natgillin/translations-raw huggingface dataset:
Prometax 4.6 mg/24 h transdermal patch Prometax 9.5 mg/24 h transdermal patch Prometax 13.3 mg/24 h transdermal patch
Prometax 4,6 mg/24 h transdermalni flaster Prometax 9,5 mg/24 h transdermalni flaster Prometax 13,3 mg/24 h transdermalni flaster
Patients and caregivers should be instructed on important administration instructions:
O tome bolesnici i njegovatelji trebaju dobiti odgovarajuće upute.
Prometax 4.6 mg/24 h transdermal patch Prometax 9.5 mg/24 h transdermal patch Prometax 13.3 mg/24 h transdermal patch rivastigmine
Prometax 4,6 mg/24 h transdermalni flaster Prometax 9,5 mg/24 h transdermalni flaster Prometax 13,3 mg/24 h transdermalni flaster rivastigmin
The outside of the backing layer is beige and labelled with “Prometax”, “9.5 mg/24 h” and “BHDI”.
Vanjski dio potpornog sloja je bež boje s oznakama „Prometax“, „9.5 mg/24 h“ i „BHDI“.
Prometax transdermal patches 9.5 mg/24 h
Prometax transdermalni flasteri 9,5 mg/24 h
They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions.
Mogli bi osjetiti više nuspojava te uslijed toga biti skloniji prekidu liječenja zbog nuspojava.
• Ulcer in the intestine
• Čir u crijevima
Transdermal patches
Transdermalni flaster
• Feeling restless
• Osjećaj nemira
Keep the patch in the sachet until use.
Čuvati flaster u vrećici sve do primjene.
At least 4 points improvement on ADAS-Cog with no worsening on ADCSCGIC and ADCS-ADL
Poboljšanje od najmanje 4 boda na ADAS-Cog bez pogoršanja na
Type III amber glass bottle with a child-resistant cap, dip tube and self aligning plug.
Smeđa staklena boca tipa III sa sigurnosnim zatvaračem za djecu i umetnutom cjevčicom s čepom utisnutim u grlo boce.
Hepatitis, elevated liver function tests Skin and subcutaneous tissue disorders Common
Hepatitis, povišeni rezultati testova funkcije jetre
• Use Prometax oral solution within 1 month of opening the bottle.
• Prometax oralnu otopinu treba primijeniti unutar mjesec dana od prvog otvaranja bočice.
112 capsules.
56 ili 112 kapsula.
Total patients studied Total patients with pre-defined AE(s) Tremor
Ukupan broj bolesnika s unaprijed određenom štetnim događajem (događajima)
Pruritus, allergic dermatitis (disseminated) General disorders and administration site conditions Common
Svrbež, alergijski dermatitis (diseminirani) Opći poremećaji i reakcije na mjestu primjene Često
Patients involved in the placebo-controlled study had an MMSE (Mini-Mental State Examination) score of 10-20.
Bolesnici uključeni u placebom kontrolirano ispitivanje imali su rezultat na MMSE-u (eng.
Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
Utvrđeno je da su na gastrointestinalne nuspojave i gubitak tjelesne težine bolesnice u kliničkim ispitivanjima bile osjetljivije od muških bolesnika.
No study was conducted with Prometax transdermal patches in subjects with renal impairment.
Nije provedeno nikakvo ispitivanje s Prometax transdermalnim flasterima u ispitanika s oštećenjem bubrega.
• Take off the previous patch before putting ONE new patch on.
• Uklonite prethodni flaster prije stavljanja JEDNOG novog flastera.
- Prometax 4.5 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and red body, with a white imprint “ENA 713 4,5 mg” on the body.
- Prometax 4,5 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju crvenu kapicu i crveno tijelo, s bijelom oznakom „ENA 713 4,5 mg“ na tijelu kapsule.
How to store Prometax
Kako čuvati Prometax
• Feeling agitated
• Osjećaj omaglice
Hallucinations, restlessness, nightmares
Halucinacije, nemir, noćne more Poremećaji živčanog sustava Često
Prometax 2 mg/ml oral solution rivastigmine
Prometax 2 mg/ml oralna otopina rivastigmin
Children and adolescents There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer's disease.
