natgillin/translations-raw huggingface dataset:
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Nositelj odobrenja će provoditi ispitivanja i dodatne aktivnosti predviđene Farmakovigilancijskim planom, kako je dogovoreno RMP-om prikazanim u Modulu 1.8.2 odobrenja za stavljanje gotovog lijeka u promet te sve daljnje dopune RMP-a dogovorene od strane Povjerenstva za humane lijekove (CHMP).
This medicine does not require any special storage precautions.
Lijek ne zahtijeva posebne uvjete čuvanja.
What Pioglitazone Accord looks like and contents of the pack
Kako Pioglitazone Accord izgleda i sadržaj pakiranja
• if you have cysts on your ovaries (polycystic ovary syndrome).
• ako imate ciste na jajnicima (sindrom policističnih jajnika).
Postmarketing, bone fractures have been reported in both male and female patients (see section 4.4).
Slučajevi prijeloma kostiju nakon stavljanja lijeka u promet zabilježeni su i u muškaraca i žena (vidjeti dio 4.4).
Pioglitazone Accord tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Tablete Pioglitazone Accord sadrže laktozu hidrat te se stoga ne smiju primjenjivati u bolesnika s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcijom glukoze-galaktoze.
Pioglitazone Accord is available in Aluminium/Aluminium blister packs containing 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Pioglitazone Accord je dostupan u aluminij/aluminij blister pakiranjima s 14, 28, 30, 50, 56, 84, 90, 98, 112 ili 196 tableta.
Environmental Risk Assessment (ERA): No environmental impact is anticipated from the clinical use of pioglitazone.
Procjena rizika za okoliš: Ne očekuje se utjecaj na okoliš tijekom kliničke primjene pioglitazona.
• The risk of bladder cancer and relevant risk minimisation advice.
• Rizik od karcinoma mokraćnog mjehura i odgovarajuće savjete o smanjivanju rizika.
Pioglitazone Accord contains pioglitazone.
Pioglitazone Accord sadrži pioglitazon.
The usual starting dose is one tablet of 15 mg or of 30 mg of pioglitazone to be taken once daily.
Uobičajena početna doza je jedna tableta od 15 mg ili 30 mg pioglitazona jedanput na dan.
Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
- Pioglitazon je također indiciran u kombinaciji s inzulinom u odraslih bolesnika sa šećernom bolešću tipa 2 i nedostatnom kontrolom glikemije pomoću inzulina u kojih je metformin neprikladan zbog kontraindikacija ili nepodnošljivosti (vidjeti dio 4.4).
common common common common common blood creatine phosphokinase increased common increased lactic dehydrogenase uncommon alanine aminotransferase increased 7
povišena kreatin fosfokinaza u krvi povišena laktična dehidrogenaza manje često aminotransferaza7 nepoznato nepoznato nepoznato nepoznato nepoznato
- hypersensitivity to the active substance or to any of the excipients listed in 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
- preosjetljivošću na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 - zatajenjem srca ili anamnezom zatajenja srca (NYHA stadiji I do IV) - oštećenjem funkcije jetre - dijabetičkom ketoacidozom - postojećim ili preboljenim karcinomom mokraćnog mjehura - neispitanom makroskopskom hematurijom.
The other side effects that have been experienced by some patients when Pioglitazone Accord is taken with other antidiabetic medicines:
Druge nuspojave koje su neki bolesnici osjetili kod uzimanja lijeka Pioglitazone Accord s drugim antidijabetičkim lijekovima su:
• The active substance in Pioglitazone Accord is pioglitazone.
• Djelatna tvar u lijeku Pioglitazone Accord je pioglitazon.
Combination with with sulpho with with insulin therapy metformin nylurea metformin and sulphonylurea
Kombinacija s metforminom sa sulfonilurejom s metforminom i sulfonilurejom s inzulinom
Pioglitazone Accord 15 mg tablets: 3 years Pioglitazone Accord 30 mg/ 45 mg tablets: 4 years
Pioglitazone Accord 15 mg tablete: 3 godine Pioglitazone Accord 30 mg/ 45 mg tablete: 4 godine
Marketing Authorisation Holder: Accord Healthcare S.L.U.
Nositelj odobrenja za stavljanje gotovog lijeka u promet Accord Healthcare S.L.U.
