qanastek/EMEA-V3 huggingface dataset:
Intrinsa is used to treat women who have had their uterus (womb) and both ovaries removed, when they have a lack of sexual thoughts and sexual desire that is causing them distress.
Intrinsa jintuża fit- trattament ta ’ nisa li jkun tneħħielhom kemm l- utru (il- ġuf) kif ukoll iż- żewġ ovarji, u jkunu qegħdin jesperjenzaw nuqqas ta ’ ħsibijiet u xewqat sesswali, ħaġa li tkun qegħda toħolqilhom inkwiet.
It is used in patients already taking an oestrogen (a female sex hormone).
Jintuża f’ pazjenti li diġà jkunu qegħdin jieħdu l- estroġenu (ormon sesswali feminili).
How is Intrinsa used?
Kif jintuża Intrinsa?
Intrinsa is used as a continuous treatment, as one patch twice a week.
Intrinsa jintuża bħala trattament kontinwu, bħala roqgħa waħda darbtejn fil- ġimgħa.
The patch is applied to dry, clean skin on the lower abdomen (the tummy, below the waist).
Ir- roqgħa tiġi applikata ma ’ ġilda xotta u nadifa fuq in- naħa ta ’ isfel taż- żaqq (’ l isfel mill- qadd).
The patch remains on the skin for three or four days and is then replaced by a new patch in a different place.
Ir- roqgħa tibqa ’ mal- ġilda għal tlieta jew erbat ijiem u mbagħad tiġi sostitwita b’ roqgħa ġdida f’ post ieħor.
The same place must not be used again until at least seven days later.
M’ għandux jerġa ’ jintuża l- istess post qabel sebat ijiem.
It may take longer than a month for the patient to see an improvement.
Jista ’ jkollu jgħaddi iktar minn xahar qabel ma l- pazjenta tibda tesperjenza titjib.
If a patient is not getting a benefit after three to six months of treatment, she should contact her doctor and have her treatment reviewed.
Jekk il- pazjenta ma tkunx qegħda tara benefiċċju wara bejn tlieta u sitt xhur ta ’ trattament, għandha tikkuntattja lit- tabib tagħha u t- trattament tagħha għandu jiġi rivedut.
How does Intrinsa work?
Kif jaħdem Intrinsa?
The active substance in Intrinsa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Is- sustanza attiva f’ Intrinsa, it- testosteronu, huwa ormon sesswali naturali prodott mill- irġiel u, sa ċertu punt fin- nisa.
Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Intwera li livelli baxxi ta ’ testosteronu għandhom rabta ma ’ xewqa sesswali baxxa u ma ’ tnaqqis fix- xewqat u l- eċitament sesswali.
In women who have had their uterus and ovaries removed, the amount of testosterone produced is halved.
Fin- nisa li jkunu tneħħewlhom kemm l- utru kif ukoll l- ovarji, l- ammont ta ’ testosteronu prodott jonqos bin- nofs.
Intrinsa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the uterus and ovaries.
Intrinsa jirrilaxxa t- testosteronu minn ġol - ġilda għal ġod- demm u jipproduċi livelli ta ’ testosteronu li jaqblu mal- livelli li kienu preżenti qabel it - tneħħija ta ’ l- utru u l- ovajri.
How has Intrinsa been studied?
Kif ġie studjat Intrinsa?
Because testosterone is a well-known substance that is already used in other medicines, the company used data from the published literature as well as carrying out studies itself.
Billi t- testosteronu huwa sustanza magħrufa tajjeb li diġà tintuża f’ mediċini oħrajn, il- kumpanija użat tagħrif mil- letteratura ppubblikata kif ukoll għamlet studji hija stess.
The two main studies involved 1,095 women with an average age of 49 years who received Intrinsa for up to a year.
Fiż- żewġ studji ewlenin ħadu sehem 1, 095 mara b’ età medja ta ’ 49 sena li ngħataw Intrinsa għal perjodu ta ’ mhux iktar minn sena.
Intrinsa was compared with placebo (a patch containing no active substance).
Intrinsa tqabbel ma ’ plaċebo (roqgħa li ma fiha l- ebda sustanza attiva).
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L- istudji użaw kwestjonarju ddisinjat speċifikament biex ikejjel l- interess u l- attività sesswali billi rreġistra l- għadd ta ’ episodji 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. sexual episodes in a four-week period.
Reproduction is authorised provided the source is acknowledged. sesswali sodisfaċenti f’ perjodu ta ’ erba ’ ġimgħat.
The main measure of effectiveness was based on the change in the questionnaire score before the study began and after six months of treatment.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien ibbażat fuq il- bidla fil- punteġġ tal- kwestjonarju qabel ma beda l- istudju u wara sitt xhur ta ’ trattament.
What benefit has Intrinsa shown during the studies?
X’ benefiċċji wera Intrinsa matul dawn l- istudji?
Intrinsa was more effective than placebo.
Intrinsa kien iktar effettiv minn plaċebo.
When the results of the two studies were looked at together, the women who used Intrinsa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Meta r- riżultati taż- żewġ studji ġew analizzati flimkien, in - nisa li użaw Intrinsa kellhom medja ta ’ 1. 07 episodji sesswali sodisfaċenti iktar min- nisa li ngħataw il - plaċebo matul perjodu ta ’ erba ’ ġimgħat.
On average, women who had three satisfying sexual episodes in a four-week period before treatment had around five episodes over four weeks after using Intrinsa for six months.
Bħala medja, in- nisa li kellhom tliet episodji sesswali sodisfaċenti matul perjodu ta ’ erba ’ ġimgħat qabel it- trattament kellhom madwar ħames episodji matul l- erba ’ ġimgħat ta ’ wara l- użu ta ’ Intrinsa għal sitt xhur.
In contrast, women who used placebo had around four episodes in a four-week period after six months.
B’ kuntrast, in- nisa li użaw il- plaċebo kellhom madwar erba ’ episodji f’ perjodu ta ’ erba ’ ġimgħat wara s- sitt xhur ta ’ trattament.
What is the risk associated with Intrinsa?
X’ inhu r- riskju assoċjat ma ’ Intrinsa?
The most common side effects with Intrinsa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip), and reactions at the site of application of the patch (redness and itching).
L- iktar effetti sekondarji komuni ma ’ Intrinsa (li dehru f’ iktar minn pazjent 1 minn kull 10) huma żieda fix- xagħar (speċjalment fuq il- geddum u fix- xoffa ta ’ fuq), u reazzjonijiet fis- sit ta ’ l - applikazzjoni tar- roqgħa (ħmura u ħakk).
