FrancophonIA/ELRC3.0 huggingface dataset:
English: - Allergic skin reactions (sometimes severe), including rapid swelling (oedema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues, itchy or sore patches of thick, red skin with silvery scales of skin, irritation of the skin and mucous membranes, life-threatening skin condition that causes large portions of the epidermis, the skin's outermost layer, to detach from the layers of skin below - Small dry scaly skin patches, sometimes thick with spikes or ‘horns'
Slovenian: podkožnega tkiva, sluznice in podsluzničnih tkiv, srbeča ali boleča območja debele rdeče kože s srebrnkastimi luskami, draženje kože in sluznic, smrtno nevarno kožno stanje, pri katerem se veliki deli povrhnjice, najbolj zunanje plasti kože, odluščijo od spodaj ležečih plasti kože - majhni, suhi, luskasti predeli kože, včasih odebeljeni in s koničastimi izrastki ali ''rogovi''
English: Voriconazole Cmax  104% Voriconazole AUCτ  87%
Slovenian: v primerjavi z 200 mg vorikonazola BID, vorikonazol Cmax  104 % vorikonazol AUC  87 %
English: High dose (400 mg BID) Low dose (100 mg BID)*
Slovenian: majhni odmerki (100 mg BID)*
English: 2 In clinical studies, response to voriconazole in patients with C glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
Slovenian: glabrata za 21 % manjši kot pri C. albicans, C. parapsilosis in C. tropicalis.
English: [CYP3A4 substrates]
Slovenian: [substrati CYP3A4]
English: [increases gastric pH]
Slovenian: [zvišuje pH v želodcu]
English: Ibuprofen (400 mg single dose)
Slovenian: ibuprofen (enkratni 400 mg odmerek) diklofenak (enkratni 50 mg odmerek)
English: inflammation of the skin, hives, sunburn or severe skin reaction following exposure to light or sun, skin redness and irritation, red or purple discoloration of the skin which may be caused by low platelet count, eczema - Infusion site reaction - Allergic reaction or exaggerated immune response
Slovenian: rdeče ali vijoličasto obarvanje kože, ki ga lahko povzroči nizko število krvnih ploščic, ekcem - reakcije na mestu infundiranja
English: If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking Voriconazole Accord.
Slovenian: Zdravilo Vorikonazol Accord vsebuje laktozo Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: In an oral multiple-dose study, AUCτ was similar in subjects with moderate hepatic cirrhosis (ChildPugh B) given a maintenance dose of 100 mg twice daily and subjects with normal hepatic function given 200 mg twice daily.
Slovenian: V študiji večkratnih peroralnih odmerkov je bila AUCτ pri preiskovancih z zmerno cirozo jeter (ChildPugh B), ki so dobivali vzdrževalni odmerek 100 mg dvakrat na dan, podobna kot pri preiskovancih z normalnim delovanjem jeter, ki so dobivali 200 mg dvakrat na dan. Farmakokinetičnih podatkov za bolnike s hudo cirozo jeter (Child-Pugh C) ni (glejte poglavji 4.2 in 4.4).
English: Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy).Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Slovenian: Med bolniki brez drugih prepoznavnih dejavnikov tveganja so se pojavile prehodne jetrne reakcije, vključno s hepatitisom in ikterusom.
English: Voriconazole was investigated as secondary prophylaxis in an open-label, non-comparative, multicenter study of adult allogeneic HSCT recipients with prior proven or probable IFI.
Slovenian: V odprti neprimerjalni multicentrični študiji pri odraslih prejemnikih homolognih HSCT s predhodno dokazano ali verjetno IGO, so vorikonazol raziskovali kot sekundarno profilakso.
