natgillin/translations-raw huggingface dataset:
The medicine has a number of effects on the heart muscle, including reducing the flow of potassium ions (charged particles) out of the heart cells.
Zdravilo ima številne učinke na srčno mišico, med drugim zmanjšuje tok kalijevih ionov (nabitih delcev) iz srčnih celic.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Na podlagi pregleda začetne dokumentacije CHMP do 120. dne pripravi seznam vprašanj, ki ga pošlje podjetju.
What are the consequences of the withdrawal for patients undergoing clinical trials with MULTAQ?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila MULTAQ?
The studies examined how long it took for atrial fibrillation or flutter to return.
V raziskavah so preverjali, kako dolgo traja, da se atrijska fibrilacija oz. plapolanje znova pojavita.
Both illnesses cause a rapid heart rate, but atrial fibrillation also makes the heart rhythm irregular.
Pri obeh boleznih pride do hitrega bitja srca, vendar se pri atrijski fibrilaciji pojavi tudi nepravilen ritem srca.
Atrial fibrillation and atrial flutter are caused by problems in the conduction of electrical impulses in the upper chambers of the heart (atria).
Do atrijske fibrilacije in atrijskega plapolanja pride zaradi težav pri prevajanju električnih impulzov v preddvorih srca (atrijih).
MULTAQ was expected to help patients maintain normal heart rhythm and to reduce the heart rate.
Zdravilo MULTAQ naj bi pomagalo bolnikom ohranjati normalen srčni ritem in zniževati srčno frekvenco.
What is MULTAQ?
Kaj je zdravilo MULTAQ?
MULTAQ was to be used to treat patients with atrial fibrillation or atrial flutter.
Zdravilo MULTAQ bi se uporabljalo za zdravljenje bolnikov z atrijsko fibrilacijo ali atrijskim plapolanjem.
Based on the review of the data and the company's response to the CHMP's list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that MULTAQ could not be approved for the treatment of atrial fibrillation or atrial flutter.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj s strani CHMP, je imel odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo MULTAQ ni mogoče odobriti dovoljenja za zdravljenje bolnikov z atrijsko fibrilacijo ali atrijskim plapolanjem.
The company also presented the results of a third study that compared the effects of MULTAQ and placebo on the heart rate in 174 patients who had had atrial fibrillation continuously for over six months.
Podjetje je predložilo rezultate tretje raziskave, kjer so primerjali učinke zdravila MULTAQ in placeba na srčno frekvenco pri 174 bolnikih, ki so imeli atrijsko fibrilacijo neprekinjeno v zadnjih šestih mesecih.
The Company has informed the CHMP that there are no consequences for patients currently included in clinical trials with MULTAQ.
Podjetje je obvestilo CHMP, za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila MULTAQ, ni nobenih posledic.
What was MULTAQ expected to be used for?
Za kaj naj bi se zdravilo MULTAQ uporabljalo?
The company presented the results of two clinical trials comparing the effects of MULTAQ and placebo (a dummy treatment) on the maintenance of normal heart rhythm.
Podjetje je predložilo rezultate dveh kliničnih preskušanj, kjer so primerjali učinke zdravila MULTAQ in placeba (zdravila brez zdravilne učinkovine) na ohranjanje normalnega srčnega ritma.
The patients' heart rates were measured when they were resting.
Srčne frekvence so merili, ko so bolniki počivali.
The CHMP was also concerned that the levels of MULTAQ could be altered in patients taking some other medicines, including medicines used to treat the heart.
CHMP je izrazil zaskrbljenost glede spreminjanja ravni zdravila MULTAQ pri bolnikih, ki jemljejo druga zdravila, med drugim zdravila za zdravljenje bolezni srca.
The CHMP also had concerns over a higher rate of side effects in patients taking MULTAQ than those taking placebo.
CHMP je imel zadržke tudi glede višje pojavnosti neželenih učinkov pri bolnikih, ki so jemali zdravilo MULTAQ v primerjavi z bolniki, ki so jemali placebo.
The CHMP was concerned that the studies presented by the company had not sufficiently shown that MULTAQ's effects on heart rate and rhythm would be beneficial to patients, since they had not compared MULTAQ to an existing medicine licensed for the same conditions.
CHMP je imel zadržke, da predstavljene raziskave niso zadostno prikazale koristi učinkov zdravila MULTAQ na srčno frekvenco in ritem, saj v teh raziskavah niso primerjali zdravila MULTAQ z obstoječim zdravilom, ki je odobren za isti bolezni.
According to their guidelines for medicines used to correct heart rhythm, the CHMP would need to assess the results of a trial comparing MULTAQ to an existing medicine before it can be granted a licence.
