natgillin/translations-raw huggingface dataset:
Hs-CRP (mg/L) a Number of patients b Mean percent change (least square mean ± standard error) between baseline measured after 8 weeks on Pravastatin 40 mg and 12 additional weeks with Pravafenix 40 mg/160 mg or Pravastatin 40 mg c Pairwise p-value is significant if <0.05
a Število bolnikov b Povprečna sprememba v odstotkih (povprečje najmanjših kvadratov ± standardna napaka) med izhodiščno vrednostjo, izmerjeno po 8 tednih jemanja pravastatina 40 mg, in vrednostjo po 12
Clinically important elevation (CK ≥ 10 times the ULN without muscular symptoms) was seen in 0.06% of the patients treated with Pravafenix.
kratnika ZMN brez simptomov v mišicah) je prišlo pri 0,06 % bolnikov, ki so prejemali zdravilo Pravafenix (glejte poglavje 4.4).
Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Pravafenix 40 mg/160 mg trde kapsule pravastatin/fenofibrat
Clinically important elevations in serum transaminases (ALT and/or AST ≥ 5 times the ULN) were seen in 0.38% of the patients treated with Pravafenix.
Med bolniki, ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3-kratnika ZMN < 5-kratnika ZMN) znašala 0,83 %.
Routine monitoring of CK is systematically recommended every 3 months during the first 12 months of the combination therapy and let to the appreciation of the clinician beyond this initial period.
V prvih 12 mesecih kombiniranega zdravljenja je sistematično priporočljivo rutinsko spremljanje kreatin-fosfokinaze na vsake 3 mesece, po tem začetnem obdobju pa je odločitev o tem prepuščena zdravniku.
Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents, ATC code: C10BA03
Farmakoterapevtska skupina: Učinkovine, ki vplivajo na lipide, zaviralci reduktaze hidroksimetilglutaril koencima A v kombinaciji z drugimi učinkovinami, ki vplivajo na lipide, oznaka
Diabetes mellitus aggravated, Obesity
Presnovne in prehranske motnje poslabšanje sladkorne bolezni, debelost občasni
In clinical studies, the incidence of important elevations in serum transaminases (ALT
Do klinično pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 5-kratnika ZMN) je prišlo pri
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules
IME ZDRAVILA Pravafenix 40 mg/160 mg trde kapsule
A small amount of pravastatin is excreted in human breast milk; therefore pravastatin is contraindicated during breastfeeding (see section 4.3).
Pravastatin se v majhnih količinah izloča v materino mleko, zato je med dojenjem kontraindiciran
Treatment should be discontinued in case of an estimated creatinine clearance < 60 ml/min.
Če je ocenjeni očistek kreatinina < 60 ml/min, je treba zdravljenje prekiniti.
CK levels should be measured prior to initiation of therapy.
Pred začetkom zdravljenja je treba izmeriti vrednosti kreatin-fosfokinaze.
The pharmacokinetics properties of Pravafenix are not completely identical to the co-administration of the existing monotherapies when taken with fat-meal or in fasting state.
Če se zdravilo Pravafenix vzame med obrokom, ki vsebuje maščobe, ali med postenjem, njegove farmakokinetične lastnosti niso popolnoma enake kot pri sočasni uporabi obstoječih monoterapij.
Dizziness, headache, paraesthesia
Bolezni živčevja omotica, glavobol, parestezija občasni
There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination (see section 4.5).
Pri bolnikih, ki so prejemali to kombinacijo, so poročali o rabdomiolizi (vključno s smrtnimi izidi) (glejte poglavje
Always take Pravafenix exactly as your doctor has told you.
Pri jemanju zdravila Pravafenix natančno upoštevajte zdravnikova navodila.
Haemoglobin decreased, White blood cell count decreased
Bolezni krvi in limfatičnega sistema znižanje ravni hemoglobina, zmanjšano število belih krvničk redki
Arthralgia, back pain, blood creatine phosphokinase increased, muscle spasms, musculoskeletal pain, myalgia, pain in extremity.
mišični krči, mišično-skeletne bolečine, mialgija, bolečine v udih občasni
In interaction studies, no statistically significant differences in bioavailability were observed when pravastatin was administered with acetylsalicylic acid, antacids (when given one hour prior to pravastatin), nicotinic acid or probucol.
Če je bil pravastatin sočasno uporabljen z acetilsalicilno kislino, antacidi (kadar so bili vzeti eno uro pred pravastatinom), nikotinsko kislino ali probukolom, v študijah medsebojnega delovanja niso opazili statistično pomembnih razlik v biološki uporabnosti.
