natgillin/translations-raw huggingface dataset:
Generally ACOMPLIA 20 mg had no significant effect on Total-C or LDL-C levels.
pro Na splošno ACOMPLIA 20 mg ni pomembno vplivala na koncentracijo celotnega holesterola ali holesterola LDL.
In the trial in type 2 diabetic patients (RIO-Diabetes) who were overweight or obese treated with Me
V preskušanju pri pretežkih ali debelih diabetikih tipa 2 (RIO – Diabetes), ki so dobivali metformin ali
metformin or sulfonylurea improvements in HbA1c and body weight were observed.
Razlike so bile statistično značilne (razlika – 0, 7%, IZ95% – 0, 80, – 0, 5; p < 0, 001).
The absolute change in HbA1c at one year was -0.6 for rimonabant 20 mg (baseline 7.3%) and +0.1 on placebo (baseline 7.2%).
Ob uporabi 20 mg zdravila ACOMPLIA se je telesna masa po enem letu v povprečju zmanjšala za 5, 3 kg, ob uporabi placeba pa za 1, 4 kg (razlika – 3, 9 kg, IZ95% – 4, 6; – 3, 3, p < 0, 001).
Differences were statistically significant (Difference -0.7%, CI95% -0.80; -0.5, p < 0.001).
Tabela 2 lje
8 At one year a mean weight loss of 5.3 kg was shown for ACOMPLIA 20 mg versus a loss on placebo of 1.4 kg (Difference – 3.9 kg CI95% -4.6; -3.3 p < 0.001).
10% izhodiščne telesne vo
The percentage of patients who lost 5% and 10% of their baseline body weight after 1 year of treatment are given in the table 2.
V drugo preskušanje (Serenade) so bili vključeni debeli bolniki z diabetesom tipa 2, ki pred tem še do
d In a second trial in treatment naïve type 2 diabetic obese patients (Serenade), the absolute change in HbA1c (with a baseline of 7.9% for both groups) at six months was -0.8 for rimonabant 20 mg and
Absolutna sprememba HbA1c po šestih mesecih je bila v skupini, ki je prejemala 20 mg rimonabanta, – 0, 8 in v skupini, ki je prejemala placebo, – 0, 3 (razlika – eā
ise -0.3 under placebo (Difference -0.51 CI95% -0.78, -0.24 p < 0.001).
0, 51, IZ95% – 0, 78, – 0, 24, p < 0, 001).
The percentage of patients reaching HbA1c < 7% was 51% in the rimonabant group and 35% in the placebo group.
HbA1c < 7% je doseglo 51% bolnikov, ki so dobivali rimonabant, in 35% bolnikov, ki so dobivali placebo.
The difference in mean body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p < 0.001).
med prejemniki 20 mg rimonabanta in prejemniki placeba je bila 3, 8 kg (IZ95% – 5, 0, – 2, 6, p < 0, 001).
It is
Spremembe holesterola HDL in trigliceridov so bile v tej populaciji podobne kot v nediabetični nim
or estimated that approximately half of the mean improvement in HbA1c in patients receiving rimonabant 20 mg was beyond that expected from weight loss alone.
Ocenjujejo, da je približno polovica povprečnega izboljšanja HbA1c pri bolnikih, ki so dobivali 20 mg rimonabanta, presegala izboljšanje, ki bi ga pričakovali zgolj zaradi zmanjšanja telesne mase. ilo
uth 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti rav
AUC increased less than in proportion to dose above 20 mg.
Zd
ra Absorption:
9 Absorpcija:
Rimonabant displays high in vitro permeability and is not a substrate of P-glycoprotein.
Rimonabant ima in vitro veliko permeabilnost in ni substrat P- glikoproteina.
ge to healthy subjects in the fasted state, maximum plasma concentrations of rimonabant are achieved in approximately 2 hours with steady state plasma levels achieved within 13 days (Cmax = 196 ± 28.1 ng/ ml; Ctrough = 91.6 ± 14.1 ng/ ml; AUC0-24 = 2960 ± 268 ng. h/ ml).
