natgillin/translations-raw huggingface dataset:
Common: nausea, vomiting, abdominal pain, diarrhoea Rare: rises in serum amylase, pancreatitis
bol u abdomenu, proljev Rijetko: porast vrijednosti amilaza u serumu, pankreatitis
ANTIFUNGALS Fluconazole/Abacavir
ANTIMIKOTICI flukonazol/abakavir
HLA-B*5701 screening for risk of ABC hypersensitivity should never be substituted for appropriate clinical vigilance and patient management in individuals receiving ABC.
ABC preosjetljivost nikad ne smije biti zamjena za odgovarajuće kliničko praćenje i zbrinjavanje osoba koje uzimaju ABC.
Atovaquone/Zidovudine (750 mg twice daily with food/200 mg thrice daily)
atovakon/zidovudin (750 mg dva puta na dan uz obrok/200 mg tri puta na dan)
The malformative risk is unlikely in humans based on the mentioned moderate amount of data.
rizik od malformacija kod ljudi je malo vjerojatan.
• if you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia) Check with your doctor if you think any of these apply to you.
• ako imate vrlo nizak broj crvenih krvnih stanica (anemija) ili vrlo nizak broj bijelih krvnih stanica (neutropenija).
Retinoid compounds (e.g. isotretinoin)/Lamivudine No drug interaction studies
spojevi retinoida (npr. izotretinoin)/lamivudin Nema studija interakcije.
• wind (flatulence)
• vjetrovi (nadutost) • svrbež
Rare: cardiomyopathy
Rijetko: kardiomiopatija
Trimethoprim/sulfamethoxazole (Co-trimoxazole)/Abacavir
trimetoprim/sulfametoksazol (kotrimoksazol)/abakavir
Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Ispitivanja na bolesnicima s oštećenjem funkcije bubrega pokazuju da disfunkcija bubrega utječe na eliminaciju lamivudina.
Lactic acidosis is a rare but serious side effect Some people taking Trizivir develop a condition called lactic acidosis, together with an enlarged liver.
Neki ljudi koji uzimaju Trizivir razvijaju stanje koje se zove laktacidoza, zajedno s povećanjem jetre.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARTON x 60 FILM-COATED TABLETS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER x 60 FILMOM OBLOŽENIH
One randomised, double blind, placebo controlled clinical study has compared the combination of abacavir, lamivudine and zidovudine to the combination of indinavir, lamivudine and zidovudine in treatment naive patients.
Kombinacija abakavira, lamivudina i zidovudina ispitivana je u usporedbi s kombinacijom indinavira, lamivudina i zidovudina tijekom jednog randomiziranog, dvostruko slijepog, placebom kontroliranog ispitivanja prethodno neliječenih bolesnika.
• After stopping treatment with Trizivir for reasons of a suspected HSR, Trizivir or any other medicinal product containing abacavir (e.g. Kivexa, Ziagen, Triumeq) must never be reinitiated.
• Nakon prekida liječenja lijekom Trizivir zbog suspektne reakcije preosjetljivosti, nikada se ne smije ponovno započeti liječenje lijekom Trizivir niti bilo kojim drugim lijekom koji sadrži abakavir (npr. Kivexa, Ziagen, Triumeq).
• if you have moderate or severe liver disease
Morate biti svjesni dodatnih rizika: • ako imate umjerenu ili tešku bolest jetre
Anaemia, neutropenia and leucopenia occurred more frequently at higher doses (1,200-1,500 mg/day) and in patients with advanced HIV disease (especially when there is poor bone marrow reserve prior to treatment) and particularly in patients with CD4 cell counts less than 100/mm3.
mg/dan), kao i u bolesnika s uznapredovalom HIV bolešću (posebice kada je rezerva koštane srži bila slaba i prije početka liječenja), naročito u bolesnika s brojem CD4 stanica manjim od 100/mm3.
Ethanol/Zidovudine
etanol/zidovudin
MARKETING AUTHORISATION NUMBER(S) EU/1/00/156/002 PCTFE/PVC-Al EU/1/00/156/004 PVC/PCTFE/PVC-Al/Paper
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/156/002 PCTFE/PVC-Al
Symptoms related to this HSR worsen with continued therapy and can be life- threatening and in rare instance, have been fatal.