Pedijatrijska populacija Nema relevantne primjene Prometaxa u pedijatrijskoj populaciji u liječenju Alzheimerove bolesti.
organizačná zložka Tel: + 421 2 4820 0600
Slovenská republika Sandoz d.d. organizačná zložka Tel: + 421 2 4820 0600
• to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrio-ventricular block) (see section 4.8);
• u bolesnika s bolešću sinusnog čvora ili smetnjama provođenja (sinus-atrijski blok,
• Uneven heartbeat and poor control of movements Other side effects seen with Prometax transdermal patches and which may occur with the hard capsules:
Ostale nuspojave zabilježene s Prometax transdermalnim flasterima a koje se mogu pojaviti s tvrdim kapsulama:
• A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches.
• Bolesnik koji primjenjuje oralni rivastigmin u dozi od 12 mg/dan može prijeći na transdermalni flaster u dozi od 9,5 mg/24 h.
• Do not store above 30°C.
• Ne čuvati na temperaturi iznad 30 C.
• Rash, itching
• Osip, svrbež
Filling the syringe
Punjenje štrcaljke
- Prometax 6.0 mg hard capsules, which contain an off-white to slightly yellow powder, have a red cap and orange body, with a red imprint “ENA 713 6 mg” on the body.
- Prometax 6,0 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju crvenu kapicu i narančasto tijelo, s crvenom oznakom „ENA 713 6 mg“ na tijelu kapsule.
• A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
• Bolesnik koji primjenjuje oralni rivastigmin u dozi od 3 mg/dan može prijeći na transdermalni flaster u dozi od 4,6 mg/24 h.
Last Observation Carried Forward
Last Observation Carried Forwardprijenos posljednjeg provedenog opažanja
Prometax 1.5 mg hard capsules
Prometax 1,5 mg tvrde kapsule
• Swallow your medicine straight from the syringe.
• Progutajte Prometax oralnu otopinu izravno iz štrcaljke.
Therefore, the ability of patients with dementia on rivastigmine to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Zbog toga odgovorni liječnik treba rutinski procijeniti sposobnost bolesnika s demencijom koji uzimaju rivastigmin, da nastave upravljati vozilima ili raditi na složenim strojevima.
The patients studied had an MMSE (Mini-Mental State Examination) score of 10-24.
MiniMental State Examination - Skraćeni pregled mentalnog stanja) od 10-20.
Prometax 3.0 mg hard capsules
Prometax 3,0 mg tvrde kapsule
• A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6 mg/24 h transdermal patches.
• Bolesnik koji primjenjuje oralni rivastigmin u dozi od 6 mg/dan može prijeći na transdermalni flaster u dozi od 4,6 mg/24 h.
Common (may affect up to 1 in 10 people)
Često (mogu se javiti u do 1 na 10 ljudi)
Prometax 1.5 mg hard capsules rivastigmine
Prometax 1,5 mg tvrde kapsule rivastigmin
Prometax 6.0 mg hard capsules rivastigmine
Prometax 6,0 mg tvrde kapsule rivastigmin
Prometax 3.0 mg hard capsules rivastigmine
Prometax 3,0 mg tvrde kapsule rivastigmin
Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “ENA 713 1,5 mg” on body.
Bjelkasti do blago žuti prašak u kapsuli sa žutom kapicom i žutim tijelom, s crvenom oznakom „ENA 713 1,5 mg“ na tijelu kapsule.
Prometax 4.6 mg/24 h transdermal patch rivastigmine
Prometax 4,6 mg/24 h transdermalni flaster rivastigmin
Prometax 6.0 mg hard capsules
Prometax 6,0 mg tvrde kapsule
- Prometax 3.0 mg hard capsules, which contain an off-white to slightly yellow powder, have an orange cap and orange body, with a red imprint “ENA 713 3 mg” on the body.
- Prometax 3,0 mg tvrde kapsule, sadrže bjelkasti do blago žuti prašak, imaju narančastu kapicu i narančasto tijelo, s crvenom oznakom „ENA 713 3 mg“ na tijelu kapsule.
Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “ENA 713 4,5 mg” on body.
Bjelkasti do blago žuti prašak u kapsuli s crvenom kapicom i crvenim tijelom, s bijelom oznakom „ENA 713 4,5 mg“ na tijelu kapsule.
• Uneven heartbeat
• Nepravilni otkucaji srca
Prometax 4.5 mg hard capsules rivastigmine
Prometax 4,5 mg tvrde kapsule rivastigmin
ITT: Intent-To-Treat; RDO: Retrieved Drop Outs
Retrieved Drop Outs - slučajevi koji su ispali, a uzeti su u obzir); LOCF (eng.
