natgillin/translations-raw huggingface dataset:
33 Pemetrexed was not mutagenic in either the in vitro chromosome aberration test in Chinese hamster ovary cells, or the Ames test.
Pemetreksed ni bil mutagen niti v testu kromosomskih aberacij in vitro na celicah jajčnika kitajskih hrčkov niti v testu Ames.
For storage conditions of the reconstituted medicinal product see section 6.3.
33 Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6. 3.
34 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ ml pemetrexed.
500 mg viale pripravite z 20 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ ml pemetrekseda.
35 ANNEX II
35 DODATEK II
36 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Summary of Product Characteristics, 4.2)
Povzetek glavnih značilnosti zdravila, 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
37 ANNEX III
37 DODATEK III
38 LABELLING
OZNAČEVANJE
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
39 PODATKI NA ZUNANJI OVOJNINI
After reconstitution with 4.2 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, each vial contains 25 mg/ ml of pemetrexed.
Po pripravi s 4, 2 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje vsaka viala vsebuje 25 mg/ ml pemetrekseda.
Further dilution required prior to intravenous infusion (see package leaflet).
Pred intravenskim infundiranjem je potrebno še nadaljnje redčenje (glejte navodilo za uporabo).
Mannitol, hydrochloric acid, sodium hydroxide.
Manitol, klorovodikova kislina, natrijev hidroksid.
1 vial, powder for concentrate for solution for infusion.
1 viala, prašek za koncentrat za raztopino za infundiranje.
Eli Lilly Nederland B. V., Grootslag 1-5, NL-3991 RA, Houten, The Netherlands
Eli Lilly Nederland B. V., Grootslag 1- 5, NL- 3991 RA, Houten, Nizozemska
Lot {number}
{številka}
41 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
41 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ALIMTA 100 mg powder for concentrate for solution for infusion pemetrexed For intravenous use after reconstitution and dilution.
ALIMTA 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed Za intravensko uporabo po pripravi in redčenju.
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
42 PODATKI NA ZUNANJI OVOJNINI
After reconstitution with 20 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, each vial contains 25 mg/ ml of pemetrexed.
Po pripravi z 20 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje vsaka viala vsebuje 25 mg/ ml pemetrekseda.
44 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
44 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
ALIMTA 500 mg powder for concentrate for solution for infusion pemetrexed For intravenous use after reconstitution and dilution.
ALIMTA 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed Za intravensko uporabo po pripravi in redčenju.
45 PACKAGE LEAFLET
NAVODILO ZA UPORABO
46 PACKAGE LEAFLET:
46 NAVODILO ZA UPORABO
Read all of this leaflet carefully before you start receiving this medicine.
Pred začetkom prejemanja tega zdravila, natančno preberite navodilo!
- If you have further questions, please ask your doctor or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
if their symptoms are the same as yours.
škodovalo, čeprav imajo simptome bolezni, podobne vašim.
What ALIMTA is and what it is used for 2.
Kaj je zdravilo ALIMTA in za kaj ga uporabljamo 2.
Before you are given ALIMTA 3.
Kaj morate vedeti, preden boste prejeli zdravilo ALIMTA 3.
How ALIMTA is given 4.
Kako se zdravilo ALIMTA daje 4.
How to store ALIMTA 6.
Shranjevanje zdravila ALIMTA 6.
ALIMTA is a medicinal product used in the treatment of cancer.
ALIMTA je zdravilo, ki ga uporabljamo pri zdravljenju raka.
ALIMTA is a treatment for malignant pleural mesothelioma, which is given in combination with cisplatin, another anti-cancer medicine, to patients who have not received prior chemotherapy.
ALIMTA je namenjena zdravljenju malignega plevralnega mezotelioma, ki jo dajemo v kombinaciji s cisplatinom, drugim zdravilom proti raku, bolnikom, ki pred tem še niso prejemali kemoterapije.
ALIMTA is also a treatment, which is given in combination with cisplatin, for the initial treatment of patients with advanced stage of lung cancer.
ALIMTA je namenjena tudi zdravljenju, ki se daje v kombinaciji s cisplatinom, za začetno zdravljenje bolnikov z napredovalim stadijem pljučnega karcinoma.
ALIMTA is also a treatment for patients with advanced stage of lung cancer after other chemotherapy has been used.
ALIMTA je namenjena tudi zdravljenju bolnikov z napredovalim stadijem pljučnega karcinoma po tem, ko je bila že uporabljena druga kemoterapija.
