natgillin/translations-raw huggingface dataset:
The MAH was requested to propose and scientifically justify a common EU wide approach as the contraindications text was nor harmonised between Member States especially relating to the use in patients with: • (severe) liver and renal disease and gallbladder disease.
MAH so zaprosili, da predlaga in znanstveno utemelji splošni pristop po EU, saj besedilo kontraindikacij med državami članicami ni bilo usklajeno, zlasti kar se tiče uporabe pri bolnikih s: • (hudo) okvarjenim delovanjem jeter in okvarjenim delovanjem ledvic ter žolčnimi kamni.
A recently reported drug interaction with repaglinide has been added to the contraindications.
Kontraindikacijam je bilo dodano medsebojno delovanje z repaglinidom, ki je bilo pred kratkim ugovljeno.
The combination of gemfibrozil with repaglinide resulted in an 8-fold increased exposure of repaglinide, resulting in hypoglycaemia.
Kombinacija gemfibrozila z repaglinidom je povzročila 8- krat povečano izpostavitev repaglinidu, kar je imelo za posledico hipoglikemijo.
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 4.3 Contraindications:
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. 3 Kontraindikacije naslednje:
Hypersensitivity to gemfibrozil or any of the excipients.
Preobčutljivost za gemfibrozil ali katerokoli od pomožnih snovi.
Hepatic impairment.
Okvarjeno delovanje jeter.
Severe renal impairment.
Hudo okvarjeno delovanje ledvic.
History of/ or pre-existing gall bladder or biliary tract disease, including gallstones Concomitant use of repaglinide (see section 4.5).
Sočasna uporaba repaglinida (glej poglavje 4. 5).
Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates.
Bolniki s fotoalergijsko ali fototoksično reakcijo med zdravljenjem s fibrati v preteklosti.
Section 4.4.
Poglavje 4. 4.
Special warnings and precautions for use 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 most suitable harmonised Section 4.4 Special Warnings and Precautions for Use text was approved (See Annex III).
Posebna opozorila in previdnostni ukrepi Po oceni dokumentacije, ki jo je predložil MAH, ter vrednotenju trenutnih kliničnih praks po EU glede uporabe Lopida, je bilo odobreno najustreznejše usklajeno besedilo Poglavja 4. 4 Posebna opozorila in previdnostni ukrepi (Glej Dodatek III).
The risk of muscle disorders (myopathy/ rhabdomyolysis) and the special warnings and special precautions for use in case of concomitant administration of HMG CoA reductase inhibitors were further emphasised in the harmonised SPC.
V usklajenem SPC- ju so še dodatno poudarili tveganje za mišične motnje (miopatijo/ rabdomiolizo) ter posebna opozorila in previdnostne ukrepe v primeru sočasnega dajanja zaviralcev HMG CoA reduktaze.
In addition, recently reported interactions with other medicinal products have been added to the SPC for Lopid.
Poleg tega so v SPC Lopida dodali še medsebojna delovanja z drugimi zdravili, o katerih so poročali v zadnjem času.
Section 4.5.
Poglavje 4. 5.
In addition, CHMP/ 1268/ 04
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Po oceni dokumentacije, ki jo je predložil MAH, ter vrednotenju trenutnih kliničnih praks po EU glede uporabe Lopida, je bilo odobreno najustreznejše usklajeno besedilo Poglavja 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij (Glej Dodatek III).
recently reported interactions with other medicinal products have been added to the SPC for Lopid.
Poleg tega so v SPC Lopida dodali še medsebojna delovanja z drugimi zdravili, o katerih so poročali v zadnjem času.
The risk of interaction with other medicinal products (esp. with those products metabolised through CYP2C9 and CYP2C8) was further emphasised in the harmonised SPC.
V usklajenem SPC- ju so še posebej poudarili tveganje za medsebojno delovanje z drugimi zdravili (zlasti z zdravili, ki se presnavljajo s CYP2C9 in CYP2C8).
All other sections of the SPC were harmonised as a result of the referral procedure (except See Below; Administrative Issues).
Vsa druga poglavja SPC- ja so uskladili s postopkom napotila (razen Glej spodaj; Administrativna vprašanja).