Mokraćni sustav povišene razine kreatinina, zatajenje bubrega Simptomi povezani s tom reakcijom preosjetljivosti pogoršavaju se s nastavkom liječenja i mogu ugroziti život, a u rijetkim su slučajevima imali smrtni ishod.
Therefore, as dose adjustments of these may be necessary, it is recommended that separate preparations of abacavir, lamivudine and zidovudine be administered to patients with reduced renal function (creatinine clearance ≤ 50 ml/min).
Budući da bi možda bilo nužno prilagoditi doze navedenih lijekova u bolesnika sa smanjenom funkcijom bubrega (klirens kreatinina ≤ 50 ml/min), kod njih se preporučuje primjena odvojenih pripravaka abakavira, lamivudina i zidovudina.
The study Data Safety Monitoring Board stopped the ZDV/3TC/ABC arm at this time based on the higher proportion of patients with virologic failure.
Povjerenstvo za praćenje sigurnosti ispitivanja, temeljem većeg udjela bolesnika s virološkim neuspjehom, u tom trenutku obustavilo je daljnje sudjelovanje u ispitivanju skupine ZDV/3TC/ABC.
MARKETING AUTHORISATION NUMBER(S) EU/1/00/156/002 - opaque white PCTFE/PVC-Al Blister pack (60 Tablets) EU/1/00/156/003 -Bottle pack (60 Tablets)
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/156/002 - PCTFE/PVC/Al blister pakiranje (60 tableta)
30% of the body surface (toxic epidermal necrolysis) If you notice any of these symptoms contact a doctor urgently.
30% površine tijela (toksična epidermalna nekroliza).
Drug Interactions:
Interakcije s lijekovima
Treatment with Trizivir should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Ako se jave klinički znakovi, simptomi ili abnormalni laboratorijski nalazi koji upućuju na pankreatitis, liječenje lijekom Trizivir treba odmah prekinuti.
- shortness of breath, sore throat or cough
- nedostatak daha, grlobolja ili kašalj
Abacavir is metabolised by UDP-glucuronyltransferase (UGT) enzymes and alcohol dehydrogenase; co-administration of inducers or inhibitors of UGT enzymes or with compounds eliminated through alcohol dehydrogenase could alter abacavir exposure.
Istodobna primjena s induktorima ili inhibitorima UGT enzima ili spojeva koji se eliminiraju putem alkoholdehidrogenaze može utjecati na samu izloženost abakaviru.
Stavudine/Abacavir
stavudin/abakavir
After a median follow-up of 144 weeks, 25 % of subjects on the ZDV/3TC/ABC/EFV arm and 26 % on the ZDV/3TC/EFV arm were categorised as having virological failure.
ZDV/3TC/ABC/EFV i 26% u terapijskoj grani ZDV/3TC/EFV kategorizirano je kao skupina s virološkim neuspjehom.
Probenecid/Lamivudine
probenecid/lamivudin
After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/3TC/ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26 % of subjects on the ZDV/3TC/ABC arm, 16 % on the ZDV/3TC/EFV arm and 13 % on the 4 drug arm categorised as having virological failure (HIV RNA >200 copies/ml).
100 000 kopija/ml) s 26% ispitanika u terapijskoj skupini ZDV/3TC/ABC, 16% u terapijskoj skupini ZDV/3TC/EFV i 13% u skupini koja je primala 4 lijeka koji su kategorizirani je kao virološki neuspjeh (HIV RNA >200 kopija/ml).
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORAN (NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Very Rare : lactic acidosis
Vrlo rijetko: laktacidoza
Major symptoms associated with ABC HSR are fever (~80%), rash (~70%), gastrointestinal symptoms (>50%) such as nausea, abdominal pain, vomiting, and diarrhoea, generalise malaise, fatigue, and headache (~50%) and other symptoms (~30%) such as respiratory, mucosal, and musculoskeletal symptoms.
(>50%) kao što su mučnina, bol u abdomenu, povraćanje i proljev, opća malaksalost, umor i glavobolja (~50%) i ostali simptomi (~30%) kao što su respiratorni simptomi, simptomi povezani sa sluznicom, te mišićno-koštani simptomi.
Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine (see section 4.8).
Istodobna terapija, osobito akutna terapija s potencijalno nefrotoksičnim ili mijelosupresivnim lijekovima (npr. sistemski pentamidin, dapson, pirimetamin, kotrimoksazol, amfotericin, flucitozin,
Rare side effects that may show up in blood tests are:
Rijetke nuspojave koje se mogu pokazati u krvnim pretragama:
Some medicines can make it more likely that you will have side effects, or make side effects worse These include:
Neki lijekovi mogu povećati mogućnost razvoja nuspojava ili pogoršati postojeće nuspojave
- severe tiredness or achiness or generally feeling ill
- izrazit umor ili tupa bol ili opći osjećaj bolesti
Care must be taken to eliminate the possibility of a hypersensitivity reaction if any of these symptoms occur.
Ako se pojavi bilo koji od navedenih simptoma, s oprezom je potrebno isključiti mogućnost da se radi o reakciji preosjetljivosti.
Single doses up to 1,200 mg and daily doses up to 1,800 mg of abacavir have been administered to patients in clinical studies.
U kliničkim ispitivanjima bolesnici su primili jednokratne doze abakavira do 1200 mg te dnevne doze do 1800 mg.
Abacavir, lamivudine and zidovudine are all NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2.All three medicinal products are metabolised sequentially by intracellular kinases to the respective 5′-triphosphate (TP).
Abakavir, lamivudin i zidovudin su inhibitori nukleozid reverzne transkriptaze (NRTI) te su snažni selektivni inhibitori virusa HIV-1 i HIV-2.
To date there are insufficient data on the efficacy and safety of Trizivir given concomitantly with NNRTIs or PIs.
Do danas ne postoji dovoljno podataka o djelotvornosti i sigurnosti istovremene primjene lijeka Trizivir s nenukleozidnim inhibitorima reverzne transkriptaze (NNRTI) i inhibitorima proteaze (PI).
Didanosine/Zidovudine
didanozin/zidovudin
Valproic acid/Abacavir
valproična kiselina/abakavir
Drugs by Therapeutic Area Interaction Geometric mean change
Interakcija geometrijska sredina promjene (%)
Active renal secretion of lamivudine in the urine is mediated through organic cation transporters (OCTs); co-administration of lamivudine with OCT inhibitors may increase lamivudine exposure.
Aktivna renalna sekrecija lamivudina u urin je posredovana putem transportera organskog kationa (OCT).
Many of the adverse reactions listed in the table occur commonly (nausea, vomiting, diarrhoea, fever, lethargy, rash) in patients with abacavir hypersensitivity.
Mnoge od nuspojava navedenih u tablici javljaju se često (mučnina, povraćanje, proljev, vrućica,
Adverse reactions have been reported with abacavir, lamivudine and zidovudine used separately or in combination for therapy of HIV disease.
Prijavljene su nuspojave tijekom liječenja HIV bolesti abakavirom, lamivudinom i zidovudinom kao zasebnim lijekovima ili u kombinaciji.
Rifampicin/Zidovudine (600mg once daily/200 mg thrice daily)
rifampicin/zidovudin (600 mg jednom dnevno/200 mg tri puta na dan)
Number of Subjects Number of Virological Failures Number of On-Therapy Genotypes K65R L74V Y115F M184V/I TAMs1 1.
K65R L74V Y115F M184V/I TAM1 1. Broj bolesnika s ≥1 mutacijom analoga timidina (TAMs, "Thymidine Analogue Mutations").
To date there are insufficient data on the efficacy and safety of Trizivir given concomitantly with NNRTIs or PIs (see section 5.1).
Do danas nema dovoljno podataka o djelotvornosti i sigurnosti istovremene primjene lijeka Trizivir s nenukleozidnim inhibitorima reverzne transkriptaze (NNRTI) i inhibitorima proteaze (PI) (vidjeti dio
The active substances in each Trizivir film-coated tablet are 300 mg of abacavir (as sulfate), 150 mg lamivudine and 300 mg zidovudine.
Djelatne tvari u jednoj Trizivir filmom obloženoj tableti su 300 mg abakavira (u obliku abakavirsulfata), 150 mg lamivudina i 300 mg zidovudina.
