natgillin/translations-raw huggingface dataset:
• The PRAC considered the totality of the data submitted with regard to safety and efficacy in female children, women of childbearing potential and pregnant women treated with valproate and related substances.
• je PRAC razmotrio ukupnost dostavljenih podataka s obzirom na sigurnost i djelotvornost u ženske djece, žena reproduktivne dobi i trudnica liječenih valproatom i povezanim tvarima.
The Committee, as a consequence, concluded that the benefit-risk balance of valproate and related substances-containing medicinal products, remains favourable subject to the conditions to the marketing authorisations, and taking into account the amendments to the product information, where applicable, and other risk minimisation measures recommended.
Stoga, Povjerenstvo je zaključilo da omjer koristi i rizika za valproat i lijekove koji sadrže povezane tvari ostaje povoljan, te da je predmetom uvjeta odobrenja za stavljanje lijeka u promet, uzimajući u obzir dopune informacija o proizvodu, kada su iste primjenjive, i druge preporučene mjere za smanjivanje rizika.
Grounds for the variation to the terms of the marketing authorisation Whereas
Razlozi za izmjene uvjeta odobrenja za stavljanje lijeka u promet Budući da
Scientific conclusions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Znanstveni zaključci i detaljno pojašnjenje za znanstvene razloge za razlike u odnosu na preporuku PRAC-a
The CMDh included a clarification on the use of prolonged release formulation to avoid high peak plasma concentrations in the summary of product characteristics.
U sažetak opisa svojstava lijeka, CMDh je uključio pojašnjenje o primjeni formulacije produljenog otpuštanja kako bi se izbjegle visoke vršne koncentracije plazme.
Therefore, the PRAC recommends the variation to the terms of the marketing authorisation for the valproate and related substances containing medicinal products referred to in Annex I, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.
Stoga, PRAC je preporučio izmjenu uvjeta za izdavanje odobrenja za stavljanje u promet lijekova koji sadrže valproat i povezane tvari navedene u Dodatku I., za koje su relevantni dijelovi sažetka opisa svojstava lijeka i uputa o lijeku navedeni u Dodatku III. preporuke PRAC-a.
• The PRAC concluded that valproate and related substances should be contraindicated in prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate.
• je PRAC zaključio da valproat i povezane tvari treba kontraindicirati u profilaksi migrenskih napadaja u trudnica i žena reproduktivne dobi koje ne koriste djelotvorne metode kontracepcije tijekom liječenja valproatom.
• The PRAC concluded that valproate and related substances should not be used in female children, women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated in the following indications:
• je PRAC zaključio da se valproat i povezane tvari ne smiju koristiti u ženske djece, žena reproduktivne dobi i trudnica osim ako alternativne terapije nisu nedjelotvorne ili se ne podnose, i to u sljedećim indikacijama:
Therefore, the PRAC concluded that valproate and related substances should not be used in female children, women of childbearing potential and pregnant women for the treatment of epilepsy and manic episode in bipolar disorder unless alternatives treatments are ineffective or not tolerated.
Stoga, PRAC je zaključio da se valproat i povezane tvari ne smiju primjenjivati u ženske djece, žena reproduktivne dobi i trudnica za potrebe liječenja epilepsije i maničnih epizoda u bipolarnom poremećaju, osim ako su alternativne terapije nedjelotvorne ili se ne podnose.
Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations subject to conditions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Znanstveni zaključci i razlozi za izmjenu uvjeta odobrenja za stavljanja lijeka u promet koji su predmetom uvjeta i detaljnog pojašnjenja znanstvenih razloga za razlike u odnosu na preporuku PRAC-a
9 Cohen M.J et al. Fetal Antiepileptic Drug Exposure: Motor, Adaptive and Emotional/Behavioural Functioning at age 3
Drug Exposure: Motor, Adaptive and Emotional/Behavioural Functioning at age 3
2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
- Detaljno pojašnjenje znanstvenih razloga za razlike u odnosu na preporuku PRAC-a
In addition, the PRAC considered the views of patients, families and carers, and the views of healthcare professionals for the understanding and the awareness of the risks associated with valproate in utero exposure.
Nadalje, PRAC je razmotrio mišljenja bolesnika, obitelji i skrbnika kao i mišljenja zdravstvenih djelatnika i vezi s razumijevanjem i upoznatošću s rizicima povezanima s in-utero izlaganju valproatu.
