natgillin/translations-raw huggingface dataset:
If you are switching from a medicine with less than 2,000 mg of prolonged-nicotinic acid, you should start by taking one tablet of Tredaptive a day.
Če prehajate z zdravila, ki vsebuje manj kot 2.000 mg nikotinske kisline s podaljšanim sproščanjem, morate na začetku jemati po eno tableto zdravila Tredaptive na dan.
Your total cholesterol is made up mainly of ‘bad' (LDL) and ‘good' (HDL) cholesterol.
Celotni holesterol v glavnem sestavljata "slabi" holesterol (LDL)
Rare: rhinitis
Redki: anksioznost
In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥ 3 X ULN, consecutive) was 1.0 % for patients treated with Tredaptive with or without a statin.
V kontroliranih kliničnih študijah je bila pri bolnikih, ki so prejemali zdravilo Tredaptive (s statinom ali brez njega), incidenca klinično pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 3 x ZMN, zaporedno) 1,0 %.
No studies in lactating animals have been conducted with Tredaptive.
Na doječih živalih študije z zdravilom Tredaptive niso bile izvedene.
Paediatric population Tredaptive: No studies have been performed in paediatric patients.
Tredaptive: Študij pri pediatričnih bolnikih niso izvedli.
In a multicentre, double-blind, 12-week factorial study, Tredaptive 1,000 mg/20 mg co-administered with simvastatin, when compared with simvastatin alone or Tredaptive 1,000 mg/20 mg alone, for 4 weeks, significantly lowered LDL-C (-44.2 %, -37.4 %, -8.2 % respectively), TG (-25.8 %, -15.7 %, -18.7 % respectively), TC (-27.9 %, -25.8 %, -4.9 % respectively) and significantly increased HDL-C (19.2 %, 4.2 %, 12.5 % respectively).
V multicentrični, dvojno slepi 12-tedenski faktorski študiji je 4-tedenska uporaba zdravila Tredaptive 1.000 mg/20 mg skupaj s simvastatinom v primerjavi s simvastatinom samim oz. z zdravilom Tredaptive 1.000 mg/20 mg samim bistveno znižala hLDL (-44,2 %, -37,4 % oz. -8,2 %), trigliceride (-25,8 %, -15,7 % oz. -18,7 %), Ch (-27,9 %, -25,8 % oz. -4,9 %) in bistveno zvišala hHDL (19,2 %, 4,2 % oz. 12,5 %).
• nicotinic acid, a lipid modifying medicine, and
• nikotinsko kislino, ki je zdravilo z vplivom na maščobe (lipide), in
The starting dose is one modified-release tablet (1,000 mg nicotinic acid/20 mg laropiprant) once a day.
Odmerjanje Začetni odmerek je ena tableta s prirejenim sproščanjem (1.000 mg nikotinske kisline/20 mg laropipranta) enkrat na dan.
Reproduction toxicity studies showed slight treatment-related decreases in mean maternal weight gain and foetal body weight, slight increases in pup mortality, and increased incidence of supernumerary rib and incomplete ossification of the sternebra in the foetus were observed in rats at systemic exposure levels at least 513 times the human exposure based on the AUC of the recommended daily human dose.
Študije reproduktivne toksičnosti so pri podganah pokazale majhno z zdravilom povezano zmanjšanje povprečnega povečanja telesne mase samice matere in plodu, rahlo povečanje umrljivosti mladičev ter večjo incidenco nadštevilnih reber in nepopolnega zakostenevanja sternebre pri plodu pri sistemski izpostavljenosti, ki je bila vsaj 513-krat tolikšna, kot je (na podlagi AUC)
Following a 2,000 mg dose of nicotinic acid administered orally as two modified-release tablets of nicotinic acid/laropiprant with food, nicotinic acid was absorbed with a median time to peak plasma concentration (Tmax) of 4 hours, a mean area under the plasma concentration-time curve (AUC0-last) of approximately 58.0 μM·hr and a mean peak plasma concentration (Cmax) of approximately 20.2 μM.
