natgillin/translations-raw huggingface dataset:
HOW TO STORE STALEVO
KAKO SHRANJEVATI ZDRAVILO STALEVO
Do not use after the expiry date which is stated on the bottle and the carton after EXP.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici in na škatli poleg oznake » EXP «.
These measures will help to protect the environment.
Ti ukrepi pomagajo varovati okolje.
- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Zdravilne učinkovine zdravila Stalevo so levodopa, karbidopa in entakapon.
- Each Stalevo 50 mg/ 12.5 mg/ 200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa
- Vsaka tableta zdravila Stalevo 50 mg/ 12, 5 mg/ 200 mg vsebuje 50 mg levodope, 12, 5 mg
and 200 mg of entacapone.
karbidope in 200 mg entakapona.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize
- Ostale sestavine v jedru tablete so: premrežen natrijev karmelozat, magnezijev stearat, koruzni
starch, mannitol (E421) and povidone (E1201)
škrob, manitol (E421) in povidon (E1201)
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium
- Sestavine v filmski oblogi so glicerol (85 odstotkov) (E422), hipromeloza, magnezijev stearat,
stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172).
polisorbat 80, rdeči železov oksid (E172), saharoza, titanov dioksid (E171) in rumeni železov oksid (E172).
What Stalevo looks like and contents of the pack
63 Izgled zdravila Stalevo in vsebina pakiranja
Stalevo 50 mg/ 12.5 mg/ 200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘ LCE 50’ on one side.
Zdravilo Stalevo 50 mg/ 12, 5 mg/ 200 mg so rjavkaste ali sivkasto- rdeče, okrogle, konveksne filmsko obložene tablete brez zareze, z oznako » LCE 50 « na eni strani.
63 Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Zdravilo Stalevo je na razpolago v šestih različnih velikostih pakiranja (10, 30, 100, 130, 175 ali 250 tablet).
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Za vse informacije o tem zdravilu se obrnite na lokalnega predstavnika imetnika dovoljenja za promet z zdravilom.
Tel: +31 26 37 82 111 Norge Orion Pharma AS Tlf: +47 40 00 42 10 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 Polska Orion Oyj S. A.
Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 Polska Orion Oyj S. A.
Ireland Orion Pharma (Ireland) Ltd. c/ o Allphar Services Ltd.
64 Ireland Orion Pharma (Ireland) Ltd. c/ o Allphar Services Ltd.
This leaflet was last approved on {date}
Datum zadnje revizije navodil:
Stalevo 100 mg/ 25 mg/ 200 mg film-coated tablets Levodopa/ carbidopa/ entacapone
Stalevo 100 mg/ 25 mg/ 200 mg filmsko obložene tablete levodopa/ karbidopa/ entakapon
Do not pass it to others.
- Zdravilo je bilo predpisano vam osebno. Ne dajajte ga naprej drugim.
Possible side effects 5 How to store Stalevo 6.
Možni neželeni učinki 5 Kako shranjevati Stalevo 6.
- if you have narrow-angle glaucoma (an eye disorder)
- če imate angularni glavkom (bolezen oči)
- if you have a severe liverdisease.
- če imate hudo bolezen jeter;
- phenytoin (used to prevent convulsions) and papaverine (used to relax the muscles)
- Feniton (za preprečevanje konvulzij) in papaverin (za mišično relaksacijo)
Tell your doctor if you are taking these medicines, or if you notice that Stalevo does not work as well when you take them.
67 Posvetujte se s svojim zdravnikom, če jemljete ta zdravila ali če opazite, da zdravilo Stalevo ne deluje tako dobro, kadar jih vzamete.
67 Stalevo may make it harder for you to digest iron.
Zaradi zdravila Stalevo boste morda težje presnavljali železo.
If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel fully awake again before driving or doing anything else that requires you to be alert.
Če postanete nenadoma zelo zaspani ali se vam zgodi, da v trenutku zaspite, počakajte, dokler ne boste zopet popolnoma budni, preden vozite ali počnete kar koli, kar zahteva, da ste pozorni.
