qanastek/EMEA-V3 huggingface dataset:
A similar increase in BMD was seen in the treatment population who received OPTRUMA for up to 7 years.
L dz gu KMB palielin šanos nov roja rstniecisk s lietošanas grup, kas sa ma OPTRUMA l dz septi iem gadiem ilgi.
In the prevention trials, the percentage of subjects experiencing an increase or decrease in BMD during raloxifene therapy was: for the spine 37% decreased and 63% increased; and for the total hip 29% decreased and 71% increased.
Profilaktiskas lietošanas p t jum procentu lais pacientu skaits, kuriem raloksif na terapijas laik palielin j s vai samazin j s KMB: mugurkaulam samazin j s par 37% un palielin j s par 63%, g žas kauliem – samazin j s par 29% un palielin j s par 71%.
iii) Calcium kinetics.
iii) Kalcija kin tika.
OPTRUMA and oestrogen affect bone remodelling and calcium metabolism similarly.
OPTRUMA un estrog ni ietekm kaulu remodel šanu un kalcija metabolismu vien di.
OPTRUMA was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
OPTRUMA lietošana saist ta ar samazin tu kaulu rezorbciju un vid ji pozit vu novirzi kalcija l dzsvar par 60 mg dien, ko izraisa galvenok rt samazin ta kalcija izvad šana ar ur nu.
iv) Histomorphometry (bone quality).
iv) Histomorfometrija (kaulu kvalit te).
In a study comparing OPTRUMA with oestrogen, bone from patients treated with either medicinal product was histologically normal, with no evidence of mineralisation defects, woven bone or marrow fibrosis.
P t jum, kur tika sal dzin ti OPTRUMA un estrog ni, pacienšu, kuras tika rst tas ar k du no šiem medikamentiem, kauli bija histolo iski norm li, bez mineraliz cijas defektu paz m m, kaulu deform cijas vai kaulu smadze u fibrozes.
Raloxifene decreases resorption of bone; this effect on bone is manifested as reductions in the serum and urine levels of bone turnover markers, decreases in bone resorption based on radiocalcium kinetics studies, increases in BMD and decreases in the incidence of fractures.
Š iedarb ba uz kauliem izpaužas k kaulu apmai as mar ieru l me a samazin šan s serum un ur n, kaulu rezorbcijas samazin šan s, ko apliecina radioakt v kalcija kin tikas p t jumi, k ar KMB palielin šan s un l zumu biežuma samazin šan s.
b) Effects on lipid metabolism and cardiovascular risk
b) Ietekme uz lip du vielmai u un kardiovaskul ro risku
Clinical trials showed that a 60 mg daily dose of OPTRUMA significantly decreased total cholesterol (3 to 6%), and LDL cholesterol (4 to 10%).
Kl niskie p t jumi r da, ka OPTRUMA 60 mg dienas dev b tiski pazemina kop j holester na (3 – 6%) un ZBL holester na (4 – 10%) l meni.
Women with the highest baseline cholesterol levels had the greatest decreases.
Sieviet m ar s kotn ji augst ku holester na l meni pazemin šan s bija izteikt ka.
HDL cholesterol and triglyceride concentrations did not change significantly.
ABL holester na un triglicer du koncentr cijas b tiski nemain j s.
After 3 years therapy OPTRUMA decreased fibrinogen (6.71%).
P c 3 gadu terapijas OPTRUMA samazin ja fibrinog na l meni (6, 71%).
In the osteoporosis treatment study, significantly fewer OPTRUMA-treated patients required initiation of hypolipidaemic therapy compared to placebo.
Osteoporozes rst šanas p t jum daudz maz kam ar OPTRUMA rst tu pacienšu skaitam bija j s k hipolipidemiz joša terapija nek pacient m placebo grup.
OPTRUMA therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
8 gadu OPTRUMA terapija b tiski neietekm ja kardiovaskul ro trauc jumu risku pacient m, kuras piedal j s osteoporozes rst šanas p t jum.
Similarly, in the RUTH study, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, stroke or overall mortality, including overall cardiovascular mortality, compared to placebo (for the increase in risk of fatal stroke see section 4.4).
L dz gi p t jum RUTH raloksif ns neietekm ja miokarda infarkta, ak ta koron ra sindroma ar hospitaliz ciju, insulta biežumu vai kop jo mirst bu, ieskaitot kop jo kardiovaskul ru notikumu izrais tu mirst bu, biežumu, sal dzinot ar placebo (inform ciju par fat la insulta riska palielin šanos skat t apakšpunkt 4. 4).
8 The relative risk of venous thromboembolic events observed during raloxifene treatment was 1.60 (CI 0.95, 2.71) when compared to placebo, and was 1.0 (CI 0.3, 6.2) when compared to oestrogen or hormonal replacement therapy.
Raloksif na terapijas laik nov rotais venoz s trombembolijas relat vais risks bija 1, 60 (TI 0, 95, 2, 71), sal dzinot ar placebo, un 1, 0 (TI 0, 3, 6, 2), sal dzinot ar estrog nu vai hormonu aizst jterapiju.
The risk of a thromboembolic event was greatest in the first four months of therapy.
Liel kais trombembolisku trauc jumu rašan s risks bija terapijas pirmajos etros m nešos.
c) Effects on the endometrium and on the pelvic floor
c) Ietekme uz endometriju un iegur a pamatni
In clinical trials, OPTRUMA did not stimulate the postmenopausal uterine endometrium.
Kl niskos p t jumos OPTRUMA nestimul ja dzemdes endometriju p cmenopauz.
Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
Sal dzinot ar placebo, raloksif na lietošana nebija saist ta ar asi ainu izdal jumu rašanos, asi ošanu vai endometrija hiperpl ziju.
Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Veica gandr z 3000 transvagin lu ultraska as (TVU) izmekl jumu 831 sievietei vis s devu grup s.
Raloxifene treated women consistently had an endometrial thickness which was indistinguishable from placebo.
Ar raloksif nu rst t m sieviet m past v gi bija t ds pats endometrija biezums k placebo grup.
After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9% of the 211 women treated with raloxifene 60 mg/ day compared to 1.8% of the 219 women who received placebo.
P c 3 gadu rst šanas 1, 9% no 211 ar 60 mg raloksif na dien rst t m sieviet m nov roja endometrija biezuma palielin šanos vismaz par 5 mm, sal dzinot ar 1, 8% no 219 sieviet m, kuras sa ma placebo.