Po peroralni uporabi 2.000 mg nikotinske kisline v obliki dveh tablet nikotinske kisline/laropipranta s prirejenim sproščanjem, zaužitih s hrano, je bila mediana časa do največje koncentracije nikotinske kisline v plazmi (tmax) 4 ure, povprečna površina pod krivuljo plazemske koncentracije v odvisnoti od časa (AUC0-last) približno 58,0 µM·h in povprečna največja koncentracija v plazmi (Cmax) približno
Common: elevations in ALT and/or AST (consecutive, ≥ 3 X ULN), fasting glucose (see below) Uncommon: elevations in CK (≥ 10 X ULN), LDH, uric acid (see
Pogosti: zvišanje ALT in/ali AST (zaporedno, ≥ 3 x ZMN), Občasni: zvišanje CK (≥ 10 x ZMN), LDH, sečne kisline (glejte Redki: zvišanje celokupnega bilirubina, amilaze; znižanje fosforja in števila trombocitov (glejte spodaj)
• swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (angioedema, which may require treatment right away)
• oteklost obraza, ustnic, jezika in/ali žrela, ki lahko povzroči težave z dihanjem in požiranjem
Each tablet contains 1,000 mg nicotinic acid and 20 mg laropiprant.
Vsaka tableta vsebuje 1.000 mg nikotinske kisline in 20 mg laropipranta.
Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Tredaptive.
Pri predpisovanju zdravila Tredaptive morate upoštevati vnos nikotinske kisline z vitamini in prehranskimi dopolnili.
The incidence and frequency of moderate or greater flushing in patients treated with Tredaptive for the duration of the study decreased.
Pri bolnikih, zdravljenih z zdravilom Tredaptive, sta se pojavnost in pogostnost zmernega ali izrazitejšega zardevanja v času študije zmanjšali.
If muscle pain, weakness or cramps occur while a patient is receiving Tredaptive with a statin, their CK levels should be measured.
Če se med jemanjem zdravila Tredaptive skupaj s statinom pojavijo bolečine v mišicah, oslabelost mišic ali mišični krči, je treba bolniku izmeriti raven CK.
How to take Tredaptive
Kako jemati zdravilo Tredaptive
Hepatic insufficiency Tredaptive: Use in patients with hepatic insufficiency has not been studied.
Ledvična insuficienca Tredaptive: Uporaba pri bolnikih z ledvično insuficienco ni raziskana.
Common: headache; paraesthesia Uncommon: dizziness Rare: migraine; syncope
Pogosti: glavobol; parestezija Občasni: omotica Redki : migrena; sinkopa
In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Tredaptive declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6).
Med bolniki, ki so nadaljevali sodelovanje v prvi študiji (24 tednov), se je pogostnost zmernega ali izrazitejšega zardevanja med tistimi, ki so prejemali zdravilo Tredaptive, zmanjšala in se je približala tisti pri bolnikih, ki so dobivali placebo (glejte sliko 1).
Because the risk of myopathy with statins is dose-related, the use of Tredaptive with simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg is not recommended in Chinese patients.
Ker je tveganje za miopatijo pri statinih odvisno od odmerka, pri kitajskih bolnikih ne priporočamo uporabe zdravila Tredaptive skupaj s simvastatinom 80 mg ali z ezetimibom/simvastatinom 10/80 mg. Ni znano, ali je tveganje za miopatijo povečano tudi pri drugih azijskih bolnikih, zdravljenih z zdravilom Tredaptive in s simvastatinom ali z ezetimibom/simvastatinom.
Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Tredaptive.
Acetilsalicilna kislina zardevanja ne zmanjša nič bolj, kot ga že zdravilo Tredaptive.
Rare cases of myopathy/rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥ 1,000 mg/day) of nicotinic acid and HMG-CoA reductase inhibitors (statins) (see section 4.8).
Redki primeri miopatije/rabdomiolize so bili povezani s sočasno uporabo nikotinske kisline v odmerkih, ki vplivajo na lipide (≥ 1.000 mg/dan), in zaviralcev reduktaze HMG-CoA (statinov).
