natgillin/translations-raw huggingface dataset:
croscarmellose sodium, magnesium stearate and lactose monohydrate.
premreženi natrijev karmelozat, magnezijev stearat in laktoza monohidrat.
What INTELENCE looks like and contents of the pack White to off-white, oval tablet, with “T125” on one side and “100” on the other side.
Izgled zdravila INTELENCE in vsebina pakiranja Bela do belkasta ovalna tableta z oznako “ T125 ” na eni strani in “ 100 ” na drugi.
Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Imetnik dovoljenja za promet z zdravilom Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340 Beerse, Belgija
Manufacturer Janssen-Cilag SpA, Via C.
Izdelovalec Janssen- Cilag SpA, Via C.
Janssen, 0 4010 Borgo San Michele, Latina, Italy
Janssen, 04010 Borgo San Michele, Latina, Italija
50-100 Holmers Farm Way Saunderton High Wycombe Buckinghamshire HP12 4EG - UK Tel: +44 1494 567 444
50- 100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG - UK Tel: +44 1494 567 444
36
36 Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Obliž sprosti 300 mikrogramov zdravilne učinkovine testosteron v obdobju 24 ur.
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.
Zdravilo Intrinsa se uporablja za zdravljenje žensk, ki so jim odstranili maternico in oba jajčnika, v primeru pomanjkanja spolnih misli in spolnega poželenja, zaradi česar so v osebni stiski.
The patch is applied to dry, clean skin on the lower abdomen (the tummy, below the waist).
Obliž se namesti na suho in čisto kožo na spodnji del trebuha (pod pasom).
It may take longer than a month for the patient to see an improvement.
Bolnica utegne zaznati izboljšanje tudi šele po več kot enem mesecu.
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.
Bolnica, pri kateri se po treh do šestih mesecih zdravljenja ne pojavi koristen učinek, se naj posvetuje s svojim zdravnikom, ki naj ponovno presodi zdravljenje.
The active substance in Intrinsa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Učinkovina v zdravilu Intrinsa, testosteron, je naravni spolni hormon, ki se tvori pri moških in v manjši meri pri ženskah.
In women who have had their uterus and ovaries removed, the amount of testosterone produced is halved.
Pri ženskah, ki so jim odstranili maternico in jajčnike, se raven proizvedenega testosterona zmanjša na polovico.
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.
Zdravilo Intrinsa sprosti testosteron skozi kožo v krvni obtok, s čimer se vzpostavi raven testosterona, ki ustreza ravni, izmerjeni pred odstranitvijo maternice in jajčnikov.
The two main studies involved 1,095 women with an average age of 49 years who received Intrinsa for up to a year.
V dveh glavnih študijah je sodelovalo 1095 žensk s povprečno starostjo 49 let, ki so prejemale zdravilo Intrinsa v obdobju do enega leta.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V študijah je bil uporabljen posebej oblikovan vprašalnik, s katerim so na podlagi 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. beleženja števila zadovoljivih spolnih odnosov v štiritedenskem obdobju merili spolno zanimanje in spolne aktivnosti.
Intrinsa was more effective than placebo.
Zdravilo Intrinsa bilo učinkovitejše od placeba.
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.
Analiza skupnih rezultatov obeh študij je pokazala, da so ženske, ki so uporabljale zdravilo Intrinsa, v štiritedenskem obdobju imele v povprečju za 1, 07 več zadovoljivih spolnih odnosov kot ženske, ki so uporabljale placebo.
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.
V povprečju so ženske, ki so imele pred zdravljenjem povprečno tri zadovoljive spolne odnose v štiritedenskem obdobju, po šestmesečnem jemanju zdravila Intrinsa imele okoli pet zadovoljivih spolnih odnosov v štiritedenskem obdobju.
In contrast, women who used placebo had around four episodes in a four-week period after six months.
V nasprotju s tem so ženske, ki so uporabljale placebo, imele po šestih mesecih okoli štiri spolne odnose v štiritedenskem obdobju.
