qanastek/EMEA-V3 huggingface dataset:
Fibrinogen and Thrombin are packaged together as two vials each containing the same volume (1ml, 2ml or 5ml) of frozen, sterile solution, which is colourless or yellowish when thawed.
Fibrinoġen u Trombina huma ppakkjati flimkien bħala żewġ kunjetti kull wieħed fih l- istess volum (1ml, 2ml jew 5ml) ta 'soluzzjoni sterili, iffriżata, li hija bla kulur jew safranija meta tinħall.
Fibrinogen is a concentrate of clottable protein and Thrombin is an enzyme that causes clottable protein to coalesce.
Fibrinoġen huwa konċentrat ta 'proteina li tgħaqqad u t- trombina hija enzima li tikkawża l- fużjoni tal- proteina li tgħaqqad.
Thus, when the two components are mixed together they clot instantly.
Għalhekk, meta ż- żewġ komponenti jitħalltu flimkien huma jagħqdu immedjatament.
Marketing Authorisation Holder:
Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
For any information about this medicine, please contact the Manufacturer:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lill- Manifattur:
OMRIX Biopharmaceuticals Ltd Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat Gan 52621, Israel Att:
OMRIX Biopharmaceuticals Ltd Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat Gan 52621, Iżrael Att:
Moshe Kamar, MD Head of PV and Medical Director Tel: +972-3-5316512 Fax: +972-3-5316590
Moshe Kamar, MD Kap ta 'PV u Direttur Mediku Tel: +972- 3- 5316512 Faks: +972- 3- 5316590
This leaflet was last approved in {MM/YYY}
Dan il- fuljett kien approvat l- aħħar fi {XX/ SSSS}
The following information is intended for medical or healthcare professionals only.
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
INSTRUCTIONS FOR USE
STRUZZJONIJIET GĦALL- UŻU
Read this before you open the package:
Aqra dan qabel tiftaħ il- pakkett:
EVICEL comes in sterile packages and therefore it is important to use only undamaged packages which have not been opened (post-sterilisation is not possible).
EVICEL jiġi f' pakketti sterili u għaldaqstant huwa importanti li tuża biss pakketti li ma jkunx fihom ħsara, li ma jkunux infetħu (sterilizzazzjoni wara mhijiex possibbli).
Preparation:
Preparazzjoni:
No needles are involved in the preparation of EVICEL for administration.
L- ebda labra ma hija involuta fil- preparazzjoni għal għoti ta 'EVICEL.
Draw the contents of the two vials into the administration device, following the instructions in Figure 1.
Iġbed il- kontenuti taż- żewġ kunjetti għal ġo l- apparat ta 'l- għoti, billi ssegwi l- istruzzjonijiet fil- Figura 1.
Both syringes should be filled with equal volumes, and should not contain air bubbles.
Iż- żewġ siringi għandhom jimtlew b' volumi ndaqs, u m' għandux ikun fihom bżieżaq ta 'l- arja.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull residwu tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
The solutions should be clear or slightly opalescent.
Is- soluzzjonijiet għandhom ikunu ċari jew xi ftit opalexxenti.
Do not use solutions that are cloudy or have deposits.
Tużax soluzzjonijiet li huma mdardrin jew li fihom xi depożiti.
STORAGE OF EVICEL
KIF TAĦŻEN EVICEL
Do not use after the expiry date stated on the carton and label.
Tużax wara d- data ta 'skadenza tal- prodott li hemm fuq il- pakkett u t- tikketta.
23 Fibrinogen and Thrombin:
23 Fibrinoġen u Trombina:
Long term storage Store in a freezer at -18°C or colder.
Ħażna fit- tul Aħżen fi friżer f' temperatura ta '- 18°C jew iktar kiesħa.
Do not use after the expiry date stated on the carton.
Tużax wara d- data ta 'skadenza tal- prodott li hemm fuq il- pakkett.
Short term storage Store at 2C-8C (in a refrigerator) for no more than 30 days.
Ħażna għal żmien qasir Aħżen f' temperatura ta '2C– 8C (fi friġġ) għal mhux iktar minn 30 jum.
The date on which refrigerator storage was started should be marked on the carton in the space provided.
Id- data meta bdiet il- ħażna fil- friġġ għandha tkun immarkata fuq il- pakkett fl- ispazju pprovdut.
Do not re-freeze.
Terġax tiffriża.
Fibrinogen and Thrombin are stable at room temperature for 24 hours but when they have been drawn up into the administration device, they must be used immediately.
Fibrinoġen u Trombina huma stabbli f' temperatura ambjentali għal 24 siegħa iżda meta jkunu nġibdu għal ġo l- apparat ta 'l- għoti, għandhom jintużaw minnufih.
Application Device:
Apparat ta 'l- applikazzjoni:
Store separately from the Fibrinogen and Thrombin, at room temperature.
Aħżen separatament mill- Fibrinoġen u t- Trombina, f' temperatura ambjentali.
2-8°C (refrigerator): vials thaw within 1 day, or 20-25°C (room temperature): vials thaw within 1 hour, or 37ºC (e.g. water bath, using aseptic technique, or by warming vials in the hand): vials should be thawed within 10 minutes and must not be left at this temperature for longer than 10 minutes or until fully thawed.
