natgillin/translations-raw huggingface dataset:
Hypoglycaemia (when used with SU or insulin)
Presnovne in prehranske motnje hipoglikemija (med uporabo s sulfonilsečnin ami ali insulinom)
a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
• značilno zmanjšanje absolutnega tveganja za celotno umrljivost: metformin 13,5 dogodka/1000 bolnik-let v primerjavi s samo dieto 20,6 dogodka/1000 bolnik-let (p = 0,011) in v primerjavi z združenimi podatki skupin monoterapije s sulfonilsečnino in z insulinom 18,9 dogodka/1000 bolnik-let, (p = 0,021);
You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Ebymect.
Morda boste morali pogosteje opravljati preiskave glukoze v krvi in delovanja ledvic,
on one side and “1069” on the other side.
Na eni strani imajo vtisnjeno oznako "5/1000" in na drugi strani "1069".
Dapagliflozin as an add-on with either metformin alone, metformin in combination with sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant mean reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 4, 5 and 6).
Dapagliflozin kot dodatek bodisi metforminu samemu, metforminu v kombinaciji s sitagliptinom, sulfonilsečnino ali insulinom (z dodatnimi peroralnimi antidiabetiki (vključno z metforminom) ali brez njih) je po 24 tednih statistično značilno znižal HbA1c v primerjavi s prejemniki placeba (p < 0.0001, preglednice 4, 5 in 6).
Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with sodium-glucose co-transporter 2 (SGLT2) inhibitors, including dapagliflozin.
Pri bolnikih, zdravljenih z zaviralci natrij-glukoznega soprenašalca 2 (SGLT2 - sodium-glucose cotransporter 2), (vključno z dapagliflozinom), so poročali o redkih primerih diabetične ketoacidoze (DKA), med njimi tudi o smrtno nevarnih in smrtnih primerih.
In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in FPG at Week 24: -1.19 mmol/L (-21.46 mg/dL) compared to0.27 mmol/L (-4.87 mg/dL) for placebo (p=0.001).
V namenski študiji pri sladkornih bolnikih z eGFR od ≥ 45 do < 60 ml/min/1,73 m2 je zdravljenje z dapagliflozinom 24. teden doseglo znižanje glukoze v plazmi na tešče: sprememba je znašala -1,19 mmol/l (-21,46 mg/dl) v primerjavi z -0,27 mmol/l (-4,87 mg/dl) s placebom (p = 0,001).
• Ebymect 5 mg/850 mg are 9.5 x 20 mm oval, brown film-coated tablets.
• Zdravilo Ebymect 5 mg/850 mg so 9,5 x 20 mm velike, ovalne, rjave filmsko obložene tablete.
Subjects (%) achieving HbA1c 7%
Preiskovanci (%), ki so dosegli: HbA1c < 7 % Korigirano za izhodišče
Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min.
Pri bolnikih z GFR < 60 ml/min je treba pred uvedbo zdravila Ebymect pregledati dejavnike, ki lahko povečajo tveganje za laktacidozo (glejte poglavje 4.4).
Each Ebymect 5 mg/850 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride.
Ena filmsko obložena tableta (tableta) zdravila Ebymect 5 mg/850 mg vsebuje dapagliflozin-propandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in 850 mg metforminijevega klorida.
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017;
• značilno zmanjšanje absolutnega tveganja vseh zapletov sladkorne bolezni v skupini z metforminom (29,8 dogodka/1000 bolnik-let) v primerjavi z dieto samo (43,3 dogodka/1000 bolnik-let), p = 0,0023, ter v primerjavi z združenimi podatki skupin monoterapije s sulfonilsečnino in z insulinom (40,1 dogodka/1000 bolnik-let), p = 0,0034;
Each Ebymect 5 mg/1,000 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg metformin hydrochloride.
Ena filmsko obložena tableta (tableta) zdravila Ebymect 5 mg/1000 mg vsebuje dapagliflozin-propandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in 1000 mg metforminijevega klorida.
Ebymect 5 mg/850 mg film-coated tablets Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Talc (E553b)
Ebymect 5 mg/1000 mg filmsko obložene tablete polivinilalkohol (E1203) makrogol 3350 (E1521) smukec (E553b) titanov dioksid (E171) rumeni železov oksid (E172)
Liver function disorders Hepatitis
Bolezni jeter, žolčnika in motnje delovanja jeter
104, respectively.
z -0,7 %.
