natgillin/translations-raw huggingface dataset:
Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States.
Na podlagi nacionalnih, nesoglasnih odločitvah pristojnih organov v državah članicah EU so bili odobreni različni Povzetki glavnih značilnosti zdravila (SPC).
On 6 January 2003, the European Commission presented to the EMEA (see Annex 1) a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the national SPCs of the medicinal product Lopid and associated names.
6. januarja 2003 je Evropska Komisija EMEA (glej Dodatek 1) predložila predlog za postopek na podlagi člena 30 Direktive 2001/ 83/ ES, z vsemi spremembami, za uskladitev nacionalnih Povzetkov glavnih značilnosti (SPC) zdravila Lopid in z njim povezanih imen.
The referral procedure started on 23 January 2003.
Postopek obravnave se je začel 23. januarja 2003.
The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/ risk ratio of Lopid is considered to be positive in the following indications:
Ob upoštevanju poročil o oceni zdravila poročevalca in so- poročevalca, znanstvenih razprav znotraj odbora in pripomb Imetnikov dovoljenja za promet z zdravilom (MAH) CPMP meni, da je razmerje koristi in tveganja Lopida pozitivno v naslednjih indikacijah:
Lopid is indicated as an adjunct to diet and other non-pharmacological treatment (e. g. exercise, weight reduction) for the following:
Lopid je indiciran kot dopolnilo ustrezni prehrani in drugemu nefarmakološkemu zdravljenju (npr. telesni vadbi, znižanju telesne mase) za naslednje:
Treatment of dyslipidemia Mixed dyslipidaemia characterised by hypertriglyceridaemia and/ or low HDL-cholesterol.
Zdravljenje dislipidemije Mešana dislipidemija s hipertrigliceridemijo in/ ali nizko vrednostjo HDL holesterola.
Primary hypercholesterolaemia, particularly when a statin is considered inappropriate or is not tolerated.
Primarna hiperholesterolemija zlasti, kadar se statin izkaže za neustreznega ali ga bolnik ne prenaša.
Primary prevention Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event, particularly when a statin is considered inappropriate or is not tolerated (see section 5.1).
Primarno preprečevanje Zmanjšanje srčnožilne obolevnosti pri moških s povišanimi vrednostmi ne- HDL holesterola in visokim tveganjem za prvi srčnožilni dogodek zlasti, kadar se statin izkaže za neustreznega ali ga bolnik ne prenaša (glejte poglavje 5. 1).
The CPMP gave a positive opinion on 24 March 2004 recommending the harmonisation of the SPC for Lopid and associated names.
Odbor za lastniška zdravila CPMP je 24. marca 2004 dal pozitivno mnenje, s katerim priporoča usklajevanje SPC za Lopid in z njim povezana imena.
The list of product names concerned is given in Annex I.
Seznam zadevnih imen proizvodov je predložen v Dodatku I.
The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.
Znanstvene sklepne ugotovitve so določene v Dodatku II skupaj s spremenjenim Povzetkom glavnih značilnosti zdravila v Dodatku III.
A Decision was issued by the European Commission on 29 July 2004.
Odločbo je Evropska Komisija izdala 29. julija 2004.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Member State
1 Država članica
Pfizer Corporation Austria Ges. m. b. H Seidengasse 33 - 35 A – 1070 Wien
Pfizer Corporation Austria Ges. m. b. H Seidengasse 33 - 35 A – 1070 Dunaj
Rue Léon Theodor 102 B – 1090 Bruxelles
Rue Léon Theodor 102 B – 1090 Bruselj
Member State
2 Država članica
Lannelongue F – 75014 Paris
Lannelongue F – 75014 Pariz
Member State
3 Država članica
Lopid Parke Davis Lambert Court Chestnut Avenue Eastleigh Hampshire SO53 3ZQ United Kingdom
Lopid Parke Davis Lambert Court Chestnut Avenue Eastleigh Hampshire SO53 3ZQ Velika Britanija
Member State
4 Država članica
Lopid Via Valbondione 113 I – 00188 Roma
Via Valbondione 113 I – 00188 Rim
Via Valbondione 113 I – 00188 Roma
Via Valbondione 113 I – 00188 Rim
Member State
5 Država članica
Member State
6 Država članica
Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)
Parque Empresarial La Moraleja 28108 Alcobendas (Madrid)
Lopid Parke Davis Lambert Court Chestnut Avenue Eastleigh, Hampshire SO53 3ZQ United Kingdom
Lopid Parke Davis Lambert Court Chestnut Avenue Eastleigh, Hampshire SO53 3ZQ Velika Britanija
ANNEX II
7 DODATEK II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA (POVZETKOV) GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA VREDNOTENJE ZDRAVIL (European Medical Evaluation Agency - EMEA)
CHMP/ 1268/ 04 SCIENTIFIC CONCLUSIONS
8 ZNANSTVENI ZAKLJUČKI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LOPID AND ASSOCIATED NAMES (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENE OCENE LOPID- a IN PRIDRUŽENIH IMEN (glej Dodatek I)
- Quality issues
- Vprašanja o kakovosti
No significant issues relating to Quality were identified.