2- 8°C (friġġ): il- kunjetti jinħallu mis- silġ fi żmien jum, jew 20- 25°C (temperatura ambjentali): il- kunjetti jinħallu mis- silġ fi żmien siegħa, jew 37ºC (eż:, banju marija, bl- użu ta 'teknika asettika, jew billi l- kunjetti jissaħħnu fl- id): il- kunjetti għandhom jiġu maħlula mis- silġ fi żmien 10 minuti u jeħtieġ li ma jitħallewx f' din it- temperatura għal iktar minn 10 minuti, jew sakemm is- silġ jinħall għal kollox.
The temperature must not exceed 37ºC.
It- temperatura m' għandhiex taqbeż is- 37ºC.
Draw the contents of the two vials into the application device, following the instructions for use in the device package.
Iġbed il- kontenuti taż- żewġ kunjetti għal ġewwa l- apparat ta 'l- applikazzjoni, billi timxi skond l - istruzzjonijiet għall- użu fil- pakkett ta' l- apparat.
No needles are involved in the preparation of EVICEL for administration.
L- ebda labra ma hija nvoluta fil- preparazzjoni ta 'EVICEL għall - għoti.
 Application by dripping
 Applikazzjoni permezz ta 'qtar
If the applicator tip becomes blocked, the catheter tip can be cut back in 0.5 cm increments.
Jekk it- tarf ta 'l - applakatur jimblokka, it- tarf tal- katetere jista' jinqata 'f' inkrementi ta' 0. 5 ċm.
EVICEL can be sprayed using pressurised CO2 or compressed air.
EVICEL jista 'jiġi sprejjat bl- użu ta' CO2 taħt pressjoni jew arja kkumpressata.
Connect the short tube on the application device to the male luer-lock end of the long gas tube.
Qabbad it- tubu l- qasir fuq l- apparat ta 'l- applikazzjoni mat- tarf tal- lukkett luwer male tat- tubu t- twil tal- gass.
Connect the female luer lock of the gas tube (with the 0.2 μm bacteriostatic filter) to a pressure regulator capable of delivering 1.0 to 2.0 bars pressure.
Qabbad il- lukkett luwer female tat- tubu tal- gass (mal- filtru 0. 2 μm batterjostatiku) mar- regolatur tal - pressjoni li kapaċi li jwassal pressjoni ta '1. 0 sa 2. 0 bars.
The pressure regulator should be used in accordance with the manufacturer’s instructions.
Ir- regolatur tal- pressjoni għandu jintuża skond l - istruzzjonijiet tal- manifattur.
The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer.
24 Imbagħad, il- prodott għandu jiġi sprejjat fuq il- wiċċ tat- tessut fi splużjonijiet qosra (0. 1- 0. 2 ml) biex jifforma saff indaqs, irqiq.
24  Disposal
 Rimi
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l - liġijiet lokali.
Instructions for use of the administration device.
Struzzjonijiet għall- użu ta 'l- apparat ta' l- għoti.
Ensure all connections are tight.
Assigura li t- tqabbid kollu huwa ssikkat.
Holding the syringe barrels with one hand, loosen the syringe pistons by sliding them back and forth.
Billi żżomm iċ- ċilindri tas- siringa f' id waħda, ħoll il- pistuni tas - siringa billi żżerżaqhom lura u l- quddiem.
Insert the two vials (Fibrinogen and Thrombin) into the two sterile vial cups.
Daħħal iż- żewġ kunjetti (Fibrinoġen u Trombina) fiż- żewġ tazzi tal- kunjetti sterili.
The vial cups must be handled using sterile technique.
It- tazzi tal- kunjetti jeħtieġ jiġu mmanipolati bl- użu ta 'teknika sterili.
Holding the vial cup, press the top of the vial into the vial connector which is attached to the applicator (as shown).
Billi żżomm it- tazza tal- kunjett, għafas l - parti ta 'fuq tal- kunjett għal ġewwa t- tqabbid tal- kunjett li huwa mwaħħal ma' l- applikatur (kif muri).
Repeat with the second vial.
Irrepeti bit- tieni kunjett.
Holding the syringe barrels with one hand, aspirate both syringes slowly (vials facing up).
Billi żżomm it- tubu taċ- ċilindru tas - siringa b' id waħda, iġbed iż- żewġ siringi bil- mod (kunjetti jħarsu 'l fuq).
If needed, inject back into vial and aspirate again to expel air.
Injetta lura għal ġol- kunjett u erġa 'iġbed biex tkeċċi l- arja, jekk meħtieġ.
While holding the syringe barrels with one hand, gently turn the vial connector anti-clockwise with the other hand.
Waqt li żżomm it- tubu taċ- ċilindru tas - siringa b' id waħda, dawwar il- konnekter tal - kunjett dawran xellugi b' mod ġentili bl- id l - oħra.
The vial connector/vial/vial cup combination disconnects automatically.
Il- konnekter tal- kunjett/ kunjett/ tazza tal- kunjett jiskonnettja awtomatikament.
25 5 If spraying is required, connect the tubing to the pressure regulator.
25 5 Jekk ikun meħtieġ l- isprejjar, qabbad it- tubu mar- regolatur tal- pressjoni.