There were no differences between the raloxifene and placebo groups with respect to the incidence of reported uterine bleeding.
Nebija atš ir bu starp raloksif na un placebo grup m attiec b uz zi oto dzemdes asi ošanu biežumu.
Endometrial biopsies taken after six months therapy with OPTRUMA 60 mg daily demonstrated non- proliferative endometrium in all patients.
Turkl t p t jum, kur lietoja 2, 5
In addition, in a study with 2.5 x the recommended daily dose of OPTRUMA there was no evidence of endometrial proliferation and no increase in uterine volume.
8 reizes liel ku OPTRUMA dienas devu nek ieteikts, nenov roja endometrija prolifer cijas paz mes un dzemdes tilpuma palielin šanos.
In the osteoporosis treatment trial, endometrial thickness was evaluated annually in a subset of the study population (1,644 patients) for 4 years.
Osteoporozes rst šanas p t jum iesaist to sieviešu apakšgrupai (1644 pacient m) 4 gadus katru gadu noteica endometrija biezumu.
Endometrial thickness measurements in OPTRUMA treated women were not different from baseline after 4 years of therapy.
Endometrija biezuma m r jumi ar OPTRUMA rst t m sieviet m p c 4 gadu terapijas neatš r s no s kotn jiem m r jumiem.
There was no difference between OPTRUMA and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Starp sieviet m, kuras tika rst tas ar OPTRUMA un placebo, nebija atš ir bu vagin las asi ošanas (sm r šan s) un vagin lu izdal jumu zi.
Fewer OPTRUMA treated women than placebo treated women required surgical intervention for uterine prolapse.
Maz kam ar OPTRUMA rst tu sieviešu skaitam nek ar placebo rst t m sieviet m bija nepieciešama dzemdes prolapsa irur iska rst šana.
Safety information following 3 years of raloxifene treatment suggests that raloxifene treatment does not increase pelvic floor relaxation and pelvic floor surgery.
Inform cija par lietošanas droš bu p c 3 gadu raloksif na terapijas liecina, ka raloksif na terapija nepastiprina iegur a pamatnes atsl bšanu un nepalielina irur iskas iejaukšan s nepieciešam bu iegur a pamatn.
After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
P c etriem gadiem raloksif ns nepalielin ja endometrija un oln cu v ža risku.
In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
Sieviet m p cmenopauz, kuras sa ma raloksif na terapiju 4 gadus, labdab gi endometrija polipi nov roti 0, 9% gad jumu, sal dzinot ar 0, 3% gad jumu sieviet m, kuras sa ma placebo terapiju.
d) Effects on breast tissue
d) Ietekme uz kr ts dziedzera audiem
OPTRUMA does not stimulate breast tissue.
OPTRUMA nestimul kr ts dziedzera audus.
Across all placebo-controlled trials, OPTRUMA was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
Visos ar placebo kontrol tos p t jumos OPTRUMA nevar ja atš irt no placebo attiec b uz kr šu dziedzeru simptomu rašan s biežumu un smagumu (nebija piet kuma, jut guma un s pju kr šu dziedzeros).
Over the 4 years of the osteoporosis treatment trial (involving 7705 patients), OPTRUMA treatment compared to placebo reduced the risk of total breast cancer by 62% (RR 0.38; CI 0.21, 0.69), the risk of invasive breast cancer by 71% (RR 0.29, CI 0.13, 0.58) and the risk of invasive oestrogen receptor (ER) positive breast cancer by 79% (RR 0.21, CI 0.07, 0.50).
4 gadu osteoporozes rst šanas p t jum (piedal j s 7705 pacientes) OPTRUMA terapija sal dzin jum ar placebo mazin ja kop j kr ts v ža risku par 62% (RR 0, 38, TI 0, 21, 0, 69), invaz va kr ts v ža risku par 71% (RR 0, 29, TI 0, 13, 0, 58) un invaz va estrog nreceptoru (ER) pozit va kr ts v ža risku par 79% (RR 0, 21, TI 0, 07, 0, 50).
OPTRUMA has no effect on the risk of ER negative breast cancers.
OPTRUMA neietekm ja ER negat va kr ts v ža risku.
These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
Šie nov rojumi apstiprina secin jumu, ka raloksif nam nav iekš jas estrog na agonista iedarb bas kr ts dziedzera audos.
e) Effects on cognitive function
e) Ietekme uz kognit vo funkciju
No adverse effects on cognitive function have been seen.
Nav nov rota negat va ietekme uz kognit vo funkciju.
9 5.2 Pharmacokinetic properties
5. 2 Farmakokin tisk s paš bas
Absorption
Uzs kšan s
Raloxifene is absorbed rapidly after oral administration.
P c iekš gas lietošanas raloksif ns tri uzs cas.
Approximately 60% of an oral dose is absorbed.
Uzs cas aptuveni 60% peror l s devas.
Presystemic glucuronidation is extensive.
Notiek plaša presist miska glikuronid cija.
Absolute bioavailability of raloxifene is 2%.
Raloksif na absol t biolo isk pieejam ba ir 2%.
The time to reach average maximum plasma concentration and bioavailability are functions of systemic interconversion and enterohepatic cycling of raloxifene and its glucuronide metabolites.
Laiks l dz vid j s maksim l s koncentr cijas saniegšanai plazm un biolo isk pieejam ba ir raloksif na un t glikuron du metabol tu sist misk s interkonversijas un enterohepatisk s cirkul cijas funkcijas.
Distribution
Izplat šan s
Raloxifene is distributed extensively in the body.
Raloksif ns plaši izplat s organism.
The volume of distribution is not dose dependent.
Izplat šan s tilpums nav atkar gs no devas.
Raloxifene is strongly bound to plasma proteins (98-99%).
Raloksif ns izteikti saist s ar plazmas olbaltumiem (98 – 99%).
Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4 '- glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′ -diglucuronide.
Raloksif ns pak auts ekstens vam pirm loka metabolismam l dz glikuron du savienojumiem raloksif na- 4 ’ - glikuron dam, raloksif na- 6- glikuron dam un raloksif na- 6, 4 ’ - diglikuron dam.
No other metabolites have been detected.
Citi metabol ti nav konstat ti.
