FrancophonIA/ELRC3.0 huggingface dataset:
English: Solution for injection/infusion 1 pre-filled syringe with 0.8 mL 5 pre-filled syringes with 0.8 mL 10 pre-filled syringes with 0.8 mL
Slovenian: raztopina za injiciranje/infundiranje 1 napolnjena injekcijska brizga z 0,8 ml 5 napolnjenih injekcijskih brizg z 0,8 ml 10 napolnjenih injekcijskih brizg z 0,8 ml
English: The first dose of ffilgrastim should be administered at least 24 hours after cytotoxic chemotherapy.
Slovenian: Bolnik lahko prvi odmerek filgrastima prejme najmanj 24 ur po citotoksični kemoterapiji.
English: EU/1/08/445/003 2 x 5 pre-filled syringes
Slovenian: EU/1/08/445/003 2 x 5 napolnjenih injekcijskih brizg
English: Tevagrastim 30 MIU/0.5 mL solution for injection/infusion Tevagrastim 48 MIU/0.8 mL solution for injection/infusion
Slovenian: Tevagrastim 30 milijonov i.e./0,5 ml raztopina za injiciranje/infundiranje Tevagrastim 48 milijonov i.e./0,8 ml raztopina za injiciranje/infundiranje
English: EU/1/08/445/005 EU/1/08/445/006 EU/1/08/445/007 EU/1/08/445/008 EU/1/08/445/012 EU/1/08/445/013 EU/1/08/445/014
Slovenian: EU/1/08/445/010 EU/1/08/445/011 EU/1/08/445/005 EU/1/08/445/006 EU/1/08/445/007 EU/1/08/445/008
English: In patients with severe chronic neutropenia (SCN)
Slovenian: Bolniki s hudo kronično nevtropenijo Odmerjanje
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.Infants and young children (below 2 years of age) may not yet be diagnosed with HFI.
Slovenian: Pri dojenčkih in majhnih otrocih (mlajših od 2 let) morda še ni diagnosticirana dedna intoleranca za fruktozo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton - Pre-filled Syringe
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina - napolnjena brizga
English: Fertility Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Slovenian: Plodnost Filgrastim ni vplival na sposobnost razmnoževanja ali plodnost podganjih samcev ali samic.
English: Solution for injection/infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.8 mL.
Slovenian: raztopina za injiciranje/infundiranje Skupno pakiranje: 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg, ki vsebujejo 0,8 ml
English: Pseudogout (chondrocalcinosis pyrophosphate) has been reported in patients with cancer treated with filgrastim.
Slovenian: Psevdoprotin (pirofosfatna hondrokalcinoza) Pri rakavih bolnikih, ki so bili zdravljeni s filgrastimom, so poročali o psevdoprotinu (pirofosfatna hondrokalcinoza).
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Slovenian: Varnosti in učinkovitosti uporabe filgrastima še niso ovrednotili pri zdravih darovalcih, mlajših od
English: Capillary leak syndromea Aortitis
Slovenian: Žilne bolezni hipertenzija hipotenzija venookluzivna bolezend sindrom kapilarne prepustnostia aortitis
English: Tevagrastim 30 MIU/0.5 mL solution for injection/infusion Filgrastim
Slovenian: Tevagrastim 30 M i.e./0,5 ml raztopina za injiciranje/infundiranje filgrastim
English: Solution for injection/infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.5 mL.
Slovenian: raztopina za injiciranje/infundiranje Skupno pakiranje: 10 (2 pakiranji po 5) napolnjenih injekcijskih brizg, ki vsebujejo 0,5 ml
English: Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim.
Slovenian: Splenomegalija in ruptura vranice Po uporabi filgrastima so poročali o splenomegaliji in rupturi vranice.
English: Tevagrastim contains sodium
Slovenian: Zdravilo Tevagrastim vsebuje natrij
English: (300 μg)/day is recommended.
Slovenian: Priporoča se prilagoditev dnevnega odmerka v vrednosti 30 milijonov i.e. (300 μg)/dan.
English: Tevagrastim 48 MIU/0.8 mL solution for injection/infusion Filgrastim
Slovenian: Tevagrastim 48 M i.e./0,8 ml raztopina za injiciranje/infundiranje filgrastim
English: 1 pre-filled syringe with 0.5 mL with a needle safety guard 5 pre-filled syringes with 0.5 mL with a needle safety guard 10 pre-filled syringes with 0.5 mL with a needle safety guard
Slovenian: 1 napolnjena injekcijska brizga z 0,5 ml z varnostno zaščito za iglo 5 napolnjenih injekcijskih brizg z 0,5 ml z varnostno zaščito za iglo 10 napolnjenih injekcijskih brizg z 0,5 ml z varnostno zaščito za iglo
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned below.