English: • Oral contraceptives (if you take Voriconazole Accord whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Slovenian: Vorikonazol Accord, se pri vas lahko pojavijo neželeni učinki, kot npr. slabost s siljenjem na bruhanje ali motnje menstruacije)
English: Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets voriconazole
Slovenian: Vorikonazol Accord 50 mg filmsko obložene tablete Vorikonazol Accord 200 mg filmsko obložene tablete vorikonazol
English: o bone pain
Slovenian: Okvare vida
English: When voriconazole is discontinued, ciclosporin levels must be carefully monitored and the dose
Slovenian: Po koncu uporabe vorikonazola je treba koncentracijo ciklosporina natančno nadzirati in njegov odmerek povečati, kot je potrebno.
English: In an independent published study,
Slovenian: V eno študijo so vključili
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets
Slovenian: Vorikonazol Accord 50 mg filmsko obložene tablete Vorikonazol Accord 200 mg filmsko obložene tablete
English: Other significant side effects whose frequency is not known, but should be reported to your doctor immediately: Skin cancer Inflammation of the tissue surrounding the bone - Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
Slovenian: - rak kože, - vnetje tkiva, ki obdaja kost, - rdeča luskasta območja ali obročaste kožne lezije, ki so lahko simptom avtoimunske bolezni,
English: Voriconazole Accord 200 mg film-coated tablets
Slovenian: Vorikonazol Accord 200 mg filmsko obložene tablete vorikonazol
English: Voriconazole Accord 50 mg film-coated tablets voriconazole
Slovenian: Vorikonazol Accord 50 mg filmsko obložene tablete vorikonazol
English: , leukopenia, anaemia bone marrow failure, lymphadenopathy, eosinophilia disseminated intravascular coagulation
Slovenian: Bolezni krvi in limfatičnega sistema agranulocitoza1, pancitopenija, trombocitopenija2, levkopenija, anemija odpoved kostnega mozga, limfadenopatija, eozinofilija diseminirana intravaskularna koagulacija
English: - Visual impairment (change in vision including blurred vision, visual color alterations, abnormal intolerance to visual perception of light, colour blindness, eye disorder, halo vision, night blindness, swinging vision, seeing sparks, visual aura, visual acuity reduced, visual brightness,
Slovenian: nenormalno občutljivostjo pri vidnem zaznavanju svetlobe, barvno slepoto, okvaro vida, videnjem svetlobnih krogov (halo), nočno slepoto, nihajočim vidom, videnjem iskrenja, avro z vidnimi pojavi, zmanjšano ostrino vida, občutkom svetlosti pri gledanju, izpadom običajnega vidnega polja, pikami v vidnem polju) - vročina - izpuščaj - siljenje na bruhanje, bruhanje, driska - glavobol - otekanje okončin - bolečine v trebuhu
English: 400 mg every 12 hours 200 mg every 12 hours
Slovenian: 6 mg/kg vsakih 12 ur 400 mg vsakih 12 ur 200 mg vsakih 12 ur vzdrževalni odmerek (po prvih 24 urah)
English: Voriconazo le (N=98)
Slovenian: Opazovani dogodki v študiji Vorikonazol (n = 98)
English: Stevens-Johnson syndrome, phototoxicity, purpura, urticaria, dermatitis allergic, rash papular, rash macular, eczema toxic epidermal necrolysis, angioedema, actinic keratosis*, pseudoporphyri a erythema multiforme, psoriasis, drug eruption, drug reaction with eosinophilia and systemic symptoms (DRESS)
Slovenian: Stevens-Johnsonov sindrom, fototoksičnost, purpura, urtikarija, alergijski dermatitis, papulozni izpuščaj, makulozni izpuščaj,
English: Hepatobiliary disorders liver function test abnormal jaundice, jaundice cholestatic, hepatitis10
Slovenian: Bolezni jeter, žolčnika in žolčevodov nenormalni izvidi testov jetrne funkcije ikterus, holestatski ikterus, hepatitis10 jetrna odpoved, hepatomegalija, holecistitis, holelitiaza
English: What Voriconazole Accord looks like and contents of the pack Voriconazole Accord 50 mg film-coated tablets are supplied as white to off white, round, approximate 7.0mm in diameter, film-coated tablets, debossed with ‘V50' on one side and plain on the other side.