Finally, the CPMP considered that all presentations may be useful to treat the patients in the approved indications.
Končno so v CPMP sklenili, da so vse oblike uporabne za zdravljenje bolnikov za odobrene indikacije.
Benefit/ Risk considerations Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CPMP considered that the benefit/ risk ratio of Lopid is favourable for use relating to:
12 Razmerje koristi/ tveganja Na podlagi dokumentacije, ki jo je predložil MAH, ter znanstvene razprave v okviru Odbora, so v CPMP sklenili, da je razmerje med koristmi in tveganji Lopida ugodno za uporabo pri:
Lopid as an adjunct to diet and other non-pharmacological treatment (e. g. exercise, weight reduction) for the following:
Lopid kot pomožno sredstvo k ustrezni prehrani in drugemu nefarmakološkemu zdravljenju (npr. telesni vadbi, zmanjšanju telesne mase) za naslednje:
Treatment of dyslipidemia Mixed dyslipidaemia characterised by hypertriglyceridaemia and/ or low HDL-cholesterol.
Zdravljenje dislipidemije Mešana dislipidemija, za katero je značilna hipertrigliceridemija in/ ali nizka koncentracija HDL holesterola.
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 povišanimi koncentracijami ne- HDL holesterola in z visokim tveganjem za prvo srčnožilno težavo, zlasti kadar statin ne ustreza ali ga bolnik ne prenaša (glej poglavje 5. 1).
GROUNDS FOR AMENDMENT CHARACTERISTICS
PODLAGA ZA DOPOLNILO POVZETKA (POVZETKOV) GLAVNIH ZNAČILNOSTI ZDRAVILA
OF
Ker
SUMMARY(IES) OF
je bil cilj napotila uskladitev Povzetkov glavnih značilnosti zdravila, je bil Povzetek glavnih značilnosti zdravila, ki so ga predlagali imetniki dovoljenj za promet ocenjen v okviru Odbora na podlagi predložene dokumentacije in znanstvene razprave,
• the scope of the referral was the harmonisation of the Summaries of Products Characteristics, • the Summary of Products Characteristic proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee, • Important new information on interactions with several medicinal products was included in the SPC,
so bili v SPC vključeni pomembni novi podatki o medsebojnih delovanjih z različnimi zdravili,
the CPMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III of the Opinion for Lopid and associated names (see Annex I).
so v CPMP priporočili dopolnilo Dovoljenja za promet, za katerega je Povzetek glavnih značilnosti zdravila najti v Dodatku III Mnenja za Lopid in pridružena imena (glej Dodatek I).
The divergences identified at the start of the referral have been resolved.
Razlike, ugotovljene na začetku napotila, so razrešili.
ANNEX III
13 DODATEK III
This SPC is the one that was Annexed to the Commission Decision on this Article 30 referral for gemfibrozil containing medicinal products.
Ta Povzetek glavnih značilnosti zdravila je bil priložen k odločbi Komisije v zvezi s tem postopkom, ki je bil sprožen v skladu s členom 30, za zdravila, ki vsebujejo gemfibrozila.
15/ 22
14 1.
 EMEA 2004
IME ZDRAVILA
< (LOPID and associated names) > < (strength) > mg< tablets > < capsules > < granules > < film-coated tablets > < coated tablets >
< (LOPID in povezana imena) > < (jakost) > mg < tablete > < kapsule > < zrnca > < filmsko obložene tablete > < obložene tablete >
[See Annex I.
[Glej Dodatek I.
To be implemented nationally]
Dopolniti nacionalno]
Each capsule contains 300 mg gemfibrozil.
Ena kapsula vsebuje 300 mg gemfibrozila.
Each film-coated tablet contains 450 mg, 600 mg or 900 mg gemfibrozil.
Ena filmsko obložena tableta vsebuje 450 mg, 600 mg ali 900 mg gemfibrozila.
