natgillin/translations-raw huggingface dataset:
In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre- existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
V PROaktivni študiji kardiovaskularnega izida je bilo 5238 bolnikov s sladkorno boleznijo tipa 2 in že prej obstoječimi težjimi makrovaskularnimi boleznimi naključno dodatno do 3, 5 let zdravljenih s pioglitazonom ali placebom k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju.
Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Skoraj vse osebe (95%) so prejemale kardiovaskularna zdravila (beta blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate), Čeprav študija ni dosegla svojega prvotnega cilja, ki je bil sestavljen iz smrtnosti iz vseh razlogov, neusodnih miokardnih infarktov, kapi, akutnih koronarnih sindromov, težjih amputacij nog, koronarnih revaskularizacij in revaskularizacij nog, rezultati kažejo, da ni dolgoročnih kardiovaskularnih skrbi glede uporabe pioglitazona.
Insulin release:
Izločanje insulina:
Extrapancreatic activity:
Ekstrapankreatično delovanje:
The uptake of glucose from blood into peripheral muscle and fat tissues occurs via a special transport proteins, located in the cells membrane.
11 Prenos glukoze iz krvi v periferna mišična in maščobna tkiva poteka preko posebnih transportnih proteinov, ki se nahajajo v membrani celic.
11 Glimepiride increases the activity of the glycosyl-phosphatidylinositol-specific phospholipase C which may be correlated with the induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Glimepirid poveča aktivnost za glikozil- fosfatidilinozitol specifične fosfolipaze C, kar je morda povezano z indukcijo lipogeneze in glikogeneze, ki jo zdravilo povzroči v izoliranih maščobnih in mišičnih celicah.
Glimepiride inhibits the glucose production in the liver by increasing the intracellular concentration of fructose-2,6-bisphosphate, which in turn inhibits the gluconeogenesis.
Glimepirid poveča znotrajcelično koncentracijo fruktoza- 2, 6- bisfosfata, kar zavira glukoneogenezo in zato s tem zavira glukoneogenezo.
In healthy persons, the minimum effective oral dose is approximately 0.6 mg.
Pri zdravih osebah je najmanjši učinkoviti peroralni odmerek približno 0, 6 mg.
Although the hydroxy metabolite of glimepiride caused a small but significant decrease in serum glucose in healthy persons, it accounts for only a minor part of the total effect.
Čeprav je hidroksi- presnovek glimepirida povzročil majhno, a pomembno znižanje glukoze v serumu zdravih ljudi, to predstavlja le manjši del celotnega učinka zdravila.
Studies in human volunteers have shown Tandemact to be bioequivalent to the administration of pioglitazone and glimepiride given as separate tablets.
Raziskave pri zdravih prostovoljcih so pokazale, da je Tandemact bioekvivalenten sočasnemu jemanju pioglitazona in glimepirida kot dveh posameznih tablet.
The following statements reflect the pharmacokinetic properties of the individual active substances of Tandemact
Sledeče ugotovitve odražajo farmakokinetične lastnosti individualnih zdravilnih učinkovin v zdravilu Tandemacta
12 Elimination:
12 Študije medsebojnih delovanj so pokazale, da pioglitazon nima pomembnega učinka na farmakokinetiko ali farmakodinamiko digoksina, varfarina, fenprokumona in metoformina.
The bioavailability of glimepiride after oral administration is complete.
Biološka uporabnost glimepirida je po preoralnem dajanju popolna.
Maximum serum concentrations (Cmax) are reached approximately 2.5 hours after oral intake (mean 0.3 µg/ ml during multiple dosing of 4 mg daily) and there is a linear relationship between dose and both Cmax and AUC (area under the time/ concentration curve).
Maksimalne koncentracije v serumu (Cmax) so dosežene približno 2, 5 uri po peroralnem jemanju (v povprečju 0, 3 µg/ ml med večkratnim odmerjanjem po 4 mg dnevno) in med odmerkom ter Cmax in AUC obstaja linearna povezanost (površina pod krivuljo koncentracije zdravila in časa).
Glimepiride has a very low distribution volume (approximately 8.8 litres) which is roughly equal to the albumin distribution space, high protein binding (> 99%), and a low clearance (approximately 48 ml/ min).
Glimepirid ima zelo nizek volumen porazdelitve (približno 8, 8 litrov), kar je približno enako površini porazdelitve albumina, visoko vezavo na beljakovine (99%) in nizek očistek (približno 48 ml/ min).
Passage of the blood brain barrier is low.
Prehajanje preko krvno - možganske pregrade je počasno.