In addition, the views of patients, families and carers, and the view of healthcare professionals regarding the implications, the understanding and awareness of the risks associated with valproate in utero exposure were taken into account in the recommendation.
Nadalje, u preporuci su u obzir uzeta mišljenja bolesnika, obitelji i skrbnika, te mišljenja zdravstvenih djelatnika u vezi s implikacijama, razumijevanjem i svjesnošću rizika povezanih s in-utero izlaganjem valproatu.
This overview was last updated in 04-2018.
Ovaj pregled informacija posljednji je put ažuriran u 4-2018.
Every year, the Agency will review any new information that becomes available and this summary will be updated as necessary.
Svake godine Agencija procjenjuje sve nove informacije koje postanu dostupne te se ovaj sažetak po potrebi ažurira.
Further information on Bosulif can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Više informacija o lijeku Bosulif možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bosulif is available as tablets (100, 400 and 500 mg).
Lijek Bosulif dostupan je u obliku tableta (od 100, 400 i 500 mg).
The doctor may increase the dose up to 600 mg once a day or reduce it or interrupt treatment according to how the medicine is working and the side effects the patient has.
Liječnik može povećati dozu do 600 mg jedanput na dan, smanjiti je ili prekinuti liječenje, ovisno o djelovanju lijeka i nuspojavama u bolesnika.
The recommended dose is 400 mg once a day for newly diagnosed patients, and 500 mg once a day for patients who have already been treated with other medicines.
Preporučena doza je 400 mg jedanput na dan u novodijagnosticiranih bolesnika i 500 mg jedanput na dan u bolesnika prethodno liječenih drugim lijekovima.
Bosulif has been given ‘conditional authorisation'.
Za lijek Bosulif izdano je „uvjetno odobrenje”.
Bosulif was not compared with another treatment.
Bosulif nije uspoređen s drugim terapijama.
After one year of treatment, 47% (116 out of 246) of patients treated with Bosulif had a major molecular response, compared with 37% (89 out of 241) of patients treated with imatinib.
Nakon jedne godine liječenja, 47 % (116 od 246) bolesnika liječenih lijekom Bosulif imalo je velik molekularni odgovor, u usporedbi s 37 % (89 od 241) bolesnika liječenih imatinibom.
What measures are being taken to ensure the safe and effective use of Bosulif?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bosulif?
Side effects reported with Bosulif are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Bosulif pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Bosulif must not be used in patients with reduced liver function.
Lijek Bosulif ne smije se primjenjivati u bolesnika sa smanjenom jetrenom funkcijom.
What is Bosulif and what is it used for?
Što je Bosulif i za što se koristi?
Effectiveness was also measured in other ways including ‘haematological response' (a return to normal of the number of white cells in the blood).
Djelotvornost je mjerena i na druge načine, uključujući „hematološki odgovor” (kada se broj bijelih krvnih stanica vrati na normalnu razinu).
The European Medicines Agency therefore decided that the benefits of Bosulif are greater than in its risks and recommended that it can be authorised for use in the EU.
Stoga je Europska agencija za lijekove zaključila da koristi od lijeka Bosulif nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
Bosulif received a marketing authorisation valid throughout the EU on 27 March 2013.
Lijek Bosulif dobio je odobrenje za stavljanje u promet koje vrijedi na prostoru EU-a od 27. ožujka
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bosulif 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 Bosulif nalaze se u sažetku opisa svojstava i u uputi o lijeku.
Why is Bosulif authorised in the EU?
Zašto je lijek Bosulif odobren u EU-u?
It can only be obtained with a prescription and treatment should be started by a doctor who is experienced in the diagnosis and treatment of CML.
Lijek se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u dijagnosticiranju i liječenju KML-a.
As for all medicines, data on the use of Bosulif are continuously monitored.
Kao za sve lijekove, podatci o primjeni lijeka Bosulif kontinuirano se prate.
What are the risks associated with Bosulif?
Koji su rizici povezani s lijekom Bosulif?
By blocking their action, Bosulif helps to control cell division, thereby controlling the growth and spread of the leukaemia cells in CML.
Inhibiranjem njihovog djelovanja Bosulif pomaže pri kontroli diobe stanica, čime se kontrolira rast i širenje stanica leukemije kod KML-a.
It blocks the action of enzymes known as Src and Bcr-Abl tyrosine kinases found on leukaemia cells where they are involved in stimulating the cells to divide uncontrollably.
On inhibira djelovanje enzima poznatih pod nazivom Src i Bcr-Abl tirozin kinaze koji se nalaze na stanicama leukemije, gdje sudjeluju u stimulaciji nekontrolirane diobe stanica.
