natgillin/translations-raw huggingface dataset:
Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5).
Rimonabant morate uporabljati previdno v kombinaciji z močnimi zaviralci CYP3A4 (npr. ketokonazolom, itrakonazolom, ritonavirjem, telitromicinom, klaritromicinom, nefazodonom) (glejte poglavje 4.5).
Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in vitro.
Rimonabant se in vitro presnavlja s CYP3A in amidohidrolazo (pretežno jetrno).
Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic impairment.
Rimonabant se presnavlja v jetrih, zato je pri bolnikih z zmerno okvaro jeter potrebna previdnost.
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.
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.
It is estimated that approximately half of the observed improvement in HDL-C and triglycerides in patients who received rimonabant 20 mg was beyond that expected from weight loss alone.
Ocenjujejo, da je približno polovica ugotovljenega izboljšanja holesterola HDL in trigliceridov pri bolnikih, ki so dobivali 20 mg rimonabanta, presegala izboljšanje, ki bi ga pričakovali zgolj zaradi zmanjšanja telesne mase.
THE MARKETING AUTHORISATION HOLDER Medicinal product subject to medical prescription.
DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le na recept.
One film-coated tablet contains 20 mg rimonabant.
Ena filmsko obložena tableta vsebuje 20 mg rimonabanta.
Serious psychiatric events including depression or mood changes have been reported in patients taking ACOMPLIA (see section POSSIBLE SIDE EFFECTS).
Pri bolnikih, ki so jemali zdravilo ACOMPLIA, so poročali o pojavu resnih duševnih motenj, vključno z depresijo ali motnjami razpoloženja (glejte poglavje MOŽNI NEŽELENI UČINKI).
In patients with current suicidal ideations and/or with a history of suicidal ideation and depressive disorder rimonabant should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient.
Pri bolnikih, ki imajo samomorilne misli in/ali bolnikih, ki so kdaj imeli samomorilne misli ali depresivno motnjo, se rimonabanta ne sme uporabljati, če koristi zdravljenja pri posameznem bolniku ne prevladajo nad temi tveganji (glejte poglavji 4.3 in 4.8).
What ACOMPLIA contains
Kaj vsebuje zdravilo ACOMPLIA
Joint sprain *frequency is based only on reports in obese or overweight diabetic patients.
* pogostnost temelji na poročilih pri debelih ali čezmerno težkih bolnikih s sladkorno boleznijo.
− gastrointestinal disorders: stomach discomfort, dry mouth.
− bolezni prebavil: nelagodje v želodcu, suha usta.
− if you have impaired liver function
− če imate okvarjeno delovanje jeter,
However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8.
Vendar rimonabant in vitro rahlo zavira CYP2C8.
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
In the non-diabetic studies including a mixed population of subjects with/without (treated) dyslipidemia, an increase in HDL-C and decrease in triglycerides (at one year) was observed.
Obvladovanje telesne mase in dodatni dejavniki tveganja V študijah nediabetičnih bolnikov, vključno z mešano populacijo preiskovancev z (zdravljeno) dislipidemijo ali brez nje, so (po enem letu) ugotovili zvišanje holesterola HDL in znižanje trigliceridov.
• Other psychiatric conditions
• Druge duševne motnje
Sporadic malformations (anencephaly, micro-ophthalmia, widened brain ventricles and omphalocele) 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 povzročili izpostavljenosti, podobne kliničnim izpostavljenostim.
ACOMPLIA 20 mg film-coated tablets (rimonabant)
ACOMPLIA 20 mg filmsko obložene tablete (rimonabant)
This medicinal product does not require any special storage conditions Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
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.
Each tablet contains 20 mg rimonabant.
Ena tableta vsebuje 20 mg rimonabanta.
In a single-dose tolerability study, doses up to 300 mg were administered to a limited number of subjects with only minor symptoms reported.
V študijah prenašanja posamičnega odmerka so omejenemu številu preiskovancev dali odmerke do 300 mg.
PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet 98 filmsko obloženih tablet 500 filmsko obloženih tablet
• Diabetic patients
• Bolniki s sladkorno boleznijo
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.
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%).
Po enem letu je bila absolutna sprememba HbA1c z 20 mg rimonabanta -0,6 (izhodiščno 7,3 %) in s placebom +0,1 (izhodiščno 7,2 %).
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.
The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p< 0.001).
Razlika je bila statistično značilna (razlika 7,9 %, IZ95 % 6,6 %, 9,2 %; p<0,001).
Tell your doctor if you are breast-feeding or if you are planning to breast-feed your baby.
Zdravniku morate povedati, če otroka dojite ali ga nameravate dojiti.
Differences were statistically significant (Difference -0.7%, CI95% -0.80;-0.5, p<0.001).
Razlike so bile statistično značilne (razlika -0,7 %, IZ95 % -0,80, -0,5; p<0,001).
Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate
Jedro tablete: koruzni škrob, laktoza monohidrat, povidon K 30 (E1201), premreženi natrijev karmelozat (E468), natrijev lavrilsulfat (E487), mikrokristalna celuloza (E460), magnezijev stearat
If you forget to take ACOMPLIA Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.
Ne vzenite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Nausea
Dojenje.
The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p< 0.001).
Razlika je bila statistično značilna (razlika13,3 %, IZ95 % -16,5 %, -10,2 %; p<0,001).
ACOMPLIA should not be used in patients with severe renal impairment (see section 4.4 and
Zdravila ACOMPLIA ne smete uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavji 4.4 in
Sadness, depressed mood; loss of interest in previously pleasurable activities; agitation; irritability; slowed, inhibited actions; poor concentration; anxiety; difficulty in sleeping (insomnia); thoughts or words about death or suicide.
Znaki in simptomi povezani z depresijo so lahko: žalost, depresivno razpoloženje, izguba interesa za aktivnosti, pri katerih ste nekoč uživali, vznemirjenost, razdražljivost, upočasnjena, zavrta aktivnost, slaba koncentracija, tesnoba, težave pri spanju (nespečnost), misli ali pogovor o smrti ali samomoru.
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).
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).
Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
Jedro tablete: koruzni škrob, laktoza monohidrat, povidon K 30 (E1201), premreženi natrijev karmelozat (E468), natrijev lavrilsulfat (E487), mikrokristalna celuloza (E460), magnezijev stearat Obloga tablete: laktoza monohidrat, hipromeloza 15 mPa.s (E464), titanov dioksid (E171), makrogol
ACOMPLIA should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2).
Zdravila ACOMPLIA ne smete uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavji 4.4 in 5.2).
The active ingredient of ACOMPLIA is rimonabant.
Zdravilna učinkovina v zdravilu ACOMPLIA je rimonabant.
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.
Tabela 2 prikazuje odstotek bolnikov, ki so po enem letu zdravljenja izgubili 5 % oz. 10 % izhodiščne telesne mase.
No treatment-related malformations were seen in the rat.
Pri podganah niso ugotovili z zdravljenjem povezanih malformacij.
− ketoconazole (antifungal medicine)
− ketokonazol (zdravilo proti glivicam),
− itraconazole (antifungal medicine)
− itrakonazol (zdravilo proti glivicam),
Carton of the presentations of 28, 98 and 500 film-coated tablets in HDPE bottles / HDPE bottle label for the presentations of 28, 98 and 500 film-coated tablets
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI 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
Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg.
Pri 3,2% debelih bolnikov oziroma čezmerno težkih bolnikih, pri katerih so bili prisotni tudi dejavniki tveganja in ki so dobivali rimonabant 20 mg, so poročali o depresivnih motnjah.
You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Če se kateri od zgoraj navedenih simptomov pojavi ali poslabša po začetku zdravljenja, morate o tem obvestiti zdravnika.
Rimonabant pharmacokinetics are fairly dose proportional up to about 20 mg. AUC increased less than in proportion to dose above 20 mg.