Slovenian: Zdravilo Vorikonazol Accord 50 mg filmsko obložene tablete je na voljo v obliki belih do skoraj belih okroglih filmsko obloženih tablet premera približno 7,0 mm z vtisnjeno oznako »V50« na eni strani in brez oznake na drugi.
English: [CYP450 inducer; CYP3A4 inhibitor and substrate]
Slovenian: [induktor CYP450; zaviralec in substrat CYP3A4]
English: Coadministration of oral voriconazole and oral fluconazole resulted in a significant increase in Cmax and AUCτ of voriconazole in healthy subjects.
Slovenian: Flukonazol (zaviralec CYP2C9, CYP2C19 in CYP3A4) Sočasno peroralno jemanje vorikonazola in flukonazola je imelo za posledico pomembno povečanje Cmax in AUCτ vorikonazola pri zdravih osebah.
English: Voriconazole Cmax  34% Voriconazole AUCτ  39%
Slovenian: v primerjavi z 200 mg vorikonazola BID, vorikonazol Cmax  34 % vorikonazol AUC  39 %
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: You may experience abnormal intolerance to light as a result of taking more Voriconazole Accord than you should.
Slovenian: Če vzamete večji odmerek zdravila Vorikonazol Accord, kot bi smeli, se pri vas lahko pojavi nenormalna preobčutljivost na svetlobo.
English: Oral bioavailability may be limited in paediatric patients aged 2-<12 years with malabsorption and very low body weight for age.
Slovenian: Pri pediatričnih bolnikih, starih od 2 do < 12 let, ki imajo malabsorpcijo in zelo majhno telesno maso glede na starost, je biološka uporabnost peroralno uporabljenega zdravila lahko omejena.
English: 200 mg every 12 hours for the first 24 hours
Slovenian: 200 mg vsakih 12 ur v prvih 24 urah odmerek po prvih 24 urah (vzdrževalni odmerek)
English: The frequency of phototoxicity reactions is higher in the paediatric population.
Slovenian: • Resni dermatološki neželeni učinki (vključno s ploščatoceličnim karcinomom) Pri pediatrični populaciji je pogostnost fototoksičnih reakcij večja.
English: Voriconazole Cmax  4% Voriconazole AUCτ  32%
Slovenian: v primerjavi z 200 mg vorikonazola BID, vorikonazol Cmax  4 % vorikonazol AUC  32 %
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister (Blister foil for 50 mg film-coated tablets (all blister packs))
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Pretisni omot (folija za 50 mg filmsko obložene tablete (vsa pakiranja)) IME ZDRAVILA Vorikonazol Accord 50 mg filmsko obložene tablete vorikonazol IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: White to off white, oval, approximately 15.6 mm in length and 7.8 mm in width, film-coated tablets, debossed with ‘V200' on one side and plain on the other side.
Slovenian: Vorikonazol Accord 200 mg filmsko obložene tablete Bele do skoraj bele, okrogle filmsko obložene tablete premera približno 15,6 mm in širine približno 7,8 mm z vtisnjeno oznako »V200« na eni strani in brez oznake na drugi.
English: Therefore unless your doctor instructs you to stop treatment, it is important to keep taking Voriconazole Accord correctly, as described above.
Slovenian: Zato je pomembno, da zdravilo Vorikonazol Accord jemljete pravilno, kot je opisano zgoraj, razen če vam zdravnik ne naroči, da zdravljenje končajte.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
English: Study endpoints
Slovenian: Opazovani dogodki v študiji
English: Contact your doctor immediately if you become pregnant while taking Voriconazole Accord.
Slovenian: Če med jemanjem zdravila Vorikonazol Accord zanosite, se takoj posvetujte z zdravnikom.
English: [CYP3A4 substrate]
Slovenian: [substrat CYP3A4]
English: The recommended dose for adults (including elderly patients) is as follows: Tablets Patients 40 kg and above Patients less than 40 kg
Slovenian: tablete bolniki s telesno maso 40 kg in več bolniki s telesno maso manj kot 40 kg odmerek v prvih 24 urah (polnilni odmerek)
English: It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine.