< Capsule > < Film-coated tablet > < Tablet > < Granules > < Coated tablet >
< Kapsula > < Filmsko obložena tableta > < Tableta > < Zrnca > < Obložena tableta >
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 je treba kar najbolje urediti druge zdravstvene težave, denimo, hipotiroidizem in diabetes mellitus, bolniki pa naj se pred zdravljenjem in med njim držijo ustaljene prehrane za znižanje vrednosti lipidov.
Adult The dose range is 900 mg to 1200 mg daily.
Odrasli Razpon odmerkov je od 900 mg do 1200 mg na dan.
The only dose with documented effect on morbidity is 1200 mg daily.
Edini odmerek z ugotovljenim učinkom na obolevnost je 1200 mg na dan.
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 na dan, pol ure pred zajtrkom in pol ure pred večernim obrokom.
CHMP/ 1268/ 04 Elderly (over 65 years old) As for adults
Starejši (starejši od 65 let) 15 Kot pri odraslih
Due to the lack of data the use of Lopid in children is not recommended.
Zaradi pomanjkanja podatkov se uporaba Lopida pri otrocih odsvetuje.
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.
Ledvična okvara Pri bolnikih z blago do zmerno ledvično okvaro (stopnja glomerulne filtracije 50 - 80 oziroma 30 - < 50 ml/ min/ 1, 73 m2) zdravljenje začnemo z 900 mg na dan 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 ledvično okvaro ne smemo uporabljati (glejte poglavje 4. 3).
Hepatic impairment Gemfibrozil is contraindicated in hepatic impairment (see section 4.3).
Jetrna okvara Gemfibrozil je pri jetrni okvari kontraindiciran (glejte poglavje 4. 3).
Hypersensitivity to gemfibrozil or any of the excipients.
Preobčutljivost za gemfibrozil ali katerokoli pomožno snov.
History of/ or pre-existing gall bladder or biliary tract disease, including gallstones Concomitant use of repaglinide (see section 4.5).
Sočasna uporaba repaglinida (glejte poglavje 4. 5).
Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates.
Bolniki s fotoalergijo ali fototoksično reakcijo med zdravljenjem s fibrati v preteklosti.
Muscle disorders (myopathy/ rhabdomyolysis) There have been reports of myositis, myopathy and markedly elevated creatine phosphokinase associated with gemfibrozil.
Bolezni mišic (miopatija/ rabdomioliza) V povezavi z gemfibrozilom so poročali o miozitisu, miopatiji in pomembno povišani vrednosti kreatin- fosfokinaze (CPK – » creatine phosphokinase «).
Muscle damage must be considered in any patient presenting with diffuse myalgia, muscle tenderness and/ or marked increase in muscle CPK levels (> 5x ULN); under these conditions treatment must be discontinued.
Na poškodbe mišic moramo pomisliti pri vsakem bolniku z difuzno mialgijo, občutljivostjo mišic na dotik in/ ali povišanimi vrednostmi mišične CPK (> 5 x ULN); v takih okoliščinah je treba z zdravljenjem prenehati.
Concomitant HMG CoA reductase inhibitors The risk of muscle damage may be increased in the event of combination with an HMG-CoA reductase inhibitor.
Sočasna uporaba zaviralcev reduktaze HMG CoA Nevarnost za poškodbe mišic je lahko povečana pri sočasnem jemanju zaviralca reduktaze HMG CoA.
Pharmacokinetic interactions may also be present (see also section 4.5) and dosage adjustments may be necessary.
Pojavijo se lahko tudi farmakokinetična medsebojna delovanja (glejte tudi poglavje 4. 5) in morda bodo potrebne prilagoditve odmerkov.
The benefit of further alterations in lipid levels by the combined use of gemfibrozil and HMG-CoA reductase inhibitors should be carefully weighed against the potential risks of such combinations and clinical monitoring is recommended.
V takem primeru priporočamo klinično spremljanje.
