natgillin/translations-raw huggingface dataset:
There are three different pack sizes (bottles containing 30, 60, or 100 tablets).
Postoje tri različite veličine pakiranja (bočice koje sadrže 30, 60 ili 100 tableta).
Therefore, the use of Comtan in children or adolescents cannot be recommended.
Stoga se ne preporučuje primjena Comtana u djece ili adolescenata.
What you need to know before you take Comtan
Što morate znati prije nego počnete uzimati Comtan
EU/1/98/081/001 30 film-coated tablets (glass) EU/1/98/081/002 60 film-coated tablets (glass) EU/1/98/081/003
EU/1/98/081/001 30 filmom obloženih tableta (staklo) EU/1/98/081/002 60 filmom obloženih tableta (staklo) EU/1/98/081/003
Elderly (≥65 years) No dosage adjustment of entacapone is required for older people.
Stariji (≥65 godina) Starijim osobama nije potrebno posebno prilagođavati doziranje entakapona.
Comtan may make it harder for you to digest iron.
Comtan može otežati probavu željeza.
If you forget to take Comtan
Ako ste zaboravili uzeti Comtan
Do not take Comtan
Nemojte uzimati Comtan
Comtan in association with levodopa may have a major influence on the ability to drive and use machines.
Comtan udružen s levodopom može imati velik utjecaj na sposobnost upravljanja vozilima i strojevima.
If you experience such effects at the start of treatment with Comtan you should contact your doctor who may decide to adjust your dosage of levodopa.
Ako osjetite te nuspojave na početku liječenja Comtanom, trebate se obratiti svom liječniku, koji može odlučiti o prilagođavanju doziranja levodope.
[carton only]
[samo kutija]
Do not use Comtan during pregnancy or if you are breast-feeding.
Comtan nemojte koristiti tijekom trudnoće i dojenja.
Comtan 200 mg [carton only]
Comtan 200 mg [samo kutija]
Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtan and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Neuroleptički maligni sindrom (NMS) je ozbiljna ali rijetka reakcija na neke lijekove, i može se javiti naročito kada se naglo prekine uzimanje Comtana i drugih lijekova za terapiju Parkinsonove bolesti, ili se njihova doza naglo smanji.
If you forget to take the Comtan tablet with your levodopa dose, you should continue the treatment by taking the next Comtan tablet with your next levodopa dose.
Ako uz dozu levodope zaboravite uzeti Comtan, nastavite Vaše liječenje uzimanjem sljedeće Comtan tablete s Vašom sljedećom dozom levodope.
Comtan and iron supplements at the same time.
Zbog toga ne uzimajte Comtan i preparate željeza u isto vrijeme.
Comtan has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa.
Comtan nema učinak ublažavanja simptoma Parkinsonove bolesti ako nije uzet s levodopom.
Comtan taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Comtan uzet zajedno s levodopom može sniziti Vaš krvni tlak, zbog čega možete osjetiti laganu ošamućenost ili omaglicu.
• if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS).
• ako ste bilo kada imali rijetku reakciju na antipsihotike zvanu neuroleptički maligni sindrom
Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Stoga, bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom sukraze-izomaltaze ne bi trebali uzimati ovaj lijek.
It is characterised by stiffness, muscle twitching, shaking, agitation, confusion, coma, high body temperature, increased heart rate and unstable blood pressure;
Karakteriziran je ukočenošću, trzanjem mišića, drhtavicom, uznemirenošću, smetenošću, komom, visokom tjelesnom temperaturom, povećanom brzinom otkucaja srca i nestabilnim krvnim tlakom;
• discolouration of the skin, hair, beard and nails.
• promjena boje kože, kose, brade i noktiju.
Uncommon (may affect up to 1 in 100 people): • Heart attack.
Manje često (mogu se javiti u manje od 1 na 100 osoba): • Srčani udar.
• if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.
• ako imate povećani gubitak apetita, slabost, iscrpljenost i gubitak tjelesne težine unutar relativno kratkog vremenskog perioda, potrebno je razmisliti o općem liječničkom pregledu,
The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtan.