Po večkratni uporabi 20 mg enkrat na dan na tešče pri zdravih preiskovancih doseže rimonabant največjo plazemsko koncentracijo v približno 2 urah, plazemsko koncentracijo v stanju dinamičnega ravnovesja pa v 13 dneh (Cmax = 196 ± 28, 1 ng/ ml; Cdno = 91, 6 ± 14, 1 ng/ ml; AUC0– 24 = 2960 ± 268 ng. h/ ml).
Steady state rimonabant lon exposures are 3.3-fold higher than those observed after the first dose.
Izpostavljenost rimonabantu v stanju dinamičnega ravnovesja je 3, 3- krat večja kot po prvem odmerku.
As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% and Ctrough is expected to increase by 5%.
Ko se telesna masa poveča s 65 na 200 kg, je pričakovano zmanjšanje Cmax 24% in pričakovano povečanje Cdno za 5%.
Population no
Čas do stanja dinamičnega ravnovesja je pri debelih bolnikih daljši (25 dni), ker je volumen porazdelitve pri njih večji.
pharmacokinetic analysis indicated that rimonabant pharmacokinetics are similar between healthy non-smoking subjects and patients who smoke.
Analiza populacijske farmakokinetike je pokazala, da je farmakokinetika rimonabanta pri zdravih nekadilcih podobna kot pri bolnikih, ki kadijo.
Effect of food: ct
t me Vpliv hrane:
Administration of rimonabant to healthy subjects in the fasted state or with a high fat meal demonstrated that Cmax and AUC were increased 67% and 48% respectively, under fed conditions.
pro bila Cmax na poln želodec večja za 67% in AUC za 48%.
In clinical studies, ACOMPLIA 20 mg was taken in the morning usually before breakfast. du
V kliničnih študijah so preiskovanci Zdravilo ACOMPLIA 20 mg jemali zjutraj, ponavadi pred zajtrkom.
wide concentration range.
za Vezava rimonabanta na človeške plazemske beljakovine je in vitro velika (> 99, 9%) in v širokem razponu koncentracij ne kaže saturacije.
The apparent peripheral volume of distribution of rimonabant appears to be related to body weight, with obese patients having a higher volume of distribution than normal-weight subjects. lp
Zdi se, da je navidezni periferni volumen porazdelitve nja rimonabanta povezan s telesno maso; debeli bolniki imajo večji volumen porazdelitve kot preiskovanci z normalno telesno maso. lje
Biotransformation:
Biotransformacija: vo
Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in ina
Rimonabant se in vitro presnavlja s CYP3A in amidohidrolazo (pretežno jetrno).
Circulating metabolites do not contribute to its pharmacologic activity.
Presnovki v obtoku ne prispevajo k njegovemu farmakološkemu delovanju. do
Only dic
Le približno eā
an approximate 3% of the dose of rimonabant is eliminated in the urine, while approximately 86% of the dose is excreted in the faeces as unchanged drug and metabolites.
Pri debelih bolnikih je eliminacijski razpolovni čas zaradi av
Me
večjega volumna porazdelitve daljši (okrog 16 dni) kot pri bolnikih, ki niso debeli (okrog 9 dni). nim
9 Special Populations Race:
Posebne populacije Rasa:
In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese
V študijah s posamičnimi in ponavljajočimi se odmerki sta bili Cmax in AUC rimonabanta pri zdravih japonskih preiskovancih in belcih podobni.
d and Caucasian subjects, whereas elimination half-life was shorter in Japanese subjects (3-4 days) compared to Caucasian subjects (about 9 days).
preiskovancih krajši (od 3 do 4 dni) kot pri belcih (okrog 9 dni).
The difference in half-life was due to differences in
Razlika v razpolovnem času je bila posledica razlik v perifernem volumnu porazdelitve zaradi manjše telesne mase japonskih rav
ise peripheral volume of distribution as a consequence of lower weight in Japanese subjects.
preiskovancev.
Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.
Zd
or The pharmacokinetics of rimonabant are similar in female and male patients.
Farmakokinetika rimonabanta je pri bolnicah in bolnikih podobna.
uth Elderly patients have slightly higher exposure than young patients.
Izpostavljenost starejših bolnikov je rahlo večja kot izpostavljenost mladih bolnikov.
Based on a population pharmacokinetic analysis (age range 18 - 81 years) a 75 year old patient is estimated to have a 21% higher Cmax and a 27% higher AUC than a 40 year old patient.