The applicator is now ready for use.
L- applikatur issa huwa lest għall- użu.
What is Evista?
X’ inhu Evista?
Evista is a medicine containing the active substance raloxifene hydrochloride.
Evista huwa mediċina li fiha s- sustanza attiva raloxifene kloridrat (hydrochloride).
It is available as white, oval tablets (60 mg).
Huwa disponibbli bħala pilloli bojod ovali (60 mg).
What is Evista used for?
Għal xiex jintuża Evista?
Evista is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Evista jintuża għat- trattament u l- prevenzjoni tal- osteoporożi (marda li tagħmel l- għadam fraġli) f’ nisa li għaddew mill- menopawża.
Evista has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.
Intwera li Evista jnaqqas b’ mod sinifikanti l- ksur vertebrali (tas- sinsla tad- dahar), iżda mhux il- ksur fil- ġenbejn.
How is Evista used?
Kif jintuża Evista?
The recommended dose for adults and the elderly is one tablet taken once a day, with or without food.
Id- doża rakkomandata għall- adulti u għall- anzjani hija ta ’ pillola waħda kuljum, fuq stonku vojt jew le.
Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet.
Il- pazjenti jistgħu jirċievu wkoll supplimenti ta ’ kalċju u ta ’ vitamina D jekk ma jkunux qegħdin jieħdu biżżejjed mid- dieta tagħhom.
Evista is intended for long-term use.
Evista huwa maħsub għal użu fit- tul.
How does Evista work?
Kif jaħdem Evista?
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
L- osteoporożi sseħħ meta ma jikbirx għadam ġdid biżżejjed biex jissostitwixxi l- għadam li jitkisser b’ mod naturali.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Gradwalment, l- għadam isir irqieq u fraġli, u jsir iktar probabbli li jinqasam (ksur).
Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
L - osteoporożi hija aktar komuni fin- nisa li għaddew mill- menopawża minħabba t- tnaqqis tal- livelli tal - ormoni tan- nisa, l- estroġeni: l- estroġenu jnaqqas ir- ritmu li bih jitkisser l- għadam u jagħmel l- għadam inqas suxxettibbli għall- ksur.
The active substance in Evista, raloxifene, is a selective oestrogen receptor modulator (SERM).
Is- sustanza attiva f’ Evista, raloxifene, hija modulatur selettiv tar- riċettur tal- estroġenu (SERM).
Raloxifene acts as an ‘ agonist ’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Raloxifene jaġixxi bħala ‘ agonista ’ tar- riċettur tal- estroġenu (sustanza li tistimula r- riċettur għal estroġenu) f’ xi tessuti fil- ġisem.
Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb.
Raloxifene għandu l- istess effett bħal estroġenu fl- għadam, iżda ma għandux effett fuq is- sider jew fuq il- ġuf.
How has Evista been studied?
Kif ġie studjat Evista?
Evista has been studied in the treatment and the prevention of osteoporosis in four main studies.
Evista ġie studjat fit- trattament u fil- prevenzjoni tal- osteoporożi f’ erba ’ studji prinċipali.
Three studies looked at the prevention of osteoporosis in 1,764 women who took either Evista or placebo (a dummy treatment) for two years.
Tliet studji eżaminaw il- prevenzjoni tal- osteoporożi f’ 1, 764 mara ttrattati b’ Evista jew bil- plaċebo (trattament finta) għal sentejn.
The studies measured the density of the bones.
L- istudji kejlu d- densità tal- għadam.
What benefit has Evista shown during the studies?
Liema benefiċċju wera Evista waqt l- istudji mwettqa?
Evista was more effective than placebo in preventing and treating osteoporosis.
Evista rriżulta aktar effikaċi mill- plaċebo fil- prevenzjoni u fit- trattament tal- osteoporożi.
In the prevention of osteoporosis, women receiving Evista had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.
Fil- prevenzjoni tal- osteoporożi, in- nisa ttrattati b’ Evista kellhom żieda fid- densità tal- għadam fil - ġenbejn jew fis- sinsla tad- dahar ta ’ 1. 6% fuq sentejn, u dawk ittrattati bil- plaċebo kellhom tnaqqis ta ’ 0. 8%.
When used to treat osteoporosis, Evista was more effective than placebo in reducing the number of vertebral fractures.
Meta użat fit- trattament tal- osteoporożi, Evista rriżulta aktar effikaċi mill- plaċebo fit- tnaqqis tan - numru ta ’ ksur vertebrali.
Over four years, in comparison with placebo, Evista decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture.
Fuq erba ’ snin, meta mqabbel mal- plaċebo, Evista naqqas in- numru ta ’ ksur vertebrali ġodda b’ 46% f’ nisa li jbatu mill- osteoporożi u bi 32% f’ nisa li jbatu mill- osteoporożi u ksur eżistenti.
There was no effect of Evista on hip fractures.
Ma kien hemm ebda effett ta ’ Evista fuq ksur tal- ġenbejn.
What is the risk associated with Evista?
X’ inhu r- riskju assoċjat ma ’ Evista?
The most common side effects with Evista (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
L- effetti sekondarji l- aktar komuni b’ Evista (li jidhru f’ aktar minn pazjent 1 minn kull 100) huma t - twessigħ tal- arterji u tal- vini (vasodilation) (fwawar) u sintomi simili għal dawk tal- influwenza.