For the full list of all side effects reported with Intrinsa, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji rrappurati ma ’ Intrinsa, ara l- Fuljett ta ’ Tagħrif.
Because testosterone is a male sex hormone, women who are taking Intrinsa should be monitored to see if they develop any ‘ androgenic’ side effects (development of male characteristics) such as hair growth on the face, deepening of the voice or hair loss.
Billi t- testosteronu huwa ormon sesswali maskili, in- nisa li jkunu qed jieħdu Intrinsa għandhom jiġu sorveljati biex ikun magħruf jekk jiżviluppawx effetti sekondarji ‘ androġeniċi (l- iżvilupp ta ’ karatteristiċi maskili) bħax- xagħar fil- wiċċ, tħaxxin tal- leħen jew telf ta ’ xagħar.
Women should contact their doctor if they notice any of these effects.
In- nisa għadhom jikkuntattjaw lit- tabib tagħhom jekk jinnutaw xi effett minn dawn.
Intrinsa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients.
Intrinsa m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għat- testosteronu jew għal xi sustanza oħra tiegħu.
It should also not be used in women who have, or have had breast cancer or another oestrogen-dependent cancer, or who have other conditions that mean that they cannot take oestrogen- containing medicines.
Lanqas ma għandu jintuża f’ nisa li jkollhom, jew li qabel kellhom kanċer tas - sider jew xi kanċer ieħor dipendenti mill- estroġenu, jew li jkollhom kundizzjonijiet oħra li minħabba fihom ma jkunux jistgħu jieħdu mediċini bl- estroġenu.
Women using Intrinsa should also use oestrogens, but not of the type known as ‘ conjugated oestrogens ’ as this combination is not as effective.
Nisa li jkunu qegħdin jużaw Intrinsa għandhom jużaw estroġeni wkoll, iżda mhux tat- tip magħruf bħala ‘ estroġeni konġugati ’ għax din il- kombinazzjoni mhijiex effettiva.
Why has Intrinsa been approved?
Għaliex ġie approvat Intrinsa?
The Committee for Medicinal Products for Human Use (CHMP) decided that Intrinsa’ s benefits are greater than its risks for the treatment of hypoactive sexual desire disorder in bilaterally oophorectomised and hysterectomised women receiving concomitant oestrogen therapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Intrinsa huma ikbar mir- riskji tiegħu għat- trattament ta ’ disturbi dovuti għal xewqat sesswali baxxi f’ pazjenti li jkunu tneħħewlhom iż- żewġ ovarji u l- utru u li fl- istess ħin ikunu qegħdin jingħataw terapija bl- estroġenu.
The Committee recommended that Intrinsa be given marketing authorisation.
Il- Kumitat irrakkomanda li Intrinsa jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Which measures are being taken to ensure the safe use of Intrinsa?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Intrinsa?
The company that makes Intrinsa will monitor some of the side effects of Intrinsa closely, such as androgenic side effects.
Il- kumpanija li tagħmel Intrinsa se tissorvelja mill- qrib uħud mill- effetti sekondarji ta ’ Intrinsa, bħall - effetti sekondarji androġeniċi.
The company will review all ongoing studies with Intrinsa to look at potential long-term risks including breast cancer, endometrial cancer (cancer of the lining of the womb) and side effects affecting the heart and blood vessels.
Il- kumpanija se tirrevedi l- istudji li għaddejjin bħalissa b’ Intrinsa, biex tħares lejn ir- riskji potenzjali fit- tul fosthom il- kanċer tas- sider, il- kanċer endometrijali (kanċer fil- kisi ta ’ l- utru) u l- effetti sekondarji li jaffettwaw il- qalb u l- arterji u l- vini.
The company will also provide an educational plan for doctors and patients.
Il- kumpanija se tipprovdi wkoll pjan edukattiv għat- tobba u l- pazjenti.
Other information about Intrinsa:
Informazzjoni oħra dwar Intrinsa:
The European Commission granted a marketing authorisation valid throughout the European Union for Intrinsa to Procter & Gamble Pharmaceuticals UK Ltd. on 28 July 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Intrinsa lil Procter & Gamble Pharmaceuticals UK Ltd. fit- 28 ta ’ Lulju 2006.
The full EPAR for Intrinsa can be found here.
L- EPAR sħiħ għal Intrinsa jista ’ jinstab hawnhekk.
This summary was last updated in 05-2008.
Dan is- sommarju ġie aġġornat l- aħħar f’ 05- 2008.
Invented name
Numru tal- pro edura ta ’ l- EMEA Isem ivvintat Qawwa
Pharmaceutical Form
G amla farma ewtika
Route of administration
Mnejn jing ata
EU/ 1/ 06/ 352/ 001
EMEA/ H/ C/ 000634/ 0000/ 001
300 micrograms/ 24 hours
300 mikrogramma/ 24 sieg a
Transdermal patch
Gar a li tipprovdi medi ina li tg addi minn ol - ilda
Transdermal use
U u minn fuq il - ilda
2 patches
qartas (karta/ polyethylene/ fojl ta ’ 2 gar i l- aluminju/ ethylene methacrylic acid copolymer)
EU/ 1/ 06/ 352/ 002
EMEA/ H/ C/ 000634/ 0000/ 002
8 patches
qartas (karta/ polyethylene/ fojl ta ’ 8 gar i l- aluminju/ ethylene methacrylic acid copolymer)
EU/ 1/ 06/ 352/ 003
EMEA/ H/ C/ 000634/ 0000/ 003
24 patches
qartas (karta/ polyethylene/ fojl ta ’ 24 gar i l- aluminju/ ethylene methacrylic acid copolymer)
Intrinsa 300 micrograms/ 24 hours transdermal patch
Intrinsa 300 mikrogramma/ 24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol- ġilda
Each patch of 28 cm2 contains 8.4 mg testosterone and provides 300 micrograms of testosterone per 24 hours.
Kull garża ta ’ 28 ċm2 fiha 8. 4 mg ta ’ testosterone u tipprovdi 300 mikrogramma ta ’ testosterone kull 24 siegħa.
Thin, clear, oval matrix-type transdermal patch consisting of three layers: a translucent backing film, an adhesive matrix drug layer, and a protective release liner that is removed prior to application.
Rita ta ’ rinforz fid- dahar, transluċida, b’ saff ta ’ mediċina matrix li twaħħal, u b’ inforra li tipproteġi r- reħi tal- mediċina, li titneħħa qabel ma titwaħħal.
