natgillin/translations-raw huggingface dataset:
There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score > 9).
Pri bolnikih s hudo jetrno insuficienco (Child- Pughova lestvica > 9) kliničnih izkušenj ni.
However, because sitagliptin is primarily renally eliminated, severe hepatic insufficiency is not expected to affect the pharmacokinetics of sitagliptin.
13 Ker pa se sitagliptin primarno izloča prek ledvic, ne pričakujemo, da bi huda jetrna insuficienca vplivala na farmakokinetiko sitagliptina.
Elderly No dose adjustment is required based on age.
Starejši bolniki Prilagajanje odmerka glede na starost ni potrebno.
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.
Pri analizi populacijske farmakokinetike na podlagi podatkov iz I. in II. faze starost ni imela kliničnega pomena za farmakokinetiko sitagliptina.
Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Pri starejših bolnikih (od 65 do 80 let) so bile plazemske koncentracije sitagliptina približno za 19% večje kot pri mlajših osebah.
Other patient characteristics No dose adjustment is necessary based on gender, race, or body mass index (BMI).
Druge značilnosti pri bolnikih Na podlagi spola, rase ali indeksa telesne mase (ITM) odmerka ni treba prilagajati.
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a 13 composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Na podlagi sestavljene analize farmakokinetičnih podatkov iz I. faze in analize populacijske farmakokinetike na podlagi podatkov iz I. in II. faze te značilnosti nimajo kliničnega pomena za farmakokinetiko sitagliptina.
Metformin Absorption After an oral dose of metformin, tmax is reached in 2.5 h.
Absorpcija Po peroralnem odmerku metformina je vrednost tmax dosežena v 2, 5 ure.
Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Pri zdravih posameznikih je absolutna biološka uporabnost 500- miligramske tablete metformina približno 50 do 60%.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Po peroralnem odmerku je odkrit neabsorbiran delež v blatu znašal 20 do 30%.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ ml, even at maximum doses.
V nadzorovanih kliničnih preskušanjih največja koncentracija metformina v plazmi (Cmax) tudi pri največjih odmerkih ni presegla 4 μg/ ml.
Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Po dajanju 850- miligramskega odmerka so opazili za 40% manjšo največjo koncentracijo v plazmi, za 25% zmanjšano vrednost AUC in 35- minutno podaljšanje časa za doseg največje koncentracije v plazmi.
Distribution Plasma protein binding is negligible.
Porazdelitev Vezava na beljakovine v plazmi je zanemarljiva.
The mean Vd ranged between 63 – 276 l.
Povprečna vrednost volumna porazdelitve (Vd) je od 63 do 276 litrov.
Elimination Renal clearance of metformin is > 400 ml/ min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Izločanje Ledvični očistek metformina je > 400 ml/ min ter kaže, da se metformin izloča z glomerularno filtracijo in tubularno sekrecijo.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h.
Po peroralnem odmerku je bila končna razpolovna doba izločanja približno 6, 5 ure.
When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
V primeru oslabljenega delovanja ledvic se ledvični očistek zmanjša sorazmerno s kreatininskim in tako se razpolovna doba izločanja podaljša, kar vodi v zvišanje ravni metformina v plazmi.
In 16-week studies in which dogs were treated with either metformin alone or a combination of metformin and sitagliptin, no additional toxicity was observed from the combination.
14 V 16- tedenskih študijah, v katerih so psom dajali metformin sam ali v kombinaciji s sitagliptinom, zaradi kombinacije niso opazili nobenih dodatnih škodljivih učinkov.
The NOEL in these studies was observed at exposures to sitagliptin of approximately 6 times the human exposure and to metformin of approximately 2.5 times the human exposure.
Koncentracijo brez opaznega učinka (NOEL – No Observable Effect Level) so v teh študijah opazili pri izpostavljenosti sitagliptinu, ki je bila približno 6- krat večja od izpostavljenosti pri človeku, in pri izpostavljenosti metforminu, ki je bila približno 2, 5- krat večja od izpostavljenosti pri človeku.
