FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of WHO/ECOG performance status (PS) of 1 or PS of 0 and prior pelvic irradiation, the treatment should be started at the dose of 280 mg/m².
Croatian: U slučaju izvedbenog statusa bolesnika procijenjenog prema WHO/ECOG ljestvici kao 1 ili 0 i prethodnog zračenja zdjelice, liječenje treba započeti dozom od 280 mg/m².
English: Therefore the concomitant use of vinflunine and potent CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole and grapefruit juice) or inducers (such as rifampicin and Hypericum perforatum (St John's wort)) should be avoided since they may increase or decrease vinflunine and DVFL concentrations (see section 4.4 and 5.2).
Croatian: Zbog toga treba izbjegavati istodobnu uporabu vinflunina i potentnih inhibitora CYP3A4 (kao što su ritonavir, ketokonazol, itrakonazol i sok od grejpa) ili induktora (kao što su rifampicin i Hypericum perforatum (Gospina trava)) budući da mogu povećati ili smanjiti koncentracije vinflunina i DVFL-a
English: Protein binding mainly involves high density lipoproteins and serum albumin and is non-saturable on the range of vinflunine concentrations observed in patients.
Croatian: Vezanje na bjelančevine uglavnom uključuje lipoproteine visoke gustoće i serumski albumin te je nezasićeno u rasponu koncentracija vinflunina primijećenih kod bolesnika.
English: - Delay until recovery (ANC ≥ 1,000/mm3 and platelets ≥ 100,000/mm3) and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks
Croatian: Odgoditi do oporavka (ABN ≥ 1000/mm³ i trombociti ≥ 100 000/mm³) i prilagoditi dozu ako je potrebno (vidjeti tablicu 2) Prekid ako nije došlo do oporavka unutar 2 tjedna
English: Imaging distribution studies following radioactive vinflunine in rats, illustrated that the compound levels in lungs, kidneys, liver, salivary and endocrine glands, and gastrointestinal tract were rapidly higher than those in blood.
Croatian: Ispitivanja sa snimanjem distribucije nakon davanja radioaktivnog vinflunina štakorima pokazala su da razine tog spoja u plućima, bubrezima, jetri, žlijezdama slinovnicama i endokrinim žlijezdama te probavnom sustavu rastu brže nego u krvi.
English: Based on both PK and safety data, dose reductions are recommended in the elder groups: 75 ≤ age < 80 years; and age ≥ 80 years.
Croatian: Na temelju farmakokinetike i podataka o sigurnosti preporučuju se smanjenja doze kod starijih skupina: bolesnika u dobi od 75 do 80 godina; i starijih od 80 godina.
English: Cardiac ischaemia in patients with prior history of myocardial infarction or angina pectoris
Croatian: Srčana ishemija u bolesnika s prethodnom anamnezom infarkta miokarda ili angine pektoris
English: For further cycles the dose should be adjusted in the event of toxicities (see section 4.2).
Croatian: Za daljnje cikluse dozu treba prilagoditi u slučaju toksičnosti (vidjeti dio 4.2).
English: Special attention is recommended when vinflunine is administered to patients with prior history of myocardial infarction/ischaemia or angina pectoris (see section 4.8).
Croatian: Preporučuje se poseban oprez prilikom primjene vinflunina u bolesnika s prethodnom povijesti infarkta miokarda/ishemije ili angine pektoris (vidjeti dio 4.8).
English: Javlor solution for infusion should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Croatian: Javlor otopinu za infuziju smije pripremiti i primijeniti samo osoblje koje je odgovarajuće osposobljeno za rukovanje citotoksičnim lijekovima.
English: Constipation is reversible and can be prevented by special dietary measures such as oral hydration and fibre intake, and by administration of laxatives such as stimulant laxatives or faecal softners from day 1 to day 5 or 7 of the treatment cycle.
Croatian: Konstipacija je reverzibilna i može se spriječiti posebnim dijetetskim mjerama kao što su oralna hidracija i unos vlakana te primjenom laksativa kao što su stimulirajući laksativi ili omekšivači stolice od 1. dana do 5. ili 7. dana ciklusa liječenja.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Javlor Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Javlor will be given to you by a qualified healthcare professional as an intravenous infusion (drip into your vein) lasting 20 minutes.
