natgillin/translations-raw huggingface dataset:
Prilagoditev odmerjanja pri bolnikih z blago okvaro jeter ni potrebna. 
No posology adjustment is required in patients with mild hepatic impairment.
Bolezni živčevja omotica, glavobol, parestezija občasni 
Dizziness, headache, paraesthesia
s fenofibratom in pravastatinom na zdravilo Pravafenix (glejte poglavje 5.2). 
Patients should not be switched from a free co-administration of fenofibrate and pravastatin preparation to Pravafenix (see section 5.2.
(kot so simvastatin, atorvastatin, pravastatin ali rosuvastatin) ali fibrati (kot sta fenofibrat in bezafibrat), težave z mišicami (npr. miopatija ali rabdomioliza). 
- 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).
Pri jemanju zdravila Pravafenix natančno upoštevajte zdravnikova navodila. 
Always take Pravafenix exactly as your doctor has told you.
mišični krči, mišično-skeletne bolečine, mialgija, bolečine v udih občasni 
Arthralgia, back pain, blood creatine phosphokinase increased, muscle spasms, musculoskeletal pain, myalgia, pain in extremity.
Bolezni mišično skeletnega sistema, vezivnega tkiva in kosti bolezen mišic (npr. 
Musculoskeletal, connective tissue and bone disorders
znižanje hemoglobina (krvnega barvila, ki prenaša kisik) in levkocitov (belih krvničk). 
Rare side effects (may affect up to 1 in 1,000 people) • Decrease in haemoglobin (oxygen-carrying pigment in blood) and leukocytes (white blood cells).
Trigliceridi (mg/dl) 
TG (mg/dl)
Organski sistem Neželeni učinek 
Immune system disorders
imeli težave z mišicami, - če jemljete ali ste v zadnjih 7 dnevih jemali ali prejeli zdravilo, imenovano fusidna kislina (zdravilo za bakterijsko okužbo), 
Tell your doctor if any of the following applies to you: - Liver or kidney problems - Thyroid problems - You are more than 70 years old - You have ever had muscle problems during a treatment with cholesterol-lowering medicines such as a statin or fibrate - You are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (a medicine for bacterial infection - You or your close family members have a hereditary muscle disorder - You have alcohol problems (regularly drinking large amounts of alcohol)
Pri podganah in miših so pri visokih odmerkih našli 
In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation.
miozitis, mišična oslabelost) 
Muscle disorder (e.g. myositis, muscular weakness)
sladkorne bolezni, debelost občasni 
Diabetes mellitus aggravated, Obesity
Za nadaljnje informacije o tem zdravilu 
See leaflet for further information
skupni holesterol, holesterol LDL, apolipoprotein B, holesterol VLDL in trigliceride. 
In both healthy subjects and patients with hypercholesterolaemia, pravastatin lowers the following lipid values: total cholesterol, LDL-cholesterol, apolipoprotein B, VLDL-cholesterol and triglycerides; while HDL-cholesterol and apolipoprotein A are elevated.
EU/1/11/679/004, 30 trdih kapsul 
EU/1/11/679/004 30 hard capsules
transaminaz na vsake 3 mesece, po tem začetnem obdobju pa je odločitev o tem prepuščena zdravniku. 
It is recommended that transaminase levels be monitored every 3 months during the first 12 months of treatment and let to the appreciation of the clinician beyond this initial period.
Bolezni krvi in limfatičnega sistema znižanje ravni hemoglobina, zmanjšano število belih krvničk redki 
Haemoglobin decreased, White blood cell count decreased
Opazili so embriotoksične učinke v odmerkih, katerih količine so bile v okviru količin toksičnosti pri materi. Pri velikih odmerkih so opazili podaljšanje gestacijske dobe in težave med porodom. 
Embryotoxic effects were observed at doses in the range of maternal toxicity.
izpuščaji, kožni izpuščaj, srbenje, koprivnica ali reakcija na sončno svetlobo ali izpostavljenost 
• Rashes, skin rash, itching, hives or reactions to sunlight or exposure to UV light (photosensitivity reactions), scalp/hair abnormality (including hair loss)
Porazdelitev Pravastatin 
Adverse reaction (Pravastatin)
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) 
Common side effects (may affect up to 1 in 10 people)
Trda kapsula s svetlozelenim spodnjim in olivno zelenim zgornjim delom. 
Hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet.
PLASTENKE ZA 60 IN 90 TRDIH KAPSUL 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLES FOR 60 AND 90 HARD CAPSULES
Prilagoditev odmerjanja pri bolnikih z blago okvarno lednic ni potrebna. 
No modification of posology should be necessary in patients with mild renal impairment.
Pri sočasni uporabi fenofibrata in ciklosporina poročajo o nekaj resnih primerih reverzibilne okvare ledvične funkcije. 
Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin.
s pravastatinom za celotno obdobje zdravljenja s fusidno kislino. 
If treatment with fusidic acid is necessary, pravastatin treatment should be discontinued throughout the duration of the fusidic acid treatment.
Solartium Group S.r.l. Tel: +40 21 211 71 83 
Tel: +40 21 211 71 83
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH PLASTENKA 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Plazemska razpolovna doba izločanja fenofibratne kisline 
The plasma elimination half-life of fenofibric acid is approximately 20 hours.
in 
OTHER
ZMN < 5-kratnika ZMN) znašala 0,83 %. 
and/or AST ≥ 3 times the ULN, < 5 times the ULN) was 0.83% for patients treated with Pravafenix.
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijske pnevmopatije neznana 
Respiratory, thoracic and mediastinal disorders
s pravastatinom 40 mg in fenofibratom 160 mg dodatno koristno za uravnavanje glavnih parametrov lipidov. 
The incremental benefit of Pravafenix 40 mg/160 mg on main lipid parameters versus Pravastatin 40 mg and Fenofibrate 160 mg monotherapy was also established.
- Preden začnete jemati zdravilo Pravafenix, mora zdravnik opraviti preiskavo vaše krvi. 
- Your doctor should do a blood test before you start taking Pravafenix.
Holesterol LDL (mg/dl) 
LDL-C (mg/dl)
Venski tromboembolični dogodki 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 
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.
Pri bolnikih, ki so jemali fenofibrat ali pravastatin, so poročali o pankreatitisu (glejte poglavje 4.3). To lahko kaže na neučinkovitost zdravila pri bolnikih 
Pancreatitis has been reported in patients taking fenofibrate or pravastatin (see sections 4.3).
Holesterol HDL (mg/dl) 
HDL-C (mg/dl)
KAKO JEMATI ZDRAVILO PRAVAFENIX 
How to take pravafenix
in če je vaš „slabi“ holesterol ustrezno nadzorovan samo s pravastatinom (statinom, zdravilom za zniževanje ravni holesterola). 
Pravafenix is used if you are an adult with an elevated risk for heart disease and need to improve cholesterol and triglycerides fat levels in your blood when your ‘bad' cholesterol levels are being adequately controlled with pravastatin alone (a statin, a cholesterol-lowering medicine).
simptomov v mišicah) je prišlo pri 0,06 % bolnikov, ki so prejemali zdravilo Pravafenix (glejte poglavje 4.4). 
Clinically important elevation (CK ≥ 10 times the ULN without muscular symptoms) was seen in 0.06% of the patients treated with Pravafenix.
Ime in naslov izdelovalca, odgovornega za sproščanje serije: SMB Technology s.a. rue du Parc Industriel 39 
SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgium
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. 
Do not pass it on to others.
s hemodializo. 
• Diabetes.
se imenuje Pravafenix. 
The name of your medicine is Pravafenix.
Bolezni sečil 
Hepatic impairment
Pri nekaterih bolnikih pa je povečanje 
In some patients, however, the increase in pravastatin exposure may be larger.
Presnovne in prehranske motnje poslabšanje 
Metabolism and nutrition disorders
Do klinično pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 5-kratnika ZMN) je prišlo pri 
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.
peroralna uporaba 
Oral use.
EU/1/11/679/002, 60 trdih kapsul 
EU/1/11/679/002 60 hard capsules
Bolezni kože in podkožja pruritus, urtikarija občasni 
Skin and subcutaneous tissue disorders
ZA PROMET Z ZDRAVILOM • Redno posodobljena poročila o varnosti zdravila (PSUR) 
• Periodic Safety Update Reports
Če bolnica načrtuje nosečnost ali če zanosi, mora biti zdravnik o tem 
If a patient plans to become pregnant or becomes pregnant, the physician has to be informed immediately and pravastatin should be discontinued because of the potential risk to the foetus.
s hudo okvaro jeter pa je kontraindicirano (glejte poglavje 4.3). 