BEFORE YOU ARE GIVEN ALIMTA
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO ALIMTA
You should not be given ALIMTA:
Zdravila ALIMTA ne smete prejeti:
- if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of ALIMTA.
- če ste alergični na (preobčutljivi za) pemetreksed ali na katerokoli sestavino zdravila ALIMTA.
- if you are breast-feeding; you must discontinue breast-feeding during treatment with ALIMTA.
- če dojite, morate med zdravljenjem z ALIMTO dojenje prekiniti.
Take special care with ALIMTA:
Bodite posebno pozorni pri uporabi zdravila ALIMTA:
If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive ALIMTA.
Če imate ali ste imeli težave z ledvicami, se pogovorite s svojim zdravnikom ali bolnišničnim farmacevtom, ker morda ne boste mogli prejeti ALIMTE.
Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive ALIMTA.
Pred vsako infuzijo vam bomo odvzeli vzorce krvi za vrednotenje vašega ledvičnega in jetrnega delovanja ter oceno, ali imate dovolj krvnih celic za prejemanje ALIMTE.
Your doctor may decide to change the dose or put off treating you depending on your general condition and if your blood cell counts are too low.
Vaš zdravnik se bo morda odločil spremeniti odmerek ali odložiti zdravljenje, odvisno od vašega splošnega stanja, ter ob prenizkem številu krvnih celic.
If you have had or are going to have radiation therapy, please tell your doctor.
47 Če ste imeli ali če boste imeli zdravljenje z radiacijo, prosimo, povejte to svojemu zdravniku.
47 If you have been recently vaccinated, please tell your doctor.
Če ste bili nedavno cepljeni, prosimo, povejte to svojemu zdravniku.
If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you ALIMTA.
Če se vam okrog pljuč nabira tekočina, se bo vaš zdravnik morda odločil tekočino pred dajanjem ALIMTE odstraniti.
Taking other medicines Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “ nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor’ s prescription (such as ibuprofen).
Jemanje drugih zdravil Prosimo, povejte svojemu zdravniku, če jemljete kaka zdravila proti bolečinam ali vnetju (oteklinam), denimo zdravila, imenovana “ nesteroidna protivnetna zdravila ” (NSAID- i), vključno z zdravili, ki ste jih dobili brez recepta (kot denimo, ibuprofen).
There are many sorts of NSAIDs with different durations of activity.
Obstaja veliko vrst NSAID- ov z različnimi trajanji delovanja.
Based on the planned date of your infusion of ALIMTA and/ or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Na podlagi načrtovanega datuma vaše infuzije ALIMTE in/ ali glede na stanje vašega ledvičnega delovanja, vam mora vaš zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Če niste prepričani, vprašajte svojega zdravnika ali farmacevta, ali so katera od vaših zdravil NSAID- i.
Pregnancy If you are pregnant, or thinking about becoming pregnant, tell your doctor.
Nosečnost Če ste noseči, načrtujete nosečnost ali mislite, da bi lahko bili noseči, to povejte svojemu zdravniku.
The use of ALIMTA should be avoided during pregnancy.
Uporabi ALIMTE med nosečnostjo se izogibamo.
Your doctor will discuss with you the potential risk of taking ALIMTA during pregnancy.
S svojim zdravnikom se pogovorite o možnem tveganju pri prejemanju ALIMTE v času nosečnosti.
Women must use effective contraception during treatment with ALIMTA.
Med zdravljenjem z ALIMTO morajo ženske uporabljati učinkovito metodo kontracepcije.
Breast-feeding If you are breast-feeding, tell your doctor.
Dojenje Če dojite, to povejte svojemu zdravniku.
Breast-feeding must be discontinued during ALIMTA treatment.
Dojenje morate med zdravljenjem z ALIMTO prekiniti.
Driving and using machines ALIMTA may make you feel tired.
Vpliv na sposobnost upravljanja vozil in strojev ALIMTA lahko povzroči, da se boste počutili utrujene.
Be careful when driving a car or using machinery.
Pri vožnji ali upravljanju strojev bodite previdni.
HOW ALIMTA IS GIVEN
KAKO SE ZDRAVILO ALIMTA DAJE
The dose of ALIMTA is 500 milligrams for every square metre of your body’ s surface area.
Odmerek ALIMTE je 500 miligramov za vsak kvadratni meter površine vašega telesa.
This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition.
