natgillin/translations-raw huggingface dataset:
Pemetrexed Hospira is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Zdravilo Pemetreksed Hospira je indicirano kot monoterapija za zdravljenje drugega izbora bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim karcinomom, ki nima pretežno ploščatocelične histologije (glejte poglavje 5.1).
The resulting solution contains 25 mg/ml pemetrexed.
Tako dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Imetnik dovoljenja za promet z zdravilom Pfizer Europe MA EEIG Boulevard de la Plaine 17
Pemetrexed Hospira 500 mg contains approximately 54 mg sodium per vial.
Pemetreksed Hospira 500 mg vsebuje približno 54 mg natrija v eni viali.
- if you are breast-feeding; you must discontinue breast-feeding during treatment with
- če dojite, morate med zdravljenjem z zdravilom Pemetreksed Hospira dojenje prekiniti.
Pemetrexed/Cisplatin (N = 839)
Pemetreksed/cisplatin (N = 839)
Each 500 mg vial contains approximately 54 mg sodium.
Pomožna snov z znanim učinkom Ena 500 mg viala vsebuje približno 54 mg natrija.
METHOD AND ROUTE(S) OF ADMINISTRATION Single use only
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Patients received maintenance
Bolniki s popolnim dopolnjevanjem
Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their pemetrexed therapy.
Pancitopenija - skupno nizko število belih krvnih celic, rdečih krvnih celic in trombocitov Radiacijska pljučnica (brazgotinjenje pljučnih mešičkov, povezano z obsevanjem) se lahko pojavi pri bolnikih, ki so zdravljeni tudi z obsevanjem pred, med ali po zdravljenju s pemetreksedom.
Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Pemetreksed Hospira 100 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 100 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
Pemetrexed / Cisplatin (N = 226)
Parameter učinkovitosti pemetreksed / cisplatin (N = 226)
Pemetrexed/Cisplatin (N = 168)
pemetreksed / cisplatin (N = 168)
After reconstitution, each vial contains 25 mg/ml of pemetrexed
Po rekonstituciji ena viala vsebuje 25 mg/ml pemetrekseda.
PARAMOUNT: Kaplan-Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Kaplan Meier-jev graf preživetja brez napredovanja in skupnega preživetja za nadaljevanje vzdrževalnega zdravljenja s pemetreksedom v primerjavi s placebom pri bolnikih z nedrobnoceličnim karcinomom pljuč, ki nima pretežno ploščatocelične histologije (merjeno od randomizacije)
Hospira and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
50 % predhodnega odmerka (obeh - zdravila Pemetreksed Hospira in cisplatina) Ta merila ustrezajo Merilom pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (National Cancer Institute Common Toxicity Criteria, CTC v2.0; NCI 1998), definiciji za ≥ CTC stopnjo krvavitve 2
For precautions to be taken before handling or administering Pemetrexed Hospira, see section 6.6.
Za previdnostne varnostne ukrepe pri pripravi in dajanju zdravila Pemetreksed Hospira glejte poglavje
Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) Alergijske reakcije: kožni izpuščaji/pekoč ali zbadajoč občutek Okužba vključno s sepso
Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Pemetreksed Hospira 500 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 500 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
500 mg viale pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa.
In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Hospira is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Zdravilo Pemetreksed Hospira kot samostojno zdravilo Pri bolnikih, pri katerih zdravimo nedrobnocelični pljučni karcinom po predhodni kemoterapiji, je priporočeni odmerek zdravila Pemetreksed Hospira 500 mg/m2 TP, dan kot intravenska infuzija v
Warnings and precautions Talk to your doctor or hospital pharmacist before receiving Pemetrexed Hospira.
Pred začetkom uporabe zdravila Pemetreksed Hospira se posvetujte z zdravnikom ali bolnišničnim farmacevtom.
What Pemetrexed Hospira contains
Kaj vsebuje zdravilo Pemetreksed Hospira
Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion: Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Pemetreksed Hospira 1.000 mg prašek za koncentrat za raztopino za infundiranje: Ena viala vsebuje 1.000 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
White to either light yellow or green-yellow lyophilised powder.
