natgillin/translations-raw huggingface dataset:
Among the 2,993 children given PROCOMVAX, 33 had serious adverse experiences within 14 days of vaccination.
V 14 dneh po cepljenju je resne neželene pojave doživelo 33 od 2993 otrok, ki so dobili PROCOMVAX.
Parenteral medicinal products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit.
Kadar koli raztopina in vsebnik to dopuščata, je treba parenteralna zdravila pred uporabo pregledati, da ne vsebujejo tujih delcev in niso
Rarely : anaphylaxis, angioedema, urticaria, erythema multiforme.
Redko: anafilaksa, angioedem, urtikarija, multiformni eritem Živčevje
- if you are a hepatitis B virus surface antigen (HBsAg)-positive mother, your infant should receive Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
- če je otrokova mati pozitivna na površinski antigen hepatitisa B, mora dojenček dobiti imunoglobulin proti hepatitisu B (HBIG) in rekombinantno cepivo proti hepatitisu B ob rojstvu ter opraviti celoten niz cepljenj proti hepatitisu B. Nadaljnja uporaba cepiva PROCOMVAX za dokončanje niza cepljenj proti hepatitisu B pri dojenčkih HBsAg pozitivnih mater, ki so dobili HBIG, in pri dojenčkih mater z neznanim statusom ni raziskana.
125 µg of the B11 strain of Neisseria meningitidis subgroup B) Adsorbed hepatitis B surface antigen produced in recombinant yeast cells
Neisserie meningitidis (seva B11 Neisserie meningitidis podskupine B) Adsorbiran površinski antigen hepatitisa B, pridobljen v rekombinantnih celicah kvasovk
Posology
SERIJE
Excipients: Amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9 % sodium chloride
Pomožne snovi: amorfni aluminijev hidroksifosfat sulfat in natrijev borat v 0,9 % natrijevem kloridu.
Post-dose 2, 93 % to 100 % of infants developed a protective level of anti-HBs (≥ 10 mIU/ml) and the GMTs ranged from 125 mIU/ml to 417 mIU/ml.
Po 2. odmerku se je zaščitna raven anti-HBs (≥ 10 mi.e./ml) razvila pri 93 % do 100 % dojenčkov, GMT pa je bil od 125 mi.e./ml do 417 mi.e./ml.
QUALITATIVE AND QUANTITATIVE COMPOSITION Polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as PRP-OMPC 7.5 µg Neisseria meningitidis OMPC (outer membrane protein complex
KAKOVOSTNA IN KOLIČINSKA SESTAVA Poliribozilribitolfosfat (PRP) Haemophilusa influenzae tipa b kot PRP - OMPC
Post-dose 2, 77% to 96% of infants developed a protective level of anti-HBs (≥ 10 mIU/ml) and the GMTs ranged from 30 mIU/ml to 190 mIU/ml.
Po 2. odmerku se je zaščitna raven anti-HBs (≥ 10 mi.e./ml) razvila pri 77 % do 96 % dojenčkov, GMT (geometrično povprečje titrov) pa je bil od 30 mi.e./ml do 190 mi.e./ml.
The other ingredients are: amorphous aluminium hydroxyphosphate sulphate and sodium borate in 0.9% sodium chloride
Pomožne snovi so amorfni aluminijev hidroksifosfat sulfat in natrijev borat v 0,9 % natrijevem
In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 722 infants, approximately 2 months of age, who had previously received a single dose of hepatitis B vaccine at birth.
V 4 kliničnih preskušanjih v obdobju med 1992 in 2000 je cepivo PROCOMVAX dobilo 722 dojenčkov, starih približno 2 meseca, ki so ob rojstvu že dobili en odmerek cepiva proti hepatitisu B. Ti dojenčki so cepivo PROCOMVAX prejeli v starosti 2-3, 4-5 in 12-15 mesecev.
Pharmacotherapeutic group : anti infectious, ATC code : J07CA PROCOMVAX is a sterile bivalent vaccine made of the antigenic components used in producing Merck PRP-OMPC Vaccine and Merck Hepatitis B (Recombinant) Vaccine.