Ugotovljena niso bila nobena pomembna vprašanja glede kakovosti.
The pharmaceutical particulars of the SPC were harmonised, except the sections, which need to be introduced nationally by the Member States when implementing the harmonised SPC (section 6).
Usklajene so bile farmacevtske lastnosti SPC- ja (Summary Product Characteristics – Povzetek splošnih značilnosti), razen poglavij, ki jih morajo države članice uvesti na nacionalni ravni ob uporabi usklajenega SPC- ja (poglavje 6).
- Efficacy issues
- Vprašanja o učinkovitosti
The divergences that previously existed across the SPCs of EU Member States included:
Razhajanja, ki so obstajala po SPC- jih držav članic EU, so vključevala:
Section 4.1 Therapeutic Indications
Poglavje 4. 1 Terapevtske indikacije
The MAH was requested to propose and scientifically justify a common EU wide approach as there were divergences between national approvals regarding the use of Lopid in:
Zaradi spodnjih razlik med nacionalnimi odobritvami glede uporabe Lopida so MAH (Marketing Authorisation Holder – Imetnik dovoljenja za promet) zaprosili, da predlaga in znanstveno utemelji skupni pristop po EU:
• The treatment of hyperlipoproteinaemia, • The primary prevention of cardiovascular morbidity.
• Zdravljenje hiperlipoprotinemije, • primarno preprečevanje srčno- žilne zbolevnosti.
After an assessment of the documentation provided by the MAH and an evaluation of the current EU- wide clinical practices relating to the use of Lopid, the following was considered to be the most suitable harmonised Section 4.1 indications text:
Po oceni dokumentacije, ki jo je predložil MAH, ter po vrednotenju trenutnih kliničnih praks po EU glede uporabe Lopida, je najbolj ustrezno usklajeno besedilo Poglavja 4. 1 Terapevtske indikacije naslednje:
Currently, statins are the first-line treatment for patients with lipid abnormalities where pharmacological intervention has been definitely associated with a beneficial outcome.
Trenutno je zdravljenje s statini prva izbira za bolnike z nenormalnostmi lipidov, kjer se farmakološko posredovanje definitivno povezuje s koristnim izidom.
The statins have shown convincing efficacy regarding both primary and secondary prevention of cardiac mortality and morbidity.
Statini so pokazali prepričljivo učinkovitost pri primarni in sekundarni preventivi srčne umrljivosti in zbolevnosti.
Treatment with gemfibrozil should be considered mainly in situations were statins may not be used such as intolerance to statins or in patients with particular lipid disorders.
Zdravljenje z gemfibrozilom se uvaja predvsem v situacijah, kjer statinov ne moremo uporabiti zaradi neprenašanja statinov ali pri bolnikih z določenimi motnjami lipidov.
In addition, the unrestricted recommendation to use a product which is not a statin to treat patients with dyslipoproteinaemia of Fredrickson types II a and b (and probably also type III) does not reflect the current practice.
Poleg tega neomejeno priporočanje uporabe zdravila, ki ni statin, za zdravljenje bolnikov z dislipoproteinemijo tipov po Fredricksonu II a in b (in verjetno tudi tipa III) ne odraža trenutne prakse.