Each patch surface is stamped with PG T001.
Kull wiċċ tal- garża hu stampat bil- kliem PG T001.
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.
Intrinsa hu indikat għat- trattament ta ’ mard li fih persuna jkollha nuqqas ta ’ xewqa sesswali (hypoactive sexual desire disorder, HSDD) f’ nisa li kellhom ooforektomija u isterektomija b’ mod bilaterali (menopawsa ikkaġunata b’ mod kirurġiku) li kienu qed jirċievu terapija bl- estroġenu fl- istess ħin.
The recommended daily dose of testosterone is 300 micrograms.
Id- doża rakkomandata ta ’ kuljum ta ’ testosterone hi ta ’ 300 mikrogramma.
This is achieved by applying the patch twice weekly on a continuous basis.
Din tinkiseb billi l- garża tiġi applikata darbtejn f’ ġimgħa fuq bażi kontinwa.
The patch should be replaced with a fresh patch every 3 to 4 days.
Il- garża għandha tinbidel b’ garża ġdida kull 3 sa 4 ijiem.
A particular application site should be rotated with an interval of at least 7 days between applications.
Sit partikulari ta ’ l- applikazzjoni għandu jinbidel b’ intervall ta ’ mill- inqas 7 ijiem bejn l - applikazzjonijiet.
Only one patch is to be worn at a time.
Għandha titwaħħal garża waħda biss f’ ħin wieħed.
The adhesive side of the patch should be applied to a clean, dry area of skin on the lower abdomen below the waist.
In- naħa li twaħħal tal- garża għandha tiġi applikata fuq żona tal- ġilda nadifa u xotta fuq in- naħa t’ isfel taż- żaqq, taħt il- qadd.
Patches should not be applied to the breasts or other body regions.
Il- garżi m’ għandhomx jiġu applikati fuq is- sider jew fuq partijiet oħra tal- ġisem.
A skin site with minimal wrinkling and not covered by tight clothing is recommended.
Żona fuq il- ġilda li ma tantx ikollha tikmix u li ma tkunx miksija b’ ilbies issikkat hi rakkomandata.
The site should not be oily, damaged, or irritated.
Il - parti li tintgħażel m’ għandhiex tkun żejtnija, b’ xi ferita, jew qed tirritak.
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.
Biex tevita l- interferenza mal - proprjetajiet adeżivi ta ’ Intrinsa, l- ebda kremi, żjut jew terra m’ għandhom jiġu applikati fuq il- ġilda fejn il- garża tkun ser titwaħħal.
The patch should be applied immediately after opening the sachet and removing both parts of the protective release liner.
Il- garża għandha tiġi applikata immedjatament wara li l- qartas jinfetaħ u jitneħħew iż- żewġ partijiet ta ’ l- inforra li tipproteġi r- reħi tal- mediċina.
The patch should be pressed firmly in place for about 10 seconds, making sure there is good contact with the skin, especially around the edges.
Il- garża għandha tingħafas fil- post b’ mod sod għal madwar 10 sekondi, u trid taċċerta ruħek li jkun hemm kuntatt tajjeb mal- ġilda, speċjalment madwar it- truf tagħha.
If an area of the patch lifts, pressure should be applied to that area.
Jekk xi żona tal- garża tintrefa ’, applika pressjoni lil dik iż- żona.
If the patch detaches prematurely, it may be reapplied.
Jekk l- garża tinqala ’ qabel iż- żmien, din tista ’ terġa ’ tiġi applikata mill- ġdid.
If the same patch cannot be reapplied, a new patch should be applied to another location.
Jekk l- istess garża ma tkunx tista ’ terġa ’ tiġi applikata mill- ġdid, garża ġdida għandha tiġi applikata fuq żona oħra.
In either case, the original treatment regimen should be maintained.
Fiż- żewġ każijiet, il- kors original tat- trattament għandu jinżamm.
The patch is designed to remain in place during a shower, bath, swimming or exercising.
Il- garża hi maħsuba b’ tali mod li tibqa ’ fil- post matul doċċa, banju, għawm jew eżerċizzju fiżiku.
Concomitant estrogen treatment The appropriate use and restrictions associated with estrogen therapy should be considered before Intrinsa therapy is initiated and during routine re-evaluation of treatment.
2 It- trattament bl- estroġenu fl- istess ħin L- użu xieraq u restrizzjonijiet marbuta mat- terapija bl- estroġenu għandhom jiġu kkunsidrati qabel ma tinbeda t- terapija b’ Intrinsa, u matul l- evalwazzjoni mill- ġdid ta ’ rutina tat- trattament.
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).
It- tkomplija ta ’ l- użu b’ Intrinsa hu rakkomandat biss meta l- użu fl- istess ħin ta ’ l- estroġenu hu kkunsidrat li hu adattat (i. e. l- inqas doża effettiva għall- inqas tul ta ’ żmien possibbli).
2 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).
Pazjenti trattati b’ conjugated equine estrogen (CEE) mhumiex rakkomandati li jużaw Intrinsa, għax l - effikaċja ma ntwerietx (ara sezzjonijiet 4. 4 u 5. 1).
Duration of treatment Intrinsa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate.
Tul tat- trattament Ir- rispons għat- trattament b’ Intrinsa għandu jiġi evalwat fi żmien 3- 6 xhur minn meta jibda, biex jiġi stabbilit jekk it- tkomplija tat- terapija hix adattata.
Patients who do not experience a meaningful benefit should be re- evaluated and discontinuation of therapy be considered.
Pazjenti li ma jkollhomx benefiċċju sinifikanti, għandhom jiġu evalwati mill- ġdid, u t- twaqqif tat- terapija għandu jiġi kkunsidrat.
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.
Minħabba li l- effikaċja u s- sigurtà ta ’ Intrinsa ma kienux evalwati fi studji ta ’ iktar minn sena, hu rakkomandat li ssir evalwazzjoni tat- trattament kull 6 xhur.
There is no relevant indication for use of Intrinsa in children and adolescents.
M’ hemmx indikazzjoni rilevanti għall- użu ta ’ Intrinsa fit- tfal u adolexxenti.
Known, suspected or past history of cancer of the breast or known or suspected estrogen-dependent neoplasia, or any other condition consistent with the contraindications for the use of estrogen.
Kanċer tas- sider magħruf, issuspettat jew li għalih hemm storja medika, jew neoplasja magħrufa jew issuspettata, li hi dipendenti fuq l- estroġenu, jew kwalunkwe kundizzjoni oħra li hi konsistenti mal - kontraindkazzjonijiet għall- użu ta ’ l- estroġenu.