Nad 20 mg je AUC naraščala manj kot sorazmerno odmerku.
in people under 18 years of age.
Podatkov o uporabi zdravila ACOMPLIA pri osebah, mlajših od 18 let,
No dosage adjustment is required in elderly (see section 5.2).
Pri starejših bolnikih odmerjanja ni treba prilagoditi (glejte poglavje 5.2).
Marketing Authorisation Holder sanofi-aventis
Imetnik dovoljenja za promet sanofi-aventis
Tendonitis Muscle cramp Muscle spasms
Bolezni mišičnoskeletnega sistema in vezivnega tkiva tendinitis mišični krč mišični spazmi
NAME OF THE MEDICINAL PRODUCT ACOMPLIA 20 mg film-coated tablets rimonabant
IME ZDRAVILA ACOMPLIA 20 mg filmsko obložene tablete
Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone).
Med sočasno uporabo zdravila ACOMPLIA in močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, ritonavirja, telitromicina, klaritromicina, nefazodona) je potrebna previdnost.
NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM sanofi-aventis
sanofi-aventis 174 avenue de France F-75013 Paris France
sanofi-aventis 174 avenue de France F-75013 Paris Francija
No dosage adjustment is required for patients with mild and moderate renal impairment (see section 5.2).
Pri bolnikih z blago ali zmerno okvaro ledvic odmerka ni potrebno prilagoditi (glejte poglavje 5.2).
For HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 1.24 mmol/l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/l).
Ob 20 mg rimonabanta se je holesterol HDL v povprečju zvišal za 16,4 % (izhodiščni holesterol HDL 1,24 mmol/l), ob placebu pa za 8,9 % (izhodiščni holesterol HDL 1,21 mmol/l).
In clinical trials no difference in the incidence of seizures was seen in patients receiving rimonabant or placebo.
V kliničnih preskušanjih se pojavnost epileptičnih napadov pri bolnikih, ki so prejemali rimonabant ni razlikovala od pojavnosti pri bolnikih, ki so prejemali placebo, vendar pa je treba rimonabant pri teh bolnikih uporabljati previdno.
No dosage adjustment is required for patients with mild or moderate hepatic impairment.
Pri bolnikih z blago ali zmerno okvaro jeter odmerka ni potrebno prilagoditi.
− Skin and subcutaneous tissue disorders: rash.
− bolezni kože in podkožja: izpuščaj.
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).
Razlika v povprečni spremembi telesne mase med prejemniki 20 mg rimonabanta in prejemniki placeba je bila 3,8 kg (IZ95 % -5,0, -2,6, p < 0,001).
Weight Management
Obvladovanje telesne mase
Rimonabant has not been studied in patients being treated for epilepsy.
Pri bolnikih, ki so se zdravili zaradi epilepsije, uporabe rimonabanta niso proučevali.
ACOMPLIA 20 mg
ACOMPLIA 20 mg placebo
Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach pain.
Med postmarketiško izkušnjo so poročali o naslednjih neželenih učinkih (pogostnost neznana): krči, motnje pozornosti, privid (napačno prepričanje), paranoja, izpuščaj, glavobol in bolečina v trebuhu.
The prescriber should carefully investigate if the patient has had a depressive disorder in the past in order to evaluate the potential risks with rimonabant treatment.
Pri vrednotenju možnih tveganj zdravljenja z rimonabantom mora zdravnik skrbno preveriti, če je bolnik kdaj imel depresivno motnjo.
Therapy with rimonabant is not recommended in patients with uncontrolled psychiatric illness.
Pri bolnikih z nenadzorovanimi resnimi duševnimi motnjami zdravljenja z rimonabantom ne priporočamo.
Memory loss Dizziness Hypoaesthesia Sciatica Paresthesia
Bolezni živčevja poslabšanje spomina omotica hipestezija išias parestezija letargija tremor
Rimonabant is mainly eliminated by metabolism and subsequent biliary excretion of metabolites.
