FrancophonIA/ELRC3.0 huggingface dataset:
English: Talzenna 1 mg is supplied as opaque, approximately 14.30 mm x 5.32 mm hard capsules with a light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).
Slovenian: Zdravilo Talzenna 1 mg je na voljo v obliki neprozornih trdih kapsul, velikih približno 14,30 mm × 5,32 mm, s pokrovčkom svetlo rdeče barve (s črno natisnjeno oznako ''Pfizer'') in belim telesom (s črno natisnjeno oznako ''TLZ 1'').
English: Feeling dizzy
Slovenian: Okvara jeter
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja zelo pogosti alopecija
English: Patients should be treated until disease progression or unacceptable toxicity occurs.
Slovenian: Priporočeni odmerek je 1 mg talazopariba enkrat na dan. Bolnike je treba zdraviti do napredovanja bolezni ali pojava nesprejemljive toksičnosti.
English: Talzenna may cause foetal harm when administered to a pregnant woman.
Slovenian: Če zdravilo Talzenna dajemo nosečnicam, lahko škoduje plodu.
English: Carbamazepine and phenytoin - anti-epileptics used to treat seizures or fits.
Slovenian: Naslednja zdravila lahko zmanjšajo učinek zdravila Talzenna: - karbamazepin in fenitoin - protiepileptični zdravili, ki ju uporabljamo za zdravljenje epileptičnih napadov ali krčev; - šentjanževka (Hypericum perforatum) - pripravek rastlinskega izvora, ki ga uporabljamo za zdravljenje blage depresije in tesnobe.
English: Opaque, approximately 14.30 mm x 5.32 mm hard capsule with an ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).
Slovenian: Neprozorna trda kapsula, velika približno 14,30 mm × 5,32 mm, s pokrovčkom slonokoščene barve (s črno natisnjeno oznako ''Pfizer'') in belim telesom (s črno natisnjeno oznako ''TLZ 0.25'').
English: Recommended starting dose
Slovenian: - Navodilo shranite.
English: Gender, n (%)
Slovenian: Spol, n (%) ženski moški
English: NAME OF THE MEDICINAL PRODUCT Talzenna 1 mg capsules talazoparib
Slovenian: Talzenna 1 mg kapsule talazoparib
English: a. Includes preferred terms of thrombocytopenia and platelet count decreased.
Slovenian: Vključuje priporočena izraza trombocitopenija in zmanjšanje števila trombocitov.
English: Talzenna 1 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Slovenian: - Talzenna 1 mg trde kapsule: ena kapsula vsebuje talazoparibijev tosilat v količini, ki ustreza
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Slovenian: Ena kapsula vsebuje talazoparibijev tosilat v količini, ki ustreza 0,25 mg talazopariba.
English: The active substance is talazoparib.
Slovenian: Kaj vsebuje zdravilo Talzenna - Učinkovina je talazoparib.
English: NAME OF THE MEDICINAL PRODUCT Talzenna 0.25 mg hard capsules talazoparib
Slovenian: Talzenna 0,25 mg trde kapsule talazoparib
English: In particular, the following may increase the risk of side effects with Talzenna: Amiodarone, carvedilol, dronedarone, propafenone, quinidine, ranolazine and verapamilgenerally used to treat heart problems.
Slovenian: Tveganje za pojav neželenih učinkov zdravila Talzenna lahko še zlasti povečajo naslednja zdravila: - amjodaron, karvedilol, dronedaron, propafenon, kinidin, ranolazin in verapamil - na splošno jih uporabljamo za zdravljenje težav s srcem; - antibiotika klaritromicin in eritromicin - uporabljamo ju za zdravljenje bakterijskih okužb; - itrakonazol in ketokonazol - uporabljamo ju za zdravljenje glivičnih okužb; - kobicistat, darunavir, indinavir, lopinavir, ritonavir, sakvinavir, telaprevir in tipranavir uporabljamo jih za zdravljenje okužbe z virusom HIV/aidsa; - ciklosporin - uporabljamo ga pri presaditvah organov za preprečevanje zavrnitve presadka; - lapatinib - uporabljamo ga za zdravljenje bolnikov z določenimi vrstami raka dojk; - kurkumin (najdemo ga na primer v koreniki kurkume) v nekaterih zdravilih (glejte tudi poglavje
English: Discuss contraception with your doctor if there is any possibility that you or your partner may become pregnant.