Sitagliptin Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Pri glodalcih so pri sistemski izpostavljenosti, ki je bila 58- krat večja od izpostavljenosti pri človeku, opazili škodljive učinke na ledvice in jetra, izpostavljenost brez škodljivih učinkov pa je bila 19- krat večja od izpostavljenosti pri človeku.
Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no- effect level for this finding was 58-fold based on the 14-week rat study.
V 14- tedenskih študijah na podganah je bila izpostavljenost brez škodljivega učinka 58- krat večja.
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/ or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Pri psih so pri izpostavljenosti, ki je bila približno 23- krat večja od izpostavljenosti pri klinični uporabi, opazili z zdravljenjem povezane prehodne fizične znake, med katerimi so nekateri kazali na škodljive učinke na živčevje, na primer dihanje z odprtimi usti, slinjenje, bruhanje bele spenjene vsebine, ataksija, tresenje, zmanjšana aktivnost in/ ali zgrbljena drža.
In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times
Poleg tega so pri odmerkih, ki so povzročili približno 23- krat večjo sistemsko izpostavljenost od izpostavljenosti človeka pri klinični uporabi, s histološko preiskavo ugotovili zelo blago do blago degeneracijo skeletne mišičnine.
A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Pri tem je bila izpostavljenost brez škodljivega učinka 6- krat večja od izpostavljenosti pri klinični uporabi.
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Pri podganah so pri sistemski izpostavljenosti, ki je bila 58- krat večja od izpostavljenosti človeka pri klinični uporabi, opazili večjo pojavnost jetrnih adenomov in karcinomov.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Ker je bila pri podganah dokazana povezava med hepatotoksičnostjo in indukcijo jetrnih neoplazij, obstaja verjetnost, da je pri podganah pojavnost jetrnih tumorjev povečana sekundarno zaradi kronične hepatotoksičnosti pri tem velikem odmerku.
Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Zaradi visoke meje varnosti (19- kratna izpostavljenost brez škodljivega učinka) teh neoplastičnih sprememb ne ocenjujemo kot pomembne za klinično uporabo pri človeku.
No treatment related effects on fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Pri samcih in samicah podgan, ki so sitagliptin prejemali/ prejemale pred parjenjem in med njim, niso opazili z zdravljenjem povezanih učinkov na plodnost.
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
Študije, izvedene s sitagliptinom na podganah, niso pokazale neželenih učinkov na pre - / post- natalni razvoj.
Reproductive toxicity studies showed a slight treatment-related increased incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Pri študijah vpliva na sposobnost razmnoževanja so pri mladičih podgan pri sistemski izpostavljenosti, ki je bila več kot 29- krat večja od izpostavljenosti pri človeku, opazili nekoliko večjo z zdravilom povezano pojavnost deformacij plodovih reber (izostala, hipoplastična in valovita rebra).
Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
Pri kuncih je bila toksičnost za mater opažena pri izpostavljenosti, ki je bila več kot 29- krat večja od izpostavljenosti pri človeku.
Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Zaradi visoke meje varnosti te ugotovitve ne kažejo na relevantno tveganje za sposobnost razmnoževanja pri človeku.
Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/ plasma ratio:
Pri doječih podganah se je sitagliptin v večjih količinah izločal z mlekom (razmerje mleko/ plazma 4:
4:1).
1).
Metformin Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Predklinični podatki za metformin na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Tablet core: microcrystalline cellulose (E460) povidone K29/ 32 (E1201) sodium lauril sulfate sodium stearyl fumarate
Jedro tablete: mikrokristalna celuloza (E460) povidon K29/ 32 (E1201) natrijev lavrilsulfat natrijev stearilfumarat
Film coating: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) iron oxide red (E172) iron oxide black (E172)
Filmska obloga: polivinilni alkohol makrogol 3350 smukec (E553b) titanov dioksid (E171) rdeči železov oksid (E172) črni železov oksid (E172)
Opaque blisters (PVC/ PE/ PVDC and aluminum).
