent with chronic hepatitis C. Unless otherwise indicated, INCIVO was administered at a dosage of 750 mg every 8 hours (q8h); the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1,000 mg/day (patients weighing < 75 kg) or 1,200 mg/day (patients weighing ≥ 75 kg).
Ako nije bilo indicirano drugačije, INCIVO se primjenjivao u dozi od 750 mg svakih 8 sati (q8h); doza peginterferona alfa-2a bila je 180 µg/tjednu, a doza ribavirina bila je 1000 mg/danu (bolesnici s tjelesnom težinom < 75 kg) ili 1200 mg na dan (bolesnici s tjelesnom težinom ≥ 75 kg).
The 1,088 enrolled patients had a median age of 49 years (range: 18 to 69); 58% of the patients were male; 23% had a body mass index ≥ 30 kg/m2; 9% were Black; 11% were Hispanic or Latino; 77% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 6% had cirrhosis; 59% had HCV genotype 1a; and 40% had HCV genotype 1b.
Medijan dobi 1088 uključena bolesnika bio je 49 godina (raspon: 18 do 69 godina); 58% bolesnika bili su muškarci; 23% imalo je indeks tjelesne mase ≥ 30 kg/m2; 9% bili su crne rase; 11% bili su hispano ili latino porijekla; 77% imalo je početnu koncentraciju HCV RNK ≥ 800 000 IU/ml; 15% imalo je premoštavajuću fibrozu; 6% imalo je cirozu; 59% imalo je HCV genotip 1a; a 40% imalo je
QT interval prolongation and Torsade de Pointes have been reported with voriconazole and posaconazole.
Uz vorikonazol i posakonazol zabilježeni su produljenje QT intervala i torsade de pointes.
amiodarone, bepridil, quinidine, other Class Ia or III antiarrhythmics to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
amiodaron, bepridil, kinidin, ostali antiaritmici skupine Ia ili III
to treat some stomach conditions (gastrointestinal motility agents)
cisaprid za liječenje nekih želučanih tegoba (sredstva koja djeluju na pokretljivost probavnog sustava)
The 740 enrolled patients had a median age of 51 years (range: 18 to 70); 60% of the patients were male; 21% had a body mass index ≥ 30 kg/m2; 5% were Black; 2% were Asian; 85% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 14% had cirrhosis; 57% had HCV genotype 1a; and 43% had HCV genotype 1b.
740 uključenih bolesnika imalo je medijan dobi 51 godinu (raspon: 18 do 70); 60% bolesnika bili su muškarci; 21% je imalo indeks tjelesne mase ≥ 30 kg/m2; 5% je bilo crne rase; 2% je bilo azijatskog porijekla; 85% je imalo početne vrijednosti HCV RNK ≥ 800 000 IU/ml; 15% imalo je premoštavajuću fibrozu; 14% imalo je cirozu; 57% imalo je HCV genotip 1a i 43% imalo je HCV
Prior relapsers Prior partial responders Prior null responders
Bolesnici s prethodno djelomičnim odgovorom Bolesnici s prethodnim potpunim izostankom odgovora
If you are taking INCIVO twice daily (morning and evening) If you notice the missed dose within 6 hours, you must take three tablets immediately.
Ako primijetite da ste propustili uzeti dozu lijeka, a prošlo je manje od 6 sati, morate odmah uzeti tri tablete.
Do not
I DOHVATA
Telaprevir had no effects on fertility or fecundity when evaluated in rats.
U ispitivanjima na štakorima telaprevir nije imao učinke na plodnost.
The 540 enrolled patients had a median age of 51 years (range: 19 to 70); 60% of the patients were male; 32% had a body mass index ≥ 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV RNA levels > 800,000 IU/ml; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b.
Medijan dobi 540 uključenih bolesnika bio je 51 godina (raspon: 19 do 70 godina); 60% bolesnika bili su muškarci; 32% je imalo indeks tjelesne mase ≥ 30 kg/m2; 14% bili su crnci; 10% bili su hispano ili latino porijekla; 82% imalo je početnu koncentraciju HCV RNK > 800 000 IU/ml; 16% je imalo premoštavajuću fibrozu; 11% imalo je cirozu; 72% imalo je HCV genotip 1a; a 27% je imalo
The 662 enrolled patients had a median age of 51 years (range: 21 to 70); 70% of the patients were male; 26% had a body mass index ≥ 30 kg/m2; 5% were Black; 11% were Hispanic or Latino; 89% had baseline HCV RNA levels > 800,000 IU/ml; 22% had bridging fibrosis; 26% had cirrhosis; 54% had HCV genotype 1a; and 46% had HCV genotype 1b.