A creatine phosphokinase (CPK) level should be measured before starting such a combination in patients with pre-disposing factors for rhabdomyolysis as follows: • renal impairment • hypothyroidism • alcohol abuse • age > 70 years • personal or family history of hereditary muscular disorders • previous history of muscular toxicity with another fibrate or HMG-CoA reductase inhibitor
Pred uvedbo take kombinacije moramo pri bolnikih s spodaj naštetimi predispozicijskimi dejavniki za rabdomiolizo izmeriti vrednost kreatin- fosfokinaze (CPK): • ledvična okvara, • hipotiroidizem, • zloraba alkohola, • starost > 70 let, • dedne mišične motnje v osebni ali družinski anamnezi, • mišična toksičnost ob jemanju drugega fibrata ali zaviralca reduktaze HMG CoA v preteklosti.
Use in patients with gallstone formation Gemfibrozil may increase cholesterol excretion into the bile raising the potential for gallstone formation.
Uporaba pri bolnikih z žolčnimi kamni Gemfibrozil lahko poveča izločanje holesterola v žolč ter tako poveča možnost tvorbe žolčnih kamnov.
Cases of cholelithiasis have been reported with gemfibrozil therapy.
Pri zdravljenju z gemfibrozilom so poročali o primerih holelitiaze.
suspected, gallbladder studies are indicated.
Če posumimo na holelitazo, moramo opraviti preiskave žolčnika.
Gemfibrozil therapy should be discontinued if gallstones are found.
Če odkrijemo žolčne kamne, moramo zdravljenje z gemfibrozilom prekiniti.
Monitoring serum lipids Periodic determinations of serum lipids are necessary during treatment with gemfibrozil.
Spremljanje serumskih koncentracij lipidov 16 Med zdravljenjem z gemfibrozilom moramo redno določati vrednosti serumskih lipidov.
Sometimes a paradoxical increase of (total and LDL) cholesterol can occur in patients with hypertriglyceridaemia.
Pri bolnikih s hipertrigliceridemijo se včasih pojavi paradoksno povišanje koncentracij (celokupnega in LDL) holesterola.
If the response is insufficient after 3 months of therapy at recommended doses treatment should be discontinued and alternative treatment methods considered.
Če odziv še po 3 mesecih zdravljenja s priporočenimi odmerki ni zadosten, moramo zdravljenje prekiniti in razmisliti o alternativnih metodah zdravljenja.
Monitoring liver function Elevated levels of ALAT, ASAT, alkaline phosphatase, LDH, CK and bilirubin have been reported.
Spremljanje delovanja jeter Poročali so o povišanih koncentracijah ALAT, ASAT, alkalne fosfataze, LDH, CK in bilirubina.
These are usually reversible when gemfibrozil is discontinued.
Ta povišanja so po ukinitvi zdravljenja z gemfibrozilom običajno reverzibilna.
Therefore liver function tests should be performed periodically.
Zato moramo redno spremljati vrednosti testov jetrnega delovanja.
Gemfibrozil therapy should be terminated if abnormalities persist.
V kolikor nenormalne vrednosti vztrajajo, moramo zdravljenje z gemfibrozilom prekiniti.
Monitoring blood counts Periodic blood count determinations are recommended during the first 12 months of gemfibrozil administration.
Spremljanje krvne slike V prvih 12 mesecev dajanja gemfibrozila je priporočljivo redno spremljanje krvne slike.
Anaemia, leucopenia, thrombocytopenia, eosinophilia and bone marrow hypoplasia have been reported rarely (see section 4.8).
Redko so poročali o anemiji, levkopeniji, trombocitopeniji, eozinofiliji ter hipoplaziji kostnega mozga (glejte poglavje 4. 8).
Interactions with other medicinal products (see also sections 4.3 and 4.5).
Medsebojna delovanja z drugimi zdravili (glejte tudi poglavji 4. 3 in 4. 5).
Concomitant use with CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1 and UGTA3 substrates.
Sočasna uporaba s substrati CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1 in UGTA3.
The interaction profile of gemfibrozil is complex resulting in increased exposure of many medicinal products if administered concomitantly with gemfibrozil.
Profil medsebojnih delovanj gemfibrozila je zapleten in povzroči povečano izpostavljenost mnogih zdravil, če jih dajemo sočasno z gemfibrozilom.
