natgillin/translations-raw huggingface dataset:
- if you are pregnant or nursing,
61 Bodite posebno pozorni pri jemanju zdravila Xeloda Pred začetkom zdravljenja z zdravilom Xeloda obvestite svojega zdravnika, če
- if you have liver ailments or kidney problems,
- imate jetrno ali ledvično bolezen,
- if you have a known deficiency for the enzyme dihydropyrimidine dehydrogenase (DPD), or
- imate ali ste imeli druge bolezni, kot so težave s srcem ali bolečina v prsih,
Take special care with Xeloda:
- imate možgansko bolezen,
- have liver or kidney diseases
- imate porušeno ravnovesje kalcija,
- have calcium imbalances
- imate sladkorno bolezen.
Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
You need to be particularly careful if you are taking any of the following: • gout medicines (allopurinol), • blood-thinning medicines (coumarin, warfarin), • certain anti-viral medicines (sorivudine and brivudine) or • medicines for seizures or tremors (phenytoin).
Posebno previdni morate biti pri jemanju naslednjih zdravil: − zdravil proti protinu (alopurinol), − zdravil proti strjevanju krvi (kumarini, varfarin), − določenih protivirusnih zdravil (sorivudin in brivudin) ali − zdravil za preprečevanje epileptičnih napadov ali tremorja (fenitoin).
You should take Xeloda no later than 30 minutes after meals.
Jemanje zdravila Xeloda skupaj s hrano in pijačo Zdravilo Xeloda morate vzeti najpozneje 30 minut po obroku.
Pregnancy and breast-feeding Before starting treatment, you must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant.
Nosečnost in dojenje Svojemu zdravniku morate povedati, če ste noseči, če mislite, da ste noseči ali če nameravate zanositi.
You should not take Xeloda if you are pregnant or think you might be.
Če ste noseči ali če obstaja sum na nosečnost, zdravila Xeloda ne smete jemati.
You should not breast-feed if you are taking Xeloda.
Med zdravljenjem z zdravilom Xeloda ne smete dojiti.
It is therefore possible that Xeloda could affect your ability to drive a car or operate machinery.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Xeloda lahko povzroči omotico, slabost ali občutek utrujenosti, zato lahko vpliva na vašo sposobnost za vožnjo in upravljanje s stroji.
This medicinal product contains anhydrous lactose as an excipient.
Pomembne informacije o nekaterih sestavinah zdravila Xeloda Zdravilo vsebuje brezvodno laktozo kot pomožno snov.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Xeloda.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
HOW TO TAKE XELODA
KAKO JEMATI ZDRAVILO XELODA
Xeloda tablets should be swallowed with water.
Tablete Xeloda je treba pogoltniti z vodo.
The usual dose for adults is 1250 mg/ m2 of body surface area taken two times daily (morning and evening).
Običajni odmerek za odrasle je 1250 mg/ m2 telesne površine dvakrat na dan (zjutraj in zvečer).
A person whose body weight is 64 kg and height is 1.64 m has a body surface area of 1.7 m2 and should take 4 tablets of 500 mg and 1 tablet of 150 mg two times daily.
Navedena sta dva primera: oseba, ki tehta 64 kg in je visoka 1, 64 m, ima telesno površino 1, 7 m2 in jemlje 4 tablete po 500 mg in 1 tableto po 150 mg dvakrat na dan.
A person whose body weight is 80 kg and height is 1.80 m has a body surface area of 2.00 m2 and should take 5 tablets of 500 mg two times daily.
Oseba, ki tehta 80 kg in je visoka 1, 80 m, ima telesno površino 2, 00 m2 in jemlje 5 tablet po 500 mg dvakrat na dan.
Xeloda tablets are usually taken for 14 days followed by a 7 day rest period (when no tablets are taken).
Tablete zdravila Xeloda se običajno jemljejo 14 dni, čemur sledi 7- dnevni premor (ko se tablet ne jemlje).
This 21 day period is one treatment cycle.
To 21- dnevno obdobje je en cikel zdravljenja.
In combination with other agents the usual dose for adults may be less than 1250 mg/ m2 of body surface area, and you may need to take the tablets over a different time period (e. g. every day, with no rest period).