Medijan dobi 662 uključena bolesnika bila je 51 godina (raspon: 21 do 70 godina); 70% bolesnika bili su muškarci; 26% imalo je indeks tjelesne mase ≥ 30 kg/m2; 5% bili su crne rase; 11% bili su hispano ili latino porijekla; 89% imalo je početnu koncentraciju HCV RNK > 800 000 IU/ml; 22% imalo je premoštavajuću fibrozu; 26% imalo je cirozu; 54% imalo je HCV genotip 1a; a 46% imalo je
a Grade ≥ 2) that represent a worsening from baseline and are considered adverse drug reactions in HCV-infected patients treated with INCIVO combination treatment from the pooled data from the placebo-controlled
Tablica 4: Promjene vrijednosti odabranih laboratorijskih nalaza (DAIDS predstavljaju pogoršanje u odnosu na početno stanje i smatraju se nuspojavama, u bolesnika s HCV infekcijom liječenih kombiniranom terapijom s INCIVOM na temelju objedinjenih podataka iz faze II i III placebom kontroliranih ispitivanja
oral midazolam*
OPIJATNI ANALGETICI metadon*
Duration of treatment - Previously treated adults with prior partial or prior null response Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks, followed by peginterferon alfa and ribavirin therapy alone (without INCIVO) for a total treatment duration of 48 weeks (see figure 2).
INCIVO se mora početi uzimati u kombinaciji s peginterferonom alfa i ribavirinom i primjenjivati tijekom 12 tjedana, a nakon toga se liječenje nastavlja samo peginterferonom alfa i ribavirinom (bez INCIVA) do ukupnog trajanja liječenja od 48 tjedana (vidjeti sliku 2).
ul.
SVR
INCIVO in combination with peginterferon alfa and ribavirin was evaluated in 74 HCV-1 infected, post-liver transplant patients without cirrhosis receiving either tacrolimus or cyclosporine A. At the initiation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly reduced, including a prolongation in the dosing interval for tacrolimus, in order to maintain therapeutic plasma concentrations of the immunosuppressant.
INCIVO je bio procijenjen u kombinaciji s peginterferonom alfa i ribavirinom u 74 bolesnika s HCV-1 infekcijom nakon transplantacije jetre bez ciroze koji su dobivali ili takrolimus ili ciklosporin A.
It is important to stay hydrated with fluids during INCIVO combination treatment.
INCIVO važno je održavanje hidracije organizma tekućinom.
SVR in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12
SVR u bolesnika s nemjerljivom HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu SVR u bolesnika koji nisu imali nemjerljivu HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu
Prior relapsers
Relaps
T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
T12/PR48: INCIVO tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana; Pbo/PR: placebo tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana
T12/PR: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
T12/PR: INCIVO tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 24 ili 48 tjedana; Pbo/PR: placebo tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana
A total of 352 (65%) patients had undetectable HCV RNA (target not detected) at weeks 4 and 12.
Nemjerljiv HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu imalo je ukupno 352 (65%) bolesnika.
AUC 0.80 (0.76-0.85) Cmax 0.79 (0.74-0.84) Cmin 0.85 (0.75-0.98) ↑ atazanavir AUC 1.17 (0.97-1.43) Cmax 0.85 (0.73-0.98) Cmin 1.85 (1.40-2.44) inhibition of CYP3A by telaprevir
↔telaprevir AUC 1,07 (1,00-1,15) Cmax 1,07 (0,98-1,16) Cmin 1,14 (1,04-1,26) ↑ raltegravir AUC 1,31 (1,03-1,67) Cmax 1,26 (0,97-1,62) Cmin 1,78 (1,26-2,53)
Table 3: Adverse drug reactions to INCIVO (taken in combination with peginterferon alfa and ribavirin) in HCV-infected patients in clinical trials a and post-marketing Adverse Drug Reactions INCIVO, peginterferon alfa, and ribavirin combination therapy oral candidiasis anaemia thrombocytopenia b, lymphopenia hypothyroidism hyperuricaemia b, hypokalaemia gout dysgeusia, syncope
Tablica 3: Nuspojave INCIVA (koji se uzima u kombinaciji s peginterferonom alfa i ribavirinom) u bolesnika zaraženih HCV-om u kliničkim ispitivanjima a i postmarketinški
Your doctor should check your rash to determine how to manage it.