Glede na analizo populacijske farmakokinetike (starostni razpon od 18 do 81 let) ocenjujejo, da ima 75- letni bolnik 21% večjo Cmax in 27% večjo AUC kot 40- letni bolnik.
ra Patients with hepatic insufficiency:
Bolniki z insuficienco jeter:
ge Patients with renal impairment:
10 Bolniki z okvaro ledvic:
The effect of renal function on the pharmacokinetics of rimonabant has not been studied specifically. lon Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect the pharmacokinetics of rimonabant.
Učinek delovanja ledvic na farmakokinetiko rimonabanta ni posebej raziskan.
Limited data suggest an increased exposure in patients with moderate renal impairment (40% increase in AUC).
Glede na podatke študij populacijske farmakokinetike blaga okvara ledvic ne vplivata na farmakokinetiko rimonabanta.
There are no data in severe renal impairment.
Omejeni podatki kažejo na večjo izpostavljenost pri bolnikih z zmerno okvaro ledvic (40% povečanje AUC).
5.3 Preclinical safety data no
Podatkov za bolnike s hudo okvaro ledvic ni.
observed in dogs during a 3 month study.
5. 3 Predklinični podatki o varnosti
In some, but not all cases, initiation of convulsions appeared to be associated with procedural stress such as handling of the animals.
V kliničnih študijah niso opazili škodljivih reakcij, v študijah na živalih pa so jih opazili pri stopnjah izpostavljenosti, podobnih stopnjam klinične izpostavljenosti.
A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies.
Konvulzije so sporadično opažali v študijah na glodalcih in makakih.
No adverse effect of rimonabant du
Med 3- mesečno študijo na psih
treatment was observed on EEG patterns in rats.
V nekaterih primerih – ne pa v vseh – je bila sprožitev konvulzij po vsem
Increased incidence and/ or severity of clinical signs suggestive of increased tactile hyperesthesia were ro
Pri podganah niso ugotovili
A direct effect of rimonabant cannot be ruled out.
pro neželenega vpliva rimonabanta na vzorec EEG.
Liver steatosis and a dose-related increase in centrilobular necrosis were observed in long-term studies lp
V študijah na glodalcih so ugotovili večjo incidenco in/ ali izrazitost kliničnih znakov, ki nakazujejo povečano taktilno hiperestezijo.
In standard fertility studies in female rats (dosing for 2 weeks prior to mating) there was abnormal ina
V standardnih študijah plodnosti na podganjih samicah (uporaba zdravila 2 tedna pred parjenjem) so lje
oestrous cyclicity and a decrease in corpora lutea and fertility index at doses of rimonabant that induced maternal toxicity (30 and 60 mg/ kg/ day).
odmerkih rimonabanta, ki so povzročili toksične učinke pri samicah- materah (30 in 60 mg/ kg/ dan).
Following dosing for a longer treatment duration prior to mating (9 weeks) that permitted recovery from the initial effects of rimonabant, no adverse effects were seen on fertility or oestrous cyclicity.
Po dolgotrajnejši uporabi pred parjenjem (9 tednov), ki je omogočila okrevanje po uvodnih vplivih do
differences were observed between treated animals and controls, at 60 mg/ kg effects were still observed (decreased number of corpora lutea, implantations, total and viable fetuses).
Kar zadeva reproduktivne parametre pri 30 mg/ kg niso ugotovili razlik med zdravljenimi in kontrolnimi živalmi, pri 60 mg/ kg so bili učinki še vedno opazni (zmanjšano število rumenih telesc, skupno število eā
Sporadic malformations (anencephaly, micro-ophthalmia, widened brain ventricles and omphalocele) Me
implantacij in plodov, sposobnih za življenje). av
were observed in the rabbit embryofetal toxicity studies at doses resulting in exposures comparable with the clinical exposures.
V študijah embrio- fetalnih toksičnih učinkov pri kuncih so opažali sporadične malformacije (anencefalija, mikrooftalmija, razširitev možganskih prekatov in omfalokela) ob odmerkih, ki so nim
Although maternal toxicity was observed at these doses, a relation to treatment cannot be excluded.
povzročili izpostavljenosti, podobne kliničnim izpostavljenostim.
No treatment-related malformations were seen in the rat.