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).
Najpogostejši neželeni učinki zdravila Intrinsa (opaženi pri več kot 1 od 10 bolnic) so hirsutizem (povečana rast dlak, zlasti na bradi in nad zgornjo ustnico) in reakcije na mestu namestitve obliža (rdečica in srbenje).
For the full list of all side effects reported with Intrinsa, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Intrinsa, glejte navodilo za uporabo.
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.
Glede na to, da je testosteron moški spolni hormon, je potrebno ženske, ki jemljejo zdravilo Intrinsa, spremljati, da bi tako opazili, ali se pri njih pojavljajo „ androgeni “ neželeni učinki (pojavljanje moških značilnosti), kot so rast dlake na obrazu, znižanje glasu ali izpadanje las.
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.
Ravno tako ga ne smejo uporabljati ženske, ki imajo ali so imele raka dojke ali katerega drugega od estrogena odvisnega raka oziroma katero drugo zdravstveno stanje, zaradi katerega ne smejo prejemati zdravil, ki vsebujejo estrogen.
Women using Intrinsa should also use oestrogens, but not of the type known as ‘ conjugated oestrogens ’ as this combination is not as effective.
Ženske, ki uporabljajo zdravilo Intrinsa, morajo jemati tudi estrogene, vendar ne tipa, znanega kot „ konjugirani estrogeni “, saj ta kombinacija ni učinkovita.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Intrinsa večje od z njim povezanih tveganj pri zdravljenju hipoaktivnega spolnega poželenja pri ženskah z bilateralno ooforektomijo in histerektomijo, ki sočasno prejemajo zdravljenje z estrogenom.
The Committee recommended that Intrinsa be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Intrinsa odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Intrinsa?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Intrinsa?
The company that makes Intrinsa will monitor some of the side effects of Intrinsa closely, such as androgenic side effects.
Družba, ki proizvaja zdravilo Intrinsa, bo skrbno spremljala nekatere neželene učinke zdravila Intrinsa, kot so npr. androgeni neželeni učinki.
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.
Družba bo pregledala vse potekajoče študije z zdravilom Intrinsa z namenom preučitve morebitnih dolgoročnih tveganj, ki vključujejo rak dojke, rak endometrija (rak maternične sluznice) in učinke, ki vplivajo na srce in ožilje.
The European Commission granted a marketing authorisation valid throughout the European Union for Intrinsa to Procter & Gamble Pharmaceuticals UK Ltd. on 28 July 2006.
Evropska komisija je dovoljenje za promet z zdravilom Intrinsa, veljavno po vsej Evropski uniji, odobrila družbi Procter & Gamble Pharmaceuticals UK Ltd. dne 28. julija 2006.
The full EPAR for Intrinsa can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Intrinsa je na voljo tukaj.
300 micrograms/ 24 hours
300 mikrogramov/ 24 ur
sachet (paper/ PE/ Alu/ ethylene methacrylic acid copolymer)
Zaščitna
2 patches
2 transdermalnih obližev
EU/ 1/ 06/ 352/ 002
vrečka (papir/ polietilen/ aluminij / kopolimer etilena in metakrilne kisline) EU/ 1/ 06/ 352/ 002
sachet (paper/ PE/ Alu/ ethylene methacrylic acid copolymer)
Zaščitna vrečka (papir/ polietilen/ aluminij / kopolimer etilena in metakrilne kisline)
8 patches
8 transdermalnih obližev
24 patches
24 transdermalnih obližev
Intrinsa 300 micrograms/ 24 hours transdermal patch
Intrinsa 300 mikrogramov/ 24 ur transdermalni obliž
Each patch of 28 cm2 contains 8.4 mg testosterone and provides 300 micrograms of testosterone per 24 hours.
Vsak obliž s površino 28 cm2 vsebuje 8, 4 mg testosterona in sprosti 300 mikrogramov testosterona v 24 urah.