Mean dominant serum half-life, which is of relevance for the serum concentrations under multiple- dose conditions, is about 5 to 8 hours.
Povprečni razpolovni čas dominantnega seruma je približno 5 do 8 ur, kar je pomembno za serumske koncentracije pod pogoji večkratnega odmerjanja.
Two metabolites – most probably resulting from hepatic metabolism (major enzyme is CYP2C9) – were identified both in urine and faeces: the hydroxy derivative and the carboxy derivative.
Dva metabolita – verjetno zaradi jetrne presnove (glavni encim je CYP2C9) – sta bila najdena tako v urinu kot tudi v blatu: hidroksi - derivat in karboksi- derivat.
Pharmacokinetics were similar in males and females, as well as in young and elderly (above 65 years) patients.
13 Farmakokinetike so bile podobne pri moških in ženskah ter pri mlajših in starejših (nad 65 let) bolnikih.
The following data are findings in studies performed with pioglitazone or glimepiride individually.
Sledeči podatki so bili ugotovljeni pri posamičnih raziskavah pioglitazona ali glimepirida.
Cellulose microcrystalline Croscarmellose sodium Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Polysorbate 80
Mikrokristalna celuloza Premrežen natrijev karmelozat Hidroksipropilceluloza Laktoza monohidrat Magnezijev stearat Polisorbat 80.
This medicinal product does not require any special storage conditions.
Za shranjevanje tega zdravila ni posebnih navodil.
Aluminium/ aluminium blisters; packs of 14, 28, 30, 50, 90 or 98 tablets.
Aluminij/ aluminij pretisni omoti, pakiranja po 14, 28, 30, 50, 90 in 98 tablet.
8th January 2007
8/ 01/ 2007
Tandemact 30 mg/ 4 mg tablets.
Tandemact 30 mg/ 4 mg tablete
Each tablet contains approximately 177 mg lactose monohydrate.
Vsaka tableta vsebuje približno 177 mg laktoze monohidrata.
White to off-white, round, convex and embossed ‘ 4833 G’ on one face and ‘ 30/ 4’ on the other.
Tablete so bele do umazano bele barve, okrogle, izbočene z oznako ‘ 4833 G ’ na eni strani in ‘ 30/ 4 ’ na drugi.
16 4.3 Contraindications
16 4. 3 Kontraindikacije
17 Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
17 Po uvedbi zdravljenja s Tandemactom je priporočeno, da jetrne encime spremljate redno po klinični presoji.
In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures
18 V 3, 5 letni PROactive študiji kardiovaskualarnega tveganja, je 44/ 870 (5, 1%; 1, 0 zlom na 100 bolnik - let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/ 905 (2, 5%; 0, 5 zlomov na 100 bolnk- let) žensk, zdravljenih s primerjalnim zdravilom.
19 phenylbutazone, azapropazon and oxyfenbutazone insulin and oral antidiabetic products metformin salicylates and p-amino-salicylic acid anabolic steroids and male sex hormones chloramphenicol coumarin anticoagulants fenfluramine fibrates ACE inhibitors fluoxetine allopurinol sympatholytics cyclo-, tro-and iphosphamides sulphinpyrazone certain long-acting sulphonamides tetracyclines MAO-inhibitors quinolone antibiotics probenecid miconazol pentoxyfylline (high dose parenteral) tritoqualine fluconazole
19 Ob jemanju katere izmed naslednjih zdravilnih učinkovin se lahko poveča učinek na znižanje koncentracije glukoze v krvi, zato lahko v nekaterih primerih pride do hipoglikemije: fenilbutazon, azapropazon in oksifenbutazon insulin in peroralni antidiabetiki metformin salicilati in p- aminosalicilna kislina anabolni steroidi in moški spolni hormoni kloramfenikol kumarinski antikoagulansi fenfluramin fibrati zaviralci ACE fluoksetin alopurinol simpatikolitiki ciklo -, tro - in ifosfamidi sulfinpirazon nekateri dolgo delujoči sulfonamidi tetracikilini zaviralci MAO kinolonski antibiotiki probenecid mikonazol pentoksifilin (velik parenteralen odmerek) tritokalin flukonazol
20 Sulphonylurea-derivatives like glimepiride pass into the breast milk.
20 Derivati sulfonilsečnin, kot je glimepirid, se izločajo v materino mleko.
21 Renal and urinary disorders Uncommon:
21 Bolezni sečil Občasni:
22 Immune system disorders Very rare:
22 Bolezni imunskega sistema Zelo redki:
Vomiting, diarrhoea, nausea, abdominal pressure, feeling of fullness in the stomach, abdominal pain
bruhanje, driska, slabost, napetost trebuha, občutek polnosti v želodcu, bolečine v trebuhu
23 Treatment of overdosage of Tandemact primarily consists of preventing absorption of glimepiride by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium-sulphate (laxative).