Slovenian: Če ste prenehali jemati zdravilo Vorikonazol Accord Dokazano je, da lahko redno jemanje zdravila, brez izpuščanja odmerkov, ter jemanje ob pravem času zelo poveča njegovo učinkovitost.
English: red area on the skin that is covered with small confluent bumps, redness of the skin - Itchiness - Hair loss - Back pain - Kidney failure, blood in the urine, changes in kidney function tests
Slovenian: zastajanje tekočine v pljučih - zaprtje, prebavne težave, vnetje ustnic - zlatenica, vnetje jeter in poškodbe jeter - kožni izpuščaji, ki lahko povzročijo hude mehurje in luščenje kože, za katere je značilna ravna rdeča površina kože, prekrita z majhnimi zlivajočimi izboklinami, pordelost kože - srbenje - izguba las - bolečine v hrbtu - odpoved ledvic, kri v urinu, spremembe izidov krvnih preiskav za spremljanje delovanja ledvic
English: Indinavir Cmax ↔ Indinavir AUCτ ↔ Voriconazole Cmax ↔ Voriconazole AUCτ ↔
Slovenian: indinavir Cmax ↔ indinavir AUC ↔ vorikonazol Cmax ↔ vorikonazol AUC ↔
English: Voriconazole Cmax 23% Voriconazole AUCτ  7%
Slovenian: v primerjavi z 200 mg vorikonazola BID, vorikonazol Cmax  23 % vorikonazol AUCτ  7 %
English: Monitoring for adverse reactions related to oral contraceptives, in addition to those for voriconazole, is recommended ol (1 mg/0.035 mg QD)
Slovenian: noretisteron/etinilestradiol (1 mg/0,035 mg QD)
English: Breast-feeding must be stopped on initiation of treatment with Voriconazole Accord.
Slovenian: Ko se začne zdravljenje z zdravilom Vorikonazol Accord, mora ženska prenehati z dojenjem.
English: Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
Slovenian: Fenitoin se lahko uporablja sočasno z vorikonazolom, če se vorikonazola BID)*
English: White to off white, round, approximate 7.0 mm in diameter, film-coated tablets, debossed with ‘V50' on one side and plain on the other side.
Slovenian: Vorikonazol Accord 50 mg filmsko obložene tablete Bele do skoraj bele, okrogle filmsko obložene tablete premera približno 7,0 mm z vtisnjeno oznako »V50« na eni strani in brez oznake na drugi.
English: Common to < 1/10
Slovenian: Pogosti ≥ 1/100 do
English: 6 mg/kg every 12 hours
Slovenian: 3 mg/kg.
English: [CYP3A4 substrates and inhibitors]
Slovenian: [substrati in inhibitorji CYP3A4]
English: EOT
Slovenian: KT
English: Phenytoin (CYP2C9 substrate and potent CYP450 inducer)
Slovenian: Fenitoin (substrat CYP2C9 in močan induktor CYP450) Med sočasno uporabo fenitoina in vorikonazola je priporočljivo natančno nadziranje koncentracije fenitoina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/352/001-003
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/352/001-003
English: Increased appetite
Slovenian: - povečanje apetita
English: WHAT INTRINSA IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO INTRINSA IN ZA KAJ GA UPORABLJAMO
English: As the efficacy and safety of Intrinsa have not been evaluated in studies of longer duration than 1 year, it is recommended that an appraisal of the treatment is undertaken every 6 months.
Slovenian: Ker učinkovitost in varnost zdravila Intrinsa nista bili ocenjeni v študijah, ki bi trajale dlje kot 1 leto, se priporoča ocenjevanje zdravljenja vsakih 6 mesecev.
English: Use Intrinsa only as long as you experience a positive effect of the treatment.
Slovenian: Zdravilo Intrinsa uporabljajte samo, dokler opažate ugodne učinke zdravljenja.
English: Intrinsa is used to treat HSDD.
Slovenian: Zdravilo Intrinsa se uporablja za zdravljenje HSDD.