Each patch surface is stamped with PG T001.
Na površini vsakega obliža je natisnjen napis PG T001.
The patch should be applied immediately after opening the sachet and removing both parts of the protective release liner.
Obliž je treba aplicirati neposredno po odprtju zaščitne vrečke in odstranitvi obeh delov zaščitne plasti.
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.
Sočasno zdravljenje z estrogenom Pred zdravljenjem z zdravilom Intrinsa in med rutinskimi ponovnimi ocenitvami zdravljenja je treba upoštevati ustrezno uporabo in omejitve, povezane z zdravljenjem z estrogenom.
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).
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).
2 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).
Duration of treatment 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.
There is no relevant indication for use of Intrinsa in children and adolescents.
Ustreznih indikacij za uporabo zdravila Intrinsa pri otrocih in mladostnikih ni.
At regular intervals during treatment, physicians should monitor patients for potential androgenic undesirable effects (e. g. acne, changes in hair growth or hair loss).
Med zdravljenjem morajo zdravniki v rednih presledkih nadzorovati bolnice zaradi morebitnih androgenih neželenih učinkov (npr. akne, spremembe rasti dlake ali izpadanje las).
In clinical trials these reactions were reversible in the majority of patients (see section 4.8).
V kliničnih študijah so bile te reakcije reverzibilne pri večini bolnic (glejte poglavje 4. 8).
3 Intrinsa is recommended for use in surgically menopausal women up to the age of 60.
3 Zdravilo Intrinsa se priporoča pri ženskah po kirurški menopavzi, starih do 60 let.
Efficacy and safety of Intrinsa 300 micrograms in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
Učinkovitosti in varnosti zdravila Intrinsa 300 mikrogramov pri ženskah po naravni menopavzi s HSDD, ki sočasno uporabljajo estrogen, s progestagenom ali brez njega, niso ocenili.
Intrinsa 300 micrograms is not recommended in naturally menopausal women.
Uporaba zdravila Intrinsa 300 mikrogramov se ne priporoča ženskam po naravni menopavzi.
Therefore, Intrinsa should not be used in women on concomitant CEE (see sections 4.2 and 5.1).
Zato zdravila Intrinsa ne smejo uporabljati ženske, ki sočasno prejemajo CEE (glejte poglavji 4. 2 in 5. 1).
Intrinsa must not be used in women who are or may become pregnant or by breast-feeding women.
Zdravila Intrinsa ne smejo uporabljati nosečnice, ženske, ki lahko zanosijo, ali doječe ženske.
The adverse reaction most often reported (30.4%) was application site reactions.
Najpogostejši neželeni učinek, o katerem so poročali (30, 4%), so bile reakcije na mestu aplikacije.
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.
Največ poročil se je nanašalo na brado in zgornjo ustnico, učinki so bili blagi (≥ 90%), zaradi hirsutizma pa je zdravljenje prekinilo manj kot 1% vseh bolnic.
Other androgenic effects commonly reported were acne, voice deepening and alopecia.
Drugi androgeni učinki, o katerih so poročali pogosto, so bili akne, znižan glas in alopecija.
More than 90% of these reports were considered mild.
Več kot 90% teh učinkov v poročilih je bilo blagih.
Less than 1% of patients withdrew from the studies because of any of these reactions.
Zaradi njih je sodelovanje v študiji prekinilo manj kot 1% bolnic.
All other common adverse events resolved in the majority of patients.
Vsi drugi pogosti neželeni dogodki so se pri večini bolnic prenehali.
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.
Če se je neželeni učinek pojavil pogosteje v integriranih študijah III. faze (bolnice, ki so prejemale zdravilo Intrinsa: n = 1. 498, bolnice, ki so prejemale placebo: n = 1. 297), je pogostnost navedena v tabeli.