At regular intervals during treatment, physicians should monitor patients for potential androgenic undesirable effects (e. g. acne, changes in hair growth or hair loss).
F’ intervalli regolari matul it- trattament, it- tobba għandhom jimmonitorjaw il- pazjenti għal effetti mhux mixtieqa potenzjali androġeniċi (eż. akne, tibdil fit- tkabbir tax- xagħar jew telf ta ’ xagħar).
Patients should be advised to self assess for androgenic undesirable effects.
Il - pazjenti għandhom jingħataw parir biex jevalwaw lilhom infushom għal effetti mhux mixtieqa androġeniċi.
Signs of virilisation, such as voice deepening, hirsutism or clitoromegaly, may be irreversible and discontinuation of treatment should be considered.
Sinjali ta ’ virilizzazzjoni, bħal meta l- vuċi ssir ħoxna, ix- xagħar jikber b’ mod eċċessiv u f’ postijiet mhux tas- soltu jew klitoromegalija, jistgħu jkunu rriversibbli, u t- twaqqif tat- trattament għandu jiġi kkunsidrat.
In clinical trials these reactions were reversible in the majority of patients (see section 4.8).
Fi studji kliniċi, dawn ir- reazzjonijiet kienu riversibbli fil- maġġoranza tal - pazjenti (ara sezzjoni 4. 8).
Severe skin erythema, local oedema and blistering may occur due to hypersensitivity to the patch at the site of application.
Eritema severa tal- ġilda, edema lokali u nfafet jistgħu jseħħu minħabba s- sensittività eċċessiva għall - garża fis- sit ta ’ applikazzjoni.
Use of the patch should be discontinued if this occurs.
L- użu tal- garża għandu jitwaqqaf jekk dan iseħħ.
The safety of Intrinsa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Is- sigurtà ta ’ Intrinsa ma kinitx evalwata fi studji double blind ikkontrollati bil- plaċebo li damu iktar minn sena.
There is little information on long-term safety, including effects on breast tissue, the cardiovascular system and increase in insulin resistance.
Hemm ftit informazzjoni dwar is- sigurtà fuq tul ta ’ żmien, li tinkludi effetti fuq it- tessut tas- sider, is- sistema kardjovaskulari u żieda fir- reżistenza għall- insulina.
Data in the literature regarding the influence of testosterone on the risk of breast cancer in women are limited, inconclusive and conflicting.
Informazzjoni fil- letteratura dwar l- influwenza tat- testosterone fuq ir- riskju ta ’ kanċer tas- sider fin - nisa hi limitata, mhux konklużiva u konfliġġenti.
The long-term effect of testosterone treatment on the breast is currently unknown, therefore patients should be carefully monitored with regard to breast cancer in accordance with currently accepted screening practises and individual patient needs.
L- effett fit- tul tat- trattament bit- testosterone fuq is - sider mhuwiex magħruf bħalissa, u għalhekk il- pazjenti għandhom ikunu mmonitorjati b’ attenzjoni fir- rigward tal- kanċer tas- sider skond il- prattiċi kurrenti aċċettati ta ’ l- iscreening u l- ħtiġijiet individwali tal- pazjent.
Patients with known cardiovascular disease have not been studied.
Pazjenti b’ mard kardjovaskulari magħruf ma kienux studjati.
Patients with cardiovascular risk factors, in particular hypertension, and patients with known cardiovascular disease should be carefully monitored, specifically regarding changes in blood pressure and weight.
Pazjenti b’ fatturi ta ’ riskju kardjovaskulari, b’ mod partikulari l- pressjoni tad- demm għolja, u pazjenti b’ mard kardjovaskulari magħruf, għandhom ikunu mmonitorjati b’ attenzjoni, speċifikament għal tibdil fil- pressjoni tad- demm u l- piż.
In diabetic patients the metabolic effects of testosterone may decrease blood glucose and therefore insulin requirements.
F’ pazjenti dijabetiċi, l- effetti metaboliċi tat- testosterone jistgħu jnaqqsu l- glucose (zokkor) fid- demm, u b’ riżultat ta ’ dan, il- ħtiġijiet ta ’ l- insulina.
Patients with diabetes mellitus have not been studied.
Pazjenti b’ dijabete mellitus ma kienux studjati.
Little information is available on the effects of testosterone on the endometrium.
3 Ftit informazzjoni hi disponibbli fuq l- effetti ta ’ testosterone fuq l- endometriju.
The limited data evaluating the effect of testosterone on the endometrium neither allow conclusions nor reassurances on the incidence of endometrial cancer.
L- informazzjoni limitata li tevalwa l- effett ta ’ testosterone fuq l- endometriju, la tippermetti konklużjonijiet u lanqas assigurazzjonijiet dwar l- inċidenza ta ’ kanċer endometrijali.
Oedema (with or without congestive heart failure) may be a serious complication from high doses of testosterone or other anabolic steroids in patients with pre-existing cardiac, renal, or hepatic disease.
L- edema (bi jew mingħajr kollass konġestiv tal- qalb) tista ’ tkun kumplikazzjoni serja kkawżata minn dożi qawwija ta ’ testosterone jew sterojdi anaboliċi oħrajn f’ pazjenti li qabel kellhom mard kardijaku, tal- kliewi, jew tal- fwied.
However, this is not expected from the low dose of testosterone delivered by the Intrinsa patch.
Madankollu, dan mhuwiex mistenni minħabba doża baxxa ta ’ testosterone fornuta mill- garża ta ’ Intrinsa.
3 Intrinsa is recommended for use in surgically menopausal women up to the age of 60.
Intrinsa hu rakkomandat għall- użu f’ nisa sa l- età ta ’ 60 sena, li fihom il- menopawsa kienet ikkaġunata b’ mod kirurġiku.
Consistent with the prevalence of HSDD, there are limited data above the age of 60.
B’ mod konsistenti mal- prevalenza ta ’ HSDD, hemm informazzjoni limitata fuq pazjenti li għandhom iktar minn 60 sena.
Efficacy and safety of Intrinsa 300 micrograms in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
L- effikaċja u s- sigurtà ta ’ Intrinsa 300 mikrogramma f’ nisa li jkollhom menopawsa naturali, bl- HSDD u qed jużaw l- estroġenu fl- istess ħin, bi jew mingħajr progestogen, ma kienux evalwati.
Intrinsa 300 micrograms is not recommended in naturally menopausal women.
Intrinsa 300 mikrogramma mhux rakkomandat f’ nisa li jkollhom menopawsa naturali.