Metformin may act via three mechanisms: by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle; by delaying intestinal glucose absorption.
• z zmernim povečanjem občutljivosti za insulin, s čimer izboljša periferni privzem glukoze in porabo v mišicah,
Change from baseline Difference from placebo d
Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom d
What you need to know before you take Ebymect 3.
Kaj je zdravilo Ebymect in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ebymect Kako jemati zdravilo Ebymect Možni neželeni učinki
Powder and solvent for concentrate for solution for infusion
Prašek in vehikel za koncentrat za raztopino za infundiranje
concentrate: 25 ml (20 mg/ml); diluent: 500 ml
25 ml (20 mg/ml) vehikel: 500 ml
Intravenous use powder: vial (glass); bottle (glass)
Prašek: viala (steklo); vehikel: steklenica (steklo)
10 vials + 3 bottles
10 vial steklenice
Pack size
Koncentrat:
7 (7 x 1) vials + 7 (7 x 1) pre-filled solvent syringes + 7 (7 x 1) vial adapters + 7 (7 x 1) needles + 14 (7 x 2) swabs (multipack)
7 (7 x 1) vial + 7 (7 x 1) napolnjenih injekcijskih brizg z vehiklom + 7 (7 x 1) nastavkov za vialo + 7 (7 x 1) igel + 14 (7 x 2) blazinic (večodmerno pakiranje)
7 (7 kits x (1 vial + 1 pre-filled solvent syringe + 1 vial adapter + 1 needle + 2 swabs)) (multipack)
7 (7 kompletov x (1 viala + 1 napolnjena injekcijska brizga + 1 nastavek za vialo + 1 igla + 2 blazinici)) (večodmerno pakiranje)
1 vial + 1 pre-filled solvent syringe + 1 vial adapter + 1 needle + 2 swabs
1 napolnjena injekcijska brizga z vehiklom + 1 nastavek za vialo + 1 igla + 2 blazinici
Pharmaceutical Form Route of administration
Farmacevtska oblika Pot uporabe Pakiranje
Blister (PVC/alu) 60
filmsko obložene tablete peroralna uporabaplastenka (HDPE) 60
Tradename Strength
Ime zdravila Jakost
Dr Harald Enzmann (Germany)
Dr. Harald Enzmann (Nemčija)
The European Commission issued a decision on 2 June 2010.
Evropska komisija je odločitev izdala dne 4. junija 2010.
Prof Pieter de Graeff (the Netherlands)
Prof. Pieter de Graeff (Nizozemska)
As, the Member States were not able to reach an agreement, the German medicines regulatory agency referred the matter to the CHMP for arbitration on 29 October 2009.
Ker države članice niso dosegle soglasja, je nemški regulatorni organ za zdravila dne 29. oktobra 2009 zadevo napotili na CHMP v arbitražo.
The grounds for the referral were concerns from Sweden that patients would be exposed to the antioxidant butylated hydroxyanisole (BHA) unnecessarily.
Razlogi za napotitev so bili pomisleki Švedske, da bi bili bolniki po nepotrebnem izpostavljeni antioksidantu butiliran hidroksianizol (BHA).
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Clopidogrel Teva outweigh its risks and recommended that the marketing authorisation be granted in all the concerned Member States.
Na podlagi ocenjevanja trenutno razpoložljivih podatkov in znanstvene razprave v okviru odbora je CHMP zaključil, da koristi zdravila Clopidogrel Teva odtehtajo njegova tveganja, zato je priporočil odobritev dovoljenja za promet z zdravilom v vseh zadevnih državah članicah.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Clopidogrel Teva outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden and the United Kingdom.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da koristi zdravila Clopidogrel Teva odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom odobri v Nemčiji in tudi v naslednjih državah članicah EU: v Avstriji, Belgiji, Bolgariji, na Cipru, Češkem, Danskem, v Estoniji, na Finskem, v Franciji, Grčiji, na Madžarskem, Irskem, v Italiji, Latviji, Litvi, Luksemburgu, na Nizozemskem, Norveškem, Poljskem, v Romuniji, na Slovaškem, v Španiji, na Švedskem in v Združenem kraljestvu.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Clopidogrel Teva and associated names.
