natgillin/translations-raw huggingface dataset:
Oral bioavailability may be limited in paediatric patients aged 2-<12 years with malabsorption and very low body weight for age. 
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.
200 mg every 12 hours for the first 24 hours 
200 mg vsakih 12 ur v prvih 24 urah odmerek po prvih 24 urah (vzdrževalni odmerek)
The frequency of phototoxicity reactions is higher in the paediatric population. 
• Resni dermatološki neželeni učinki (vključno s ploščatoceličnim karcinomom) Pri pediatrični populaciji je pogostnost fototoksičnih reakcij večja.
Voriconazole Cmax  4% Voriconazole AUCτ  32% 
v primerjavi z 200 mg vorikonazola BID, vorikonazol Cmax  4 % vorikonazol AUC  32 %
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister (Blister foil for 50 mg film-coated tablets (all blister packs)) 
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
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. 
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.
Therefore unless your doctor instructs you to stop treatment, it is important to keep taking Voriconazole Accord correctly, as described above. 
Zato je pomembno, da zdravilo Vorikonazol Accord jemljete pravilno, kot je opisano zgoraj, razen če vam zdravnik ne naroči, da zdravljenje končajte.
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 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
Study endpoints 
Opazovani dogodki v študiji
Contact your doctor immediately if you become pregnant while taking Voriconazole Accord. 
Če med jemanjem zdravila Vorikonazol Accord zanosite, se takoj posvetujte z zdravnikom.
[CYP3A4 substrate] 
[substrat CYP3A4]
The recommended dose for adults (including elderly patients) is as follows: Tablets Patients 40 kg and above Patients less than 40 kg 
tablete bolniki s telesno maso 40 kg in več bolniki s telesno maso manj kot 40 kg odmerek v prvih 24 urah (polnilni odmerek)
It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine. 
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.
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 
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
Indinavir Cmax ↔ Indinavir AUCτ ↔ Voriconazole Cmax ↔ Voriconazole AUCτ ↔ 
indinavir Cmax ↔ indinavir AUC ↔ vorikonazol Cmax ↔ vorikonazol AUC ↔
Voriconazole Cmax 23% Voriconazole AUCτ  7% 
v primerjavi z 200 mg vorikonazola BID, vorikonazol Cmax  23 % vorikonazol AUCτ  7 %
Monitoring for adverse reactions related to oral contraceptives, in addition to those for voriconazole, is recommended ol (1 mg/0.035 mg QD) 
noretisteron/etinilestradiol (1 mg/0,035 mg QD)
Breast-feeding must be stopped on initiation of treatment with Voriconazole Accord. 
Ko se začne zdravljenje z zdravilom Vorikonazol Accord, mora ženska prenehati z dojenjem.
Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole. 
Fenitoin se lahko uporablja sočasno z vorikonazolom, če se vorikonazola BID)*
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. 
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.
Common to < 1/10 
Pogosti ≥ 1/100 do
6 mg/kg every 12 hours 
3 mg/kg.
[CYP3A4 substrates and inhibitors] 
[substrati in inhibitorji CYP3A4]
EOT 
KT
Phenytoin (CYP2C9 substrate and potent CYP450 inducer) 
Fenitoin (substrat CYP2C9 in močan induktor CYP450) Med sočasno uporabo fenitoina in vorikonazola je priporočljivo natančno nadziranje koncentracije fenitoina.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/352/001-003 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/352/001-003
Increased appetite 
- povečanje apetita
WHAT INTRINSA IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO INTRINSA IN ZA KAJ GA UPORABLJAMO
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. 
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.
Use Intrinsa only as long as you experience a positive effect of the treatment. 
Zdravilo Intrinsa uporabljajte samo, dokler opažate ugodne učinke zdravljenja.
Intrinsa is used to treat HSDD. 
Zdravilo Intrinsa se uporablja za zdravljenje HSDD.
The testosterone in Intrinsa is the same hormone as that produced naturally in men and women. 
Testosteron v zdravilu Intrinsa je enak hormon kot tisti, ki se naravno proizvaja pri moških in ženskah.
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). 
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).
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. 
Učinke zdravila Intrinsa so opazili 4 tedne po začetku zdravljenja (prva točka merjenja) in pri vseh naslednjih mesečnih točkah merjenja učinkovitosti.
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. 
Zdravila Intrinsa ne uporabljajte, če ste noseči, sumite, da ste noseči ali lahko zanosite, ker lahko škoduje nerojenemu otroku.
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. 
O vrsti estrogena se morate torej posvetovati z zdravnikom, ki vam lahko svetuje, katera vrsta estrogena je ustrezna za uporabo skupaj z zdravilom Intrinsa.
Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt Germany 
Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt
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: 
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:
It is not known whether Intrinsa increases the risk of breast cancer and endometrium cancer. 
Ni znano, ali zdravilo Intrinsa poveča tveganje za rak dojke in raka endometrija.
Intrinsa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate. 
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.
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. 
Intrinsa ne opazite v 3-6 mesecih, morate obvestiti svojega zdravnika, ki vam bo predlagal, da zdravljenje prekinete.
The safety of Intrinsa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration. 
Varnost zdravila Intrinsa ni bila ocenjena v dvojno slepih, s placebom nadzorovanih študijah, ki bi trajale dlje kot 1 leto.
Children and adolescents Intrinsa is not for use in children and adolescents. 
Zdravilo Intrinsa ni namenjeno uporabi pri otrocih in mladostnikih.
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. 
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.
Intrinsa has no influence on the ability to drive and use machines. 
Zdravilo Intrinsa nima vpliva na sposobnost vožnje in upravljanja s stroji.
If you stop estrogen therapy you must also stop using Intrinsa. 
Če prekinete zdravljenje z estrogenom, morate prenehati uporabljati tudi zdravilo Intrinsa.
What Intrinsa looks like and contents of the pack Intrinsa is a thin, clear, oval patch with T001 stamped on the back. 
Izgled zdravila Intrinsa in vsebina pakiranja Intrinsa je tanek, prozoren, ovalen obliž z napisom T001, natisnjenim na zadnji strani.
There is no information on the safety of Intrinsa beyond 12 months. 
Podatkov o varnosti uporabe zdravila Intrinsa, daljše od 12 mesecev, ni.
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). 
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).
Paediatric population There is no relevant use of Intrinsa in the paediatric population. 
Pediatrična populacija Zdravilo Intrinsa ni primerno za uporabo pri pediatrični populaciji.
In case of inadvertent exposure during pregnancy, use of Intrinsa must be discontinued. 
V primeru nenamerne izpostavitve med nosečnostjo je treba zdravljenje z zdravilom Intrinsa prekiniti.
Testosterone from Intrinsa is transported across intact skin by a passive diffusion process that is primarily controlled by permeation across the stratum corneum. 
Testosteron iz zdravila Intrinsa se transportira prek nepoškodovane kože s pasivno difuzijo, ki jo nadzoruje predvsem prepuščanje skozi stratum corneum.
Intrinsa is a transdermal patch which constantly releases small amounts of testosterone that is absorbed through your skin into the bloodstream. 
Intrinsa je transdermalni obliž, ki neprekinjeno sprošča majhne količine testosterona, ki se skozi kožo vpijejo v krvni obtok.
If you have any of the above, tell your doctor before you start to use Intrinsa. 
Če imate karkoli od navedenega, povejte svojemu zdravniku, preden začnete uporabljati zdravilo
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. 
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.
Toxicological studies of testosterone have only revealed effects which can be explained based on the hormone profile. 
5.3 Predklinični podatki o varnosti Toksikološke študije testosterona so odkrile samo učinke, ki jih lahko razložimo na podlagi hormonskega profila.
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. 
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.
HOW TO USE INTRINSA 
KAKO UPORABLJATI ZDRAVILO INTRINSA
Overdosing with Intrinsa is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body. 
Pri zdravilu Intrinsa preveliko odmerjanje ni verjetno, kadar se uporablja skladno z navodili, ker se po odstranitvi obliža testosteron hitro odstrani iz telesa.
- If you are also using estrogen patches, make sure that the Intrinsa patch and the estrogen patch do not overlap. 
− Če uporabljate tudi estrogenske obliže, pazite, da se ta obliž zdravila Intrinsa in estrogenski obliž ne prekrivata.
The efficacy of Intrinsa is reduced if your estrogen therapy is of a certain type (‘conjugated equine estrogens'). 
Učinkovitost zdravila Intrinsa se zmanjša, če se zdravite z določeno vrsto estrogenov (‘konjugirani konjski estrogeni').
Intrinsa is designed to systemically deliver 300 micrograms/day. 
Zdravilo Intrinsa je oblikovano tako, da sistemsko dovaja 300 mikrogramov/dan.
Take special care with Intrinsa - if you have a history of heart, liver or kidney disease. 
Bodite posebno pozorni pri uporabi zdravila Intrinsa če ste v preteklosti imeli bolezen srca, ledvic ali jeter.
Intrinsa should not be used in women on concomitant CEE Whereas Intrinsa is indicated with concomitant estrogen therapy, the subgroup of patients receiving oral conjugated equine estrogens (CEE) did not demonstrate a significant improvement in sexual function. 