Po smernicah CHMP je treba za zdravila, s katerimi se popravlja srčni ritem, pred odobritvijo dovoljenja ovrednotiti rezultate preskušanja, v katerem bodo primerjali zdravilo MULTAQ z obstoječim zdravilom.
The active substance in MULTAQ, dronedarone, is an anti-arrhythmic agent.
Zdravilna učinkovina zdravila MULTAQ je dronedaron, ki je sredstvo proti aritmiji.
How is MULTAQ expected to work?
Kako naj bi zdravilo MULTAQ delovalo?
It is expected to correct altered heartbeat by affecting the electrical activity of the heart muscle.
Zdravilo MULTAQ naj bi vplivalo na električno aktivnost srčne mišice in s tem popravilo spremenjen srčni ritem.
Patients should be instructed not to increase their dose of ZIMULTI.
Bolnikom morate naročiti, naj ne povečujejo odmerka zdravila ZIMULTI.
ZIMULTI should not be taken during pregnancy.
Zdravila ZIMULTI ne smete jemati med nosečnostjo.
In clinical studies, ZIMULTI 20 mg was taken in the morning usually before breakfast.
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 wide concentration range.
Vezava rimonabanta na človeške plazemske beljakovine je in vitro velika (> 99,9 %) in v širokem razponu koncentracij ne kaže saturacije.
INFORMATION IN BRAILLE ZIMULTI
PODATKI V BRAILLOVI PISAVI ZIMULTI
WHAT ZIMULTI IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ZIMULTI IN ZA KAJ GA UPORABLJAMO
ZIMULTI 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3800 patients in other indications.
Varnost zdravila ZIMULTI 20 mg so raziskali pri približno 2500 bolnikih, vključenih v študije, ki so proučevale presnovne učinke in učinke na zmanjšanje telesne mase pri čezmerno težkih in debelih bolnikih, ter pri približno 3800 bolnikih z drugimi indikacijami.
Patients who received ZIMULTI 20 mg for one year were re-randomized to ZIMULTI 20 mg or placebo.
Bolnike, ki so eno leto dobivali ZIMULTI 20 mg, so ponovno randomizirali na ZIMULTI 20 mg ali placebo.
− if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ZIMULTI
− če ste preobčutljivi za (alergični na) rimonabant ali katerokoli sestavino zdravila ZIMULTI
Very common (≥10%); Common (≥ 1, <10%); Uncommon (≥ 0.1, <1%); Rare (≥ 0.01, <0.1%); Very rare (<0.01%), Not known (cannot be estimated from the available data).
Razvrstitev pričakovanih pogostnosti neželenih učinkov: 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), neznani (ni mogoče oceniti iz razpoložljivih podatkov).
The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events ≥1%) or considered clinically relevant (for events <1%).
Naslednja tabela (tabela 1) prikazuje vse neželene učinke, ki so se pojavili med zdravljenjem v s placebom kontroliranih študijah, pri bolnikih zdravljenih za zmanjšanje telesne mase in zaradi sorodnih presnovnih motenj, če je bila njihova incidenca statistično značilno večja kot pri placebu (za dogodke ≥1%) ali so bile ocenjene kot klinično pomembne (za dogodke <1%).
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 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 implantacij in plodov, sposobnih za življenje).
There is no information available on the use of ZIMULTI in people under 18 years of age.
Podatkov o uporabi zdravila ZIMULTI pri osebah, mlajših od 18 let, ni.
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.
Patients had a BMI ≥30 kg/m² or BMI>27 kg/m² with hypertension and/or dyslipidemia at inclusion.
Bolniki so imeli ITM 30 kg/m2 ali ITM > 27 kg/m2 ter hipertenzijo in/ali dislipidemijo ob vključitvi.
Taking ZIMULTI with food and drink ZIMULTI should be taken once daily in the morning before breakfast.
Jemanje zdravila ZIMULTI skupaj s hrano in pijačo Zdravilo ZIMULTI morate vzeti enkrat na dan, zjutraj pred zajtrkom.
Since ZIMULTI tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Tablete ZIMULTI vsebujejo laktozo, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze, ne smejo jemati tega zdravila.
The activity of ZIMULTI is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:
Delovanje zdravila ZIMULTI se poveča, če hkrati uporabljate določena zdravila (t. i. zaviralce CYP3A4), npr.:
ZIMULTI 20 mg nITT
ZIMULTI 20 mg nZNZ
ZIMULTI 20 mg was effective in maintaining weight loss up to two years.
ZIMULTI 20 mg je učinkovito vzdrževala zmanjšano telesno maso do dve leti.
Do not use ZIMULTI after the expiry date which is stated on the outer packaging after EXP.
Zdravila ZIMULTI ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake "Upor.
