natgillin/translations-raw huggingface dataset:
ise or Most of the observed weight reduction was obtained within the first nine months of treatment.
Zmanjšanje telesne mase po dveh letih je bilo pri bolnikih, ki so dobivali ZIMULTI 20 mg, 5, 1 kg in pri bolnikih, ki so eā
uth ZIMULTI 20 mg was effective in maintaining weight loss up to two years.
dobivali placebo, 1, 2 kg (razlika – 3, 8 kg, IZ95% – 4, 4, – 3, 3; p < 0, 001). av
ra Rimonabant 20 mg reduced the risk of weight regain.
Rimonabant v odmerku 20 mg je zmanjšal tveganje za ponovno povečanje telesne mase.
Patients who received ZIMULTI 20 mg for one ge year were re-randomized to ZIMULTI 20 mg or placebo.
V dveh nim
At two years, patients continuing on rimonabant had a mean total weight loss of 7.5 kg over 2 years whereas patients re-randomized to on
letih je bilo pri bolnikih, ki so dobivali rimonabant, povprečno skupno zmanjšanje telesne mase 7, 5 kg, pri bolnikih, ki so bili v drugem letu randomizirani v skupino s placebom, pa je bilo povprečno skupno zmanjšanje telesne mase v dveh letih 3, 1 kg. V dveh letih je bila razlika v skupnem zmanjšanju telesne ilo
placebo group during the second year had a mean total weight loss of 3.1 kg over 2 years.
mase med zdravilom ZIMULTI in placebom – 4, 2 kg (IZ95% – 5, 0, – 3, 4; p < 0, 001). v
Treatment with rimonabant was associated with significant reductions in waist circumference, a uc
Zdravljenje z rimonabantom je spremljalo pomembno zmanjšanje obsega pasu, ki je znan kazalec ra
known marker of intra-abdominal fat. d
Zd
of Black patients weight loss was less pronounced (mean difference to placebo -2.9 kg).
Pri omejenem številu bolnikov črncev je bilo zmanjšanje telesne mase manj izrazito (povprečna razlika v primerjavi s placebom – 2, 9 kg).
No conclusions can be drawn with regard to effects in patients over 75 years or in Asian/ Oriental patients lp
Zaradi majhnega števila bolnikov ni mogoče sklepati o učinkih pri bolnikih, starejših od 75 let, in pri bolnikih azijskega/ orientalskega porekla.
due to the low number of patients. ina
Razlika je bila statistično značilna (razlika 7, 9%, IZ95% 6, 6%, 9, 2%; p < 0, 001).
Weight management and additional risk factors In the non-diabetic studies including a mixed population of subjects with/ without (treated) dic
Trigliceridi so se ob 20 mg rimonabanta v povprečju znižali za 6, 9% (izhodiščni trigliceridi 1, 62 mmol/ l), ob placebu pa zvišali za 5, 8% (izhodiščni trigliceridi 1, 65 mmol/ l).
dyslipidemia, an increase in HDL-C and decrease in triglycerides (at one year) was observed.
Razlika je bila statistično značilna (razlika – 13, 3%, IZ95% – 16, 5%, – 10, 2%; p < 0, 001).
For HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 1.24 Me
Na splošno ZIMULTI 20 mg ni pomembno vplival na koncentracijo celotnega holesterola ali holesterola LDL.
mmol/ l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/ l).
t V preskušanju pri pretežkih ali debelih diabetikih tipa 2 (RIO – Diabetes), ki so dobivali metformin ali
The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p < 0.001).
me sulfonilsečnino, so ugotovili izboljšanje HbA1c in telesne mase.
For the triglycerides an average decrease of 6.9% was seen under rimonabant 20 mg (baseline TG 1.62 mmol/ l) compared to an increase of 5.8% for placebo (baseline TG 1.65 mmol/ l).
Po enem letu je bila absolutna sprememba HbA1c z 20 mg rimonabanta – 0, 6 (izhodiščno 7, 3%) in s placebom +0, 1 (izhodiščno
The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p < 0.001).
Razlike so bile statistično značilne (razlika – 0, 7%, IZ95% – 0, 80, – 0, 5; p < 0, 001).
Generally ZIMULTI 20 mg had no significant effect on Total-C or LDL-C levels.
Ob uporabi 20 mg zdravila ZIMULTI se je telesna masa po enem letu v povprečju zmanjšala za
In the trial in type 2 diabetic patients (RIO-Diabetes) who were overweight or obese treated with metformin or sulfonylurea improvements in HbA1c and body weight were observed.