Raloxifene comprises less than 1% of the combined concentrations of raloxifene and the glucuronide metabolites.
Raloksif ns sast da maz k nek 1% no raloksif na un glikuron da metabol tu kombin t s koncentr cijas.
Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Raloksif na l meni uztur enterohepatisk recirkul cija, nodrošinot 27, 7 stundu plazmas elimin cijas pusperiodu.
Results from single oral doses of raloxifene predict multiple dose pharmacokinetics.
9 Rezult ti, ko sniedz raloksif na vienreiz jas peror las devas p rbaudes, ir t di paši k vair kk rt ju devu farmakokin tikai.
Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
Arvien pieaugošas raloksif na devas rada nedaudz maz k par proporcion lu laukuma palielin šanos zem plazmas laika- koncentr cijas l knes (AUC).
Excretion
Izvad šana
The majority of a dose of raloxifene and glucuronide metabolites are excreted within 5 days and are found primarily in the faeces, with less than 6% excreted in urine.
Liel k raloksif na devas da a un glikuron da metabol ti tiek izvad ti 5 dienu laik un konstat jami galvenok rt izk rn jumos, ur n tiek izvad ti maz k nek 6%.
Special populations
pašas pacientu grupas
Renal insufficiency - Less than 6% of the total dose is eliminated in urine.
Maz k par 6% kop j s devas tiek izvad ti ur n.
In a population pharmacokinetic study, a 47% decrease in lean body mass adjusted creatinine clearance resulted in a 17% decrease in raloxifene clearance and a 15% decrease in the clearance of raloxifene conjugates.
Farmakokin tikas p t jum šai pacienšu grup konstat ts, ka p c erme a masas bez liek tauku sl a kori t kreatin na kl rensa samazin jums par 47% izrais ja raloksif na kl rensa samazin šanos par 17% un raloksif na konjug tu kl rensa samazin šanos par 15%.
Hepatic insufficiency - The pharmacokinetics of a single dose of raloxifene in patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) have been compared to that in healthy individuals.
Raloksif na vienreiz jas devas farmakokin tika pacientiem ar cirozi un viegli izteiktu aknu boj jumu (A klase p c Child- Pugh klasifik cijas) sal dzin ta ar farmakokin tiku veseliem indiv diem.
Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Raloksif na koncentr cija plazm bija aptuveni 2, 5 reizes augst ka nek kontroles grup un korel ja ar bilirub na koncentr ciju.
In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/ theca cell origin was observed in high-dose females (279 mg/ kg/ day).
Divus gadus ilg kancerogenit tes p t jum žurk m nov roja graudain sl a vai teka š nu cilmes oln cu audz ju biežuma palielin šanos m t t m, kas sa ma lielas devas (279 mg/ kg dien).
Systemic exposure (AUC) of raloxifene in this group was approximately 400 times that in postmenopausal women administered a 60 mg dose.
Raloksif na sist misk iedarb ba (AUC) šai grup apm ram 400 reizes p rsniedza AUC sieviet m p cmenopauz, kuras sa ma 60 mg devu.
In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/ kg, and prostatic leiomyoblastoma in males given 210 mg/ kg.
21 m nesi ilg kancerogenit tes p t jum pel m biež k nov roja s klinieku interstici lo š nu audz jus, priekšdziedzera adenomas un adenokarcinomas t vi iem, kam ievad ja 41 – 210 mg/ kg, k ar priekšdziedzera leiomioblastomu t vi iem, kam ievad ja 210 mg/ kg.
In female mice, an increased incidence of ovarian tumours in animals given 9 to 242 mg/ kg (0.3 to 32 times the AUC in humans) included benign and malignant tumours of granulosa/ theca cell origin and benign tumours of epithelial cell origin.
Pe u m t t m, kam ievad ja 9 – 242 mg/ kg (0, 3 – 32 reizes p rsniedz AUC cilv kam), biež k nov rotie oln cu audz ji bija graudain sl a vai teka š nu cilmes labdab gi un aundab gi audz ji un epit lija š nu cilmes labdab gi audz ji.
The female rodents in these studies were treated during their reproductive lives, when their ovaries were functional and highly responsive to hormonal stimulation.
Grauz ju m t tes šajos p t jumos tika rst tas reprodukt v period, kad to oln cas funkcion ja un labi rea ja pret stimul ciju ar hormoniem.
In contrast to the highly responsive ovaries in this rodent model, the human ovary after menopause is relatively unresponsive to reproductive hormonal stimulation.
Atš ir b no oti jut gaj m oln c m šim grauz ju modelim, cilv ka oln cas p c menopauzes ir sal dzinoši nejut gas pret stimul ciju ar dzimumhormoniem.
10 Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
Raloksif ns nebija genotoksisks nevien no izmantotaj m plašaj m testu sist m m.
The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Dz vniekiem nov rot ietekme uz reprodukciju un att st bu atbilst raloksif na zin m m farmakolo isk m paš b m.
At doses of 0.1 to 10 mg/ kg/ day in female rats, raloxifene disrupted estrous cycles of female rats during treatment, but did not delay fertile matings after treatment termination and only marginally reduced litter size, increased gestation length, and altered the timing of events in neonatal development.
Ievad ts 0, 1 – 10 mg/ kg dienas dev žurku m t t m, terapijas laik raloksif ns p rtrauca dz vnieku mekl šan s ciklu, bet neaizkav ja augl gu p rošanos p c rst šanas pabeigšanas un tikai nedaudz samazin ja metiena apm rus, palielin ja gr sn bas ilgumu un main ja neonat l s att st bas r d t ju par d šan s laiku.
When given during the preimplantation period, raloxifene delayed and disrupted embryo implantation resulting in prolonged gestation and reduced litter size but development of offspring to weaning was not affected.
Ievadot pirmsimplant cijas period, raloksif ns aizkav ja un p rtrauca embrija implant šanos, kas izrais ja gr sn bas laika pagarin šanos un metiena apm ru samazin šanos, ta u neietekm ja mazu a att st bu l dz patst v gam vecumam.
Teratology studies were conducted in rabbits and rats.
Teratolo ijas p t jumi tika veikti trušiem un žurk m.
In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/ kg) and hydrocephaly (≥ 10 mg/ kg) were seen.
Trušiem konstat ja abortus, zemu kambara starpsienas defektu l meni (> 0, 1 mg/ kg) un hidrocef liju (> 10 mg/ kg).