Stalevo contains sucrose (1.6 mg/ tablet).
Zdravilo Stalevo vsebuje saharozo (1, 6 mg/ tableto).
Strictly follow your doctor’ s instructions on when and how to use Stalevo, other levodopa medicines and other antiparkinson medicines.
Dosledno upoštevajte zdravnikova navodila, kdaj in kako jemati zdravila Stalevo, zdravila z levodopo in druga antiparkinsonska zdravila.
68 If you forget to take Stalevo
68 Če ste po naključju vzeli preveč tablet zdravila Stalevo, se nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
If it is more than an hour until your next dose:
Če pozabite vzeti zdravilo Stalevo
Take one tablet now, and the next tablet at the normal time.
Če je do naslednjega odmerka več kot uro časa: vzemite eno tableto takoj, drugo pa ob normalnem času za odmerek.
Take a tablet now, wait an hour, then take another tablet.
Če je do naslednjega odmerka manj kot uro časa: vzemite tableto takoj, počakajte eno uro in nato vzemite naslednjo tableto.
- shortness of breath
- pogosto padanje
- muscle cramps
- zasoplost
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerkoli neželeni učinek, ki ni omenjen v tem navodilu, se posvetujte s svojim zdravnikom ali farmacevtom.
The expiry date refers to the last day of that month.
Datum izteka roka uporabnosti se nnaša na zadnji dan navedenega meseca.
- Each Stalevo 100 mg/ 25 mg/ 200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa
- Vsaka tableta zdravila Stalevo 100 mg/ 25 mg/ 200 mg vsebuje 100 mg levodope, 25 mg
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize
- Ostale sestavine v jedru tablete so premreženi natrijev karmelozat, magnezijev stearat, koruzni
What Stalevo looks like and contents of the pack
70 Izgled zdravila Stalevo in vsebina pakiranja
Stalevo 100 mg/ 25 mg/ 200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘ LCE 100’ on one side.
Zdravilo Stalevo 100 mg/ 25 mg/ 200 mg so rjavkaste ali sivkasto- rdečkaste filmsko obložene ovalne tablete brez zareze, z oznako » LCE 100 « na eni strani.
70 Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Zdravilo Stalevo je na razpolago v šestih različnih velikostih pakiranja (10, 30, 100, 130, 175 ali 250 tablet).
Ireland Orion Pharma (Ireland) Ltd. c/ o Allphar Services Ltd.
71 Ireland Orion Pharma (Ireland) Ltd. c/ o Allphar Services Ltd.
Tel: +421 2 5542 5439
Tel: +421 2 5542 5439 Suomi/ Finland Orion Corporation Puh. / Tel: +358 10 4261
Stalevo 150 mg/ 37.5 mg/ 200 mg film-coated tablets Levodopa/ carbidopa/ entacapone
Stalevo 150 mg/ 37, 5 mg/ 200 mg filmsko obložene tablete levodopa/ karbidopa/ entakapon
- if you have a severe liver disease.
- če imate hudo bolezen jeter;
Tell your doctor if you are taking these medicines, or if you notice that Stalevo does not work as well when you take them.
74 Posvetujte se s svojim zdravnikom, če jemljete ta zdravila ali če opazite, da zdravilo Stalevo ne deluje tako dobro, kadar jih vzamete.
74 Stalevo may make it harder for you to digest iron.
Zaradi zdravila Stalevo boste morda težje presnavljali železo.
Stalevo contains sucrose (1.9 mg/ tablet).
Zdravilo Stalevo vsebuje saharozo (1, 9 mg/ tableto).
Strictly follow your doctor’ s instructions on when and how to use Stalevo, other levodopa medicines and other antiparkinson medicines.
Dosledno upoštevajte zdravnikova navodila, kdaj in kako jemati zdravilo Stalevo, zdravila z levodopo in druga antiparkinsonska zdravila.