Croatian: Javlor će Vam dati kvalificirani zdravstveni djelatnik u obliku intravenske infuzije (kapanje u venu)
English: A pharmacokinetic and tolerability phase I study in patients with altered liver functions test has been completed (see section 5.2).
Croatian: Dovršeno je ispitivanje faze I farmakokinetike i podnošljivosti u bolesnika s promijenjenim testovima jetrene funkcije (vidjeti dio 5.2).
English: In case of Grade 2 constipation, defined as requiring laxatives, for 5 days or more or Grade ≥ 3 of any duration, the dose of vinflunine should be adjusted (see section 4.2).
Croatian: U slučaju konstipacije 2. stupnja, koji se definira kao konstipacije za koji su potrebni laksativi, tijekom 5 ili više dana ili konstipacije ≥3. stupnja bilo kojeg trajanja, treba prilagoditi dozu vinflunina (vidjeti dio 4.2).
English: Diluted solution The diluted solution should be use immediately
Croatian: Razrijeđena otopina Razrijeđenu otopinu treba odmah primijeniti.
English: For detailed instructions on administration, see section 6.6.
Croatian: Za detaljne upute o primjeni vidjeti dio 6.6.
English: In the multi-centre, open-label controlled phase III clinical trial, 253 patients were randomised to treatment with vinflunine + BSC (best supportive care) and 117 patients to the BSC arm.
Croatian: U multicentričnom, otvorenom, kontroliranom kliničkom ispitivanju faze III 253 bolesnika randomizirana su u skupinu koja je primala terapiju vinfluninom + BSC (najbolju potpornu njegu) dok je 117 bolesnika primalo samo BSC.
English: Hypersensitivity to the active substance or other vinca alkaloids.
Croatian: Preosjetljivost na djelatnu tvar ili druge vinka alkaloide.
English: When infused through a peripheral vein, vinflunine can induce Grade 1 (22% of the patients, 14.1% of the cycles), Grade 2 (11.0% of the patients, 6.8% of the cycles) or Grade 3 (0.8% of the patients, 0.2% of the cycles) venous irritation.
Croatian: Kad se daje kao infuzija kroz perifernu venu, vinflunin može potaknuti vensku iritaciju 1. stupnja (22% bolesnika, 14,1% ciklusa), 2. stupnja (11,0% bolesnika, 6,8% ciklusa) ili 3. stupnja (0,8%
English: There is no known antidote for vinflunine overdose.
Croatian: Nema poznatog protulijeka za predoziranje vinfluninom.
English: Nevertheless, vinflunine should be used with caution in patients with increase of the proarrhythmic risk (e.g. congestive heart failure, known history of QT interval prolongation, hypokalaemia) (see section 4.8).
Croatian: Ipak, vinflunin se treba primjenjivati s oprezom u bolesnika s povećanim proaritmijskim rizikom (npr. kongestivno zatajenje srca, poznata anamneza produljenja QT intervala, hipokalijemija) (vidjeti dio 4.8).
English: In order to prevent constipation, laxatives and dietary measures including oral hydration are recommended from day 1 to day 5 or 7 after each vinflunine administration (see section 4.4).
Croatian: Preporučena istodobna primjena lijekova Da bi se spriječila konstipacija, preporučuju se laksativi i dijetetske mjere uključujući oralnu hidraciju od 1. do 5. ili 7. dana nakon svake primjene vinflunina (vidjeti dio 4.4).
English: No age-related dose modification is required in patients less than 75 years old (see section 5.2).
Croatian: Nije potrebna prilagodba doze vezana uz dob u bolesnika koji imaju manje od 75 godina (vidjeti dio 5.2).
English: In the reproduction studies, vinflunine appeared to be embryolethal and teratogenic in rabbits and teratogenic in rats.
Croatian: Ispitivanja reprodukcije pokazala su da vinflunin ima embrioletalne i teratogene učinke u kunića i teratogene učinke u štakora.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i kartonskoj kutiji iza „Rok valjanosti“ ili oznake EXP.