In rats retardation of foetal development, wavy ribs and kidney cavitation occurred (≥ 1 mg/ kg).
Žurk m rad s aug a att st bas aizkav šan s, vi veid gas ribas un kavit cija nier s (> 1 mg/ kg).
Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Raloksif nam ir sp c ga antiestrog na darb ba žurkas dzemd un tas aizkav estrog natkar gu kr ts dziedzera audz ju augšanu žurk m un pel m.
Tablet core:
Povidons
Povidone Polysorbate 80 Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
10 Polisorb ts 80 Bez dens laktoze Laktozes monohidr ts Krospovidons Magnija stear ts
Titanium dioxide (E 171) Polysorbate 80 Hypromellose Macrogol 400 Carnauba wax
Tit na dioks ds (E 171) Polisorb ts 80 Hipromeloze Makrogols 400 Karnaubas vasks
Shellac Propylene glycol Indigo carmine (E 132)
Šelaks Propil nglikols Indigokarm ns (E 132)
6.3 Shelf-life
6. 3 Uzglab šanas laiks
Store in the original package.
Uzglab t ori in laj iepakojum.
OPTRUMA tablets are packed either in PVC/ PE/ PCTFE blisters or in high density polyethylene bottles.
OPTRUMA tabletes iesai otas PVC/ PE/ PCTFE blisteros vai augsta bl vuma polietil na pudel s.
Blister boxes contain 14, 28, or 84 tablets.
Kast t ir 14, 28 vai 84 tabletes.
Bottles contain 100 tablets.
Pudel ir 100 tablešu.
11 Not all pack sizes may be marketed in all countries.
Visi iepakojuma lielumi tirg var neb t pieejami.
6.6 Special precautions for disposal
6. 6 paši nor d jumi atkritumu likvid šanai
No special requirements.
Nav pašu pras bu.
Eli Lilly Nederland B. V Grootslag 1-5 NL-3991 RA Houten The Netherlands
Eli Lilly Nederland B. V Grootslag 1 – 5 NL- 3991 RA Houten, N derlande
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
RE ISTR CIJAS/ P RRE ISTR CIJAS DATUMS
Date of first authorisation:
S kotn j s re istr cijas datums:
5 August 1998 Date of last renewal:
1998. gada 5. augusts P d j s p rre istr cijas datums:
5 August 2003
2003. gada 5. augusts
DATE OF REVISION OF THE TEXT
TEKSTA P RSKAT ŠANAS DATUMS
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
RAŽOŠANAS LICEN U PAŠNIEKI, KURI ATBILD PAR S RIJAS IZLAIDI
Name and address of the manufacturers responsible for batch release
Ražot ju, kas atbild par s rijas izlaidi, nosaukumi un adreses
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid Spain
Lilly SA Avda de la Industria 30 28108 Alcobendas Madrid Sp nija
• CONDITIONS OR RESTRICTIONS WITH REGARDS TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• NOSAC JUMI VAI IEROBEŽOJUMI AATTIEC B UZ DROŠU UN EFEKT VU ŠO Z U LIETOŠANU
The Marketing Authorisation Holder will provide the PSUR at 3-yearly intervals.
Re istr cijas apliec bas pašniekam ik p c 3 gadiem ir j iesniedz periodiski atjaunojamais droš bas zi ojums (PSUR).
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
16 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA UN UZ TIEŠ IEPAKOJUMA
BOTTLE LABEL, BOTTLE CARTON:
PUDELES ETI ETE, PUDELES KARTONA K RBI A
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
OPTRUMA 60 mg apvalkot s tabletes Raloxifene hydrochloride
STATEMENT OF ACTIVE SUBSTANCE(S)
AKT V S( O) VIELAS( U) NOSAUKUMS (I)
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Katr apvalkot tablet ir 60 mg raloksif na hidrohlor da, kas atbilst 56 mg raloksif na.
Also includes lactose
Sast v ir ar laktoze.
See leaflet for further information
Papildu inform ciju skat t lietošanas instrukcij.
PHARMACEUTICAL FORM AND CONTENTS
U FORMA UN AKT. VIELAS DAUDZUMS
For oral use
Iekš gai lietošanai
EXP {MM/ YYYY}
Der. l dz {MM/ GGGG}
Marketing Authorisation Holder:
Re istr cijas apliec bas pašnieks:
Eli Lilly Nederland B. V Grootslag 1-5 NL-3991 RA Houten The Netherlands
Eli Lilly Nederland B. V Grootslag 1- 5 NL- 3991 RA Houten, N derlande
Medicinal product subject to medical prescription.
Recepšu z les.
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
18 INFORM CIJA, KAS J NOR DA UZ R J IEPAKOJUMA
BLISTER BOX FILM COATED TABLETS:
PL KSN ŠU K RBI A AR APVALKOT M TABLET M
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Apvalkot tablet ir 60 mg raloksif na hidrohlor da, kas atbilst 56 mg raloksif na.
14 film coated tablets 28 film coated tablets 84 film coated tablets
14 apvalkot s tabletes 28 apvalkot s tabletes 84 apvalkot s tabletes
EU/ 1/ 98/ 074/ 001 14 film coated tablets EU/ 1/ 98/ 074/ 002 28 film coated tablets EU/ 1/ 98/ 074/ 003 84 film coated tablets
EU/ 1/ 98/ 074/ 003
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
20 MINIM L INFORM CIJA IZVIETOJAMA UZ BLISTERA VAI PL KSN TES PL KSN TES (VISI PL KSN ŠU IEPAKOJUMI)
NAME OF THE MARKETING AUTHORISATION HOLDER
RE ISTR CIJAS APLIEC BAS PAŠNIEKA NOSAUKUMS
22 PACKAGE LEAFLET:
22
INFORMATION FOR THE USER
U LIETOT JAM
OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
OPTRUMA 60 mg apvalkot s tabletes (raloxifene hydrochloride)
Read all of this leaflet carefully before you start taking your medicine. • Keep this leaflet.
Pirms z u lietošanas uzman gi izlasiet visu instrukciju.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
- Ja jums rodas jebk di jaut jumi, vaic jiet rstam vai farmaceitam.
Do not pass it on to others.
T s var nodar t aunumu pat tad, ja šiem
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
min taj m blakuspar d b m Jums izpaužas smagi, l dzu izst stiet to savam rstam vai farmaceitam.