Oznaka ATC: J07CA PROCOMVAX je sterilno dvovalentno cepivo iz antigenskih sestavin, ki se uporabljajo za pripravo Merckovih cepiv PRP - OMPC in (rekombinantnega) cepiva proti hepatitisu B. Ti sestavini sta kapsulni polisaharid (PRP) Haemophilusa influenzae tipa b, kovalentno vezan na beljakovinski kompleks zunanje membrane (OMPC) Neisserie meningitidis, ter površinski antigen hepatitisa B (HBsAg) iz rekombinantnih kultur kvasovk.
Post-dose 3, 92 % to 99 % of infants developed >1.0 µg/ml of anti-PRP, a level associated with longterm protection against invasive Hib disease, and the GMTs ranged from 7.7 µg/ml to 14.0 µg/ml.
Po 3. odmerku se je pri 92 % do 99 % dojenčkih razvila raven antiPRP > 1,0 µg/ml - to je raven povezana s dolgotrajno zaščito proti invazivni bolezni Hib, GMT pa je
In 4 clinical trials conducted between 1992 and 2000, PROCOMVAX was administered to 1809 infants, approximately 2 months of age, who had not previously received any hepatitis B vaccine.
V 4 kliničnih preskušanjih v obdobju med 1992 in 2000 je cepivo PROCOMVAX dobilo 1809 dojenčkov, starih približno 2 meseca, ki prej še niso bili cepljeni s cepivom proti hepatitisu B. Ti dojenčki so cepivo PROCOMVAX dobili v starosti 2, 4, in 12 - 15 mesecev.
Most children received DTP and OPV concomitantly with the first two doses of PROCOMVAX or Merck PRP-OMPC Vaccine or Merck Hepatitis B (Recombinant) Vaccine.
Večina otrok je DTP in OPV dobila sočasno s prvima odmerkoma cepiva PROCOMVAX ali Merckovih cepiv PRP - OMPC in (rekombinantnega) cepiva proti hepatitisu B. Pri vseh treh odmerkih cepiva PROCOMVAX se pogostnost neželenih pojavov ni pomembno razlikovala med cepivom PROCOMVAX ter monovalentnima Merckovima cepivoma PRP - OMPC in rekombinantnim cepivom proti hepatitisu B. Vendar pa je bila pogostnost razdražljivosti po vseh treh injekcijah cepiva PROCOMVAX skupaj in po prvi injekciji cepiva PROCOMVAX v primerjavi z monovalentnima cepivoma statistično večja.
Post-dose 3, 98 % to 100 % of infants developed a protective level of anti-HBs and the GMTs ranged from 1509 mIU/ml to 3913 mIU/ml.
Po 3. odmerku se je zaščitna raven anti-HBs razvila pri 98 % do 100 % dojenčkov, GMT pa je bil od 1509 mi.e/ml do
Name and address of the manufacturer of the biological active substances
A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK
Infants born of HBsAg-positive mothers should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series.
Dojenčki HBsAg pozitivnih mater morajo ob rojstvu dobiti imunoglobulin proti hepatitisu B in (rekombinantno) cepivo proti hepatitisu B ter opraviti celoten niz cepljenj proti hepatitisu B. Nadaljnja uporaba cepiva PROCOMVAX za dokončanje niza cepljenj proti hepatitisu B pri dojenčkih HBsAg pozitivnih mater, ki so dobili HBIG, in pri dojenčkih mater z neznanim statusom ni raziskana.
- elevation of liver enzymes, fatigue, fever, malaise, influenza-like symptoms, bronchospasm-like symptoms, serum sickness, thrombocytopenia - dizziness, headache, paresthesia - nausea, vomiting, diarrhea, abdominal pain - arthralgia, myalgia - rash, pruritus, - hypotension, syncope - paralysis (Bell's palsy), neuropathy, neuritis (including Guillain Barre Syndrome, myelitis including transverse myelitis), encephalitis, optical neuritis.
- zvišanje jetrnih encimov, utrujenost, zvišana telesna temperatura, splošno slabo počutje, gripi podobni simptomi, bronhospazmu podobni simptomi, serumska bolezen, trombocitopenija;
In this leaflet: What PROCOMVAX is and what it is used for
Navodilo vsebuje: Kaj je zdravilo PROCOMVAX in za kaj ga uporabljamo Kaj morate vedeti pred cepljenjem z zdravilom PROCOMVAX
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose = 0.5 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
PROCOMVAX suspenzija za injiciranje konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) in rekombinantno cepivo proti hepatitisu B
Merck Hepatitis B (Recombinant) Vaccine Common reactions
Rekombinantno Merckovo cepivo proti hepatitisu B
Suspension for injection in vial.