For the full list of side effects reported with Evista, see the Package Leaflet.
Għal - lista sħiħa tal- effetti sekondarji kollha rrappurtati b’ Evista, ara l- Fuljett ta ’ Tagħrif.
Evista should not be used in women who: • could become pregnant; • have or have had any blood clot disorders, including deep vein thrombosis and pulmonary embolism (a blood clot in the lungs); • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).
Evista ma għandux jintuża minn nisa li: • jistgħu jinqabdu tqal; • għandhom jew kellhom disturbi fl- għaqid tad- demm, inkluż trombożi tal- vini fil- fond u emboliżmu pulmonari (ċappa demm fil- pulmun); • għandhom marda fil- fwied, marda gravi fil- kliewi, fsada mingħajr raġuni mill- ġuf jew kanċer tal- endometriju (kanċer tal- inforra tal- ġuf).
Evista should not be used in people who may be hypersensitive (allergic) to raloxifene or any of the other ingredients.
Evista ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal raloxifene jew għal xi sustanza oħra tiegħu.
Why has Evista been approved?
Għaliex ġie approvat Evista?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Evista had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li Evista wera l - effikaċja tiegħu fil- prevenzjoni u fit- trattament tal- osteoporożi, u ma kellu ebda effett fuq is- sider jew fuq il- ġuf.
The Committee decided that Evista’ s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Evista huma akbar mir- riskji tiegħu għat- trattament u l- prevenzjoni tal- osteoporożi f’ nisa li jkunu għaddew mill- menopawża.
The Committee recommended that Evista be given marketing authorisation.
Il- Kumitat irrakkomanda li Evista jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Evista:
Aktar tagħrif dwar Evista:
The European Commission granted a marketing authorisation valid throughout the European Union for Evista on 5 August 1998.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq fl- Unjoni Ewropea kollha għal Evista fil- 5 ta ’ Awwissu 1998.
The marketing authorisation was renewed on 5 August 2003 and on 5 August 2008.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet mġedda fil- 5 ta ’ Awwissu 2003 u fil- 5 ta ’ Awwissu 2008.
The marketing authorisation holder is Daiichi Sankyo Europe GmbH.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq huwa Daiichi Sankyo Europe GmbH.
The full EPAR for Evista is available here.
L- EPAR sħiħ għal Evista jista ’ jiġi kkonsultat hawn.
Strength
Il- pakkett
Pharmaceutical Form
Daqs tal- pakkett
Route of Administration
Pillola miksija b’ rita
Packaging
Użu orali
Package size
folja (PVC/ PE/ PCTFE)
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita
Oral use Oral use Oral use Oral use
Pillola miksija b’ rita
blister (PVC/ PE/ PCTFE) blister (PVC/ PE/ PCTFE) blister (PVC/ PE/ PCTFE) bottle (HDPE)
folja (PVC/ PE/ PCTFE)
EVISTA 60 mg film coated tablets
EVISTA 60 mg pilloli miksija b’ rita
Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Kull pillola miksija b’ rita fiha 60 mg raloxifene hydrochloride, ekwivalenti għal 56 mg ta ’ raloxifene bażi libera.
Excipient: each tablet contains lactose (149.40 mg).
Sustanza mhux attiva: kull pillola fiha lactose (149. 40 mg)
Film coated tablet.
Pillola miksija b’ rita.
Elliptically shaped, white tablets imprinted with the code ’ 4165’.
Pilloli bojod ovali bil- kodiċi ‘ 4165 ’ stampat fuqhom.
EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
EVISTA hija indikata għall- kura u l- prevenzjoni ta ’ l- osteoporożi fin- nisa wara l- menopawża.
A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Intwera tnaqqis sinifikanti fl- inċidenza ta ’ ksur tal- vertebri, iżda mhux ksur ta ’ l- għadam tal- ġenbejn.
When determining the choice of EVISTA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Meta wieħed jagħżel bejn EVISTA u terapiji oħra, inkluż l- estroġenu, għal mara li qiegħda fil - menopawsa, fuq bażi individwali jridu jitqiesu s- sintomi tal- menopawsa, l- effetti fuq it- tessuti ta ’ l - utru u s- sider, ir- riskji u l- benefiċji kardjovaskulari (ara sezzjoni 5. 1).
The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals.
Id- doża rrakkomandata hija pillola waħda kuljum, meħuda oralment, li tista ’ tittieħed fi kwalunkwe ħin tal- ġurnata mingħajr rigward għall- ikel.
No dose adjustment is necessary for the elderly.
M’ hemmx bżonn ta ’ tibdil fid- doża għall- anzjani.
Due to the nature of this disease process, EVISTA is intended for long term use.
Minħabba n- natura tal- proċess naturali tal- marda, EVISTA hija intenzjonata biex tittieħed għal żmien twil.
Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
Ġeneralment huwa rrakkomandat li n- nisa li għandhom livelli baxxi tal- calcium u l- vitamina D fid - dieta, għandhom jingħataw supplimenti ta ’ dawn.
Use in renal impairment:
L- użu f’ indeboliment renali:
EVISTA should not be used in patients with severe renal impairment (see section 4.3).