Tablete boste morda jemali po drugi shemi (npr. vsak dan brez premora).
Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose. • Take the tablets in the combination prescribed by your doctor for your morning and evening doses. • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner). • It is important that you take all your medication as prescribed by your doctor.
62 Zdravnik vam bo morda predpisal jemanje kombinacije 150- mg in 500- mg tablet pri vsakem odmerku. • Tablete v kombinaciji, ki vam jo je predpisal zdravnik, jemljite kot jutranji in večerni odmerek. • Tablete zaužijte v 30 minutah po koncu obroka (zajtrka in večerje). • Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal vaš zdravnik.
59 If you take more Xeloda than you should, contact your doctor before taking the next dose.
Če ste vzeli večji odmerek zdravila Xeloda, kot bi smeli, se posvetujte z zdravnikom, še preden boste zaužili naslednjega.
If you forget to take Xeloda: do not take the missed dose at all and do not double the next one.
Če ste pozabili vzeti zdravilo Xeloda: ne zaužijte izpuščenega odmerka in naslednjič ne vzemite dvojnega odmerka.
There are no side-effects caused by stopping treatment with Xeloda.
Če ste prenehali jemati zdravilo Xeloda Po prenehanju zdravljenja z zdravilom Xeloda se ne pojavijo neželeni škodljivi učinki.
In case you are using coumarin anticoagulants (e. g.
Če sočasno jemljete kumarinske antikoagulante (npr.
Marcumar), stopping Xeloda might require that your doctor adjusts your anticoagulant dose.
Marcumar) vam bo zdravnik v primeru prekinitve zdravljenja z zdravilom Xeloda morda moral prilagoditi odmerek antikoagulanta.
Like all medicines, Xeloda can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Xeloda neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The most common side effects of Xeloda which may affect more than 1 person in 10 are: • diarrhoea, nausea, vomiting, stomatitis (sores in mouth and throat) and abdominal pain • hand-and-foot skin-reaction (palms of the hands or soles of the feet tingle, become numb, painful, swollen or red), rash, dry or itchy skin • tiredness • loss of appetite (anorexia)
Najpogostnejši neželeni učinki zdravila Xeloda, ki se lahko pojavijo pri več kot 1 bolniku od 10 so: • driska, slabost, bruhanje, stomatitis (rane v ustih in žrelu) in bolečina v trebuhu; • kožna reakcija na roki in nogi (ščemenje, zbadanje, mravljinci na dlaneh rok ali podplatih, dlani ali podplati postanejo otrpli, boleči, otekli ali rdeči), izpuščaj, suha ali srbeča koža; • utrujenost; • izguba apetita (anoreksija).
These side effects can become severe; therefore, it is important that you always contact your doctor immediately when you start to experience a side effect.
Ti neželeni učinki lahko postanejo resni.
Your doctor may instruct you to decrease the dose and/ or temporarily discontinue treatment with Xeloda.
Če se pojavijo, se takoj posvetujte s svojim zdravnikom.
This will help reduce the likelihood that the side effect continues or becomes severe.
Zdravnik vam bo morda zmanjšal odmerek ali začasno prekinil zdravljenje z zdravilom Xeloda ali oboje, kar bo pomagalo zmanjšati verjetnost, da bi se nadaljevali ali postali resni.
STOP taking Xeloda immediately and contact your doctor if any of these symptoms occur: • Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night. • Vomiting: if you vomit more than once in a 24-hour time period. • Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual. • Stomatitis: if you have pain, redness, swelling or sores in your mouth. • Hand-and-foot skin-reaction: if you have pain, swelling, and redness of hands and/ or feet • Fever or Infection: if you have a temperature of 38°C or greater, or other signs of infection. • Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.