Gemfibrozil potently inhibits CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1 and UGTA3 enzymes (see section 4.5)
Gemfibrozil močno zavira encime CYP2C8, CYP2C9, CYP2C19, CYP1A2, UGTA1 in UGTA3 (glejte poglavje 4. 5)
Concomitant use with hypoglycaemic agents There have been reports of hypoglycaemic reactions after concomitant use with gemfibrozil and hypoglycaemic agents (oral agents and insulin).
Sočasna uporaba s hipoglikemičnimi zdravili Po sočasni uporabi gemfibrozila in hipoglikemičnih zdravil (peroralnih zdravil in insulina) so poročali o hipoglikemiji.
Monitoring of glucose levels is recommended.
Priporočljivo je spremljanje koncentracij glukoze.
Concomitant oral anticoagulants Gemfibrozil may potentiate the effects of oral anticoagulants, which necessitates careful monitoring of the anticoaglant dosing.
Sočasna uporaba peroralnih antikoagulantov Gemfibrozil lahko potencira učinke peroralnih antikoagulantov, zato je nujno skrbno spremljanje odmerjanja antikoagulanta.
Caution should be exercised when anticoagulants are given in conjunction with gemfibrozil.
Kadar dajemo antikoagulante skupaj z gemfibrozilom, je potrebna previdnost.
The dosage of the anticoagulant may need to be reduced to maintain desired prothrombin time levels (see Section 4.5.)
Morda bo treba za vzdrževanje želenih vrednosti protrombinskega časa odmerjanje antikoagulanta zmanjšati (glejte poglavje 4. 5.)
The interaction profile of gemfibrozil is complex.
Profil medsebojnih delovanj gemfibrozila je zapleten.
In vivo studies indicate that gemfibrozil is a potent inhibitor of CYP2C8 (an enzyme important for the metabolism of e. g. repaglinide, rosiglitazone and paclitaxel).
Študije in vivo kažejo, da je gemfibrozil močan zaviralec CYP2C8 (encima, pomembnega za presnovo, npr. repaglinida, rosiglitazona in paklitaksela).
In vitro studies have shown that gemfibrozil is a strong inhibitor of CYP2C9 (an enzyme involved in the metabolism of e. g. warfarin and glimepiride), but also of CYP 2C19, CYP1A2 and UGTA1 and UGTA3 (see Section 4.4).
Študije in vitro so pokazale, da je gemfibrozil močan zaviralec CYP2C9 (encima, ki sodeluje v presnovi, npr. varfarina in glimepirida), pa tudi CYP 2C19, CYP1A2 in UGTA1 ter UGTA3 (glejte poglavje 4. 4).
Repaglinide The combination of gemfibrozil with repaglinide is contra-indicated (see Section 4.3).
Repaglinid Kombinacija gemfibrozila z repaglinidom je kontraindicirana (glejte poglavje 4. 3).
Concomitant administration has resulted in 8-fold increase in repaglinide plasma concentration probably by inhibition of the CYP2C8 enzyme, resulting in hypoglycaemic reactions.
Sočasno dajanje je povzročilo 8- kratno povišanje plazemskih koncentracij repaglinida, verjetno z zaviranjem encima CYP2C8, kar je povzročilo hipoglikemijo.
Rosiglitazone The combination of gemfibrozil with rosiglitazone should be approached with caution.
Rosiglitazon Gemfibrozil smemo dajati sočasno z rosiglitazonom le izredno previdno.
Co- administration with rosiglitazone has resulted in 2.3-fold increase in rosiglitazone systemic exposure, probably by inhibition of the CYP2C8 isozyme (see section 4.4).
Sočasno dajanje z rosiglitazonom je povzročilo 2, 3- kratno povečanje sistemske izpostavljenosti rosiglitazonu, verjetno z zaviranjem izocima CYP2C8 (glejte poglavje 4. 4).
The combined use of gemfibrozil and a statin should generally be avoided (see section 4.4).
Zaviralci reduktaze HMG CoA Kombinirani uporabi gemfibrozila in statina se je treba na splošno izogibati (glejte poglavje 4. 4).
The use of fibrates alone is occasionally associated with myopathy.
Uporabo fibratov samih občasno povezujejo z miopatijo.
An increased risk of muscle related adverse events, including rhabdomyolysis, has been reported when fibrates are co-administered with statins.