The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Učinak pioglitazona (monoterapija dozom od 45 mg naspram placeba) ispitivao se u malom ispitivanju u trajanju od 18 tjedana u bolesnika sa šećernom bolešću tipa
NAME OF THE MARKETING AUTHORISATION HOLDER Accord (Logo)
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Accord (Logo) ROK VALJANOSTI
Conditions or restrictions with regard to the safe and effective use of the medicinal product
Uvjeti ili ograničenja vezani uz sigurnu i učinkovitu primjenu lijeka
common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
često (mogu se pojaviti u od 1 do 10 na 100 osoba) - infekcija dišnih puteva - poremećen vid - povećanje tjelesne težine - utrnulost manje često (mogu se pojaviti u od 1 do 10 na 1000 osoba) - upala sinusa (sinusitis) - poteškoće sa spavanjem (nesanica)
What Pioglitazone Accord contains
Što Pioglitazone Accord sadrži
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Pioglitazone Accord and have also been reported in male patients (frequency cannot be estimated from the available data) taking Pioglitazone Accord.
Prijelomi kostiju često (može se pojaviti u od 1 do 10 na 100 osoba) su zabilježeni u žena koje su uzimale Pioglitazone Accord, kao i u muškaraca (učestalost nije moguće utvrditi iz dostupnih podataka) koji su uzimali Pioglitazone Accord.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Accord and insulin experienced the development of heart failure.
U nekih bolesnika koji su dugo imali šećernu bolest tipa 2 i srčanu bolest ili su preboljeli moždani udar, a liječili su se lijekom Pioglitazone Accord i inzulinom došlo je do zatajenja srca.
If you stop taking Pioglitazone Accord
Ako prestanete uzimati Pioglitazone Accord
If you forget to take Pioglitazone Accord
Ako ste zaboravili uzeti Pioglitazone Accord
METHOD AND ROUTE (S) OF ADMINISTRATION
NAČIN I PUT(EVI) PRIMJENE LIJEKA
Each tablet contains 111.70 mg of lactose monohydrate (see section 4.4).
Jedna tableta sadrži 111,70 mg laktoze hidrata (vidjeti dio 4.4).
How to take Pioglitazone Accord
Kako uzimati Pioglitazone Accord
• The other ingredients are lactose monohydrate, carmellose calcium, hydroxypropyl cellulose (E
• Ostali sastojci su laktoza hidrat, karmelozakalcij, hidroksipropilceluloza (E 465) i magnezijev stearat (E 572).
Each tablet contains 37.24 mg of lactose monohydrate (see section 4.4).
Jedna tableta sadrži 37,24 mg laktoze hidrata (vidjeti dio 4.4).
Each tablet contains 74.46 mg of lactose monohydrate (see section 4.4).
Jedna tableta sadrži 74,46 mg laktoze hidrata (vidjeti dio 4.4).
Pioglitazone Accord 15 mg tablets Pioglitazone Accord 30 mg tablets Pioglitazone Accord 45 mg tablets
Pioglitazone Accord 15 mg tablete Pioglitazone Accord 30 mg tablete Pioglitazone Accord 45 mg tablete
Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Zatajenje srca uz primjenu pioglitazona zabilježeno je nakon stavljanja lijeka u promet i bilo je češće kad se pioglitazon primjenjivao u kombinaciji s inzulinom ili u bolesnika sa zatajenjem srca u anamnezi.
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) in patients taking Pioglitazone Accord.
Karcinom mokraćnog mjehura manje je često (može se pojaviti u od 1 do 10 na 1000 osoba) nastao u bolesnika koji uzimaju Pioglitazone Accord.
How to store Pioglitazone Accord
Kako čuvati Pioglitazone Accord
There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Accord.
Kad uzimate Pioglitazone Accord, možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Infekcije i infestacije Infekcije gornjih dišnih puteva bronhitis sinusitis manje često manje često manje često manje često manje često
Your doctor may increase the dose to a maximum of 45 mg once a day.
Vaš liječnik može povećati dozu na najviše 45 mg jedanput dnevno. liječnik će Vam reći koju dozu trebate uzimati.
as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is in appropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin
kao dvojna peroralna terapija u kombinaciji s - metforminom, u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) s nedostatnom kontrolom glikemije usprkos monoterapiji metforminom u najvećoj podnošljivoj dozi - sulfonilurejom, samo u odraslih bolesnika s nepodnošenjem metformina ili u kojih je metformin kontraindiciran, s nedostatnom kontrolom glikemije usprkos monoterapiji sulfonilurejom u najvećoj podnošljivoj dozi.
Pioglitazone Accord contains lactose monohydrate If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Pioglitazone Accord.
Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije nego što uzmete Pioglitazone Accord.
common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness
često (mogu se pojaviti u do 1 na 10 osoba) - glavobolja - omaglica - bol u zglobovima - impotencija - križobolja - nedostatak zraka - malo sniženje broja crvenih krvnih stanica - nadutost manje često (mogu se pojaviti u od 1 do 10 na 1000 osoba)
• if you have blood in your urine that your doctor has not checked.
ako imate ili ste imali karcinom mokraćnog mjehura. ako imate krv u mokraći, a niste proveli odgovarajuće pretrage.
You can usually continue to take other medicines whilst you are being treated with Pioglitazone Accord.
Za vrijeme liječenja lijekom Pioglitazone Accord obično možete nastaviti uzimati druge lijekove.
• Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
• Jedna Pioglitazone Accord 30 mg tableta sadrži 30 mg pioglitazona (u obliku klorida).
Blurred vision due to swelling (or fluid) at the back of the eye (frequency cannot be estimated from the available data) has also been reported in patients taking Pioglitazone Accord.
U bolesnika koji uzimaju Pioglitazone Accord zabilježen je i zamagljen vid zbog oticanja (ili tekućine) stražnje strane oka (učestalost se ne može procijeniti iz dostupnih podataka).
EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tablets in alu/alu blister)
EU/1/11/722/001-010 (14/28/30/50/56/84/90/98/112/196 tableta u Al/Al blisterima) EU/1/11/722/011-020 (14/28/30/50/56/84/90/98/112/196 tableta u Al/Al blisterima) EU/1/11/722/021-030 (14/28/30/50/56/84/90/98/112/196 tableta u Al/Al blisterima)
Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Accord.
Liječnik će tražiti da za vrijeme liječenja lijekom Pioglitazone Accord povremeno napravite krvne pretrage, da bi se provjerilo radi li Vaša jetra normalno.
• Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
• Jedna Pioglitazone Accord 45 mg tableta sadrži 45 mg pioglitazona (u obliku klorida).
Adverse reaction Frequency of adverse reactions of pioglitazone by treatment regimen
Učestalost nuspojava pioglitazona prema režimu liječenja Monoterapija
Allergic reactions have been reported (frequency cannot be estimated from the available data) in patients taking Pioglitazone Accord.
Kod bolesnika koji su uzimali Pioglitazone Accord prijavljene su alergijske reakcije (učestalost se ne može procijeniti iz dostupnih podataka).
MARKETING AUTHORISATION HOLDER
Nositelj odobrenja će podnijeti dopunjeni
• Pioglitazone Accord 45 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
• Pioglitazone Accord 45 mg tablete su bijele do gotovo bijele boje, plosnate, okrugle tablete bez ovojnice sa zaobljenim rubovima i utisnutom oznakom ‘PIO' s jedne strane i ‘45' s druge strane.
After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Nakon isključenja bolesnika koji su u vrijeme dijagnoze karcinoma mokraćnog mjehura bili izloženi ispitivanom lijeku kraće od godinu dana, u skupinama koje su primale pioglitazon bilo je 7
Pioglitazone Accord 30 mg tablets
Pioglitazone Accord 30 mg tablete
Pioglitazone Accord 45 mg tablets
Pioglitazone Accord 45 mg tablete
See the package leaflet for further information.
Za dodatne informacije vidjeti Uputu o lijeku.
• Pioglitazone Accord 30 mg tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
• Pioglitazone Accord 30 mg tablete su bijele do gotovo bijele boje, okrugle, plosnate tablete bez ovojnice sa zaobljenim rubovima i utisnutom oznakom ‘PIO' s jedne strane i ‘30' s druge strane.
Localised swelling (oedema) has also been experienced very commonly (may affect more than 1 in 10 people) in patients taking Pioglitazone Accord in combination with insulin.
Lokalizirano oteknuće (edemi) također su vrlo često nastajali u bolesnika koji su uzimali Pioglitazone Accord u kombinaciji s inzulinom.
• Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
• Jedna Pioglitazone Accord 15 mg tableta sadrži 15 mg pioglitazona (u obliku klorida).
• Pioglitazone Accord 15 mg tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
• Pioglitazone Accord 15 mg tablete su bijele do gotovo bijele boje, okrugle, bikonveksne, bez ovojnice i s utisnutom oznakom ‘P' s jedne strane i ‘15' s druge strane.
The tablets are white to off white, round, biconvex, uncoated tablets debossed with ‘P' on one side and ‘15' on other side.
Tablete su bijele do gotovo bijele, okrugle, bikonveksne, bez ovojnice s utisnutom oznakom ‘P' s jedne strane i ‘15' s druge strane.
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Jedna tableta sadrži 45 mg pioglitazona (u obliku klorida).
Pioglitazone Accord 15 mg tablets
Pioglitazone Accord 15 mg tablete
Each tablet contains 30 mg of pioglitazone (as hydrochloride).