Slovenian: - Če obstaja možnost, da lahko zanosite oziroma zanosi vaša partnerka, se posvetujte z zdravnikom glede kontracepcije.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.
Slovenian: Ena kapsula vsebuje talazoparibijev tosilat v količini, ki ustreza 1 mg talazopariba.
English: Hair loss
Slovenian: PRETISNI OMOT
English: Duration of response by investigatord
Slovenian: Trajanje odziva po oceni raziskovalca n = 137
English: Myelosuppression-related adverse reactions of anaemia, neutropenia, and thrombocytopenia were very commonly reported in patients treated with talazoparib 1 mg/day.
Slovenian: Pri bolnikih, ki so se zdravili s talazoparibom 1 mg/dan, so zelo pogosto poročali o neželenih učinkih, povezanih z mielosupresijo, tj. anemiji, nevtropeniji in trombocitopeniji.
English: If you are breast-feeding.
Slovenian: - če dojite.
English: 90 × 1 capsules
Slovenian: trda kapsula 30 × 1 kapsula 60 × 1 kapsula 90 × 1 kapsula
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/005 (30 hard capsules)
Slovenian: EU/1/19/1377/005 (30 trdih kapsul)
English: NAME OF THE MEDICINAL PRODUCT Talzenna 1 mg hard capsules talazoparib
Slovenian: Talzenna 1 mg trde kapsule talazoparib
English: Talzenna 0.25 mg hard capsules: each capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.
Slovenian: - Talzenna 0,25 mg trde kapsule: ena kapsula vsebuje talazoparibijev tosilat v količini, ki ustreza
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Slovenian: Izgled zdravila Talzenna in vsebina pakiranja
English: BRCA status by central or local laboratory assessment, n (%)
Slovenian: Status gena BRCA glede na centralno ali lokalno laboratorijsko oceno, n (%) pozitiven na mutacijo gena BRCA1 pozitiven na mutacijo gena BRCA2
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1377/006 (30 hard capsules)
Slovenian: EU/1/19/1377/006 (30 trdih kapsul)
English: Fatigue/asthenia or dizziness may occur following administration of talazoparib.
Slovenian: Po uporabi talazopariba se lahko pojavita utrujenost/astenija ali omotica.
English: Platelet count < 50,000/μL
Slovenian: število trombocitov < 50.000/μl ≥ 75.000/μl število nevtrofilcev < 1.000/μl
English: TABLET
Slovenian: TABLETA
English: United Kingdom SoliCol D3
Slovenian: Združeno kraljestvo Solicol D3
English: Annex IC - SoliCol D3 Member State in EU/EEA
Slovenian: Priloga IC - SoliCol D3 država članica EU/EGP
English: Member State in EU/EEA
Slovenian: država članica EU/EGP
English: United Kingdom Lutigest
Slovenian: Združeno kraljestvo Lutigest
English: ORAL USE
Slovenian: PERORALNA UPORABA
English: Annex IA - Lutinus and associated names Member State in
Slovenian: Priloga IA - Lutinus in povezana imena država članica
English: United Kingdom Dutasteride Actavis Group
Slovenian: Združeno kraljestvo Dutasteride Actavis Group
English: Ferring Hellas Mepe Progesterone
Slovenian: Ferring Hellas Mepe progesteron
English: Annex IB - Dutasteride Actavis and associated names Member State in
Slovenian: Priloga IB - Dutasteride Actavis in povezana imena država članica
English: EU/EEA
Slovenian: EU/EGP
English: Ferring Legemidler As Progesterone
Slovenian: Ferring Legemidler As progesteron
English: Ferring Läkemedel Ab Progesterone
Slovenian: Ferring Läkemedel Ab progesteron
English: Ferring Lääkkeet Oy Progesterone
Slovenian: Ferring Lääkkeet Oy progesteron
English: COLECALCIFEROL 20,000 IU
Slovenian: Pharmaceutics (UK) Limited holekalciferol holekalciferol 20.000 i.e.