NALEPKA NA VIALI
Intramuscular use.
- Navodilo shranite.
PROCOMVAX can be administered simultaneously with the primary series of diphtheria, tetanus, pertussis vaccine (DTP) and oral polio vaccine (OPV).
Pri takšnih bolnikih je mogoče, da cepivo ne prepreči hepatitisa B. Uporaba drugih cepivPROCOMVAX se lahko daje hkrati z osnovnim nizom cepiva proti davici, tetanusu in oslovskemu kašlju (DTP) in peroralnega cepiva proti poliovirusu (OPV).
6.6 Instructions for use and handling
6.3 Rok uporabnosti
For Haemophilus B conjugate and Hepatitis B surface antigen:
Ime in naslov izdelovalca bioloških zdravilnih učinkovin Za konjugirani antigen hemofilusa B in površinski antigen hepatitisa B: Merck & Co. Inc.
The active substances are:
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Uporabno do:
SPECIAL STORAGE CONDITIONS Store in a refrigerator Do not freeze
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi med 2°C in 8°C (v hladilniku).
DATE OF REVISION OF THE TEXT
FARMACEVTSKI PODATKI
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Imetnik dovoljenja za promet z zdravilom:
and Rubella Virus Vaccine Live) using separate sites and syringes for injectable vaccines.
Pertussis vaccine - cepivo proti davici, tetanusu in brezcelično cepivo proti oslovskemu kašlju), če se cepivo za injiciranje daje na drugo mesto in z drugo brizgo.
The addition of fenofibrate to simvastatin seems to reduce the incremental risk in this population and this has been reflected in the given indications for this product.
Zdi se, da dodajanje fenofibrata simvastatinu zmanjšuje naraščajoče tveganje v tej populaciji, kar odražajo tudi indikacije, podane za to zdravilo.
• The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing fenofibrate, bezafibrate, ciprofibrate and gemfibrozil.
• CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo fenofibrat, bezafibrat, ciprofibrat in gemfibrozil.
Regarding co-administration of fibrates with statins, there are insufficient data on the long term efficacy of such a therapy to allow any positive recommendations for most fibrates.
V zvezi s sočasno uporabo fibratov in statinov ni dovolj podatkov o dolgoročni učinkovitosti takšnega zdravljenja, ki bi omogočali kakršnakoli pozitivna priporočila za večino fibratov.
Fibrates have been shown to reduce plasma triglycerides (TG) by 30% to 50% and raise the level of high density lipoprotein cholesterol (HDL-C) by 2% to 20%.
Fibrati dokazano znižujejo trigliceride v plazmi (TG) za 30-50 % in zvišujejo raven holesterola v lipoproteinih visoke gostote (HDL-C) za 2-20 %.
Based on the above, the CHMP recommended the amendments of the marketing authorisations and concluded that the benefit risk profile of fibrates is still positive in the agreed indications.
Na osnovi zgoraj navedenega CHMP priporoča dopolnitev dovoljenj za promet in zaključuje, da je profil koristi in tveganja pri fibratih v okviru dogovorjenih indikacij še vedno ugoden.
• The CHMP considered the PhVWP recommendations on the review of the benefit risk of fibrates in the treatment of cardiovascular (mortality and morbidity) and dyslipidaemic diseases.
• CHMP je obravnaval priporočila delovne skupine za farmakovigilanco (PhVWP) glede pregleda koristi in tveganj fibratov pri zdravljenju kardiovaskularnih (umrljivost in obolevnost) in dislipidemičnih bolezni.
However in severe hypertriglyceridaemia and certain dyslipidaemias where a statin cannot be used patients can still benefit from treatment with fibrates.
Pri močni hipertrigliceridemiji in določenih dislipidemijah, pri katerih ni mogoče uporabiti statina, pa zdravljenje s fibrati lahko pacientom vseeno koristi.
No randomised, controlled trial data are available for ciprofibrate, but differences across the class in surrogate marker effects have not been shown.