Jedna tableta sadrži 30 mg pioglitazona (u obliku klorida).
Pioglitazone Accord 15 mg tablets Pioglitazone
Pioglitazone Accord 15 mg tablete pioglitazon
The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘45' on the other side.
Tablete su bijele do gotovo bijele boje, plosnate, okrugle, bez ovojnice sa zaobljenim rubovima i utisnutom oznakom ‘PIO' s jedne strane i ‘45' s druge strane.
Pioglitazone Accord 30 mg tablets Pioglitazone
Pioglitazone Accord 30 mg tablete pioglitazon
Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Jedna tableta sadrži 15 mg pioglitazona (u obliku klorida).
EU/1/11/722/021 14 tablets EU/1/11/722/022 28 tablets EU/1/11/722/023 30 tablets EU/1/11/722/024 50 tablets EU/1/11/722/025 56 tablets EU/1/11/722/026 84 tablets EU/1/11/722/027 90 tablets EU/1/11/722/028 98 tablets EU/1/11/722/029 112 tablets EU/1/11/722/030 196 tablets
EU/1/11/722/021 14 tableta EU/1/11/722/022 28 tableta EU/1/11/722/023 30 tableta EU/1/11/722/024 50 tableta EU/1/11/722/025 56 tableta EU/1/11/722/026 84 tableta EU/1/11/722/027 90 tableta EU/1/11/722/028 98 tableta EU/1/11/722/029 112 tableta EU/1/11/722/030 196 tableta
EU/1/11/722/001 14 tablets EU/1/11/722/002 28 tablets EU/1/11/722/003 30 tablets EU/1/11/722/004 50 tablets EU/1/11/722/005 56 tablets EU/1/11/722/006 84 tablets EU/1/11/722/007 90 tablets EU/1/11/722/008 98 tablets EU/1/11/722/009 112 tablets EU/1/11/722/010 196 tablets
EU/1/11/722/001 14 tableta EU/1/11/722/002 28 tableta EU/1/11/722/003 30 tableta EU/1/11/722/004 50 tableta EU/1/11/722/005 56 tableta EU/1/11/722/006 84 tableta EU/1/11/722/007 90 tableta EU/1/11/722/008 98 tableta EU/1/11/722/009 112 tableta EU/1/11/722/010 196 tableta
The tablets are white to off white, flat, round uncoated tablets with beveled edges debossed with ‘PIO' on one side and ‘30' on the other side.
Tablete su bijele do gotovo bijele boje, plosnate, okrugle, bez ovojnice sa zaobljenim rubovima i utisnutom oznakom ‘PIO' s jedne strane i ‘30' s druge strane.
EU/1/11/722/011 14 tablets EU/1/11/722/012 28 tablets EU/1/11/722/013 30 tablets EU/1/11/722/014 50 tablets EU/1/11/722/015 56 tablets EU/1/11/722/016 84 tablets EU/1/11/722/017 90 tablets EU/1/11/722/018 98 tablets EU/1/11/722/019 112 tablets EU/1/11/722/020 196 tablets
EU/1/11/722/011 14 tableta EU/1/11/722/012 28 tableta EU/1/11/722/013 30 tableta EU/1/11/722/014 50 tableta EU/1/11/722/015 56 tableta EU/1/11/722/016 84 tableta EU/1/11/722/017 90 tableta EU/1/11/722/018 98 tableta EU/1/11/722/019 112 tableta EU/1/11/722/020 196 tableta
Pioglitazone Accord 45 mg tablets Pioglitazone
Pioglitazone Accord 45 mg tablete pioglitazon
Breast-feeding
PSUR-evi
Do not take Pioglitazone Accord: • if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in Section
Nemojte uzimati Pioglitazone Accord: ako ste preosjetljivi (alergični) na pioglitazon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). ako imate zatajenje srca ili ste prije imali zatajenje srca. ako imate bolest jetre. ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti koja uzrokuje nagli gubitak na tjelesnoj težini, mučninu i povraćanje).
NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 45 mg tablets
NAZIV LIJEKA Pioglitazone Accord 45 mg tablete pioglitazon IME NOSITELJA
NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 15 mg tablets
NAZIV LIJEKA Pioglitazone Accord 15 mg tablete pioglitazon IME NOSITELJA
NAME OF THE MEDICINAL PRODUCT Pioglitazone Accord 30 mg tablets
NAZIV LIJEKA Pioglitazone Accord 30 mg tablete pioglitazon IME NOSITELJA
Best Response
Najbolji odgovor
Estimates based on other analysis
Procjene temeljene na drugoj analizi
Concentrate (ml)*
Koncentrat (ml)*
The infusion will be given over 2 hours.