English: COLECALCIFEROL 50,000 IU
Slovenian: Pharmaceutics (UK) Limited holekalciferol holekalciferol 50.000 i.e.
English: Czech Republic
Slovenian: Češka republika Lutinus
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: 5 February 2016
Slovenian: 5. februar 2016
English: Legal Requirements
Slovenian: Zakonske zahteve
English: How to contact the Agency
Slovenian: Kako stopiti v stik z Agencijo
English: Article 57 (2) of Regulation (EC) No 726/2004
Slovenian: Člen 57 (2) Uredbe (ES) št. 726/2004
English: This information will be used to support regulatory business activities, including:
Slovenian: Te informacije bodo uporabljene za podporo regulativnim poslovnim dejavnostim, ki vključujejo:
English: How to submit: Registration & Training
Slovenian: Kako poteka predložitev: registracija in usposabljanje
English: What to submit: Information on medicinal products
Slovenian: Kaj je treba predložiti: informacije o zdravilih
English: Why submit: Scope
Slovenian: Zakaj je potrebna predložitev: obseg
English: To ensure the quality of data submitted to the EudraVigilance database, at least one user from each organisation should receive training.
Slovenian: Da bi zagotovili kakovost podatkov, vnesenih v podatkovno bazo EudraVigilance, se mora vsaj en uporabnik iz posamezne organizacije ustrezno usposobiti.
English: The submission of medicinal product data by marketing-authorisation holders (MAHs) is a legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004.
Slovenian: Predložitev podatkov o zdravilu s strani imetnikov dovoljenja za promet z zdravilom je zakonska zahteva, ki jo določa člen 57(2) Uredbe (ES) št. 726/2004.
English: Marketing-authorisation holders were initially required to submit information on medicinal products for human use by 2 July 2012.
Slovenian: Imetniki dovoljenja za promet z zdravilom so prvotno morali predložiti informacije o zdravilih za uporabo v humani medicini do 2. julija 2012.
English: This is to ensure that privacy and security measures are in place and that the principles of integrity, accountability and availability of data are adhered to.
Slovenian: Registracija je potrebna zato, da se zagotovijo varnost in varstvo zasebnosti ter spoštovanje načel integritete, odgovornosti in razpoložljivosti podatkov.
English: • strengthening transparency and communication with the Agency's stakeholders by establishing the European medicines web portal, granting access to safety data, efficiently exchanging data within the EU Network and international partners, and supporting communication between the Agency's Committees and pharmaceutical industry.
Slovenian: • krepitev preglednosti in komunikacije z interesnimi skupinami Agencije z vzpostavitvijo evropskega spletnega portala o zdravilih, zagotavljanjem dostopa do podatkov o varnosti, učinkovito izmenjavo podatkov znotraj mreže EU in z mednarodnimi partnerji ter s spodbujanjem komunikacije med odbori Agencije in farmacevtsko industrijo.
English: • facilitating the coordination of regulatory decisions and actions to safeguard public health, e.g. to support referral procedures, the establishment of a repository of Periodic Safety Update Reports (PSURs) and literature monitoring;
Slovenian: • spodbujanje usklajevanja regulativnih odločitev in ukrepov za varovanje javnega zdravja, na primer za podporo pri napotitvenih postopkih, vzpostavitvi registra redno posodobljenih poročil o varnosti zdravil (PSUR) in spremljanju literature;
English: Electronic submission of medicinal product information by marketing-authorisation holders
Slovenian: Elektronska predložitev informacij o zdravilu za imetnike dovoljenja za promet z zdravilom
English: For enquiries related to the EU SME definition please contact the SME office (sme@ema.europa.eu).
Slovenian: Za vprašanja, povezana z opredelitvijo MSP v EU, se obrnite na urad za MSP (sme@ema.europa.eu).