The oxidative metabolism of laropiprant is catalysed primarily by CYP3A4, whereas several UGT isoforms (1A1, 1A3, 1A9 and 2B7) catalysed the acyl glucuronidation.
CYP3A4, acilglukuronidacijo pa več izooblik UGT (1A1, 1A3, 1A9 in 2B7).
As with other nicotinic acid medicinal products, elevations in fasting glucose (a median increase of approximately 4 mg/dL), and uric acid (mean change from baseline of +14.7 %), and reductions in platelet counts (a mean change from baseline of -14.0 %) were reported in controlled clinical studies with Tredaptive (2,000 mg/40 mg) (see section 4.4).
Tako kot pri drugih zdravilih z nikotinsko kislino so v kontroliranih kliničnih študijah z zdravilom Tredaptive (2.000 mg/40 mg) poročali o zvišanju glukoze na tešče (mediana vrednost zvišanja je bila približno 4 mg/dl) in sečne kisline (povprečna sprememba glede na izhodišče +14,7 %) ter zmanjšanju števila trombocitov (povprečna sprememba glede na izhodišče -14,0 %) (glejte poglavje 4.4).
Therefore, patients switching from immediate-release nicotinic acid to Tredaptive should be initiated at the 1,000 mg/20 mg dose.
Pri bolnikih, ki preidejo na zdravilo Tredaptive z nikotinske kisline s takojšnjim sproščanjem, morate zdravljenje začeti z odmerkom 1.000 mg/20 mg.
Caution should be used when treating Chinese patients with Tredaptive co-administered with simvastatin or ezetimibe/simvastatin (particularly simvastatin doses of 40 mg or higher).
Pri zdravljenju kitajskih bolnikov, ki jemljejo zdravilo Tredaptive skupaj s simvastatinom ali z ezetimibom/simvastatinom (zlasti pri odmerkih simvastatina 40 mg ali več), je potrebna previdnost.
In clinical trials, over 5,700 patients received Tredaptive alone or with an HMG-CoA reductase inhibitor.
V kliničnih preskušanjih je zdravilo Tredaptive samo ali skupaj z zaviralcem reduktaze HMG-CoA
In three large clinical trials measuring patient-reported flushing symptoms, patients taking Tredaptive experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
V treh velikih kliničnih preskušanjih, v katerih so ugotavljali simptome zardevanja po navedbi bolnikov, je bilo zardevanja manj med bolniki, ki so prejemali zdravilo Tredaptive, kot med bolniki,
The following adverse reactions have been reported during clinical studies and/or post-marketing use with Tredaptive (with or without a statin).
V času kliničnih študij in/ali obdobju trženja zdravila Tredaptive (z ali brez statina) so poročali o naslednjih neželenih učinkih.
Physicians contemplating combined therapy with statins and Tredaptive should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
Poleg tega morate bolnika natančno spremljati glede mišičnih bolečin, občutljivosti ali šibkosti mišic, še posebej v prvih mesecih zdravljenja in ob povečanju kateregakoli zdravila.
• Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Tredaptive.
• Ne pijte alkohola ali vročih pijač in ne jejte začinjene hrane malo pred zaužitjem odmerka zdravila Tredaptive ali kmalu po njem.
Tredaptive 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Tredaptive 1.000 mg/20 mg tablete s prirejenim sproščanjem nikotinska kislina/laropiprant
Patients receiving Tredaptive, nicotinic acid (prolonged-released formulation), or placebo were also taking statins (29 % atorvastatin [5-80 mg], 54 % simvastatin [10-80 mg], 17 % other statins [2.5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), of which 9 % were also taking ezetimibe [10 mg].
simvastatin [10-80 mg], 17 % druge statine [2,5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)) in 9 % od teh jih je jemalo tudi ezetimib [10 mg].