Za ciprofibrat podatki randomiziranega in kontroliranega preskušanja niso na voljo, vendar v celotni skupini ni dokazanih razlik v nadomestnih kazalnikih učinka.
Their effect on low density lipoprotein cholesterol (LDL-C) is variable, ranging from no effect to a small decrease of the order of
Na holesterol v lipoproteinih nizke gostote (LDL-C) učinkujejo različno; lahko so brez učinka ali pa prispevajo k majhnemu znižanju v obsegu 10 %.
Fibrates (fenofibrate, bezafibrate, ciprofibrate and gemfibrozil) are a class of lipid-lowering drugs and exert their effects mainly by activating the peroxisome proliferator-activated receptor-alpha (PPARalpha), apart from bezafibrate which is an agonist for all three PPAR isoforms alpha, gamma, and delta.
Fibrati (fenofibrat, bezafibrat, ciprofibrat in gemfibrozil) so skupina zdravil, ki znižujejo lipide in v glavnem učinkujejo z aktiviranjem receptorja alfa, aktiviranega s peroksisomskim proliferatorjem (PPAR-alfa), razen bezafibrata, ki je agonist za vse tri izooblike PPAR, in sicer alfa, gama in delta.
Overall summary of the scientific evaluation of fenofibrate, bezafibrate, ciprofibrate and gemfibrozil containing medicinal products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo fenofibrat, bezafibrat, ciprofibrat in gemfibrozil (glejte Dodatek I)
Furthermore fenofibrate showed benefit as add on treatment to statins as detailed above.
Kot je podrobneje opisano zgoraj, se je fenofibrat poleg tega izkazal za koristnega kot dodatek pri zdravljenju s statini.
Scientific conclusions and grounds for amendment of the summaries of product characteristics and package leaflets presented by the EMA
Znanstveni zaključki in podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodil za uporabo, ki jih je predstavila Evropska agencija za zdravila
The fibrates share a common mechanism of action and exert qualitatively similar effects on serum lipid triglycerides (decrease) and HDL-cholesterol concentrations (increase).
Vsem fibratom je skupen enak mehanizem delovanja, imajo pa tudi kvalitativno podobne učinke na trigliceride v serumu (ki jih znižujejo) in koncentracije holesterola HDL (ki jih zvišujejo).
The long term efficacy and safety of the currently licensed fibrates has mainly been examined in six large randomised, placebo controlled trials: the Helsinki Heart Study (HHS) and Veterans Affairs HDL Intervention Trial (VA-HIT) with gemfibrozil, the Bezafibrate Infarction Prevention (BIP) Study and the Lower Extremity Arterial Disease Event Reduction (LEADER) Study with bezafibrate, the Fenofibrate Intervention in Event Lowering in Diabetes (FIELD) Study and the Action to Control Cardiovascular Risk in Diabetes study (ACCORD) with fenofibrate.
Dolgoročna učinkovitost in varnost fibratov, za katere je trenutno izdano dovoljenje, sta bili v glavnem preučeni v šestih velikih randomiziranih in s placebom kontroliranih študijah: v študiji z nazivom Helsinško srce (Helsinki Heart, HHS) in intervencijskem preskušanju učinkov uravnavanja holesterola HDL, ki jo je sponzoriral ameriški urad za vojne veterane (Veterans Affairs HDL Intervention Trial, VA-HIT), so preučevali gemfibrozil, v študiji preprečevanja infarkcije s pomočjo bezafibrata (Bezafibrate Infarction Prevention, BIP) in študiji zmanjševanja dogodkov v zvezi z arterijskimi boleznimi spodnjih okončin (Lower Extremity Arterial Disease Event Reduction, LEADER) so preučevali bezafibrat, v intervencijski študiji zmanjševanja dogodkov pri sladkornih bolnikih s pomočjo fenofibrata (Fenofibrate Intervention in Event Lowering in Diabetes, FIELD) in študiji nadzorovanja kardiovaskularnega tveganja pri sladkornih bolnikih (Action to Control Cardiovascular Risk in Diabetes, ACCORD) pa so preučevali fenofibrat.
However, the effect of fibrates mainly on triglycerides but also a smaller but overall positive effect on HDL and LDL cholesterol suggest that there are subgroups of patients who may still benefit from this therapy.