If confirmed, the treatment should definitively not be initiated (see section 4.3).
Če je zaznana in potrjena izrazito zvišana vrednost kreatin-fosfokinaze (večja od petkratne ZMN), je treba zdravljenje z zdravilom Pravafenix prekiniti. O prekinitvi zdravljenja je treba razmisliti tudi v primeru, če so simptomi v mišicah hudi in motijo dnevne dejavnosti (ne glede na to, kakšne so vrednosti kreatin-fosfokinaze). 
Treatment discontinuation should also be considered if the muscular symptoms are severe and cause daily discomfort (whatever CK levels).
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom. 
- If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you.
ZA PROMET EU/1/11/679/005, 60 trdih kapsul 
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/005 60 hard capsules
Ovojnica kapsule želatina, indigo karmin, 
Capsule shell Gelatine
s hrano poveča, učinkovitost pravastatina pri zniževanju koncentracije lipidov pa se ne spremeni. 
In line with several formulations for fenofibrate, the fixed combination is recommended to be taken with food because the bioavailability of fenofibrate is increased when administered with food and the lipid-lowering efficacy of pravastatin is not altered.
Pri sočasni uporabi fenofibrata in pravastatina niso opazili nobenih pomembnih farmakokinetičnih interakcij. 
No clinically significant pharmacokinetic interaction was seen when fenofibrate was coadministered with pravastatin.
ZA PROMET EU/1/11/679/001, 30 trdih kapsul 
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001 30 hard capsules
simptomov v mišicah) pri 0,38 % bolnikov, ki so prejemali zdravilo Pravafenix. Do klinično pomembnih zvišanj (KF ≥ 10kratnika 
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.
bruhanje, driska in flatulenca, zaprtje, suha usta, bolečina v zgornjem delu trebuha z napihnjenostjo (dispepsija), spahovanje), • učinki na jetra: zvišane vrednosti serumskih transaminaz. 
• Digestive effects: gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence, constipation, dry mouth, upper abdominal pain with bloating (dyspepsia), burping
FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti 
5.1 Pharmacodynamic properties
- Zdravilo Pravafenix vedno vzemite skupaj s hrano, saj se na tešče 
Pravafenix with food, drink and alcohol - Always take Pravafenix with food as Pravafenix is less well absorbed from an empty stomach.
Interakcije, pomembne za pravastatin Holestiramin/holestipol 
Jaundice, fulminant hepatic necrosis
Bolezni kože in podkožja kožni izpuščaj, bolezenska sprememba na lasišču/laseh (vključno z alopecijo) 
Skin rash, Scalp/hair abnormality (including alopecia)
Splošne težave in spremembe na mestu aplikacije astenija, utrujenost, gripi podobno bolezensko stanje občasni 
Asthenia, fatigue, influenza like illness
Odmerjanje 
Distribution
NAVODILO ZA UPORABO Pravafenix 40 mg/160 mg trde kapsule pravastatin/fenofibrat 
NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
EU/1/11/679/003, 90 trdih kapsul 
EU/1/11/679/003 90 hard capsules
VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo Pravafenix 
Additional information on the individual active substances of the fixed dose combination Pravafenix contains pravastatin and fenofibrate.
ZA PROMET EU/1/11/679/007, 14 trdih kapsul 
MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/007 14 hard capsules
Pri kombinirani uporabi fenofibrata in pravastatina ni podatkov o vplivu na plodnost. 
There are no data on fertility from the combined use of fenofibrate and pravastatin
so bili vzeti eno uro pred pravastatinom), nikotinsko kislino ali probukolom, v študijah medsebojnega delovanja niso opazili statistično pomembnih razlik v biološki uporabnosti. 
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.
SHRANJEVANJE ZDRAVILA PRAVAFENIX 
Other medicines and Pravafenix
Bolezni jeter, žolčnika in žolčevodov zvišana vrednost transaminaz pogosti bolečina v jetrih, zvišana gama-glutamiltransferaza občasni 
Hepatic pain, gammaglutamyl transferase increased.