Čeprav so pri teh odmerkih opazili toksične učinke pri samicah- materah, ni mogoče izključiti povezave s terapijo.
10 Effects of rimonabant on pre- and post-natal development were assessed in the rat at doses up to 10 mg/ kg/ day.
Vplive rimonabanta na pre - in postnatalni razvoj so raziskali pri podganah v odmerkih do 10 mg/ kg/ dan.
The increased pup mortality might be attributable to a failure of the dam to nurse or ingestion of
Opažena je bila večja s terapijo povezana umrljivost mladičev podgan v obdobju pred rav
There are reports in the
Večjo umrljivost mladičev podgan je morda mogoče pripisati nezmožnosti samic za dojenje ali pa zaužitju rimonabanta z mlekom in/ ali zavrtju sesalnega refleksa, za katerega je v Zd
ise literature that, in both rodents and humans, the spatial distribution and density of CB1 receptors in the brain changes during development.
literaturi opisano, da ga pri novoskotenih miših sproži endokanabinoidni prenos prek receptorjev CB1.
The potential relevance of this to administration of a CB1 antagonist is unknown.
V literaturi je opisano, da se prostorska porazdelitev in gostota receptorjev CB1 v možganih med razvojem spreminjata tako pri glodalcih kot pri človeku.
In the pre- and post-natal development study in rats, exposure to rimonabant in utero and via lactation produced no alterations on learning or memory, but equivocal effects on motor
V študiji pre - in postnatalnega razvoja pri podganah izpostavljenost rimonabantu in utero prek dojenja ni povzročila sprememb pri učenju ali pomnjenju, so pa pri mladičih podgan kot posledico izpostavljenosti rimonabantu opažali nejasne učinke na motorično delovanje in zdrznitev na slušni dražljaj.
ra Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201),
Jedro tablete: koruzni škrob, laktoza monohidrat, povidon K 30 (E1201), premreženi natrijev karmelozat (E468), natrijev lavrilsulfat (E487), mikrokristalna celuloza (E460), magnezijev stearat
ge croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate lon Tablet coating: lactose monohydrate, hypromellose 15 mPa. s (E464), no
me laktoza monohidrat, hipromeloza 15 mPa. s (E464),
titanium dioxide (E171), macrogol 3000
pro titanov dioksid (E171), makrogol 3000
Tablet polishing: ct
Glazura tablete:
carnauba wax (E903)
za karnauba vosek (E903) nja 6. 2 Inkompatibilnosti
6.2 Incompatibilities du
Navedba smiselno ni potrebna. lje vo
Not applicable ro
6. 3 Rok uporabnosti do
3 years lp
3 leta
6.4 Special precautions for storage ina
6. 4 Posebna navodila za shranjevanje eā
This medicinal product does not require any special storage conditions.
Za shranjevanje zdravila niso potrebna posebna navodila. av
6.5 Nature and contents of container dic
6. 5 Vrsta ovojnine in vsebina nim
PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets.
Pretisni omoti iz PVC- aluminija s 14, 28, 30, 56, 84, 90 in 98 filmsko obloženimi tabletami.
70 x 1 film-coated tablets in PVC-aluminium perforated unit dose blister packs.
Perforirani pretisni omoti za enkratni odmerek iz PVC- aluminija s 70 x 1 filmsko obloženo tableto.
Opaque white HDPE bottles containing 28, 98 and 500 film-coated tablets.
Neprozorne bele plastenke iz HDPE z 28, 98 ali 500 filmsko obloženimi tabletami. ilo
Me
Na trgu ni vseh navedenih pakiranj. rav
6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje Zd
174 Avenue de France
sanofi- aventis 174 Avenue de France F- 75013 Paris Francija
or EU/ 1/ 06/ 344/ 001-011
EU/ 1/ 06/ 344/ 001- 011
ge Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu. lon no ct du ro lp ina dic Me
t me Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
12 d ise or uth ra ge lon ANNEX II
13 t me pro za nja DODATEK II lje
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE no
ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE do
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM eā av nim ilo rav Zd
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
d Name and address of the manufacturers responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije
ise Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France
Sanofi Winthrop Industrie, 30- 36 Avenue Gustave Eiffel, BP 27166, F- 37071 Tours Cedex 2, Francija
sanofi-aventis S. p. A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy
sanofi- aventis S. p. A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italija
or The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
uth B.
t me B.
