natgillin/translations-raw huggingface dataset:
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• s sulfonilsečnino in z metforminom, če urejenost glikemije z dieto in s telesno aktivnostjo ter z dvojnim zdravljenjem s tema zdraviloma ni zadostna.
Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Glede na analizo populacijske farmakokinetike na podlagi podatkov iz I. in II.
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• z metforminom, če urejenost glikemije z dieto in s telesno aktivnostjo ter z zdravljenjem z metforminom samim ni zadostna.
Round, light beige film-coated tablet with “112” on one side.
Okrogla, svetlo sivorjava filmsko obložena tableta z oznako “112” na eni strani.
Sitagliptin 100 mg once daily added to ongoing glimepiride + metformin therapy (N=115)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z glimepiridom in metforminom (N = 115)
Some patients have experienced the following side effects while taking sitagliptin alone in clinical studies, or during post-approval use alone and/or with other diabetes medicines: Common: low blood sugar, headache, upper respiratory infection, stuffy or runny nose and sore throat, osteoarthritis, arm or leg pain
Pogosti: nizek krvni sladkor, glavobol, okužba zgornjih dihal, zamašen nos ali izcedek iz nosu in vnetje grla, osteoartritis, bolečine v rokah ali nogah Občasni: omotica, zaprtje, srbenje
If bullous pemphigoid is suspected, Ristaben should be discontinued.
Ob sumu na bulozni pemfigoid je treba zdravljenje z zdravilom Ristaben prekiniti.
The incidence of hypoglycaemia was also similar in patients treated with sitagliptin or placebo.
Tudi pojavnost hipoglikemije je bila pri bolnikih, ki so prejemali sitagliptin, in tistih, ki so prejemali placebo, podobna.
Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
V eni študiji so pri odmerku 800 mg sitagliptina opazili minimalno podaljšanje intervala QTc, ki pa ni veljalo za klinično pomembno.
Another study comparing sitagliptin at 25 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in 129 patients with ESRD who were on dialysis.
V drugi študiji so primerjali sitagliptin v odmerku 25 mg enkrat na dan in glipizid v odmerkih 2,5 do 20 mg/dan.
Treatment with sitagliptin at 100 mg once daily as monotherapy provided significant improvements in HbA1c, fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hour PPG), compared to placebo in two studies, one of 18- and one of 24-weeks duration.
V dveh študijah, od katerih je ena trajala 18 druga pa 24 tednov, so se v primerjavi s placebom pri samostojnem zdravljenju s sitagliptinom v odmerku 100 mg enkrat na dan pomembno izboljšale vrednosti HbA1c, vrednosti glukoze v plazmi na tešče in vrednosti glukoze v plazmi 2 uri po obroku.
Some patients have experienced the following side effects while taking sitagliptin in combination with a sulphonylurea and metformin:
Pri nekaterih bolnikih, ki so jemali sitagliptin v kombinaciji s sulfonilsečnino in metforminom, so se pojavili naslednji neželeni učinki:
Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 39
Imetnik dovoljenja za promet z zdravilom Merck Sharp & Dohme B.V.