Tabela 2
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%).
za prikazuje odstotek bolnikov, ki so po enem letu zdravljenja izgubili 5% oz.
Differences were statistically significant (Difference -0.7%, CI95% -0.80; -0.5, p < 0.001).
10% izhodiščne telesne mase. ja V drugo preskušanje (Serenade) so bili vključeni debeli bolniki z diabetesom tipa 2, ki pred tem še niso dobivali terapije (terapevtsko naivni bolniki).
8 At one year a mean weight loss of 5.3 kg was shown for ZIMULTI 20 mg versus a loss on placebo of 1.4 kg (Difference – 3.9 kg CI95% -4.6; -3.3 p < 0.001).
Izhodiščni HbA1c je bil v obeh skupinah (skupini z en rimonabantom in skupini s placebom) 7, 9%.
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.
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 – lj vo
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 -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).
Changes in HDL-C and TG in this population were similar to that of the non-diabetic population.
Ocenjujejo, da je približno polovica povprečnega izboljšanja HbA1c pri bolnikih, ki so eā
It is estimated that approximately half of the mean improvement in HbA1c in patients receiving rimonabant 20 mg was beyond that expected from weight loss alone.
dobivali 20 mg rimonabanta, presegala izboljšanje, ki bi ga pričakovali zgolj zaradi zmanjšanja telesne mase. av
5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti nim
AUC increased less than
Nad 20 mg je AUC naraščala manj kot sorazmerno odmerku. ilo
ise Absorption:
Absorpcija: v
or 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.
The absolute
Absolutna biološka ra
uth bioavailability of rimonabant has not been determined.
uporabnost rimonabanta ni ugotovljena.
Following multiple once-daily doses of 20 mg 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
Po večkratni uporabi 20 mg enkrat na dan na tešče pri zdravih preiskovancih doseže rimonabant največjo plazemsko koncentracijo v približno 2 urah, plazemsko Zd
ra ng/ ml; Ctrough = 91.6 ± 14.1 ng/ ml; AUC0-24 = 2960 ± 268 ng. h/ ml).
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 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.
Population pharmacokinetic analysis ge demonstrated less fluctuation in peak to trough plasma concentration but no differences in steady state AUC as weight increases.
Analiza populacijske farmakokinetike ob povečevanju telesne mase je pokazala manj nihanja v razmerju med najvišjo in najnižjo koncentracijo v plazmi, a nobenih razlik v AUC v stanju dinamičnega ravnovesja.
As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% on
Ko se telesna masa poveča s 65 na 200 kg, je pričakovano zmanjšanje Cmax 24% in pričakovano povečanje Cdno za 5%.
analysis indicated that rimonabant pharmacokinetics are similar between healthy non-smoking subjects and patients who smoke. tn uc
Analiza populacijske farmakokinetike je pokazala, da je farmakokinetika rimonabanta pri zdravih nekadilcih podobna kot pri bolnikih, ki kadijo.
Effect of food:
9 Vpliv hrane:
In ro
Uporaba rimonabanta pri zdravih preiskovancih na tešče ali z zelo mastnim obrokom je pokazala, da je bila Cmax na poln želodec večja za 67% in AUC za 48%.
clinical studies, ZIMULTI 20 mg was taken in the morning usually before breakfast. lp
V kliničnih študijah so preiskovanci ZIMULTI 20 mg jemali zjutraj, ponavadi pred zajtrkom.
The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a ina
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 dic
Zdi se, da je navidezni periferni volumen porazdelitve rimonabanta povezan s telesno maso; debeli bolniki imajo večji volumen porazdelitve kot preiskovanci z normalno telesno maso.
Elimination:
t me Eliminacija:
Rimonabant is mainly eliminated by metabolism and subsequent biliary excretion of metabolites.
Le približno
Only 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
In obese patients, the elimination half-life is longer (about 16 days) than in non-obese patients (about 9 days) due to a larger volume of distribution.
p večjega volumna porazdelitve daljši (okrog 16 dni) kot pri bolnikih, ki niso debeli (okrog 9 dni).
9 Special Populations Race:
za Posebne populacije ja Rasa:
In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese and Caucasian subjects, whereas elimination half-life was shorter in Japanese subjects (3-4 days) compared to Caucasian subjects (about 9 days).
V študijah s posamičnimi in ponavljajočimi se odmerki sta bili Cmax in AUC rimonabanta pri zdravih en japonskih preiskovancih in belcih podobni.
The difference in half-life was due to differences in peripheral volume of distribution as a consequence of lower weight in Japanese subjects.
Razlika v razpolovnem času je bila lj vo
Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.