English: Caution should be exercised in patients with a history of cardiac disease and the benefit / risk assessment should be carefully evaluated regularly.
Croatian: Potreban je oprez kod bolesnika s anamnezom srčane bolesti, te je potrebno pažljivo procijeniti omjer koristi i rizika.
English: Baseline ANC < 1,500/mm3 for the first administration, baseline ANC < 1,000/mm3 for subsequent administrations (see section 4.4).
Croatian: Početni ABN < 1500/mm³ za prvu primjenu, početni ABN < 1000/mm³ za naredne primjene (vidjeti dio 4.4).
English: This leaflet was last revised in MM/YYYY Other sources of information
Croatian: Ova uputa je zadnji puta revidirana u MM/GGGG.
English: • The Javlor solution for infusion should be piggy-backed to the side injection port closest to the 500 mL bag to further dilute Javlor during administration.
Croatian: • Javlor otopinu za infuziju treba uvesti u bočno mjesto za injekciju najbliže 500-mililitarskoj vrećici kako bi se Javlor tijekom primjene dodatno razrijedio.
English: In patients with severe renal impairment (20 mL/min ≤ CrCl < 40 mL/min) the recommended dose is 250 mg/m² every 3 weeks (see section 5.2).
Croatian: U bolesnika s teškim oštećenjem bubrega (20 mL/min ≤ CrCl < 40 mL/min) preporučena je doza 250 mg/m² svaka 3 tjedna (vidjeti dio 5.2).
English: The concomittant use of two or more QT/QTc interval prolonging substances is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena dviju ili više tvari koje produljuju QT/QTc interval (vidjeti dio 4.5).
English: 2 NCI CTC Grade 3 nausea is defined as no significant intake, requiring intravenous fluids.
Croatian: 2 Mučnina 3. stupnja prema kriterijima NCI CTC definira se kao neznačajan unos koji zahtijeva intravensku primjenu tekućine.
English: In clinical studies, patients with CrCl (creatinine clearance) > 60 mL/min were included and treated at the recommended dose.
Croatian: Bolesnici s CrCl (klirensom kreatinina) > 60 mL/min bili su uključeni u klinička ispitivanja i liječeni preporučenom dozom.
English: Mucositis Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening”.
Croatian: Mukozitis 2. stupnja definira se kao "umjeren", 3. stupnja kao "težak", a 4. stupnja kao "opasan po život".
English: In addition a pre-specified multivariate analysis performed on the ITT population demonstrated that vinflunine had a statistically significant treatment effect (p=0.036) on overall survival when prognostic factors (PS, visceral involvement, alkaline phosphatases, haemoglobin, pelvic irradiation) were taken into consideration; hazard ratio 0.77 (95% CI 0.61, 0.98).
Croatian: Također, prethodno određena multivarijantna analiza provedena na populaciji koju se namjeravalo liječiti (ITT) pokazala je da vinflunin ima statistički značajan terapijski učinak (p=0,036) na ukupno preživljenje kad se uzmu u obzir prognostički čimbenici (izvedbeni status, visceralna zahvaćenost, alkalna fosfataza, hemoglobin, zračenje zdjelice); omjer hazarda 0,77 (95%-tni CI 0,61, 0,98).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima za citotoksične lijekove.
English: Neutropenia (ANC < 1000/mm3 ) or
Croatian: Neutropenija (ABN < 1000 /mm³) ili
English: Adverse reactions occurring in patients with transitional cell carcinoma of the urothelium and in patients with other disease than this indication and potentially severe or adverse reactions that are a class effect of the vinca alkaloids are described below:
Croatian: Nuspojave u svim indikacijama Nuspojave koje se javljaju u bolesnika s karcinomom prijelaznih stanica urotela i u bolesnika s drugim indikacijama te potencijalno teške ili nuspojave koje su posljedica učinaka vinka alkaloida, opisane su u nastavku:
English: Mucositis or Constipation Grade 2 ≥ 5 days or Grade ≥ 3 any duration1
Croatian: Mukozitis ili konstipacija 2. stupnja ≥ 5 dana ili ≥ 3. stupnju bilo kojeg trajanja1
English: Uncommon Extravasation
Croatian: Manje često Ekstravazacija
English: How Javlor is given
Croatian: Kako se Javlor daje
English: Constipation is managed by medical care (see section 4.4).