75 If you forget to take Stalevo
75 Če ste po naključju vzeli preveč tablet zdravila Stalevo, se nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
- Each Stalevo 150 mg/ 37.5 mg/ 200 mg tablet contains 150 mg of levodopa, 37.5 mg of
- Vsaka tableta zdravila Stalevo 150 mg/ 37, 5 mg/ 200 mg vsebuje 150 mg levodope, 37, 5 mg
carbidopa and 200 mg of entacapone.
karbidope in 200 mg entakapona.
starch, mannitol (E421) and povidone (E1201).
škrob, manitol (E421), povidon (E1201)
What Stalevo looks like and contents of the pack
77 Izgled zdravila Stalevo in vsebina pakiranja
Stalevo 150 mg/ 37.5 mg/ 200 mg: brownish or greyish red, elongated-ellipse shaped, unscored film- coated tablets marked with ‘ LCE 150’ on one side.
Zdravilo Stalevo 150 mg/ 37, 5 mg/ 200 mg so rjavkaste ali sivkasto- rdeče, podolgovate filmsko obložene tablete v obliki elipse brez zareze, z oznako » LCE 150 « na eni strani.
77 Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets).
Stalevo je na razpolago v šestih različnih velikostih pakiranja (10, 30, 100, 130, 175 ali 250 tablet).
Ireland Orion Pharma (Ireland) Ltd. c/ o Allphar Services Ltd.
78 Ireland Orion Pharma (Ireland) Ltd. c/ o Allphar Services Ltd.
Stalevo 200 mg/ 50 mg/ 200 mg film-coated tablets Levodopa/ carbidopa/ entacapone
Stalevo 200 mg/ 50 mg/ 200 mg filmsko obložene tablete levodopa/ karbidopa/ entakapon
Do not pass it to others.
- Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
- if you are allergic (hypersensitive) to levodopa, carbidopa or entacapone, or any of the other
- če ste alergični na (preobčutljivi za) levodopo, karbidopo, entakapon ali katerokoli drugo
ingredients of Stalevo
sestavino zdravila Stalevo;
- notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion,
- postanejo mišice zelo otrple ali močno trzajo, se tresete, ste vznemirjeni, zmedeni, vročični,
fever, rapid pulse, or wide fluctuations in your blood pressure.
imate hiter srčni utrip ali velika nihanja krvnega tlaka.
Tell your doctor if you are taking these medicines, or if you notice that Stalevo does not work as well when you take them.
81 Posvetujte se s svojim zdravnikom, če jemljete ta zdravila ali če opazite, da zdravilo Stalevo ne deluje tako dobro, kadar jih vzamete.
81 Stalevo may make it harder for you to digest iron.
Zaradi zdravila Stalevo boste morda težje presnavljali železo.
Stalevo contains sucrose (2.3 mg/ tablet).
Zdravilo Stalevo vsebuje saharozo (2, 3 mg/ tableto).
Do not take more than 7 tablets of this strength each day.
Ne vzemite več kot 7 tablet te jakosti dnevno.
82 If you forget to take Stalevo
82 Če ste po naključju vzeli preveč tablet zdravila Stalevo, se nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
If it is more than an hour until your next dose:
Če ste pozabili vzeti zdravilo Stalevo
Abrupt discontinuation of Stalevo and other antiparkinsonian medicines may result in unwanted side effects.
Nenadna ukinitev jemanja tablet zdravila Stalevo in drugih antiparkinsonikov lahko povzroči neželene učinke.
Many of the side effects can be relieved by adjusting the dose.
Mnoge od teh neželenih učinkov se da odpraviti s prilagajanjem odmerka.
The exact frequencies of these side effects are not known, but are based on reports received since the product has been on the market: colitis (inflammation of the colon), hepatitis and skin, hair, beard and nail discolorations.
Natančna pogostost naslednjih neželenih učinkov ni znana, podatki temeljijo na poročilih iz obdobja po prihodu zdravila na trg: kolitis (vnetje debelega črevesa), hepatitis (vnetje jeter) in sprememba barve kože, las, brade in nohtov.
NMS is a rare severe reaction to medicines used to treat disorders of the central nervous system and characterised by stiffness, muscle twitching, tremor, mental changes, coma, high body temperature, increased heart rate, and unstable blood pressure.