Slovenian: se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
English: - to increase the number of white blood cells if you suffer from severe chronic neutropenia to help prevent infections.
Slovenian: - za povečevanje števila belih krvničk, če imate hudo kronično nevtropenijo, kot pomoč pri preprečevanju okužb; - pri bolnikih z napredovalo okužbo z virusom HIV, kar bo pripomoglo k zmanjšanju tveganja za okužbe.
English: EU/1/08/445/001 EU/1/08/445/002 EU/1/08/445/003 EU/1/08/445/004 EU/1/08/445/009 EU/1/08/445/010 EU/1/08/445/011
Slovenian: EU/1/08/445/003 EU/1/08/445/004 EU/1/08/445/009
English: It is important to contact your doctor immediately - if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
Slovenian: - če se vam pojavi alergijska reakcija, vključno z oslabelostjo, padcem krvnega tlaka, težavami z dihanjem, zatekanjem obraza (anafilaksa), kožnim izpuščajem, srbečim izpuščajem
English: Common (≥ 1/100 to
Slovenian: (> 1/10.000 do
English: For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MIU (10 μg)/kg/day for 4 to 5 consecutive days.
Slovenian: Za postopek izplavljanja matičnih celic iz periferne krvi zdravi darovalci 4 do 5 dni zapored prejmejo filgrastim v odmerku 1,0 milijon i.e. (10 μg)/kg/dan.
English: Solution for injection/infusion 1 pre-filled syringe with 0.5 mL 5 pre-filled syringes with 0.5 mL 10 pre-filled syringes with 0.5 mL
Slovenian: 1 napolnjena injekcijska brizga z 0,5 ml 5 napolnjenih injekcijskih brizg z 0,5 ml 10 napolnjenih injekcijskih brizg z 0,5 ml
English: Permanently discontinue Tevagrastim in patients with clinically significant hypersensitivity.
Slovenian: Pri bolnikih s klinično pomembno preobčutljivostjo je treba zdravljenje s filgrastimom trajno prekiniti.
English: Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as described in section 6.6.
Slovenian: Če ni razredčeno v skladu z navodili v poglavju 6.6, se razredčen filgrastim lahko adsorbira na steklene in plastične materiale.
English: For the mobilisation of PBPC in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Slovenian: Za izplavljanje matičnih celic v periferno kri pri bolnikih, zdravljenih z mielosupresivno ali mieloablativno terapijo, ki ji sledi avtologna presaditev matičnih celic iz periferne krvi Odmerjanje
English: Mobilisation
Slovenian: POSTOPEK UPORABE
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Slovenian: Sweetov sindrom Pri bolnikih, ki so se zdravili s filgrastimom, so poročali o primerih Sweetovega sindroma (akutni febrilni nevtrofilni dermatozi).
English: • decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
Slovenian: Zmanjšanje števila trombocitov zmanjša sposobnost strjevanja vaše krvi (trombocitopenija).
English: EU/1/08/445/005 1 pre-filled syringe EU/1/08/445/006 5 pre-filled syringes EU/1/08/445/008 10 pre-filled syringes
Slovenian: EU/1/08/445/005 1 napolnjena injekcijska brizga EU/1/08/445/006 5 napolnjenih injekcijskih brizg EU/1/08/445/008 10 napolnjenih injekcijskih brizg
English: Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koncetrirana ocetna kislina; ledocet natrijev hidroksid sorbitol (E420)
English: EU/1/08/445/009 1 pre-filled syringe with a needle safety guard EU/1/08/445/010 5 pre-filled syringe with a needle safety guard EU/1/08/445/01110 pre-filled syringe with a needle safety guard
Slovenian: EU/1/08/445/009 1 napolnjena injekcijska brizga z varnostno zaščito za iglo EU/1/08/445/010 5 napolnjenih injekcijskih brizg z varnostno zaščito za iglo EU/1/08/445/011 10 napolnjenih injekcijskih brizg z varnostno zaščito za iglo
English: 1 pre-filled syringe with 0.8 mL with a needle safety guard 5 pre-filled syringes with 0.8 mL with a needle safety guard 10 pre-filled syringes with 0.8 mL with a needle safety guard
Slovenian: raztopina za injiciranje/infundiranje 1 napolnjena injekcijska brizga z 0,8 ml z varnostno zaščito za iglo 5 napolnjenih injekcijskih brizg z 0,8 ml z varnostno zaščito za iglo 10 napolnjenih injekcijskih brizg z 0,8 ml z varnostno zaščito za iglo
English: Transfusion reactione a See section c (Description of selected adverse reactions) b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy c. Description of selected adverse reactions
Slovenian: c vključuje bolečino v kosteh, bolečino v hrbtu, artralgijo, mialgijo, bolečine v okončinah, mišičnoskeletne bolečine, mišično-skeletne bolečine v prsih, bolečine v vratu d v obdobju trženja so opažali primere pri bolnikih, ki so jim presadili kostni mozeg ali opravili izplavljanje PBPC
English: EU/1/08/445/001 1 pre-filled syringe EU/1/08/445/002 5 pre-filled syringes EU/1/08/445/004 10 pre-filled syringes
Slovenian: EU/1/08/445/001 1 napolnjena injekcijska brizga EU/1/08/445/002 5 napolnjenih injekcijskih brizg EU/1/08/445/004 10 napolnjenih injekcijskih brizg
English: Reversal of neutropenia or maintaining normal neutrophil counts:Filgrastim should be given by subcutaneous injection.