Hipoglikemijo lahko spremljajo nevrološki simptomi kot so nemir, tremor, motnje vida, težave s koordinacijo, zaspanost, koma in konvulzije.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/ creatinine ratio compared to baseline.
24 V enoletnih kliničnih preskušanjih je pioglitazon vedno statistično značilno znižal razmerje albumin/ kreatinin v primerjavi z izhodiščnimi vrednostmi.
24 The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Učinek pioglitazona (45 mg monoterapija v primerjavi s placebom) so preučevali v majhnem 18 - tedenskem preskušanju pri diabetikih tipa 2.
The uptake of glucose from blood into peripheral muscle and fat tissues occurs via a special transport proteins, located in the cells membrane.
25 Prenos glukoze iz krvi v periferna mišična in maščobna tkiva poteka preko posebnih transportnih proteinov, ki se nahajajo v membrani celic.
25 Glimepiride increases the activity of the glycosyl-phosphatidylinositol-specific phospholipase C which may be correlated with the induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Glimepirid poveča aktivnost za glikozil- fosfatidilinozitol specifične fosfolipaze C, kar je morda povezano z indukcijo lipogeneze in glikogeneze, ki jo zdravilo povzroči v izoliranih maščobnih in mišičnih celicah.
26 Elimination:
26 Študije medsebojnih delovanj so pokazale, da pioglitazon nima pomembnega učinka na farmakokinetiko ali farmakodinamiko digoksina, varfarina, fenprokumona in metoformina.
Pharmacokinetics were similar in males and females, as well as in young and elderly (above 65 years) patients.
27 Farmakokinetike so bile podobne pri moških in ženskah ter pri mlajših in starejših (nad 65 let) bolnikih.
27 Pharmacokinetics in five non-diabetic patients after bile duct surgery were similar to those in healthy persons.
Farmakokinetika pri petih nediabetičnih bolnikih po operaciji žolčevoda je bila podobna tisti pri zdravih ljudeh.
28 6.2 Incompatibilities
28 6. 2 Inkompatibilnosti
Tandemact 45 mg/ 4 mg tablets.
Tandemact 45 mg/ 4 mg tablete
Each tablet contains approximately 214 mg lactose monohydrate.
Vsaka tableta vsebuje približno 214 mg laktoze monohidrat.
White to off-white, round, flat and embossed ‘ 4833 G’ on one face and ‘ 45/ 4’ on the other.
Tablete so bele do umazano bele barve, okrogle, ploske in z oznako ‘ 4833 G ’ na eni strani in ‘ 45/ 4 ’ na drugi.
30 4.3 Contraindications
30 4. 3 Kontraindikacije
There have been cases of cardiac failure reported from the market when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Poročali so o primerih srčnega popuščanja, ko so pioglitazon uporabljali v kombinaciji z insulinom ali pri bolnikih z zgodovino srčnega popuščanja.
This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study.
Študija je pokazala povečanje poročanih srčnih odpovedi, vendar pa v tej študiji to ni povzročilo povečane smrtnosti.
31 Following initiation of therapy with Tandemact, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
31 Po uvedbi zdravljenja s Tandemactom je priporočeno, da jetrne encime spremljate redno po klinični presoji.
In clinical trials with pioglitazone and sulphonylurea monotherapy or in combination there was evidence of dose related weight gain, which may be due to fat accumulation and in some cases associated with fluid retention.
V kliničnih preskušanjih z monoterapijo ali kombinacijo pioglitazona in sulfonilsečnine so opažali pridobivanje telesne mase, odvisno od odmerka, ki je morda posledica nabiranja maščob, v nekaterih primerih pa je povezana z zastajanjem tekočine.
In some cases weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored.
V nekaterih primerih je lahko povišanje telesne mase posledica srčne odpovedi, zato je treba telesno maso skrbno spremljati.
In the 3.5 year cardiovascular risk PROactive study, 44/ 870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/ 905 (2.5%; 0.5 fractures
32 V 3, 5 letni PROactive študiji kardiovaskualarnega tveganja, je 44/ 870 (5, 1%; 1, 0 zlom na 100 bolnik - let) žensk, zdravljenih s pioglitazonom imelo zlome, v primerjavi s 23/ 905 (2, 5%; 0, 5 zlomov na 100 bolnk- let) žensk, zdravljenih s primerjalnim zdravilom.
