FrancophonIA/ELRC3.0 huggingface dataset:
English: AMENDMENTS TO BE INCLUDED IN SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR VALPROIC ACID/VALPROATE CONTAINING MEDICINAL PRODUCTS, AS RELEVANT
Slovenian: DODATKI, KI MORAJO BITI VKLJUČENI V POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA ZA VALPROJSKO KISLINO IN/ALI NATRIJEV VALPROAT, KJER JE TO USTREZNO
English: Mean daily dose The recommended daily doses usually range between 1000 mg and 2000 mg.
Slovenian: Priporočeni dnevni odmerki so po navadi od 1000 mg do 2000 mg.
English: AMENDMENTS TO BE INCLUDED IN SECTIONS OF THE PACKAGE LEAFLET FOR VALPROIC ACID /VALPROATE CONTAINING PRODUCTS, AS RELEVANT
Slovenian: DODATKI, KI MORAJO BITI VKLJUČENI V POGLAVJA NAVODILA ZA UPORABO ZA VALPROJSKO KISLINO IN/ALI NATRIJEV VALPROAT, KJER JE TO USTREZNO
English: ANNEX III AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND THE PACKAGE LEAFLET These amendments to the SPC and package leaflet are valid at the time of the Commission Decision.
Slovenian: Ta dopolnila povzetka glavnih značilnosti zdravila in navodila za uporabo so veljavna ob času odločbe komisije.
English: {Invented name} is used in the treatment of
Slovenian: Zdravilo Depakine chrono se uporablja za zdravljenje
English: A meta-analysis of randomised placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Nekoliko večje tveganje za razmišljanje o samomoru in samomorilno obnašanje je pokazala tudi metaanaliza randomiziranih, s placebom kontroliranih preskušanj antiepileptičnih zdravil.
English: Take special care with {INVENTED NAME}
Slovenian: Bodite posebno pozorni pri uporabi zdravila Depakine chrono
English: PACKAGE LEAFLET
Slovenian: Začetni odmerek
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Slovenian: Pri bolnikih, ki so zaradi različnih indikacij dobivali antiepileprike, so poročali o razmišljanju o samomoru in samomorilnem obnašanju.
English: HOW TO TAKE {INVENTED NAME}
Slovenian: KAKO JEMATI ZDRAVILO DEPAKINE CHRONO Manija
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtske oblike, jakosti zdravila, načina uporabe, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: 8 , Quinta da Beloura 2710-444 Sintra Portugal
Slovenian: 8 , Quinta da Beloura 2710-444 Sintra
English: 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex
Slovenian: 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex France
English: Kemistvägen 1B, Box 1150, 18311 Täby, Sweden
Slovenian: Novartis Sverige AB Kemistvägen 1B, Box 1150, 18311 Täby, Sweden
English: 12 km of National Road Athens, Lamia N° 1, 14451 Metamorphosis, Athens Greece
Slovenian: 12 km of National Road Athens, Lamia N° 1, 14451
English: Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47 Hungary
Slovenian: Madžarska Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43
English: Novartis Norge AS Postboks 4284 Nydalen, 0401 Oslo
Slovenian: Novartis Norge AS Postboks 4284 Nydalen,
English: United Kingdom Novartis Pharmaceuticals UK Limited Trading as Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Slovenian: Trading as Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom
English: Czech Republic Novartis s.r.o., Gemini, budova B Na Pankráci 1724/129
Slovenian: Novartis s.r.o., Gemini, budova B Na Pankráci 1724/129 140 00 Prague 4
English: Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800 Vilvoorde Belgium
Slovenian: Medialaan, 40 bus 1, 1800 Vilvoorde
English: Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, N° 764 08013 Barcelona
Slovenian: Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, N° 764
English: Novartis Pharma B.V.
Slovenian: Nizozemska Novartis Pharma B.V.
English: Slovak Republic Novartis, s.r.o.
Slovenian: Novartis, s.r.o.
English: Novartis Europharm Ltd Wimblehurst Road
Slovenian: Novartis Europharm Ltd Wimblehurst Road RH12 5 Ab - Horsham (West
English: Novartis Farma - Produtos Farmacêuticos S.A.