Ta odmerek lahko prilagodimo, ali zdravljenje odložimo, odvisno od vašega števila krvnih celic ter vašega splošnega stanja.
A hospital pharmacist, nurse or doctor will have mixed the ALIMTA powder with 9 mg/ ml (0.9%) sodium chloride solution for injection before it is given to you.
Bolnišnični farmacevt, medicinska sestra ali zdravnik bo prašek ALIMTA, preden ga boste prejeli, zmešal z 9 mg/ ml (0, 9%) raztopino za injiciranje natrijevega klorida.
You will always receive ALIMTA by infusion into one of your veins.
ALIMTO boste vedno prejeli v obliki infuzije v veno.
When using ALIMTA in combination with cisplatin:
Kadar uporabljamo ALIMTO v kombinaciji s cisplatinom:
Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of ALIMTA has finished.
Cisplatin tudi dajemo v obliki infuzije v veno, približno 30 minut po zaključku infuzije ALIMTE.
Additional medicines:
48 Dodatna zdravila:
Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after ALIMTA treatment.
Kortikosteroidi: vaš zdravnik vam bo predpisal tablete steroidov (ustrezno 4 miligramom deksametazona dvakrat dnevno), ki jih boste morali jemati dan pred zdravljenjem z ALIMTO, na dan zdravljenja in na dan po zdravljenju z ALIMTO.
48 Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking ALIMTA.
Dopolnjevanje vitaminov: vaš zdravnik vam bo predpisal peroralno folno kislino (vitamin) ali multivitaminski pripravek, ki jo vsebuje (350 do 1000 mikrogramov), ki ga boste morali med prejemanjem ALIMTE jemati enkrat dnevno.
You must take at least 5 doses during the seven days before the first dose of ALIMTA.
V sedmih dneh pred prvim odmerkom ALIMTE morate vzeti vsaj 5 odmerkov.
You must continue taking the folic acid for 21 days after the last dose of ALIMTA.
Po zadnjem odmerku ALIMTE morate še 21 dni jemati folno kislino.
You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of ALIMTA and then approximately every 9 weeks (corresponding to 3 courses of ALIMTA treatment).
V tednu pred dajanjem ALIMTE boste prejeli tudi injekcijo vitamina B12 (1000 mikrogramov), nato pa še približno na vsakih 9 tednov (ustrezno 3 ciklusom zdravljenja z ALIMTO).
If you have further questions on the use of this product ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Like all medicines, ALIMTA can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo ALIMTA neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In this leaflet, when a side effect is described as “ very common” this means that it has been reported in at least 1 in every 10 patients taking the medicine.
Ko je v tem navodilu za uporabo neželeni učinek opisan kot “ zelo pogost ”, to pomeni, da je o njemu poročal najmanj 1 izmed 10 bolnikov, ki so jemali zdravilo.
When a side effect is described as “ common” this means that it has been reported in at least 1 in every 100 patients but less than 1 in every 10 patients.
Ko je neželeni učinek opisan kot “ pogost ”, pomeni, da je o njemu poročal najmanj 1 izmed 100 bolnikov, vendar manj kot 1 izmed 10 bolnikov.
When a side effect is described as “ uncommon”, this means it has been reported in at least 1 in every 1,000 patients, but less than 1 in every 100 patients.
Ko je neželeni učinek opisan kot “ občasen ”, pomeni, da je o njemu poročal najmanj 1 izmed 1. 000 bolnikov, vendar manj kot 1 izmed 100 bolnikov.
When a side effect is described as “ rare”, this means it has been reported in at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients.
Ko je neželeni učinek opisan kot “ redek ”, pomeni, da je o njemu poročal najmanj 1 izmed 10. 000 bolnikov, vendar manj kot 1 izmed 1. 000 bolnikov.
Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
Povišana telesna temperatura ali okužba (pogosto): če se pojavi temperatura 38 ºC ali višja, znojenje ali drugi znaki okužbe (ker imate lahko manj belih krvničk kot normalno, kar je zelo pogosto).