Bel do svetlorumen ali zelenorumen liofiliziran prašek.
Each 1,000 mg vial contains approximately 108 mg sodium.
Pomožna snov z znanim učinkom Ena 1.000 mg viala vsebuje približno 108 mg natrija.
Reconstitute 1,000 mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
1.000 mg viale pripravite s 40 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa.
Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
3. 100 mg viale pripravite s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa.
NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Hospira 1.000 mg prašek za koncentrat za raztopino za infundiranje
Other medicines and Pemetrexed Hospira
Shranjevanje zdravila Pemetreksed Hospira
After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Po rekonstituciji vsebuje ena viala 25 mg/ml pemetrekseda (glejte poglavje 6.6).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 1,000 mg presentation
Zunanja škatla 1.000 mg oblike
Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion
Pemetreksed Hospira 100 mg prašek za koncentrat za raztopino za infundiranje
NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Hospira 500 mg prašek za koncentrat za raztopino za infundiranje
Stomatitis/Pharyngitis 23.2 Nausea
Stomatitis/ faringitis
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 mg presentation
Zunanja škatla 500 mg oblike
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg presentation
Zunanja škatla 100 mg oblike
NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion pemetrexed
Pemetreksed Hospira 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 mg
Pemetreksed kot edino učinkovino so preučevali v odmerku 500 mg/m2 pri
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,000 mg
3 ter število trombocitov na ≥ 100.000 celic/mm
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 1,000 mg presentation
Nalepka na viali 1.000 mg oblike
London, 14 August 2008 EMEA/CHMP/524284/2008
London, 14. avgust 2008 EMEA/CHMP/524278/2008
Octegra was initially approved in June 1999.
Zdravilo Octegra so prvič odobrili junija 1999.
Octegra film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Zdravilo Octegra, filmsko obložene tablete, vsebuje 400 mg moksifloksacina v obliki hidroklorida.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Octegra and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION *
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 6(12) ZA ZDRAVILO Octegra in povezana imena Mednarodno nelastniško ime (INN): moksifloksacin OSNOVNE INFORMACIJE*
In general, safety reviews indicate that about 40% of such reports are in patients over 60 years of age.
Na splošno varnostni pregledi kažejo, da približno 40 % teh poročil vključuje bolnike, starejše od 60 let.
Contact our press officers Monika Benstetter or Martin Harvey
Monika Benstetter ali Martin Harvey
Restrictions on the use of domperidone-containing medicines
Omejitev uporabe zdravil, ki vsebujejo domperidon
The product information has been amended appropriately.
Informacije o zdravilu so bile ustrezno spremenjene.
The available evidence of efficacy was not sufficient to support its use for other indications.
Razpoložljivi dokazi o učinkovitosti niso bili zadostni, da bi podprli uporabo pri drugih indikacijah.
• Data in support of other indications were extremely limited.
• Podatki za podporo drugih indikacij so bili izjemno omejeni.
• Domperidone should be used at the lowest effective dose for the shortest possible duration.
• Domperidon je treba uporabljati v najmanjšem učinkovitem odmerku in najkrajšem mogočem obdobju.
The injectable form of domperidone was withdrawn in 1985 because of such side effects.
Domperidon za injiciranje je bil zaradi takih učinkov umaknjen leta 1985.
These recommendations are based on careful consideration of data on the safety and efficacy of domperidone from various sources.
Ta priporočila temeljijo na skrbni presoji podatkov o varnosti in učinkovitosti domperidona iz različnih virov.
The review of domperidone was initiated on 1 March 2013 at the request of the Belgian medicines authority, the Federal Agency for Medicines and Health Products (FAGG-AFMPS), under Article 31 of Directive 2001/83/EC.
Pregled domperidona se je na zahtevo belgijske agencije za zdravila (Federal Agency for Medicines and Health Products, FAGG-AFMPS) začel 1. marca 2013, skladno s členom 31 Direktive 2001/83/ES.
Some products will be withdrawn from the market because their strength does not match the new doses.
Nekatera zdravila bodo umaknjena iz prometa, saj njihova jakost ni skladna z novimi odmerki.
