natgillin/translations-raw huggingface dataset:
Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.
Če se telesna masa bolnika po 12 tednih ne zmanjša vsaj za 5% izhodiščne telesne mase, zdravljenje z orlistatom ukinemo.
Adults The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal.
Odrasli Priporočeni odmerek orlistata je ena 120- mg kapsula, ki naj jo bolnik vzame z vodo tik pred ali med vsakim glavnim obrokom ali do eno uro po njem.
The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat.
Bolnik mora med zdravljenjem uživati uravnovešeno, zmerno nizkokalorično prehrano, v kateri znaša kalorični delež maščob približno 30%.
Special populations The effect of orlistat in patients with hepatic and/ or renal impairment, children and elderly patients has not been studied.
Posebne skupine Učinek orlistata pri bolnikih z jetrno in/ ali ledvično odpovedjo, pri otrocih, mlajših od 12 let, in pri starejših bolnikih ni bil raziskan.
- Hypersensitivity to the active substance or to any of the excipients.
- Znana preobčutljivost za zdravilno učinkovino ali katerokoli sestavino zdravila,
- Chronic malabsorption syndrome.
- kronični malabsorpcijski sindrom,
- Cholestasis.
- holestaza,
- Breast-feeding.
- dojenje.
Co-administration of orlistat with ciclosporin is not recommended (see section 4.5).
Sočasno jemanje orlistata s ciklosporinom ni priporočljivo (glejte poglavje 4. 5).
Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).
Bolnikom svetujemo, naj upoštevajo dietna navodila (glejte poglavje 4. 2).
The possibility of experiencing gastrointestinal adverse reactions (see section 4.8) may increase when orlistat is taken with a diet high in fat (e. g. in a 2000 kcal/ day diet, > 30% of calories from fat equates to > 67 g of fat).
Možnost gastrointestinalnih neželenih učinkov (glejte poglavje 4. 8) se med zdravljenjem poveča, če bolnik med jemanjem orlistata uživa hrano z veliko vsebnostjo maščob (na primer pri dieti, ki vsebuje 2000 kilokalorij na dan, več kot 30% kalorij iz maščob ustreza več kot 67 g maščob).
If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase.
Če vzame orlistat z obrokom, ki vsebuje zelo veliko maščob, se lahko poveča nevarnost neželenih učinkov v prebavilih.
Prescribers should investigate further in case of severe and/ or persistent symptoms.
Če so simptomi hudi ali dolgotrajni ali oboje, naj zdravniki raziščejo njihov vzrok.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5).
Ker je med hudo drisko lahko peroralna kontracepcija neučinkovita, je v tem primeru priporočljiva uporaba dodatne metode kontracepcije (glejte poglavje 4. 5).
Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants (see section 4.5 and 4.8).
Pri bolnikih, ki se sočasno zdravijo s peroralnimi antikoagulanti, je treba spremljati koagulacijske parametre (glejte poglavji 4. 5 in 4. 8).
The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy in patients with underlying chronic kidney disease and/ or volume depletion (see section 4.8).
Uporaba orlistata je lahko povezana s hiperoksalurijo in oksalatno nefropatijo pri bolnikih s kronično ledvično boleznijo in/ ali izgubo tekočine (glejte poglavje 4. 8).
Rare occurrence of hypothyroidism and/ or reduced control of hypothyroidism may occur.
Redko se lahko pojavi hipotiroidizem in/ ali zmanjšana kontrola hipotiroidizma.
The mechanism, although not proven, may involve a decreased absorption of iodine salts and/ or levothyroxine (see section 4.5).
Mehanizem, ki pa ni potrjen, vključuje zmanjšano absorpcijo jodovih soli in/ ali levotiroksina (glejte poglavje 4. 5).
Orlistat may unbalance anticonvulsivant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions (see section 4.5).
Bolniki, ki jemljejo antiepileptike: orlistat lahko deluje na antikonvulzivno zdravljenje tako, da zmanjša absorpcijo antiepileptikov, kar lahko vodi do konvulzij (glejte poglavje 4. 5).
Ciclosporin A decrease in ciclosporin plasma levels has been observed in a drug-drug-interaction study and also reported in several cases, when orlistat was administered concomitantly.
Ciklosporin Zmanjšanje plazemske koncentracije ciklosporina so opazili v interakcijski študiji zdravilo- zdravilo, o tem pa so poročali tudi v nekaj primerih, ko so sočasno dajali orlistat.
Therefore the combination is not recommended (see section 4.4).
Kombinacije zato ne priporočamo (glejte poglavje 4. 4).