The inclusion of the Fredrickson classification in the wording of the indication was questioned by the CPMP, partly due to the fact that this classification is becoming obsolete.
Vključitev Fredricksonove razvrstitve v besedilo indikacije se je zdela CPMP (Committee for Proprietary Medicinal Products – Odbor za lastniška zdravila) vprašljiva, deloma zaradi dejstva, da ta razvrstitev postaja zastarela.
Finally, the harmonized indication is in line with European and US guidelines for the management of lipid disorders, which requires both confirmation of diagnosis by laboratory testing and lifestyle modification before initiating lipid-lowering treatment.
Usklajena indikacija je končno poenotena z evropskimi smernicami in smernicami ZDA za zdravljenje motenj lipidov, ki zahteva tako potrditev diagnoze z laboratorijskim testiranjem kot prilagoditev načina življenja pred uvedbo zdravljenja za zniževanje koncentracije lipidov.
• Treatment of dyslipidaemia
• Zdravljenje dislipidemije
The mechanism of action of gemfibrozil has not been definitively established.
Način delovanja gemfibrozila ni dokončno ugotovljen.
In man, gemfibrozil stimulates the peripheral lipolysis of triglyceride rich lipoproteins such as very low-density lipoproteins (VLDL) and chylomicrons (by stimulation of the lipoprotein lipase, LPL).
Pri človeku gemfibrozil spodbuja periferno lipolizo lipoproteinov, bogatih s trigliceridi, kot so lipoproteini zelo majhne gostote (very low- density lipoproteins, VLDL) in hilomikroni (preko spodbujanja lipoproteinske lipaze, LPL).
Gemfibrozil also inhibits synthesis of VLDL in the liver.
Gemfibrozil zavira tudi sintezo VLDL v jetrih.
Gemfibrozil increases the high-density lipoproteins HDL2 and HDL3 subfractions as well as apolipoprotein A-I and A-II.
Gemfibrozil povečuje koncentracije podfrakcij lipoproteinov velike gostote (high- density lipoproteins) HDL2 in HDL3, pa tudi koncentracije apolipoproteina A- I in A- II.
Due to the increased risk of muscular disorders, combined use of gemfibrozil and statins is no longer CHMP/ 1268/ 04
Statini so danes primarna izbira pri bolnikih s hiperholesterolemijo zaradi najboljših lastnosti nižanja koncentracije holesterola lipoproteinov nizke gostote (low- density lipoproteins, LDL) ter dokazano koristnega izida.
This was shown by two outcome-studies conducted with gemfibrozil (known as the Helsinki Heart and the Veterans Affairs HDL Intervention Trial [denoted by VA-HIT] studies).
Zaradi povečanega tveganja za mišične motnje kombinirana uporaba gemfibrozila in 9 statinov ni več priporočena in je torej uporaba gemfibrozila prvenstveno omejena na bolnike z dislipidemijo, za katero so značilne visoke koncentracije trigliceridov in/ ali nizke koncentracije HDL holesterola, kar se je pokazalo v dveh študijah izida, ki so ju izvajali z gemfibrozilom (študiji, imenovani Helsinki Heart in Veterans Affairs HDL Intervention Trial [okrajšano VA- HIT]).
The Helsinki Heart study was published by Frick MH, Elo O, Haapa K et al.
Študijo Helsinki Heart so objavili Frick MH, Elo O, Haapa K et al.
The VA-HIT study was published by Rubins HB, Robins SJ, Collins D et al.
Študijo VA- HIT so objavili Rubins HB, Robins SJ, Collins D et al.
In a subgroup analysis of the Helsinki Heart Study it was found that gemfibrozil was particularly effective in preventing heart disease in patients with high serum triglyceride concentrations, plus either low HDL-cholesterol or a high LDL/ HDL cholesterol ratio (Circulation 1992; 85:
V analizi podskupine študije Helsinki Heart so ugotovili, da je bil gemfibrozil zlasti učinkovit pri preprečevanju srčne bolezni pri bolnikih z visokimi serumskimi koncentracijami trigliceridov, skupaj z nizko koncentracijo HDL holesterola ali visokim razmerjem LDL/ HDL holesterola (Circulation 1992; 85:
In the second outcome study, the VA-HIT study, gemfibrozil resulted in a significant reduction in the risk of major cardiovascular events in patients with coronary heart disease whose primary lipid abnormality was a low HDL cholesterol, with LDL-cholesterol levels considered normal (≤ 3.6 mmol/ l).