Najveća preporučena doza je 10 tableta na dan, odnosno 2000 mg Comtana.
As Comtan tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
S obzirom da se Comtan tablete uzimaju zajedno s lijekovima na bazi levodope, molimo da pažljivo pročitate upute o lijeku i tih drugih lijekova.
30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
30 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta
Comtan tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Comtan tablete sadrže entakapon i primjenjuju se zajedno s levodopom za liječenje Parkinsonove bolesti.
• Inflammation of the colon (colitis), inflammation of the liver (hepatitis) with yellowing of the skin and whites of the eyes;
• Upala debelog crijeva (kolitis), upala jetre (hepatitis) s požutjelom kožom i bjeloočnicama;
Your doctor may advise you to slowly discontinue the treatment with Comtan and other medicines to treat Parkinson's disease.
Liječnik Vam može savjetovati polagano prekidanje liječenja Comtanom i drugim lijekovima za terapiju Parkinsonove bolesti.
Table 1* Adverse drug reactions
Tablica 1* Nuspojave na lijek
Each tablet contains 1.82 mg sucrose.
Jedna tableta sadržava 1,82 mg saharoze.
Table 2 Daily ON time (Mean ± SD)
Tablica 2 Dnevno trajanje „ON“ faze (srednja vrijednost ± SD)
- The film-coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171), magnesium stearate.
Ovojnica tablete hipromeloza polisorbat 80 glicerol 85% saharoza željezov oksid, žuti (E172) željezov oksid, crveni (E172) titanijev dioksid (E171) magnezijev stearat
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtan in association with levodopa (see section 4.4).
Poremećaji kontrole impulsa: Patološko kockanje, pojačan libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, nekontrolirano prejedanje i kompulzivno jedenje mogu se javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergicima poput Comtana zajedno s levodopom (vidjeti dio 4.4).
The recommended dose of Comtan is one 200 mg tablet with each levodopa dose.
Peporučena doza Comtana je jedna tableta od 200 mg, uz svaku dozu levodope.
Brownish-orange, oval, biconvex film-coated tablet with “Comtan” engraved on one side.
Smećkasto-narančasta, ovalna, bikonveksna filmom obložena tableta, s utisnutim „Comtan“ na jednoj strani.
Orion Pharma d.o.o.
Orion Pharma d.o.o. Tel.
Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
(E 172), crveni željezov oksid (E 172), titanijev dioksid (E 171) i magnezijev stearat.
Comtan aids levodopa in relieving the symptoms of Parkinson's disease.
Comtan pomaže levodopi u ublažavanju simptoma Parkinsonove bolesti.
Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-Omethyl transferase (COMT), e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
Stoga entakapon treba primjenjivati s oprezom u bolesnika koji se liječe lijekovima metaboliziranim putem katehol-O-metil transferaze (COMT), npr. rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa i apomorfin (vidjeti također dio 4.5).
How to take Comtan
Kako uzimati Comtan
Comtan taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Comtan uzet s levodopom može izazvati pospanost i može dovesti do toga da ponekad iznenada utonete u san.
White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60 or 100 tablets.
Bijele bočice od polietilena visoke gustoće (HDPE), s bijelim polipropilenskim (PP) zatvaračem sa zaštitom od otvaranja, koje sadrže 30, 60 ili 100 tableta.
Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtan in association with levodopa.
Bolesnici i osobe koje se brinu o njima trebaju biti svjesni da se simptomi poremećaja ponašanja kontrole impulsa kao što su patološko kockanje, pojačan libido, hiperseksualnost, kompulzivno trošenje ili kupovanje, nekontrolirano prejedanje i kompulzivno jedenje mogu javiti u bolesnika liječenih agonistima dopamina i/ili drugim dopaminergicima poput Comtana u kombinaciji s levodopom.