However, if such concomitant use is unavoidable, more frequent monitoring of ciclosporin blood levels should be performed both after addition of orlistat and upon discontinuation of orlistat in ciclosporin treated patients.
Vendar pa je v primeru, da se sočasnemu jemanju ne moremo izogniti, potrebno pri bolnikih zdravljenih s ciklosporinom pogosteje spremljati koncentracije ciklosporina v krvi, tako pri uvedbi kot tudi pri ukinitvi orlistata.
Acarbose In the absence of pharmacokinetic interaction studies, the concomitant administration of orlistat with acarbose should be avoided.
Akarboza Ker farmakokinetične interakcijske študije niso bile opravljene, se je sočasnemu jemanju orlistata z akarbozo potrebno izogibati.
Oral anticoagulants When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).
Peroralni antikoagulanti Pri sočasnem jemanju varfarina ali drugih antikoagulantov in orlistata moramo nadzorovati vrednosti INR (internacionalno normalizirano razmerje) (glejte poglavje 4. 4).
Fat soluble vitamins Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K).
Vitamini, topni v maščobi Zdravljenje z orlistatom lahko potencialno vpliva na absorpcijo liposolubilnih vitaminov (A, D, E in K).
In order to ensure
Če je treba,
3 adequate nutrition, patients on a weight control diet should be advised to have a diet rich in fruit and vegetables and use of a multivitamin supplement could be considered.
3 uporabimo multivitaminske pripravke.
Amiodarone A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly.
Amiodaron Pri majhnem številu zdravih prostovoljcev so po enkratnem odmerku amiodarona in sočasnem jemanju orlistata opazili rahlo zmanjšanje koncentracij amiodarona v plazmi.
Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs e. g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded.
Pri bolnikih, ki so se sočasno zdravili z orlistatom in antiepileptiki npr. valproatom, lamotriginom so poročali o konvulzijah.
Therefore, these patients should be monitored for possible changes in the frequency and/ or severity of convulsions.
Vzročne povezave za medsebojno delovanje ni mogoče izključiti, zato je treba pri takih bolnikih nadzorovati morebitne spremembe v pogostosti in resnosti konvulzij.
The mechanism, although not proven, may involve a decreased absorption of iodine salts and/ or levothyroxine (see section 4.4).
Mehanizem, ki pa ni potrjen, vključuje zmanjšano absorpcijo jodovih soli in/ ali levotiroksina (glejte poglavje 4. 4).
Lack of interactions No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GITS), nifedipine slow release, sibutramine or alcohol have been observed.
Odsotnost interakcij Interakcij z amitriptilinom, atorvastatinom, bigvanidi, digoksinom, fibrati, fluoksetinom, losartanom, fenitoinom, fenterminom, pravastatinom, nifedipin gastrointestinalnim terapevtskim sistemom (GITS), s pripravki nifedipina z upočasnjenim sproščanjem, sibutraminom ali z alkoholom niso opazili.
The absence of these interactions has been demonstrated in specific drug-drug-interaction studies.
Odsotnost teh interakcij so dokazali v specifičnih interakcijskih študijah zdravilo- zdravilo.
The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies.
Odsotnost interakcij med peroralnimi kontraceptivi in orlistatom so dokazali v specifičnih interakcijskih študijah zdravilo- zdravilo.
For orlistat no clinical data on exposed pregnancies are available.
Za orlistat ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
4.8 Undesirable effects Adverse reactions to orlistat are largely gastrointestinal in nature.
Neželeni učinki pri jemanju orlistata so večinoma povezani s prebavili.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000) and very rare (< 1/ 10,000) including isolated reports.
Pogostnost neželenih učinkov je razvrščena na naslednji način: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1000) in zelo redki (< 1/ 10. 000), vključno s posameznimi primeri.
4 The following table of undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of > 2% and with an incidence ≥ 1% above placebo in clinical trials of 1 and 2 years duration:
Spodnja preglednica neželenih učinkov (prvo leto zdravljenja) prikazuje neželene učinke, ki so se pojavili s pogostnostjo > 2% in z incidenco ≥ 1% v primerjavi s placebom v kliničnih preskušanjih, ki so potekala 1 ali 2 leti:
Adverse reaction/ event
Neželeni učinki
Nervous system disorders Very common:
Bolezni živčevja Zelo pogosti: glavobol.
Upper respiratory infection
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti: okužba zgornjih dihal.
Common:
Pogosti: okužba spodnjih dihal.