English: • coding of substance and product information reported in Individual Case Safety Reports (ICSRs) within the Eudravigilance system to support Pharmacovigilance signal management activities and the performance of data analysis and business intelligence at the Agency;
Slovenian: • šifriranje predloženih informacij o učinkovini in zdravilu v varnostnih poročilih o posameznih primerih (ICSR) znotraj sistema Eudravigilance, da bi podprli dejavnosti upravljanja signalov farmakovigilance ter izvajanje analiz podatkov in poslovno obveščanje pri Agenciji;
English: The aim of the data submission is to establish a complete inventory of all medicines authorised for human use in the EEA, including medicines authorised centrally via the EMA and those authorised at national level via the National Competent Authorities (NCAs).
Slovenian: Cilj predložitve podatkov je, da bi zagotovili celovit popis vseh zdravil, odobrenih za uporabo v humani medicini v EGS, vključno z zdravili, odobrenimi po centraliziranem postopku, ki ga vodi EMA, in zdravili, ki jih na nacionalni ravni odobrijo pristojni nacionalni organi.
English: For enquires on how to register contact the Eudravigilance registration office (eudravigilanceregistration@ema.europa.eu).
Slovenian: Za vprašanja o postopku registracije se obrnite na urad za registracijo v sistem Eudravigilance (eudravigilanceregistration@ema.europa.eu).
English: This legal provision requires all holders of marketing authorisations for medicinal products for human use in the European Economic Area (EEA) to submit information to the European Medicines Agency (EMA) using the electronic format referred to as Article 57 format or eXtended EudraVigilance Product Report Message (XEVPRM) format.
Slovenian: Ta zakonska določba zahteva, da vsi imetniki dovoljenj za promet z zdravilom za zdravila za uporabo v humani medicini v Evropskem gospodarskem prostoru (EGS) Evropski agenciji za zdravila (EMA) predložijo informacije v elektronski obliki, in sicer v formatu v skladu s členom 57 ali formatu XEVPRM (razširjeno sporočilo s poročilom o zdravilu v EudraVigilance).
English: For information related to submission of authorised medicines data visit the Data submission webpage.
Slovenian: Za informacije, povezane s predložitvijo podatkov o odobrenih zdravilih, obiščite spletno stran o predložitvi podatkov.
English: Since July 2012, MAHs are required to submit information on new marketing authorisations granted after 2 July 2012 within 15 calendar days from the date of notification of the granting of the marketing authorisation by the NCA.
Slovenian: Od julija 2012 morajo imetniki dovoljenja za promet z zdravilom predložiti informacije o novih dovoljenjih za promet, odobrenih po 2. juliju 2012, v 15 koledarskih dneh od datuma obvestila o odobritvi dovoljenja za promet z zdravilom, ki ga izda pristojni nacionalni organ.
English: Information on any amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation or withdrawal shall be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised as per guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Slovenian: Informacije o kakršnih koli spremembah pogojev dovoljenj za promet z zdravilom po spremembi, prenosu, obnovitvi, začasnem umiku, odvzemu ali umiku dovoljenja je treba Evropski agenciji za zdravila sporočiti najkasneje v 30 koledarskih dneh od datuma odobritve sprememb v skladu s smernicami in postopki, opisanimi v Poglavju 3.II: Dokument s smernicami za uporabo razširjenega sporočila s poročilom o zdravilu v EudraVigilance (XEVPRM).
English: To begin data submission of authorised medicinal products, marketing-authorisation holders need to register with Eudravigilance.
Slovenian: Za predložitev podatkov o odobrenih zdravilih se morajo imetniki dovoljenj za promet z zdravilom najprej registrirati v sistem Eudravigilance.
English: An eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course is available as a face-to-face or e-learning training course.
Slovenian: Na voljo je tečaj usposabljanja za delo z razširjenim slovarjem zdravil EudraVigilance (XEVMPD), ki se lahko izvede v predavalnici ali v obliki e-učenja.
English: • calculating the Pharmacovigilance Fees payable by MAHs;
Slovenian: • izračun pristojbin za farmakovigilanco, ki jih plačajo imetniki dovoljenja za promet z zdravilom;
English: Enquiries related to Article 57(2) submissions can be submitted to the EMA via the EMA Service Desk portal (https://servicedesk.ema.europa.eu).
