natgillin/translations-raw huggingface dataset:
ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Pravafenix has no or negligible influence on the ability to drive and use machines.
se pojavi v 4 do 5 urah po peroralni uporabi.
Maximum plasma concentrations (Cmax) occur within 4 to 5 hours after oral administration.
debelost,
• Obesity.
Kapsule so iz trde želatine z olivno zelenim zgornjim in s svetlozelenim
The capsules are hard gelatine capsule with olive cap and light green body containing a waxy white beige mass and a tablet.
s trigliceridi, iz plazme, tako da aktivira lipoproteinsko lipazo
Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of
Interakcije, povezane
Interactions relevant to pravastatin
Okvara ledvic
Renal impairment
Pravafenix 40 mg/160 mg trde kapsule pravastatin/fenofibrat
Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
If you get any side effects, talk to your doctor or pharmacist.
Pravastatin je kompetitiven zaviralec reduktaze 3-hidroksi-3-metilglutaril-koencima A (HMG-CoA),
Pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing the early rate-limiting step in cholesterol biosynthesis, and produces its lipid-lowering effect in two ways.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
6.6 Special precautions for disposal
Zdravilni učinkovini sta fenofibrat in pravastatin.
• The active substances are fenofibrate and pravastatin.
Med vožnjo motornih vozil ali delom
Driving and using machines
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.
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.
Pravastatin se v majhnih količinah izloča v materino mleko, zato je med dojenjem kontraindiciran
A small amount of pravastatin is excreted in human breast milk; therefore pravastatin is contraindicated during breastfeeding (see section 4.3).
Med bolniki, ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3-kratnika
In clinical studies, the incidence of important elevations in serum transaminases (ALT
IME ZDRAVILA Pravafenix 40 mg/160 mg trde kapsule
NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules
Pred začetkom zdravljenja je treba izmeriti vrednosti kreatin-fosfokinaze.
CK levels should be measured prior to initiation of therapy.
Preiskava zvišana koncentracija holesterola v krvi, zvišana koncentracija trigliceridov v krvi, zvišana koncentracija lipoproteinov majhne gostote, povečana telesna masa.
Blood cholesterol increased, blood triglycerides increased, lowdensity lipoprotein increased, weight increased.
Druga vrsta maščob v krvi so trigliceridi.
Triglycerides are another fat in your blood.
smrtnega izida in kardiovaskularni smrtji (razmerje tveganja [RT] 0,92, 95 % IZ 0,79-1,08, p = 0,32; absolutno zmanjšanje tveganja: 0,74 %).
Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32 ; absolute risk reduction: 0.74%).
Kadar se zdravilo Pravafenix uporablja pri bolnikih, ki imajo v anamnezi obolenje jeter ali čezmerno uživajo alkohol, je potrebna previdnost.
Caution should be exercised when Pravafenix is administered to patients with a history of liver disease or heavy alcohol ingestion.
Koncentracija sečne kisline v plazmi je povečana pri približno 20 % bolnikov
Plasma uric acid levels are increased in approximately 20% of hyperlipidaemic patients, particularly in those with type IV disease.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena trda kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Splošne težave:
General disorders:
Zdravilo Pravafenix
Pravafenix
Prvič, z reverzibilnim in specifičnim kompetitivnim zaviranjem reduktaze
Firstly, with the reversible and specific competitive inhibition of HMG-CoA reductase, it effects modest reduction in the synthesis of intracellular cholesterol.
Zdravilo Pravafenix vsebuje laktozo
Pravafenix contains lactose
preobčutljivost,
• Hypersensitivity.
Aktivacija PPARα vzpodbudi tudi hitrejšo sintezo apoproteinov A-I in A-II ter holesterola HDL.
Activation of PPARα also induces an increase in the synthesis of Apoproteins A-I,
Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Zato fiksna kombinacija odmerkov (zdravilo Pravafenix) ne more veljati za medsebojno zamenljivo
Therefore the fixed dose combination (Pravafenix) could not be considered interchangeable with the free co-administration of fenofibrate and pravastatin mono-component drug products.
Če je ocenjeni očistek kreatinina < 60 ml/min, je treba zdravljenje prekiniti.
Treatment should be discontinued in case of an estimated creatinine clearance < 60 ml/min.
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