Phenobarbital/Lamivudine
fenobarbital/lamivudin
Trizivir 300 mg/150 mg/300 mg film-coated tablets abacavir/lamivudine/zidovudine
Trizivir 300 mg/150 mg/300 mg tablete abakavir/lamivudin/zidovudin
Diagnosis of Abacavir Hypersensitivity Reaction
• Klinički opis reakcije preosjetljivosti na abakavir
Some medicines interact with Trizivir These include:
Neki lijekovi imaju interakciju s lijekom Trizivir
Clinically significant reduction of susceptibility to abacavir has been demonstrated in clinical isolates of patients with uncontrolled viral replication, who have been pre-treated with and are resistant to other nucleoside inhibitors.
U kliničkim izolatima bolesnika s nekontroliranom replikacijom virusa koji su prethodno liječeni drugim inhibitorima nukleozida i koji su rezistentni na njih, zabilježeno je klinički značajno smanjenje osjetljivosti na abakavir.
Fluconazole/Lamivudine
flukonazol/lamivudin
Very rarely, patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
Vrlo se rijetko reakcija preosjetljivosti razvila u bolesnika koji su ponovno počeli uzimati lijekove koji sadrže abakavir, a nisu imali nijedan simptom preosjetljivosti tijekom prethodne primjene tih lijekova.
Anaemia, neutropenia and leucopenia (usually secondary to neutropenia) can be expected to occur in patients receiving zidovudine.
U bolesnika koji primaju zidovudin mogu se očekivati anemija, neutropenija i leukopenija (obično kao posljedica neutropenije).
Lactic acidosis
Hematološki simptomi limfopenija
Valproic acid/Zidovudine (250 mg or 500 mg thrice daily/100 mg thrice daily)
valproična kiselina/zidovudin (250 mg ili 500 mg tri puta na dan/100 mg tri puta na dan)
No studies on the effects on the ability to drive and use machines have been performed.
Nisu se provedena ispitivanja o učincima abakavira, lamivudina i zidovudina na sposobnost upravljanja vozilima i rada sa strojevima.
Common: malaise Uncommon: fever, generalised pain and asthenia Rare: chills, chest pain, and influenza-like syndrome
Rijetko: zimica, bolovi u prsnom košu i sindrom nalik na gripu
Didanosine/Lamivudine
didanozin/lamivudin
Zidovudine is primarily metabolised by UGT enzymes; co-administration of inducers or inhibitors of UGT enzymes could alter zidovudine exposure.
Istodobna primjena s induktorima ili inhibitorima UGT enzima može utjecati na samu izloženost zidovudinu.
The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy and confers high-level resistance to lamivudine.
Rezistencija in vivo (prethodno liječeni bolesnici): u bolesnika zaraženih HIV-1 koji su primali antiretrovirusnu terapiju koja uključuje lamivudin i koji pokazuju visoku rezistenciju na lamivudin dolazi do stvaranja varijanti M184V ili M184I.
Fluconazole/Zidovudine (400 mg once daily/200 mg thrice daily)
flukonazol/zidovudin (400 mg jednom dnevno/200 mg tri puta na dan)
Common side effects that may show up in blood tests are:
Česte nuspojave koje se mogu pokazati u krvnim pretragama:
• phenytoin, for treating epilepsy Tell your doctor if you are taking phenytoin.
Obavijestite svog liječnika ako uzimate fenitoin.
Lamivudine
• proljev
ANTIRETROVIRAL MEDICINAL PRODUCTS Didanosine/Abacavir
LIJEKOVI didanozin/abakavir
• diarrhoea
• utrnulost
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Zabilježeni su slučajevi osteonekroze, osobito u bolesnika s opće poznatim faktorima rizika,
A bioequivalence study compared Trizivir with abacavir 300 mg, lamivudine 150 mg and zidovudine 300 mg taken together.
Ispitivanje bioekvivalencije uspoređivalo je Trizivir s istodobno uzetim abakavirom 300 mg,
• feeling breathless
• osjećaj omaglice
• if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavirKivexa, Triumeq or Ziagen), lamivudine or zidovudine, or any of the other ingredients of this medicine (listed in Section 6) Carefully read all the information about hypersensitivity reactions in Section 4.