Evropska agencija za zdravila je zaključila arbitražni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Clopidogrel Teva in povezanih imen/povezana imena.
This means that it helps to prevent blood clots from forming.
To pomeni, da pomaga pri preprečevanju tvorbe krvnih strdkov.
It is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as a heart attack or stroke.
Uporablja se pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost arterij), kot je srčni napad ali infarkt.
Why was Clopidogrel Teva reviewed?
Zakaj je bilo zdravilo Clopidogrel Teva pregledano?
This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
To preprečuje, da bi trombociti postali „lepljivi“, kar zmanjšuje tveganje za nastanek krvnega strdka in prispeva k preprečevanju novega srčnega napada ali kapi.
in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden and the United Kingdom).
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Nemčija), oceni zdravilo z namenom odobritve dovoljenja za promet z njim, ki bo veljavno v tej državi in v drugih državah članicah („zadevnih državah članicah“, v tem primeru v Avstriji, Belgiji, Bolgariji, na Cipru, Češkem, Danskem, v Estoniji, na Finskem, v Franciji, Grčiji, na Madžarskem, Irskem, v Italiji, Latviji, Litvi, Luksemburgu, na Nizozemskem, Norveškem, Poljskem, v Romuniji, na Slovaškem, v Španiji, na Švedskem in v Združenem kraljestvu).
Clopidogrel Teva is a generic medicine based on a ‘reference medicine', Plavix which is authorised in the EU.
Clopidogrel Teva je generično zdravilo na osnovi „referenčnega zdravila“ Plavix, ki je odobreno v EU.
Clopidogrel base is less stable than the salt form, and BHA is included in the medicine to stabilise it.
Klopidogrelna baza je manj stabilna kot sol, zato je za njeno stabilizacijo v zdravilo vključen BHA.
The company had chosen to use ‘clopidogrel base' as the form of the active substance in the medicine, and not a salt such as the ‘hydrogen sulfate salt' used in Plavix.
Družba se je odločila, da kot obliko zdravilne učinkovine v zdravilu uporabi „klopidogrelno bazo“ in ne sol, kot npr. „hidrogensulfatna sol“, ki se uporablja v zdravilu Plavix.
What is Clopidogrel Teva?
Kaj je zdravilo Clopidogrel Teva?
Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Klopidogrel ustavi agregacijo trombocitov tako, da spojini, imenovani adenozin difosfat (ADP), prepreči vezavo na posebne receptorje na njihovi površini.
When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Kri se strjuje zaradi posebnih celic v krvi, imenovanih trombociti, ki se agregirajo (zlepljajo) med seboj.
Teva Pharma B.V. submitted Clopidogrel Teva to Germany for a decentralised procedure.
je predložila zdravilo Clopidogrel Teva Nemčiji v decentraliziran postopek.
Clopidogrel Teva is a medicine that contains the active substance clopidogrel.
Clopidogrel Teva je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
4 June 2010
4. junij 2010
18 February 2010
18. februar 2010
18 January 2010
18. januar 2010
The active substance, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina klopidogrel je zaviralec agregacije trombocitov.
• There is insufficient data on Abseamed to know the size of any increased immunogenicity risk with sc use
• Podatkov o zdravilu Abseamed je premalo, da bi vedeli, za koliko se poveča tveganje za pojav imunogenosti pri subkutani uporabi zdravila.
On 11 March 2016, pursuant to Article 20 of Regulation (EC) No 726/2004, the European Commission requested the opinion of the Agency on whether the marketing authorisation of Zydelig (idelalisib) should be maintained, varied, suspended or revoked.
Dne 11. marca 2016, v skladu s členom 20 Uredbe (ES) št. 726/2004, je Evropska komisija agencijo zaprosila za mnenje o tem, ali je treba ohraniti, spremeniti, začasno odvzeti ali preklicati dovoljenje za promet z zdravilom Zydelig (idelalizib).
In addition, neutrophil count monitoring is recommended.
Poleg tega se priporoča spremljanje števila nevtrofilcev.
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zydelig (idelalisib).
• Odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za zdravilo Zydelig (idelalizib).
The PRAC also reviewed all the other relevant data presented by the MAH and the views expressed by the oncology scientific advisory group.