NMS je redka huda reakcija na zdravila za zdravljenje centralnega živčnega sistema, za katero so značilni okorelost, trzanje mišic, drhtenje, termor, spremembe duševnega stanja, koma, zvišana telesna temperatura, pospešen utrip srca in nestabilen krvni tlak.
HOW TO STORE STALEVO
SHRANJEVANJE ZDRAVILA STALEVO
Do not use after the expiry date which is stated on the bottle and the carton after EXP.
Zdravila Stalevo ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici in na škatli poleg oznake » EXP «.
- Each Stalevo 200 mg/ 50 mg/ 200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and
- Ena tableta zdravila Stalevo 200 mg/ 50 mg/ 200 mg vsebuje 200 mg levodope, 50 mg karbidope
200 mg of entacapone.
in 200 mg entakapona.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize
- Druge pomožne snovi v jedru tablete so premrežen natrijev karmelozat, magnezijev stearat,
starch, mannitol (E421) and povidone (E1201).
koruzni škrob, manitol (E421) in povidon (E1201)
stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).
polisorbat 80, rdeči železov oksid (E172), saharoza in titanov dioksid (E171).
What Stalevo looks like and contents of the pack
84 Izgled zdravila zdravila Stalevo in vsebina pakiranja
Stalevo 200 mg/ 50 mg/ 200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘ LCE 200’ on one side.
Zdravilo Stalevo 200 mg/ 50 mg/ 200 mg: temno rjavo- rdeče ovalne filmsko obložene tablete brez zareze z oznako „ LCE 200 “ na eni strani.
Stalevo 200 mg/ 50 mg/ 200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Tablete zdravila Stalevo 200 mg/ 50 mg/ 200 mg so na voljo v petih različnih velikostih pakiranja (10, 30, 100, 130 ali 175 tablet).
84 Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom
Danmark Orion Pharma A/ S Tlf: +45 49 12 66 00 Deutschland Orion Pharma GmbH Tel: +49 40 899 689-0 Eesti Orion Pharma Eesti OÜ Tel: +372 6 616 863
Danmark Orion Pharma A/ S Tlf: +45 49 12 66 00 Deutschland Orion Pharma GmbH Tel: +49 40 899 689- 0
Tel: +31 26 37 82 111 Norge Orion Pharma AS Tlf: +47 40 00 42 10 Österreich Novartis Pharma GmbH Tel: +43 1 86 6570
Tel: +31 26 37 82 111 Norge Orion Pharma AS Tlf: +47 40 00 42 10
Ελλάδα Novartis (Hellas) Α .Ε .Β .Ε.
Eesti Orion Pharma Eesti OÜ Tel: +372 6 616 863 Ελλάδα Novartis (Hellas) Α. Ε. Β. Ε.
Polska Orion Oyj S. A.
Österreich Novartis Pharma GmbH Tel: +43 1 86 6570 Polska Orion Oyj S. A.
Ireland Orion Pharma (Ireland) Ltd. c/ o Allphar Services Ltd.
85 Ireland Orion Pharma (Ireland) Ltd. c/ o Allphar Services Ltd.
Detailed information on this medicine is available on the European Medicine’ s Agency (EMEA) web site: http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu.
Other studies also looked at ‘ switching ’ from an antidiabetes medicine to Starlix, and ‘ adding’ Starlix to other antidiabetes medicines.
V drugih študijah so preučevali tudi „ prehod “ z zdravila za sladkorno bolezen na zdravilo Starlix ter „ dodajanje “ zdravila Starlix drugemu zdravilu za sladkorno bolezen.
789 received it for at least six months, and 190 received it for a year.
Večina bolnikov je prejemala zdravilo v trajanju do največ šest mesecev, 789 bolnikov je prejemalo zdravilo najmanj šest mesecev, 190 bolnikov pa je prejemalo zdravilo eno leto.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Starlix shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo Starlix izkazalo med raziskavami?