Triumeq ili Ziagen), lamivudin ili zidovudin, ili neki drugi sastojak ovog lijeka (naveden u dijelu
• stiffness in the joints
• bol u zglobu
Tel: + 34 902 051 260
Laboratorios ViiV Healthcare, S.L. Tel: + 34 902 051 260
Very rare side effects
Vrlo česte nuspojave
GlaxoSmithKline Pharmaceuticals S.A. ul.
GlaxoSmithKline Pharmaceuticals S.A. ul. Grunwaldzka 189
In antiretroviral-naive patients treated with a combination of abacavir, lamivudine, zidovudine and efavirenz in a small, ongoing, open label pilot study, the proportion of patients with undetectable viral load (< 400 copies/ml) was approximately 90 % with 80 % having < 50 copies/ml after 24 weeks of treatment.
(< 400 kopija/ml) nakon 24 tjedna liječenja s kombinacijom abakavira, lamivudina, zidovudina i efavirenza bio je oko 90% od čega je 80% imalo < 50 kopija/ml.
Uncommon: thrombocytopenia and pancytopenia with marrow hypoplasia
Manje često: trombocitopenija i pancitopenija s hipoplazijom koštane srži
ANTICONVULSANTS Phenobarbital/Abacavir
LIJEKOVI fenobarbital/abakavir
Gastrointestinal disorders Common: nausea, vomiting, diarrhoea
Poremećaji probavnog sustava Često: mučnina, povraćanje,
Retinoid compounds (e.g. isotretinoin)/Zidovudine
spojevi retinoida (npr. izotretinoin)/zidovudin
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL x 60 FILM-COATED TABLETS
NALJEPNICA ZA BOČICU x 60 FILMOM OBLOŽENIH
Atovaquone/Lamivudine
atovakon/lamivudin
NAME OF THE MEDICINAL PRODUCT Trizivir 300 mg/150 mg/300 mg film-coated tablets abacavir/lamivudine/zidovudine
Trizivir 300 mg/150 mg/300 mg filmom obložene tablete abakavir/lamivudin/zidovudin
• if you are seriously overweight (especially if you are a woman) Talk to your doctor if any of these apply to you before using Trizivir.
• ako ste izrazite prekomjerne tjelesne težine (posebice ako ste žena)
Appropriate use of abacavir can be guided using currently recommended resistance algorithms.
Za pravilnu primjenu abakavira i lamivudina potrebno je slijediti važeće algoritme rezistencije.
These medicines should not be used with Trizivir: • stavudine or emtricitabine, to treat HIV infection
• stavudin ili emtricitabin, za liječenje infekcije HIV-om
The safety and efficacy of Trizivir has not been established in patients with significant underlying liver disorders.
U bolesnika s ozbiljnom predležećom bolešću jetre nije ustanovljena sigurnost primjene i djelotvornost lijeka Trizivir.
Lymphopenia
Lipoatrofija
• Trizivir should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavir-containing regimen.
• Liječenje lijekom Trizivir ne smije se nikada započeti u bolesnika s pozitivnim HLA-B*5701
Renal impairment
Lamivudin zidovudin
Nervous system disorders Common: headache
Poremećaji živčanog sustava
• development of 1 or more symptom from at least 2 of the following groups: - Fever - Shortness of breath, sore throat or cough - Nausea or vomiting or diarrhoea or abdominal pain - Extreme tiredness or achiness or generally ill feeling
• razvoja 1 ili više simptoma iz najmanje 2 od sljedećih grupa: - vrućica
Teл.
HIV-a.
An uncommon side effect that may show up in blood tests is:
Manje česta nuspojava koja se može pokazati u krvnim pretragama:
Musculoskeletal
Hematološke nuspojave
Interactions involving binding site displacement are not anticipated with Trizivir.
Kod lijeka Trizivir se ne očekuju interakcije koje uključuju istiskivanje s veznog mjesta.
Patients should be regularly assessed for signs of lipoatrophy during therapy with zidovudine and zidovudine-containing products (Combivir and Trizivir).
Tijekom liječenja zidovudinom i lijekovima koji sadrže zidovudin (Combivir i Trizivir), bolesnike valja redovito ocjenjivati na znakove lipoatrofije.