Neprosojni pretisni omoti (PVC/ PE/ PVDC in aluminij).
Packs of 14, 28, 56, 112, 168, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) film-coated tablets.
Pakiranja po 14, 28, 56, 112, 168, 196 filmsko obloženih tablet, multi pakiranja po 196 (2 zavoja po 98) filmsko obloženih tablet.
Pack of 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakiranje po 50 x 1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek.
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16 1.
1.
Efficib 50 mg/ 1000 mg film-coated tablets
17 Efficib 50 mg/ 1. 000 mg filmsko obložene tablete
Each tablet contains 50 mg of sitagliptin (as phosphate monohydrate) and 1,000 mg of metformin hydrochloride.
Vsaka tableta vsebuje 50 mg sitagliptina (v obliki sitagliptinijevega fosfata monohidrata) in 1. 000 mg metforminijevega klorida.
Capsule-shaped, red film-coated tablet with “ 577” debossed on one side.
Rdeče filmsko obložene tablete v obliki kapsule, z oznako "577" na eni strani.
17 For the different doses on metformin, Efficib is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Za različne odmerke metformina je zdravilo Efficib na voljo v jakostih po 50 mg sitagliptina in 850 mg metforminijevega klorida ali 1. 000 mg metforminijevega klorida.
All patients should continue their diet with an adequate distribution of carbohydrate intake during the day.
18 Vsi bolniki morajo nadaljevati z dieto z ustrezno dnevno količino zaužitih ogljikovih hidratov.
Lactic acidosis Lactic acidosis is a very rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation.
19 Laktacidoza Laktacidoza je zelo redek, vendar nevaren presnovni zaplet (visoka stopnja smrtnosti, če se zdravljenje ne začne takoj), ki se lahko pojavi zaradi kopičenja metformina.
The incidence of lactic acidosis can and should be reduced by also assessing other associated
Incidenco laktacidoze je mogoče in tudi potrebno zmanjševati z oceno drugih povezanih dejavnikov tveganja, kot so slabo nadzorovana sladkorna bolezen, ketoza, dolgotrajno stradanje, čezmerno uživanje alkohola, jetrna insuficienca in katerakoli stanja, povezana s hipoksijo.
19 Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Efficib who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Spremembe kliničnega statusa pri bolnikih s predhodno nadzorovano sladkorno boleznijo tipa 2 Pri bolnikih s sladkorno boleznijo tipa 2, predhodno dobro nadzorovano z jemanjem zdravila Efficib, pri katerih se pojavijo nenormalni izvidi laboratorijskih preiskav ali klinične bolezni (zlasti nejasne ali slabo opredeljene bolezni), je treba čim prej ugotoviti, če imajo ketoacidozo ali laktacidozo.
4.5 Interaction with other medicinal products and other forms of interaction
20 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
20 In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Študije in vitro so pokazale, da je primarni encim, odgovoren za omejeno presnovo sitagliptina, CYP3A4, pri presnovi pa sodeluje tudi CYP2C8.
In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and OAT3.
21 Študije transporta in vitro so pokazale, da je sitagliptin substrat za p- glikoprotein in OAT3.
21 4.8 Undesirable effects
4. 8 Neželeni učinki
Frequencies are defined as: very common (≥ 1/ 10); 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).
22 opredeljena kot: zelo pogosti (≥ 1/ 10); 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).
22 with glimepiride and metformin was 18.1% compared to treatment with the addition of placebo to the ongoing treatment with glimepiride and metformin which was 7.1%.