Abdominal pain/ discomfort Oily spotting from the rectum Flatus with discharge Faecal urgency Fatty/ oily stool Flatulence Liquid stools Oily evacuation Increased defecation
Bolezni prebavil Zelo pogosti: bolečina/ neudobje v trebuhu, oljni madeži iz rektuma, flatus z izcedkom, nujno odvajanje, mastno/ oljnato blato, flatulenca, tekoče blato, oljnato odvajanje, povečana pogostnost odvajanja.
Urinary tract infection Metabolism and nutrition disorders Infections and infestations
Pogosti: bolečina/ neudobje v rektumu, mehko blato, inkontinenca pri odvajanju, abdominalna distenzija *, bolezni zob, bolezni dlesni.
Very common:
Bolezni sečil Pogosti: okužba sečil.
Very common:
Presnovne in prehranske motnje Zelo pogosti: hipoglikemija *.
General disorders and administration site conditions
Infekcijske in parazitske bolezni Zelo pogosti: influenca.
Reproductive system and breast disorders
Splošne težave in spremembe na mestu aplikacije Pogosti: utrujenost.
Psychiatric disorders
Motnje reprodukcije in dojk Pogosti: neredna menstruacija.
Anxiety
Psihiatrične motnje Pogosti: anksioznost.
* only unique treatment adverse events that occurred at a frequency of > 2% and with an incidence ≥ 1% above placebo in obese type 2 diabetic patients.
* le enkratni neželeni učinki, ki so se pojavili s pogostnostjo > 2% in incidenco ≥ 1% v primerjavi s placebom pri bolnikih s preveliko telesno maso, ki imajo sladkorno bolezen tipa II.
In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period.
Skupna incidenca neželenih učinkov, povezanih s prebavili, ki so se pojavili v 1. letu, se je v štiriletnem obdobju zmanjševala leto za letom.
5 The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown:
5 Spodnja preglednica prikazuje neželene učinke, zbrane preko spontanega sistema poročanja po prihodu zdravila na trg, zato njihova pogostnost ni znana:
Investigations Increase in liver transaminases and in alkaline phosphatase.
Povečanje vrednosti jetrnih transaminaz in alkalne fosfataze.
Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat (see section 4.4 and 4.5)
Zmanjšana vrednost protrombina, povečan INR in neuravnovešeno antikoagulacijsko zdravljenje, ki povzroča spremembe hemostatskih parametrov pri bolnikih, ki se zdravijo z antikoagulansi in orlistatom (glejte poglavji 4. 4 in 4. 5).
Rectal bleeding Diverticulitis Pancreatitis Bullous eruptions Hypersensitivity (e. g. pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis) Cholelithiasis Hepatitis that may be serious
Bolezni prebavil krvavitev iz rektuma divertikulitis pankreatitis Bolezni kože in podkožja bulozni izpuščaj Bolezni imunskega sistema preobčutljivost (npr. pruritus, izpuščaj, urtikarija, angioedem, bronhospazem in anafilaksa) Bolezni jeter, žolčnika in žolčevodov Holelitiaza; hepatitis, ki je lahko resen.
Oxalate nephropathy
oksalatna nefropatija
Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
Enkratni odmerki orlistata po 800 mg in večkratni odmerki do 400 mg 3- krat na dan 15 dni niti pri osebah z normalno telesno maso niti pri debelih bolnikih niso imeli pomembnejših neželenih učinkov.
In addition, doses of 240 mg tid have been administered to obese patients for 6 months.
Za zdravljenje debelosti so bolniki 6 mesecev prejemali odmerke po 240 mg 3- krat na dan.
Pharmaco-therapeutic group:
Farmakoterapevtska skupina: zaviralci apetita s perifernim delovanjem.
In the 2-year studies and the 4-year study, a hypocaloric diet was used in association with treatment in both the orlistat and the placebo treated groups.
V 2- letnih študijah in 4- letni študiji so bolniki skupaj z zdravljenjem s placebom ali orlistatom prejemali tudi nizkokalorično dieto.
6 Pooled data from five 2 year studies with orlistat and a hypocaloric diet showed that 37% of orlistat patients and 19% of placebo patients demonstrated a loss of at least 5% of their baseline body weight after 12 weeks of treatment.
Združeni rezultati petih 2 leti trajajočih študij orlistata in hipokalorične diete so pokazali, da je 37% bolnikov, ki so jemali orlistat in 19% bolnikov, ki so jemali placebo, po 12 tednih zdravljenja izgubilo najmanj 5% njihove izhodiščne telesne mase.
Of these, 49% of orlistat treated patients and 40% of placebo treated patients went on to lose ≥ 10% of their baseline body weight at one year.