Rimonabant se v glavnem izloča s presnovo in nadaljnjo izločitvijo presnovkov v žolču.
HOW TO STORE ACOMPLIA
SHRANJEVANJE ZDRAVILA ACOMPLIA
No adverse effect of rimonabant treatment was observed on EEG patterns in rats.
Pri podganah niso ugotovili neželenega vpliva rimonabanta na vzorec EEG.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Injury, Poisoning and procedural complications
Poškodbe in zastrupitve padec kontuzija zvin sklepa
Weight loss at two years was 5.1 kg for patients who received ACOMPLIA 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p< 0.001).
Zmanjšanje telesne mase po dveh letih je bilo pri bolnikih, ki so dobivali zdravilo ACOMPLIA 20 mg, 5,1 kg in pri bolnikih, ki so dobivali placebo, 1,2 kg (razlika -3,8 kg, IZ95 % -4,4, -3,3; p<0,001).
Diarrhoea Vomiting
Žilne bolezni valovi vročine
The steady-state pharmacokinetics of an ethinyl estradiol/levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant.
Sočasna uporaba rimonabanta ni pomembno spremenila farmakokinetike kombiniranega peroralnega kontraceptiva z etinilestradiolom/levonorgestrelom v stanju dinamičnega ravnovesja.
The active substance is rimonabant.
Zdravilna učinkovina je rimonabant.
MARKETING AUTHORIZATION NUMBER
IMETNIK DOVOLJENJA ZA PROMET
There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment.
O bolnikih z zmerno okvaro ledvic so na voljo le omejeni podatki.
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
PODATKI NA ZUNANJI OVOJNINI Škatla s 14, 28, 30, 56, 70, 84, 90 in 98 filmsko obloženimi tabletami v pretisnih omotih
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja srbenje hiperhidroza nočno znojenje
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).
Eliminacijski razpolovni čas pa je bil pri japonskih preiskovancih krajši (od 3 do 4 dni) kot pri belcih (okrog 9 dni).
ACOMPLIA 20 mg film-coated tablets
ACOMPLIA 20 mg filmsko obložene tablete rimonabant
Liver steatosis and a dose-related increase in centrilobular necrosis were observed in long-term studies in the rat.
Med dolgotrajnimi študijami na podganah so opazili steatozo jeter in z odmerkom povezano povečanje centrilobularne nekroze.
Upper respiratory tract infection
Infekcijske in parazitske bolezni okužba zgornjih dihal gastroenteritis
Always take ACOMPLIA exactly as your doctor has told you.
Natančno upoštevajte zdravnikova navodila.
In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast.
Priporočeni odmerek za odrasle je ena 20 mg tableta na dan.
Tell your doctor before you start to take this medicine
Bodite posebno pozorni pri jemanju zdravila ACOMPLIA Preden začnete jemati zdravilo, morate zdravniku povedati:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 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
ACOMPLIA should be used with caution in patients with moderate hepatic impairment.
Pri bolnikih z zmerno okvaro jeter je zdravilo ACOMPLIA potrebno uporabljati previdno.
Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low blood sugar).
Občasni neželeni učinki, ki se pojavijo pri manj kot 1 od 100, a več kot 1 na 1000 oseb, in so bili zabeleženi pri bolnikih, ki so uporabljali zdravilo ACOMPLIA, vključujejo: zaspanost (letargija), drhtenje (tremor), nočno znojenje, simptome panike, kolcanje, jezo, nemir (disforijo), čustveno motnjo, samomorilne misli, agresivnost ali agresivno vedenje, hipoglikemija (nizek krvni sladkor).
There are no data in severe renal impairment.
Podatkov za bolnike s hudo okvaro ledvic ni.
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 placebo group during the second year had a mean total weight loss of 3.1 kg over 2 years.
V dveh 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 mase med zdravilom ACOMPLIA in placebom -4,2 kg (IZ95 % -5,0, -3,4; p<0,001).
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).
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).