EVISTA m’ għandhiex tintuża f’ pazjenti b’ indeboliment renali sever (ara sezzjoni 4. 3).
In patients with moderate and mild renal impairment, EVISTA should be used with caution.
F’ pazjenti b’ indeboliment renali moderat u ħafif, EVISTA għandha tintuża b’ kawtela.
Use in hepatic impairment:
L- użu f’ indeboliment epatiku:
EVISTA should not be used in patients with hepatic impairment (see section 4.3).
EVISTA m’ għandhiex tintuża f’ indeboliment epatiku (ara sezzjoni 4. 3).
Must not be used in women with child bearing potential.
M’ għandiex tintuża fin- nisa li għad jistgħu joħorġu tqal.
Active or past history of venous thromboembolic events (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis.
Passat mediku jew kundizzjoni preżenti ta ’ avvenimenti tromboemboliċi fil- vini (VTE), li jinkludu t - trombożi tal- vini fondi, emoboliżmu pulmonari u trombożi tal- vina tar- retina.
2 Hepatic impairment including cholestasis.
2 Indeboliment epatiku inkluża kolestażi.
Severe renal impairment.
Indeboliment renali sever.
Unexplained uterine bleeding.
Tnixxija ta ’ demm mill- utru mingħajr ma tkun magħrufa l- kawża.
EVISTA should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
EVISTA m’ għandhiex tintuża meta jkun hemm sinjali jew sintomi ta ’ kanċer ta ’ l- endometriju għaliex is- sigurtà f’ dan il- grupp ta ’ pazjenti ma ġietx studjata biżżejjed.
Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy.
Raloxifene huwa assoċjat ma ’ riskju miżjud ta ’ avvenimenti tromboembolitiċi fil- vini, li huwa simili għal dak irrappurtat li hu assoċjat ma ’ l- użu kurrenti tat- terapija bl- ormoni, bħala sostitut.
The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
Il- bilanċ bejn ir- riskji u l- benefiċiji għandu jitqies f’ pazjenti li huma f’ riskju ta ’ avvenimenti tromboembolitiċi fil- vini, hi x’ inhi l- kawża.
EVISTA should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
EVISTA għandha titwaqqaf fl- eventwalità ta ’ marda jew kundizzjoni li żżomm għal perijodu twil l- individwa immobilizzata.
Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.
Il- waqfien irid isir mill- aktar fis f’ każ ta ’ mard, jew minn 3 ijiem qabel ma jseħħ l- immobilizzar.
Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
It- terapija m’ għandhiex terġa ’ tinbeda sakemm il - kundizzjoni tal- bidu tkun għaddiet u l- pazjenta tkun mobbli għal kollox.
However, there was an increase in death due to stroke in women assigned to raloxifene.
Fi studju kliniku li sar fin- nisa wara l- menopawża u li huwa dokumentat li jbatu minn mard tal- qalb koronarju jew li qegħdin f’ riskju ogħla li jkollhom xi problemi koronarji, raloxifene meta mqabbel ma ’ plaċebo, ma kellu ebda effett fuq l- inċidenza ta ’ attakk ta ’ qalb, ta ’ bżonn li tidħol l- isptar minħabba sindromu koronarju akut, ta ’ mortalità in ġenerali li tinkludi l- imwiet kardjovaskulari kollu jew ta ’ attakk ta ’ puplesija.
The incidence of stroke mortality was 1.5 per 1000 women per year for placebo versus 2.2 per 1000 women per year for raloxifene.
Madankollu, kien hemm żieda fl- imwiet minħabba attakki ta ’ puplesija fin- nisa li ġew mgħotija raloxifene.
This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation.
L- inċidenza fil- mortalità minħabba attakki ta ’ puplesija kienet ta ’ 1. 5 minn kull 1000 mara kull sena għal dawk fuq plaċebo kontra 2. 2 minn kull 1000 mara kull sena għal dawk fuq raloxifene. Trid iżżomm dawn ir- riżultati f’ moħħok meta tordna raloxifene għal nisa wara l- menopawża u li għandhom passat mediku ta ’ attakk ta ’ puplesija jew xi fatturi sinifikanti oħra ta ’ riskju għal attakki ta ’ puplesija bħal attakk iskemiku tranżitorju jew fibbrillazzjoni atrijali
There is no evidence of endometrial proliferation.
M’ hemmx evidenza ta ’ proliferazjoni ta ’ l- endometriju.
Any uterine bleeding during EVISTA therapy is unexpected and should be fully investigated by a specialist.
Kwalunkwe tnixxija ta ’ demm mill- utru, waqt it- terapija b’ EVISTA mhux mistennija u din għandha tiġi investigata sew minn speċjalista.
The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps.
L- aktar żewġ kundizzjonijiet dijanjostikati ta ’ spiss waqt il- kura b’ raloxifene, assoċjati mat- tnixxija ta ’ demm mill- utru, kienu l- atrofija ta ’ l- endometriju u l- qarnit beninju ta ’ l- endometriju.
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.
Fin- nisa wara l - menopawsa li ngħataw kura b’ raloxifene għal 4 snin, il- qarnit beninju ta ’ l- endometriju kien irrapportat f’ 0. 9% meta mqabbel ma ’ 0. 3% fin- nisa li rċevew trattament bil- plaċebo.