EU/1/08/459/001 14 modified-release tablets EU/1/08/459/002 28 modified-release tablets EU/1/08/459/003 56 modified-release tablets EU/1/08/459/004 84 modified-release tablets EU/1/08/459/005 98 modified-release tablets EU/1/08/459/006 168 modified-release tablets EU/1/08/459/007 196 modified-release tablets EU/1/08/459/008 49 x 1 modified-release tablets EU/1/08/459/012 196 (2 packs of 98) modified-release tablets
EU/1/08/459/003 56 tablet s prirejenim sproščanjem EU/1/08/459/004 84 tablet s prirejenim sproščanjem EU/1/08/459/005 98 tablet s prirejenim sproščanjem EU/1/08/459/006 168 tablet s prirejenim sproščanjem
What Tredaptive contains
Kaj vsebuje zdravilo Tredaptive
• In the event of an overdose, the following side effects were reported:
Če ste vzeli večji odmerek zdravila Tredaptive, kot bi smeli • V primeru prevelikega odmerjanja so poročali o naslednjih neželenih učinkih:
In these studies, the percentage of patients taking Tredaptive, nicotinic acid (pooled prolonged-release formulations) or pooled placebo/simvastatin who discontinued due to any flushing-related symptom (redness, warmth, itching and tingling) was 7.2 %, 16.6 %, and 0.4 %, respectively.
Zaradi kateregakoli od simptomov zardevanja (rdečica, toplota, srbenje in mravljinčenje) je zdravilo Tredaptive v teh študijah nehalo jemati 7,2 % bolnikov, nikotinsko kislino (skupno vse pripravke s podaljšanim delovanjem) 16,6 % bolnikov in placebo/simvastatin 0,4 % bolnikov.
The most commonly reported adverse reactions from the subjects who received this higher dose were consistent with a high dose of nicotinic acid and included: flushing, headache, pruritus, nausea, dizziness, vomiting, diarrhoea, epigastric and abdominal pain/discomfort, and back pain.
Osebe, ki so dobie ta višji odmerek, so najpogosteje poročale o neželenih učinkih, ki so se skladali z neželenimi učinki velikih odmerkov nikotinske kisline in vključujejo: zardevanje, glavobol, srbenje, navzeo, omotico, bruhanje, drisko,
As with other nicotinic acid medicinal products, Tredaptive (2,000 mg/40 mg) was associated with small increases in uric acid levels (see section 4.8).
Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Tredaptive (2.000 mg/40 mg) povezano z majhnim zvišanjem koncentracije sečne kisline (glejte poglavje 4.8).
Uncommon: chills; pain; peripheral oedema Rare: asthaenia; face oedema; generalised oedema
Občasni: mrzlica; bolečina; periferni edem Redki: astenija; edem obraza; generaliziran edem
Patients receiving Tredaptive concomitantly with acetylsalicylic acid and clopidogrel should be closely monitored as recommended in the Summary of Product Characteristics for those medicinal products and should be told that it might take longer than usual to stop bleeding and that they should report any unusual bleeding (site or duration) to their physician.
Povedati jim je treba, da lahko traja dalj časa kot običajno, da se krvavitev ustavi, ter da morajo svojemu zdravniku poročati kakršnokoli neobičajno krvavitev (mesto ali trajanje).
Degeneration in the stomach and hepatocyte vacuolation were observed in rats following 6 months of dosing at systemic exposure values at least 179 times the human exposure based on the AUC of the recommended daily human dose.
Pri podganah so po 6-mesečni uporabi pri sistemski izpostavljenosti, ki je bila na podlagi AUC vsaj 179-krat večja od izpostavljenosti med uporabo priporočenega dnevnega odmerka pri človeku, opažali degeneracijo v želodcu in vakuolacijo.
Nicotinic acid: No dose adjustment is necessary based on gender.
Nikotinska kislina: Odmerka ni treba prilagoditi glede na spol.
As with other nicotinic acid medicinal products, Tredaptive was associated with small decreases in phosphorus levels.
Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Tredaptive povezano z manjšim zmanjšanjem koncentracije fosforja, zato morate bolnike s tveganjem za hipofosfatemijo skrbno spremljati.
Gender has no clinically meaningful effect on pharmacokinetics of nicotinic acid (prolonged-release formulation).