Vendar pa učinki, ki jih imajo fibrati v glavnem na trigliceride (v manjši meri pa vplivajo tudi na holesterola HDL in LDL, vendar je ta vpliv na splošno pozitiven), kažejo, da obstajajo podskupine pacientov, ki bi jim tovrstno zdravljenje lahko vseeno koristilo.
Based on the above data, it was concluded that the product information for all fibrates should be updated to reflect the available evidence and current clinical practice, and define groups of patients that were more likely to derive benefit from fibrates such as patients with severe hypertriglyceridaemia with or without low HDL cholesterol or with mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
Na osnovi zgoraj navedenih podatkov je bilo ugotovljeno, morajo biti podatki o zdravilu za vse fibrate posodobljeni, tako da bodo odražali razpoložljive dokaze in trenutno klinično prakso, in da je treba določiti skupine pacientov, ki jim bodo fibrati najverjetneje koristili, na primer paciente z močno hipertrigliceridemijo z nizko vrednostjo holesterola HDL ali brez njega ali paciente s kombinirano hiperlipidemijo, pri katerih je uporaba statina kontraindicirana ali pa ga ne prenašajo.
In this regard, the Pharmacovigilance Working Party (PhVWP) review of all available data on the benefit risk of fibrates in the treatment of cardiovascular (mortality and morbidity) and dyslipidaemic diseases, as initially endorsed by the CHMP, concluded that in most cases, the indications for fibrates had been granted mainly on the basis of their effects on these surrogate parameters and that little evidence was available on the effects of the different fibrates on cardiovascular morbidity and mortality.
Zato je bilo v pregledu vseh razpoložljivih podatkov v zvezi s koristmi in tveganji uporabe fibratov pri zdravljenju kardiovaskularnih (umrljivost in obolevnost) in dislipidemičnih bolezni, ki ga je opravila delovna skupina za farmakovigilanco (PhVWP) in ga je prvotno odobril CHMP, zaključeno, da so indikacije za fibrate odobrene večinoma na osnovi njihovega učinkovanja na te nadomestne parametre, dokazov glede učinkov različnih fibratov na umrljivost in obolevnost zaradi kardiovaskularnih bolezni pa je na voljo le malo.
Despite differences in methodology and study populations, the major fibrate trials have shown that treatment with fibrates may reduce coronary heart disease events but there is no clear evidence that they can reduce all cause mortality in the primary or secondary prevention of cardiovascular disease.
Kljub razlikam v metodologiji in študijskih populacijah so glavni preskusi s fibrati dokazali, da lahko zdravljenje z njimi zmanjša pogostost dogodkov v zvezi s koronarno boleznijo, ni pa jasnega dokaza, da lahko pri primarnem ali sekundarnem preprečevanju kardiovaskularne bolezni znižajo umrljivost ne glede na vzrok smrti.
• The CHMP considered additional published data for the fibrates, including results of the ACCORD lipid trial which were supportive of the use of fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets) as add on therapy to a statin in patients with mixed hyperlipidaemia at high cardiovascular risk when triglycerides and HDL cholesterol are not adequately controlled with a statin alone.
• CHMP je upošteval dodatne objavljene podatke o fibratih, vključno z rezultati preskušanja v zvezi lipidi (ACCORD), ki potrjujejo koristi fenofibrata (100, 300, 67, 200 in 250 mg kapsule ter 160 in 145 mg filmsko obložene tablete), uporabljenega kot dodatek statinu pri zdravljenju pacientov s kombinirano hiperlipidemijo in visokim tveganjem za kardiovaskularne bolezni, kadar samo s statinom ni mogoče ustrezno nadzirati trigliceridov in holesterola HDL.
Since therapeutic efficacy cannot be obtained from the data provided the use of fibrates as first line treatment for these indications is no longer justified for all fibrates, with the exception of gemfibrozil which showed benefit on primary prevention of cardiovascular morbidity in males when a statin cannot be used.
Ker iz zbranih podatkov ni mogoče dokazati terapevtske učinkovitosti, uporaba fibratov kot zdravila prve izbire pri teh indikacijah za vse fibrate ni več upravičena, razen za gemfibrozil, pri katerem je dokazana korist pri primarnem preprečevanju umrljivosti moških zaradi kardiovaskularnih bolezni, če ni mogoče uporabiti statina.