Magyarország sanofi-aventis zrt., Magyarország Tel.: +36 1 505 0050
Magyarország Tel.: +36 1 505 0050
• Seizures
• Starostniki
Like all medicines, ACOMPLIA can cause side effects, although not everybody gets them Very common side effects, that affect more than 1 per 10, that have occurred in patients on ACOMPLIA include: nausea and upper respiratory tract infection.
Zelo pogosti neželeni učinki, ki se pojavijo pri več kot 1 od 10 oseb in so bili zabeleženi pri bolnikih, ki so uporabljali zdravilo ACOMPLIA, vključujejo: slabost v želodcu in okužbo zgornjih dihal.
BEFORE YOU TAKE ACOMPLIA
Če ste pozabili vzeti zdravilo ACOMPLIA
Significant mean weight reductions from baseline to one year for ACOMPLIA 20 mg versus placebo were demonstrated in three studies conducted in non-diabetic patients.
V treh študijah pri nediabetičnih bolnikih so po enem letu zdravljenja z zdravilom ACOMPLIA 20 mg v primerjavi s placebom dokazali značilno zmanjšanje povprečne telesne mase od izhodišča.
Metabolism and nutrition disorders
Presnovne in prehranske motnje hipoglikemija*
Contusion
ZDRAVILA
A mean weight loss of 6.5 kg from baseline to one year was shown for ACOMPLIA 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI95% -5.3;-4.4, p< 0.001).
Povprečno zmanjšanje telesne mase po enem letu v primerjavi z izhodiščem je bilo z zdravilom ACOMPLIA 20 mg 6,5 kg in s placebom 1,6 kg (razlika -4,9 kg, IZ95 % -5,3, -4,4; p<0,001).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of rimonabant.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 20 mg rimonabanta.
− gastrointestinal disorders: abdominal pain.
− bolezni prebavil: bolečina v trebuhu.
Table 1: System Organ Class
Tabela 1: organski sistem zelo pogosti pogosti občasni redki
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).
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 (razlika0,51, IZ95 % -0,78, -0,24, p < 0,001).
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 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
Rimonabant should not be used in patients with severe renal impairment (see section 4.2 and 5.2).
Podatkov o bolnikih s hudo okvaro ledvic ni. Rimonabanta ne smete uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavji 4.2 in
Lethargy Tremor
• Okvara jeter
− if you are breast-feeding
− če dojite
Gastrointestinal disorders
študije pri nediabetikih študija pri diabetikih placebo
CMDh agreement
Dogovor skupine CMDh
The timetable for the implementation of the agreement is set out in Annex VI.
Časovni razpored za izvajanje dogovora je opredeljen v Prilogi VI.
Numeta has been registered through the decentralised procedure (DCP) in Europe in 18 countries.
Zdravilo Numeta je z decentraliziranim postopkom (DCP) registrirano v 18 evropskih državah.
1 Canadian Laboratory Initiative on PEdiatric Reference Intervals, http://www.caliperdatabase.com/caliperdatabase/controller?op=menu_reference_intervals&sm=0, accessed 29/08/2013
1 Canadian Laboratory Initiative on PEdiatric Reference Intervals, http://www.caliperdatabase.com/caliperdatabase/controller?op=menu_reference_intervals&sm=0, dostop 29/08/2013.
• The PRAC also concluded that there was need for further risk minimisation measures such as information to healthcare professionals.
• odbor PRAC je prav tako zaključil, da so potrebni dodatni ukrepi za zmanjšanje tveganja, na primer informacije za zdravstvene delavce.
b. the marketing authorisation holders should implement risk minimisation measures;
b. imetniki dovoljenj za promet z zdravili izvajajo ukrepe za zmanjšanje tveganja;
Overall conclusion and conditions to the Marketing Authorisations
Splošni zaključki in pogoji dovoljenj za promet z zdravili
In terms of efficacy measurements, the different Numeta formulations were able to maintain or increase body weight.
V povezavi z merili za učinkovitost so različne formulacije zdravila Numeta vzdrževale ali povečale telesno maso.