If you take more ZIMULTI than you should If you take more ZIMULTI than you should tell a doctor or pharmacist.
Če ste vzeli večji odmerek zdravila ZIMULTI, kot bi smeli Če ste vzeli večji odmerek zdravila ZIMULTI, kot bi smeli, morate to povedati zdravniku ali farmacevtu.
Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ZIMULTI include: hallucinations.
Redki neželeni učinki, ki se pojavijo pri manj kot 1 od 1000 oseb in so bili zabeleženi pri bolnikih, ki so uporabljali zdravilo ZIMULTI, vključujejo: halucinacije.
Non-diabetic studies
študije pri nediabetikih študija pri diabetikih placebo
Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in patients on ZIMULTI include: upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness, diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint sprain.
Pogosti neželeni učinki, ki se pojavijo pri več kot 1 od 100, a manj kot 1 od 10 oseb, in so bili zabeleženi pri bolnikih, ki so jemali zdravilo ZIMULTI, vključujejo: razdražen želodec, bruhanje, težave s spanjem, živčnost, depresijo, razdražljivost, omotico, drisko, tesnobnost, srbenje, čezmerno znojenje, mišične krče ali spazme, utrujenost, podplutbe, bolečine in vnetje tetiv (tendinitis), poslabšanje spomina, bolečino v hrbtu (išias), spremenjeno zaznavanje (manjša občutljivost ali nenormalen pekoč občutek ali mravljinčenje) v dlaneh in stopalih, valove vročine, padec, gripo in izvin sklepov.
Driving and using machines At the recommended dose, ZIMULTI is not expected to reduce your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev V priporočenem odmerku ni pričakovati, da bi ZIMULTI zmanjšal sposobnost upravljanja vozil in strojev.
Laboratory adverse events ZIMULTI has not been shown to alter laboratory test values.
Laboratorijski neželeni učinki Ni ugotovljeno, da bi ZIMULTI spreminjal vrednosti laboratorijskih testov.
ZIMULTI is contraindicated during breast-feeding (see section 4.3).
ZIMULTI je kontraindicirana med obdobjem dojenja (glejte poglavje 4.3).
Important information about some of the ingredients of ZIMULTI ZIMULTI tablets include lactose.
Pomembne informacije o nekaterih sestavinah zdravila ZIMULTI Tablete ZIMULTI vsebujejo laktozo.
Generally ZIMULTI 20 mg had no significant effect on Total-C or LDL-C levels.
Na splošno ZIMULTI 20 mg ni pomembno vplival na koncentracijo celotnega holesterola ali holesterola LDL.
ZIMULTI is indicated in the treatment of obese or overweight patients with additional risk factors such as diabetes or high levels of fatty substances in the blood called lipids (dyslipidaemia; mainly cholesterol and triglycerides) as adjunct to diet and exercise.
Zdravilo ZIMULTI je namenjeno za zdravljenje debelih ali bolnikov s čezmerno telesno maso z dodatnimi dejavniki tveganja, kot sta diabetes ali povišane vrednosti maščob v krvi - t. i. lipidi (dislipidemija; predvsem holesterol in trigliceridi) kot dopolnilo k dieti in telesni dejavnosti.
ZIMULTI is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.
ZIMULTI je na voljo v pretisnih omotih s 14, 28, 30, 56, 84, 90 in 98 tabletami,perforiranih pretisnih omotih za enkratni odmerek, ki vsebujejo 70 x 1 tableto in belih plastenkah z 28, 98 ali 500 tabletami.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ZIMULTI.
Če med jemanjem zdravila ZIMULTI zanosite, sumite, da ste zanosili, ali načrtujete nosečnost, se morate takoj posvetovati z zdravnikom.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/345/007
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/06/345/007
If you experience symptoms of depression (see below) during treatment with ZIMULTI you should contact your doctor and stop the treatment.
Če se med zdravljenjem z zdravilom ZIMULTI pojavijo simptomi depresije (glejte spodaj), zdravilo ZIMULTI prenehajte jemati in se posvetujte s svojim zdravnikom.
What ZIMULTI looks like and contents of the pack ZIMULTI 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on one side.
Izgled zdravila ZIMULTI in vsebina pakiranja ZIMULTI 20 mg so bele filmsko obložene tablete v obliki solze, ki imajo na eni strani vtisnjeno oznako "20".
ZIMULTI should be used with caution in patients over 75 years of age (see section 4.4).
Pri bolnikih, starejših od 75 let, ZIMULTI uporabljajte previdno (glejte poglavje 4.4).
ZIMULTI 20 MG FILM-COATED TABLETS (RIMONABANT)
ZIMULTI 20 mg filmsko obložene tablete (rimonabant)
− gastrointestinal disorders:stomach discomfort, dry mouth.