No posology adjustment is required in patients with mild hepatic impairment.
Prilagoditev odmerjanja pri bolnikih z blago okvaro jeter ni potrebna.
Adverse reaction (Pravastatin)
Porazdelitev Pravastatin
Muscle disorder (e.g. myositis, muscular weakness)
miozitis, mišična oslabelost)
TG (mg/dl)
Trigliceridi (mg/dl)
Immune system disorders
Organski sistem Neželeni učinek
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/005 60 hard capsules
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/679/005, 60 trdih kapsul
EU/1/11/679/004 30 hard capsules
EU/1/11/679/004, 30 trdih kapsul
Side effects of unknown frequency (frequency cannot be estimated from the available data) • Muscle weakness that is constant
Neželeni učinki neznane pogostnosti:
Clinically important elevations in creatine phosphokinase (CK ≥ 5 times the ULN, < 10 times the ULN without muscular symptoms) were seen in 0.38% of the patients treated with Pravafenix.
Kreatin-fosfokinaza se jeklinično pomembno zvišala (KF ≥ 5-kratnika ZMN ≥ 10-kratnika ZMN brez simptomov v mišicah) pri
Common side effects (may affect up to 1 in 10 people)
Občasni neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 1000 bolnikov)
Sodium hydrogen carbonate Lauroyl macrogolglycerides Type 1500 Hydroxypropylcellulose Macrogol 20 000
Vsebina kapsule laktoza monohidrat, mikrokristalna celuloza, askorbilpalmitat, povidon K29-32, natrijev karboksimetilškrob, magnezijev stearat, smukec, triacetin, natrijev hidrogenkarbonat, lauroil makrogolgliceridi tip 1500, hidroksipropilceluloza, makrogol 20 000.
How to take pravafenix
KAKO JEMATI ZDRAVILO PRAVAFENIX
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001 30 hard capsules
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/679/001, 30 trdih kapsul
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijske pnevmopatije neznana
Immune-mediated necrotizing myopathy (see section 4.4).
posamezni primeri okvar kit, pri katerih včasih pride do zapleta s pretrganjem rabdomioliza imunsko posredovana nekrotizirajoča miopatija (glejte poglavje 4.4.)
Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin.
Pri sočasni uporabi fenofibrata in ciklosporina poročajo o nekaj resnih primerih reverzibilne okvare ledvične funkcije.
In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p=0.022) and a statistically non significant increase in deep vein thrombosis (placebo 1.0% 48/4,900 patients) versus fenofibrate 1.4% (67/4,895); p=0.074.
V študiji FIELD so poročali o statistično pomembnem povečanju pogostosti pojavljanja pljučne embolije (0,7 % v skupini, ki je prejemala placebo, v primerjavi z 1,1 % v skupini, ki je prejemala fenofibrat; p = 0,022) in o statistično nepomembnem povečanju pogostosti globoke venske tromboze
- Your doctor should do a blood test before you start taking Pravafenix.
- Preden začnete jemati zdravilo Pravafenix, mora zdravnik opraviti preiskavo vaše krvi.
LDL-C (mg/dl)
Holesterol LDL (mg/dl)
OTHER
in
HDL-C (mg/dl)
Holesterol HDL (mg/dl)
Tel. +32 (2) 411 48 28 Fax.
Faks +32 (2) 411 28 28
Mean (%)± SEb p-valuec
b vrednost p b
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/007 14 hard capsules
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/679/007, 14 trdih kapsul
SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgium
Ime in naslov izdelovalca, odgovornega za sproščanje serije: SMB Technology s.a. rue du Parc Industriel 39
PHARMACEUTICAL PARTICULARS
PROMET Z ZDRAVILOM
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLES FOR 60 AND 90 HARD CAPSULES
PLASTENKE ZA 60 IN 90 TRDIH KAPSUL
- You have a history of muscle problems (e.g. myopathy or rhabdomyolysis) during treatment with cholesterol-controlling medicines called ‘statins' (such as simvastatin, atorvastatin, pravastatin or rosuvastatin) or fibrates (such as fenofibrate and bezafibrate).
(kot so simvastatin, atorvastatin, pravastatin ali rosuvastatin) ali fibrati (kot sta fenofibrat in bezafibrat), težave z mišicami.
- If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
EU/1/11/679/002 60 hard capsules
EU/1/11/679/002, 60 trdih kapsul
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja pruritus, urtikarija občasni
Other medicines and Pravafenix
SHRANJEVANJE ZDRAVILA PRAVAFENIX
Check with your doctor or pharmacist if you are not sure.