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.
Filwaqt li Intrinsa hu indikat biex jintuża fl- istess ħin ma ’ terapija bl- estroġenu, is- sotto- grupp ta ’ pazjenti li kienu qed jirċievu conjugated equine estrogens (CEE) orali, ma wrewx titjib sinifikanti fil - funzjoni sesswali.
Therefore, Intrinsa should not be used in women on concomitant CEE (see sections 4.2 and 5.1).
Għalhekk, Intrinsa m’ għandux jintuża f’ nisa li qed jużaw CEE fl- istess ħin (ara sezzjonijiet 4. 2 u 5. 1).
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4.
L- androġeni jistgħu jnaqqsu l- livelli ta ’ globulin li teħel ma ’ thyroxin, li jirriżulta f’ livelli totali mnaqqsa ta ’ T4 fis- serum, u f’ żieda fit- teħid tar- reżina ta ’ T3 u T4.
Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Madankollu, il- livelli ta ’ l- ormon ħielsa tat- tirojde jibqgħu mhux mibdula, u m’ hemm l- ebda evidenza klinika ta ’ disfunzjoni tat- tirojde.
When testosterone is given concomitantly with anticoagulants, the anticoagulant effect may increase.
Meta testosterone jingħata fl- istess ħin ma ’ mediċini li jraqqu d- demm, l- effett tal- mediċini li jraqqu d - demm jista ’ jiżdied.
Patients receiving oral anticoagulants require close monitoring, especially when testosterone therapy is started or stopped.
Pazjenti li qed jirċievu mediċini orali li jraqqu d- demm, għandhom bżonn ta ’ monitoraġġ mill- qrib, speċjalment meta t- terapija b’ testosterone tinbeda jew titwaqqaf.
Intrinsa must not be used in women who are or may become pregnant or by breast-feeding women.
Intrinsa m’ għandux jintuża f’ nisa li huma tqal jew li jistgħu joħorġu tqal, jew minn nisa li qed ireddgħu.
Testosterone may induce virilising effects on the female foetus when administered to a pregnant woman.
Testosterone jista ’ jikkaġuna effetti virilising fuq il- fetu femminili meta jingħata lil mara tqila.
In case of inadvertent exposure during pregnancy, use of Intrinsa must be discontinued.
F’ każ ta ’ espożizzjoni nvolontarja waqt it- tqala, l- użu ta ’ Intrinsa jrid jitwaqqaf.
Intrinsa has no influence on the ability to drive and use machines.
Intrinsa m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
The adverse reaction most often reported (30.4%) was application site reactions.
Ir- reazzjoni avversa li kienet l- aktar irrappurtata (30. 4%) kienet reazzjonijiet fis- sit ta ’ l- applikazzjoni.
The majority of these adverse reactions consisted of mild erythema and itching and did not result in patient withdrawal.
Il- maġġoranza ta ’ dawn ir- reazzjonijiet avversi kienu jikkonsistu f’ eritema ħafifa u ħakk, u ma rriżultawx f’ li l- pazjenta tieqaf tieħu din il- mediċina.
Hirsutism was also very commonly reported.
Ix- xagħar li jikber b’ mod eċċessiv u f’ postijiet mhux tas- soltu kien ukoll irrappurtat b’ mod komuni ħafna.
Most reports concerned the chin and upper lip, were mild (≥ 90%), and less than 1% of all patients withdrew from the studies due to hirsutism.
4 ħfief (≥ 90%), u inqas minn 1% tal- pazjenti kollha irtiraw mill- istudji minħabba xagħar li jikber b’ mod eċċessiv u f’ postijiet mhux tas- soltu.
Hirsutism was reversible in the majority of patients.
Ix- xagħar li jikber b’ mod eċċessiv u f’ postijiet mhux tas- soltu kien riversibbli fil- maġġoranza tal- pazjenti.
Other androgenic effects commonly reported were acne, voice deepening and alopecia.
Effetti androġeniċi oħrajn li kienu rrappurtati b’ mod komuni kienu akne, il- vuċi ssir ħoxna u alopeċja.
More than 90% of these reports were considered mild.
Iktar minn 90% ta ’ dawn ir- rapporti kienu kkunsidrati li huma ħfief.
These reactions were reversible in the majority of patients.
Dawn ir- reazzjonijiet kienu riversibbli fil- maġġoranza tal- pazjenti.
Less than 1% of patients withdrew from the studies because of any of these reactions.
Inqas minn 1% tal- pazjenti irtiraw mill- istudju minħabba xi waħda minn dawn ir- reazzjonijiet.
All other common adverse events resolved in the majority of patients.
L- avvenimenti avversi l- oħrajn kollha li kienu komuni, fiequ fil - maġġoranza tal- pazjenti.
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.
Matul l- espożizzjoni double blind għal 6 xhur, ir- reazzjonijiet avversi li ġejjin seħħew fil- grupp tat - trattament (n=549) f’ inċidenza akbar milli fil- grupp tal- plaċebo (n=545) u kienu evalwati mill - investigaturi bħala possibbilment jew probabbilment relatati mat- trattament ta ’ 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.
Jekk reazzjoni avversa seħħet fi frekwenza ogħla fl- istudji integrati ta ’ fazi III (pazjenti fuq Intrinsa n=1, 498, pazjenti fuq il- plaċebo n=1, 297), din il- frekwenza hi rrappurtata fit- tabella.