Slovenian: Način uporabe Odpravljanje nevtropenije ali ohranjanje normalnega števila nevtrofilcev:
English: Tevagrastim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution.
Slovenian: 1 ml raztopine za injiciranje/vsebuje 60 milijonov mednarodnih enot [i.e.] (600 mikrogramov) filigrastima Tevagrastim 30 milijonov i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 30 milijonov mednarodnih enot [i.e.] (300 mikrogramov) filgrastima v 0,5 ml raztopine.
English: Cases of decreased bone density and osteoporosis have been reported in paediatric patients with SCN receiving chronic treatment with filgrastim.
Slovenian: Pri pediatričnih bolnikih s hudo kronično nevtropenijo, ki prejemajo kronično zdravljenje s filgrastimom, so poročali o primerih zmanjšane kostne gostote in osteoporoze.
English: What Tevagrastim is used for
Slovenian: Za kaj uporabljamo zdravilo Tevagrastim
English: If you become pregnant during Tevagrastim treatment, please inform your doctor
Slovenian: Med zdravljenjem z zdravilom Tevagrastim takoj obvestite zdravnika, če:
English: Do not use any Tevagrastim that is left in the syringe.
Slovenian: Zdravila Tevagrastim, ki morebiti ostane v injekcijski brizgi, ne smete več uporabiti.
English: - sickle cell anaemia, as this medicine may cause sickle cell crisis
Slovenian: Pred začetkom zdravljenja se posvetujte z zdravnikom, če imate: - anemijo srpastih celic, saj lahko to zdravilo povzroči srpastocelično krizo.
English: • a change in how your body regulates fluids within your body and may result in puffiness (fluid volume disturbances)
Slovenian: • spremenjeno telesno uravnavanje tekočin, ki lahko povzroči zabuhlost (motnje volumna
English: Dilution to a final concentration less than 0.2 MIU (2 μg) per mL is not recommended at any time.
Slovenian: Zdravila nikoli ne smete razredčiti v tolikšni meri, da bi koncentracija padla pod 0,2 milijona i.e. (2 μg).
English: Thrombocytopenia has been reported in patients receiving filgrastim.
Slovenian: Trombocitopenija Pri bolnikih, ki so prejemali filgrastim, so poročali o trombocitopeniji.
English: • It is important to tell your doctor if you:are pregnant or breast-feeding
Slovenian: morate zdravniku povedati, da imate (ali ima vaš otrok) dedno intoleranco za fruktozo.
English: Myelodysplastic syndrome or Chronic myeloid leukemia
Slovenian: mielodisplastičnega sindroma ali levkemične preobrazbe.
English: Tevagrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Slovenian: Pri bolnikih, pri katerih se pojavi resna alergijska reakcija, je treba zdravljenje s filgrastimom trajno prekiniti.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: 4.3 Kontraindikacije Preobčutljivost na zdravilno učinkovino (zdravilne učinkovine) ali katero koli pomožno snov,
English: Luxembourg/Luxemburg
Slovenian: Belgique/Belgien
English: Fatiguea Mucosal inflammatio na
Slovenian: Bolezni živčevja glavobola omotica hipestezija parestezija
English: - to increase the number of white blood cells after a bone marrow transplant to help prevent infections.