Other information about Bosulif
Ostale informacije o lijeku Bosulif
The side effects of the medicine are considered to be manageable.
Smatra se da je moguće kontrolirati nuspojave lijeka.
Bosulif is a cancer medicine that is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in adults with a special chromosome in their cells called the Philadelphia chromosome.
Bosulif je lijek protiv raka koji se primjenjuje za liječenje kronične mijeloične leukemije (KML), raka bijelih krvnih stanica u odraslih osoba s posebnim kromosomom u stanicama, naziva Philadelphia kromosom.
The active substance in Bosulif, bosutinib, is a tyrosine kinase inhibitor.
Djelatna tvar u lijeku Bosulif, bosutinib, inhibitor je tirozin kinaze.
The most serious side effects (which may affect more than 1 in 20 people) include thrombocytopenia, anaemia, diarrhoea, rash, neutropenia (low levels of neutrophils, a type of white blood cell) and blood tests suggesting damage to the liver and pancreas.
Najozbiljnije nuspojave (koje se mogu javiti u više od 1 na 20 osoba) uključuju trombocitopeniju, anemiju, proljev, osip, neutropeniju (niske razine neutrofila, vrste bijelih krvnih stanica) i krvne pretrage koje ukazuju na oštećenje jetre i gušterače.
For more information about treatment with Bosulif, read the package leaflet (also part of the EPAR) or contact a doctor or pharmacist.
Više informacija o liječenju lijekom Bosulif pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se liječniku ili ljekarniku.
Among these patients, 36 had chronic phase CML and 16 had either accelerated or blast phase CML.
Među tim bolesnicima bilo je 36 bolesnika s KMLom u kroničnoj fazi i 16 bolesnika s KML-om u ubrzanoj ili blastičnoj fazi.
What information is still awaited for Bosulif?
Koje se još informacije očekuju o lijeku Bosulif?
Bosulif treatment was effective in patients with an unmet medical need: 18 out of 36 patients with chronic phase CML had a ‘major cytogenetic response', while 7 out of the 16 patients with advanced (accelerated or blast phase) CML also had a sufficient response based on other measurements.
Liječenje lijekom Bosulif bilo je djelotvorno u bolesnika s nezadovoljenom medicinskom potrebom: „velik citogenetski odgovor” zabilježen je u 18 od 36 bolesnika s KML-om u kroničnoj fazi, dok je u 7 od 16 bolesnika s KML-om u uznapredovaloj fazi (ubrzana ili blastična faza) također zabilježen dostatan odgovor na temelju drugih mjerenja.
Bosulif was investigated in one main study involving 570 patients with Ph+ CML who had previously been treated with at least one tyrosine kinase inhibitor.
Lijek Bosulif ispitivan je u jednom glavnom ispitivanju koje je obuhvatilo 570 bolesnika s Ph+ KML-om koji su prethodno liječeni barem jednim inhibitorom tirozin kinaze.
Bosulif has been shown to improve the condition of patients with CML, including by reducing the number of cancer cells with the Philadelphia chromosome and returning white blood cell levels to normal.
Utvrđeno je da lijek Bosulif poboljšava stanje bolesnika s KML-om, između ostalog smanjivanjem broja stanica raka s Philadelphia kromosomom i vraćanjem bijelih krvnih stanica na normalne razine.
It is used to treat three stages of CML called ‘chronic phase', ‘accelerated phase' and ‘blast phase' in patients who have already been treated with one or more tyrosine kinase inhibitors (medicines for CML which work in a similar way to Bosulif), and when the tyrosine kinase inhibitors called dasatinib, imatinib and nilotinib are not suitable.
Primjenjuje se za liječenje tri faze KML-a naziva „kronična faza”, „ubrzana faza” i „blastična faza” u bolesnika koji su prethodno liječeni s jednim ili više inhibitora tirozin kinaze (lijekovi za liječenje KML-a koji djeluju na sličan način kao Bosulif) te kada primjena inhibitora tirozin kinaze naziva dasatinib, imatinib i nilotinib nije prikladna.
How does Bosulif work?
Kako djeluje Bosulif?
How is Bosulif used?
Kako se Bosulif koristi?
The most common side effects with Bosulif (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), abdominal pain (belly ache), vomiting, rash, anaemia (low red blood cell counts), tiredness, fever and increased levels of liver enzymes.