Kako bi mogao odrediti kako liječiti osip, liječnik Vas treba pregledati.
T12(DS)/PR % (n/N) ≥ 1 log10 reduction in HCV RNA at week 4
Sniženje HCV RNK ≥ 1 log10 u 4. tjednu
Dose modification of INCIVO is not required when administered to hepatitis C patients with mild hepatic impairment (Child-Pugh A, score 5-6).
Kad se INCIVO primjenjuje u bolesnika s hepatitisom C i blagim oštećenjem funkcije jetre (Child-Pugh A, rezultat 5-6), prilagodba doze nije potrebna.
See also section 4.3 for medicinal products which are contraindicated with INCIVO.
Za lijekove koji su kontraindicirani s INCIVOM, vidjeti također dio 4.3.
regimen results in the same daily dose with similar drug exposures of telaprevir, the relative drug interactions are expected to be similar.
Očekuje se da će relativne interakcije lijekova biti slične, ako se uzme u obzir da shema uzimanja 1125 mg b.i.d. dovodi do istih dnevnih doza sa sličnim izloženostima telapreviru.
Cmin 1.10 (0.97-1.24) induction of CYP3A by carbamazepine, and inhibition of CYP3A by telaprevir
↓ telaprevir ↑ rifabutin rifabutin inducira CYP3A, a telaprevir inhibira
Patients with undetectable HCV RNA (target not detected) at weeks 4 and 12
Nemjerljiv HCV RNK (cilj nije izmjeren) u 4. i
SVR in patients who did not have undetectable HCV RNA (target not detected) at weeks 4
Nazivnik je bio broj bolesnika s nemjerljivim HCV RNK (cilj nije izmjeren) na kraju liječenja
↓ ethinylestradiol AUC 0.72 (0.69-0.75) Cmax 0.74 (0.68-0.80) Cmin 0.67 (0.63-0.71) ↔ norethindrone AUC 0.89 (0.86-0.93) Cmax 0.85 (0.81-0.89) Cmin 0.94 (0.87-1.00) mechanism unknown
 telaprevir AUC 0,46 (0,41-0,52) Cmax 0,47 (0,41-0,52) Cmin 0,48 (0,40-0,56) ↔ lopinavir AUC 1,06 (0,96-1,17) Cmax 0,96 (0,87-1,05) Cmin 1,14 (0,96-1,36) mehanizam nije poznat
Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
Za informacije o smanjenju doze i/ili prekidu primjene ribavirina pogledajte Sažetak opisa svojstava lijeka za ribavirin.
to treat fungal infections (antifungals)
za liječenje upalnog artritisa (sredstva protiv uloga) za liječenje određenih infekcija (antimikobakterijski lijekovi)
Serious skin reactions including rash with systemic symptoms, progressive severe rash,
Ozbiljne kožne reakcije uključujući osip sa sistemskim simptomima, progresivni teški osip, sumnja ili dijagnoza generalizirane bulozne erupcije, DRESS, SJS/TEN, akutna generalizirana egzantematozna pustuloza,
See the package leaflets for peginterferon alfa and ribavirin for a list of their contraindications (e.g. pregnancy precautions for men and women) since INCIVO must be used in combination with peginterferon alfa and ribavirin.
S obzirom da se INCIVO mora primjenjivati u kombinaciji s peginterferonom alfa i ribavirinom, kontraindikacije za peginterferon alfa i ribavirina pogledajte u pripadajućoj uputi o lijeku (npr. mjere zaštite od trudnoće za muškarce i žene).
Treatment-Experienced Patients by Subgroup
Bolesnice reproduktivne dobi i njihovi partneri
Increases in serum uric acid occur very commonly during treatment with INCIVO in combination with peginterferon alfa and ribavirin.