Zdravila Intrinsa se ne sme uporabljati pri ženskah, ki sočasno uporabljajo CEE Čeprav je zdravilo Intrinsa indicirano za sočasno zdravljenje z estrogenom, podskupina bolnic, ki so prejemale peroralne konjugirane konjske estrogene (CEE, conjugated equine estrogen), ni pokazala pomembnega izboljšanja spolne funkcije.
Intrinsa is only indicated for women in their menopause after the ovaries and uterus have been removed. 
Zdravilo Intrinsa je indicirano samo za ženske v menopavzi, potem ko so jim odstranili jajčnike in maternico.
In the combined phase III data, excluding patients taking oral CEE, in whom there was no significant improvement in sexual function, 50.7 % of women (n=274) treated with Intrinsa and 29.4 % of those treated with placebo (n=269) were responders with regard to total satisfying sexual activity (primary endpoint), when a responder was predefined as having an increase in the 4-week frequency of satisfying activities of > 1. 
V kombiniranih podatkih iz študije III. faze, iz katerih so izključili ženske, ki so prejemale peroralne CEE, pri katerih ni bilo pomembnega izboljšanja spolne funkcije, se je glede povsem zadovoljive spolne aktivnosti (primarni cilj) na zdravljenje odzvalo 50,7% žensk, ki so prejemale zdravilo Intrinsa (n=274), in 29,4% žensk, ki so prejemale placebo (n=269).
Intrinsa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones. 
Zdravilo Intrinsa ni vplivalo na koncentracije globulina v serumu, ki veže spolne hormone (SHBG, sex hormone binding globulin), estrogenov ali hormonov nadledvične žleze.
Intrinsa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels. 
Intrinsa je transdermalno zdravilo za HSDD, ki izboljša spolno željo, medtem ko dosega koncentracije testosterona, primerljive s koncentracijami pred menopavzo.
Like all medicines, Intrinsa can cause side effects, although not everybody gets them. 
MOŽNI NEŽELENI UČINKI Kot vsa zdravila ima lahko tudi zdravilo Intrinsa neželene učinke, ki pa se ne pojavijo pri vseh bolnicah.
Pregnancy Intrinsa must not be used in women who are or may become pregnant. 
Nosečnost Zdravila Intrinsa ne smejo uporabljati nosečnice ali ženske, ki lahko zanosijo.
To prevent interference with the adhesive properties of Intrinsa, no creams, lotions or powder should be applied to the skin where the patch is to be applied. 
Da ne bi ovirali lepilnih lastnosti zdravila Intrinsa, se na kožo, kamor se obliž aplicira, ne sme nanesti kreme, losjona ali pudra.
Two multi-centre, double-blind, placebo-controlled six month studies in 562 (INTIMATE SM1) and 533 (INTIMATE SM2) oophorectomised and hysterectomised women (surgically induced menopause), aged 20 to 70 years, with HSDD on concomitant estrogen were used to evaluate the efficacy and safety of Intrinsa. 
Učinkovitost in varnost zdravila Intrinsa so ocenili v dveh multicentričnih, dvojno slepih, s placebom nadzorovanih šestmesečnih študijah pri 562 (INTIMATE SM1) in 533 (INTIMATE SM2) ženskah z ooforektomijo in histerektomijo (kirurško sproženo menopavzo) s HSDD, starih od 20 do 70 let, ki so sočasno prejemale estrogen.
Intrinsa is recommended for use in surgically menopausal women up to the age of 60. 
Uporaba zdravila Intrinsa se priporoča pri ženskah po kirurški menopavzi do 60. leta starosti.
Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy. 
Zdravilo Intrinsa je indicirano za zdravljenje motnje hipoaktivne spolne želje (HSDD, hypoactive sexual desire disorder) pri ženskah z bilateralno ooforektomijo in histerektomijo (kirurško sproženo menopavzo), ki sočasno prejemajo zdravljenje z estrogenom.
- sinusitis (inflammation of nasal sinus) - abnormal clotting factor - hypersensitivity (allergic reactions) - increased appetite - agitation 
- sinusitis (vnetje nosnih sinusov) - nenormalen faktor strjevanja krvi - preobčutljivost (alergijske reakcije)
Testosterone, the primary circulating androgen in women, is a naturally occurring steroid, secreted by the ovaries and adrenal glands. 
Testosteron, primarni androgen v krvnem obtoku pri ženskah, je naravni steroid, ki ga izločajo jajčniki in nadledvične žleze.