Slovenian: Vprašanja, povezana s predložitvijo podatkov v skladu s členom 57(2), se lahko pošljejo Evropski agenciji za zdravila preko EMA Service Desk portala (https://servicedesk.ema.europa.eu).
English: By 31 December 2014 MAHs were also required to improve quality of information on authorised medicines submitted to the EMA, bring their medicinal product entries up-to-date and submit additional information in line with the guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Slovenian: Do 31. decembra 2014 so morali imetniki dovoljenja za promet z zdravilom tudi izboljšati kakovost informacij o odobrenih zdravilih, predloženih Evropski agenciji za zdravila, posodobiti vnesene podatke o svojih zdravilih in predložiti dodatne informacije v skladu s smernicami in postopki, opisanimi v Poglavju 3.II: Dokument s smernicami za uporabo razširjenega sporočila s poročilom o zdravilu v EudraVigilance (XEVPRM).
English: • medicinal products authorised through the mutual recognition procedure;
Slovenian: • za zdravila, odobrena po postopku z medsebojnim priznavanjem;
English: • medicinal products authorised through the decentralised procedure.
Slovenian: • za zdravila, odobrena po decentraliziranem postopku.
English: For documents related to submission of authorised medicines data visit the Guidance document webpage.
Slovenian: Za dokumente, povezane s predložitvijo podatkov o odobrenih zdravilih, obiščite spletno stran z dokumenti s smernicami.
English: When to submit
Slovenian: Kdaj je potrebna predložitev:
English: MAHs are required to submit to the EMA information on all medicinal products for which they hold a marketing authorisation in the EEA, i.e.:
Slovenian: Imetniki dovoljenja za promet z zdravilom morajo Evropski agenciji za zdravila predložiti informacije o vseh zdravilih, za katera imajo dovoljenje za promet v EGS, kar pomeni:
English: MAHs are also obliged to maintain the submitted medicinal product information and notify the EMA of any newly authorised medicines or variations to the terms of the marketing authorisation using the XEVPRM format.
Slovenian: Prav tako so imetniki dovoljenja za promet z zdravilom dolžni vzdrževati predložene informacije o zdravilu in Evropsko agencijo za zdravila obvestiti o odobritvi katerega koli novega zdravila ali spremembah pogojev dovoljenja za promet z zdravilom v formatu XEVPRM.
English: • nationally authorised medicinal products;
Slovenian: • za zdravila, odobrena po nacionalnih postopkih;
English: • centrally authorised medicinal products;
Slovenian: • za zdravila, odobrena po centraliziranem postopku;
English: % of treated dogs*
Slovenian: % zdravljenih psov
English: During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged.
Slovenian: V prvih 21 dneh zdravljenja lahko količina hrane, ki jo prejme žival, ostane nespremenjena.
English: • This medicine has been prescribed for your dog only and you should not pass it on to others.
Slovenian: • Zdravilo je bilo predpisano samo vašemu psu in ga ne smete dajati drugim.
English: Generally, the severity of these effects increased with increasing dose.
Slovenian: Na splošno se resnost teh učinkov poveča s povečanjem odmerka.
English: Your veterinary surgeon will advise you on the type of food your dog will need.
Slovenian: Veterinar vam bo svetoval o vrsti hrane, ki jo potrebuje vaš pes.
English: * : in line with the recommended treatment schedule
Slovenian: * Skladno s priporočenim režimom zdravljenja.
English: Once the dog has eaten the complete portion, give the remaining amount of food to the dog.
Slovenian: Ko je pes pojedel cel del, mu dajte preostalo količino hrane.
English: Thereafter, feeding should be in accordance with energy requirements for maintenance (to be calculated by the veterinarian).
Slovenian: Potem mora biti hranjenje skladno s potrebami po kalorijah za vzdrževanje (izračuna jih veterinar).
English: This results in blockage of the uptake of dietary lipids.
Slovenian: To povzroča blokado privzema dietnih lipidov.