In this leaflet:
Šaj instrukcij varat uzzin t:
What OPTRUMA is and what it is used for 2.
Kas ir OPTRUMA un k dam nol kam to lieto 2.
Before you take OPTRUMA 3.
Pirms OPTRUMA lietošanas 3.
How to take OPTRUMA 4.
K lietot OPTRUMA 4.
How to store OPTRUMA 6.
Iesp jam s blakuspar d bas 5 K uzglab t OPTRUMA 6.
WHAT OPTRUMA IS AND WHAT IT IS USED FOR
KAS IR OPTRUMA UN K DAM NOL KAM TO LIETO
OPTRUMA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
OPTRUMA pieder pie nehormonu medikamentu grupas, ko sauc par selekt viem estrog nu receptoru modulatoriem (SERM).
When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down.
Kad sievietei iest jas menopauze, sieviš o dzimumhormonu estrog nu l menis pazemin s.
OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.
OPTRUMA imit dažus estrog nu labv l g s iedarb bas veidus p c menopauzes.
OPTRUMA is used to treat and prevent osteoporosis in postmenopausal women.
OPTRUMA lieto osteoporozes rst šanai un profilaksei sieviet m p cmenopauzes period.
OPTRUMA reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
OPTRUMA mazina mugurkaula skrieme u l zumu risku sieviet m ar p cmenopauzes osteoporozi.
A reduction in the risk of hip fractures has not been shown.
Nav pier d ts, ka mazin s g žas kaula l zumu risks.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
Š slim ba paši bieži sastopama sieviet m p c menopauzes.
Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.
Lai gan s kum var neb t nek du simptomu, osteoporoze palielina kaulu l zumu risku, paši mugurkaul, g ž s un plaukstas loc tav s, un var rad t muguras s pes, auguma garuma samazin šanos un l ku muguru.
BEFORE YOU TAKE OPTRUMA
PIRMS OPTRUMA LIETOŠANAS
Do not take OPTRUMA:
Nelietojiet OPTRUMA š dos gad jumos:
This must be investigated by your doctor. • If you have active uterine cancer, as there is insufficient experience of OPTRUMA use in women with this disease. • If you have severe kidney problems.
• Jums ir aler ija (paaugstin ts jut gums) pret raloksif nu vai jebkuru no OPTRUMA sast vda m; • ja past v iesp ja, ka Jums v l var iest ties gr tniec ba, OPTRUMA var kait t J su v l nedzimušajam b rnam; • Ja lietojat vai esat lietojusi z les pret asins trombu veidošanos (dzi o v nu trombozi, plaušu emboliju vai t klenes v nu trombozi); • Ja Jums ir aknu slim ba (aknu slim bu piem ri ir ciroze, viegli izteikti aknu darb bas trauc jumi vai holest tiska dzelte). • Ja Jums ir neizskaidrojama vagin la asi ošana. rstam J s j izmekl. • Ja Jums ir akt vs dzemdes v zis, jo sieviet m ar šo slim bu nav pietiekamas OPTRUMA lietošanas pieredzes. • Ja Jums ir nopietnas nieru darb bas probl mas.
23 Take special care with OPTRUMA
23 paša piesardz ba, lietojot OPTRUMA, nepieciešama š dos gad jumos:
The following are reasons why this product may not be suitable for you.
T l k min ti iemesli, k p c š s z les var tu b t Jums nepiem rotas.
If any of them apply to you, talk to your doctor before you take the medicine.
Ja k ds no tiem attiecas uz Jums, pirms z u lietošanas aprun jieties ar rstu.
• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness. • If you are receiving oral oestrogen therapy • If you are suffering from breast cancer, as there is insufficient experience of OPTRUMA use in women with this disease. • If you have had a cerebrovascular accident (e. g. stroke), or if your doctor has told you that you are at high risk of having one.
Imobiliz cijas piem ri: p rvietošan s rati kr sl, hospitaliz cijas vai gultas rež ma nepieciešam ba atvese ojoties p c oper cijas vai negaid tas slim bas. • J s iekš gi lietojat estrog nus. • Jums ir kr ts v zis, jo nav pietiekamas pieredzes par OPTRUMA lietošanu sieviet m ar šo slim bu. • Ja Jums ir bijis cerebrovaskul rs notikums (piem ram, insults), vai ar J su rsts ir teicis, ka Jums ir augsts insulta risks.
It is unlikely that OPTRUMA will cause vaginal bleeding.
Maz ticams, ka OPTRUMA izrais s vagin lu asi ošanu.
So any vaginal bleeding while you take OPTRUMA is unexpected.
T p c vagin lai asi ošanai OPTRUMA lietošanas laik nevajadz tu b t.
You should have this investigated by your doctor.
Ja t da rodas, rstam J s j izmekl.
OPTRUMA does not treat postmenopausal symptoms, such as hot flushes.
OPTRUMA nemazina p cmenopauzes simptomus, piem ram, karstuma vi us.
OPTRUMA lowers total cholesterol and LDL ("bad") cholesterol.
OPTRUMA pazemina kop j holester na un ZBL (“ slikt ”) holester na l meni.
In general, it does not change triglycerides or HDL ("good") cholesterol.
Parasti tas nemaina triglicer du un ABL (“ lab ”) holester na l meni.
However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking OPTRUMA.
Ta u, ja J s agr k esat lietojusi estrog nus un Jums stipri paaugstin jies triglicer du l menis, pirms OPTRUMA lietošanas Jums j aprun jas ar rstu.
Taking other medicines
Citu z u lietošana
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Past stiet rstam vai farmaceitam par vis m z l m, kuras lietojat vai p d j laik esat lietojusi, ieskaitot z les, ko var ieg d ties bez receptes.
If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.
Ja lietojat uzpirkst tes prepar tus sirdij vai antikoagulantus (piem ram, varfar nu) asins š idrin šanai, rstam varb t vajadz s kori t šo medikamentu devu.
Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.
Past stiet savam rstam, ja lietojat holestiram nu, kuru lieto galvenok rt lip du l me a pazemin šanai.
Pregnancy and breast-feeding OPTRUMA is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Sievietes, kur m v l var b t b rni, to nedr kst lietot.
Optruma could harm your unborn child.
OPTRUMA var kait t J su v l nedzimušajam b rnam.