Side effects with ALIMTA may include:
Neželeni učinki z ALIMTO lahko vključujejo:
Very common (occur in at least 1 in 10 patients) Low white blood cells Low haemoglobin level (anaemia) Low platelet count Diarrhoea Vomiting Pain, redness, swelling or sores in your mouth Nausea Loss of appetite Fatigue (tiredness) Skin rash Hair loss Constipation Loss of sensation Kidney: abnormal blood tests
Zelo pogosto (vsaj 1 izmed 10 bolnikov) Nizko število belih krvnih celic Nizka raven hemoglobina (anemija) Nizko število trombocitov Diareja Bruhanje Bolečina, rdečina, otekanje ali rane v vaših ustih Slabost Izguba apetita Utrujenost (izčrpanost)
49 Fever Dehydration Kidney failure Irritation of the skin and itching Chest pain Muscle weakness.
49 Kožni izpuščaji Izguba las Zaprtje Izguba občutka Ledvice: nenormalne vrednosti krvnih testov
Uncommon (occur in at least 1 in 1000 patients but less than 1 in 100 patients) Fast heart rate Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (Excess fluid in body tissue, causing swelling).
Pogosto (vsaj 1 izmed 100 bolnikov, vendar manj kot 1 izmed 10 bolnikov) Alergijske reakcije: kožni izpuščaji / pekoč ali zbadajoč občutek Okužba Vročina Dehidracija Odpoved ledvic Draženje kože in srbenje Bolečina v prsnem košu Mišična oslabelost Konjunktivitis (vnetje očesa) Razdražen želodec Bolečina v trebuhu Sprememba okusa Jetra: nenormalne vrednosti krvnih testov
Rare (occur in more than 1 in 10000 patients but less than 1 in 1000 patients)
Občasno (vsaj 1 izmed 1. 000 bolnikov, vendar manj kot 1 izmed 100 bolnikov) Hiter srčni utrip Kolitis (vnetje sluznice debelega črevesa, ki ga lahko spremlja krvavitev iz črevesa ali danke) Intersticijska pljučnica (vnetje pljučnih mešičkov) Edem (preveč tekočine v telesnih tkivih, kar povzroča oteklino)
Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Redko (vsaj 1 izmed 10. 000 bolnikov, vendar manj kot 1 izmed 1. 000 bolnikov) Radiacijski izpuščaj (kožni izpuščaj kot pri hudi sončni opeklini), ki se lahko pojavi na koži, ki je bila v preteklosti izpostavljena radioterapiji, dneve oz. leta po radiaciji.
You might have any of these symptoms and/ or conditions.
Pojavi se lahko katerikoli od teh simptomov in/ ali stanj.
Uncommonly some patients have experienced a stroke or “ mini-stroke” while receiving ALIMTA usually in combination with another anticancer therapy.
Občasno so nekateri bolniki med prejemanjem ALIMTE, običajno v kombinaciji z drugim zdravilom proti raku, doživeli kap ali "manjšo kap".
Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy) may occur in patients who are also treated with radiation either before, during or after their ALIMTA therapy.
Pri bolnikih, ki se zdravijo z radiacijo pred, med ali po njihovem zdravljenju z ALIMTO, se lahko pojavi radiacijska pljučnica (brazgotinjenje pljučnih mešičkov v povezavi z zdravljenjem z radiacijo).
Extremity pain, low temperature and discolouration have been reported.
Poročali so o bolečini, nizki temperaturi ali bledosti okončin.
This medicinal product does not require any special storage conditions.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pakiranju.
The product should be used immediately.
Za shranjevanje ni posebnih navodil.
50 6.
50 Pripravljene raztopine in raztopine za infundiranje:
What ALIMTA contains
Kaj vsebuje zdravilo ALIMTA
Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium) ALIMTA 500 mg:
Vsaka viala vsebuje 100 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium)
Vsaka viala vsebuje 500 miligramov pemetrekseda (v obliki dinatrijevega pemetrekseda).
After reconstitution, the solution contains 25 mg/ ml of pemetrexed.
Po pripravi raztopina vsebuje 25 mg/ ml pemetrekseda.
What ALIMTA looks like and contents of the pack ALIMTA is a white to either light yellow or green-yellow lyophilised powder.
ALIMTA je bel do bodisi svetlo rumen ali zeleno- rumen liofiliziran prašek.
Each pack of ALIMTA consists of one ALIMTA vial.
Vsako pakiranje ALIMTE vsebuje eno vialo ALIMTE.
Lilly France S. A. S., rue du Colonel Lilly, F-67640, Fegersheim, France
Lilly France S. A. S., rue du Colonel Lilly, F- 67640, Fegersheim, Francija
51 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
51 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Belgique/ België/ Belgien Eli Lilly Benelux S. A Tél/ Tel: + 32-(0)2 548 84 84 България ТП "Ели Лили Недерланд "Б .В. - България тел. + 359 2 491 41 40 Č eská republika ELI LILLY Č R, s. r. o.