Bolniki črnci imajo lahko do 31% manjšo Cmax in 43% manjšo AUC kot bolniki drugih ras.
Gender:
Spol: eā
The pharmacokinetics of rimonabant are similar in female and male patients.
Farmakokinetika rimonabanta je pri bolnicah in bolnikih podobna. av
Elderly patients have slightly higher exposure than young patients.
Glede na analizo nim
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.
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.
d ise Patients with hepatic insufficiency:
Bolniki z insuficienco jeter: ilo
Data are insufficient to draw conclusions
Podatkov ni dovolj za sklepanje o v
or regarding pharmacokinetics in moderate hepatic impairment.
farmakokinetiki pri zmerni okvari jeter.
Patients with severe hepatic impairment
Bolnikov s hudo okvaro jeter niso ocenili. ra
Patients with renal impairment:
Zd
ra The effect of renal function on the pharmacokinetics of rimonabant has not been studied specifically.
Učinek delovanja ledvic na farmakokinetiko rimonabanta ni posebej raziskan.
Based on data from population pharmacokinetic studies, mild renal impairment do not seem to affect ge the pharmacokinetics of rimonabant.
Glede na podatke študij populacijske farmakokinetike blaga okvara ledvic ne vplivata na farmakokinetiko rimonabanta.
There are no data in severe renal impairment. on
Podatkov za bolnike s hudo okvaro ledvic ni.
5.3 Preclinical safety data ol
10 5. 3 Predklinični podatki o varnosti
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to tn
V kliničnih študijah niso opazili škodljivih reakcij, v študijah na živalih pa so jih opazili pri stopnjah izpostavljenosti, podobnih stopnjam klinične izpostavljenosti.
clinical exposure levels and with possible relevance to clinical use were as follows: uc
Možen pomen za klinično uporabo je naslednji:
No convulsions were observed in dogs during a 3 month study.
Med 3- mesečno študijo na psih konvulzij niso zabeležili.
In some, but not all cases, initiation of convulsions appeared d
V nekaterih primerih – ne pa v vseh – je bila sprožitev konvulzij po vsem sodeč povezana s stresom zaradi postopka, npr. rokovanja z živalmi.
to be associated with procedural stress such as handling of the animals.
Prokonvulzivno delovanje rimonabanta so ugotovili v eni od dveh študij farmakološke varnosti.
A proconvulsant activity of ro
Pri podganah niso ugotovili neželenega vpliva rimonabanta na vzorec EEG.
rimonabant was found in one of two safety pharmacology studies.
V študijah na glodalcih so ugotovili večjo incidenco in/ ali izrazitost kliničnih znakov, ki nakazujejo povečano taktilno hiperestezijo.
No adverse effect of rimonabant treatment was observed on EEG patterns in rats. lp
Neposrednega učinka rimonabanta ni mogoče izključiti.
Increased incidence and/ or severity of clinical signs suggestive of increased tactile hyperesthesia were ina
t Med dolgotrajnimi študijami na podganah so opazili steatozo jeter in z odmerkom povezano povečanje
observed in rodent studies.
me centrilobularne nekroze.
A direct effect of rimonabant cannot be ruled out. dic
Neposrednega učinka rimonabanta ni mogoče izključiti.
Liver steatosis and a dose-related increase in centrilobular necrosis were observed in long-term studies in the rat.
ro V standardnih študijah plodnosti na podganjih samicah (uporaba zdravila 2 tedna pred parjenjem) so ugotovili nenormalno cikličnost estrusa ter zmanjšanje rumenih telesc in indeksa plodnosti ob
A direct effect of rimonabant cannot be ruled out.
p odmerkih rimonabanta, ki so povzročili toksične učinke pri samicah- materah (30 in 60 mg/ kg/ dan).
Me
Po
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.
za dolgotrajnejši uporabi pred parjenjem (9 tednov), ki je omogočila okrevanje po uvodnih vplivih rimonabanta, niso ugotovili neželenih učinkov na plodnost in cikličnost estrusa.
Regarding reproductive parameters, at 30 mg/ kg no 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 ja 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 en implantacij in plodov, sposobnih za življenje). lj
No treatment-related malformations were seen in the rat.
V študijah embrio- fetalnih toksičnih učinkov pri kuncih so opažali sporadične malformacije vo
10 Effects of rimonabant on pre- and post-natal development were assessed in the rat at doses up to 10 mg/ kg/ day.
(anencefalija, mikrooftalmija, razširitev možganskih prekatov in omfalokela) ob odmerkih, ki so do
There was a treatment related increase in pup mortality in the pre-weaning period.
povzročili izpostavljenosti, podobne kliničnim izpostavljenostim.