Do not take OPTRUMA if you are breast-feeding as it might be excreted in mother 'milk. s
Nelietojiet OPTRUMA, ja barojat b rnu ar kr ti, jo z les var p riet m tes pien.
OPTRUMA has no known effects on driving or using machines.
OPTRUMA neietekm sp ju vad t transportl dzek us un apkalpot meh nismus.
Important information about some ingredients of OPTRUMA:
Svar ga inform cija par k du no OPTRUMA sast vda m:
If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product..
Ja rsts ir teicis, ka Jums ir laktozes (cukura veids) nepanes ba, pirms OPTRUMA lietošanas konsult jieties ar rstu.
HOW TO TAKE OPTRUMA
K LIETOT OPTRUMA
Always take this product exactly as your doctor has told you.
Vienm r lietojiet š s z les tieši t, k farmaceitam.
You should check with your doctor or pharmacist if you are not sure.
Neskaidr bu gad jum vaic jiet rstam vai
The dose is one tablet a day.
Deva ir pa vienai tabletei dien.
It does not matter what time of day you take your tablet but taking the tablet at the same time each day will help you remember to take it.
Nav svar gi, kur dienas laik J s lietojat z les, ta u, katru dienu iev rojot noteiktu z u lietošanas laiku, Jums b s viegl k atcer ties to izdar t.
You may take it with or without food.
Tabletes var lietot gan dienreizes laik, gan cit laik.
The tablets are for oral use.
Norijiet tableti veselu.
If you wish you may take a glass of water with it.
24 rsts Jums pateiks, cik ilgi j turpina OPTRUMA lietošana. rsts var Jums ar ieteikt papildus lietot kalcija un D vitam na prepar tus.
Your doctor will tell you how long you should continue to take OPTRUMA.
Ja esat lietojusi vair k OPTRUMA nek noteikts Inform jiet par to rstu vai farmaceitu.
If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.
Ja esat aizmirsusi lietot OPTRUMA Ie emiet tableti l dzko atceraties, un tad turpiniet k iepriekš.
Take a tablet as soon as you remember and then continue as before.
Ja J s p rtraucat lietot OPTRUMA Vispirms aprun jieties ar rstu.
Tell your doctor or pharmacist.
Ja Jums liekas, ka šo z u iedarb ba ir par stipru vai par v ju, konsult jieties ar savu rstu vai farmaceitu.
Like all medicines, OPTRUMA can cause side effects although not everybody gets them.
T pat k citas z les, OPTRUMA var izrais t blakuspar d bas, kaut ar ne visiem t s izpaužas.
The majority of side effects seen with OPTRUMA have been mild.
Vairums nov roto OPTRUMA blakuspar d bu bijušas viegli izteiktas.
The most common side effects (affects more than 1 user in 10) are: • Hot flushes (vasodilatation) • Flu syndrome
oti biežas (vair k nek 1 no 10 lietot j m) blakuspar d bas ir: • karstuma vi i (vazodilat cija), • gripas sindroms.
Common side effects (affects 1 to 10 users in 100) are: • Leg cramps • Swelling of hands, feet and legs (peripheral oedema) • Gallstones
Biežas blakuspar d bas (1 - 10 no 100 lietot j m) ir: • krampji k j s, • roku, p du un k ju piet kums (perif ra t ska), • žultsakme i.
Uncommon side effects (affects 1 to 10 users in 1000) are: • Increased risk of blood clots in the legs (deep vein thrombosis) • Increased risk of blood clots in the lungs (pulmonary embolism) • Increased risk of blood clots in the eyes (retinal vein thrombosis) • Skin around the vein is red and painful (superficial vein thrombophlebitis)
Ret kas blakuspar d bas (1 - 10 no 1000 lietot j m) ir: • palielin ta trombu veidošan s iesp jam ba k j s (dzi o v nu tromboze), • palielin ta trombu veidošan s iesp jam ba plauš s (plaušu embolija), • palielin ta trombu veidošan s iesp jam ba ac s (t klenes v nu tromboze), • aps rtusi un s p ga da v nas apvid (virspus jo v nu trombofleb ts).
Very rare side effects (affects less than 1 user in 10,000) are: • Rash • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset • Increased blood pressure • Decrease in the number of the platelets in the blood • Blood clot in an artery (for example stroke) • Headache including migraine • Mild breast symptoms such as pain, enlargement and tenderness
oti retas blakuspar d bas (maz k nek 1 no 10 000 lietot j m) ir: • izsitumi, • ku a- zarnu trakta darb bas trauc jumi, piem ram, slikta d ša, vemšana, s pes v der un ku a darb bas trauc jumi, • paaugstin ts asinsspiediens; • tromboc tu skaita samazin šan s asin s, • asins trombs art rij (piem ram, insults), • galvass pes, tostarp, migr na, • vid ji smagi kr šu simptomi, piem ram, s pes, palielin šan s un jut gums.
In rare cases, blood levels of liver enzymes may increase during treatment with OPTRUMA.
Retos gad jumos OPTRUMA lietošanas laik var paaugstin ties aknu enz mu l menis asin s.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Ja nov rojat jebk das blakuspar d bas, kas šaj instrukcij nav min tas vai k da no min taj m blakuspar d b m Jums izpaužas smagi, l dzam par t m izst st t rstam vai farmaceitam.
HOW TO STORE OPTRUMA
K UZGLAB T OPTRUMA
Keep out of the reach and sight of children.
Uzglab jiet b rniem nepieejam un neredzam viet.
Do not use after the expiry date which is stated on the pack.
25 Nelietot p c der guma termi a, kas nor d ts uz iepakojuma.
Medicines should not be disposed of via wastewater or household waste.
Z les nedr kst izmest kop ar saimniec bas atkritumiem vai kanaliz cij.
What OPTRUMA contains
Ko OPTRUMA satur
- The active substance is raloxifene hydrochloride.
− Akt v viela ir raloksif na hidrohlor ds.
hydrochloride, which is equivalent to 56 mg raloxifene.
Katr tablet ir 60 mg raloksif na hidrohlor da, kas atbilst 56 mg raloksif na.
- The other ingredients of OPTRUMA tablets are:
− Citas sast vda as ir:
Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate.
Tabletes kodols: povidons, polisorb ts 80, bez dens laktoze, laktozes monohidr ts, krospovidons, magnija stear ts.
Titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax.