Slovenian: Portugalska Novartis Farma - Produtos filmsko obložena
English: Femara 2.5mg Filmcoated Tablets
Slovenian: Femara 2.5mg Film-coated Tablets
English: 140 00 Prague 4
Slovenian: 0401 Oslo
English: Novartis Sverige AB
Slovenian: Novartis Finland Oy filmsko obložena
English: Femara 2.5mg Tablets 2.5 mg
Slovenian: Femara 2,5mg Filmtabletten 2,5 mg
English: Femara 2,5mg filmtabletta
Slovenian: Femara 2,5mg filmtabletta 2,5 mg
English: Laboratorios Padró, S.A.
Slovenian: Farmacêuticos S.A.
English: International Non-proprietary Name (INN): dronedarone
Slovenian: Mednarodno nelastniško ime (INN): dronedaron
English: The studies involved a total of 1,237 patients with an average age above 60 years.
Slovenian: V raziskavo je bilo vključenih skupno 1237 bolnikov, v povprečju starih nad 60 let.
English: London, 21 September 2006 Doc.Ref.
Slovenian: London, 21. september 2006 Sklic dok.
English: Atrial fibrillation and flutter are very common conditions, particularly in people over 65 years of age.
Slovenian: Atrijska fibrilacija in plapolanje sta zelo pogosti stanji, zlasti pri osebah, starejših od 65 let.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Slovenian: Dopis podjetja, s katerim EMEA obvešča o umiku vloge, je na voljo tukaj.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če pa ste vključeni v klinično preskušanje in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
English: The study measured the change in heart rate between the start of the study and day 14 of treatment.
Slovenian: V raziskavi so merili spremembo v srčni frekvenci med začetkom raziskave in 14. dnevom zdravljenja.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Slovenian: Ko je CHMP je ocenjeval odgovore podjetja na seznam vprašanj, je še vedno ostalo nekaj vprašanj nerešenih.
English: In addition, MULTAQ can alter the levels of some other medicines.
Slovenian: Ravno tako pa lahko zdravilo MULTAQ spremeni ravni drugih zdravil.
English: What documentation has the company presented to support its application to the CHMP?
Slovenian: Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi?
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for MULTAQ
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo MULTAQ
English: On 6 September 2006, sanofi-aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for MULTAQ, for the treatment of atrial fibrillation and atrial flutter.
Slovenian: Podjetje sanofi-aventis je 6. septembra 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet za zdravilo MULTAQ za zdravljenje atrijske fibrilacije in atrijskega plapolanja.
English: The application was at day 174 when the company withdrew.
Slovenian: Podjetje je umaknilo vlogo na 174. dan.
English: MULTAQ is a medicine that consists of tablets containing 400 mg of dronedarone.
Slovenian: Zdravilo MULTAQ so tablete, ki vsebujejo 400 mg dronedarona.
English: The effects of MULTAQ were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila MULTAQ so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: Therefore, at the time of the withdrawal, the CHMP's view was that further studies were needed to adequately assess the medicine's benefits and risks.
Slovenian: Zato je bil v času umika CHMP mnenja, da so za ustrezno ovrednotenje koristi in tveganj, povezanih s tem zdravilom potrebne dodatne raziskave.
English: All of the patients had had atrial fibrillation or flutter at least once in the past three months but had a normal heart rhythm at the start of the study.
Slovenian: Vsi bolniki so imeli v preteklih treh mesecih najmanj eno epizodo atrijske fibrilacije ali plapolanja, vendar so imeli ob vstopu v raziskavo normalen srčni ritem.
English: Following a CHMP opinion, it usually takes around 2 months for the European Commission to grant a licence.
Slovenian: Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih izda dovoljenje.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Slovenian: Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko do 180. dne zaprosi podjetje še za odgovore na dodatna vprašanja.
English: 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.
Slovenian: Zdravilo ima številne učinke na srčno mišico, med drugim zmanjšuje tok kalijevih ionov (nabitih delcev) iz srčnih celic.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Slovenian: Na podlagi pregleda začetne dokumentacije CHMP do 120. dne pripravi seznam vprašanj, ki ga pošlje podjetju.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with MULTAQ?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila MULTAQ?