V drugi študiji izida, študiji VA- HIT, je gemfibrozil povzročil značilno zmanjšanje tveganja za večje srčnožilne dogodke pri bolnikih s koronarno srčno boleznijo, katerih primarna nenormalnost lipidov je bila nizka koncentracija HDL holesterola, z normalnimi koncentracijami LDL holesterola (≤ 3, 6 mmol/ l).
Gemfibrozil is therefore particularly indicated for patients with high triglycerides and/ or low HDL- cholesterol.
Gemfibrozil je zato indiciran zlasti pri bolnikih z visoko koncentracijo trigliceridov in/ ali nizko koncentracijo HDL holesterola.
Hypercholesterolemia still is an indication, but mainly in combination with such dyslipidaemia.
Hiperholesterolemija ostaja indikacija, a predvsem v kombinaciji s tako dislipidemijo.
• Primary prevention (Reduction of cardiovascular morbidity)
• Primarna preventiva (Zmanjševanje srčno- žilne zbolevnosti)
This indication is mainly based on the Helsinki Heart Study, which was a large placebo-controlled study with 4081 male subjects, 40 to 55 years of age, with primary dyslipidaemia (predominantly raised non-HDL cholesterol +/ - hypertriglyceridaemia), but no previous history of coronary heart disease, gemfibrozil 600 mg twice daily, produced a significant reduction in total plasma triglycerides, total and low density lipoprotein cholesterol and a significant increase in high density lipoprotein cholesterol.
Gemfibrozil 600 mg dvakrat dnevno je povzročil značilno znižanje plazemske koncentracije celokupnih trigliceridov, celokupnega holesterola in LDL holesterola ter značilno povišanje koncentracije HDL holesterola.
The cumulative rate of cardiac end-points (cardiac death and non-fatal myocardial infarction) during a 5 year follow-up was 27.3/ 1000 in the gemfibrozil group (56 subjects) and 41.4/ 1000 in the placebo group (84 subjects) showing a relative risk reduction of 34.0% (95% confidence interval 8.2 to 52.6, p < 0.02) and an absolute risk reduction of 1.4% in the gemfibrozil group compared to placebo.
Kumulativna stopnja srčnih končnih točk (srčna smrt in miokardni infarkt brez smrtnega izida) v 5- letnem sledenju je bila 27, 3/ 1000 v skupini gemfibrozila (56 oseb) in 41, 4/ 1000 v skupini placeba (84 oseb), kar kaže zmanjšanje relativnega tveganja za 34, 0% (95% interval zaupanja 8, 2 do 52, 6, p < 0, 02) ter zmanjšanje absolutnega tveganja za 1, 4% v skupini gemfibrozila v primerjavi s placebom.
There was a 37% reduction in non-fatal myocardial infarction and a 26% reduction in cardiac deaths.
Opazili so tudi 37% zmanjšanje pojavnosti miokardnega infarkta brez smrtnega izida in 26% zmanjšanje srčnih smrti.
The number of deaths from all causes was, however, not different (44 in the gemfibrozil group and 43 in the placebo group).
Število smrti zaradi vseh vzrokov pa se ni razlikovalo (44 v skupini gemfibrozila in 43 v skupini placeba).
Diabetes patients and patients with severe lipid fraction deviations showed a 68% and 71% reduction of CHD endpoints, respectively.
Bolniki s sladkorno boleznijo ter bolniki s hudimi odstopanji lipidnih frakcij so pokazali 68% oziroma 71% znižanje CHD končnih točk.
The study is only carried out in men between 40 and 55 years of age in a Finland, where at that time men were at particularly high risk for ischemic heart disease.
Študija je bila narejena samo med moškimi na Finskem, starimi od 40 do 55 let, kjer je bilo v tem obdobju za moške posebej povečano tveganje za ishemično srčno bolezen.
This hampers the external validity to the general population.
To moti siceršnjo veljavnost za splošno populacijo.