Tabletes apvalks: tit na dioks ds (E 171), polisorb ts 80, hipromeloze, makrogols 400, karnaubas vasks.
Shellac, propylene glycol, indigo carmine (E 132).
Tinte: šellaks, propil nglikols, indigokarm ns (E 132).
What OPTRUMA looks like and contents of the pack OPTRUMA are white, oval, film coated tablets which are marked with the number 4165.
OPTRUMA ir baltas, ov las, apvalkot s tabletes, kas apz m tas ar numuru 4165.
They are packed in blisters or in plastic bottles.
T s iesai otas pl ksn t s vai plastmasas pudel s.
The blister boxes contain 14, 28, or 84 tablets.
Kast t ir 14, 28 vai 84 tabletes.
The bottles contain 100 tablets.
Pudel ir 100 tablešu.
Marketing Authorisation Holder Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Re istr cijas apliec bas pašnieks ir Eli Lilly Nederland BV, Grootslag 1- 5, NL- 3991 RA Houten, N derlande.
- Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain.
Ražot js ir Lilly S. A., Avda de la Industria 30, 28108 Alcobendas (Madride), Sp nija.
26 For any information about this medicinal product, please contact the representative of Eli Lilly in your country:
26 Lai ieg tu papildus inform ciju par š m z l m, l dzam kontat ties ar Re istr cijas apliec bas pašnieka viet jo p rst vniec bu:
Polska
Polska! "$$# & (.). *.) #"% "'
#$: +30 210 629 4600
+,: + 30 2 10 629 4600 -
Tel: + 34-91-623-1732
Tel: + 34- 93 446 60 00.
27 Sverige Phadisco Ltd #$: +357 22 715000
Sverige! # "Phadisco Ltd +,: +357 22 715000 -
Latvija Eli Lilly Holdings Limited p%rst%vniec & ba Latvij% Tel: +371 67364000
27 Latvija Eli Lilly Holdings Limited p rst vniec ba Latvij Tel: +371 67364000
Lietuva Eli Lilly Holdings Limited atstovyb 'Tel. +370 (5) 2649600
Tel. +370 (5) 2649600
This leaflet was last approved on:
Š lietošanas instrukcija akcept ta:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
S k ka inform cija par š m z l m ir pieejama Eiropas z u a ent ras (EMEA) m jas lap http: // www. emea. europa. eu
London, 26 January 2006 Doc. Ref.
Londona, 2006. gada 26. janvāris Ats. dok.
EMEA/ 282451/ 2008
EMEA/ 604217/ 2007
QUESTIONS AND ANSWERS ON WITHDRAWAL OF MARKETING APPLICATION for Orathecin
JAUTĀJUMI UN ATBILDES PAR ATSAUKTO REĢISTRĀCIJAS APLIECĪBAS PIETEIKUMU par Orathecin
Rubitecan
Starptautiskais nepatentētais nosaukums (SNN): rubitekāns
On 19 January 2006, EuroGen Pharmaceuticals Ltd officially notified the Agency’ s Committee for Medicinal Products for Human Use (CHMP) of its decision to withdraw its application for marketing authorisation for the medicinal product orathecin (rubitecan).
2006. gada 19. janvārī EuroGen Pharmaceuticals Ltd. oficiāli informēja aģentūru Cilvēkiem paredzēto zāļu komiteja (CHMP) par savu lēmumu atsaukt pieteikumu zāļu Orathecin (Rubitecan) reģistrācijas apliecības saņemšanai.
The indication applied for was the treatment of patients with advanced or metastatic pancretic cancer.
Pieteikumā norādītā indikācija bija progresējuša aizkuņģa dziedzera vēža, kā arī aizkuņģa dziedzera vēža ar metastāzēm ārstēšana.
Orathecin was designated as an orphan medicinal product on 10 June 2003.
2003. gada 10. jūnijā Orathecin tika atzīts par zālēm retu slimību ārstēšanai.
Link to withdrawal EMEA press release.
Norāde uz EMEA informāciju presei.
What is Orathecin?
Kas ir Orathecin?
Orathecin is a capsule to be taken orally.
Orathecin ir perorāli lietojama kapsula.
Orathecin contains 0.5 or 1.25 of the active substance rubitecan.
Orathecin satur no 0, 5 mg līdz 1, 25 mg aktīvās vielas rubitekāna.
What was Orathecin expected to be used for?
Kāpēc bija paredzēts lietot Orathecin?
Orathecin was to be used to treat patients with advanced cancer of the pancreas, who cannot be operated or who have metastasis (cancer cells that spread from the original site to other parts of the body), and who do not respond to the other anticancer drugs used for the treatment of their disease.
Ar Orathecin bija iecerēts ārstēt pacientus ar progresējušu aizkuņģa dziedzera vēzi, kas nav operējams vai kam izveidojušās metastāzes (vēža šūnas no primārā perēkļa ir pārvietojušās uz citām vietām ķermenī), ja citas lietotās pretvēža zāles neiedarbojās.
How is Orathecin expected to work?
Kā Orathecin vajadzētu darboties?
Orathecin belongs to a group of alkaloids called camptothecins.
Orathecin ir alkaloīdu, tā saukto kamptotecīnu, grupas viela.
Alkaloids are substances that are naturally found in plants.
Alkaloīdi ir dabiskas augos esošas vielas.
Certain camptothecins are used in medicine as anti-cancer agents.
Atsevišķus kamptotecīnus izmanto medicīnā kā pretvēža līdzekļus.
When cells are growing, as in the case for cancer cells, the genetic material (DNA) inside the cell may become twisted.
Augot šūnām, kā tas notiek ar vēža šūnām, ģenētiskais materiāls (DNS) šūnas iekšienē var izliekties.
Cells have several proteins, which help to remove any twists in the DNA.
Šūnās ir vairāki proteīni, kas palīdz likvidēt DNS izliekumus.
This avoids that the DNA breaks, which would damage the cells.
Tā tiek novērsta DNS salūšana, kas bojātu šūnas.
Camptothecins are able to block one of the proteins that can remove twists in the DNA.
Kamptotecīni spēj bloķēt vienu no proteīniem, kas var likvidēt DNS izliekumus.
This protein is called topoisomerase I.
Šis proteīns ir topoizomerāze I.
By blocking this protein, Orathecin is expected to damage the cancer cells.