Raloxifene is metabolised primarily in the liver.
Raloxifene jiġi metaboliżżat primarjament fil- fwied.
Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5 times the controls.
Doża waħda ta ’ raloxifene li ngħatat lill- pazjenti li għandhom ċirrożi u indeboliment moderat tal- fwied (Klassi A Child- Pugh) wasslet għall - konċentrazzjonijiet ta ’ raloxifene fil- plażma li kienu madwar 2. 5 drabi akbar minn dawk li ma kellhomx dawn il- kundizzjonijiet.
The increase correlated with total bilirubin concentrations.
Din iż- żieda kienet korrelata mal- livelli totali tal- konċentrazzjoni tal- bilirubin.
Until safety and efficacy have been evaluated further in patients with hepatic insufficiency, the use of EVISTA is not recommended in this patient population.
Sakemm is- sigurtà u l- effikaċja jiġu evalwati aktar f’ pazjenti b’ insuffiċjenza tal- fwied, l - użu ta ’ Evista mhux irrakkomandat f’ dan il- grupp ta ’ pazjenti.
Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Il- livelli tal- bilirubin fis- serum, gamma- glutamyl transferase, alkaline phosphatase, ALT u AST għandhom ikunu immoniterjati mill - qrib waqt il- kura jekk jinstabu livelli għoljin.
Limited clinical data suggest that in patients with a history of oral oestrogen-induced hypertriglyceridemia (> 5.6 mmol/ l), raloxifene may be associated with a marked increase in serum triglycerides.
Informazzjoni klinika limitata tissuġġerixxi, li f’ pazjenti b’ passat mediku ta ’ ipertrigliċeridimja (> 5. 6 mmol/ l), dovuti għall- estroġenu orali, raloxifene jista ’ jkun assoċjat ma ’ żieda qawwija fil - livelli tat- trigliċeridi fis- serum.
Patients with this medical history should have serum triglycerides monitored when taking raloxifene.
Il- pazjenti li għandhom dan il- passat mediku, jeħtieġu li l- livelli tat - trigliċeridi fis- serum jiġu immoniterjati meta jkunu qegħdin jieħdu raloxifene.
The safety of EVISTA in patients with breast cancer has not been adequately studied.
Is- sigurtà ta ’ EVISTA f’ pazjenti li għandhom kanċer tas- sider għadha ma ġietx studjata biżżejjed.
No data are available on the concomitant use of EVISTA and agents used in the treatment of early or advanced breast cancer.
M’ hemmx informazzjoni disponibbli dwar l- użu ta ’ EVISTA flimkien ma ’ sustanzi wżati fil- kura tal - kanċer tas- sider, kemm fil- fażi bikrija jew f’ dik avvanzata.
Therefore, EVISTA should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Għalhekk, EVISTA għandha tintuża għall - kura ta ’ l- osteoporożi u l- prevenzjoni tagħha, wara li l- kura għall- kanċer tas- sider, inkluża t- terapija miżjuda, tkun tlestiet.
As safety information regarding co-administration of raloxifene with systemic oestrogens is limited, such use is not recommended.
3 Peress li l- informazzjoni dwar is- sigurtà fl- użu fl- istess żmien ta ’ raloxifene u estroġeni sistemiċi hi limitata, dan l- użu mhux irrakkomandat.
3 EVISTA is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
EVISTA mhix effettiva biex tnaqqas il- vażodilatazzjoni (fwawar) u sintomi oħra tal- menopawsa assoċjati ma ’ defiċjenza ta ’ l- estroġenu.
EVISTA contains lactose.
Evista fih lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għal galactose, ta ’ difett fil- Lapp lactase jew ta ’ nuqqas fl- assorbiment ta ’ glucose- galactose m’ għandhomx jieħdu din il- mediċina.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott.
Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
It- teħid konkomittanti ta ’ calcium carbonate jew ta ’ aluminium u magnesium hydroxide li jinstabu fil - mediċini kontra l- aċidu ta ’ l- istonku, ma jaffetwax l- espożizzjoni sistemika ta ’ raloxifene.
Co-administration of raloxifene and warfarin does not alter the pharmacokinetics of either compound.
It- teħid ta ’ raloxifene flimkien ma ’ warfarin ma jbiddilx il- farmakokinetiċi ta ’ l- ebda waħda minn dawn is- sustanzi.
However, modest decreases in the prothrombin time have been observed, and if raloxifene is given concurrently with warfarin or other coumarin derivatives, the prothrombin time should be monitored.
Madankollu, tnaqqis moderat fil- ħin tal- protrombina kien osservat, u jekk raloxifene jingħata flimkien ma ’ warfarin jew ma xi derivattivi oħra tal- coumarin, il- ħin tal- protrombina jrid ikun immoniterjat.
Effects on prothrombin time may develop over several weeks if EVISTA treatment is started in patients who are already on coumarin anticoagulant therapy.
L- effetti fuq il- ħin tal- protrombina jistgħu jiżviluppaw tul diversi ġimgħat, jekk il- kura b’ EVSITA tinbeda f’ pazjenti li diġa qegħdin fuq it- terapija antikoagulanti bil- coumarin.