− bolezni prebavil: nelagodje v želodcu, suha usta.
What ZIMULTI is and what it is used for Before you take ZIMULTI How to take ZIMULTI Possible side effects
Kaj je zdravilo ZIMULTI in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ZIMULTI Kako jemati zdravilo ZIMULTI Možni neželeni učinki
HOW TO TAKE ZIMULTI
KAKO JEMATI ZDRAVILO ZIMULTI
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).
5 How to store ZIMULTI Further information
5 Shranjevanje zdravila ZIMULTI Dodatne informacije
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).
MARKETING AUTHORIZATION NUMBER EU/1/06/345/001-011
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/345/001-011
NAME OF THE MEDICINAL PRODUCT ZIMULTI 20 mg film-coated tablets
IME ZDRAVILA ZIMULTI 20 mg filmsko obložene tablete
ZIMULTI 20 mg
ZIMULTI 20 mg placebo
If you forget to take ZIMULTI 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.
Serious psychiatric events including depression or mood changes have been reported in patients taking ZIMULTI (see section POSSIBLE SIDE EFFECTS).
Pri bolnikih, ki so jemali zdravilo ZIMULTI, so poročali o pojavu resnih duševnih motenj, vključno z depresijo ali motnjami razpoloženja (glejte poglavje MOŽNI NEŽELENI UČINKI).
The percentage of patients who lost 5% and 10% of their baseline body weight after 1 year of treatment are given in table 2:
Spodaj v tabeli 2 so prikazani deleži bolnikov, ki so imeli po 1 letu zdravljenja telesno maso za 5 % oz. 10 % manjšo kot izhodiščno:
sanofi-aventis 174 avenue de France F-75013 Paris France
sanofi-aventis 174 Avenue de France F-75013 Paris Francija
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
A. IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN
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
(ODGOVORNI) ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serije 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 V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
ZIMULTI should not be used in patients with severe renal impairment (see section 4.4 and 5.2).
ZIMULTI ne smete uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavji 4.4 in 5.2).
Caution is advised during concomitant use of ZIMULTI and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone).
Med sočasno uporabo zdravila ZIMULTI in močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, ritonavirja, telitromicina, klaritromicina, nefazodona) je potrebna previdnost.
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).
ZIMULTI should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2).
ZIMULTI ne smete uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavji 4.4 in 5.2).
MARKETING AUTHORIZATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
Weight loss at two years was 5.1 kg for patients who received ZIMULTI 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 ZIMULTI 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).
Tell your doctor before you start to take this medicine
Bodite posebno pozorni pri jemanju zdravila ZIMULTI Preden začnete jemati zdravilo, morate zdravniku povedati:
ZIMULTI is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Zaradi pomanjkanja podatkov o učinkovitosti in varnosti uporaba zdravila ZIMULTI pri otrocih pod 18 let ni priporočljiva.
The active ingredient of ZIMULTI is rimonabant.
Zdravilna učinkovina v zdravilu ZIMULTI je rimonabant.
ZIMULTI should be used with caution in patients with moderate hepatic impairment.
Pri bolnikih z zmerno okvaro jeter je ZIMULTI potrebno uporabljati previdno.
(See section 4.3 and 4.8).Obesity is a condition that can be associated with depressive disorders.
Debelost je stanje, ki je lahko povezano z depresivnimi motnjami.
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 ZIMULTI, 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).
What ZIMULTI contains
Kaj vsebuje zdravilo ZIMULTI
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 ZIMULTI 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 ZIMULTI 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 ZIMULTI 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).
A mean weight loss of 6.5 kg from baseline to one year was shown for ZIMULTI 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 ZIMULTI 20 mg 6,5 kg in s placebom 1,6 kg (razlika -4,9 kg, IZ95 % -5,3, -4,4; p<0,001).
Significant mean weight reductions from baseline to one year for ZIMULTI 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 ZIMULTI 20 mg v primerjavi s placebom dokazali značilno zmanjšanje povprečne telesne mase od izhodišča.
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).
Like all medicines, ZIMULTI 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 ZIMULTI 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 ZIMULTI, vključujejo: slabost v želodcu in okužbo zgornjih dihal.
Anger
Serija
Always take ZIMULTI exactly as your doctor has told you.
Natančno upoštevajte zdravnikova navodila.
If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped.
Če bolnica med zdravljenjem z zdravilom ZIMULTI zanosi, mora o tem obvestiti zdravnika.
Do not take ZIMULTI
Ne uporabljajte zdravila ZIMULTI
Date of renewal authorisation:13 February 2008
Datum zadnjega podaljšanja: 13. februar 2008