EU/1/10/621/013 14 film-coated tablets EU/1/10/621/014 28 film-coated tablets EU/1/10/621/023 30 film-coated tablets EU/1/10/621/015 56 film-coated tablets EU/1/10/621/016 84 film-coated tablets EU/1/10/621/024 90 film-coated tablets EU/1/10/621/017 98 film-coated tablets EU/1/10/621/018 50 x 1 film-coated tablets
EU/1/10/621/013 14 filmsko obloženih tablet EU/1/10/621/014 28 filmsko obloženih tablet EU/1/10/621/023 30 filmsko obloženih tablet EU/1/10/621/015 56 filmsko obloženih tablet EU/1/10/621/016 84 filmsko obloženih tablet EU/1/10/621/024 90 filmsko obloženih tablet EU/1/10/621/017 98 filmsko obloženih tablet EU/1/10/621/018 50 x 1 filmsko obložena tableta
EU/1/10/621/001 14 film-coated tablets EU/1/10/621/002 28 film-coated tablets EU/1/10/621/019 30 film-coated tablets EU/1/10/621/003 56 film-coated tablets EU/1/10/621/004 84 film-coated tablets EU/1/10/621/020 90 film-coated tablets EU/1/10/621/005 98 film-coated tablets EU/1/10/621/006 50 x 1 film-coated tablets
EU/1/10/621/001 14 filmsko obloženih tablet EU/1/10/621/002 28 filmsko obloženih tablet EU/1/10/621/019 30 filmsko obloženih tablet EU/1/10/621/003 56 filmsko obloženih tablet EU/1/10/621/004 84 filmsko obloženih tablet EU/1/10/621/020 90 filmsko obloženih tablet EU/1/10/621/005 98 filmsko obloženih tablet EU/1/10/621/006 50 x 1 filmsko obložena tableta
Ristaben 25 mg film-coated tablets
Ristaben 25 mg filmsko obložene tablete
Frequency of adverse reaction angioedema
Bolezni kože in podkožja pruritus občasni angioedem neznana pogostnost
Some patients have experienced the following side effects after adding sitagliptin to metformin: Common (may affect up to 1 in 10 people): low blood sugar, nausea, flatulence, vomiting Uncommon (may affect up to 1 in 100 people): stomach ache, diarrhoea, constipation, drowsiness
Pogosti (lahko se pojavijo pri največ 1 od 10 ljudi): nizek krvni sladkor, siljenje na bruhanje, napenjanje, bruhanje
EU/1/10/621/007 14 film-coated tablets EU/1/10/621/008 28 film-coated tablets EU/1/10/621/021 30 film-coated tablets EU/1/10/621/009 56 film-coated tablets EU/1/10/621/010 84 film-coated tablets EU/1/10/621/022 90 film-coated tablets EU/1/10/621/011 98 film-coated tablets EU/1/10/621/012 50 x 1 film-coated tablets
EU/1/10/621/007 14 filmsko obloženih tablet EU/1/10/621/008 28 filmsko obloženih tablet EU/1/10/621/021 30 filmsko obloženih tablet EU/1/10/621/009 56 filmsko obloženih tablet EU/1/10/621/010 84 filmsko obloženih tablet EU/1/10/621/022 90 filmsko obloženih tablet EU/1/10/621/011 98 filmsko obloženih tablet EU/1/10/621/012 50 x 1 filmsko obložena tableta
Ristaben 100 mg film-coated tablets
Ristaben 100 mg filmsko obložene tablete
In addition, patients should be alerted to the risk of hypoglycaemia when Ristaben is used in combination with a sulphonylurea or with insulin.
Poleg tega je treba bolnike, ki jemljejo zdravilo Ristaben skupaj s sulfonilsečnino ali z insulinom, opozoriti na tveganje za pojav hipoglikemije.
Frequency not known acute renal failure
Bolezni sečil okvara ledvične funkcije neznana pogostnost akutna odpoved ledvic neznana pogostnost
Ristaben 100 mg film-coated tablets Sitagliptin
Ristaben 100 mg filmsko obložene tablete sitagliptin
Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju s pioglitazonom in metforminom (N = 152)
Ristaben 25 mg film-coated tablets Sitagliptin
Ristaben 25 mg filmsko obložene tablete sitagliptin
Ristaben 50 mg film-coated tablets
Ristaben 50 mg filmsko obložene tablete
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Ena tableta vsebuje sitagliptinijev fosfat monohidrat, ki ustreza 100 mg sitagliptina.
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Ena tableta vsebuje sitagliptinijev fosfat monohidrat, ki ustreza 25 mg sitagliptina.
Ristaben 50 mg film-coated tablets Sitagliptin
Ristaben 50 mg filmsko obložene tablete sitagliptin
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Ena tableta vsebuje sitagliptinijev fosfat monohidrat, ki ustreza 50 mg sitagliptina.
Oral use.
peroralna uporaba
Sitagliptin 100 mg once daily provided significant improvements in glycaemic parameters compared with placebo in two 24-week studies of sitagliptin as add-on therapy, one in combination with metformin and one in combination with pioglitazone.