English: The testosterone in Intrinsa is the same hormone as that produced naturally in men and women.
Slovenian: Testosteron v zdravilu Intrinsa je enak hormon kot tisti, ki se naravno proizvaja pri moških in ženskah.
English: Continued use of Intrinsa is only recommended while concomitant use of estrogen is considered appropriate (i.e. the lowest effective dose for the shortest possible duration).
Slovenian: Neprekinjena uporaba zdravila Intrinsa se priporoča samo, dokler se ocenjuje, da je sočasna uporaba estrogena ustrezna (tj. najnižji možni učinkoviti odmerek v najkrajšem možnem času).
English: Effects of Intrinsa were observed at 4 weeks after initiation of therapy (the first measured time point) and at all monthly efficacy time points thereafter.
Slovenian: Učinke zdravila Intrinsa so opazili 4 tedne po začetku zdravljenja (prva točka merjenja) in pri vseh naslednjih mesečnih točkah merjenja učinkovitosti.
English: Do not use Intrinsa if you are, or suspect that you may be pregnant or are able to become pregnant, because it may cause harm to the unborn child.
Slovenian: Zdravila Intrinsa ne uporabljajte, če ste noseči, sumite, da ste noseči ali lahko zanosite, ker lahko škoduje nerojenemu otroku.
English: Therefore, you need to discuss your type of estrogen with your doctor, who could advise you which type of estrogen is suitable together with Intrinsa.
Slovenian: O vrsti estrogena se morate torej posvetovati z zdravnikom, ki vam lahko svetuje, katera vrsta estrogena je ustrezna za uporabo skupaj z zdravilom Intrinsa.
English: Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt Germany
Slovenian: Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Intrinsa remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Slovenian: Na osnovi podatkov, pridobljenih od pridobitve dovoljenja za promet z zdravilom, Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da ostaja razmerje med koristnostjo in tveganjem za zdravilo Intrinsa pozitivno, vendar je še vedno potreben skrben nadzor nad varnostnim profilom zdravila zaradi naslednjih razlogov:
English: It is not known whether Intrinsa increases the risk of breast cancer and endometrium cancer.
Slovenian: Ni znano, ali zdravilo Intrinsa poveča tveganje za rak dojke in raka endometrija.
English: Intrinsa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate.
Slovenian: Trajanje zdravljenja Odziv na zdravljenje z zdravilom Intrinsa je treba oceniti v 3-6 mesecih po začetku zdravljenja, da bi določili, ali je nadaljevanje zdravljenja primerno.
English: If you have not experienced a positive effect of Intrinsa within 3-6 months, you should inform your doctor, who will suggest that treatment be discontinued.
Slovenian: Intrinsa ne opazite v 3-6 mesecih, morate obvestiti svojega zdravnika, ki vam bo predlagal, da zdravljenje prekinete.
English: The safety of Intrinsa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Slovenian: Varnost zdravila Intrinsa ni bila ocenjena v dvojno slepih, s placebom nadzorovanih študijah, ki bi trajale dlje kot 1 leto.
English: Children and adolescents Intrinsa is not for use in children and adolescents.
Slovenian: Zdravilo Intrinsa ni namenjeno uporabi pri otrocih in mladostnikih.
English: In the combined study analysis at 24 weeks, the difference in the mean frequency of total satisfying episodes between Intrinsa and placebo was 1.07 per 4 weeks.
Slovenian: Pri analizi kombinirane študije po 24 tednih je bila razlika srednje vrednosti skupne pogostosti zadovoljivih epizod med zdravilom Intrinsa in placebom 1,07 na 4 tedne.
English: Intrinsa has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Intrinsa nima vpliva na sposobnost vožnje in upravljanja s stroji.
English: If you stop estrogen therapy you must also stop using Intrinsa.
Slovenian: Če prekinete zdravljenje z estrogenom, morate prenehati uporabljati tudi zdravilo Intrinsa.
English: What Intrinsa looks like and contents of the pack Intrinsa is a thin, clear, oval patch with T001 stamped on the back.