The Committee for Medicinal products for Human Use (CHMP) decided that Starlix’ s benefits are greater than its risks for the treatment of type 2 diabetes, in combination with metformin, in patients who are not controlled despite receiving the maximum daily dose of metformin.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Starlix večje od z njim povezanih tveganj pri zdravljenju sladkorne bolezni tipa 2 v kombinaciji z metforminom pri bolnikih, pri katerih ni bil dosežen zadosten nadzor bolezni kljub prejemanju največjega dnevnega odmerka metformina.
Each film-coated tablet contains 60 mg nateglinide.
Vsaka filmsko obložena tableta vsebuje 60 mg nateglinida.
Lactose monohydrate:
Pomožne snovi: laktoza monohidrat:
141.5 mg per tablet.
141, 5 mg na tableto.
60 mg pink, round, bevelled-edge tablets with “ STARLIX” marked on one side and “ 60” on the other.
60 mg rožnate, okrogle tablete z zaobljenimi robovi in oznako “ STARLIX ” na eni ter “ 60 ” na drugi strani.
The dosage of nateglinide should be determined by the physician according to the patient’ s requirements.
Odmerjanje nateglinida mora določiti zdravnik v skladu z bolnikovimi potrebami.
Since the primary therapeutic effect of Starlix is to reduce mealtime glucose, (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1– 2 hour post-meal glucose.
Ker je primarni terapevtski učinek Starlixa zniževanje glukoze v času obroka (ki je eden od dejavnikov, ki prispevajo k HbA1c), lahko terapevtski odziv na Starlix spremljamo tudi z glukozo 1- 2 uri po obroku.
Specific patient groups Elderly The clinical experience in patients over 75 years of age is limited.
Posebne skupine bolnikov Starejši bolniki Klinične izkušnje pri bolnikih, starejših od 75 let, so omejene.
Children and adolescents There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended.
Otroci in mladostniki O uporabi nateglinida pri bolnikih, mlajših od 18 let, ni podatkov, zato njegova uporaba v tej starostni skupini ni priporočljiva.
Patients with hepatic impairment No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Bolniki z jetrno okvaro Pri bolnikih z blago do zmerno okvaro jeter ni potrebno prilagajanje odmerka.
As patients with severe liver disease were not studied, nateglinide is contraindicated in this group.
Ker bolniki s hudo
2 Patients with renal impairment No dose adjustment is necessary in patients with mild to moderate renal impairment.
2 boleznijo jeter niso proučeni, je nateglinid v tej skupini kontraindiciran.
Although there is a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15– 50 ml/ min) was comparable between renal subjects requiring haemodialysis and healthy subjects.
Čeprav se pri dializnih bolnikih Cmax nateglinida zmanjša za 49%, sta bila sistemska uporabnost in razpolovni čas pri sladkornih bolnikih z zmerno do hudo ledvično insuficienco (očistek kreatinina 15- 50 ml/ min) pri ledvičnih bolnikih, ki potrebujejo hemodializo, in pri zdravih osebah primerljiva.
Others In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful titration is required to avoid hypoglycaemic reactions.
Drugi Pri oslabljenih ali podhranjenih bolnikih morata biti začetno in vzdrževalno odmerjanje konzervativna in potrebno je skrbno prilagajanje odmerjanja terapevtskemu učinku, da se preprečijo hipoglikemične reakcije.
Starlix is contraindicated in patients with: • Hypersensitivity to the active substance or to any of the excipients • Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative) • Diabetic ketoacidosis, with or without coma • Pregnancy and breast-feeding (see section 4.6) • Severe hepatic impairment
Starlix je kontraindiciran pri bolnikih: • s preobčutljivostjo za zdravilno učinkovino ali katerokoli pomožno snov; • s sladkorno boleznijo tipa 1 (od insulina odvisna, na C- peptid negativna sladkorna bolezen); • z diabetično ketoacidozo, s komo ali brez nje; • z nosečnostjo in dojenjem (glejte poglavje 4. 6); • s hudo jetrno okvaro.
General Nateglinide should not be used in monotherapy.
Splošno Nateglinid se ne sme uporabljati v monoterapiji.
Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those treated with oral antidiabetic agents (see section 4.8).
Hipoglikemija je bila opazovana pri bolnikih s sladkorno boleznijo tipa 2 na dieti in pri telesnem naporu ter pri tistih, ki se zdravijo s peroralnimi antidiabetiki (glejte poglavje 4. 8).
Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose baseline HbA1c was close to the therapeutic target (HbA1c < 7.5%).
Simptomi hipoglikemije (ki ni bila potrjena s koncentracijami glukoze v krvi) so bili opazovani pri bolnikih, katerih izhodiščni HbA1c je bil blizu terapevtske tarče (HbA1c < 7, 5%).
Starlix contains lactose monohydrate.
Starlix vsebuje laktozo monohidrat.
Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine.
Bolniki z redkimi prirojenimi motnjami kot so intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze/ galaktoze, ne smejo jemati tega zdravila.
Specific patient groups Nateglinide should be used with caution in patients with moderate hepatic impairment.
Posebne skupine bolnikov Pri bolnikih z zmerno jetrno okvaro je treba nateglinid uporabljati previdno.
No clinical studies have been conducted in patients with severe hepatic impairment or children and adolescents.
Pri bolnikih s hudo jetrno okvaro ter pri otrocih in mladostnikih niso bile opravljene klinične
3 4.5 Interaction with other medicinal products and other forms of interaction
Pri teh skupinah bolnikov zdravljenje zato ni priporočljivo.
In an interaction trial with sulfinpyrazone, a CYP2C9 inhibitor, a modest increase in nateglinide AUC (~28%) was observed in healthy volunteers, with no changes in the mean Cmax and elimination half-life.
V preskušanju interakcij z inhibitorjem CYP2C9 sulfinpirazonom je bil pri zdravih prostovoljcih opažen zmeren porast AUC nateglinida (~28%), brez sprememb srednje Cmax in razpolovnega časa izločanja iz telesa.
Particular caution is recommended when nateglinide is co-administered with other more potent inhibitors of CYP2C9, e. g. fluconazole or gemfibrozil, or in patients known to be poor metabolisers for CYP2C9.
Posebna previdnost je potrebna pri sočasni uporabi nateglinida z drugimi močnejšimi inhibitorji CYP2C9, na primer s flukonazolom ali gemfibrozilom, ali pri bolnikih, za katere je znano, da imajo počasno presnovo, ki jo posreduje CYP2C9.
Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are CYP2C9 or CYP3A4 substrates upon coadministration with Starlix.
Zato pri sočasni uporabi s Starlixom pri digoksinu, varfarinu in drugih zdravilih, ki so substrati CYP2C9 ali CYP3A4, ni potrebno prilagajanje odmerjanja.
Similarly, there was no clinically significant pharmacokinetic interaction of Starlix with other oral antidiabetic agents such as metformin or glibenclamide.
Prav tako ni bilo klinično pomembnih farmakokinetičnih interakcij Starlixa z drugimi peroralnimi antidiabetiki, na primer z metforminom ali glibenklamidom.
Studies in animals have shown developmental toxicity (see section 5.3).
Študije na živalih so pokazale vpliv na razvoj (glejte poglavje 5. 3).
There is no experience in pregnant women, therefore the safety of Starlix in pregnant women cannot be assessed.
Ni izkušenj o uporabi pri nosečnicah, zato varnost uporabe Starlixa pri nosečnicah ne more biti ocenjena.
Starlix, like other oral antidiabetic agents, is not recommended for use in pregnancy.
Starlix, podobno kot drugi peroralni antidiabetiki, v nosečnosti ni priporočljiv.
Frequencies are defined as: common (> 1/ 100 ,< 1/10); uncommon (> 1/1 ,000, < 1/100); rare (> 1/10,000, < 1/ 1,000); very rare (< 1/10 ,000).
Pogostnost je definirana takole: pogosti (> 1/ 100, < 1/ 10); občasni (> 1/ 1. 000, < 1/ 100); redki (> 1/ 10. 000, < 1/ 1. 000); zelo redki (< 1/ 10. 000).