33 phenylbutazone, azapropazon and oxyfenbutazone insulin and oral antidiabetic products metformin salicylates and p-amino-salicylic acid anabolic steroids and male sex hormones chloramphenicol coumarin anticoagulants fenfluramine fibrates ACE inhibitors fluoxetine allopurinol sympatholytics cyclo-, tro-and iphosphamides sulphinpyrazone certain long-acting sulphonamides tetracyclines MAO-inhibitors quinolone antibiotics probenecid miconazol pentoxyfylline (high dose parenteral) tritoqualine fluconazole
33 Ob jemanju katere izmed naslednjih zdravilnih učinkovin se lahko poveča učinek na znižanje koncentracije glukoze v krvi, zato lahko v nekaterih primerih pride do hipoglikemije: fenilbutazon, azapropazon in oksifenbutazon insulin in peroralni antidiabetiki metformin salicilati in p- aminosalicilna kislina anabolni steroidi in moški spolni hormoni kloramfenikol kumarinski antikoagulansi fenfluramin fibrati zaviralci ACE fluoksetin alopurinol simpatikolitiki ciklo -, tro - in ifosfamidi sulfinpirazon nekateri dolgo delujoči sulfonamidi tetracikilini zaviralci MAO kinolonski antibiotiki probenecid mikonazol pentoksifilin (velik parenteralen odmerek) tritokalin flukonazol
34 Sulphonylurea-derivatives like glimepiride pass into the breast milk.
34 Derivati sulfonilsečnin, kot je glimepirid, se izločajo v materino mleko.
Frequencies are defined as: common > 1/ 100 ,< 1/10; uncommon > 1/1000 ,< 1/100; rare > 1/ 10000 ,< 1/1000; very rare < 1/10000; isolated reports: not known (cannot be estimated from the available data).
Pogostnosti so določene kot: pogosti > 1/ 100, < 1/ 10; občasni > 1/ 1000, < 1/ 100; redki > 1/ 10000, < 1/ 1000; zelo redki < 1/ 10000; posamezni primeri: neznani (jih ne moremo oceniti iz obstoječih podatkov).
35 Renal and urinary disorders Uncommon:
35 Bolezni sečil Občasni:
Skin and subcutaneous tissue disorders Uncommon:
Bolezni kože in Občasni:
sweating
podkožja znojenje
In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included in insulin.
V študiji izida pri bolnikih z obstoječo težjo makrovaskularno boleznijo je bila incidenca resnega srčnega popuščanja 1, 6% višja pri pioglitazonu kot pri, ko je bil slednji dodan zdravljenju, ki je zajemalo insulin.
Heart failure has been reported rarely with marketing use of pioglitazone, but more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Pri tržni uporabi pioglitazona so redko poročali o srčnem popuščanju, a bolj pogosto, ko je bil pioglitazon uporabljen v kombinaciji z insulinom ali pri bolnikih z zgodovino srčnega popuščanja.
Based on experience with glimepiride and with other sulphonylureas the following adverse reactions have to be mentioned.
Na podlagi izkušenj z glimepiridom in drugimi sulfonilsečninami, je treba omeniti naslednje neželeneučinke.
36 Immune system disorders Very rare:
36 Bolezni imunskega sistema Zelo redki:
Gastro-intestinal complaints are very rare and seldom lead to discontinuation of therapy.
Bolezni prebavil so zelo redka in redko povzročijo prekinitev zdravljenja.
A pooled analysis was conducted of adverse event reports of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Opravljena je bila skupna analiza neželenih učinkov zlomov kosti iz randomiziranih, s primerjalnim zdravilom nadzorovanih, dvojno slepih kliničnih preskušanj pri več kot 8100 bolnikov v skupini zdravljeni s pioglitazonom in 7. 400 v skupini zdravljeni s primerjalnim zdravilom, ki so trajale do 3, 5 let.
37 Treatment of overdosage of Tandemact primarily consists of preventing absorption of glimepiride by inducing vomiting and then drinking water or lemonade with activated charcoal (adsorbent) and sodium-sulphate (laxative).
Hipoglikemijo lahko spremljajo nevrološki simptomi kot so nemir, tremor, motnje vida, težave s koordinacijo, zaspanost, koma in konvulzije.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/ creatinine ratio compared to baseline.