Najčešće nuspojave lijeka Bosulif (koje se mogu javiti u više od 1 na 5 osoba) su proljev, mučnina (slabosti), trombocitopenija (nizak broj trombocita u krvi), abdominalna bol (bol u trbuhu), povraćanje, osip, anemija (nizak broj crvenih krvnih stanica), umor, vrućica i povišene razine jetrenih enzima.
An overview of Bosulif and why it is authorised in the EU
Pregled informacija o lijeku Bosulif i razlozima njegova odobrenja u EU-u
The main measure of effectiveness was the number of patients who had a ‘major molecular response' (where the amount in the bone marrow of BCR-ABL, the protein produced by the Philadelphia chromosome, is greatly lowered).
Glavno mjerilo djelotvornosti bio je broj bolesnika s „velikim molekularnim odgovorom” (kada se značajno spusti razina Bcr-Abl-a, bjelančevine koju Philadelphia kromosom proizvodi u koštanoj srži).
Since Bosulif has been granted a conditional approval, the company that markets Bosulif will carry out and submit the results of a larger study with Bosulif in patients with Ph+ CML previously treated with one or more tyrosine kinase inhibitors and for whom dasatinib, imatinib and nilotinib are not considered appropriate treatment options.
Budući da je lijek Bosulif dobio uvjetno odobrenje, tvrtka koja stavlja lijek Bosulif u promet mora provesti veće ispitivanje i dostaviti rezultate ispitivanja lijeka Bosulif na bolesnicima s Ph+ KML-om koji su prethodno liječeni s jednim ili više inhibitora tirozin kinaze u kojih se liječenje dasatinibom, imatinibom i nilotinibom ne smatra prikladnom opcijom.
Studies have shown that Bosulif is effective at reducing the proportion of white blood cells with the Philadelphia chromosome.
Ispitivanja su pokazala da je lijek Bosulif učinkovit u smanjenju udjela bijelih krvnih stanica koje sadrže Philadelphia kromosom.
Of these, 52 patients were considered to have an unmet medical need, because disease resistance or the risk of severe side effects made other tyrosine kinase inhibitors unsuitable.
Zaključeno je da postoji nezadovoljena medicinska potreba u 52 bolesnika iz ispitivanja jer drugi inhibitori tirozin kinaze nisu bili prikladni zbog rezistencije bolesti ili rizika od ozbiljnih nuspojava.
Bosulif is also used to treat newly diagnosed patients who are in the ‘chronic phase' of CML.
Bosulif se također primjenjuje za liječenje novodijagnosticiranih bolesnika s KML-om u kroničnoj fazi.
What benefits of Bosulif have been shown in studies?
Koje su koristi od lijeka Bosulif utvrđene u ispitivanjima?
For more information about using Bosulif, see the package leaflet or contact a doctor or pharmacist.
Više informacija o primjeni lijeka Bosulif potražite u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
The main measure of effectiveness was the number of patients who had at least a ‘major cytogenetic response' (where the proportion of white blood cells with the Philadelphia chromosome fell below 35%) after six months of Bosulif treatment.
Glavno mjerilo djelotvornosti bio je broj bolesnika u kojih je nakon šest mjeseci liječenja lijekom Bosulif zabilježen barem „velik citogenetski odgovor” (kada se udio bijelih krvnih stanica koje sadrže Philadelphia kromosom spusti ispod 35 %).
For the full list of all side effects reported with Bosulif, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Bosulif potražite u uputi o lijeku.
A second study in 536 newly diagnosed CML patients in the ‘chronic phase' compared Bosulif with imatinib.
Lijek Bosulif uspoređen je s imatinibom u drugom ispitivanju na 536 novodijagnosticiranih bolesnika s KML-om u kroničnoj fazi.
Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled syringes (multipack)
1,0 ml (150 mg/ml) 3 (3 x 1) napunjenih štrcaljki (višestruko pakiranje)
Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 3 (3 x 1) pre-filled pens (multipack)
1,0 ml (150 mg/ml) 3 (3 x 1) napunjenih brizgalica (višestruko pakiranje)
Subcutaneous use pre-filled pen 1.0 ml (150 mg/ml) 1 pre-filled pen
1,0 ml (150 mg/ml) 1 Napunjena brizgalica
Subcutaneous use pre-filled syringe 1.0 ml (150 mg/ml) 1 pre-filled syringe
1,0 ml (150 mg/ml) 1 Napunjena štrcaljka
You may need to have blood checks if you take:
Možda ćete trebati obaviti pretrage krvi ako uzimate:
This medicinal product should not be given to children under 18 years of age because the safety and efficacy have not yet been fully established.