English: The studies examined how long it took for atrial fibrillation or flutter to return.
Slovenian: V raziskavah so preverjali, kako dolgo traja, da se atrijska fibrilacija oz. plapolanje znova pojavita.
English: Both illnesses cause a rapid heart rate, but atrial fibrillation also makes the heart rhythm irregular.
Slovenian: Pri obeh boleznih pride do hitrega bitja srca, vendar se pri atrijski fibrilaciji pojavi tudi nepravilen ritem srca.
English: Atrial fibrillation and atrial flutter are caused by problems in the conduction of electrical impulses in the upper chambers of the heart (atria).
Slovenian: Do atrijske fibrilacije in atrijskega plapolanja pride zaradi težav pri prevajanju električnih impulzov v preddvorih srca (atrijih).
English: MULTAQ was expected to help patients maintain normal heart rhythm and to reduce the heart rate.
Slovenian: Zdravilo MULTAQ naj bi pomagalo bolnikom ohranjati normalen srčni ritem in zniževati srčno frekvenco.
English: What is MULTAQ?
Slovenian: Kaj je zdravilo MULTAQ?
English: MULTAQ was to be used to treat patients with atrial fibrillation or atrial flutter.
Slovenian: Zdravilo MULTAQ bi se uporabljalo za zdravljenje bolnikov z atrijsko fibrilacijo ali atrijskim plapolanjem.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The Company has informed the CHMP that there are no consequences for patients currently included in clinical trials with MULTAQ.
Slovenian: Podjetje je obvestilo CHMP, za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila MULTAQ, ni nobenih posledic.
English: What was MULTAQ expected to be used for?
Slovenian: Za kaj naj bi se zdravilo MULTAQ uporabljalo?
English: 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.
Slovenian: Podjetje je predložilo rezultate dveh kliničnih preskušanj, kjer so primerjali učinke zdravila MULTAQ in placeba (zdravila brez zdravilne učinkovine) na ohranjanje normalnega srčnega ritma.
English: The patients' heart rates were measured when they were resting.
Slovenian: Srčne frekvence so merili, ko so bolniki počivali.
English: 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.
Slovenian: CHMP je izrazil zaskrbljenost glede spreminjanja ravni zdravila MULTAQ pri bolnikih, ki jemljejo druga zdravila, med drugim zdravila za zdravljenje bolezni srca.
English: The CHMP also had concerns over a higher rate of side effects in patients taking MULTAQ than those taking placebo.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The active substance in MULTAQ, dronedarone, is an anti-arrhythmic agent.
Slovenian: Zdravilna učinkovina zdravila MULTAQ je dronedaron, ki je sredstvo proti aritmiji.
English: How is MULTAQ expected to work?
Slovenian: Kako naj bi zdravilo MULTAQ delovalo?
English: It is expected to correct altered heartbeat by affecting the electrical activity of the heart muscle.
Slovenian: Zdravilo MULTAQ naj bi vplivalo na električno aktivnost srčne mišice in s tem popravilo spremenjen srčni ritem.
English: Patients should be instructed not to increase their dose of ZIMULTI.
Slovenian: Bolnikom morate naročiti, naj ne povečujejo odmerka zdravila ZIMULTI.
English: ZIMULTI should not be taken during pregnancy.
Slovenian: Zdravila ZIMULTI ne smete jemati med nosečnostjo.
English: In clinical studies, ZIMULTI 20 mg was taken in the morning usually before breakfast.
Slovenian: V kliničnih študijah so preiskovanci ZIMULTI 20 mg jemali zjutraj, ponavadi pred zajtrkom.
English: The in vitro human plasma protein binding of rimonabant is high (>99.9%) and non-saturable over a wide concentration range.
Slovenian: Vezava rimonabanta na človeške plazemske beljakovine je in vitro velika (> 99,9 %) in v širokem razponu koncentracij ne kaže saturacije.
English: INFORMATION IN BRAILLE ZIMULTI
Slovenian: PODATKI V BRAILLOVI PISAVI ZIMULTI
English: WHAT ZIMULTI IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO ZIMULTI IN ZA KAJ GA UPORABLJAMO
English: 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.