Infuzija će trajati 2 sata.
Talk to your doctor about contraception.
Razgovarajte s liječnikom o kontracepciji.
Patients who met each of the following criteria:
Bolesnici koji zadovoljavaju sve sljedeće kriterije:
If you (or your child) weigh less than 20 kg, the infusion time may be longer.
Vi (ili Vaše dijete) težite manje od 20 kg, vrijeme infuzije može biti i dulje.
It is important to drink plenty of water to avoid dehydration.
Važno je piti puno vode kako bi se spriječila dehidracija.
Your doctor will give you Ivozall once every day for 5 days.
Liječnik će Vam lijek Ivozall davati jednom na dan tijekom 5 dana.
CR + CRp + PR 18
KR + KRt + PR 18
Ivozall may harm both male and female reproductive organs.
Ivozall može naškoditi i muškim i ženskim reproduktivnim organima.
However, there are no known clinically significant interactions with other medicinal products or laboratory tests.
Međutim, nema poznatih klinički značajnih interakcija s drugim lijekovima ili laboratorijskim testovima.
ITT* patients (n = 61)
ITT* bolesnici (n = 61)
5.2 hours
5,2 sati
Your doctor will tell you when you need to be given this medicine.
Liječnik će Vam reći kada morate primiti lijek.
Because of the way this medicine works, it will affect your blood and other organs.
Zbog svog načina djelovanja ovaj lijek utječe na krv i druge organe.
PR = Partial remission
PR = parcijalna remisija
> 24 hours
> 24 sata
Estimates based on noncompartmental analysis (n = 14 / n = 14)
Procjene temeljene na nekompartmentalnoj analizi (n = 14 / n = 14)
The excretion of clofarabine in milk has not been studied in animals.
Izlučivanje klofarabina u mlijeko nije istraženo na životinjama.
It works best against cells which are multiplying quickly - such as cancer cells.
Najbolje djeluje protiv stanica koje se brzo dijele - poput stanica raka.
Its antitumour activity is believed to be due to 3 mechanisms:
Vjeruje se da njegovo protutumorsko djelovanje počiva na 3 mehanizma:
The reference medicine for Ivozall has been authorised under ‘exceptional circumstances'.
Referentni lijek za Ivozall odobren je u „iznimnim okolnostima”.
(There are no exposure data in rabbits.)
(Nema podataka o izloženosti u kunića.)
Children weighing < 20 kg
Djeca tjelesne težine < 20 kg
Haematuria was observed in 13% of patients overall.
Hematurija je primijećena u ukupno 13% bolesnika.
Clinical efficacy and safety
Klinička djelotvornost i sigurnost:
Ivozall contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Ivozall sadrži istu djelatnu tvar i djeluje na isti način kao „referentni lijek” koji je već odobren u
Body surface area must be calculated using the actual height and weight of the patient before the start of each cycle.
Površina tijela izračunava se na temelju stvarne visine i težine bolesnika prije početka svakog ciklusa.
See section 2 “Ivozall contains sodium”.
Vidjeti dio 2. „Ivozall sadrži natrij“.
It works by hindering the growth of abnormal white blood cells, and eventually kills them.
Djeluje tako da onemogućuje rast poremećenih bijelih krvnih stanica i naposljetku ih ubija.
• Respiratory status, blood pressure, fluid balance and weight throughout and immediately after the 5 day clofarabine administration period.
• respiratorni status, krvni tlak, ravnotežu tekućina i tjelesnu težinu tijekom i odmah nakon petodnevnog razdoblja primjene klofarabina.
Other exfoliative conditions have also been reported.
Također su prijavljena su i druga eksfolijativna stanja.
Most of the cardiac adverse reactions were reported in the first 2 cycles.
Većina srčanih nuspojava prijavljena je tijekom prva 2 ciklusa.
Therefore, Ivozall should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus).
Stoga se lijek Ivozall ne smije primjenjivati tijekom trudnoće, naročito tijekom prvog tromjesečja, osim ako to nije neophodno (tj. ako potencijalna korist za majku nadilazi rizik za plod).
Individual duration remission and survival data for patients who achieved CR or CRp
Pojedinačno trajanje remisije i podaci o preživljenju za bolesnike koji su postigli KR ili KRt
Men must also use effective contraception while they or their partner are treated with clofarabine.
Muškarci također moraju primjenjivati učinkovitu kontracepciju dok se oni ili njihove partnerice liječe klofarabinom.
Non-infectious events
Neinfektivni događaji