1 capsule contains 1.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
1 kapsula sadrži 1,5 mg rivastigmina u obliku rivastigminhidrogentartarata.
Prometax 4.5 mg hard capsules
Prometax 4,5 mg tvrde kapsule
Malaise
Nemir
1 capsule contains 6.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
1 kapsula sadrži 6,0 mg rivastigmina u obliku rivastigminhidrogentartarata.
Dizziness
Malaksalost
1 capsule contains 4.5 mg rivastigmine present as rivastigmine hydrogen tartrate.
1 kapsula sadrži 4,5 mg rivastigmina u obliku rivastigminhidrogentartarata.
Prometax 4.6 mg/24 h transdermal patch
Prometax 4,6 mg/24 h transdermalni flaster
Prometax 9.5 mg/24 h transdermal patch rivastigmine
Prometax 9,5 mg/24 h transdermalni flaster rivastigmin
Prometax 13.3 mg/24 h transdermal patch
Prometax 13.3 mg/24 h transdermalni flaster
Patients involved in this study had an MMSE (Mini-Mental State Examination) score of 10-24.
Ispitivani bolesnici imali su broj bodova od 10 do 24 na MMSE ljestvici (eng.
1 capsule contains 3.0 mg rivastigmine present as rivastigmine hydrogen tartrate.
1 kapsula sadrži 3,0 mg rivastigmina u obliku rivastigminhidrogentartarata.
Prometax 9.5 mg/24 h transdermal patch
Prometax 9.5 mg/24 h transdermalni flaster
Prometax 13.3 mg/24 h transdermal patch rivastigmine
Prometax 13,3 mg/24 h transdermalni flaster rivastigmin
Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “ENA 713 6 mg” on body.
Bjelkasti do blago žuti prašak u kapsuli s crvenom kapicom i narančastim tijelom, s crvenom oznakom „ENA 713 6 mg“ na tijelu kapsule.
- if you have, or have ever had, impaired liver function.
- ako imate ili ste imali poremećaj funkcije jetre. - ako imate drhtavicu.
• Heartburn
• Tjeskoba
• Too much saliva
• Prekomjerno stvaranje sline
Gait disturbance
Poremećaj hoda
• The previous day's patch must be removed before applying a new one every day (see section 4.9).
Bolesnici i njegovatelji trebaju dobiti važne upute o primjeni: • Flaster od prethodnog dana mora se ukloniti prije primjene novog flastera svakog dana (vidjeti dio
Quinoline yellow WS dye (E104) Purified water
6.1 Popis pomoćnih tvari natrijev benzoat citratna kiselina natrijev citrat boja kinolin žuta WS (E104) pročišćena voda
• Put the child resistant cap back on the bottle to close it.
• Zatvorite bocu pomoću sigurnosnog zatvarača za djecu.
The active substance of Prometax is rivastigmine.
Prometaxa je rivastigmin.
• Uneven heartbeat and poor control of movements Other side effects seen with Prometax transdermal patches and which may occur with the oral solution:
Ostale nuspojave zabilježene s Prometax transdermalnim flasterima a koje se mogu pojaviti s oralnom otopinom:
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Lek Pharmaceuticals d.d. Tel: +386 1 580 33 27
Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “ENA 713 3 mg” on body.
Bjelkasti do blago žuti prašak u kapsuli s narančastom kapicom i narančastim tijelom, s crvenom oznakom „ENA 713 3 mg“ na tijelu kapsule.
48-week active comparator controlled study
Tjedan 48 početne vrijednosti
EU/1/98/092/029 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/030 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/041 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/042 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
EU/1/98/092/029 60 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/030 90 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/041 60 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
EU/1/98/092/023 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/024 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/035 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/036 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
EU/1/98/092/023 7 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/024 30 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/035 7 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA) EU/1/98/092/036 30 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
EU/1/98/092/019 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/020 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/031 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/032 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
EU/1/98/092/019 7 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/020 30 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/031 7 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA) EU/1/98/092/032 30 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
• A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to
• Bolesnik na stabilnoj dozi od 9 mg/dan oralnog rivastigmina koju dobro podnosi može prijeći na transdermalni flaster u dozi od 9,5 mg/24 h.