Posvetujte se z zdravnikom ali farmacevtom, preden vzamete katerokoli zdravilo.
No clinically significant pharmacokinetic interaction was seen when fenofibrate was coadministered with pravastatin.
Pri sočasni uporabi fenofibrata in pravastatina niso opazili nobenih pomembnih farmakokinetičnih interakcij.
Fibrinogen (g/L)
Apoprotein B/apoprotein A Fibrinogen (g/l) Hs-CRP (mg/l)
• Tingling and numbness (peripheral polyneuropathy).
(INR - International Normalised Ratio).
Asthenia, fatigue, influenza like illness
Splošne težave in spremembe na mestu aplikacije astenija, utrujenost, gripi podobno bolezensko stanje občasni
• Digestive effects: gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence, constipation, dry mouth, upper abdominal pain with bloating (dyspepsia), burping
• učinki na prebavo: želodčne ali črevesne težave (bolečine v trebuhu, siljenje na bruhanje,
D.
s
Jaundice, fulminant hepatic necrosis
Interakcije, pomembne za pravastatin Holestiramin/holestipol
Hepatic pain, gammaglutamyl transferase increased.
Bolezni jeter, žolčnika in žolčevodov zvišana vrednost transaminaz pogosti bolečina v jetrih, zvišana gama-glutamiltransferaza občasni
NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules pravastatin/fenofibrate
NAVODILO ZA UPORABO Pravafenix 40 mg/160 mg trde kapsule pravastatin/fenofibrat
EU/1/11/679/006 90 hard capsules
EU/1/11/679/006, 90 trdih kapsul
EU/1/11/679/003 90 hard capsules
EU/1/11/679/003, 90 trdih kapsul
Skin rash, Scalp/hair abnormality (including alopecia)
Bolezni kože in podkožja kožni izpuščaj, bolezenska sprememba na lasišču/laseh (vključno z alopecijo)
There are no data on fertility from the combined use of fenofibrate and pravastatin
Pri kombinirani uporabi fenofibrata in pravastatina ni podatkov o vplivu na plodnost.
Reproductive system and breast disorders
Motnje reprodukcije in dojk motnje na področju spolnosti motnje na področju spolnosti občasni
Additional information on the individual active substances of the fixed dose combination Pravafenix contains pravastatin and fenofibrate.
VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo Pravafenix
Hypersensitivity reactions
Bolezni imunskega sistema preobčutljivostne reakcije občasni
Hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet.
Vsebuje voskasto snov umazano bele barve in tableto.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.3 Kontraindikacije - Preobčutljivost za zdravilno učinkovino (zdravilni učinkovini) ali katero koli pomožno snov,
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
PRILOGA I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z
Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
Republika Češka Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
Durogesic Matrix 12 µg/h
Durogesic Matrix 12 µg/h transdermalni obliž transdermalna uporaba
Durogesic Matrix 75 µg/h
Durogesic Matrix 75 µg/h transdermalni obliž transdermalna uporaba
Durogesic Matrix 25 µg/h
Durogesic Matrix 25 µg/h transdermalni obliž transdermalna uporaba
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Zadnja in odobrena besedila glavnih značilnosti zdravila, označevanja in navodila za uporabo so bila dogovorjena v okviru skupine za koordinacijo.
Summary of product characteristics, labelling and package leaflet
Povzetek glavnih značilnosti besedila, označevanje in navodilo za uporabo
It increases the range of available vaccine options.
Povečuje nabor razpoložljivih možnosti za cepljenje.
The greatest number of adverse events was reported in France.
O največjem številu neželenih dogodkov so poročali v Franciji.
The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Pristojni nacionalni organi, ki jih koordinira referenčna država članica, morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
However, from the data evaluated, a definitive conclusion could not be drawn concerning these hypotheses.
Vendar pa na podlagi ocenjenih podatkov ni bilo mogoče sprejeti končnega zaključka o teh hipotezah.
The frequency of events reported varies across Member States and does not appear to directly reflect the amount of product sold.
Pogostost neželenih dogodkov se po državah članicah razlikuje in zdi se, da ne odraža neposredno količine prodanega zdravila.
To date no adverse events have been reported in the remaining 12 concerned Member States.
Do danes v preostalih 12 zadevnih državah članicah niso poročali o nobenih neželenih dogodkih.
Based on post-authorisation safety data, there is no evidence that the product poses a risk to the user, the consumer or the environment.