Odbor PRAC je prav tako pregledal vse druge pomembne podatke, predstavljene s strani imetnika dovoljenja za promet in stališča znanstvene svetovalne skupine za onkologijo.
The PRAC concluded that the same risk minimisation measures should be applied.
Odbor PRAC je zaključil, da je treba uporabiti enake dejavnosti za zmanjševanje tveganja.
In case of very low ANC (<500/mm3), treatment should be interrupted and may be resumed, at a lower dose, once this has resolved.
V primeru zelo nizkega ANC (< 500/mm3) je treba zdravljenje prekiniti in ga ponovno nadaljevati z nižjim odmerkom, ko se to razreši.
Patients' blood counts should also be monitored during the first 6 months of treatment, adapting the frequency to the absolute neutrophil count (ANC).
Prav tako je treba pri bolnikih spremljati krvno sliko prvih 6 mesecev zdravljenja in prilagajati pogostnost glede na absolutno število nevtrofilcev (ANC).
The wording of the indication in first line CLL should be amended to reflect the above recommendation and it should be specified that this is linked to the limited data available in this setting.
Besedilo indikacije prve izbire zdravljenja KLL se mora spremeniti, da odraža zgornja priporočila, in treba je določiti, da je to povezano z omejenimi podatki, ki so na voljo pri tej kombinaciji.
In addition, the data suggest that these results reflect the fact that the known toxicity of the treatment was not outweighed by its benefits due to the good prognosis and therefore low disease-related mortality of previously untreated CLL patients.
Poleg tega podatki kažejo, da ti rezultati odražajo dejstvo, da znana toksičnost zdravljenja ni odtehtala njegovih koristi zaradi dobre prognoze in zato nizke umrljivosti, povezane z boleznijo bolnikov s KLL, ki še niso bili zdravljeni.
Whereas,
Ni pa bilo nobene
Characteristics of patients in those studies are compatible with a good prognosis, including slow disease progression, hence leading as in study -0123 to an unmasking of the idelalisib toxicity.
Značilnosti bolnikov v teh študijah so združljive z dobrimi prognozami, vključno s počasnim potekom bolezni, zato vodijo, kot v študiji -0123, do razkrivanja toksičnosti idelaliziba.
Idelalisib is known to cause very commonly infections and neutropenia and these risks are reflected in the product information.
Za idelalizib je znano, da povzroča zelo pogoste okužbe in nevtropenijo in ta tveganja se odražajo v informacijah o zdravilu.
Further, these two studies included patients with earlier disease characteristics than the population for which idelalisib is authorised.
Poleg tega so bili v ti dve študiji vključeni bolniki z značilnostmi prejšnje bolezni, kot populacija, za katero je odobren idelalizib.
These results highlight nonetheless the importance of ensuring that the risk of serious infection is adequately minimised in the authorised indications, in line with the measures employed in studies that demonstrated the positive benefit-risk balance of idelalisib.
Ti rezultati kljub temu poudarjajo pomembnost zagotavljanja, da je tveganje za resno okužbo ustrezno zmanjšano v odobrenih indikacijah v skladu z ukrepi, uporabljenimi v študijah, ki so kazale pozitivno razmerje med koristmi in tveganji idelaliziba.
This review was initiated due to a reported increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups observed in three clinical trials (GS-US-312-0123, GS-US-313-0124, GS-US-313-01251).
Ta pregled je bil uveden zaradi poročanega povečanega tveganja za smrt in višjo pojavnost resnih neželenih učinkov pri preiskovancih, ki so prejemali idelalizib, v primerjavi s kontrolnimi skupinami, opazovanimi v treh kliničnih preskušanjih (GS-US-312-0123, GS-US-313-0124, GS-US-313-01251).
While CMV and PJP are important risks, in the studies they accounted for a relatively small proportion of the serious infections observed, therefore the PRAC considered that more general measures to minimise the risk of serious infections as implemented as part of the provisional measures were justified.
Medtem ko sta okužbi s CMV in PJP pomembni tveganji, sta v študijah predstavljali relativno majhen delež opaženih resnih okužb, zato je odbor PRAC menil, da so utemeljeni bolj splošni ukrepi za zmanjšanje tveganja za resne okužbe, kot se izvajajo v okviru začasnih ukrepov.