Croatian: Konstipacija se liječi primjenom medicinskih sredstava (vidjeti dio 4.4).
English: No pharmacokinetic interaction was observed in patients when vinflunine was combined with doxorubicin.
Croatian: Nije primijećena farmakokinetička interakcija u bolesnika prilikom kombiniranja vinflunina s doksorubicinom.
English: Febrile Neutropenia (ANC < 1,000/mm3 and fever ≥ 38,5 °C)
Croatian: Febrilna neutropenija (ABN< 1000/mm³ i vrućica ≥ 38,5°C)
English: In a population pharmacokinetic analysis in 372 patients (656 pharmacokinetic profiles), the total blood clearance was 40 l/h with low inter and intra-individual variability (25% and 8%, respectively, expressed as coefficient of variation).
Croatian: U populacijskoj farmakokinetičkoj analizi u 372 bolesnika (656 farmakokinetičkih profila) ukupni klirens krvi iznosio je 40 l/h s niskom varijabilnosti između ispitanika i kod svakog ispitanika zasebno
English: Neoplasm benign, malignant and unspecified
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine
English: Cardiac effects are a known class effect of the vinca alkaloids.
Croatian: Srčani učinci poznati su učinak razreda vinka alkaloida.
English: Cytotoxic: Handle with caution
Croatian: Citotoksično: Rukujte s oprezom
English: In vivo, vinflunine displays significant antitumor activity against a broad spectrum of human xenografts in mice both in terms of survival prolongation and tumour growth inhibition.
Croatian: Vinflunin pokazuje in vivo značajno protutumorsko djelovanje protiv širokog spektra ljudskih ksenogeničnih presadaka u miševa u vidu produljenja preživljavanja i inhibicije rasta tumora.
English: Pharmacokinetics of vinflunine was not modified for patients 70 ≤ age < 75 years and 75 ≤ age < 80 years.
Croatian: Farmakokinetika vinflunina nije se promijenila za bolesnike u dobi od 70 do 75 godina i u dobi između 75 i 80 godina.
English: Common Hypertension Vein thrombosis Phlebitis
Croatian: Hipertenzija Venska tromboza Flebitis
English: Table 2: Dose adjustments due to toxicity
Croatian: Prilagodbe doze zbog toksičnosti Tablica 2: Prilagodbe doze zbog toksičnosti
English: Common Ileus Dysphagia
Croatian: Ileus Disfagija
English: Uncommon Acute respiratory distress syndrome
Croatian: Manje često Akutni respiratorni distres sindrom
English: - The active substance is vinflunine.
Croatian: - Djelatna tvar je vinflunin.
English: How to store Javlor
Croatian: Kako primjenjivati Javlor
English: The concomitant use of vinflunine with others QT/QTc interval prolonging medicinal products should be avoided (see section 4.4).
Croatian: Treba izbjegavati istodobnu primjenu vinflunina s drugim lijekovima koji produljuju QT/QTc interval (vidjeti dio 4.4).
English: Grade 3/4 neutropenia was observed in 43.8% of patients.
Croatian: Neutropenija 3./4. stupnja zabilježena je kod 43,8% bolesnika.
English: Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen
Croatian: Javlor je indiciran u monoterapiji za liječenje odraslih bolesnika s uznapredovalim ili metastatskim karcinomom prijelaznih stanica urotelijalnog trakta nakon neuspjeha prethodnog protokola koji je sadržavao platinu.
English: Blood pressure should be controlled in patients developing symptoms of PRES. To confirm the diagnosis, brain imaging is recommended.
Croatian: Potrebno je kontrolirati krvni tlak u bolesnika koji razvijaju simptome PRES-a.
English: In the two multi-centre open-label, single-arm phase II clinical trials a total of 202 patients were treated with vinflunine.
Croatian: U dva multicentrična otvorena klinička ispitivanja faze II s jednim krakom, 202 bolesnika liječena su vinfluninom.