4 MedDRA
4 Organski sistem po MedDRA
Common Common
Zelo pogosti
System organ class
Občasni
≥ 1/ 1,000, < 1/ 100
≥ 1/ 1. 000, < 1/ 100
Infections and infestations Blood and lymphatic system disorders
Infekcijske in parazitske bolezni Bolezni krvi in limfatičnega sistema Bolezni imunskega sistema Presnovne in prehranske motnje
Sinusitis Abnormal clotting factor
sinuzitis nenormalni faktor strjevanja krvi preobčutljivost povečanje apetita
Immune system disorders Metabolism and nutrition disorders
Psihiatrične motnje Bolezni živčevja
Hypersensitivity Increased appetite
nespečnost migrena
Psychiatric disorders Nervous system disorders
razdražljivost, tesnoba motnje pozornosti, disgevzija, motnje ravnotežja, hiperestezija, oralna parestezija, tranzitorna ishemična ataka
Insomnia Migraine
Očesne bolezni Srčne bolezni
Agitation, anxiety Disturbance in attention, dysgeusia, impaired balance, hyperaesthesia, oral paraesthesia, transient ischemic attack
diplopija, rdeče oko palpitacije
Eye disorders Cardiac disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Diplopia, eye redness Palpitations
znižanje glasu
Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders
nosna kongestija, stiskanje v grlu
Voice deepening Abdominal pain
bolečina v trebuhu
Nasal congestion, throat tightness Diarrhoea, dry mouth, nausea
driska, suha usta, navzea
Acnes, alopecias
akne, alopecije
Eczema, increased sweating, rosacea Arthritis
ekcem, povečano potenje, rozacea
Breast pain
artritis
No new or other adverse reactions have been identified from the post-marketing spontaneous reporting system.
V sistemu postmarketinškega spontanega poročanja niso odkrili nobenih drugih neželenih učinkov.
Removal of the patch results in a rapid decrease in serum testosterone levels (see section 5.2).
Odstranitev obliža povzroči hitro zmanjšanje ravni testosterona v serumu (glejte poglavje 5. 2).
Androgens, testosterone, ATC code:
Farmakoterapevtska skupina: androgeni, testosteron, oznaka ATC:
G03BA03
G03BA03.
5 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.
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.
Pri ženskah v premenopavzi je stopnja nastanka testosterona 100 do 400 mikrogramov/ 24 ur, od tega polovico prispevajo jajčniki v obliki testosterona ali njegovega prekurzorja.
In women, who have undergone bilateral oophorectomy, serum levels of testosterone decline by approximately 50% within days after surgery.
Pri ženskah, ki so jim opravili bilateralno ooforektomijo, se ravni testosterona v dneh po kirurškem posegu zmanjšajo za približno 50%.
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.
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.
Oseba, ki se odziva na zdravljenje, je bila poprej opredeljena kot oseba, pri kateri je pogostost zadovoljivih aktivnosti v 4 tednih povečana za > 1.
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).
Vendar se pri podskupini bolnic, ki so prejemale peroralne CEE, ni pokazalo pomembno izboljšanje spolne aktivnosti v primerjavi s placebom (glejte poglavji 4. 2 in 4. 4).
Intrinsa is designed to systemically deliver 300 micrograms/ day.
Zdravilo Intrinsa je oblikovano tako, da sistemsko dovaja 300 mikrogramov/ dan.
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.
Stanje
Serum concentrations of testosterone attain steady-state by the application of the second patch when applied in a twice-a-week regimen.
6 dinamičnega ravnovesja koncentracije testosterona v serumu se pri apliciranju dvakrat tedensko doseže z aplikacijo drugega obliža.