CI95% 45 min, 1 h 56 Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Ispitivanje II: udio dnevnog trajanja „ON“ faze (%) Entakapon (n=103) Placebo (n=102)
• Excessive movements (hyperkinesias), worsening of symptoms of Parkinson's disease,
• Pretjerani pokreti (hiperkinezije), pogoršanje simptoma Parkinsonove bolesti, produženo trajanje grčeva mišića (distonija);
• Rashes;
• Osipi;
Amber glass bottles (hydrolytic class III) with white tamper-resistant polypropylene closures containing 30, 60 or 100 tablets.
Staklene smeđe bočice (hidrolitičke klase III), s bijelim sigurnosnim polipropilenskim zatvaračem, koje sadrže 30, 60 ili 100 tableta.
If you take more Comtan than you should In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
U slučaju predoziranja, odmah se obratite Vašem liječniku, ljekarniku ili najbližoj bolnici.
When stopping, your doctor may need to re-adjust the dosage of your other medicines to treat Parkinson's disease.
Kad prekinete uzimanje, liječnik će možda morati prilagoditi dozu ostalih lijekova za terapiju Parkinsonove bolesti.
Comtan contains sucrose Comtan tablets contain a sugar called sucrose.
Comtan tablete sadrže šećer koji se zove saharoza.
Suddenly stopping Comtan and other medicines to treat Parkinson's disease may result in unwanted side effects.
Nagli prekid primjene Comtana, i drugih lijekova za terapiju Parkinsonove bolesti, može dovesti do nuspojava.
How to store Comtan
Kako čuvati Comtan
• if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtan);
• ako uzimate određene lijekove protiv depresije (upitajte svog liječnika ili ljekarnika može li se
Comtan is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Comtan se uzima zajedno s lijekovima koji sadrže levodopu (ili kombinacija levodope/karbidope ili kombinacija levodope/benzerazida).
Usually side effects caused by Comtan are mild to moderate.
Nuspojave izazvane Comtanom obično su blage do umjerene.
Comtan 200 mg film-coated tablets
Comtan 200 mg filmom obložene tablete
What Comtan looks like and contents of the pack Comtan 200 mg film-coated tablets are brownish-orange, oval tablets with “Comtan” engraved on one side.
Comtan 200 mg filmom obložene tablete su smećkasto-narančaste, ovalne tablete s utisnutim „Comtan“ na jednoj strani.
100 film-coated tablets (glass) 30 film-coated tablets (HDPE) 100 film-coated tablets (HDPE) 60 film-coated tablets (HDPE)
100 filmom obloženih tableta (staklo) 30 filmom obloženih tableta (HDPE) 100 filmom obloženih tableta (HDPE) EU/1/98/081/007 60 filmom obloženih tableta (HDPE)
In addition, Comtan taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Dodatno, Comtan uzet s levodopom može izazvati jaku pospanost ili se može dogoditi da iznenada utonete u san.
- The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium,
- Drugi sastojci su mikrokristalična celuloza, manitol, umrežena karmelozanatrij, hidrogenirano biljno ulje, magnezijev stearat.
Croscarmellose sodium Hydrogenated vegetable oil Magnesium stearate
Jezgra tablete celuloza, mikrokristalična manitol karmelozanatrij, umrežena biljno ulje, hidrogenirano magnezijev stearat
Hepatitis with mainly cholestatic features (see section 4.4) Skin and subcutaneous tissue disorders Rare:
Hepatitis s uglavnom kolestatskim obilježjima (vidjeti dio 4.4)
Comtan 200 mg film-coated tablets entacapone
Comtan 200 mg filmom obložene tablete entakapon
Urine discolouration
Diskinezija
1 tablet contains 200 mg of entacapone.
1 tableta sadržava 200 mg entakapona.
Comtan tablets contain sucrose.
Comtan sadrži saharozu.