EU/1/11/679/006, 90 trdih kapsul 
EU/1/11/679/006 90 hard capsules
občasni 
Rare
se posvetujte z zdravnikom ali farmacevtom. 
Check with your doctor or pharmacist if you are not sure.
Učinkovine, ki vplivajo na lipide, zaviralci reduktaze hidroksimetilglutaril koencima A v kombinaciji z drugimi učinkovinami, ki vplivajo na lipide, oznaka 
Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents, ATC code: C10BA03
ŠKATLA 
Posology
ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj kreatin fosfokinaze (KF ≥ 3-kratnika 
In clinical studies, the incidence of important elevations in creatine phosphokinase (CK ≥ 3 times the ULN, < 5 times the ULN) was 1.92% for patients treated with Pravafenix.
Motnje reprodukcije in dojk motnje na področju spolnosti motnje na področju spolnosti občasni 
Reproductive system and breast disorders
Zdravilo Pravafenix se ne priporoča pri bolnikih z zmerno okvaro jeter, pri bolnikih 
Pravafenix is not recommended in patients with moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3.).
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Apoprotein B/apoprotein A1 Fibrinogen (g/l) Hs-CRP (mg/l) a Število bolnikov b Povprečna sprememba v odstotkih (povprečje najmanjših kvadratov ± standardna napaka) med izhodiščno vrednostjo, izmerjeno po 8 
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
Bolezni imunskega sistema preobčutljivostne reakcije občasni 
Hypersensitivity reactions
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLES
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
PRETISNI OMOTI 
- Keep this leaflet.
ZA PRETISNE OMOTE 
Pruritus, urticaria
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
s kombinirano 
Uncommon
svojega zdravnika, da boste spremljali raven holesterola. 
Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol level.
Preiskave povečana količina sečnine v krvi redki * V študiji FIELD (študiji o fenofibratu), randomiziranem, s placebom nadzorovanem preskušanju, ki je bilo izvedeno pri 9795 bolnikih 
Rare * In the FIELD-study (fenofibrate study), a randomised placebo-controlled trial performed in 9,795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate.
ZA 
Lot
tveganjem za bolezni 
Sexual dysfunction
Najpogosteje navedeni neželeni učinki med terapijo z zdravilom Pravafenix 
The most commonly reported adverse reactions (ADRs) during Pravafenix therapy are increased transaminase and gastrointestinal disorders.
56 Eirinis Ave., 151 21, Pefki, Greece 
56 Eirinis Ave., 151 21, Pefki,
92787 ISSY-LESMOULINEAUX Cedex 
92787 ISSY-LESMOULINEAUX Cedex 9 France
Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B Austria 
Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
1123 Budapest, Nagyenyed utca 8 -14 Magyarország Hungary 
Janssen-Cilag Kft. 1123 Budapest, Nagyenyed utca 8 -14 Magyarország Hungary
Чешка република Janssen-Cilag s.r.o., Karla Engliše 3201/6, 
Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
5026 RH Tilburg PO Box 90240 
Dr. Paul Janssenweg 150 5026 RH Tilburg PO Box 90240
Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena Portugal 
Queluz de Baixo 2734-503 Barcarena Portugal
СПИСЪК НА ИМЕНАТА, ЛЕКАРСТВЕНИ ФОРМИ, КОЛИЧЕСТВО НА АКТИВНОТО ВЕЩЕСТВО 
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
Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium 
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse
JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 COLOGNO MONZESE (MI), Italy 
20093 COLOGNO MONZESE (MI), Italy
d.o.o. Oreškovićeva 6H, 
Oreškovićeva 6H, 10010 Zagreb,
Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium 
Belgium Janssen-Cilag N.V. Antwerpseweg 15-17
Janssen-Cilag Limited 50-100 Holmers Farm Way 
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Janssen-Cilag Kft. 
Janssen-Cilag B.V.
Durogesic Matrix 12 µг/ч 
Durogesic Matrix 12 µg/h
Durogesic Matrix 100 µг/ч 
Durogesic Matrix 100 µg/h
Durogesic 12 microgrammes/he ure, dispositif transdermique 
Durogesic 12 microgrammes/h eure, dispositif transdermique
4EG 
d.o.o.