Slovenian: - za povečevanje števila belih krvničk po zdravljenju s kemoterapijo, kot pomoč pri preprečevanju okužb; - za povečanje števila belih krvničk po presaditvi kostnega mozga, kot pomoč pri preprečevanju okužb; - pred visokimi odmerki kemoterapije, da kostni mozeg proizvede več matičnih celic, ki jih je mogoče odvzeti in vrniti po zdravljenju.
English: EU/1/08/445/012 1 pre-filled syringe with a needle safety guard EU/1/08/445/013 5 pre-filled syringe with a needle safety guard EU/1/08/445/014 10 pre-filled syringe with a needle safety guard
Slovenian: EU/1/08/445/013 5 napolnjenih injekcijskih brizg z varnostno zaščito za iglo EU/1/08/445/014 10 napolnjenih injekcijskih brizg z varnostno zaščito za iglo
English: Agents such as melphalan, carmustine (BCNU) and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation, may reduce progenitor yield.
Slovenian: Dolgotrajna uporaba zdravil, kot so melfalan, karmustin (BCNU) in karboplatin pred poskusom izplavljanja krvotvornih matičnih celic, lahko zmanjša pričakovani donos teh celic, vendar pa je bilo ugotovljeno, da je uporaba melfalana, karboplatina ali BCNU skupaj s filgrastimom učinkovita pri izplavljanju krvnih matičnih celic.
English: Manufacturer
Slovenian: Nemčija Izdelovalec
English: • bumpy skin rash (rash macuo-papular)
Slovenian: • izbočen kožni izpuščaj (makulopapulozni izpuščaj)
English: Congenital neutropenia
Slovenian: Zaustavitev napredovanja nevtropenije
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TEVA GmbH
English: Tevagrastim can be used - to increase the number of white blood cells after treatment with chemotherapy to help prevent infections.
Slovenian: Matične celice se vrnejo v kostni mozeg in tvorijo krvničke; - za povečevanje števila belih krvničk, če imate hudo kronično nevtropenijo, kot pomoč pri preprečevanju okužb; - pri bolnikih z napredovalo okužbo z virusom HIV, kar bo pripomoglo k zmanjšanju tveganja za okužbe.
English: Injection site reaction
Slovenian: Napolnjena injekcijska brizga
English: Acute respiratory distress syndromea Respiratory failurea Pulmonary oedemaa Pulmonary haemorrhag e
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija anemijae splenomegalijaa zmanjšanje vrednosti hemoglobinae levkocitozaa ruptura vranicea srpastocelična anemija s krizoa
English: Infestations
Slovenian: ZDRAVILA
English: • increased)
Slovenian: • tekočine)
English: The recommended starting dose of filgrastim is 1.0 MIU (10 μg)/kg/day The first dose of filgrastim should be administered at least 24 hours after cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Slovenian: Bolnik lahko prvi odmerek filgrastima prejme po najmanj 24 urah po citotoksični kemoterapiji oziroma po najmanj 24 urah v primeru presaditve kostnega mozga.
English: Please tell your doctor before starting treatment, if you have
Slovenian: Preden boste dobili zdravilo,
English: Gastrointestinal disorders
Slovenian: Navodila za samoinjiciranje
English: Key pharmaceutical parameters of the drug product, manufacturing process and control are established .
Slovenian: Vzpostavitev ključnih farmacevtskih parametrov zdravila, proizvodnega postopka in nadzora.
English: Conditions for the lifting of the marketing authorisation suspension
Slovenian: Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
English: Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Slovenian: Pred preklicem začasnega umika dovoljenj za promet z zdravilom bodo nacionalni pristojni organi, ki jih usklajuje referenčna država članica, zagotovili, da imetnik dovoljenja za promet z zdravilom izpolni naslednja pogoja:
English: • the rapporteur's and co-rapporteur's assessment reports;
Slovenian: • poročil poročevalca in soporočevalca o oceni zdravila,
English: Therefore, the Committee adopted an opinion recommending the refusal of the marketing authorisation in the concerned member states and the suspension of the marketing authorisation in the reference member state, subject to the conditions outlined in annex III of the Opinion.
Slovenian: Odbor je zato sprejel mnenje, v katerem priporoča zavrnitev dovoljenja za promet z zdravilom v zadevnih državah članicah in začasni umik dovoljenja za promet z zdravilom v referenčni državi članici v skladu s pogoji, opredeljenimi v Dodatku III tega mnenja.
English: Therapeutic equivalence to the reference product, through an appropriate clinical study or other validated model is demonstrated.
Slovenian: Prikaz terapevtske enakovrednosti z referenčnim zdravilom z ustrezno klinično študijo ali drugim validiranim modelom.