Tel: +39 02 67876111
Orion Pharma S.r.l. Tel: +39 02 67876111
Marketing Authorisation Holder Orion Corporation Orionintie 1
Nositelj odobrenja za stavljanje lijeka u promet Orion Corporation
Tel: +34 91 599 86 01
Orion Pharma S.L. Tel: +34 91 599 86 01
• Comtan taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
• U rijetkim slučajevima, nakon istodobnog uzimanja Comtana i levodope, može se dogoditi da tijekom dana osjetite prekomjernu pospanost ili da naglo utonete u san;
However, the experience of the clinical use of entacapone with several medicinal products, including MAO-A inhibitors, tricyclic antidepressants, noradrenaline reuptake inhibitors such as desipramine,
Međutim, još uvijek je ograničeno iskustvo kliničke primjene entakapona s nekoliko lijekova, uključujući MAO-A inhibitore, tricikličke antidepresive, inhibitore ponovne pohrane noradrenalina kao što su dezipramin, maprotilin i venlafaksin te lijekove koji se metaboliziraju putem COMT-a (npr. spojevi s kateholskom strukturom: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa, apomorfin i paroksetin).
Hepatobiliary disorders Rare:
Poremećaji kože i potkožnog tkiva Rijetko:
The doses of other antiparkinsonian medicinal products may need to be adjusted when entacapone treatment is initiated.
U početku liječenja entakaponom može biti potrebno prilagođavanje doze drugih lijekova za Parkinsonovu bolest.
• hives.
(NMS).
Alprolix eftrenonacog alfa
Alprolix eftrenonakog alfa
In addition, when bleeding did occur, around 90% of bleeding episodes resolved with one injection of Alprolix.
Osim toga, kada se pojavilo krvarenje, otprilike 90 % epizoda krvarenja zaustavljeno je jednom injekcijom lijeka Alprolix.
This is a summary of the European public assessment report (EPAR) for Alprolix.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Alprolix.
Hypersensitivity (allergic) reactions are seen rarely with Alprolix and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Reakcije preosjetljivosti (alergijske reakcije) rijetko su zabilježene pri primjeni lijeka Alprolix, a uključuju: oticanje, žarenje i peckanje na mjestu injekcije, zimicu, navalu crvenila, osip praćen svrbežom, glavobolju, koprivnjaču, nizak krvni tlak, letargiju, mučninu i povraćanje, nemir, brzo kucanje srca, stezanje u prsima i piskanje pri disanju.
Why is Alprolix approved?
Zašto je Alprolix odobren?
What measures are being taken to ensure the safe and effective use of Alprolix?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Alprolix?
Other information about Alprolix
Ostale informacije o lijeku Alprolix
The full EPAR for Alprolix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Alprolix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
A risk management plan has been developed to ensure that Alprolix is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Alprolix.
What is Alprolix and what is it used for?
Što je Alprolix i za što se koristi?
The summary of the opinion of the Committee for Orphan Medicinal Products for Alprolix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Alprolix dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
In the second study in 30 children aged below 12 years, Alprolix was similarly effective: 2 bleeding episodes occurred per year on average and around 75% of bleeding episodes resolved with one injection.
U drugom ispitivanju na 30 djece mlađe od 12 godina lijek Alprolix pokazao je sličnu učinkovitost: u prosjeku su se javljale dvije epizode krvarenja godišnje, a otprilike 75 % epizoda krvarenja zaustavljeno je jednom injekcijom.
Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Alprolix was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2007.
Budući da postoji mali broj bolesnika s hemofilijom B, bolest se smatra „rijetkom” te se Alprolix označava kao lijek za liječenje rijetkih bolesti od 8. lipnja 2007.
In the first study involving 123 adults and adolescents aged 12 years or above, patients given Alprolix as a weekly preventive treatment had around 3 bleeding episodes a year, patients given Alprolix as an every 10 days preventive treatment had around 2 bleeding episodes per year, and patients given Alprolix for treating bleedings on demand had around 18 bleeding episodes a year.
U prvom ispitivanju koje je uključivalo 123 odraslih osoba i adolescenata u dobi od 12 godina ili više, bolesnici kojima se davao lijek Alprolix kao preventivna terapija jednom tjedno imali su otprilike tri epizode krvarenja godišnje, dok su bolesnici kojima se davao Alprolix kao preventivna terapija svakih 10 dana imali otprilike dvije epizode krvarenja godišnje, a bolesnici kojima se davao Alprolix za liječenje krvarenja na zahtjev otprilike 18 epizoda krvarenja godišnje.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Alprolix, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Alprolix nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
Alprolix can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Alprolix se izdaje samo na liječnički recept, a liječenje mora biti pod nadzorom liječnika s iskustvom u liječenju hemofilije.