Na podlagi podatkov o varnosti po izdaji dovoljenja za promet z zdravilom ni nobenih dokazov, da zdravilo predstavlja tveganje za uporabnika, potrošnika ali okolje.
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species and marketing authorisation holders in the Member States
Seznam imen, farmacevtske oblike, jakosti veterinarskega zdravila, živalskih vrst in imetnikov dovoljenja za promet z zdravilom v državah članicah
Additionally, in Spain where approximately half of the total EU-product sales are recorded, two adverse events have been reported to date.
V Španiji, kjer so prodali okoli polovico vseh zdravil v EU, so do zdaj poročali o dveh neželenih dogodkih.
As no corrective measures can be implemented at present, it cannot be excluded that the serious adverse events reported in some Member States could also occur in others which to date have been unaffected.
Ker trenutno ni mogoče začeti izvajati korektivnih ukrepov, ni mogoče izključiti možnosti, da se lahko hudi neželeni dogodki, o katerih so poročali v nekaterih državah članicah, pojavijo tudi v drugih, ki do danes še niso bile prizadete.
The marketing authorisation holder has taken precautionary measures to stop sales of the product in the EU.
Imetnik dovoljenja za promet z zdravilom je sprejel previdnostne ukrepe za zaustavitev prodaje zdravila v EU.
Anaphylactic-type adverse events have been reported most frequently in three of the 16 Member States where the product is authorised, Belgium, France and Italy.
O anafilaktičnih neželenih dogodkih so najpogosteje poročali v treh od 16 držav članic, v katerih je bilo zdravilo odobreno, in sicer v Belgiji, Franciji in Italiji.
Following the initial placing on the market in France in 2009, the frequency of adverse events reported in relation to the amount of product sold was estimated to be approximately one affected animal for 860 animals treated (nine adverse event reports involving 69 affected animals, 18 of which died).
Po začetku trženja v Franciji leta 2009 so ocenili, da se glede na količino prodanega zdravila neželeni dogodki, o katerih so poročali, pojavljajo pri približno eni prizadeti živali na 860 zdravljenih živali (devet poročil o neželenih dogodkih pri 69 prizadetih živalih, 18 od teh je poginilo).
A second study, also investigating the potential role of bovine respiratory syncytial virus vaccines as a predisposing factor, was ongoing and results are expected by the end of July 2011.
Druga študija, v kateri prav tako preučujejo morebiten vpliv cepiv proti govejemu respiratornemu sincicijskemu virusu kot predispozicijskih dejavnikov, še poteka, rezultati pa naj bi bili na voljo do konca julija 2011.
The potential risk of such events following use of the product was considered to be not acceptable in comparison to the benefits provided.
Možno tveganje za pojav takih dogodkov po uporabi zdravila je štelo za nesprejemljivo v primerjavi s koristmi tega zdravila.
The Committee considered the possible role of additional contributory factors in relation to the adverse events reported, such as quality (batch)related effects, animal related effects (e.g. breed, age sensitivity); interactions; and/or geographical factors.
Odbor je upošteval morebitno vlogo drugih dejavnikov, ki bi lahko vplivali na pojav neželenih dogodkov, o katerih so poročali, na primer vplivi kakovosti (serije); učinki, povezani z živalmi (npr. pasma, starostna občutljivost); interakcije in/ali zemljepisni dejavniki.
The frequency of anaphylactic-type events reported following use of the product increased markedly since October 2010 in Belgium, France and Italy compared with other concerned Member States.
Pogostnost anafilaktičnih dogodkov, o katerih so poročali po uporabi zdravila, se je od oktobra 2010 v primerjavi z drugimi zadevnimi državami članicami bistveno povečala v Belgiji, Franciji in Italiji.
Adverse events concerning anaphylactic-type reactions, some of which were fatal, have been reported in four EU Member States.
O neželenih dogodkih v zvezi z anafilaktičnimi reakcijami, med katerimi so bili tudi primeri s smrtnim izidom, so poročali v štirih državah članicah EU.
In France, the incidence of anaphylactictype events reported was estimated to be 0.177% or 1 affected animal for 560 treated animals.
V Franciji je bila pojavnost anafilaktičnih dogodkov, o katerih so poročali, ocenjena na 0,177 % ali 1 prizadeto žival na 560 zdravljenih živali.
Since October 2010, the number of reports resembling anaphylactic events, some of which were fatal, has increased, (from 12 to 24), most notably in four of the 16 European Union (EU) Member States where the product is authorised.