Raloxifene has no effect on the pharmacokinetics of methylprednisolone given as a single dose.
Raloxifene m’ għandhux effett fuq il - farmakokinetika ta ’ methylprednisolone meta jingħata bħala doża waħda.
Raloxifene does not affect the steady-state AUC of digoxin.
Raloxifene m’ għandux effett fuq l- AUC fi stat stabbli ta ’ digoxin.
The Cmax of digoxin increased by less than 5%.
Is- Cmax ta ’ digoxin żdiedet b’ inqas minn 5%.
The influence of concomitant medication on raloxifene plasma concentrations was evaluated in the prevention and treatment trials.
L- effett ta ’ mediċini li jittieħdu flimkien fuq il- konċentrazzjonijiet ta ’ raloxifene fil- plażma kienu evalwati fi provi ta ’ prevenzjoni u kura.
Frequently co-administered medicinal products included: paracetamol, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, ibuprofen, and naproxen), oral antibiotics, H1 antagonists, H2 antagonists, and benzodiazepines.
Prodotti mediċinali li jingħataw spiss inkludew paracetamol, is- sustanzi kontra l- infjammazzjoni li mhumiex sterojdi (bħal acethylsalicylic acid, ibuprofen u naproxen), l- antibijotiċi orali, l- antagonisti H1, l- antagonisti H2, u l- benzodijażepini.
No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
Ma kienx hemm effetti klinikament rilevanti bl- użu konkomittanti ta ’ dawn is- sustanzi fuq il- konċentrazzjonijiet ta ’ raloxifene fil- plażma.
Concomitant use of vaginal oestrogen preparations was allowed in the clinical trial programme, if necessary to treat atrophic vaginal symptoms.
L- użu konkomittanti tas- sustanzi vaġinali ta ’ l- estroġenu tħalla fil- programm tal- prova klinika, jekk dan kien neċessarju biex jittratta s- sintomi ta ’ l- atrofija vaġinali.
Compared to placebo there was no increased use in EVISTA treated patients.
Meta mqabbel mal- plaċebo ma kienx hemm żieda fl- użu fil- pazjenti li kienu ittrattati b’ EVISTA.
In vitro, raloxifene did not interact with the binding of warfarin, phenytoin, or tamoxifen.
Raloxifene in vitro ma weriex interazzjoni ma ’ l- irbit ta ’ warfarin, phenytoin jew tamoxifen.
Raloxifene should not be co-administered with cholestyramine (or other anion exchange resins), which significantly reduces the absorption and enterohepatic cycling of raloxifene.
Raloxifene m’ għandhux jingħata flimkien ma ’ cholestyramine (jew xi reżini oħra tat- tip li jibdlu l - enajins), li jnaqqas b’ mod sinifikanti l- assorbiment u ċ- ċiklu enteroepatiku ta ’ raloxifene.
Peak concentrations of raloxifene are reduced with co-administration with ampicillin.
l- ogħla livelli ta ’ raloxifene jitnaqqsu meta jingħata flimkien ma ’ ampicillin.
However, since the overall extent of absorption and the elimination rate of raloxifene are not affected, raloxifene can be concurrently administered with ampicillin.
Madankollu, peress li l - ammont ġenerali ta ’ raloxifene li jiġi assorbit u r- rata tat- tneħħija tiegħu ma jiġux effetwati, raloxifene jista ’ jingħata flimkien ma’ ampicillin.
Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin (CBG), with corresponding increases in total hormone concentrations.
Raloxifene jżid moderatament il- konċentrazzjonijiet tal- globulini li jaqbdu ma ’ l- ormoni, inklużi l - glubulini li jaqbdu ma ’ l- ormoni sesswali sterojdi (SHBG), il- globulina li taqbad ma ’ l- ormon thyroxine (TBG) u l- globulina li taqbad mal- kortikosterojdi (CBG), b’ żidiet korrispondenti fil - konċentrazzjonijiet totali ta ’ l- ormoni.
These changes do not affect concentrations of free hormones.
Dawn il- bidliet ma jeffetwawx il- konċentrazzjonijiet ta ’ l - ormoni liberi, jiġifieri mhux marbuta.
EVISTA is only for use in postmenopausal women.
EVISTA għandha tintuża biss fin- nisa wara l- menopawsa.
EVISTA must not be taken by women of child bearing potential.
4 EVISTA m’ għandhiex tittieħed min- nisa li jistgħu joħorġu tqal.
Raloxifene may cause foetal harm when administered to a pregnant woman.
Raloxifene jista ’ jikkawża ħsara lill - fetu jekk jingħata lill- mara tqila.
If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3).
Jekk dan il- prodott mediċinali jintuża bi żball waqt it- tqala, jew il - pazjenta toħroġ tqila waqt li qed tieħdu, il- pazjenta trid tkun informata bil- potenzjal tal- ħsara lill- fetu (ara sezzjoni 5. 3).
It is not known whether raloxifene is excreted in human milk.
Mhux magħruf jekk raloxifene joħroġx fil- ħalib tas- sider.
Its clinical use, therefore, cannot be recommended in breast-feeding women.
Għalhekk, l- użu kliniku tiegħu ma jistax ikun irrakkomandat fin- nisa li qegħdin ireddgħu.