Ovaj lijek se ne smije davati djeci mlađoj od 18 godina jer sigurnost i djelotvornost nisu još u potpunosti ustanovljene.
The terminal elimination half-life of irbesartan is 11-15 hours.
Krajnje poluvrijeme eliminacije irbesartana iznosi 11-15 sati.
ATC code: C09C A04
ATK oznaka: C09C A04
Date of first authorisation: 30 October 2009 Date of latest renewal: 18 July 2014
Datum posljednje obnove: 18. srpnja 2014.
You can take Irbesartan Teva with or without food.
Irbesartan Teva može se uzimati s hranom ili bez nje.
Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2, međutim, nije moguće dati preporuku o doziranju.
See also information under the heading “Do not take Irbesartan Teva”.
Vidjeti također informacije pod naslovom „Nemojte uzimati Irbesartan Teva“.
Other medicines and Irbesartan Teva
Drugi lijekovi i Irbesartan Teva
(see section 5.3).
(vidjeti dio 5.1.).
PVC/PVdC white opaque - aluminium blisters.
PVC/PVdC bijeli neprozirni - aluminijski blisteri.
The safety and efficacy of Irbesartan Teva in children aged 0 to 18 has not been established.
Sigurnost i djelotvornost lijeka Irbesartan Teva u djece u dobi od 0 do 18 godina nisu ustanovljene.
What Irbesartan Teva is and what it is used for
Što je Irbesartan Teva i za što se koristi
Similar effects have been very rarely reported with irbesartan so far.
Do sada su vrlo rijetko zabilježeni slični učinci s irbesartanom.
It is important that you continue to take Irbesartan Teva until your doctor tells you otherwise.
Važno je da kontinuirano uzimate Irbesartan Teva sve dok Vam liječnik ne kaže drukčije.
There was no evidence of mutagenicity, clastogenicity or carcinogenicity.
Nije bilo znakova mutagenosti, klastogenosti ili karcinogenosti.
Therefore, this combination is not recommended (see section 4.4).
Ta se kombinacija, stoga, ne preporučuje (vidjeti dio 4.4.).
The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Incidencija štetnih događaja nije bila povezana s dozom (unutar preporučenog raspona doza), spolom, godinama starosti, rasom ili trajanjem liječenja.
if you are going to have an operation (surgery) or be given anaesthetics.
ako trebate ići na operaciju (kirurški zahvat) ili trebate primiti anestetike.
Plasma protein binding is approximately 96 %, with negligible binding to cellular blood components.
Vezivanje za proteine plazme iznosi oko 96%, s neznatnim vezanjem za krvne stanice.
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Tablete treba progutati s dovoljnom količinom tekućine (npr. jedna čaša vode).
• Second and third trimesters of pregnancy (see section 4.4 and 4.6).
• Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4. i 4.6).
If you get any of these symptoms or get short of breath, stop taking Irbesartan Teva and contact your doctor immediately.
Ako dobijete bilo koji od ovih simptoma ili nedostatak zraka, prestanite uzimati Irbesartan Teva i odmah se javite liječniku.
The predefined blood pressure goal was ≤ 135/85 mm Hg.
Unaprijed definirani ciljni krvni tlak bio je ≤ 135/85 mmHg.
Brampton Road Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Brampton Road Hampden Park, Eastbourne, East Sussex, BN22 9AG
The active substance is irbesartan.
Djelatna tvar je irbesartan.
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Nije bilo znakova abnormalne sistemske toksičnosti ili toksičnosti ciljnog organa pri klinički relevantnim dozama.
However, there was no difference in the half-life and accumulation of irbesartan.
Međutim, nije bilo razlika što se tiče poluvijeka i akumulacije irbesartana.
At 24 hours the reduction of blood pressure was 60-70 % of the corresponding peak diastolic and systolic responses at the recommended doses.
U 24 sata snižavanje krvnog tlaka bilo je 60-70% vršnog dijastoličkog i sistoličkog odgovora pri preporučenim dozama.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to
Učestalost nuspojava u nastavku teksta definira se na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1.000 do < 1/100); rijetko (≥ 1/10.000 do < 1/1.000); vrlo rijetko (<
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18-40 years).
Vrijednosti AUC i Cmax irbesartana također su bile nešto veće u starijih ispitanika (≥ 65 godina) u usporedbi s mlađima (18-40 godina).