Patients were selected on the basis of non-HDL cholesterol with an acceptance level ≥ 5.2 mmol/ l without specifying levels of LDL- and HDL-cholesterol and triglycerides), Subgroup analysis showed that benefit was most pronounced in the patients who probably fitted more in the patients with hypertriglyceridaemia and mixed dyslipidaemia than in those with hypercholesterolemia.
Analiza podskupin je pokazala, da je bila korist najbolj izražena pri bolnikih, ki so najbrž bolj ustrezali skupini s hipertrigliceridemijo in mešano dislipidemijo kot skupini s hiperholesterolemijo.
Statins are the products of choice to treat patients with isolated hypercholesterolemia.
Za zdravljenje bolnikov z izolirano hiperholesterolemijo so kot zdravilo izbrani statini.
Lopid is indicated as an adjunct to diet and other non-pharmacological treatment (e. g. exercise, weight reduction) for the following:
Lopid je indiciran kot pomožno sredstvo k ustrezni prehrani in drugemu nefarmakološkemu zdravljenju (npr. telesna vadba, zmanjšanje telesne mase) za naslednje:
Mixed dyslipidaemia characterised by hypertriglyceridaemia and/ or low HDL-cholesterol.
Zdravljenje dislipidemije 10 Mešana dislipidemija, za katero je značilna hipertrigliceridemija in/ ali nizka koncentracija HDL holesterola.
Primary hypercholesterolaemia, particularly when a statin is considered inappropriate or is not tolerated.
Primarna hiperholesterolemija, zlasti kadar statin ne ustreza ali ga bolnik ne prenaša.
Primary prevention Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event, particularly when a statin is considered inappropriate or is not tolerated (see section 5.1).
Primarna preventiva Zmanjšanje srčnožilne zbolevnosti pri moških s povišano koncentracijo ne- HDL holesterola z visokim tveganjem za prvo srčnožilno težavo, zlasti kadar statin ne ustreza ali ga bolnik ne prenaša (glej poglavje 5. 1).
Section 4.2.
Poglavje 4. 2.
Not all strengths were authorised in all Member States.
Vse jakosti nimajo dovoljenja za promet v vseh državah članicah.
Little divergences were identified between dose recommendations.
Glede priporočenih odmerkov so ugotovili manjša razhajanja.
More importantly, no Member States recommended a maximum dose < 1,200 mg/ day (the dose used in Helsinki Heart Trial).
Pomembnejše pa je, da v nobeni od držav članic niso priporočali največjega odmerka < 1. 200 mg/ dan (odmerek, uporabljan v preskušanju Helsinki Heart Trial).
Where a maximum dose was recommended, it was consistently 1,500 mg.
Kjer so priporočali največji odmerek, je bil ta vedno 1. 500 mg.
The MAH was requested to substantiate scientifically the divergent information across member states and justify a proposed common wording, especially with regard to therapeutic daily dose range.
MAH so prosili, da znanstveno utemelji različne podatke po državah članicah ter obrazloži predlagano skupno besedilo, zlasti kar se tiče terapevtskega razpona dnevnih odmerkov.
It was proposed to rationalise the authorised strengths of Lopid.
Predlagano je bilo, da se racionalizirajo jakosti Lopida z dovoljenjem za promet.
The 1200mg tablet and sachet formulations have already been and will be removed from the market.
Tablete po 1200 mg ter pripravki v praških so že bili ali še bodo umaknjeni s trga.
Therefore the 300 mg capsule and 450 mg, 600 mg and 900 mg tablets will still be authorised.
Dovoljenje za promet pa bodo ohranile kapsule po 300 mg in tablete po 450 mg, 600 mg in 900 mg.
The recommended dosage is 1200 mg per day with a 900 mg minimum dose and a maximum recommended dose of 1500 mg.
Priporočeno odmerjanje je 1200 mg dnevno z najmanjšim odmerkom 900 mg ter največjim priporočenim odmerkom 1500 mg.
Medical practice over the years has established the use of combinations of the smaller dosage sizes to achieve the recommended daily dose even though higher strengths have been approved.
V zdravstveni praksi so preko let ugotovili, da je za doseganje priporočenih dnevnih odmerkov najustreznejša uporaba kombinacij manjših odmerkov, čeprav so bile odobrene tudi večje jakosti.