Very
Komuni Ħafna
Common Common
Komuni
System organ class
Klassi ta ’ l- Organi tas- Sistema
≥ 1/ 1,000, < 1/ 100
1/ 1, 000, < 1/ 100
Infections and infestations Blood and lymphatic system disorders
Disturbi tad- demm u tas- sistema limfatika Disturbi fis- sistema immunitarja Disturbi fil- metabolismu u nutrizzjoni
Sinusitis Abnormal clotting factor
Fattur anormali tat- tagħqid tad - demm Sensittività eċċessiva Żieda fl- aptit
Immune system disorders Metabolism and nutrition disorders
Disturbi psikjatriċi
Hypersensitivity Increased appetite
Aġitazzjoni, ansjetà
Psychiatric disorders Nervous system disorders
Disturbi fis- sistema nervuża
Insomnia Migraine
Emigranja
Agitation, anxiety Disturbance in attention, dysgeusia, impaired balance, hyperaesthesia, oral paraesthesia, transient ischemic attack
Disturbi fl- attenzjoni, indeboliment fis- sens tat - togħma, indeboliment fis- sens tal- bilanċ, iperestesija, parestesija orali, attakk iskemiku li jgħaddi malajr
Eye disorders Cardiac disorders
Disturbi fl- għajnejn Disturbi fil- qalb
Diplopia, eye redness Palpitations
Diplopja, ħmura fl- għajnejn Palpitazzjonijiet
Voice deepening Abdominal pain
Il- vuċi ssir ħoxna Uġigħ ta ’ żaqq
Nasal congestion, throat tightness Diarrhoea, dry mouth, nausea
Konġestjoni nażali, dwejjaq fil - gerżuma Dijarea, ħalq xott, dardir
Hirsutism
Akne, alopeċja
Acnes, alopecias
Ekżema, żieda fl- għaraq, rosacea
Eczema, increased sweating, rosacea Arthritis
Disturbi muskolu- skeltrali u tal - connective tissue
Breast pain
Uġigħ fis- sider
Breast cyst, clitoral engorgement, enlarged clitoris, genital pruritus, vaginal burning sensation
Ċesti fis- sider, nefħa fil- klitoris, tkabbir tal- klitoris, ħakk ġenitali, sensazzjoni ta ’ ħruq fil - vaġina
General disorders and administration site conditions
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jingħata
Application site reaction (erythema, itching)
Reazzjoni fis - sit ta ’ l - applikazzjoni (eritema, ħakk)
Anasarca, asthenia, chest tightness, chest discomfort
Anasarka, astenja, dwejjaq fis - sider, skonfort fis- sider
Investigations
1/ 1, 000, < 1/ 100
Increased weight
Żieda fil- piż
Abnormal blood fibrinogen, increased heart rate, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides
Fibrinoġen anormali fid- demm, żieda fir- rata ta ’ taħbit tal- qalb, żieda f’ alanine aminotransferase, żieda f’ aspartate aminotransferase, żieda fil- bilirubina fid- demm, test anormali tal- funzjoni tal - fwied, żieda fit- triglycerides fid - demm
No new or other adverse reactions have been identified from the post-marketing spontaneous reporting system.
L- ebda reazzjonijiet avversi ġodda jew oħrajn ma kienu identifikati mis- sistema tar- rappurtaġġ spontanju ta ’ wara l- bejgħ.
The mode of administration of Intrinsa makes overdose unlikely.
Il- metodu ta ’ kif jingħata Intrinsa jagħmel doża eċċessiva mhux probabbli.
Removal of the patch results in a rapid decrease in serum testosterone levels (see section 5.2).
It- tneħħija tal- garża tirriżulta fi tnaqqis mgħaġġel tal- livelli tat- testosterone fis- serum (ara sezzjoni 5. 2).
Androgens, testosterone, ATC code:
Androġeni, testosterone, Kodiċi ATC:
5 Testosterone, the primary circulating androgen in women, is a naturally occurring steroid, secreted by the ovaries and adrenal glands.
Testosterone, l- androġenu primarju li jiċċirkola fin- nisa, hu sterojdi li jifforma b’ mod naturali, imnixxi mill- ovarji u mill- glandoli adrenali.
In premenopausal women, the rate of production of testosterone is 100 to 400 micrograms/ 24 hours, of which half is contributed by the ovary as either testosterone or a precursor.
F’ nisa qabel ma jkollhom il- menopawsa, ir- rata ta ’ produzzjoni ta ’ testosterone hi ta ’ 100 sa 400 mikrogramma/ 24 siegħa, li minnhom, in- nofs jiġi kkontribwit mill- ovarji bħala jew testosterone jew prekursur.
Serum levels of androgens fall as women age.
Il- livelli ta ’ l- androġeni fis- serum jaqgħu hekk kif in- nisa jixjieħu.
In women, who have undergone bilateral oophorectomy, serum levels of testosterone decline by approximately 50% within days after surgery.
F’ nisa li kellhom ooforektomija bilaterali, il- livelli fis- serum ta ’ testosterone jonqsu b’ madwar 50% fi ftit jiem wara l- operazzjoni.
Intrinsa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Intrinsa hu terapija transdermali għal HSDD, li ttejjeb ix- xewqa sesswali filwaqt li tilħaq konċentrazzjonijiet tat- testosterone li huma kompatibbli ma ’ livelli ta ’ qabel il- menopawsa.
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.
Żewġ studji multi- ċentriċi, double- blind, ikkontrollati bil- plaċebo, li damu sitt xhur, f’ 562 (INTIMATE SM1) u 533 (INTIMATE SM2) nisa li kellhom ooforektomija u isterektomija (menopawsa ikkaġunata b’ mod kirurġiku), li kellhom minn 20 sa 70 sena, bl- HSDD u bl- użu fl- istess ħin ta ’ l- estroġenu, intużaw biex tiġi evalwata l- effikaċja u s- sigurtà ta ’ Intrinsa.
Total satisfying sexual activity (primary endpoint), sexual desire, and distress associated with low sexual desire (secondary endpoints) were evaluated with validated instruments.
Attività sesswali totali li tissodisfa (riżultat aħħari primarju), xewqa sesswali, u problemi marbuta ma ’ xewqa sesswali baxxa (riżultati aħħari sekondarju) kienu evalwati bi strumenti vverifikati.
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.
Fl- analiżi ta ’ l- istudju kombinat wara 24 ġimgħa, id- differenza fil- medja tal- frekwenza ta ’ episodji totali li jissodisfa bejn Intrinsa u l- plaċebo kienet ta ’ 1. 07 kull 4 ġimgħat.
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.
Perċentwali ogħla b’ mod sinifikanti ta ’ nisa li rċivew Intrinsa rrappurtaw benefiċċju fil- tliet riżultati aħħarin, li huma kkunsidraw li kien klinikament sinifikanti meta mqabbel ma ’ nisa li rċivew il - plaċebo.
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.
Fl- informazzjoni kombinata ta ’ fażi III, li jeskludi l- pazjenti li kienu qed jieħdu CEE orali, li fihom ma kien hemm l- ebda titjib sinifikanti fil- funzjoni sesswali, 50. 7% tan- nisa (n=274) trattati b’ Intrinsa u 29. 4% ta ’ dawk trattati bil- plaċebo (n=269) irrispondew rigward l- attività sesswali li tissodisfa (riżultat aħħari primarju), meta min irrisponda kien definit minn qabel bħala li kellha żieda fuq medda ta ’ 4- ġimgħat fil- frekwenza ta ’ attivitajiet li jissodisfaw ta ’ > 1.
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.