There are reports in the literature that, in both rodents and humans, the spatial distribution and density of CB1 receptors in the brain changes during development.
Čeprav so pri teh odmerkih opazili toksične učinke pri samicah- materah, ni mogoče izključiti povezave s terapijo.
The potential relevance of this to administration of a CB1 antagonist is unknown.
Pri podganah niso ugotovili z zdravljenjem povezanih malformacij. eā
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 activity and auditory startle response were observed in the pups as a result of rimonabant exposure.
Vplive rimonabanta na pre - in postnatalni razvoj so raziskali pri podganah v odmerkih do av
PHARMACEUTICAL PARTICULARS
10 mg/ kg/ dan.
d 6.1 List of excipients
Potencialni pomen tega za uporabo ilo
ise Tablet core:
antagonista CB1 ni znan.
or maize starch,
rimonabantu in utero prek dojenja ni povzročila sprememb pri učenju ali pomnjenju, so pa pri ra
uth lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate
Zd
ge
11 6.
ra
6. 1 Seznam pomožnih snovi
on
Jedro tablete: koruzni škrob, laktoza monohidrat, povidon K 30 (E1201), premreženi natrijev karmelozat (E468), natrijev lavrilsulfat (E487), mikrokristalna celuloza (E460), magnezijev stearat
Tablet coating: lactose monohydrate, ol
Obloga tablete:
hypromellose 15 mPa. s (E464), titanium dioxide (E171), tn
t me laktoza monohidrat, hipromeloza 15 mPa. s (E464), titanov dioksid (E171),
macrogol 3000 uc
ro makrogol 3000
Tablet polishing: d
p Glazura tablete:
carnauba wax (E903) ro
za karnauba vosek (E903)
6.2 Incompatibilities lp
ja 6. 2 Inkompatibilnosti en Navedba smiselno ni potrebna. lj vo
6.3 Shelf-life dic
6. 3 Rok uporabnosti do
3 years Me
3 leta
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje eā
6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina nim
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. ilo
Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj. v ra
174 Avenue de France F-75013 Paris France
sanofi- aventis 174 Avenue de France F- 75013 Paris Francija
d ise 19 June 2006
19 junij 2006
uth Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu.
t me Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
ra ge on ol tn d uc ro lp ina dic Me
ro p za ja en lj vo do eā av nim ilo v ra Zd
ANNEX II ge
13 t me ro p za ja en DODATEK II lj
MANUFACTURING AUTHORISATION HOLDERS on
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, vo
RESPONSIBLE FOR BATCH RELEASE ol
ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE do
CONDITIONS OF THE MARKETING AUTHORISATION tn duc ro lp ina dic Me
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM eā av nim ilo v ra Zd
Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France sanofi-aventis S. p. A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy
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), Italija
d THE MARKETING AUTHORISATION HOLDER
t me • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
ise Medicinal product subject to medical prescription.
ro p Izdaja zdravila je le na recept.
or uth • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
za • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ja ZDRAVILA en Navedba smiselno ni potrebna. lj vo
• OTHER CONDITIONS ol
• DRUGI POGOJI do
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the tn
Imetnik dovoljenja za promet mora zagotoviti vzpostavljen sistem vodenja farmakovigilance, ki mora delovati že pred prihodom zdravila na trg. eā
product is placed on the market. uc
Imetnik dovoljenja za promet se zaveže da bo izvedba študij in dodatne farmakovigilančne aktivnosti podrobno opisane v farmakovigilančnem planu. av
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan. d ro
Obnovljen načrt upravljanja tveganja mora biti izdelan kot so CHMP smernice za sistem upravljanja nim
An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use. lp ina dic Me
tveganja za zdravila za humano uporabo. ilo v ra Zd
14 d ise or uth
15 t me ro p za ja DODATEK III en OZNAČEVANJE IN NAVODILO ZA UPORABO lj vo do eā av nim ilo v ra Zd
ANNEX
16 Zd ra vilo nim av eā
III ge
17 do vo lj A.
d ise Each tablet contains 20 mg of rimonabant.
t me Ena tableta vsebuje 20 mg rimonabanta.
or 3.
ro p 3.
uth Also contains lactose monohydrate.
za Vsebuje tudi laktozo monohidrat.