Če se pojavi katerikoli od navedenih simptomov, takoj PRENEHAJTE z jemanjem zdravila Xeloda in pokličite svojega zdravnika: • Driska: če pogostnost dnevnih iztrebljanj preseže število, ki je za vas običajno, za štiri ali več, ali če imate ponoči drisko. • Bruhanje: če bruhate več kot enkrat v enem dnevu. • Slabost: če izgubite tek in če je količina hrane, ki jo zaužijete vsak dan mnogo manjša kot ponavadi. • Stomatitis: če imate bolečino, rdečino, otekanje ali rane v ustih. • Kožna reakcija na rokah in nogah: če imate bolečine, otekanje in rdečino na rokah ali nogah ali obojih okončinah. • Zvišana telesna temperatura ali okužba: če imate telesno temperaturo 38 °C ali več ali druge znake okužbe. • Bolečina v prsnem košu: če občutite bolečino omejeno na sredino prsnega koša, še posebno, če se pojavi med naporom.
Other less common and usually mild side-effects which may affect between 1 and 10 people in 100 have been seen: decreases in the number of white blood cells or red blood cells, skin rashes, slight hair loss, weariness, fever, weakness, drowsiness, headache, numbness or tingling sensations, taste changes, dizziness, sleeplessness, swelling in the legs, constipation, dehydration, cold sores, inflammation of the nose and throat, chest infection, depression, problems with the eyes, inflammation of the veins (thrombophlebitis), shortness of breath, nose bleeds, cough, runny nose, bleeding from the gut, heartburn, excess wind, dry mouth, skin discolouration, nail disorder, pain in the joints, chest or back and loss of weight.
63 Drugi manj pogosti in ponavadi blagi neželeni učinki, ki se lahko pojavijo pri več kot 1 in manj kot 10 bolnikih od 100, so zmanjšanje števila belih ali rdečih krvnih celic, kožni izpuščaji, rahlo izpadanje las, utrujenost, zvišana telesna temperatura, slabotnost, zaspanost, glavobol, otrplost ali občutek ščemenja, zbadanja ali mravljincev, sprememba okusa, omotica, nespečnost, otekanje nog, zaprtje, dehidracija, mehurčki na ustnicah, vnetje nosu in žrela, okužba v prsnem košu, depresija, težave z očmi, vnetje ven (tromboflebitis), kratka sapa, krvavitev iz nosu, kašelj, izcedek iz nosu, krvavitev iz črevesa, zgaga, plini, suha usta, razbarvanje kože, spremembe na nohtih, bolečina v sklepih, prsnem košu ali hrbtu in zmanjšanje telesne mase.
60 If you are concerned about these or any other unexpected effect(s), talk to your doctor.
Če ste zaradi opisanih ali katerih koli drugih nepričakovanih pojavov zaskrbljeni, se posvetujte z zdravnikom.
HOW TO STORE XELODA
SHRANJEVANJE ZDRAVILA XELODA
Do not use Xeloda after the expiry date which is stated on the outer pack and label.
Shranjujte pri temperaturi do 30 °C.
Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in nalepki.
What Xeloda contains
Kaj vsebuje zdravilo Xeloda
- The active substance is capecitabine (150 mg per film-coated tablet).
- Zdravilna učinkovina je kapecitabin (150 mg v eni filmsko obloženi tableti).
Tablet core: anhydrous lactose, croscarmellose sodium, hypromellose, microcrystalline cellulose, magnesium stearate.
jedro tablete: brezvodna laktoza, natrijev premrežen karmelozat, hipromeloza, mikrokristalna celuloza, magnezijev stearat;
Tablet coating: hypromellose, titanium dioxide (E171), yellow and red iron oxide (E172), talc.
obloga tablete: hipromeloza, titanov dioksid (E171), rumeni in rdeči železov oksid (E172), smukec.
Xeloda 150 mg film-coated tablet pack contains 60 film-coated tablets (6 blisters of 10 tablets).
Eno pakiranje zdravila Xeloda 150 mg filmsko obložene tablete vsebuje 60 filmsko obloženih tablet (6 pretisnih omotov po 10 tablet).
Roche Pharma AG Emil-Barell-Str.
64 Izdelovalec Roche Pharma AG Emil Barell Str.
Xeloda 500 mg film-coated tablets capecitabine
Xeloda 500 mg filmsko obložene tablete kapecitabin
Xeloda contains 500 mg capecitabine, which itself is not a cytostatic agent.