EU/1/98/092/027 7 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/028 30 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/039 7 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/040 30 transdermal patches (sachet: paper/PET/PE/alu/PA)
EU/1/98/092/027 7 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/028 30 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/039 7 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA) EU/1/98/092/040 30 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
Mean data shown for convenience, categorical analysis performed using van Elteren test ITT: Intent-To-Treat; RDO: Retrieved Drop Outs; LOCF: Last Observation Carried Forward
Zbog prikladnosti su prikazani prosječni podaci, analiza po kategorijama provedena je primjenom van Elterenovog testa.
EU/1/98/092/021 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/022 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/033 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/034 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
EU/1/98/092/021 60 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/022 90 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/033 60 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA) EU/1/98/092/034 90 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
EU/1/98/092/025 60 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/026 90 transdermal patches (sachet: paper/PET/alu/PAN) EU/1/98/092/037 60 transdermal patches (sachet: paper/PET/PE/alu/PA) EU/1/98/092/038 90 transdermal patches (sachet: paper/PET/PE/alu/PA)
EU/1/98/092/025 60 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/026 90 transdermalnih flastera (vrećica: papir/PET/alu/PAN) EU/1/98/092/037 60 transdermalnih flastera (vrećica: papir/PET/PE/alu/PA)
Each ml contains rivastigmine hydrogen tartrate corresponding to 2 mg rivastigmine.
Što Prometax sadrži - Djelatna tvar je rivastigminhidrogentartarat Svaki ml sadrži rivastigminhidrogentartarat u količini koja odgovara 2,0 mg baze rivastigmina.
Dose escalation
Potporni sloj
• Some people who have been violently sick have had tearing of the tube that connects your mouth with your stomach (oesophagus)
• U nekih je bolesnika koji su imali izrazitu mučninu došlo do pucanja cijevi koja povezuje
• Fainting
• Drhtanje
• The recommended usual daily dose is Prometax 9.5 mg/24 h. If well tolerated, the treating physician may consider increasing the dose to 13.3 mg/24 h.
• Preporučena uobičajena dnevna doza je Prometax 9,5 mg/24 h.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine.
Svaka kapsula sadrži 1,5 mg rivastigmina u obliku rivastigminhidrogentartarata.
• Nightmares
• Noćne more
Following administration of
Srednja promjena nakon
Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine.
Svaka kapsula sadrži 3,0 mg rivastigmina u obliku rivastigminhidrogentartarata.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine.
Svaka kapsula sadrži 4,5 mg rivastigmina u obliku rivastigminhidrogentartarata.
Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine.
Svaka kapsula sadrži 6,0 mg rivastigmina u obliku rivastigminhidrogentartarata.
It is not for use in women and must not be given to women who are or who may be pregnant.
Nije za primjenu u žena i ne smije se davati ženama koje su trudne ili bi mogle biti trudne.
The full EPAR for Zytiga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Zytiga nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The recommended dose of Zytiga is 1,000 mg taken once a day at least two hours after eating and at least one hour before further food.
Preporučena doza lijeka Zytiga je 1 000 mg jedanput na dan najmanje dva sata nakon jela i najmanje jedan sat prije sljedećeg obroka.
Treatment may be resumed at a reduced dose if liver function returns to normal.
Liječenje se može nastaviti uz manju dozu ako se funkcija jetre vrati na normalnu razinu.
Other information about Zytiga
Ostale informacije o lijeku Zytiga
Zytiga abiraterone acetate
Zytiga abirateronacetat
Zytiga is available as tablets (250 and 500 mg) and can only be obtained with a prescription.
Lijek Zytiga dostupan je u obliku tableta (od 250 i 500 mg) te se izdaje samo na liječnički recept.
The European Commission granted a marketing authorisation valid throughout the European Union for Zytiga on 5 September 2011.
Europska komisija izdala je odobrenje za stavljanje u promet lijeka Zytigakoje vrijedi na prostoru Europske unije od 5. rujna 2011.
This is a summary of the European public assessment report (EPAR) for Zytiga.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Zytiga.
What measures are being taken to ensure the safe and effective use of Zytiga?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zytiga?
The main measure of effectiveness was how long patients lived without their disease getting worse.
Glavno mjerilo djelotvornosti bilo je razdoblje preživljenja bez pogoršanja bolesti.
What is Zytiga and what is it used for?
Što je Zytiga i za što se koristi?
It is not intended to provide practical advice on how to use Zytiga.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Zytiga.
Zytiga must not be used in patients with severely reduced liver function.
Lijek Zytiga ne smiju uzimati bolesnici sa znatno smanjenom jetrenom funkcijom.