English: • the description of the pharmaceutical development was considered to be unsatisfactory and the deficiencies resulting from this, including the absence of skin permeation or similar in vitro studies, were considered to be critical;
Slovenian: • opis farmacevtskega razvoja ni bil zadosten in pomanjkljivosti, ki izhajajo iz tega, vključno z odsotnostjo študije kožne prepustnosti ali podobne študije in vitro, so se štele kot kritične;
English: the CHMP was of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Slovenian: • znanstvene razprave v odboru je CHMP menil, da podatki, predloženi v podporo vlogi, ne izpolnjujejo zahtev iz člena 10 Direktive 2001/83/ES, kakor je bila spremenjena.
English: The CHMP considered that the data submitted in support of this application failed to show therapeutic equivalence between the test and the reference product:
Slovenian: CHMP je menil, da podatki, predloženi v podporo vlogi, niso ustrezno dokazali terapevtske enakovrednosti testnega in referenčnega zdravila:
English: • the data provided by the company was considered to be neither robust nor extensive enough to warrant waiving a clinical study, or other validated model, to show therapeutic equivalence.
Slovenian: • podatki, ki jih je predložila družba, niso bili trdni niti dovolj obsežni, da bi utemeljili opustitev klinične študije ali drugega validiranega modela, ki bi dokazal terapevtsko enakovrednost.
English: • the results from the studies provided by the MAH;
Slovenian: • rezultatov študij, ki jih je predložil imetnik dovoljenja za promet z zdravilom;
English: The study lasted four months.
Slovenian: Študija je trajala štiri mesece.
English: The name of the medicine was changed to Alli on 12 September 2008.
Slovenian: Ime zdravila je bilo 12. septembra 2008 spremenjeno v Alli.
English: Previously known as Orlistat GSK.
Slovenian: Prej znano kot Orlistat GSK
English: This authorisation was based on the authorisation already granted in 1998 to Xenical capsules.
Slovenian: Dovoljenje je temeljilo na dovoljenju, ki je leta 1998 že bilo odobreno za kapsule Xenical.
English: Alli should not be taken for more than six months.
Slovenian: Zdravilo Alli se ne sme uporabljati več kot šest mesecev.
English: Other information about Alli
Slovenian: Druge informacije o zdravilu Alli
English: The European Commission granted a marketing authorisation valid throughout the EU for Orlistat GSK on 23 July 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Orlistat GSK, veljavno po vsej Evropski uniji, odobrila dne 23. julija 2007.
English: What benefit has Alli shown during the studies?
Slovenian: Kakšne koristi je zdravilo Alli izkazalo med študijami?
English: Neither the patients nor the doctors knew which treatment each patient was taking until the end of the study.
Slovenian: Niti zdravniki niti bolniki do konca študije niso vedeli katero zdravilo bolnik prejema.
English: What is the risk associated with Alli?
Slovenian: Kakšna tveganja so povezana z zdravilom Alli?
English: The patient should be on a diet in which about 30% of the calories come from fat.
Slovenian: Bolnik mora biti na dieti, ki vsebuje približno 30 % kalorij iz maščob.
English: The full EPAR for Alli can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Alli je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In all of the studies, the main measure of effectiveness was the change in weight.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti sprememba telesne mase.
English: Alli capsules have been studied in three main studies.
Slovenian: Zdravilo Alli v obliki kapsul so proučevali v treh glavnih študijah.
English: It is available as capsules (60 mg) and as chewable tablets (27 mg).
Slovenian: Na voljo je v obliki kapsul (60 mg) in žvečljivih tablet (27 mg).
English: In general, they are mild, and occur at the beginning of treatment, going away after some time.
Slovenian: Večinoma so blagi, pojavijo se na začetku zdravljenja in sčasoma izginejo.
English: This is a summary of the European public assessment report (EPAR) for Alli.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Alli.
English: The CHMP decided that the benefits of Alli are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Alli večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: For more information about treatment with Alli, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Alli preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Patients taking Alli should start a diet and exercise regime before beginning treatment.
Slovenian: Bolniki, ki jemljejo zdravilo Alli, morajo z dieto in telesno vadbo začeti pred začetkom zdravljenja.
English: One Alli capsule or chewable tablet is taken just before, during, or up to one hour after each main meal, three times a day.
Slovenian: Ena kapsula ali žvečljiva tableta zdravila Alli se vzame trikrat na dan tik pred vsakim glavnim obrokom, med njimi ali do eno uro po njem.