Zdravilo Xeloda vsebuje 150 mg kapecitabina, ki sam nima citostatičnega učinka.
Do not take Xeloda:
Ne jemljite zdravila Xeloda:
- if you are allergic (hypersensitive) to capecitabine or any of the other ingredients of Xeloda.
Če
You must inform your doctor if you know that you have an allergy or over-reaction to Xeloda,
imate preobčutljivostno reakcijo na zdravilo Xeloda, obvestite svojega zdravnika!
- if you are pregnant or nursing,
- če ste noseči ali dojite,
- if you have blood disorders,
- če imate krvne motnje,
- if you have liver ailments or kidney problems,
- če imate jetrne bolezni ali težave z ledvicami,
- if you have a known deficiency for the enzyme dihydropyrimidine dehydrogenase (DPD), or
- če je znano, da imate pomanjkanje encima dihidropirimidin dehidrogenaze (DPD) ali
- if you are being treated now or have been treated in the last 4 weeks with brivudine, sorivudine
- če se trenutno zdravite ali ste se v preteklih 4 tednih zdravili z brivudinom, sorivudinom ali
or similar classes of substance as part of herpes zoster (chickenpox or shingles) therapy.
podobnimi učinkovinami, ki se uporabljajo kot del zdravljenja herpes zostra (norice ali pasovec).
Before treatment with Xeloda, make sure your doctor knows if you
67 Bodite posebno pozorni pri jemanju zdravila Xeloda Pred začetkom zdravljenja z zdravilom Xeloda obvestite svojega zdravnika, če
- have liver or kidney diseases
- imate jetrno ali ledvično bolezen,
- have or had other illnesses, such as heart problems or chest pain
- imate ali ste imeli druge bolezni, kot so težave s srcem ali bolečina v prsih,
- have brain diseases
- imate možgansko bolezen,
- have calcium imbalances
- imate porušeno ravnovesje kalcija,
- have diabetes
- imate sladkorno bolezen.
This is extremely important, as taking more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Posebno previdni morate biti pri jemanju naslednjih zdravil:
You need to be particularly careful if you are taking any of the following: − gout medicines (allopurinol), − blood-thinning medicines (coumarin, warfarin), − certain anti-viral medicines (sorivudine and brivudine) or − medicines for seizures or tremors (phenytoin).
- zdravil proti protinu (alopurinol),
Taking Xeloda with food and drink:
- zdravil proti strjevanju krvi (kumarini, varfarin),
Your doctor may want you to take a combination of 150 mg and 500 mg tablets for each dose. • Take the tablets in the combination prescribed by your doctor for your morning and evening doses. • Take the tablets within 30 minutes after the end of a meal (breakfast and dinner). • It is important that you take all your medication as prescribed by your doctor.
68 Zdravnik vam bo morda predpisal jemanje kombinacije 150- mg in 500- mg tablet pri vsakem odmerku. • Tablete v kombinaciji, ki vam jo je predpisal zdravnik, jemljite kot jutranji in večerni odmerek. • Tablete zaužijte v 30 minutah po koncu obroka (zajtrka in večerje). • Pomembno je, da jemljete vsa zdravila tako, kot vam je predpisal vaš zdravnik.
65 If you take more Xeloda than you should, contact your doctor before taking the next dose.
Če ste vzeli večji odmerek zdravila Xeloda, kot bi smeli, se posvetujte z zdravnikom, še preden boste zaužili naslednjega.
STOP taking Xeloda immediately and contact your doctor if any of these symptoms occur: • Diarrhoea: if you have an increase of 4 or more bowel movements compared to your normal bowel movements each day or any diarrhoea at night. • Vomiting: if you vomit more than once in a 24-hour time period. • Nausea: if you lose your appetite, and the amount of food you eat each day is much less than usual. • Stomatitis: if you have pain, redness, swelling or sores in your mouth. • Hand-and-foot skin-reaction: if you have pain, swelling, and redness of hands and/ or feet. • Fever or Infection: if you have a temperature of 38°C or greater, or other signs of infection. • Chest pain: if you experience pain localised to the centre of the chest, especially if it occurs during exercise.