Other important side effects include heart problems, liver problems, fractures and allergic alveolitis (a lung reaction causing cough and shortness of breath).
Druge važne nuspojave uključuju probleme sa srcem, probleme s jetrom, prijelome i alergijski alveolitis (reakcija pluća koja uzrokuje kašalj i otežano disanje).
Zytiga is a medicine used to treat cancer of the prostate (a gland of the male reproductive system) in adult men when the cancer is metastatic (has spread to other parts of the body).
Zytiga je lijek koji se primjenjuje za liječenje raka prostate (muške spolne žlijezda) u odraslih muškaraca kada je rak metastazirao (proširio se na druge dijelove tijela).
If patients develop liver problems treatment should be stopped.
Ako se u bolesnika pojave problemi s jetrom, liječenje treba prekinuti.
Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body.
Abirateron to čini inhibirajući djelovanje enzima CYP17 koji je prisutan u testisima i drugdje u tijelu.
The European Medicines Agency decided that Zytiga's benefits are greater than its risks and recommended that it be approved for use in the EU.
Europska agencija za lijekove zaključila je da koristi lijeka Zytiga nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za njegovu primjenu u EU-u.
The Agency noted that Zytiga in combination with prednisone or prednisolone has been shown to either delay progression of the disease or improve survival compared with placebo.
Agencija je napomenula da se lijek Zytiga u kombinaciji s prednizonom ili prednizolonom pokazao djelotvornim u usporavanju napretka bolesti ili povećanju preživljenja u usporedbi s placebom.
What are the risks associated with Zytiga?
Koji su rizici povezani s lijekom Zytiga?
In a third study involving 1,195 men with metastatic prostate cancer whose disease had got worse despite surgical or medical castration treatment and chemotherapy with docetaxel, the main measure of effectiveness was overall survival (how long the patients lived).
U trećem ispitivanju kojim je bilo obuhvaćeno 1 195 muškaraca s metastatskim rakom prostate, a čija se bolest pogoršala unatoč kirurškoj ili medicinskoj kastraciji i kemoterapiji docetakselom, glavno mjerilo djelotvornosti bilo je ukupno preživljenje (koliko su dugo bolesnici živjeli).
• when the cancer is newly diagnosed, high risk and still sensitive to hormones; Zytiga is then used in combination with a treatment called androgen deprivation therapy;
• ako je riječ o raku koji je nedavno dijagnosticiran, visokorizičan i još uvijek osjetljiv na hormone; Zytiga se tada primjenjuje u kombinaciji s terapijom deprivacije androgena;
• when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.
• ako medicinska ili kirurška kastracija i kemoterapija koja sadržava docetaksel nisu djelovale ili više ne djeluju.
Zytiga is used together with the medicines prednisone or prednisolone in the following situations:
Zytiga se primjenjuje u kombinaciji s prednizonom ili prednizolonom u sljedećim situacijama:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zytiga have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zytiga nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
Zytiga was compared with placebo (a dummy treatment) in three main studies.
Lijek Zytiga uspoređen je s placebom (prividnim liječenjem) u trima glavnim ispitivanjima.
Why is Zytiga approved?
Zašto je lijek Zytiga odobren?
• when medical castration (using medicines to stop the production of male hormones) with an androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);
• ako medicinska kastracija (primjena lijekova kako bi se zaustavilo stvaranje muških hormona) u kombinaciji s terapijom deprivacije androgena nije djelovala ili više ne djeluje u muškaraca koji nemaju simptoma bolesti ili su ti simptomi blagi, a kojima još nije potrebna kemoterapija (lijekovi protiv raka);
The most common side effects with Zytiga (seen in more than 1 patient in 10) are urinary tract infection, hypokalaemia (low blood potassium levels), high blood pressure, peripheral oedema (swelling of the limbs due to fluid retention) and increases in liver enzymes.
Najčešće su nuspojave lijeka Zytiga (zabilježene u više od 1 na 10 bolesnika) infekcije mokraćnih putova, hipokalemija (niske razine kalija u krvi), visok krvni tlak, periferni edem (oticanje udova uslijed zadržavanja tekućine) i povišene razine jetrenih enzima.
The active substance in Zytiga, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone.
Djelatna tvar lijeka Zytiga, abirateronacetat, u tijelu se pretvara u abirateron, koji zaustavlja stvaranje muškog spolnog hormona testosterona.