Although the scope of the review did not cover use outside the licensed indications (off-label use) the principles behind these recommendations should be considered whenever domperidone is used.
Čeprav presoja ni vključevala uporabe zunaj odobrenih indikacij (nenamenska uporaba), je treba načela teh priporočil upoštevati ob vsakršni uporabi domperidona.
The recommendations were originally made by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 3-6 March, after a careful evaluation of the available evidence on the benefits and risks of such medicines.
Priporočila je na svojem sestanku od 3. do 6. marca prvotno pripravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji EMA, po skrbni presoji razpoložljivih dokazov o koristih in tveganjih teh zdravil.
This helps to prevent nausea (feeling sick) and vomiting.
To pomaga preprečevati slabost (navzeo) in bruhanje.
This is in line with the data coming from drug-drug interaction studies, and from spontaneous reporting.
To je skladno s podatki iz študij medsebojnega delovanja med zdravili in spontanim poročanjem.
The product information for domperidone-containing products has been updated, and a letter has been sent to healthcare professionals explaining the new recommendations.
Informacije o zdravilih, ki vsebujejo domperidon, so bile posodobljene, zdravstvenim delavcem pa je bilo poslano pismo z razlago novih priporočil.
• Patients or carers who have any concerns should speak to a healthcare professional.
• Bolniki ali negovalci, ki imajo pomisleke, naj se posvetujejo z zdravstvenim delavcem.
There have been concerns that it might increase the risk of side effects on the heart, including dangerously irregular heartbeats in some patients.
Prisotni so bili pomisleki, da bi lahko povečal tveganje neželenih učinkov na srce, vključno z nevarno nerednim srčnim utripom pri nekaterih bolnikih.
Some of these studies also supported a greater risk in patients over 60 years of age or who were taking high doses (over 30 mg/day).
Nekatere od teh študij so prav tako podprle večje tveganje pri bolnikih, starejših od 60 let, ali bolnikih, ki jemljejo velike odmerke (nad 30 mg/dan).
In addition, it should not be used with other medicines that have similar effects on the heart or reduce the breakdown of domperidone in the body (thus increasing the risk of side effects).
Poleg tega se ne sme uporabljati skupaj z drugimi zdravili, ki imajo podobne učinke na srce ali zmanjšajo razgradnjo domperidona v telesu (in s tem povečajo tveganje neželenih učinkov).
The review of domperidone was carried out at the request of the Belgian medicines authority over concerns about the medicine's effects on the heart.
Presojo domperidona so izvedli na zahtevo belgijske agencije za zdravila zaradi pomislekov, povezanih z učinki zdravila na srce.
In particular, there was little evidence in support of the long-term efficacy of domperidone in dyspepsia and gastro-oesophageal reflux disorder.
Predvsem je bilo malo dokazov, ki bi podpirali dolgotrajno učinkovitost domperidona pri dispepsiji in gastroezofagealnem refluksu.
However, cases of heart problems in patients using the medicine continued to be reported, and the PRAC was therefore asked to examine whether the benefits still outweighed the risks for these medicines in their approved uses and forms, and whether their marketing authorisations should be maintained or changed across the EU.
Vendar pa so pri bolnikih, ki so uporabljali ta zdravila, še naprej poročali o primerih srčnih težav, zato so odbor PRAC zaprosili, naj preveri, ali so koristi teh zdravil za odobreno uporabo in v odobrenih oblikah še vedno večje od z njimi povezanih tveganj ter ali je treba dovoljenja za promet z njimi ohraniti ali spremeniti po celotni EU.
The benefits in these indications were therefore not considered to outweigh the risk.
Posledično je bil sprejet sklep, da koristi pri teh indikacijah niso večje od tveganj.
• Patients with certain existing heart problems, or who are taking certain other medicines that enhance the effects of domperidone or reduce its breakdown in the body, should not take domperidone.
• Bolniki z nekaterimi obstoječimi srčnimi težavami ali bolniki, ki jemljejo nekatera druga zdravila, ki okrepijo učinke domperidona ali zmanjšajo njegovo razgradnjo v telesu, ne smejo jemati domperidona.