Od tega je 49% bolnikov, ki so jemali orlistat in 40%
Conversely, of patients failing to demonstrate a loss of 5% of their baseline body weight after 12 weeks of treatment, only 5% of orlistat treated patients and 2% of placebo treated patients went on to lose ≥ 10% of their baseline body weight at one year.
Nasprotno pa se je izkazalo, da je od bolnikov, ki jim po 12 tednih zdravljenja ni uspelo izgubiti 5% izhodiščne telesne mase, po enem letu zdravljenja uspelo izgubiti 10% ali več izhodiščne telesne mase le 5% bolnikom, ki so jemali orlistat in 2% bolnikom, ki so jemali placebo.
Overall, after one year of treatment, the percentage of patients taking 120 mg orlistat who lost 10% or more of their body weight was 20% with orlistat 120 mg compared to 8% of patients taking placebo.
Skupno je po enoletnem zdravljenju v skupini, ki je jemala 120 mg orlistata, 20% bolnikov shujšalo za 10% ali več, medtem ko je bilo v kontrolni skupini takih bolnikov 8%.
The mean difference in weight loss with the drug compared to placebo was 3.2 kg.
Povprečna razlika v zmanjšanju telesne mase skupine z zdravilom v primerjavi s placebom je znašala 3, 2 kg.
Data from the 4-year XENDOS clinical trial showed that 60% of orlistat patients and 35% of placebo patients demonstrated a loss of at least 5% of their baseline body weight after 12 weeks of treatment.
V kliničnem preskušanju XENDOS, ki je potekalo 4 leta, je 60% bolnikov, ki so jemali orlistat in 35% bolnikov, ki so jemali placebo izgubilo najmanj 5% izhodiščne telesne mase po 12 tednih zdravljenja.
Of these, 62% of orlistat treated patients and 52% of placebo treated patients went on to lose ≥ 10% of their baseline body weight at one year.
Od teh je 62% bolnikov, ki so jemali orlistat in 52% bolnikov, ki so jemali placebo po enem letu zdravljenja izgubilo 10% ali več izhodiščne telesne mase.
Conversely, of patients failing to demonstrate a loss of 5% of their baseline body weight after 12 weeks of treatment, only 5% of orlistat treated patients and 4% of placebo treated patients went on to lose ≥ 10% of their baseline body weight at one year.
Nasprotno pa se je izkazalo, da je od bolnikov, ki jim po 12 tednih zdravljenja ni uspelo izgubiti 5% izhodiščne telesne mase, po enem letu zdravljenja uspelo izgubiti 10% ali več izhodiščne telesne mase le 5% bolnikom, ki so jemali orlistat in 4% bolnikom, ki so jemali placebo.
After 1 year of treatment, 41% of the orlistat treated patients versus 21% of placebo treated patients lost ≥ 10% of body weight with a mean difference of 4.4 kg between the two groups.
Po enem letu zdravljenja je 41% bolnikov, ki je jemalo orlistat in 21% bolnikov, ki je jemalo placebo, izgubilo ≥ 10% telesne mase s povprečno razliko med skupinama 4, 4 kg.
After 4 years of treatment 21% of the orlistat treated patients compared to 10% of the placebo treated patients had lost ≥ 10% of body weight, with a mean difference of 2.7 kg.
Po 4 letih zdravljenja je 21% bolnikov, ki so se zdravili z orlistatom in 10% bolnikov, ki so jemali placebo, izgubilo za ≥ 10% telesne mase, povprečna razlika je znašala 2, 7 kg.
More patients on orlistat or placebo lost baseline body weight of at least 5% at 12 weeks or 10% at one year in the XENDOS study than in the five 2-year studies.
V študiji XENDOS je več bolnikov, ki je jemalo orlistat ali placebo izgubilo najmanj 5% izhodiščne telesne mase po 12 tednih zdravljenja ali 10% po enem letu kot pa v petih 2- letnih študijah.
The reason for this difference is that the five 2-year studies included a 4-week diet and placebo lead-in period during which patients lost on average 2.6 kg prior to commencing treatment.
Razlog za to je razlika, da je pet 2 leti trajajočih študij vključevalo uvajalno obdobje 4 tednov diete in placeba, v katerem so bolniki v povprečju izgubili 2, 6 kg pred začetkom zdravljenja.
Data from the 4-year clinical trial also suggested that weight loss achieved with orlistat delayed the development of type 2 diabetes during the study (cumulative diabetes cases incidences:
Podatki 4- letnega kliničnega preskušanja so pokazali, da je izguba telesne mase dosežena z orlistatom med študijo zakasnila razvoj sladkorne bolezni tipa II (skupna incidenca primerov sladkorne bolezni:
3.4% in the orlistat group compared to 5.4% in the placebo-treated group).