Pri bolnikih, ki so prejemali
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1,000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
23 sitagliptin in metformin, je bila skupna pojavnost z zdravilom povezanih neželenih učinkov primerljiva s pojavnostjo pri uporabi metformina samega (14, 0% v obeh skupinah) in večja kot pri uporabi sitagliptina samega (6, 7%), pri čemer so bile razlike v primerjavi z uporabo sitagliptina samega predvsem posledica neželenih učinkov v prebavilih.
Gastrointestinal disorders
Bolezni prebavil gastrointestinalni simptomia
Skin and subcutaneous disorders urticaria, erythema, pruritis
24 Bolezni kože in podkožja urtikarija, eritem, pruritis
lactic acidosis vitamin B12 deficiencyb
laktacidoza pomanjkanje vitamina B12b
Hepatobiliary disorders liver function disorders, hepatitis a
Bolezni jeter, žolčnika in žolčevodov okvare delovanja jeter, hepatitis a
Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e. g., megaloblastic anaemia).
Gastrointestinalni simptomi, kot so navzeja, bruhanje, diareja, bolečine v trebuhu in izguba apetita, se najpogosteje pojavijo ob začetku zdravljenja in večinoma spontano prenehajo. b Dolgotrajno zdravljenje z metforminom je povezano z zmanjšanjem absorpcije vitamina B12, kar lahko zelo redko povzroči klinično pomembno pomanjkanje vitamina B12 (npr. megaloblastno anemijo).
24 Sitagliptin Sitagliptin phosphate is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase 4 (DPP-4) enzyme for the treatment of type 2 diabetes.
Sitagliptin Sitagliptinijev fosfat je peroralno aktivni, močan in zelo selektiven zaviralec encima dipeptidil - peptidaze 4 (DPP- 4) in se uporablja za zdravljenje sladkorne bolezni tipa 2.
25 Table 3:
26 Tabela 3:
-2.1‡ (-2.3, -1.8)
(– 2, 3, – 1, 8)
- by delaying intestinal glucose absorption
- upočasni absorpcijo glukoze v črevesju.
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
27 Metformin stimulira znotrajcelično sintezo glikogena tako, da deluje na glikogen- sintazo.
26 The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
V prospektivni randomizirani študiji (UKPDS) so ugotovili dolgoročno korist intenzivne urejenosti glukoze v krvi pri sladkorni bolezni tipa 2.
Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
28 Presnova Sitagliptin se primarno izloča z urinom v nespremenjeni obliki, presnova pa je manj pomemben način izločanja.
27 Elimination Following administration of an oral [14C]sitagliptin dose to healthy subjects, approximately 100% of the administered radioactivity was eliminated in faeces (13%) or urine (87%) within one week of dosing.
Izločanje Po dajanju peroralnega odmerka [14C] sitagliptina zdravim osebam se je v enem tednu po prejemu odmerka približno 100% prejete radioaktivnosti izločilo z blatom (13%) ali urinom (87%).
However, because sitagliptin is primarily renally eliminated, severe hepatic insufficiency is not expected to affect the pharmacokinetics of sitagliptin.
29 Ker pa se sitagliptin primarno izloča prek ledvic, ne pričakujemo, da bi huda jetrna insuficienca vplivala na farmakokinetiko sitagliptina.
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a 28 composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Na podlagi sestavljene analize farmakokinetičnih podatkov iz I. faze in analize populacijske farmakokinetike na podlagi podatkov iz I. in II. faze te značilnosti nimajo kliničnega pomena za farmakokinetiko sitagliptina.
In 16-week studies in which dogs were treated with either metformin alone or a combination of metformin and sitagliptin, no additional toxicity was observed from the combination.
30 V 16- tedenskih študijah, v katerih so psom dajali metformin sam ali v kombinaciji s sitagliptinom, zaradi kombinacije niso opazili nobenih dodatnih škodljivih učinkov.
30 6.4 Special precautions for storage
Ne shranjujte pri temperaturi nad 30 °C.
Do not store above 30°C.