Hypersensitivity Reactions (see also section 4.8 ):
a ne zbog simptoma reakcija preosjetljivosti (vidjeti dio 4.8 “Opis odabranih nuspojava”).
Therapy
trizivir
The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
U bolesnika zaraženih HIV-1, koji su primali antiretrovirusnu terapiju koja uključuje lamivudin, dolazi do stvaranja varijanti M184V ili M184I.
The clinical relevance of these findings is not established.
Klinički značaj ovih nalaza nije utvrđen.
Immune system disorders Common: hypersensitivity Metabolism and nutrition disorders Common: anorexia Very Rare : lactic acidosis
Poremećaji dišnog sustava, prsišta i sredoprsja Često: kašalj, nazalni simptomi Manje često:dispneja Rijetko: kašalj
Zidovudine
Trizivir
Moderate amount of data (more than 600 outcomes from first trimester)
Umjerena količina podataka (više od 600 ishoda za izloženost tijekom prvog trimestra) upućuje da ne postoji malformacijska toksičnost za abakavir.
A very rare side effect that may show up in blood tests is:  a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia)
 zatajenje stvaranja novih crvenih ili bijelih krvnih stanica iz koštane srži (aplastična anemija).
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Ako se bilo koja od nuspojava pogorša ili Vam smeta, ili ako primijetite neku nuspojavu koja nije navedena u ovoj uputi, potrebno je obavijestiti liječnika ili ljekarnika.
• if they are overweight
• ako su pretili.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON x 60 FILM COATED TABLETS
KUTIJA ZA BOČICU x 60 FILMOM OBLOŽENIH
Pharmaceutical Form
(Zaštićeno) ime Doza
Date of first authorisation: 29/01/2010 Date of latest renewal: 18/09/2014
Datum prvog odobrenja: 29/01/2010 Datum posljednje obnove odobrenja: 18/09/2014
The absolute bioavailability is approximately 32%.
Apsolutna bioraspoloživost iznosi približno 32 %.
• Do not give this medicine to children and adolescents below 18 years since there is no relevant indication for this age group.
Nemojte davati ovaj lijek djeci i adolescentima u dobi manjoj od 18 godina, budući da u toj dobnoj skupini ne postoji odgovarajuća indikacija.
• Fast or irregular heart beats (called palpitations)
• brzi ili nepravilni otkucaji srca (zvani palpitacije)
• Fainting/ Loss of consciousness
• nesvjestica / gubitak svijesti
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate,, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Very rare side effects (may affect up to 1 in 10,000 people) • Other allergic reactions with swelling of the face or throat
Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba) • druge alergijske reakcije s oticanjem lica ili grla
Food decreases Cmax by approximately 30%, increases tmax by approximately 1 hour and has little effect on AUC.
Hrana smanjuje Cmax za približno 30 %, povećava tmax za približno 1 sat i ima malo učinka na AUC.
If you take more Silodyx than you should
Ako uzmete više Silodyx nego što ste trebali
Difference (95% CI) vs placebo
Razlika (95 % CI) u odnosu na placebo
Talk to your doctor or pharmacist before taking Silodyx
Obratite se svom liječniku ili ljekarniku prije nego uzmete Silodyx.
Exposure to silodosin and its main metabolites does not change significantly with age, even in subjects of age over 75 years.
Izloženost silodozinu i njegovim glavnim metabolitima ne mijenja se značajno s dobi, čak niti u ispitanika starijih od 75 godina.
* p < 0.001 vs Placebo;°p = 0.002 vs Placebo
* p < 0,001 u odnosu na placebo; ° p = 0,002 u odnosu na placebo
Contents of the pack and other information What Silodyx contains
Sadržaj pakiranja i druge informacije Što Silodyx sadrži
5 hard capsules 10 hard capsules 20 hard capsules 30 hard capsules 50 hard capsules 90 hard capsules 100 hard capsules
5 tvrdih kapsula 10 tvrdih kapsula 20 tvrdih kapsula 30 tvrdih kapsula 50 tvrdih kapsula 90 tvrdih kapsula 100 tvrdih kapsula
Other medicines and Silodyx
Drugi lijekovi i Silodyx