English: • in dogs less than 18 months of age.
Slovenian: • je mlajši od 18 mesecev;
English: In most cases, these effects are mild and transient.
Slovenian: V večini primerov so ti učinki blagi in prehodni.
English: Day 1-21
Slovenian: 1.-21. dan
English: Interactions with other drug types were not specifically investigated.
Slovenian: Interakcij z drugimi vrstami zdravil niso natančno raziskali.
English: Butylated hydroxyanisole (E 320)
Slovenian: Butiliran hidroksianizol (E 320)
English: No specific antidote is available.
Slovenian: Specifičnega protistrupa ni.
English: Treatment should be given with food.
Slovenian: Zdravilo je treba dajati s hrano.
English: The most important metabolic transformation is sulphoxidation, which produces three active metabolites.
Slovenian: Najpomembnejša presnovna transformacija je sulfoksidacija, ki proizvede tri aktivne presnovke.
English: Do not use in dogs less than 18 months of age.
Slovenian: Ne uporabljajte pri psih, mlajših od 18 mesecev.
English: In addition, hyperkalaemia was occasionally observed.
Slovenian: Poleg tega so občasno ugotovili hiperkaliemijo.
English: • significant loss of appetite.
Slovenian: • izrazita izguba teka.
English: Mitratapide has no central effect.
Slovenian: Mitratapid nima učinka na osrednje živčevje.
English: After each dose, the syringe should be removed from the bottle.
Slovenian: Po vsakem odmerku je treba brizgo odstraniti iz stekleničke.
English: • If you have further questions, please ask your veterinary surgeon or your pharmacist
Slovenian: • Če imate dodatna vprašanja, se posvetujte z veterinarjem ali farmacevtom.
English: In addition, treatment should be interrupted and the advice of a veterinarian should be sought where the observed body weight loss is severe and rapid.
Slovenian: Poleg tega je treba zdravljenje prekiniti in se posvetovati z veterinarjem, kadar opazite, da je izguba telesne teže velika in hitra.
English: Pharmacotherapeutic group: Peripherally acting antiobesity products, ATCvet Code: QA08AB90
Slovenian: Farmakoterapevtska skupina: zdravila proti debelosti s perifernim delovanjem, oznaka ATCvet: QA08AB90
English: treatment no treatment treatment normal feeding nutrition programme nutrition programme
Slovenian: 36.-56. dan zdravljenje brez zdravljenja zdravljenje normalna prehrana dietni program dietni program
English: Mitratapide also has a slight appetite decreasing effect, which is linked to its mode of action.
Slovenian: Mitratapid ima tudi rahel učinek zmanjševanja teka, ki je povezan z njegovim načinom delovanja.
English: This can be achieved either with a regular pet food or with a low calorie (diet) pet food.
Slovenian: To lahko dosežete z navadno hrano za hišne živali ali hrano za hišne živali z malo kalorijami (dietno hrano).
English: Mitratapide is a potent inhibitor of the microsomal triglyceride transfer protein (MTP).
Slovenian: Mitratapid je močan zaviralec beljakovine za prenos mikrosomskih trigliceridov (MTP).
English: Clinical observation
Slovenian: Klinično opazovanje
English: Please inform your veterinary surgeon if your dog is taking or has recently taken any other medicines, even those not prescribed.
Slovenian: Obvestite veterinarja, če vaš pes jemlje ali je pred kratkim jemal katero koli zdravilo, tudi če ste ga dobili brez recepta.
English: Mitratapide
Slovenian: Mitratapid
English: In clinical trials, the following weight loss percentages were obtained:
Slovenian: V kliničnih preskušanjih so dobili naslednje odstotke izgube telesne teže:
English: Administer the product orally during 2 periods of 21 days with an interval of 14 days without treatment in between.
Slovenian: Izdelek uporabljajte peroralno v dveh 21-dnevnih obdobjih z vmesnim presledkom 14 dni brez zdravljenja.
English: Excretion is rapid and mainly via the faeces.
Slovenian: Izločanje je hitro in večinoma poteka prek blata.