Durogesic Matrix 75 µг/ч 
Durogesic Matrix 75 µg/h
Durogesic Matrix 25 µг/ч 
Durogesic Matrix 25 µg/h
Durogesic 100 microgrammes/he ure, dispositif transdermique 
Durogesic 100 microgrammes/h eure, dispositif transdermique
Durogesic 75 microgrammes/he ure, dispositif transdermique 
Durogesic 75 microgrammes/h eure, dispositif transdermique
Durogesic Matrix 50 µг/ч 
Durogesic Matrix 50 µg/h
Paseo de Las Doce Estrellas, 5-7 
JANSSEN-CILAG, S.A. Paseo de Las Doce Estrellas, 5-7 28042, Madrid
Durogesic 25 microgrammes/he ure, dispositif transdermique 
Durogesic 25 microgrammes/h eure, dispositif transdermique
Durogesic 50 microgrammes/he ure, dispositif transdermique 
Durogesic 50 microgrammes/h eure, dispositif transdermique
Валидната кратка характеристика на продукта, означенията върху опаковката и листовката са последните версии одобрени от Координационната група по време на процедурата. 
The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Кратка характеристика на продукта,означения върху опаковката и листовката 
Summary of product characteristics, labelling and package leaflet
Тя увеличава обхвата на наличните варианти за ваксина. 
It increases the range of available vaccine options.
Лицензите за употреба в Испания и Италия са временно спрени от националните компетентни органи съответно на 11 и 20 април 2011 г. 
The marketing authorisations in Spain and Italy were suspended by the national competent authorities on 11 and 20 April 2011, respectively.
В допълнение в Испания, където са регистрирани приблизително половината от всички продажби на продукта в ЕС, към момента са съобщени две нежелани събития. 
Additionally, in Spain where approximately half of the total EU-product sales are recorded, two adverse events have been reported to date.
Националните компетентни органи, координирани от референтната държава-членка, трябва да гарантират, че следните условия са изпълнени от притежателя на лиценза за употреба: 
The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Честотата на събитията варира сред държавитечленки и не изглежда да отразява пряко продаденото количество от продукта. 
The frequency of events reported varies across Member States and does not appear to directly reflect the amount of product sold.
Най-голям брой нежелани събития е съобщен във Франция. 
The greatest number of adverse events was reported in France.
На базата на данни за безопасността след лицензирането, няма доказателства, че продуктът представлява риск за потребителя, консуматора или околната среда. 
Based on post-authorisation safety data, there is no evidence that the product poses a risk to the user, the consumer or the environment.
Въпреки това от оценените данни не би могло да се направи категорично заключение по отношение на тези хипотези. 
However, from the data evaluated, a definitive conclusion could not be drawn concerning these hypotheses.
Към днешна дата не са съобщавани нежелани събития в останалите 12 засегнати държави-членки. 
To date no adverse events have been reported in the remaining 12 concerned Member States.
Списък на имената, фармацевтичната форма, концентрацията на ветеринарномедицинския продукт, видовете животни, за които е предназначен и притежателите на лиценза за употреба в държавитечленки 
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species and marketing authorisation holders in the Member States
Нежелани събития, касаещи реакции от анафилактичен тип, някои от които са фатални, са съобщени в четири държави-членки на ЕС. 
Adverse events concerning anaphylactic-type reactions, some of which were fatal, have been reported in four EU Member States.
Тъй като понастоящем не могат да бъдат наложени никакви коригиращи мерки, не може да се изключи възможността сериозните нежелани събития, съобщени в някои държави-членки, да се наблюдават също и в други, които досега са били незасегнати. 
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.
Притежателят на лиценза за употреба е взел предпазни мерки, за да спре продажбите на продукта в рамките на ЕС. 
The marketing authorisation holder has taken precautionary measures to stop sales of the product in the EU.
Препоръчва се нови проучвания на всички потенциални спомагащи фактори да бъдат изследвани допълнително от притежателя на лиценза за употреба. 
It was recommended that further investigation of all potential contributory factors be explored further by the marketing authorisation holder.