V dveh 24-tedenskih študijah s sitagliptinom, kot dodatnim zdravilom (v eni v kombinaciji z metforminom, v drugi v kombinaciji s pioglitazonom), so se v primerjavi s placebom pri uporabi sitagliptina v odmerku 100 mg enkrat na dan glikemični parametri pomembno izboljšali.
HbA1c (%) at week 24.
Srednja vrednost HbA1c v izhodišču
How to store Ristaben
Shranjevanje zdravila Ristaben
The observed incidence of hypoglycaemia in patients treated with sitagliptin was similar to placebo.
Pri bolnikih, ki so se zdravili s sitagliptinom, je bila opažena podobna pojavnost hipoglikemije kot pri bolnikih, ki so prejemali placebo.
Posology
Vrednost
Body weight did not increase from baseline with sitagliptin therapy in either study, compared to a small reduction in patients given placebo.
V nobeni od študij s sitagliptinom se telesna masa bolnikov v primerjavi z začetno vrednostjo ni povečala.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Ena filmsko obložena tableta (tableta) vsebuje 100 mg sitagliptina v obliki sitagliptinijevega fosfata monohidrata.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Ena filmsko obložena tableta (tableta) vsebuje 50 mg sitagliptina v obliki sitagliptinijevega fosfata monohidrata.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Ena filmsko obložena tableta (tableta) vsebuje 25 mg sitagliptina v obliki sitagliptinijevega fosfata monohidrata.
All stroke (fatal and non-fatal)
Vsi primeri možganske kapi (s smrtnim izidom in brez njega) 178 (2,4)
Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value.
Sitagliptin je povzročil podobno zmanjšanje vrednosti HbA1c kot glipizid.
Risk Management Plan was not submitted.
Načrt za obvladovanje tveganja ni bil predložen.
• not known (frequency cannot be estimated from the available data)
• ni znano (pogostnosti ni mogoče oceniti na podlagi podatkov, ki so na voljo).
8501 Novo mesto
8501 Novo mesto Slovenija
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 21. september 2009.
None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Nobena teh analiz ni imela zadostne velikosti za odkritje razlik v izidu pri slabih metabolizatorjih.
For further information please refer to section 5.1.
Za dodatne informacije glejte poglavje 5.1.
The frequency of possible side effects listed below is defined using the following convention:
Pogostnost spodaj naštetih možnih neželenih učinkov je opredeljena po naslednjem dogovoru:
• You should tell your doctor if a surgery (including dental) is planned.
• morate zdravniku povedati, če imate predvideno kakšno operacijo (tudi zobozdravstveni poseg).
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/ploda, porod ali postnatalni razvoj (glejte poglavje 5.3).
Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of
Ker CAPRIE nima moči za oceno učinkovitosti v posameznih podskupinah, ni jasno, ali so razlike pri zmanjšanju relativnega tveganja glede na vključitvene pogoje resnične ali naključne.
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
TTP je potencialno smrtno stanje in zahteva takojšnje zdravljenje, ki vključuje tudi plazmaferezo.
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
• če ste imeli strdek v možganski arteriji (ishemična kap), ki se je pojavil v zadnjih sedmih dneh,
The clinical relevance of this interaction is uncertain.
Klinični pomen te interakcije ni znan.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Njihova pogostnost je navedena po naslednjem dogovoru: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000).
Clopidogrel has been evaluated for safety in more than 42,000 patients, who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Varnost klopidogrela so vrednotili pri več kot 42.000 bolnikih, ki so sodelovali v kliničnih študijah, vključno z več kot 9.000 bolniki, ki so se zdravili eno leto ali več.
In the long-term safety follow-up of this study, 26 patients with the shunt still in place at one year of age received clopidogrel up to 18 months of age.
Med dolgoročnim varnostnim spremljanjem te študije je 26 bolnikov, ki so pri enem letu starosti še vedno imeli spoj, prejemalo klopidogrel do 18. meseca starosti.
From literature, limited data in Asian populations are available to assess the clinical implication of genotyping of this CYP on clinical outcome events.