Tijekom liječenja INCIVOM u kombinaciji s peginterferonom alfa i ribavirinom vrlo često dolazi do povišenja mokraćne kiseline u serumu.
(target not detected) at weeks 4 and 12 of treatment, the SVR rate was 89% (25/28) and the relapse rate was 7%.
U bolesnika s prethodnim relapsom u terapijskoj skupini T12/PR24 u kojih je HCV RNK bio nemjerljiv (cilj nije izmjeren) u 4. i 12. tjednu liječenja, stopa SVR iznosila je 89% (25/28), a stopa relapsa 7%.
In patients with HCV RNA between 100 IU/ml and 1,000 IU/ml at week 12,
Od bolesnika s koncentracijom HCV RNK između 100 IU/ml i 1000 IU/ml u 12. tjednu trajni virološki odgovor postiglo je 2/8 (25%) bolesnika.
Use of peginterferon alfa 2a or 2b Two types of peginterferon alfa (2a and 2b) were studied in the Phase 2a open label, randomised
U fazi II randomiziranog ispitivanja otvorenog tipa C208 ispitivale su se dvije vrste peginterferona alfa (2a i 2b) u bolesnika koji prethodno nisu bili liječeni.
and patients receiving telaprevir 750 mg every 8 hours (q8h).
↓ telaprevir 1 125 mg svakih 8 sati (u odnosu na 750 mg svakih 8 sati)
)/PR N = 369 % (n/N)
T12(b.i.d.)/PR N = 369 % (n/N)
Duration of treatment - Treatment-naïve adults and prior treatment relapsers Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks (see figure 1).
INCIVO se mora početi uzimati u kombinaciji s peginterferonom alfa i ribavirinom i primjenjivati tijekom 12 tjedana (vidjeti Sliku 1).
Contact your doctor immediately if you get a skin rash.
Ako dobijete kožni osip, odmah se javite liječniku.
↑ alprazolam AUC 1.35 (1.23-1.49) Cmax 0.97 (0.92-1.03)
Cmin 1,93 (1,55-2,41)
You must read the package leaflets for peginterferon alfa and ribavirin for additional information.
Za dodatne informacije, morate pročitati upute o lijeku za peginterferon alfa i ribavirin.
After weaning, rat pup body weight gain silica colloidal anhydrous sodium lauryl sulphate croscarmellose sodium sodium stearyl fumarate
Po prestanku sisanja, porast tjelesne težine mladunčadi štakora vratio se na kalcijev hidrogenfosfat, bezvodni silicijev dioksid, koloidni, bezvodni
All treatment regimens had a 48-week duration of peginterferon alfa-2a and ribavirin treatment.
U svim terapijskim skupinama liječenje peginterferonom alfa-2a i ribavirinom trajalo je 48 tjedana.
- who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders (see
INCIVO je indiciran u kombinaciji s peginterferonom alfa i ribavirinom za liječenje odraslih bolesnika s kroničnim hepatitisom C genotipa 1 i kompenziranom bolešću jetre (uključujući cirozu): - koji prethodno nisu bili liječeni, - koji su prethodno bili liječeni samo interferonom alfa (pegiliranim ili nepegiliranim) ili u kombinaciji s ribavirinom, uključujući bolesnike s relapsom, s djelomičnim terapijskim odgovorom i one koji nisu odgovorili na ranije liječenje (vidjeti dijelove 4.4 i 5.1).
Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia.
Za zbrinjavanje anemije nastale liječenjem, prednost se daje smanjenju doze ribavirina.
When administered twice daily (b.i.d.
Ako uzimate INCIVO dva puta na dan (ujutro i navečer)
Treatment Outcome Treatment-Naïve Patients N = 64 % (n/N)
Bolesnici s iskustvom u liječenju prema podskupini S prethodnim relapsom N = 29 % (n/N)
Treatment is started at a low dose, which the doctor may then increase slowly until an appropriate dose is reached.
Liječenje započinje s malom dozom, koju liječnik potom može polako povećavati dok ne dosegne odgovarajuću dozu.
Enzepi is available as capsules (5,000; 10,000; 25,000 and 40,000 units).
Lijek Enzepi je dostupan u obliku kapsula (5 000, 10 000, 25 000 i 40 000 jedinica).
The full EPAR for Enzepi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Enzepi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Capsules should be swallowed whole and not chewed or crushed.