• Formulations not consistent with the new dosage recommendations will be withdrawn from the market, as will combinations of domperidone with cinnarizine.
• Formulacije, ki niso skladne s priporočili za novo odmerjanje, bodo umaknjene iz prometa, kar velja tudi za kombinacije domperidona in cinarizina.
Domperidone-containing medicines have been authorised in most EU Member States via national procedures since the 1970s and are widely available as over-the-counter or prescription-only medicines.
Zdravila, ki vsebujejo domperidon, so v večini držav članic EU z nacionalnimi postopki odobrena že od 70-tih let 20. stoletja in so široko razpoložljiva kot zdravila brez recepta ter zdravila na recept.
The medicine should not normally be used for longer than one week.
Zdravilo se navadno ne sme uporabljati dlje kot en teden.
• Domperidone is a medicine that has been used for various stomach and digestive problems.
• Domperidon je zdravilo, ki se uporablja pri različnih težavah z želodcem in prebavo.
The maximum treatment duration should not usually exceed one week.
Najdaljše trajanje zdravljenja običajno ne sme preseči enega tedna.
• Although the results of the thorough QT study with domperidone indicate that it does not significantly prolong the QTc interval when administered to healthy subjects at 10 mg and 20 mg four times daily, there are limitations in the study that restrict the conclusions that can be drawn.
• Čeprav rezultati podrobne študije QT z domperidonom kažejo, da ne povzroča pomembnega podaljšanja intervala QTc, če se daje zdravim preizkušancem v odmerkih 10 mg in 20 mg štirikrat na dan, je bila študija omejena, zato ni mogoče sprejeti dokončnih sklepov.
Serious effects on the heart with domperidone, including prolongation of the QT interval (an alteration of the electrical activity of the heart) and arrhythmias (unstable heartbeats), have previously been evaluated by the EMA and the product information updated with relevant warnings.
Resne učinke domperidona na srce, vključno s podaljšanjem intervala QT (spremembo električne aktivnosti srca) in aritmijami (nestabilnim srčnim utripom), je predhodno že ocenila agencija EMA, informacije o zdravilu pa so bile posodobljene z ustreznimi opozorili.
Appropriate risk minimisation measures have therefore been included in the product information to address this issue.
V informacije o zdravilu so bili zato vključeni ustrezni ukrepi za zmanjševanje tveganja, s katerimi bo ta težava obravnavana.
Of 57 reported cardiovascular fatalities, 27 had other risk factors, while 13 had either an implausible relationship to domperidone administration or an alternative aetiology.
Od 57 primerov kardiovaskularnih smrti je imelo 27 preskušancev dejavnike tveganja, 13 pa nedokazljivo povezavo z uporabo domperidona ali drugo etiologijo.
• Epidemiological studies mostly suggest that domperidone exposure was associated with an increase in risk for sudden cardiac death or ventricular arrhythmia.
• Epidemiološke študije večinoma kažejo, da je bila izpostavljenost domperidonu povezana s povečanjem tveganja nenadne srčne smrti ali ventrikularne aritmije.
Those who are taking domperidone long-term or in higher doses, or for conditions other than nausea and vomiting, should consult their doctor at their next scheduled appointment or speak to their pharmacist to discuss their treatment.
Bolniki, ki domperidon jemljejo dolgotrajno ali v večjih odmerkih ali pa za stanja, ki niso slabost ali bruhanje, naj se posvetujejo s svojim zdravnikom ob naslednjem načrtovanem obisku ali pa naj se o svojem zdravljenju posvetujejo s farmacevtom.
Products supplying a dose of 20 mg by mouth, and suppositories of 10 or 60 mg are no longer recommended for use and should be withdrawn, as should combination products with cinnarizine (an antihistamine) where available.
Zdravila v peroralnem odmerku 20 mg ter svečke v odmerku 10 ali 60 mg niso več priporočeni za uporabo in jih je treba umakniti, kar velja tudi za kombinirana zdravila s cinarizinom (antihistaminikom), kjer so na voljo.
As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU.