V literaturi je za azijske populacije na voljo malo podatkov za oceno kliničnih posledic genotipizacije tega CYP na dogodke kliničnega izida.
Some other medicines may influence the use of Clopidogrel Qualimed or vice versa.
Nekatera druga zdravila lahko vplivajo na jemanje zdravila Klopidogrel Qualimed in obratno.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified.
Vloga za pridobitev dovoljenja za promet temelji na referenčnem zdravilu, za katerega ne obstajajo varnostni pomisleki, zato dodatne aktivnosti za zmanjšanje tveganja niso potrebne.
Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Približno 88 % bolnikov je sočasno prejemalo ASA (v razponu od 1 do 23 mg/kg/dan).
Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Analiza skupne umrljivosti kot sekundarnega opazovanega dogodka ni pokazala pomembne razlike med klopidogrelom (5,8 %) in ASA (6 %).
Clopidogrel Qualimed is not intended for use in children or adolescents.
Zdravilo Klopidogrel Qualimed ni namenjeno za zdravljenje otrok ali mladostnikov.
These results indicate that clopidogrel can be administered with pantoprazole.
Ti rezultati kažejo, da se klopidogrel lahko uporablja skupaj s pantoprazolom.
No new safety concerns were noted during this long-term follow-up.
Med tem dolgoročnim spremljanjem niso ugotovili novih težav ali zadržkov v zvezi z varnostjo.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predstavljen v modulu 1.8.1. pridobitve dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo na trg in toliko časa, kolikor bo zdravilo v prometu.
• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel
• če ste alergični na (preobčutljivi za) klopidogrel ali katerokoli sestavino zdravila Klopidogrel
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be
Posledično ni mogoče izključiti neposrednega učinka (blaga toksičnost) ali posrednega učinka (neprijetnost).
You should not breastfeed while taking this medicine.
Med jemanjem tega zdravila ne smete dojiti.
This is linked to the way your medicine works as it prevents the ability of blood clots to form.
To je povezano z delovanjem zdravila, saj preprečuje strjevanje krvi.
The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Vpliv CYP2C19-genotipa na klinične izide pri bolnikih, zdravljenih s klopidogrelom, ni bil ocenjen v prospektivnih, randomiziranih, kontroliranih preskušanjih.
A patient with poor metaboliser status will possess two loss-of-function alleles as defined above.
Bolnik, ki je slab metabolizator, ima dva hipofunkcijska alela, kot je pojasnjeno zgoraj.
Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Pri vsakem organskem sistemu so neželeni učinki navedeni po padajoči resnosti.
Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Drugi aleli, povezani z odsotno ali zmanjšano presnovo, so redkejši in vključujejo CYP2C19*4, *5, *6, *7 in *8.
The incidence of severe cases was similar for clopidogrel and ASA.
Incidenca hujših primerov je bila podobna za klopidogrel in za ASA.
Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Klopidogrel naj se pri otrocih ne uporablja iz razlogov, ki zadevajo učinkovitost (glejte poglavje 5.1.
The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Razpolovni čas izločanja glavnega (neaktivnega) krožečega metabolita je bil 8 ur po enkratnem in večkratnem dajanju.
It also contains hydrogenated castor oil.
Vsebuje hidrogenirano ricinusovo olje.
If you experience prolonged bleeding when taking Clopidogrel Qualimed If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Če doživite podaljšanje krvavitve v času jemanja zdravila Klopidogrel Qualimed Če se urežete ali poškodujete, lahko traja dlje kot običajno, da se krvavitev ustavi.
Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Objavljene pogostnosti genotipa slabega metabolizatorja s CYP2C19 so približno 2% pri Kavkazijcih, 4% pri črncih in 14% pri Kitajcih.
In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
Poleg tega analiza podskupin glede na starost nakazuje, da so koristi od zdravljenja s klopidogrelom pri bolnikih, starejših od 75 let, manjše od tistih, ki so jih opazili pri bolnikih starih 75 let ali manj.
• Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
• Aktivna patološka krvavitev, npr. peptična razjeda ali intrakranialna krvavitev.
The mean bleeding time prolongation was also similar in the two groups.