Pri sočasnem dajanju fibratov s statini so poročali o povečanem tveganju za neželene dogodke, povezane z mišicami, vključujoč rabdomiolizo.
Gemfibrozil has also been reported to influence the pharmacokinetics of simvaststin, lovastatin, pravastatin and rosuvastatin.
17 Poročali so, da gemfibrozil vpliva tudi na farmakokinetiko simvastatina, lovastatina, pravastatina in rosuvastatina.
Gemfibrozil caused an almost 3-fold increased in AUC of simvastatin acid possibly due to inhibition of glucoronidation via UGTA1 and UGTA3, and a 3-fold increase in pravastatin AUC which may be due to interference with transport proteins.
Gemfibrozil je povzročil skoraj 3- kratno povečanje AUC simvastatina, verjetno z zaviranjem glukuronidacije z UGTA1 in UGTA3, in 3- kratno povečanje AUC pravastatina, morda zaradi vpliva na transportne beljakovine.
One study indicated that the co-administration of a single rosuvastatin dose of 80 mg to healthy volunteers on gemfibrozil (600 mg twice daily) resulted in a 2.2-fold increase in mean Cmax and a 1.9-fold increase in mean AUC of rosuvastatin.
V eni študiji so pokazali, da sočasno dajanje enkratnega odmerka 80 mg rosuvastatina zdravim prostovoljcem, ki jemljejo gemfibrozil (600 mg dvakrat na dan), povzroči 2, 2- kratno povečanje povprečne Cmax in 1, 9- kratno povečanje povprečne AUC rosuvastatina.
Oral anticoagulants Gemfibrozil may potentiate the effects of oral anticoagulants, which necessitates careful monitoring of the anticoagulant dosing (see section 4.4).
Peroralni antikoagulanti Gemfibrozil lahko potencira učinke peroralnih antikoagulantov, zato je treba odmerjanje antikoagulanta skrbno spremljati (glejte poglavje 4. 4).
Bexarotene Concomitant administration of gemfibrozil with bexarotene is not recommended.
Beksaroten Sočasno dajanje gemfibrozila z beksarotenom odsvetujemo.
A population analysis of plasma bexarotene concentrations in patients with cutaneous T-cell lymphoma (CTCL) indicated that concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene.
Populacijska analiza plazemskih koncentracij beksarotena pri bolnikih s kožnim T- celičnim limfomom (CTCL – » cutaneous T- cell lymphoma «) je pokazala, da sočasno dajanje gemfibrozila povzroči pomembna povišanja plazemskih koncentracij beksarotena.
Bile Acid – Binding Resins Reduced bioavailability of gemfibrozil may result when given simultaneously with resin-granule drugs such as colestipol.
Smole, ki vežejo žolčne kisline Sočasno dajanje gemfibrozila z zdravili v obliki smolnih zrnc, denimo, kolestipolom, lahko povzroči zmanjšano biološko razpoložljivost gemfibrozila.
Administration of the products two hours or more apart is recommended.
Ta zdravila je priporočljivo dajati v razmaku vsaj 2 ur.
Pregnancy There are no adequate data on use of Lopid in pregnant women.
Nosečnost Zadostnih podatkov o uporabi Lopida pri nosečnicah ni.
Animal studies are insufficiently clear to allow conclusions to be drawn on pregnancy and foetal development (see section 5.3).
Študije na živalih niso dale dovolj jasnih rezultatov, ki bi omogočili zaključke o nosečnosti in razvoju ploda (glejte poglavje 5. 3).
Lopid should not be used during pregnancy unless it is clearly necessary.
Lopida med nosečnostjo ne smemo uporabljati, razen če to ni nujno potrebno.
Lactation There are no data on excretion of gemfibrozil in milk.
Dojenje Podatkov o izločanju gemfibrozila v mleko ni.
Lopid should not be used when breast feeding.
Lopida v času dojenja ne smemo uporabljati.
In isolated cases dizziness and visual disturbances can occur which may negatively influence driving.
V posameznih primerih se lahko pojavijo omotica in motnje vida, kar lahko negativno vpliva na vožnjo.