Če se pojavi katerikoli od navedenih simptomov, takoj PRENEHAJTE z jemanjem zdravila Xeloda in pokličite svojega zdravnika: • Driska: če pogostnost dnevnih iztrebljanj preseže število, ki je za vas običajno, za štiri ali več, ali če imate ponoči drisko. • Bruhanje: če bruhate več kot enkrat v enem dnevu. • Slabost: če izgubite tek in če je količina hrane, ki jo zaužijete vsak dan mnogo manjša kot ponavadi. • Stomatitis: če imate bolečino, rdečino, otekanje ali rane v ustih. • Kožna reakcija na rokah in nogah: če imate bolečine, otekanje in rdečino na rokah ali nogah ali obojih okončinah. • Zvišana telesna temperatura ali okužba: če imate telesno temperaturo 38 °C ali več ali druge znake okužbe. • Bolečina v prsnem košu: če občutite bolečino omejeno na sredino prsnega koša, še posebno, če se pojavi med naporom.
Other less common and usually mild side-effects which may affect between 1 person and 10 people in 100 have been seen: decreases in the number of white blood cells or red blood cells, skin rashes, slight hair loss, weariness, fever, weakness, drowsiness, headache, numbness or tingling sensations, taste changes, dizziness, sleeplessness, swelling in the legs, constipation, dehydration, cold sores, inflammation of the nose and throat, chest infection, depression, problems with the eyes, inflammation of the veins (thrombophlebitis), shortness of breath, nose bleeds, cough, runny nose, bleeding from the gut, heartburn, excess wind, dry mouth, skin discolouration, nail disorder, pain in the joints, chest or back and loss of weight.
69 Drugi manj pogosti in ponavadi blagi neželeni učinki, ki se lahko pojavijo pri več kot 1 in manj kot 10 bolnikih od 100, so zmanjšanje števila belih ali rdečih krvnih celic, kožni izpuščaji, rahlo izpadanje las, utrujenost, zvišana telesna temperatura, slabotnost, zaspanost, glavobol, otrplost ali občutek ščemenja, zbadanja ali mravljincev, sprememba okusa, omotica, nespečnost, otekanje nog, zaprtje, dehidracija, mehurčki na ustnicah, vnetje nosu in žrela, okužba v prsnem košu, depresija, težave z očmi, vnetje ven (tromboflebitis), kratka sapa, krvavitev iz nosu, kašelj, izcedek iz nosu, krvavitev iz črevesa, zgaga, plini, suha usta, razbarvanje kože, spremembe na nohtih, bolečina v sklepih, prsnem košu ali hrbtu in zmanjšanje telesne mase.
66 If you are concerned about these or any other unexpected effect(s), talk to your doctor.
Če ste zaradi opisanih ali katerih koli drugih nepričakovanih pojavov zaskrbljeni, se posvetujte z zdravnikom.
- The active substance is capecitabine (500 mg per film-coated tablet).
- Zdravilna učinkovina je kapecitabin (500 mg v eni filmsko obloženi tableti).
Xeloda 500 mg film-coated tablet pack contains 120 film-coated tablets (12 blisters of 10 tablets).
Eno pakiranje zdravila Xeloda 500 mg filmsko obložene tablete vsebuje 120 filmsko obloženih tablet (12 pretisnih omotov po 10 tablet).
Roche Pharma AG Emil-Barell-Str.
70 Izdelovalec Roche Pharma AG Emil Barell Str.
Xenical is used together with dieting for the treatment of obese (very overweight) patients with a body mass index (BMI) greater than or equal to 30 kg per square metre, or overweight patients (BMI greater than or equal to 28 kg/ m2) who are at risk of illness because of their weight.
Zdravilo Xenical se hkrati z dieto uporablja za zdravljenje debelosti (izrazito prevelike telesne mase) pri bolnikih z indeksom telesne mase (ITM) 30 kg na kvadratni meter ali več ter pri bolnikih s preveliko telesno maso (ITM večji od ali enak 28 kg/ m²), katerih zdravje je ogroženo zaradi njihove teže.