English: Infection with Grade 3/4 neutropenia was observed in 2.8 % of patients.
Croatian: Infekcija s neutropenijom 3./4. stupnja zabilježena je kod 2,8% bolesnika.
English: Vinflunine is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Javlor.
Croatian: Vinflunin je citotoksični protutumorski lijek pa je pri rukovanju s Javlorom, kao i s drugim potencijalno toksičnim spojevima, potreban oprez.
English: • At the request of the European Medicines Agency;
Croatian: Nadalje, nadopunjeni RMP treba dostaviti: • Na zahtjev Europske agencije za lijekove:
English: Bronchospam was reported in one patient treated with vinflunine for a different setting from the indication.
Croatian: Bronhospazam je prijavljen kod jednog bolesnika koji je primao vinflunin u drugoj indikaciji.
English: For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below:
Croatian: Za daljnje cikluse dozu je potrebno prilagoditi u slučaju toksičnosti kako je prikazano u tablici 3 u nastavku:
English: - Delay until recovery to mild toxicity or none, or to initial baseline status and adjust the dose if necessary (see table 2) - Discontinuation if recovery has not occurred within 2 weeks
Croatian: Odgoditi do oporavka tj. blage ili nikakve toksičnosti ili do postizanja početnog stanja i prilagoditi dozu ako je potrebno (vidjeti tablicu 2)
English: A possible interaction with paclitaxel and docetaxel (CYP3 substrates) has been suggested from an in vitro study (slight inhibition of vinflunine metabolism).
Croatian: Jedno in vitro ispitivanje uputilo je na moguću interakciju s paklitakselom i docetakselom (supstrati CYP3) (blaga inhibicija metabolizma vinflunina).
English: Neutropenia, leucopenia, anaemia and thrombocytopenia are frequent adverse reactions of vinflunine.
Croatian: Neutropenija, leukopenija, anemija i trombocitopenija česte su nuspojave vinflunina.
English: Javlor 25 mg/mL sterile concentrate vinflunine
Croatian: Javlor 25 mg/mL sterilni koncentrat vinflunin
English: A statistically significant difference on overall survival (p=0.040) was also seen in the eligible population (which excluded 13 patients with clinically significant protocol violations at baseline who were not eligible for treatment); hazard ratio 0.78 (95% CI 0.61, 0.99).
Croatian: Uočena je i statistički značajna razlika u ukupnom preživljenju (p=0,040) populacije koja je zadovoljila uključne kriterije (iz koje je isključeno 13 bolesnika s klinički značajnim kršenjima protokola na početku ispitivanja koji nisu bili zadovoljili uključne kriterije); omjer hazarda 0,78 (95%-tni interval pouzdanosti (CI 0,61, 0,99).
English: Vinflunine has shown to be clastogenic (induces chromosome breakage) in the in vivo micronucleus test in rat as well as mutagenic and clastogenic in a mouse lymphoma assay (without metabolic activation).
Croatian: Mikronukleus test in vivo na štakorima pokazao je da je vinflunin klastogen (inducira lomove kromosoma), dok se u testu mišjeg limfoma pokazao kao mutagen i klastogen (bez metaboličke aktivacije).
English: Table 4 Adverse reactions observed in patients with transitional cell carcinoma of the urothelium treated with vinflunine
Croatian: Tablica 4 Nuspojave zabilježene u bolesnika s karcinomom prijelaznih stanica urotela liječenih vinfluninom
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka, vidjeti u dijelu 6.3.
English: Javlor is a clear, colourless to pale yellow solution.
Croatian: Javlor je bistra, bezbojna do blijedožuta otopina.
English: For further cycles, the dose should be adjusted in the event of toxicities, as shown in table 3 below.
Croatian: Za daljnje cikluse dozu je potrebno prilagoditi u slučaju toksičnosti kako je prikazano u tablici 3 u nastavku.
English: Ear and Labyrinth disorders
Croatian: Poremećaji uha i labirinta
English: Either peripheral lines or a central catheter can be used for vinflunine administration.