Ker je skupina CMDh to stališče sprejela z večino, je bilo poslano Evropski komisiji, ki ga je potrdila in izdala končno pravno zavezujočo odločbo, veljavno v celotni EU.
On 23 April 2014, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed recommendations to restrict the use of domperidone-containing medicines.
Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), je 23. aprila 2014 potrdila priporočila za omejitev uporabe zdravil, ki vsebujejo domperidon.
As the CMDh position was adopted by majority vote, the CMDh position was sent to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU on 1 September 2014.
Ker je skupina CMDh to stališče sprejela z večino, je bilo poslano Evropski komisiji, ki ga je potrdila in 1. septembra 2014 izdala končno pravno zavezujočo odločbo, veljavno v celotni EU.
This comprised non-clinical and clinical data, both published and unpublished, including a thorough QT study, cumulative review of case reports of cardiac disorders and vascular investigations from the safety databases for domperidone products, pharmacoepidemiological studies, and published and unpublished efficacy studies.
Ti so vključevali predklinične in klinične podatke (objavljene in neobjavljene), vključno s podrobno študijo QT, kumulativnim pregledom poročil o primerih srčnih motenj in vaskularnimi raziskavami iz varnostnih podatkovnih zbirk za zdravila, ki vsebujejo domperidon, farmakoepidemiološke študije ter objavljene in neobjavljene študije učinkovitosti.
A combination product with cinnarizine (an antihistamine) is available in some Member States for the treatment of motion sickness.
Kombinirano zdravilo s cinarizinom (antihistaminikom) je v nekaterih državah članicah EU na voljo za zdravljenje potovalne slabosti.
• There is no good evidence to support the use of domperidone for other conditions such as bloating and heartburn, and so it is no longer authorised to treat these conditions.
• Dokazi, s katerimi bi lahko podprli uporabo domperidona za druga stanja, kot sta napihnjenost in zgaga, so slabi, zato ni več odobren za zdravljenje takih stanj.
The CMDh, a medicines regulatory body representing the EU Member States, agreed that these medicines should only be used to relieve symptoms of nausea and vomiting, that doses and length of treatment should be restricted and that they should be adjusted carefully by the patient's weight where available for use in children.
CMDh, regulativni organ za zdravila, ki zastopa države članice EU, se je strinjal, da se smejo ta zdravila uporabljati samo za lajšanje simptomov navzee (slabosti) in bruhanja, da je treba odmerke ter trajanje zdravljenja omejiti in da jih je treba skrbno prilagoditi bolnikovi telesni masi, če so na voljo za uporabo pri otrocih.
• Overall there was sufficient evidence to support the use of oral domperidone 10 mg up to three times a day in a general indication of treatment of nausea and vomiting in adults.
• Na splošno so bili dokazi za podporo uporabe peroralnega domperidona 10 mg do trikrat na dan pri splošni indikaciji za zdravljenje navzee in bruhanja pri odraslih zadostni.
Domperidone will no longer be authorised to treat other conditions such as bloating or heartburn.
Domperidon ne bo več odobren za zdravljenje drugih stanj, kot sta napihnjenost ali zgaga.
Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes but also for the management of symptoms such as bloating, discomfort and heartburn.
Zdravila, ki vsebujejo domperidon, so bila v posameznih državah članicah EU nacionalno odobrena za zdravljenje navzee in bruhanja zaradi različnih vzrokov ter tudi za obravnavo simptomov, kot so napihnjenost, neugodje in zgaga.
• A review of the safety database of the originator product involving 342 serious reports of cardiac events or vascular investigations highlighted the high frequency of associated cardiovascular risk factors, cardiovascular history, and concomitant medications associated with cardiac arrhythmias in the patients concerned.
• Pregled varnostne podatkovne zbirke za originatorsko zdravilo, ki vključuje 342 poročil o resnih srčnih dogodkih ali vaskularnih raziskavah, je izpostavil veliko pogostnost povezanih kardiovaskularnih dejavnikov tveganja, kardiovaskularno anamnezo in sočasna zdravila, povezane s srčnimi aritmijami pri zadevnih bolnikih.