Slovenian: Izgled zdravila Intrinsa in vsebina pakiranja Intrinsa je tanek, prozoren, ovalen obliž z napisom T001, natisnjenim na zadnji strani.
English: There is no information on the safety of Intrinsa beyond 12 months.
Slovenian: Podatkov o varnosti uporabe zdravila Intrinsa, daljše od 12 mesecev, ni.
English: Patients treated with conjugated equine estrogen (CEE) are not recommended to use Intrinsa, as efficacy has not been demonstrated (see sections 4.4 and 5.1).
Slovenian: Bolnicam, ki prejemajo konjugirani konjski estrogen (CEE, conjugated equine estrogen), se uporaba zdravila Intrinsa ne priporoča, kajti učinkovitosti še niso dokazali (glejte poglavji 4.4 in 5.1).
English: Paediatric population There is no relevant use of Intrinsa in the paediatric population.
Slovenian: Pediatrična populacija Zdravilo Intrinsa ni primerno za uporabo pri pediatrični populaciji.
English: In case of inadvertent exposure during pregnancy, use of Intrinsa must be discontinued.
Slovenian: V primeru nenamerne izpostavitve med nosečnostjo je treba zdravljenje z zdravilom Intrinsa prekiniti.
English: Testosterone from Intrinsa is transported across intact skin by a passive diffusion process that is primarily controlled by permeation across the stratum corneum.
Slovenian: Testosteron iz zdravila Intrinsa se transportira prek nepoškodovane kože s pasivno difuzijo, ki jo nadzoruje predvsem prepuščanje skozi stratum corneum.
English: Intrinsa is a transdermal patch which constantly releases small amounts of testosterone that is absorbed through your skin into the bloodstream.
Slovenian: Intrinsa je transdermalni obliž, ki neprekinjeno sprošča majhne količine testosterona, ki se skozi kožo vpijejo v krvni obtok.
English: If you have any of the above, tell your doctor before you start to use Intrinsa.
Slovenian: Če imate karkoli od navedenega, povejte svojemu zdravniku, preden začnete uporabljati zdravilo
English: A significantly higher percentage of women who received Intrinsa reported a benefit in the three endpoints, that they considered clinically meaningful compared to women who received placebo.
Slovenian: Pomembno večji odstotek žensk, ki so prejemale zdravilo Intrinsa, je poročal pri treh ciljih o izboljšanju, za katero so udeleženke raziskave menile, da je klinično pomembno, v primerjavi z ženskami, ki so prejemale placebo.
English: Toxicological studies of testosterone have only revealed effects which can be explained based on the hormone profile.
Slovenian: 5.3 Predklinični podatki o varnosti Toksikološke študije testosterona so odkrile samo učinke, ki jih lahko razložimo na podlagi hormonskega profila.
English: During 6-month double blind exposure the following adverse reactions occurred in the treatment group (n=549) at a greater incidence than placebo (n=545) and were assessed by the investigators as possibly or probably related to Intrinsa treatment.
Slovenian: Med šestmesečnim dvojno slepo raziskavo so bili v skupini, ki je prejemala zdravilo (n = 549), naslednji neželeni učinki pogostejši kot v skupini, ki je prejemala placebo (n = 545), in za katere so raziskovalci ocenili, da so morda ali verjetno povezani z zdravljenjem z zdravilom Intrinsa.
English: HOW TO USE INTRINSA
Slovenian: KAKO UPORABLJATI ZDRAVILO INTRINSA
English: Overdosing with Intrinsa is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.
Slovenian: Pri zdravilu Intrinsa preveliko odmerjanje ni verjetno, kadar se uporablja skladno z navodili, ker se po odstranitvi obliža testosteron hitro odstrani iz telesa.
English: - If you are also using estrogen patches, make sure that the Intrinsa patch and the estrogen patch do not overlap.
Slovenian: − Če uporabljate tudi estrogenske obliže, pazite, da se ta obliž zdravila Intrinsa in estrogenski obliž ne prekrivata.