6 L- effetti ta ’ Intrinsa kienu osservati wara 4 ġimgħat mill- bidu tat- terapija (l- ewwel punt fiż- żmien li fih sar il- kejl) u wara dan, l- effikaċja fil- punti kollha taż- żmien ta ’ kull xahar.
Efficacy versus placebo was significant across a range of subgroups which included patients separated by the following baseline characteristics: age (all subgroups up to age 65 years); body weight (up to 80 kg) and oophorectomy (up to 15 years ago).
L- effikaċja kontra l- plaċebo kienet sinifikanti fuq medda ta ’ sotto- gruppi li kienu jinkludu pazjenti separati skond il- karatteristiċi tal- linja bażi li ġejjin: età (is- sotto- gruppi kollha sa l- età ta ’ 65 sena); piż tal- ġisem (sa 80 kg) u ooforektomija (sa 15- il sena ilu).
Subgroup analyses suggested that the route and type of concomitant estrogen (transdermal oestradiol, oral conjugated equine estrogen (CEE), oral non-CEE) can influence patient response.
L- analiżi tas- sotto- gruppi ssuġġerew li r- rotta u t- tip ta ’ użu fl- istess ħin ta ’ l- estroġenu (oestradiol transdermali, conjugated equine estrogen (CEE) orali, u non- CEE orali) jistgħu jinfluwenzaw ir - rispons tal- pazjent.
A responder analysis of the pivotal phase II and III studies showed significant improvements in all three major clinical endpoints versus placebo in patients on concomitant transdermal and oral non-CEE estrogens.
Analiżi ta ’ dawk li rrispondew fil- fażi importanti ħafna II u III ta ’ l- istudju, uriet titjib sinifikanti fit- tliet riżultati aħħarin kliniċi maġġuri kontra l- plaċebo f’ pazjenti li kienu qed jużaw l- estroġeni non- CEE orali u transdermali fl- istess ħin.
However, the subgroup of patients receiving oral CEE did not demonstrate a significant improvement in sexual activity compared to placebo (see sections 4.2 and 4.4).
Madankollu, is- sotto- grupp tal- pazjenti li kienu qed jirċievu CEE orali, ma weriex titjib sinifikanti fl- attività sesswali meta mqabbel mal- plaċebo (ara sezzjonijiet 4. 2 u 4. 4).
Testosterone from Intrinsa is transported across intact skin by a passive diffusion process that is primarily controlled by permeation across the stratum corneum.
Testosterone minn Intrinsa, jiġi ttrasportat minn ġol- ġilda intatta permezz ta ’ proċess passiv tad - diffużjoni, li huwa primarjament ikkontrollat mix- xterid minn naħa għal oħra ta ’ l- istratum corneum.
Intrinsa is designed to systemically deliver 300 micrograms/ day.
Intrinsa hu maħsub biex iforni b’ mod sistemiku, 300 mikrogramma kuljum.
Following application of the patch on abdominal skin, maximum serum concentrations of testosterone are reached within 24-36 hours, with a wide inter-individual variability.
Wara l- applikazzjoni tal - garża fuq il- ġilda taż- żaqq, il- konċentrazzjonijiet massimi ta ’ testosterone fis- serum jintlaħqu fi żmien 24- 36 siegħa, b’ varjabilità wiesgħa bejn l- individwi.
Serum concentrations of testosterone attain steady-state by the application of the second patch when applied in a twice-a-week regimen.
Il- konċentrazzjonijiet fis- serum ta ’ testosterone jilħqu l- istat fiss sa l- applikazzjoni tat- tieni garża meta applikata f’ kors ta ’ darbtejn fil- ġimgħa.
Intrinsa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Intrinsa ma nfluwenzax il- konċentrazzjonijiet fis- serum tas- sex hormone binding globulin (SHBG), estroġeni jew ormoni adrenali.
Serum Concentrations of Testosterone and SHBG in Patients Receiving Intrinsa in Clinical Safety and Efficacy Studies Hormone
Il- Konċentrazzjonijiet fis- Serum tat- Testosterone u SHBG f’ Pazjenti li Kienu Qed Jirċievu Intrinsa fi Studji Kliniċi dwar is- Sigurtà u l- Effikaċja Ormon
Baseline
Linja bażi
Week 24
Ġimgħa 24
Week 52
Ġimgħa 52
Free testosterone (pg/ ml)
Testosterone libera (pg/ ml)
544
N 544
0.92 (0.03)
Medja (SEM) 0. 92 (0. 03)
412
N 412
4.36 (0.16)
Medja (SEM) 4. 36 (0. 16)
287
N 287
4.44 (0.31)
Medja (SEM) 4. 44 (0. 31)
Total testosterone (ng/ dl)
Testosterone totali (ng/ dl)
17.6 (0.4)
17. 6 (0. 4)
79.7 (2.7)
79. 7 (2. 7)
74.8 (3.6)
74. 8 (3. 6)
7.65 (0.34) 91.7 (2.5)
7. 65 (0. 34) 91. 7 (2. 5)
20.98 (0.98) 93.9 (2.8)
20. 98 (0. 98) 93. 9 (2. 8)
21.04 (0.97) 90.0 (3.6)
21. 04 (0. 97) 90. 0 (3. 6)
DHT = dihydrotestosterone, SHBG = sex hormone binding globulin SEM = Standard Error of the Mean
DHT = dihydrotestosterone, SHBG = sex hormone binding globulin SEM = Standard Error of the Mean
In women, circulating testosterone is primarily bound in the serum to SHBG (65-80%) and to albumin (20-30%) leaving only about 0.5-2% as the free fraction.
Fin- nisa, it- testosterone li jiċċirkola jeħel primarjament fis- serum ma ’ SHBG (65- 80%) u ma ’ l - albumina (20- 30%), u jħalli biss madwar 0. 5- 2% bħala l- porzjon ħieles.
The affinity of binding to serum SHBG is relatively high and the SHBG bound fraction is regarded as not contributing to biological activity.
L- affinità tat- twaħħil ma ’ l - SHBG fis- serum hi relattivament għolja, u l- porzjon li jeħel ma ’ SHBG hu meqjus bħala li ma jikkontribwixxix għall- attività bijoloġika.
Binding to albumin is of relatively low affinity and is reversible.
It- twaħħil ma ’ l- albumina hu ta ’ affinità relattivament baxxa u hu riversibbli.
The albumin-bound fraction and the unbound fraction are collectively termed ‘ bioavailable’ testosterone.
Il- porzjon li jeħel ma ’ l- albumina u l- porzjon mhux imwaħħal huma msejħa b’ mod kollettiv bħala testosterone ‘ bijodisponibbli ’.