6. 5 Vrsta ovojnine in vsebina
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31 ANNEX II
33 DODATEK II
Via Complutense 140 ES-28805 Alcala de Henares - Madrid Spain
Via Complutense 140 ES- 28805 Alcala de Henares - Madrid Španija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 4 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 pred začetkom trženja zdravila vzpostaviti sistem farmakovigilance, kot je opisan v različici 4 v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, in ga vzdrževati ves čas trženja zdravila.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 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 mora izvesti študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 1. 1 načrta za obvladovanje tveganja (RMP) v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vse naknadne dopolnitve načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami Odbora za zdravila za uporabo v humani medicini o sistemih za obvladovanje tveganja je treba dopolnjen načrt obvladovanja tveganja predložiti sočasno z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
33 ANNEX III
35 DODATEK III
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
37 PODATKI NA ZUNANJI OVOJNINI
Outer carton for Efficib 50 mg/ 850 mg film-coated tablets
Škatla zdravila Efficib 50 mg/ 850 mg filmsko obložene tablete
Efficib 50 mg/ 850 mg film-coated tablets sitagliptin/ metformin hydrochloride
Efficib 50 mg/ 850 mg filmsko obložene tablete sitagliptin/ metforminijev klorid
14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 112 film-coated tablets 168 film-coated tablets 196 film-coated tablets Multi-pack containing 196 (2 packs of 98) film-coated tablets 50 x 1 film-coated tablets
14 filmsko obloženih tablet 28 filmsko obloženih tablet 56 filmsko obloženih tablet 112 filmsko obloženih tablet 168 filmsko obloženih tablet 196 filmsko obloženih tablet Multi pakiranje po 196 (2 zavoja po 98) filmsko obloženih tablet 50 x 1 filmsko obloženih tablet
36 Do not store above 30°C.
Ne shranjujte pri temperaturi nad 30 °C.
EU/ 1/ 08/ 457/ 001 14 film-coated tablets EU/ 1/ 08/ 457/ 002 28 film-coated tablets EU/ 1/ 08/ 457/ 003 56 film-coated tablets EU/ 1/ 08/ 457/ 004 112 film-coated tablets EU/ 1/ 08/ 457/ 005 168 film-coated tablets EU/ 1/ 08/ 457/ 006 196 film-coated tablets EU/ 1/ 08/ 457/ 007 50 x 1 film-coated tablets EU/ 1/ 08/ 457/ 015 196 (2 x 98) film-coated tablets
EU/ 1/ 08/ 457/ 001 14 filmsko obloženih tablet EU/ 1/ 08/ 457/ 002 28 filmsko obloženih tablet EU/ 1/ 08/ 457/ 003 56 filmsko obloženih tablet EU/ 1/ 08/ 457/ 004 112 filmsko obloženih tablet EU/ 1/ 08/ 457/ 005 168 filmsko obloženih tablet EU/ 1/ 08/ 457/ 006 196 filmsko obloženih tablet EU/ 1/ 08/ 457/ 007 50 x 1 filmsko obloženih tablet EU/ 1/ 08/ 457/ 015 196 (2 x 98) filmsko obloženih tablet
37 PARTICULARS TO APPEAR ON THE INTERMEDIATE CARTON
39 PODATKI NA SEKUNDARNI OVOJNIN
Multi-packs of 196 (2 packs of 98 film-coated tablets) – without blue box - 50 mg/ 850 mg film- coated tablets
Multi pakiranje po 196 (2 zavoja po 98 filmsko obloženih tablet) – brez blue box- a - 50 mg/ 850 mg filmsko obložene tablete
Component of a multi-pack comprising 2 packs, each containing 98 film-coated tablets.
98 filmsko obloženih tablet, kot del multi pakiranja z 2 enakima zavojema
39 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
41 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH
Blister for Efficib 50 mg/ 850 mg film-coated tablets
Pretisni omot zdravila Efficib 50 mg/ 850 mg filmsko obložene tablete