Od oktobra 2010 se je povečalo število poročil (z 12 na 24) o anafilaktičnih dogodkih, med katerimi so bili tudi primeri s smrtnim izidom, predvsem v štirih od 16 držav članic Evropske unije (EU), v katerih je zdravilo odobreno.
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that the pharmacovigilance data (adverse event reports) indicated that the frequency of reported events of anaphylactic-type reactions varied across the EU.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da farmakovigilančni podatki (poročila o neželenih dogodkih) kažejo, da se pogostost dogodkov z anafilaktičnimi reakcijami, o katerih so poročali v EU, razlikuje.
The marketing authorisation holder voluntarily stopped the sales of the product in March 2011, initially in France and subsequently in all other concerned EU Member States.
Imetnik dovoljenja za promet z zdravilom je marca 2011 prostovoljno zaustavil prodajo zdravila, najprej v Franciji in nato še v vseh drugih zadevnih državah članicah EU.
The underlying mechanism for the events observed and potential contributory factors are unknown at present and subject to ongoing research.
Trenutno so osnovni mehanizem opaženih dogodkov in možni dejavniki, ki bi lahko nanje vplivali, neznani in se preučujejo v potekajočih raziskavah.
Belgium LABORATORIOS HIPRA, S.A. Avda.
Madžarska LABORATORIOS HIPRA, S.A. Avda.
Whilst the animal health and welfare and economic and benefits of vaccination against bovine respiratory disease are acknowledged, HIPRABOVIS PNEUMOS Emulsion for injection for cattle is not an essential vaccine for cattle.
Medtem ko so zdravje in dobrobit živali ter ekonomske in druge koristi cepiv proti goveji respiratorni bolezni dobro znani, pa zdravilo HIPRABOVIS PNEUMOS Emulzija za injiciranje za govedo ni osnovno cepivo za govedo.
Benefit-risk evaluation
Ocena razmerja med koristmi in tveganji
It was noted that since March 2011 the marketing authorisation holder voluntarily stopped sales of the product in all concerned EU Member States where the product is authorised.
Poudarjeno je bilo, da je imetnik dovoljenja za promet z zdravilom marca 2011 prostovoljno ustavil prodajo zdravila v vseh zadevnih državah članicah EU, v katerih je bilo zdravilo odobreno.
The underlying mechanism and potential contributory factors associated with the events have yet to be elucidated.
Osnovni mehanizem in dejavnike, ki bi lahko vplivali na te dogodke, je treba še pojasniti.
It was considered that the conditions under which the study was conducted and the limited number of animals enrolled were insufficient to draw definitive conclusions to explain the increase in anaphylactic-type events observed in the field or to recommend measures to reduce the risk of such events.
Ugotovljeno je bilo, da pogoji, pod katerimi je bila študija izvedena, in omejeno število vključenih živali ne zadostujejo za dokončne sklepe, ki bi pojasnili povečano število opaženih anafilaktičnih dogodkov na terenu ali na podlagi katerih bi se lahko priporočili ukrepi za zmanjšanje tveganja za take dogodke.
Between 1 April 2010 and 28 February 2011, the overall incidence of adverse events in the EU was estimated to be approximately 0.048% (or ‘rare') and the incidence of fatalities was estimated as approximately 0.0087% (or ‘very rare').
Med 1. aprilom 2010 in 28. februarjem 2011 je bila skupna pojavnost neželenih dogodkov v EU ocenjena na okoli 0,048 % (ali „redki“), pojavnost smrtnosti pa na okoli 0,0087 % (ali „zelo redka“).
The potential relation between the adverse events reported and possible endotoxin effects associated with the product was considered.
Preučili so tudi možno povezavo med neželenimi dogodki, o katerih so poročali, in možnimi endotoksičnimi učinki, povezanimi z zdravilom.
The marketing authorisation holder should investigate the qualitative nature of the adverse events observed; investigate the potential factors that may explain the regional differences observed concerning the adverse events; and propose appropriate measures to mitigate the risk of occurrence of such adverse events to demonstrate a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics.
Imetnik dovoljenja za promet z zdravilom mora preučiti kakovost opaženih neželenih dogodkov, preučiti možne dejavnike, ki bi lahko pojasnili opažene regionalne razlike pri pojavljanju teh neželenih dogodkov, predlagati ustrezne ukrepe za zmanjšanje tveganja za pojav takih neželenih dogodkov ter dokazati ugodno razmerje med koristmi in tveganji zdravila pri uporabi v skladu s priporočili, navedenimi v povzetku glavnih značilnosti zdravila.