Serum Concentrations of Testosterone and SHBG in Patients Receiving Intrinsa in Clinical Safety and Efficacy Studies Hormone
Koncentracije testosterona in SHBG v serumu pri bolnicah, ki so prejemale zdravilo Intrinsa v kliničnih študijah varnosti in učinkovitosti Hormon
Serum Concentrations of Testosterone and SHBG in Patients Receiving Intrinsa in Clinical Safety and Efficacy Studies Hormone
Izhodiščna vrednost Srednja N vrednost (SEM)
Week 24
24. teden Srednja N vrednost (SEM)
Week 52
52. teden Srednja vrednost (SEM)
Free testosterone (pg/ ml)
Prosti testosteron (pg/ ml)
Total testosterone (ng/ dl)
Skupni testosteron (ng/ dl)
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.
Pri ženskah je testosteron v krvnem obtoku vezan v serumu prvotno na SHBG (65– 80%) in albumin (20– 30%), delež prostega testosterona pa je le približno 0, 5– 2%.
The albumin-bound fraction and the unbound fraction are collectively termed ‘ bioavailable’ testosterone.
Delež, vezan na albumin, in nevezan delež skupaj sestavljata “ biološko uporaben ” testosteron.
Testosterone is metabolised to various 17-ketosteroids and further metabolism results in inactive glucuronides and other conjugates.
Testosteron se presnavlja v različne 17- ketosteroide in naprej v neaktivne glukuronide in druge konjugate.
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.
7 Testosteron ima maskulinizirajoči učinek na ženske plodove podgan pri subkutanem odmerjanju 0, 5 ali 1 mg/ dan (v obliki propionatnega estra) brejim samicam podgan med organogenezo.
Translucent polyethylene backing film printed with proprietary ink containing sunset yellow FCF (E110), latolrubine BK (E180) and copper phthalocyanine blue pigment.
Zunanja plast: prosojna polietilenska zunanja folija, natisnjena z zaščitenim črnilom, ki vsebuje oranžno barvilo FCF (E 110), latolrubin BK (E 180) in modri pigment bakrovega ftalocianina.
Sorbitan oleate, Acrylic co-polymer adhesive containing 2-Ethylhexylacrylate – 1-Vinyl-2-pyrrolidone co-polymer.
Samolepilna matriksna plast, ki vsebuje zdravilo: sorbitanoleat, akrilno kopolimerno lepilo, ki vsebuje 2- etilheksilakrilat – 1- vinil- 2- pirolidonski kopolimer.
Siliconised polyester film.
Zaščitna plast: silikonizirana poliestrska folija.
Each patch is packed in a sealed laminated sachet.
Vsak obliž je pakiran v zatesnjeno laminirano zaščitno vrečko.
The sachet material comprises of food grade paper/ polyethylene/ aluminium foil/ ethylene methacrylic acid copolymer (outer to inner layer).
Material zaščitne vrečke je sestavljen iz papirja/ polietilena/ aluminijaste folije/ etilenskega kopolimera z metakrilno kislino, primerno za živila (od zunanje proti notranji plasti).
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.
Etilenski kopolimer z metakrilno kislino (Surlyn®) je toplotno zatesnjena plast, ki omogoča toplotno tesnjenje dveh delov zaščitne vrečke v eno zaščitno vrečko.
Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW United Kingdom
Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW Velika Britanija
Procter & Gamble Pharmaceuticals - Germany GmbH Dr. -Otto-Röhm-Strasse 2-4 D-64331 Weiterstadt Germany
Procter & Gamble Pharmaceuticals - Germany GmbH Dr. - Otto- Röhm- Strasse 2- 4 D- 64331 Weiterstadt Nemčija
Procter & Gamble Pharmaceuticals Longjumeau Parc d’ activité de la Grande Brèche 5 rue Désir Prévost 91070 Bondoufle France
Procter & Gamble Pharmaceuticals Longjumeau Parc d’ activité de la Grande Brèche 5 rue Désir Prévost 91070 Bondoufle Francija
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance postavljen in da deluje, preden da zdravilo v promet in dokler zdravilo, ki ga trži, ostane v rabi.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne študije farmakovigilance, opisane v načrtu farmakovigilance.