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
pro • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
Medicinal product subject to medical prescription.
za Izdaja zdravila je le na recept. nja • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA lje
ge • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT lon Not applicable.
Navedba smiselno ni potrebna. vo
• OTHER CONDITIONS no
• DRUGI POGOJI do
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market. ct
Imetnik dovoljenja za promet mora zagotoviti vzpostavljen sistem vodenja farmakovigilance, ki mora delovati že pred prihodom zdravila na trg. eā
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan. du
Imetnik dovoljenja za promet se zaveže da bo izvedba študij in dodatne farmakovigilančne aktivnosti av
14 d ise or uth ra ge lon ANNEX III
podrobno opisane v farmakovigilančnem planu. nim
LABELLING AND PACKAGE LEAFLET no ct du ro lp ina dic Me
Obnovljen načrt upravljanja tveganja mora biti izdelan kot so CHMP smernice za sistem upravljanja tveganja za zdravila za humano uporabo. ilo rav Zd
15 Me dic ina lp ro du ct
15 t me pro za nja DODATEK III lje
16 no A.
16 Zd rav ilo nim av eā
LABELLING lon ge ra uth or ise d PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for the presentations of 14, 28, 30 56, 70, 84, 90 and 98 film-coated tablets in blisters
OZNAČEVANJE nja za pro me t PODATKI NA ZUNANJI OVOJNINI Škatla s 14, 28, 30, 56, 70, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih
or ACOMPLIA 20 mg film-coated tablets rimonabant
ACOMPLIA 20 mg filmsko obložene tablete rimonabant
STATEMENT OF ACTIVE SUBSTANCE(S)
t NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 2.
Each tablet contains 20 mg of rimonabant.
me Ena tableta vsebuje 20 mg rimonabanta.
ra 3.
pro 3.
ge Also contains lactose monohydrate.
za Vsebuje tudi laktozo monohidrat. nja Za dodatne informacije glejte navodilo. lje
PHARMACEUTICAL FORM AND CONTENTS
FARMACEVTSKA OBLIKA IN VSEBINA vo
14 film-coated tablets no
14 filmsko obloženih tablet do
28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 70x1 film coated-tablets ct
28 filmsko obloženih tablet 30 filmsko obloženih tablet eā
84 film-coated tablets 90 film-coated tablets du
56 filmsko obloženih tablet 70 x 1 filmsko obložena tableta av
98 film-coated tablets
84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet nim
METHOD AND ROUTE(S) OF ADMINISTRATION ro
POSTOPEK IN POT( I) UPORABE ZDRAVILA ilo
Oral use. lp
Za peroralno uporabo. rav
Read the package leaflet before use ina
Zd
Keep out of the reach and sight of children. dic
Zdravilo shranjujte nedosegljivo otrokom!
OTHER SPECIAL WARNING(S), IF NECESSARY Me
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
EXP {MM/ YYYY}
{MM/ LLLL}
uth 11.
t me 11.
ra sanofi-aventis 174 avenue de France F-75013 Paris
pro sanofi- aventis 174 avenue de France
ge France
EU/ 1/ 06/ 344/ 001 vo
MARKETING AUTHORISATION NUMBER(S) lon EU/ 1/ 06/ 344/ 001 EU/ 1/ 06/ 344/ 002 EU/ 1/ 06/ 344/ 003 EU/ 1/ 06/ 344/ 004 no
EU/ 1/ 06/ 344/ 002 EU/ 1/ 06/ 344/ 003 do
EU/ 1/ 06/ 344/ 005 EU/ 1/ 06/ 344/ 006 EU/ 1/ 06/ 344/ 010 EU/ 1/ 06/ 344/ 011 ct du
EU/ 1/ 06/ 344/ 006 EU/ 1/ 06/ 344/ 010 av
Lot ro
Serija ilo rav
GENERAL CLASSIFICATION FOR SUPPLY lp
Zd
Medicinal product subject to medical prescription. ina
Izdaja zdravila je le na recept.
INSTRUCTIONS ON USE dic
NAVODILA ZA UPORABO
18 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
d Blisters of the presentations of 14, 28, 56, 84 and 98 film-coated tablets
Pretisni omoti s 14, 28, 56, 84 in 98 filmsko obloženimi tabletami
uth 2.
t 2.
sanofi-aventis
me sanofi- aventis
ge EXP {MM/ YYYY}
{MM/ LLLL} nja 4.