Tél/ Tel: + 32 - (0) 2 548 84 84 България ТП "Ели Лили Недерланд" Б. В. - България тел. + 359 2 491 41 40
Tel: + 34-91-623-1732 France Lilly France SAS Tél: +33-(0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 Ísland Icepharma hf.
Tel: + 34 91- 623- 1732 France Lilly France SAS Tél: +33 - (0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353 - (0) 1 661 4377
This leaflet was last approved in {date}
Navodilo je bilo odobreno {datum}
Use aseptic techniques during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Pri pripravi in nadaljnjemu redčenju pemetrekseda za intravensko infundiranje uporabljajte aseptično metodo.
Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ ml pemetrexed.
100 mg viale pripravite s 4, 2 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ ml pemetrekseda.
Reconstitute each 500 mg vial with 20 ml of 9 mg/ ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ ml pemetrexed.
500 mg viale pripravite z 20 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ ml pemetrekseda.
The appropriate volume of reconstituted pemetrexed solution should be further diluted to 100 ml with 9 mg/ ml (0.9%) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Ustrezno prostornino pripravljene raztopine pemetrekseda moramo še nadalje redčiti do 100 ml z 9 mg/ ml (0, 9%) raztopino za injiciranje natrijevega klorida brez konzervansa, damo jo kot intravensko infuzijo, ki teče 10 minut.
It is available as turquoise capsules (60 mg).
Na voljo je v kapsulah turkizne barve (60 mg).
Alli is used to help patients lose weight.
Zdravilo Alli bolnikom pomaga pri izgubi telesne mase.
It is used in adults who are overweight with a body mass index (BMI) greater than or equal to 28 kg per square metre, in combination with a low-calorie diet with reduced fat levels.
Uporablja se pri odraslih s čezmerno telesno maso, katerih indeks telesne mase (ITM) je večji ali enak 28 kg na kvadratni meter, ob hkratni nizkokalorični dieti z zmanjšanim vnosom maščob.
The medicine can be obtained without a prescription.
Zdravilo se dobi brez recepta.
Alli is taken as one capsule with water just before, during, or up to one hour after each main meal, three times a day.
Zdravilo Alli se jemlje v odmerku ene kapsule, ki se vzame z vodo uro pred ali med vsakim glavnim obrokom trikrat na dan.
The patient should be on a diet in which about 30% of the calories come from fat.
Bolnik mora biti na dieti, v kateri približno 30% zajemajo maščobe.
Patients taking Alli should start a diet and exercise regime before beginning treatment.
Bolniki, ki jemljejo zdravilo Alli morajo začeti dieto in telesno vadbo pred začetkom zdravljenja.
If patients taking Alli have been unable to lose weight after 12 weeks, they should speak to their doctor or pharmacist.
Če bolniki, ki jemljejo zdravilo Alli niti po 12 tednih niso mogli zmanjšati telesne mase, naj se pogovorijo s svojim zdravnikom ali farmacevtom.
It may be necessary to stop treatment.
Morda bo treba zdravljenje prekiniti.
The active substance in Alli, orlistat, is an anti-obesity medicine, which does not affect appetite.
Zdravilna učinkovina v zdravilu Alli, orlistat, je zdravilo proti debelosti, ki ne vpliva na tek.
Orlistat blocks gastrointestinal lipases (enzymes that digest fat).
Orlistat blokira lipaze (encime, ki prebavljajo maščobe) v prebavilih.
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to pass through the gut undigested.
Če so ti encimi blokirani, ne morejo prebaviti nekaterih maščob iz hrane, zaradi česar se približno četrtina maščob, zaužitih z hrano, izloči skozi črevo neprebavljenih.
This helps weight reduction.
To pa pomaga pri zmanjševanju telesne mase.
Because Alli is based on another medicine containing the same active substance already authorised in the EU (Xenical 120 mg capsules), some of the studies involved patients who took Xenical.
Ker je zdravilo Alli enako drugemu zdravilu, ki vsebuje enako zdravilno učinkovino in je že odobreno v EU (zdravilo Xenical, 120 mg, kapsule), so bili v nekatere študije vključeni bolniki, ki so jemali zdravilo Xenical.
1 Previously known as Orlistat GSK.
1 Prej znano kot zdravilo Orlistat GSK.
Alli has been studied in three main studies.
Zdravilo Alli so proučevali v treh glavnih študijah.