Croatian: Za primjenu vinflunina mogu se koristiti periferni put ili centralni kateter.
English: 3rd consecutive event
Croatian: 3. uzastopni događaj
English: Thrombocytopenia (platelets < 100,000/mm3)
Croatian: Trombocitopenija (trombociti < 100 000/mm³)
English: A phase I study evaluating the effect of ketoconazole treatment (a potent CYP3A4 inhibitor) on vinflunine pharmacokinetics indicated that co-administration of ketoconazole (400 mg orally once daily for 8 days) resulted in a 30% and 50% increase in blood exposures to vinflunine and its metabolite 4Odeacetyl-vinflunine (DVFL), respectively.
Croatian: na farmakokinetiku vinflunina pokazalo je da je istodobna primjena ketokonazola (400 mg oralno jedanput na dan tijekom 8 dana) za posljedicu imala 30%-tno i 50%-tno povećanje izloženosti vinfluninu u krvi, odnosno njegovu metabolitu
English: Vinflunine doses were adjusted according to 3 age groups as shown below:
Croatian: Doze vinflunina bile su prilagođene prema 3 dobne skupine kako je prikazano u nastavku: Dob (y)
English: Storage conditions
Croatian: Uvjeti čuvanja
English: Javlor is used to treat advanced or metastatic cancer of the bladder and urinary tract when a previous therapy with platinum-containing medicines has failed.
Croatian: Javlor se koristi za liječenje uznapredovalog ili metastatskog raka mokraćnog mjehura i mokraćnih puteva nakon neuspjeha prethodne terapije koja je uključivala platinu.
English: One phase III and two phase II trials support the use of Javlor for treatment of advanced or metastatic transitional cell carcinoma of the urothelium as second-line therapy after failure of a prior platinumcontaining regimen.
Croatian: Klinička djelotvornost i sigurnost Jedno ispitivanje faze III i dva ispitivanja faze II podržavaju uporabu Javlora za liječenje uznapredovalog ili metastatskog karcinoma prijelaznih stanica urotela kao terapiju druge linije nakon neuspjeha prethodnog protokola s platinom.
English: Constipation is a very common side effect of Javlor.
Croatian: Zatvor je vrlo česta nuspojava Javlora.
English: The recommended dose should be reduced in patients with haematological toxicity (see section 4.2).
Croatian: Preporučenu dozu treba smanjiti u bolesnika s hematološkom toksičnosti (vidjeti dio 4.2).
English: One 2 mL vial contains 50 mg of vinflunine (as ditartrate) One 4 mL vial contains 100 mg of vinflunine (as ditartrate) One 10 mL vial contains 250 mg of vinflunine (as ditartrate)
Croatian: Jedna bočica od 2 mL sadrži 50 mg vinflunina (u obliku ditartarata) Jedna bočica od 4 mL sadrži 100 mg vinflunina (u obliku ditartarata) Jedna bočica od 10 mL sadrži 250 mg vinflunina (u obliku ditartarata)
English: Javlor MUST ONLY be administered intravenously.
Croatian: Javlor se MORA primjenjivati SAMO intravenski.
English: In particular, you should tell your doctor if you are taking medicines containing any of the following active substances: - ketoconazole and itraconazole, used to treat fungal infection, - opioids, used to treat pain, - ritonavir, used to treat HIV infection, - doxorubicin and pegylated liposomal doxorubicin, used to treat some kinds of cancer, - rifampicin, used to treat tuberculosis or meningitis, - herbal preparation containing hypericum perforatum (St John's wort) used to treat minor to moderate depression.
Croatian: opioidi, koji se koriste za liječenje boli, - ritonavir, koji se koristi za liječenje infekcije virusom HIV-a, - doksorubicin i pegilirani liposomalni doksorubicin, koji se koriste za liječenje nekih vrsta raka, - rifampicin, koji se koristi za liječenje tuberkuloze ili meningitisa, - biljni pripravak koji sadrži hypericum perforatum (Gospinu travu) koja se koristi za liječenje blage do umjerene depresije.
English: Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne France
Croatian: Pierre Fabre Médicament 45, Place Abel Gance F-92100 Boulogne Francuska