Bloķējot šo proteīnu, Orathecin vajadzētu bojāt vēža šūnas.
What documentation has been presented by the Company to support the application to the CHMP?
Kādus dokumentus uzņēmums iesniedza, lai pamatotu pieteikumu CHMP?
The effects of orathecin were first tested in experimental models before being studied in humans.
Pirms pētījumiem ar cilvēkiem Orathecin tika pārbaudīts eksperimentālos modeļos.
Orathecin has been investigated in two main clinical studies.
Orathecin tika pētīts divos galvenajos klīniskajos pētījumos.
The studies included approximately 800 patients with advanced or metastatic cancer of the pancreas.
Pētījumos piedalījās apmēram 800 pacienti ar progresējušu vai metastāzes izveidojušu aizkuņģa dziedzera vēzi.
The studies looked at how long the patients survived after receiving orathecin, compared to those receiving the standard medicines used to treat pancreatic cancer, including 5-fluorouracil (5-FU) or gemcitabine.
Šajos pētījumos tika analizēta pacientu dzīvildze pēc Orathecin saņemšanas, salīdzinot ar tiem pacientiem, kuri aizkuņģa dziedzera ārstēšanā lietoja standarta zāles, tai skaitā 5- fluoruracilu (5- FU) vai gemcitabīnu.
Orathecin was given to the patients until their cancer progressed or they could not tolerate the treatment anymore.
Orathecin tika dots pacientiem līdz brīdim, kad viņu vēzis progresēja vai arī viņi vairs nespēja paciest ārstēšanu.
Based on the review of the initial documentation, the CHMP prepares a list of questions (at day 120), which is sent to the Company.
Izskatījusi pirmos iesniegtos dokumentus, CHMP sagatavo jautājumu sarakstu (120. dienā), ko nosūta uzņēmumam.
Once the Company has supplied responses to the questions, the CHMP reviews them and may, before give an opinion, ask any remaining questions (at day 180) to the Company.
Tiklīdz uzņēmums ir iesniedzis atbildes uz šiem jautājumiem, CHMP izskata tās un, pirms izsniegt atzinumu, var uzdot arī citus jautājumus (180. dienā).
Following CHMP opinion, it usually takes around 2 months to the European Commission to give a licence.
Saskaņā ar CHMP viedokli Eiropas Komisijai licences izsniegšanai parasti ir nepieciešami 2 mēneši.
The CHMP was assessing the responses given by the Company to a list of questions.
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged CHMP izskatīja uzņēmuma sniegtās atbildes uz sarakstā iekļautajiem jautājumiem.
Based on the review of the data and the Company’ s response to the CHMP list of questions, at the time the withdrawal, the CHMP had concerns and was of the provisional opinion that Orathecin could not be approved for treatment of patients with advanced or metastatic pancretic cancer.
Izskatījusi saņemto informāciju un uzņēmuma atbildes uz CHMP saraksta jautājumiem, atsaukšanas brīdī komiteja bija neapmierināta un izteica pagaidu viedokli, ka Orathecin nevar apstiprināt tādu pacientu ārstēšanai, kuriem ir progresējošs vai metastāzes izveidojis aizkuņģa dziedzera vēzis.
In the studies presented by the Company, it could not be shown that Orathecin extends the life of patients nor improves their quality of life.
Uzņēmums, uzrādot pētījumu datus, nespēja pierādīt, ka Orathecin pagarina pacientu dzīves ilgumu vai arī uzlabo viņu dzīves kvalitāti.
Moreover, patients treated with Orathecin experienced many side effects, including serious ones.
Turklāt ar Orathecin ārstētie pacienti cieš no dažādām, tai skaitā nopietnām blakusparādībām.
Therefore, at the time of the withdrawal, the CHMP’ s view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Tāpēc atsaukšanas brīdī CHMP uzskatīja, ka zāļu efektivitāte nav pietiekami pierādīta, un tā neatsver identificētos apdraudējumus.
What were the reasons given by the Company to withdraw the application?
Norāde uz atsaukuma vēstuli.
Link to the withdrawal letter.
pacientus,
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Orathecin?
pētījumos/ eksperimentālas lietošanas programmās?
The Company informed the Agency that at the time of the withdrawal, all clinical trials in the European Union are closed to enrolment and there is no ongoing compassionate use programmes.
Uzņēmums informēja aģentūru, ka atsaukšanas brīdī visos Eiropas Savienībā notiekošajos pētījumos reģistrācija bija pārtraukta un eksperimentālas lietošanas programmas netiek īstenotas.
However, if you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving you the treatment.
Tomēr, ja jūs piedalāties klīniskajā pētījumā vai eksperimentālas lietošanas programmā un vēlaties saņemt vairāk informācijas par terapiju, jautājiet ārstam, kas jums to nodrošina.
No information has been given by the Company on the future development of the product.
Uzņēmums nav sniedzis informāciju par produkta turpmāku attīstību.
What is ORENCIA?
Kas ir ORENCIA?
ORENCIA is a vial containing a powder to be made up into a solution for infusion.
ORENCIA ir pulveris flakonā, no kura pagatavo šķīdumu infūzijai.
Each vial contains 250 mg of the active substance abatacept.
Flakons satur 250 mg aktīvās vielas abatacepta.
What is ORENCIA used for?
Kāpēc lieto ORENCIA?
ORENCIA is an anti-inflammatory medicine that is used in combination with methotrexate (another medicine that acts on the immune system) to treat adults with moderate to severe active rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).
ORENCIA ir pretiekaisuma zāles, kuras lieto kombinācijā ar metotreksātu (citām zālēm, kas iedarbojas uz imūnsistēmu), lai ārstētu pieaugušos ar vidēji līdz smagi izteiktu reimatoīdo artrītu (imūnsistēmas slimību, kas izsauc locītavu bojājumus un iekaisumu).
ORENCIA is used in patients who have not had a sufficient response to other medicines for rheumatoid arthritis including at least one ‘ tumour necrosis factor (TNF) blocker’, or who cannot be given these medicines.
ORENCIA lieto pacientiem, kas nav pietiekoši reaģējuši uz citām reimatoīdā artrīta zālēm, ieskaitot vismaz vienu ‘ tumora nekrozes faktora (TNF) bloķētāju ’, vai kuriem nevar šīs zāles dot.
How is ORENCIA used?
Kā lieto ORENCIA?