Tudi povprečno podaljšanje časa krvavitve je bilo v obeh skupinah podobno.
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Bolnike zaradi znakov krvavitve, vključno s prikrito krvavitvijo, skrbno spremljamo, zlasti prve tedne zdravljenja in/ali po invazivnih kardioloških postopkih ali kirurških posegih.
The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Povprečni čas med paliativno oskrbo s spojem in prvo uporabo raziskovanega zdravila je bil 20 dni.
Do not use Clopidogrel Qualimed after the expiry date which is stated on the carton and blister after EXP.
Zdravila Klopidogrel Qualimed ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP.
Platelets are very small structures in the blood, which clump together during blood clotting.
Trombociti so zelo majhne strukture v krvi, ki se zlepljajo pri strjevanju krvi.
However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Vendar pa zaradi pomanjkanja študij o interakcijah z drugimi nesteroidnimi protivnetnimi zdravili ni jasno, ali vsa povečajo tveganje za gastrointestinalne krvavitve.
When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Ko so slabi metabolizatorji prejemali shemo 600 mg/150 mg, je bila izpostavljenost aktivnemu presnovku večja kot s shemo 300 mg/75 mg.
When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring.
Ko so ga dajali doječim podganam, je povzročil blago zakasnitev razvoja mladičkov.
It may be given with or without food.
Bolnik lahko zdravilo vzame s hrano ali brez nje.
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Klopidogrel in glavni krožeči (neaktivni) metabolit se in vitro reverzibilno vežeta na humane plazemske proteine (98 % oziroma 94 %).
It is unknown whether clopidogrel is excreted in human breast milk.
Ni znano, ali se klopidogrel pri človeku izloča v materinem mleku.
If prompt correction of prolonged bleeding time is required, platelet transfusion may reverse the effects of clopidogrel.
Če je potrebno takojšnje korigiranje podaljšanega časa krvavitve, lahko transfuzija trombocitov deluje reverzno na učinek klopidogrela.
In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
V študiji relativne biološke uporabnosti pri odraslih je imela pripravljena raztopina klopidogrela podoben obseg in rahlo večjo hitrost absorpcije glavnega krožečega (neaktivnega) presnovka kakor odobrena tableta.
Taking Clopidogrel Qualimed with food and drink Clopidogrel Qualimed may be taken with or without food.
Jemanje zdravila Klopidogrel Qualimed skupaj s hrano in pijačo Zdravilo Klopidogrel Qualimed lahko jemljete s hrano ali brez nje.
An appropriate dose regimen for this patient population has not been established in clinical outcome trials.
Ustrezna odmerna shema za to populacijo bolnikov v kliničnih preskušanjih ni bila ugotovljena.
The PSUR submission schedule for Clopidogrel Qualimed film coated tablets should follow PSURs submission schedule for the reference medicinal product.
Razpored predložitve PSUR za Klopidogrel Qualimed filmsko obložene tablete se mora ujemati z razporedom predložitve PSUR za referenčno zdravilo.
In addition, your doctor may identify changes in your blood or urine test results.
Poleg tega lahko zdravnik ugotovi spremenjene izvide preiskav krvi ali seča.
7 film-coated tablets - calendar blister: EU/1/09/559/012 14 film-coated tablets - calendar blister: EU/1/09/559/013 28 film-coated tablets - calendar blister: EU/1/09/559/014 56 film-coated tablets - calendar blister: EU/1/09/559/015 84 film-coated tablets - calendar blister: EU/1/09/559/016
7 filmsko obloženih tablet - koledarski pretisni omot: EU/1/09/559/012 14 filmsko obloženih tablet - koledarski pretisni omot: EU/1/09/559/013 28 filmsko obloženih tablet - koledarski pretisni omot: EU/1/09/559/014 56 filmsko obloženih tablet - koledarski pretisni omot: EU/1/09/559/015 84 filmsko obloženih tablet - koledarski pretisni omot: EU/1/09/559/016
Absorption is at least 50%, based on urinary
Absorpcija je najmanj 50 %, na podlagi metabolitov klopidrogela, izločenih z urinom.