Spol na farmakokinetiko nikotinske kisline (pripravka s podaljšanim sproščanjem) ne vpliva klinično pomembno.
Further analysis showed Tredaptive (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone significantly increased apo A-I (8.6 %, 2.3 % respectively) and significantly decreased Lp(a) (-19.8 %, 0.0 % respectively ).
Kot je pokazala nadaljnja analiza, je sočasno s simvastatinom uporabljen Tredaptive 2.000 mg/40 mg v primerjavi s samim simvastatinom bistveno zvišal apo A-I (8,6 % oz.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva Splošne težave in spremembe na mestu aplikacije
EU/1/08/459/014 32 x 1 modified-release tablets
EU/1/08/459/002 28 tablet s prirejenim sproščanjem
Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Tredaptive.
Med zdravljenjem z zdravilom Tredaptive mora bolnik še naprej upoštevati dieto in druge nefarmakološke ukrepe zdravljenja (npr. telesno dejavnost, zmanjšanje telesne mase).
However, nicotinic acid a component of Tredaptive does pass into breast milk.
Znano pa je, da v materino mleko prehaja nikotinska kislina, sestavina zdravila Tredaptive.
• burning sensation
• pekoč občutek
What Tredaptive is and what it is used for
Kaj je zdravilo Tredaptive in za kaj ga uporabljamo Vaše zdravilo se imenuje Tredaptive.
If Tredaptive is missed for 7 or more consecutive days, therapy should be resumed at the 1,000 mg/20 mg dose for 1 week, before advancing to the maintenance dose of 2,000 mg/40 mg.
Če pa zdravila Tredaptive ne vzame 7 ali več dni zapored, ga mora znova začeti jemati v odmerku 1.000 mg/20 mg 1 teden.
What you need to know before you take Tredaptive
Kaj morate vedeti, preden boste vzeli zdravilo Tredaptive Ne jemljite zdravila Tredaptive:
The European Medicines Agency has waived the obligation to submit the results of studies with Tredaptive in all subsets of the paediatric population in homozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Tredaptive za vse skupine pediatrične populacije s homozigotno družinsko hiperholesterolemijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
As with other nicotinic acid medicinal products, Tredaptive (2,000 mg/40 mg) was associated with small reductions in platelet count (see section 4.8).
Tako kot druga zdravila z nikotinsko kislino je bilo tudi zdravilo Tredaptive (2.000 mg/40 mg) povezano z majhnim zmanjšanjem števila trombocitov (glejte poglavje 4.8).
Tredaptive contains lactose
Zdravilo Tredaptive vsebuje laktozo
Nicotinic acid: No dose adjustment is necessary based on race.
Nikotinska kislina: Odmerka ni treba prilagoditi glede na raso.
Opaque PVC/Aclar blister with push-through aluminium lidding in pack sizes of 14, 28, 56, 84, 98, 168, 196 modified-release tablets, multi-packs containing 196 (2 packs of 98) modified-release tablets and 49 x 1 modified-release tablets in perforated unit dose blister.
Neprozoren pretisni omot iz PVC/Aclarja z aluminijskim prekritjem, skozi katerega se potisne tableta, v pakiranjih s 14, 28, 56, 84, 98, 168, 196 tabletami s prirejenim sproščanjem, multi pakiranje s 196 (2
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Tredaptive.
Če niste prepričani, ali kaj od naštetega velja za vas, se preden vzamete zdravilo Tredaptive, posvetujte s svojim zdravnikom ali farmacevtom.
• Your doctor may also want you to periodically have blood tests after you start taking Tredaptive, to check how well your liver is working and for other side effects.
• Morda vas bo zdravnik na preiskave krvi napotil tudi med zdravljenjem z zdravilom Tredaptive,
Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat)
Redki: acanthosis nigricans; hiperpigmentacija; znojenje (nočno Neznana: vezikularni ali vezikulobulozni izpuščaj
Additional adverse reactions reported with other nicotinic acid medical products Additional adverse reactions that have been reported with other nicotinic acid medicinal products (with or without a statin) in post-marketing use or in clinical trials include the following:
Dodatni neželeni učinki, o katerih so poročali v obdobju trženja ali v kliničnih preskušanjih z drugimi zdravili z nikotinsko kislino (z ali brez statina) vključujejo: Očesne bolezni: cistoidni edem makule, toksična ambliopija.
Pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in a perforated unit dose blister.
14, 28, 56, 168 tabletami s prirejenim sproščanjem ter z 32 x 1 tableto s prirejenim sproščanjem v perforiranem pretisnem omotu za enkratni odmerek.
Very common: flushing Uncommon: hypotension Rare: orthostatic hypotension
Zelo pogosti: zardevanje Občasni: hipotenzija
Skin and subcutaneous tissue disorders
Bolezni jeter, žolčnika in žolčevodov Bolezni kože in podkožja
This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back).
(pordelost kože, občutek toplote, srbenje ali mravljinčenje, še zlasti v predelu glave, vratu, prsi in zgornjega dela hrbta).
Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
Redki: angioedem; preobčutljivost tipa I Neznana: anafilaktični šok
Tredaptive: Use in patients with renal insufficiency has not been studied.
Jetrna insuficienca Tredaptive: Uporaba pri bolnikih z jetrno insuficienco ni raziskana.
HDL is hypothesised to participate in the transport of cholesterol from tissues back to the liver, to suppress vascular inflammation associated with atherosclerosis, and to have anti-oxidative and anti-thrombotic effects.
zavira z aterosklerozo povezano žilno vnetje ter deluje antioksidativno in antitrombotično.
Tredaptive Medicinal product no longer authorised
Tredaptive Zdravilo nima veā dovoljenja za promet
In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it.
Da bo zdravilo delovalo tako kot mora, tablet ne razpolavljajte,
In rats, foetotoxic effects (significantly decreased foetal body weights associated with a decrease in the number of ossified sacrocaudal vertebrae and an increased incidence of foetuses with sites of incomplete ossification) were noted in the absence of any signs of maternal toxicity at exposure levels approximately 959 times the human AUC of nicotinic acid at the recommended daily human dose.
Pri podganah so pri izpostavljenostih, ki so bile približno 959-kratnik vrednosti AUC nikotinske kisline pri človeku pri priporočenem dnevnem odmerku, opazili škodljive učinke na plod (pomembno zmanjšanje telesne mase zarodkov, povezano z zmanjšanjem števila okostenelih križnih in trtičnih vretenc in s povečanjem pojavnosti plodov z mesti nepopolnega okostenevanja), pri tem pa niso opazili nobenih znakov škodljivih maternalnih učinkov.
Talk with your doctor before taking Tredaptive if:
Preden vzamete zdravilo Tredaptive, se posvetujte z zdravnikom:
How Tredaptive Works
Kako deluje zdravilo Tredaptive
Drinking alcohol or hot drinks or eating spicy foods can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Tredaptive.
V času zaužitja zdravila Tredaptive se je treba izogibati pitju alkohola, vročih pijač ali uživanju začinjene hrane, ker to lahko poveča zardevanje.
• To lower your chance of flushing, avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Tredaptive.
• Da zmanjšate možnost zardevanja, v času zaužitja zdravila Tredaptive (ter malo pred tem in po tem) ne pijte alkohola ali vročih pijač in ne jejte začinjene hrane.
A.
z
Some people get dizzy after taking Tredaptive.
Vpliv na sposobnost upravljanja vozil in strojev Nekateri ljudje po zaužitju zdravila Tredaptive postanejo omotični.
flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/discomfort, and back pain.
zardevanje, glavobol, srbenje, siljenje na bruhanje, omotica, bruhanje, driska,
Laropiprant was not teratogenic in rats or in rabbits at systemic exposure levels at least 153 and 438 times the human exposure based on the AUC of the recommended daily human dose.
Laropiprant pri podganah oz. kuncih ni bil teratogen pri sistemski izpostavljenosti, ki je bila vsaj 153oz.
Tredaptive contains lactose.
Zdravilo Tredaptive vsebuje laktozo.