These recommendations should be reflected in the product information together with a description of the infectious events and the MAH should conduct a study to assess healthcare practitioners' awareness to these risk minimisation measures.
Priporočila morajo biti izražena v informacijah o zdravilu skupaj z opisom nalezljivih dogodkov, imetnik dovoljenja za promet pa mora opraviti študijo za ocenitev osveščenosti zdravstvenih delavcev glede teh dejavnosti za zmanjšanje tveganja.
Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended in patients with evidence of prior infection.
Priporoča se tudi redno klinično in laboratorijsko spremljanje za okužbe s citomegalovirusom pri bolnikih z znaki predhodne okužbe.
If clinical signs of CMV infection appear, consideration should be given to interrupting idelalisib until the infection has resolved.
Če se pojavijo klinični znaki okužbe s CMV, je treba premisliti o prekinitvi zdravljenja z idelalizibom, dokler se okužba ne pozdravi.
The unfavourable results of studies -0124 and -0125 reflect the use of the additional treatment related toxicity, which is not the same as that of the authorised use in monotherapy.
Neugodni rezultati študij -0124 in -0125 odražajo toksičnost, povezano z uporabo dodatnega zdravljenja, ki ni enaka kot tista pri odobreni uporabi v monoterapiji.
The PRAC considered that further minimisation measures of the known risk of infection related to the use of idelalisib were necessary.
Odbor PRAC je menil, da so bile potrebne nadaljnje dejavnosti za zmanjšanje znanega tveganja za okužbo, povezano z uporabo idelaliziba.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Zydelig.
Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Zydelig.
The trials evaluated treatment combinations with chemotherapy and immunotherapy which are currently not authorised for Zydelig (idelalisib) in populations with earlier disease characteristics than the currently approved indication.
V preskušanjih so vrednotili kombinacije zdravljenj s kemoterapijo in imunoterapijo, ki trenutno za zdravilo Zydelig (idelalizib) niso odobrene za populacije z značilnostmi zgodnejše bolezni, kot je trenutno odobrena indikacija.
In the event of severe neutropenia, treatment should be interrupted and may be restarted at a lower dose upon resolution.
V primeru hude nevtropenije je treba prekiniti zdravljenje, zdravljenje pa ponovno pričeti pri nižjem odmerku, ko se to razreši.
The CHMP recently adopted a positive opinion to also authorise the use of idelalisib in CLL in combination with another anti CD20 monoclonal antibody, ofatumumab.
Odbor CHMP je pred kratkim sprejel pozitivno mnenje, da odobri uporabo idelaliziba pri KLL v kombinaciji z drugim monoklonskim protitelesom proti CD20, ofatumumabom.
• The PRAC noted that most of the serious adverse events reported in studies -0123, -0124 and -0125 were related to infections.
• Odbor PRAC je ugotovil, da je bila večina resnih neželenih učinkov, o katerih so poročali v študijah -0123, -0124 in -0125, povezana z okužbami.
Similarly, in studies -0124 and -0125 idelalisib was not used as monotherapy as currently authorised but in combination with rituximab or rituximab and bendamustine, respectively.
Podobno v študijah -0124 in -0125 idelalizib ni bil uporabljen kot monoterapija, kot je trenutno odobreno, ampak v kombinaciji z rituksimabom oziroma rituksimabom in bendamustinom.
The CHMP therefore concluded that it is not needed to include this statement in the SmPC.
Odbor CHMP je zato zaključil, da tega stavka ni potrebno vključiti v povzetek glavnih značilnosti zdravila.
• The PRAC noted that studies -0123, -0124 and -0125 involved patient groups and treatment combinations different from those of the authorised indications of Zydelig.
• Odbor PRAC je ugotovil, da so študije -0123, -0124 in -0125 vključevale skupine bolnikov in kombinacije zdravljenj, ki so se razlikovale od tistih, ki so odobrene indikacije zdravila Zydelig.
In addition as no controlled study was conducted in this indication, in view of the importance of the risk of serious infections, the MAH should conduct a post-authorisation safety study to collect additional safety data in those patients.
Ker pa za to indikacijo ni bila izvedena kontrolirana študija, mora imetnik dovoljenja za promet glede na pomembnost tveganja za resne okužbe izvesti študijo po pridobitvi dovoljenja za promet, da zbere dodatne podatke o varnosti teh bolnikov.