What Intrinsa is and what it is used for Before you use Intrinsa How to use Intrinsa Possible side effects How to store Intrinsa Further information 
Kaj je zdravilo Intrinsa in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Intrinsa Kako uporabljati zdravilo Intrinsa
Intrinsa is intended for use by women up to the age of 60 years who have had both their ovaries and their womb removed. 
Zdravilo Intrinsa je namenjeno za uporabo pri ženskah do 60. leta starosti, ki so jim odstranili jajčnike in maternico.
Do not use Intrinsa in case of breast-feeding because it may cause harm to the child. 
Zdravila Intrinsa ne uporabljajte, če dojite, ker lahko škoduje otroku.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo,
- if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Intrinsa (see section ‘Further information' at the end of this leaflet). 
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO INTRINSA Ne uporabljajte zdravila Intrinsa če ste alergični (preobčutljivi) na testosteron ali katerokoli sestavino zdravila Intrinsa (glejte poglavje „Dodatne informacije“ na koncu tega navodila).
Driving and using machines You can drive and use machines while using Intrinsa. 
Vpliv na sposobnost upravljanja vozil in strojev Med uporabo zdravila Intrinsa lahko vozite in uporabljate stroje.
However, patients should be informed that migraine, insomnia, disturbance in attention and diplopia have been reported during treatment with Intrinsa. 
Vendar je treba bolnicam povedati, da so med zdravljenjem z zdravilom Intrinsa poročali o migreni, nespečnosti, motnjah pozornosti in diplopiji.
Serum concentrations of testosterone and SHBG in patients receiving Intrinsa in clinical safety and 
Koncentracije testosterona in SHBG v serumu pri bolnicah, ki so prejemale zdravilo Intrinsa v kliničnih študijah varnosti in učinkovitosti Izhodiščna vrednost
Testosterone is mainly excreted in the urine as glucuronic and sulphuric acid conjugates of testosterone and its metabolites. 
Izločanje Testosteron se izloča v glavnem z urinom v obliki konjugatov glukuronske in žveplove kisline testosterona ter njegovih presnovkov.
Therefore, Intrinsa should not be used in women on concomitant CEE (see sections 4.2 and 
Zato zdravila Intrinsa ne smejo uporabljati ženske, ki sočasno prejemajo CEE (glejte poglavji 4.2 in 5.1).
However, this is not expected from the low dose of testosterone delivered by the Intrinsa patch. 
Vendar teh učinkov pri nizkih odmerkih testosterona, ki se sproščajo iz obližev Intrinsa, ni pričakovati.
Renal impairment No studies have been conducted in patients with renal insufficiency. 
Okvarjeno delovanje ledvic Študij pri bolnikih z ledvično insuficienco niso izvajali.
Intrinsa should not be used in naturally menopausal women Efficacy and safety of Intrinsa in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated. 
Učinkovitosti in varnosti zdravila Intrinsa pri ženskah po naravni menopavzi s HSDD, ki sočasno uporabljajo estrogen, s progestagenom ali brez njega, niso ocenili.
The mode of administration of Intrinsa makes overdose unlikely. 
Zaradi načina odmerjanja zdravila Intrinsa preveliko odmerjanje ni verjetno.
Fertility No data is available of the effect of Intrinsa on fertility. 
Plodnost Ni podatkov o vplivu zdravila Intrinsa na sposobnost razmnoževanja.
If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Intrinsa. 
Odstranite vse obliže in se posvetujte z zdravnikom ali s farmacevtom o tem, kako nadaljevati zdravljenje z zdravilom Intrinsa.
If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Intrinsa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table. 
Intrinsa: n = 1.498, bolnice, ki so prejemale placebo: n = 1.297), je pogostnost navedena v tabeli.
Breast pain Breast cyst, clitoral engorgement, enlarged clitoris, genital pruritus, vaginal burning sensation 
Motnje reprodukcije in dojk bolečine v dojkah cista na dojki, nabrekanje klitorisa, povečanje klitorisa, genitalni pruritus, občutek pečenja v vagini
The appropriate use and restrictions associated with estrogen therapy should be considered before Intrinsa therapy is initiated and during routine re-evaluation of treatment. 
Pred zdravljenjem z zdravilom Intrinsa in med rutinskimi ponovnimi ocenitvami zdravljenja je treba upoštevati ustrezno uporabo in omejitve, povezane z zdravljenjem z estrogenom.
On removal of an Intrinsa patch, testosterone serum concentrations return to near baseline values within 12 hours due to its short terminal exponential half-life (approximately 2 hours). 
Po odstranitvi obliža Intrinsa se zaradi kratke končne eksponentne razpolovne dobe (približno 2 uri) koncentracije testosterona v serumu v 12 urah vrnejo skoraj na izhodiščno vrednost.