Kapsule se trebaju progutati cijele i ne smiju se žvakati ili drobiti.
Other information about Enzepi
Ostale informacije o lijeku Enzepi
In one main study involving 96 patients, treatment with Enzepi led to the absorption of 84% of the fats consumed by patient over 72 hours compared with 85% absorption with the already authorised medicine.
U jednom glavnom ispitivanju koje je uključivalo 96 bolesnika, liječenje lijekom Enzepi dovelo je do apsorpcije 84 % masnoća koje je bolesnik konzumirao u 72 sata, u usporedbi s 85 %-tnom apsorpcijom kod već odobrenog lijeka.
For patients who cannot swallow capsules, the capsules may be opened and the content mixed with a small amount of acidic food such as fruit puree which should be swallowed immediately without chewing.
Bolesnicima koji ne mogu progutati kapsule one se mogu otvoriti i njihov sadržaj pomiješati s malom količinom kisele hrane kao što je voćni pire, koji treba odmah progutati bez žvakanja.
What measures are being taken to ensure the safe and effective use of Enzepi?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Enzepi?
It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Objašnjava kako je Agencija ocijenila proizvod da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
What is Enzepi and what is it used for?
Što je Enzepi i za što se koristi?
Enzepi should be taken during meals or snacks with a drink of water or juice.
Lijek Enzepi treba uzimati tijekom obroka ili međuobroka s vodom ili sokom.
This is a summary of the European public assessment report (EPAR) for Enzepi.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Enzepi.
Why is Enzepi approved?
Zašto je Enzepi odobren?
The appropriate dose depends on the symptoms of the disease, amount of fat in the stool, fat content of the diet and the patient's weight.
Odgovarajuća doza ovisi o simptomima bolesti, količini masnoća u stolici, udjelu masnoća u prehrani i težini bolesnika.
A lack of these enzymes leads to poor growth, weight loss, abdominal pain and diarrhoea.
Nedostatak tih enzima uzrokuje premali rast, gubitak težine, abdominalnu bol i proljev.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Enzepi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Enzepi nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
It is not intended to provide practical advice on how to use Enzepi.
Svrha sažetka nije davati praktične savjete o korištenju lijeka Enzepi.
Enzepi pancreas powder
Enzepi prašak gušterače
Enzepi is a medicine used to treat adults and children whose pancreas does not produce enough enzymes (a condition known as pancreatic insufficiency) due to cystic fibrosis or other conditions such as pancreatic cancer.
Enzepi je lijek koji se koristi za liječenje odraslih osoba i djece čija gušterača ne proizvodi dovoljno enzima (stanje poznato kao insuficijencija gušterače) zbog cistične fibroze ili drugih bolesti, poput raka gušterače.
The CHMP considered that the use of pancreas powder to treat pancreatic insufficiency has been well established in medical practice for more than 20 years.
CHMP je zaključio da je korištenje praška gušterače u liječenju insuficijencije gušterače ustaljeno u medicinskoj praksi više od 20 godina.
Enzepi will therefore help the body absorb nutrients better, especially fats.
Lijek Enzepi stoga pomaže tijelu da bolje apsorbira hranjive tvari, osobito masnoće.
Enzepi was shown to be as effective as the already well-known marketed medicine.
Lijek Enzepi pokazao se jednako djelotvornim kao i već dobro poznat lijek koji je u prometu.
In clinical trials most side effects were mild to moderate in severity.
U kliničkim ispitivanjima većina nuspojava bila je blaga do umjerena po ozbiljnosti.
The most common side effects with Enzepi (which may affect more than 1 in 100 people) are effects on the gut (abdominal pain, bloating, diarrhoea, vomiting, constipation and nausea) and headache.
Najčešće nuspojave lijeka Enzepi (mogu se javiti u više od 1 na 100 osoba) su učinak na crijeva (abdominalna bol, nadutost, proljev, povraćanje, zatvor i mučnina) i glavobolja.
What are the risks associated with Enzepi?
Koji su rizici povezani s lijekom Enzepi?
Enzepi can only be obtained with a prescription.
Lijek Enzepi izdaje se samo na recept.
For more information about treatment with Enzepi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Enzepi pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svojem liječniku ili ljekarniku.