The amount of SHBG and albumin in serum and the total testosterone concentration determine the distribution of free and bioavailable testosterone.
L- ammont ta ’ SHBG u albumina fis- serum u l - konċentrazzjoni totali ta ’ testosterone, tiddetermina d- distribuzzjoni ta ’ testosterone ħieles u dak bijodisponibbli.
Serum concentration of SHBG is influenced by the route of administration of concomitant estrogen therapy.
Il- konċentrazzjoni fis- serum ta ’ SHBG hi influwenzata mir- rotta ta ’ l- għoti tat- terapija ta ’ l- estroġenu li jingħata fl- istess ħin.
Testosterone is metabolised primarily in the liver.
Testosterone hu metabolat primarjament fil- fwied.
Testosterone is metabolised to various 17-ketosteroids and further metabolism results in inactive glucuronides and other conjugates.
Testosterone hu metabolat għal diversi 17- ketosteroids u metaboliżmu addizzjonali jirriżulta fi glucuronides inattivi u konjugati oħrajn.
The active metabolites of testosterone are estradiol and dihydrotestosterone (DHT).
Il - metaboliti attivi ta ’ testosterone huma estradiol u dihydrotestosterone (DHT).
DHT has a greater affinity to SHBG than does testosterone.
DHT għandu affinità akbar għal SHBG milli għandu t- testosterone.
DHT concentrations increased in parallel with testosterone concentrations during Intrinsa treatment.
Il- konċentrazzjonijiet tad- DHT żdiedu b’ mod parallel mal- konċentrazzjonijiet ta ’ testosterone matul it- trattament b’ Intrinsa.
There were no significant differences in serum estradiol and estrone levels in patients treated with Intrinsa for up to 52 weeks compared to baseline.
Ma kien hemm l- ebda differenzi 7 sinifikanti fl- estradiol tas- serum u fil- livelli ta ’ estrone f’ pazjenti trattati b’ Intrinsa sa 52 ġimgħa meta mqabbla mal- linja bażi.
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).
Meta l- garża Intrinsa titneħħa, il- konċentrazzjonijiet tat- testosterone fis- serum jerġgħu lura għal qrib il- valuri tal- linja bażi fi żmien 12- il siegħa, minħabba l- half- life esponenzjali terminali qasira tiegħu (madwar sagħtejn).
There was no evidence of accumulation of testosterone over 52 weeks of treatment.
Ma kien hemm l- ebda evidenza ta ’ akkumulazzjoni ta ’ testosterone fuq perjodu ta ’ 52 ġimgħa ta ’ trattament.
Testosterone is mainly excreted in the urine as glucuronic and sulphuric acid conjugates of testosterone and its metabolites.
Testosterone jitneħħa primarjament fl- awrina bħala konjugati tal- glucuronic u sulphuric acid tat - testosterone u l- metaboliti tiegħu.
Toxicological studies of testosterone have only revealed effects which can be explained based on the hormone profile.
Studji tossikoloġiċi dwar testosterone żvelaw biss effetti li jistgħu jiġu spjegati bbażati fuq il- profil ta ’ l- ormoni.
Testosterone has been found to be nongenotoxic.
Testosterone nstab li kien mhux ġenotossiku.
Non-clinical studies on a relationship between testosterone treatment and cancer suggest that high doses may promote tumour growth in sex organs, mammary glands and liver in laboratory animals.
Studji mhux kliniċi dwar relazzjoni bejn it- trattament bit- testosterone u l- kanċer tissuġġerixxi li dożi qawwija jistgħu jgħinu l- iżvilupp ta ’ tumuri f’ organi sesswali, glandoli mammarji u fil- fwied f’ annimali tal- laboratorju.
The significance of these data for the use of Intrinsa in patients is not known.
Is- sinifikat ta ’ din l- informazzjoni għall- użu ta ’ Intrinsa fil- pazjenti mhuwiex magħruf.
Testosterone has a masculinising effect on female rat foetuses when dosed subcutaneously at 0.5 or 1 mg/ day (as the propionate ester) to pregnant rats during organogenesis.
Testosterone għandu effett li jimmaskilizza fuq feti femminili tal- firien meta ngħataw id- doża taħt il - ġilda b’ 0. 5 jew 1 mg kuljum (bħala l- propionate ester) lil firien tqal matul l- organoġenesi.
Translucent polyethylene backing film printed with proprietary ink containing sunset yellow FCF (E110), latolrubine BK (E180) and copper phthalocyanine blue pigment.
Rinforz fid- dahar transluċidu tal- polyethylene, stampat b’ linka proprjetarja li fiha sunset yellow FCF (E110), latolrubine BK (E180) u copper phthalocyanine blue pigment.
Self adhesive matrix drug layer:
Saff tal- mediċina self adhesive matrix:
Sorbitan oleate, Acrylic co-polymer adhesive containing 2-Ethylhexylacrylate – 1-Vinyl-2-pyrrolidone co-polymer.
Sorbitan oleate, Sustanza li twaħħal ta ’ l- acrylic co- polymer li fiha 2- Ethylhexylacrylate – 1- Vinyl- 2- pyrrolidone co - polymer.
Protective release liner:
Inforra li tipproteġi r- reħi tal- mediċina:
Siliconised polyester film.
Rita tal- polyester, siliconised.
Do not refrigerate or freeze.
Tagħmlux fil- friġġ jew fil- friża.
Each patch is packed in a sealed laminated sachet.
Kull garża hi ppakkjata f’ qartas issiġillat u laminat.
The sachet material comprises of food grade paper/ polyethylene/ aluminium foil/ ethylene methacrylic acid copolymer (outer to inner layer).
Il- materjal tal- qartas jinkludi karta tal- grad ta ’ l - ikel/ polyethylene/ fojl ta ’ l- aluminju/ ethylene methacrylic acid copolymer (saff ta ’ barra sa ġewwa).
The ethylene methacrylic acid copolymer (Surlyn®) is the heat seal layer which allows the two laminate sachet stocks to be heat-sealed together to form the sachet.
Ethylene methacrylic acid copolymer (Surlyn®) hu saff issiġillat bis- sħana li jippermetti ż- żewġ stocks laminati tal- qartas li jkunu ssiġillati flimkien bis- sħana biex jiffurmaw il- qartas.
Cartons of 2, 8 and 24 patches.
Kaxxi tal- kartun ta ’ 2, 8 u 24 garżi.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GHAT- TQEGHID FIS- SUQ