Also recognizing that trials have provided evidence that gemfibrozil may differ from the rest of the class and may have a more favourable profile it was felt that a differentiation in the given indications for gemfibrozil was justified to also include treatment of primary hypercholesterolaemia and primary prevention of cardiovascular morbidity in males when a statin is contraindicated or not tolerated.
Poleg tega so upoštevani tudi s preskusi ugotovljeni dokazi, ki pričajo, da se gemfibrozil morda razlikuje od drugih fibratov v skupini in ima morda bolj ugoden profil; zato se šteje, da je diferenciacija pri danih indikacijah za gemfibrozil, ki naj vključuje še zdravljenje primarne hiperholesterolemije in primarno preprečevanje obolevnosti za kardiovaskularnimi boleznimi pri moških, pri katerih je uporaba statina kontraindicirana ali pa ga ne prenašajo, upravičena.
• The CHMP concluded from the data provided that there is a lack of therapeutic efficacy in the primary or secondary prevention of cardiovascular disease for all fibrates, with the exception of gemfibrozil which showed benefit on primary prevention of cardiovascular morbidity in males when a statin cannot be used.
• Iz predloženih podatkov CHMP zaključuje, da pri primarnem ali sekundarnem preprečevanju kardiovaskularnih bolezni noben fibrat ni terapevtsko učinkovit, razen gemfibrozil, ki se je izkazal za koristnega pri primarnem preprečevanju obolevnosti za kardiovaskularnimi boleznimi pri moških, pri katerih ni mogoče uporabljati statina.
Overall the available evidence suggested that despite the long presence of fibrates on the market, there is only limited evidence of a long term clinical benefit from their use in the primary or secondary prevention of cardiovascular disease.
Zbrani podatki, ki so na voljo, v splošnem kažejo, da je dokazov o dolgoročnih kliničnih koristih uporabe fibratov pri primarnem ali sekundarnem preprečevanju kardiovaskularne bolezni le malo, čeprav so fibrati na trgu že dolgo.
However, for certain doses of fenofibrate (100, 300, 67, 200, 250 mg capsules and 160 and 145 mg film coated tablets), results from ACCORD lipid trial, taken together with previous outcome studies and fibrate trials meta-analyses support a benefit of add on therapy in the dyslipidaemic population, when triglycerides and HDL cholesterol are not adequately controlled with a statin alone.
Vendar pa rezultati preskušanja ACCORD, kjer so spremljali lipide, skupaj s prejšnjimi rezultati študij in meta analizami preskušanj v zvezi s fibrati za določene odmerke fenofibrata (100, 300, 67, 200 in 250 mg kapsule ter 160 in 145 mg filmsko obložene tablete) potrjujejo korist pri dodatnem zdravljenju pri populaciji z dislipidemijo, kadar trigliceridov in holesterola HDL ni mogoče ustrezno nadzirati le s statinom.
the CHMP has recommended the variation of the marketing authorisation for which the relevant sections of the summaries of product characteristics and package leaflets are set out in Annex III for medicinal products containing fenofibrate, bezafibrate, ciprofibrate and gemfibrozil (see Annex I).
CHMP priporoča spremembo dovoljenj za promet za zdravila, ki vsebujejo fenofibrat, bezafibrat, ciprofibrat in gemfibrozil (glejte Dodatek I) in katerih ustrezna poglavja povzetkov glavnih značilnosti zdravila in navodil za uporabo so navedeni v Dodatku III.
Grounds for amendment of the summaries of product characteristics and package leaflets
Podlaga za dopolnilo povzetka glavnih značilnosti zdravila in navodil za uporabo
IARs are described in section 4.8.
IARs so opisane v poglavju 4.8.
The results are shown in Table 4.
Rezultati so prikazani v tabeli 4.
Patient data will be anonymously collected in this Registry.
Podatki o bolniku bodo anonimno zbrani v tem registru.
It will be given to you once every 2 weeks.
Daje se enkrat na 2 tedna.
ATC code: A16AB07.
Oznaka ATC: A16AB07.
An infusionassociated reaction can sometimes be very severe.
Infuzijske reakcije so lahko včasih zelo hude.
No interactions studies have been performed.
Študij medsebojnega delovanja niso izvedli.