3, 4% v skupini, zdravljeni z orlistatom v primerjavi s 5, 4% v skupini, ki je prejemala placebo).
The great majority of diabetes cases came from the subgroup of patients with impaired glucose tolerance at baseline, which represented 21% of the randomised patients.
Ta skupina je predstavljala 21% randomiziranih bolnikov.
In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four one- year clinical trials showed that the percentage of responders (≥ 10% of body weight loss) was 11.3% with orlistat as compared to 4.5% with placebo.
V štirih enoletnih študijah bolnikov s preveliko telesno maso, ki so imeli z antiadiabetiki neustrezno zdravljeno sladkorno bolezen tipa II, je v skupini zdravljeni z orlistatom znašala odzivnost 11, 3% (opredeljena kot zmanjšanje telesne mase za 10% ali več) v primerjavi s 4, 5% pri placebu.
In orlistat-treated patients, the mean difference from placebo in weight loss was 1.83 kg to 3.06 kg and the mean difference from placebo in HbA1c reduction was 0.18% to 0.55%.
Povprečna razlika v zmanjšanju HbA1c v primerjavi s placebom pa je znašala 0, 18 do 0, 55%.
In a multi-centre (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat (n=357) or placebo (n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks.
V multicentrični (ZDA, Kanada), vzporedni, dvojno slepi, s placebom kontrolirani študiji je bilo 539 mladostnikov z debelostjo randomiziranih v skupino, ki je prejemala ali 120 mg orlistata (n = 357) ali placebo (n = 182) trikrat na dan kot dodatek nizkokalorični dieti in telesni aktivnosti 52 tednov.
The primary endpoint was the change in body mass index (BMI) from baseline to the end of the study.
Primarni cilj raziskave je bila sprememba v indeksu telesne mase (ITM) od začetka do zaključka študije.
The results were significantly superior in the orlistat group (difference in BMI of 0.86 kg/ m2 in favour of orlistat).
Rezultati so bili signifikantno boljši v skupini, ki je prejemala orlistat (razlika v ITM za 0, 86 kg/ m2 v prid orlistatu).
9.5% of the orlistat treated patients versus 3.3% of the placebo treated patients lost ≥ 10% of body weight after 1 year with a mean difference of 2.6 kg between the two groups.
Po 1 letu je 9, 5% bolnikov, zdravljenih z orlistatom, in 3, 3% bolnikov, ki so prejemali placebo, izgubilo ≥ 10% telesne mase s povprečno razliko 2, 6 kg med skupinama.
The difference was driven by the outcome in the group of patients with ≥ 5% weight loss after 12 weeks of treatment with orlistat representing 19% of the initial population.
Na razliko je močno vplival rezultat skupine bolnikov z ≥ 5 -% izgubo telesne mase po 12 tednih zdravljenja z orlistatom, ki so predstavljali 19% prvotne populacije.
However, there was an unexplained increase in the incidence of bone fractures (6% versus 2.8% in the orlistat and placebo groups, respectively).
Neželeni učinki so bili v splošnem podobni kot pri odraslih, prišlo pa je do nepojasnjenega povečanja v incidenci zlomov kosti (6% v skupini, ki je prejemala orlistat, in 2, 8% v skupini, ki je prejemala placebo).
Absorption Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Absorpcija Študije, v katerih so sodelovale osebe z normalno in preveliko telesno maso, so pokazale, da se absorbira le minimalna količina orlistata.
Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ ml) eight hours following oral administration of orlistat.
V plazmi je bila koncentracija nespremenjenega orlistata 8 ur po peroralnem vnosu nemerljiva (< 5 ng/ ml).
In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.
Do kopičenja ni prihajalo, kar se ujema s podatki o neznatni absorpciji.
Distribution The volume of distribution cannot be determined because the drug is minimally absorbed and has no defined systemic pharmacokinetics.
Porazdelitev Porazdelitvenega volumna ni mogoče določiti, ker se absorbira le neznatna količina zdravila, in ker nima opredeljene sistemske farmakokinetike.
In vitro orlistat is > 99% bound to plasma proteins (lipoproteins and albumin were the major binding proteins).
In vitro se več kot 99% orlistata veže na beljakovine v plazmi (pretežno na lipoproteine in albumin).
Metabolism Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall.
Presnova Študije na živalih kažejo, da se orlistat presnavlja pretežno v steni prebavil.