BATCH NUMBER lon Lot
Serija vo do
OTHER no
DRUGI PODATKI eā
Monday Tuesday Wednesday ct
Ponedeljek Torek av
Thursday Friday du
Sreda Četrtek Petek nim
Saturday Sunday ro lp ina dic Me
Sobota Nedelja ilo rav Zd
19 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
d Blisters of the presentations of 30, 70 x 1 and 90 film-coated tablets
Pretisni omoti s 30, 70 x 1 in 90 filmsko obloženo tableto
OTHER no ct du ro lp ina dic Me
DRUGI PODATKI eā av nim ilo rav Zd
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
21 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
d Carton of the presentations of 28, 98 and 500 film-coated tablets in HDPE bottles / HDPE bottle
Škatla z 28, 98 in 500 filmsko obloženimi tabletami v plastenkah iz HDPE / nalepka za plastenko iz HDPE oprem z 28, 98 in 500 filmsko obloženimi tabletami
ra Each tablet contains 20 mg of rimonabant.
me Ena tableta vsebuje 20 mg rimonabanta.
ge 3.
pro 3.
See leaflet for further information.
za Vsebuje tudi laktozo monohidrat. nja Za dodatne informacije glejte navodilo. lje
PHARMACEUTICAL FORM AND CONTENTS no
28 filmsko obloženih tablet do
28 film-coated tablets 98 film-coated tablets 500 film-coated tablets ct
98 filmsko obloženih tablet 500 filmsko obloženih tablet eā av
METHOD AND ROUTE(S) OF ADMINISTRATION du
POSTOPEK IN POT( I) UPORABE ZDRAVILA
Oral use.
Za peroralno uporabo. nim
Read the package leaflet before use. ro
Pred uporabo preberite priloženo navodilo. ilo
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT lp
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK rav
Keep out of the reach and sight of children. ina
Zd
OTHER SPECIAL WARNING(S), IF NECESSARY dic
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
EXP {MM/ YYYY} Me
{MM/ LLLL}
or 174 avenue de France F-75013 Paris France
t 174 avenue de France
uth 12.
pro 12.
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) DOVOLJENJA( DOVOLJENJ) ZA PROMET
ra EU/ 1/ 06/ 344/ 007 EU/ 1/ 06/ 344/ 008 EU/ 1/ 06/ 344/ 009
za EU/ 1/ 06/ 344/ 007 EU/ 1/ 06/ 344/ 008 EU/ 1/ 06/ 344/ 009
ge 13.
nja
Lot
lje
BATCH NUMBER
ŠTEVILKA SERIJE vo
lon
Serija do eā
GENERAL CLASSIFICATION FOR SUPPLY no
NAČIN IZDAJANJA ZDRAVILA 14. av
Medicinal product subject to medical prescription.
Izdaja zdravila je le na recept. nim
INSTRUCTIONS ON USE ct du
NAVODILA ZA UPORABO ilo
INFORMATION IN BRAILLE
PODATKI V BRAILLOVI PISAVI rav
ACOMPLIA ro lp ina dic Me
ACOMPLIA Zd
23 no B.
23 Zd rav ilo nim av eā
PACKAGE LEAFLET lon ge ra uth or ise d PACKAGE LEAFLET:
24 do vo lje nja
INFORMATION FOR THE USER
NAVODILO ZA UPORABO NAVODILO ZA UPORABO
ACOMPLIA 20 mg film-coated tablets
ACOMPLIA 20 mg filmsko obložene tablete (rimonabant)
ise Read all of this leaflet carefully before you start taking this medicine.
Pred začetkom jemanja natančno preberite navodilo!
It may harm them, even if
Njim bi lahko celo
or their symptoms are the same as yours.
škodovalo, čeprav imajo znake bolezni, podobne vašim.
- If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen
tell your doctor or pharmacist.
v tem navodilu, obvestite svojega zdravnika ali farmacevta.
In this leaflet:
t me Navodilo vsebuje:
What ACOMPLIA is and what it is used for 2.
Kaj je zdravilo ACOMPLIA in za kaj ga uporabljamo