The patient should be on a diet in which about 30% of the calories come from fat, and which is rich in fruit and vegetables.
Bolnik mora biti na dieti, v kateri okoli 30% kalorij izvira iz maščob in ki je bogata s sadjem in zelenjavo.
Treatment with Xenical should be stopped after 12 weeks if patients have been unable to lose at least 5% of their body weight since the start of treatment.
Če se telesna masa bolnika po 12 tednih ne zmanjša vsaj za 5% izhodiščne telesne mase, je treba zdravljenje z zdravilom Xenical ukiniti.
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about 30% of the fat eaten in the meal to pass through the gut undigested.
Če so ti encimi blokirani, potem ne morejo razkrojiti nekaterih maščob, zaradi česar se približno 30% maščob, zaužitih z hrano, izloči skozi črevo neprebavljenih.
An additional longer study in over 3,000
V teh študijah, ki so potekale od enega do dveh let, so primerjali tri različne odmerke zdravila Xenical s placebom (zdravilom brez zdravilne učinkovine) v kombinaciji z dieto.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Niti zdravniki niti bolniki do konca študije niso vedeli, katero 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
In all studies, the main measure of effectiveness was the change in weight.
V dodatni daljši študiji, ki je obsegala več kot 3000 debelih bolnikov in je trajala štiri leta, so primerjali učinke zdravila Xenical in placeba v kombinaciji z dieto in telesno aktivnostjo.
When the results from all seven shorter studies were taken together, patients taking 120 mg Xenical three times a day had an average fall of 6.1 kg in body weight after a year, compared with 2.6 kg in those taking placebo.
Ko so povzeli rezultate vseh sedmih krajših študij, so ugotovili, da so bolniki, ki so prejemali zdravilo Xenical 120 mg trikrat dnevno, v povprečju izgubili 6, 1 kg telesne mase v letu dni, v primerjavi z 2, 6 kg pri bolnikih, ki so prejemali placebo.
The proportion of patients losing 10% or more of their body weight was 20% in the patients taking this dose of Xenical and 8% in those taking placebo.
Delež bolnikov, ki so izgubili 10% ali več svoje telesne mase, je bil 20% pri bolnikih, ki so prejemali odmerek zdravila Xenical, in 8% pri bolnikih, ki so prejemali placebo.
At the end of the four-year study, 21% of the patients treated with Xenical had lost more than 10% of their body weight, compared with 10% of the patients who received placebo.
Na koncu štiriletne študije je 21% bolnikov, ki so bili zdravljeni z zdravilom Xenical, izgubilo več kot 10% svoje telesne mase v primerjavi z 10% bolnikov, ki so prejemali placebo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Xenical’ s benefits are greater than its risks in conjunction with a mildly hypocalorific diet for the treatment of obese patients with a BMI greater or equal to 30 kg/ m2, or overweight patients (BMI ≥ 28 kg/ m2) with associated risk factors.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Xenical v kombinaciji z zmerno nizkokalorično dieto za zdravljenje debelosti pri bolnikih z indeksom telesne mase 30 kg/ m² ali več ali pri bolnikih s preveliko telesno maso (ITM ≥ 28 kg/ m2) in hkratnimi ogrožajočimi dejavniki večje od z njim povezanih tveganj.
This summary was last updated in 06-2008.
Povzetek je bil nazadnje posodobljen 07- 2008.
Blister (PVC/ PE/ PVDC)
pretisni omot (PVC/ PE/ PVDC)
The capsule has a turquoise cap and turquoise body bearing the imprint of “ ROCHE XENICAL 120”.
trda kapsula Ovoj kapsule in pokrovček sta turkizne barve z napisom ROCHE XENICAL 120.
Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/ m², or overweight patients (BMI > 28 kg/ m²) with associated risk factors.
Zdravilo Xenical je indicirano za zdravljenje debelosti ob hkratni zmerno nizkokalorični dieti pri 2 bolnikih z indeksom telesne mase (ITM) 30 kg/ m ali več ter pri bolnikih s preveliko telesno maso 2 (ITM ≥ 28 kg/ m) in hkratnimi ogrožajočimi dejavniki.