The proposed posology fits into the current recommendations.
Predlagano odmerjanje ustreza trenutnim priporočilom.
In addition to the recommended maintenance dose, the CPMP considered it appropriate to recommend both a minimum and a maximum dose as well.
Poleg priporočenega vzdrževalnega odmerka so v CPMP sklenili priporočiti tudi najmanjši in največji odmerek.
As the two major clinical outcome studies, Helsinki Heart Study and the VA- HIT study have been carried out with a 1200 mg daily dose (2x600 mg), the CPMP considered that 1200 mg should be the recommended daily dose.
Ker so poglavitni dve študiji kliničnega izida, študijo Helsinki Heart in študijo VA- HIT, opravili z dnevnim odmerkom 1200 mg (2 x 600 mg), so v CPMP sklenili, da je 1200 mg priporočeni dnevni odmerek.
Some recommendations were introduced for patients with patients with mild to moderate renal impairment.
Uvedli so tudi priporočila za bolnike z blago do zmerno okvarjenim delovanjem ledvic.
After an assessment of the documentation provided by the MAH and an evaluation of the current EU- wide clinical practices relating to the use of Lopid the following was considered to be the most suitable harmonised Section 4.2 Posology and method of administration text:
Po oceni dokumentacije, ki jo je predložil MAH, ter vrednotenju trenutnih kliničnih praks po EU glede uporabe Lopida, je bilo najustreznejše usklajeno besedilo Poglavja 4. 2 Odmerjanje in način uporabe sledeče:
Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment.
Pred uvedbo gemfibrozila moramo doseči kar najboljši nadzor drugih zdravstvenih težav, kot sta hipotiroidizem in sladkorna bolezen, bolniki pa naj se pred zdravljenjem in med njim držijo ustaljene prehrane za nižanje lipidov.
Lopid should be taken orally.
Lopid jemljemo peroralno.
Adult The dose range is 900 mg to 1200 mg daily.
Odrasli Razpon odmerkov je 900 mg do 1200 mg dnevno.
The only dose with documented effect on morbidity is 1200 mg daily.
Edini odmerek z dokazanim učinkom na zbolevnost je 1200 mg dnevno.
The 1200 mg dose is taken as 600 mg twice daily, half an hour before breakfast and half an hour before the evening meal.
Odmerek 1200 mg jemljemo kot 600 mg dvakrat dnevno, pol ure pred zajtrkom in pol ure pred večernim obrokom.
The 900 mg dose is taken as a single dose half an hour before the evening meal.
Odmerek 900 mg jemljemo kot enkratni odmerek pol ure pred večernim obrokom.
Elderly (over 65 years old) As for adults
Starejši (starejši od 65 let) Kot pri odraslih
Gemfibrozil therapy has not been investigated in children.
Otroci in mladostniki Zdravljenja z gemfibrozilom pri otrocih niso preiskovali.
Due to the lack of data the use of Lopid in children is not recommended.
Zaradi pomanjkanja podatkov odsvetujemo uporabo Lopida pri otrocih.
Renal impairment In patients with mild to moderate renal impairment (Glomerular filtration rate 50 - 80 and 30 - < 50 ml/ min/ 1.73 m2, respectively), start treatment at 900 mg daily and assess renal function before increasing dose.
Okvarjeno delovanje ledvic 11 Pri bolnikih z blago do zmerno okvarjenim delovanjem ledvic (stopnja glomerulne filtracije 50 - 80 oziroma 30 - < 50 ml/ min/ 1, 73 m2), zdravljenje začnemo z 900 mg dnevno in pred povišanjem odmerka ocenimo ledvično funkcijo.
Lopid should not be used in patients with severely impaired renal function (see section 4.3).
Lopida pri bolnikih s hudo okvarjenim delovanjem ledvic ne smemo uporabljati (glej poglavje 4. 3).
Hepatic impairment Gemfibrozil is contraindicated in hepatic impairment (see section 4.3).
Okvarjeno delovanje jeter Gemfibrozil je pri okvarjenem delovanju jeter kontraindiciran (glej poglavje 4. 3).