38 V enoletnih kliničnih preskušanjih je pioglitazon vedno statistično značilno znižal razmerje albumin/ kreatinin v primerjavi z izhodiščnimi vrednostmi.
38 The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Učinek pioglitazona (45 mg monoterapija v primerjavi s placebom) so preučevali v majhnem 18 - tedenskem preskušanju pri diabetikih tipa 2.
In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre- existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
V PROaktivni kardiovaskularni študiji izida je bilo 5238 bolnikov s sladkorno boleznijo tipa 2 in že prej obstoječimi težjimi makrovaskularnimi boleznimi naključno dodatno do 3, 5 let zdravljenih s pioglitazonom ali placebom k že obstoječemu antidiabetičnemu in kardiovaskularnemu zdravljenju.
Almost all subjects (95%) were receiving cardiovascular medications (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Skoraj vse osebe (95%) so prejemale kardiovaskularna zdravila (beta blokatorje, ACE inhibitorje, antagoniste angiotenzina II, zaviralce kalcijevih kanalčkov, nitrate, diuretike, aspirin, statine, fibrate).
The uptake of glucose from blood into peripheral muscle and fat tissues occurs via a special transport proteins, located in the cells membrane.
39 Prenos glukoze iz krvi v periferna mišična in maščobna tkiva poteka preko posebnih transportnih proteinov, ki se nahajajo v membrani celic.
39 Glimepiride increases the activity of the glycosyl-phosphatidylinositol-specific phospholipase C which may be correlated with the induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Glimepirid poveča aktivnost za glikozil- fosfatidilinozitol specifične fosfolipaze C, kar je morda povezano z indukcijo lipogeneze in glikogeneze, ki jo zdravilo povzroči v izoliranih maščobnih in mišičnih celicah.
40 Elimination:
40 Študije medsebojnih delovanj so pokazale, da pioglitazon nima pomembnega učinka na farmakokinetiko ali farmakodinamiko digoksina, varfarina, fenprokumona in metoformina.
After a single dose of radiolabeled glimepiride, 58% of the radioactivity was recovered in the urine, and 35% in the faeces.
Po enkratnem odmerku radioaktivno označenega glimepirida, se je 58% radioktivnosti izločilo v urinu in 35% v blatu.
Pharmacokinetics were similar in males and females, as well as in young and elderly (above 65 years) patients.
41 Farmakokinetike so bile podobne pri moških in ženskah ter pri mlajših in starejših (nad 65 let) bolnikih.
Aluminium/ aluminim blisters; packs of 14, 28, 30, 50, 90 or 98 tablets.
Aluminij/ aluminij pretisni omoti, pakiranja po 14, 28, 30, 50, 90 in 98 tablet.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
Takeda Italia Farmaceutici S. p. A Via Crosa 86, 28065 Cerano (NO) Italy
Takeda Italia Farmaceutici S. p. A Via Crosa 86, 28065 Cerano (NO) Italija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 7.0 presented in Module 1.8.1 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je, opisan v različici 7. 0, predstavljen v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version May 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application, and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici načrta obvladovanja tveganja (RMP) iz maja 2007, predstavljene v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA.
Poleg tega je treba posodobljen RMP predložiti: • kadar imetnik dovoljenja za uporabo z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne varnostne specifikacije, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja • v 60 dneh po doseženem pomembnem mejniku (pri farmakovigilanci ali zmanjšanju tveganja) • na zahtevo Evropske agencije za zdravila (EMEA).
Tandemact 30 mg/ 2 mg tablets
Tandemact 30 mg/ 2 mg tablete
14 tablets 28tablets 30 tablets 50 tablets 90 tablets 98 tablets
14 tablet 28 tablet 30 tablet 50 tablet 90 tablet 98 tablet
EU/ 1/ 06/ 366/ 017 14 tablets EU/ 1/ 06/ 366/ 018 28 tablets EU/ 1/ 06/ 366/ 019 30 tablets EU/ 1/ 06/ 366/ 020 50 tablets EU/ 1/ 06/ 366/ 021 90 tablets EU/ 1/ 06/ 366/ 022 98 tablets
EU/ 1/ 06/ 366/ 017 14 tablet EU/ 1/ 06/ 366/ 018 28 tablet EU/ 1/ 06/ 366/ 019 30 tablet EU/ 1/ 06/ 366/ 020 50 tablet EU/ 1/ 06/ 366/ 021 90 tablet EU/ 1/ 06/ 366/ 022 98 tablet
Batch number:
Serijska številka:
Tandemact 30 mg/ 4 mg tablets
Tandemact 30 mg/ 4 mg tablete