Slovenian: 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.
English: Patients who received ZIMULTI 20 mg for one year were re-randomized to ZIMULTI 20 mg or placebo.
Slovenian: Bolnike, ki so eno leto dobivali ZIMULTI 20 mg, so ponovno randomizirali na ZIMULTI 20 mg ali placebo.
English: − if you are allergic (hypersensitive) to rimonabant, or any of the other ingredients of ZIMULTI
Slovenian: − če ste preobčutljivi za (alergični na) rimonabant ali katerokoli sestavino zdravila ZIMULTI
English: 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).
Slovenian: 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).
English: 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%).
Slovenian: 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%).
English: 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).
Slovenian: 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).
English: There is no information available on the use of ZIMULTI in people under 18 years of age.
Slovenian: Podatkov o uporabi zdravila ZIMULTI pri osebah, mlajših od 18 let, ni.
English: The percentage of patients reaching HbA1c <7% was 51% in the rimonabant group and 35% in the placebo group.
Slovenian: HbA1c < 7 % je doseglo 51 % bolnikov, ki so dobivali rimonabant, in 35 % bolnikov, ki so dobivali placebo.
English: Patients had a BMI ≥30 kg/m² or BMI>27 kg/m² with hypertension and/or dyslipidemia at inclusion.
Slovenian: Bolniki so imeli ITM 30 kg/m2 ali ITM > 27 kg/m2 ter hipertenzijo in/ali dislipidemijo ob vključitvi.
English: Taking ZIMULTI with food and drink ZIMULTI should be taken once daily in the morning before breakfast.
Slovenian: Jemanje zdravila ZIMULTI skupaj s hrano in pijačo Zdravilo ZIMULTI morate vzeti enkrat na dan, zjutraj pred zajtrkom.
English: 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.
Slovenian: 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.
English: The activity of ZIMULTI is increased by simultaneous use of some drugs (so-called CYP3A4 inhibitors) such as:
Slovenian: Delovanje zdravila ZIMULTI se poveča, če hkrati uporabljate določena zdravila (t. i. zaviralce CYP3A4), npr.:
English: ZIMULTI 20 mg nITT
Slovenian: ZIMULTI 20 mg nZNZ
English: ZIMULTI 20 mg was effective in maintaining weight loss up to two years.
Slovenian: ZIMULTI 20 mg je učinkovito vzdrževala zmanjšano telesno maso do dve leti.
English: Do not use ZIMULTI after the expiry date which is stated on the outer packaging after EXP.
Slovenian: Zdravila ZIMULTI ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini poleg oznake "Upor.
English: If you take more ZIMULTI than you should If you take more ZIMULTI than you should tell a doctor or pharmacist.
Slovenian: 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.
English: Rare side effects, that affect less than 1 per 1000, that have occurred in patients on ZIMULTI include: hallucinations.
Slovenian: 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.
English: Non-diabetic studies
Slovenian: študije pri nediabetikih študija pri diabetikih placebo
English: 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.
Slovenian: 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.
English: Driving and using machines At the recommended dose, ZIMULTI is not expected to reduce your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev V priporočenem odmerku ni pričakovati, da bi ZIMULTI zmanjšal sposobnost upravljanja vozil in strojev.
English: Laboratory adverse events ZIMULTI has not been shown to alter laboratory test values.
Slovenian: Laboratorijski neželeni učinki Ni ugotovljeno, da bi ZIMULTI spreminjal vrednosti laboratorijskih testov.
English: ZIMULTI is contraindicated during breast-feeding (see section 4.3).
Slovenian: ZIMULTI je kontraindicirana med obdobjem dojenja (glejte poglavje 4.3).
English: Important information about some of the ingredients of ZIMULTI ZIMULTI tablets include lactose.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila ZIMULTI Tablete ZIMULTI vsebujejo laktozo.
English: Generally ZIMULTI 20 mg had no significant effect on Total-C or LDL-C levels.
Slovenian: Na splošno ZIMULTI 20 mg ni pomembno vplival na koncentracijo celotnega holesterola ali holesterola LDL.
English: 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.
Slovenian: 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.