See leaflet for further information. ra ge on
ja Za dodatne informacije glejte navodilo. en lj
PHARMACEUTICAL FORM AND CONTENTS ol
FARMACEVTSKA OBLIKA IN VSEBINA vo
14 film-coated tablets 28 film-coated tablets tn
14 filmsko obloženih tablet do
30 film-coated tablets 56 film-coated tablets uc
28 filmsko obloženih tablet 30 filmsko obloženih tablet eā
70x1 film coated-tablets 84 film-coated tablets d
56 filmsko obloženih tablet 70 x 1 filmsko obložena tableta av
90 film-coated tablets ro
84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet nim
METHOD AND ROUTE(S) OF ADMINISTRATION dic
POSTOPEK IN POT( I) UPORABE ZDRAVILA ilo
Oral use.
Za peroralno uporabo. v ra
Read the package leaflet before use Me
Zd
d ise 11.
t me 11.
sanofi-aventis
ro sanofi- aventis
or 174 avenue de France
p 174 avenue de France F- 75013 Paris
uth F-75013 Paris France
za Francija
ra ge 12.
ja en 12.
MARKETING AUTHORISATION NUMBER(S) on
ŠTEVILKA( E) DOVOLJENJA( DOVOLJENJ) ZA PROMET lj
EU/ 1/ 06/ 345/ 001 EU/ 1/ 06/ 345/ 002 ol
EU/ 1/ 06/ 345/ 002 EU/ 1/ 06/ 345/ 003 do
EU/ 1/ 06/ 345/ 003 EU/ 1/ 06/ 345/ 004 tn
EU/ 1/ 06/ 345/ 004 EU/ 1/ 06/ 345/ 005 eā
EU/ 1/ 06/ 345/ 005 EU/ 1/ 06/ 345/ 006 uc
EU/ 1/ 06/ 345/ 006 EU/ 1/ 06/ 345/ 010 av
EU/ 1/ 06/ 345/ 010 EU/ 1/ 06/ 345/ 011 d ro lp
EU/ 1/ 06/ 345/ 011 nim
BATCH NUMBER ina
ŠTEVILKA SERIJE
Lot dic
Serija ilo v ra
GENERAL CLASSIFICATION FOR SUPPLY Me
Zd
d sanofi-aventis
t me sanofi- aventis
ise 3.
ro p 3.
or uth EXP {MM/ YYYY}
{MM/ LLLL}
4.
ja en 4.
BATCH NUMBER ra ge Lot on ol
Serija vo do
OTHER tn
DRUGI PODATKI eā
Monday Tuesday uc
Ponedeljek Torek av
Wednesday Thursday d
Sreda Četrtek Petek nim
Saturday lp
Sobota Nedelja ilo v ra Zd
OTHER tn d uc ro lp ina dic Me
DRUGI PODATKI eā av nim ilo v ra Zd
ise Each tablet contains 20 mg of rimonabant.
t me Ena tableta vsebuje 20 mg rimonabanta.
or uth 3.
ro p 3.
ra Also contains lactose monohydrate.
za Vsebuje tudi laktozo monohidrat.
See leaflet for further information. ge on
ja Za dodatne informacije glejte navodilo. en lj
28 film-coated tablets tn
28 filmsko obloženih tablet do
98 film-coated tablets 500 film-coated tablets duc
98 filmsko obloženih tablet 500 filmsko obloženih tablet eā av
METHOD AND ROUTE(S) OF ADMINISTRATION ro lp
POSTOPEK IN POT( I) UPORABE ZDRAVILA
Read the package leaflet before use. ina dic
Pred uporabo preberite priloženo navodilo. ilo
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Me
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK v ra
Keep out of the reach and sight of children.
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sanofi-aventis 174 avenue de France F-75013 Paris France
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ŠTEVILKA SERIJE vo
BATCH NUMBER ra ge Lot on ol
Serija do eā
GENERAL CLASSIFICATION FOR SUPPLY tn
NAČIN IZDAJANJA ZDRAVILA 14. av
Medicinal product subject to medical prescription. uc
Izdaja zdravila je le na recept. nim
INSTRUCTIONS ON USE d ro lp
NAVODILA ZA UPORABO ilo
INFORMATION IN BRAILLE ina
PODATKI V BRAILLOVI PISAVI v ra
ZIMULTI dic Me
ZIMULTI Zd
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23 Zd ra vilo nim av eā
PACKAGE LEAFLET ra uth or ise d PACKAGE LEAFLET:
24 do vo ljen ja B.
INFORMATION FOR THE USER
NAVODILO ZA UPORABO za pro me t NAVODILO ZA UPORABO
What ZIMULTI is and what it is used for 2.
Kaj je zdravilo ZIMULTI in za kaj ga uporabljamo 2.
or 3.
ro 3.
uth 4.
p 4.
Possible side effects 5 How to store ZIMULTI 6.
Možni neželeni učinki 5 Shranjevanje zdravila ZIMULTI
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