It is not intended to provide practical advice on how to use Alprolix.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Alprolix.
Alprolix is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Alprolix je dostupan kao prašak i otapalo koji se miješaju kako bi se pripremila otopina za intravensku injekciju.
Alprolix has been shown to be effective at both preventing and treating bleeding episodes in 2 main studies in patients with haemophilia B.
Lijek Alprolix pokazao se učinkovitim i u sprečavanju i u liječenju epizoda krvarenja u dvama glavnim ispitivanjima na bolesnicima s hemofilijom B.
Factor IX medicines can also potentially cause problems due to the formation of blood clots in the blood vessels.
Lijekovi za nadomjestak faktora IX mogu također potencijalno prouzročiti probleme zbog stvaranja krvnih ugrušaka u krvnim žilama.
What are the risks associated with Alprolix?
Koji su rizici povezani s lijekom Alprolix?
The dose and frequency of treatment depend on the patient's bodyweight and whether Alprolix is used to treat or prevent bleeding, as well as the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the patient's age and health.
Doza i učestalost terapije ovise o bolesnikovoj tjelesnoj težini te o tome koristi li se Alprolix za liječenje ili sprečavanje krvarenja, kao i o tome kojeg je stupnja ozbiljnosti manjak faktora IX u bolesnika te o opsegu i mjestu krvarenja i bolesnikovoj dobi i zdravstvenom stanju.
For further information on how to use this medicine, see the summary of product characteristics (also part of the EPAR).
Za dodatne informacije o primjeni ovog lijeka pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
Patients with haemophilia B lack factor IX, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Bolesnicima s hemofilijom B nedostaje faktor IX, protein koji je potreban za normalno zgrušavanje krvi, pa stoga lako krvare.
Some patients taking factor IX medicines may develop inhibitors (antibodies) against factor IX, causing the medicine to stop working and resulting in a loss of bleeding control.
Kod nekih bolesnika koji uzimaju lijekove za nadomjestak faktora IX mogu se razviti inhibitori (protutijela) faktora IX koji onemogućuju djelovanje lijeka i dovode do gubitka kontrole krvarenja.
For more information about treatment with Alprolix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Alprolix pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
Alprolix is a medicine used to treat and prevent bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Alprolix je lijek koji se koristi za liječenje i sprečavanje krvarenja u bolesnika s hemofilijom B, nasljednim poremećajem krvarenja uzrokovanim manjkom proteina za zgrušavanje koji se naziva faktor IX. Može se primjenjivati u bolesnika svih dobi.
Patients or their carers may be able to inject Alprolix themselves at home once they have been trained appropriately.
Nakon odgovarajućeg osposobljavanja, bolesnici ili njihovi njegovatelji mogu samostalno ubrizgavati lijek Alprolix kod kuće.
For the full list of all side effects and restrictions with Alprolix, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Alprolix potražite u uputi o lijeku.
How is Alprolix used?
Kako se Alprolix koristi?
What benefits of Alprolix have been shown in studies?
Koje su koristi lijeka Alprolix utvrđene u ispitivanjima?
How does Alprolix work?
Kako djeluje Alprolix?
Alprolix contains the active substance eftrenonacog alfa.
Lijek sadrži djelatnu tvar eftrenonakog alfa.
For practical information about using Alprolix, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Alprolix pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
Studies show that Alprolix is effective at preventing and treating bleeding episodes in patients with haemophilia B and its safety is comparable to that of other factor IX products.
Ispitivanja pokazuju da je lijek Alprolix učinkovit u sprečavanju i liječenju epizoda krvarenja u bolesnika s hemofilijom B te da je njegova sigurnost usporediva sa sigurnošću drugih lijekova za liječenje manjka faktora IX. Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji stoga je odlučio da koristi od lijeka Alprolix nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.