EVISTA may affect the development of the baby.
EVISTA tista ’ teffetwa l- iżvilupp tat- tarbija.
4 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Raloxifene has no known influence on the ability to drive and use machines.
Ma jidhirx li Raloxifene għandu xi effett fuq il- ħila biex issuq u tħaddem magni
In osteoporosis treatment and prevention studies involving over 13,000 postmenopausal women all adverse reactions were recorded.
Fi studji ta ’ kura u prevenzjoni ta ’ l- osteoporożi u li nvolvew ’ l fuq minn 13, 000 mara wara l - menopawża, ir- reazzjonijiet avversi kollha ġew imniżżlin.
The duration of treatment in these studies ranged from 6 to 60 months.
It- tul taż- żmien tal- kura f’ dawn l- istudji varja minn 6 sa 60 xahar.
The majority of adverse reactions have not usually required cessation of therapy.
Il- maġġoranza tar- reazzjonijiet avversi normalment ma rrikjedux il- waqfien tat- terapija.
In the prevention population discontinuations of therapy due to any adverse reaction occurred in 10.7% of 581 EVISTA treated patients and 11.1% of 584 placebo-treated patients.
F’ pazjenti fejn EVISTA ntużat għall- prevenzjoni, kien hemm bżonn li titwaqqaf it- terapija minħabba xi reazzjoni avversa f’ 10. 7% ta ’ 581 pazjenta fuq EVISTA u 11. 1% ta ’ 584 pazjenta fuq il- plaċebo.
In the treatment population discontinuations of therapy due to any clinical adverse event occurred in 12.8% of 2,557 EVISTA treated patients and 11.1% of 2,576 placebo treated patients.
F’ dawk il- pazjenti li kienu qegħdin jieħdu EVISTA bħala kura, kien hemm bżonn li titwaqqaf it - terapija minħabba kwalunkwe avveniment kliniku avvers, f’ 12. 8% ta ’ 2, 557 pazjenta li kienu ittrattati b’ EVISTA u 11. 1% ta ’ 2, 576 pazjenta ittrattati bil- plaċebo.
The adverse reactions associated with the use of raloxifene in osteoporosis clinical trials are summarised in the table below.
Ir- reazzjonijiet avversi assoċjati ma ’ l- użu ta ’ raloxifene fil- provi kliniċi ta ’ l- osteoporożi huma mogħtija fil- qosor fit- tabella ta ’ hawn taħt.
The following convention has been used for the classification of the adverse reactions: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000) very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Ġiet użata s- sistema li ġejja bħala klassifikazzjoni tar - reazzjonijiet avversi: komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100, < 1/ 10), mhux komuni (> 1/ 1, 000, < 1/ 100), rari (> 1/ 10, 000, < 1/ 1, 000), rari ħafna (< 1/ 10, 000)
Vascular disorders Very common:
Disturbi vaskulari Komuni ħafna:
Vasodilation (hot flushes) Uncommon:
Vażodilatazzjoni (fwawar) Mhux komuni:
Venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, retinal vein thrombosis Superficial vein thrombophlebitis Musculoskeletal and connective tissue disorders Common:
Avvenimenti tromboemboliċi fil- vini, inkluża t- trombożi tal- vini fondi, l- emboliżmu pulmonari, it- trombożi tal- vina tar- retina, it- tromboflebite tal- vini superfiċjali Disturbi muskolu- skeletali u tat- tessut Konnettiv Komuni:
Leg cramps General disorders and administration site conditions Very common:
Bugħawwieġijiet tar- riġlejn Disturbi ġenerali u kondizzjonijiet ta ’ sit mnejn jingħata Komuni ħafna:
Flu syndrome Common:
Sindromu ta ’ l- influwenza Komuni:
Peripheral oedema
Edema periferali
Compared with placebo-treated patients the occurrence of vasodilatation (hot flushes) was modestly increased in EVISTA patients (clinical trials for the prevention of osteoporosis, 2 to 8 years postmenopausal, 24.3% EVISTA and 18.2% placebo; clinical trials for the treatment of osteoporosis, mean age 66, 10.6% for EVISTA and 7.1% placebo).
Meta mqabbel mal- plaċebo, l- okkorrenza tal- vażodilatazzjoni (il- fwawar) kienet moderatament aktar komuni fil- pazjenti fuq EVISTA (il- provi kliniċi għal- prevenzjoni ta ’ l- osteoporożi; minn 2 sa 8 snin wara l- menopawsa, 24. 3% bl- EVISTA u 18. 2% bil- plaċebo, il- provi kliniċi għall- kura ta ’ l - osteoporożi, età medja ta ’ 66, 10. 6% bl- EVISTA u 7. 1% bil- plaċebo).
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time.
Din ir- reazzjoni avversa kienet l- aktar komuni fl- ewwel 6 xhur tal- kura, u f’ każijiet rari okkorra de novo wara dan iż- żmien.
In a study of 10,101 postmenopausal women with documented coronary heart disease or at increased risk for coronary events (RUTH), the occurrence of vasodilatation (hot flushes) was 7.8% in the raloxifene-treated patients and 4.7% in the placebo-treated patients.
Fi studju ta ’ 10, 101 mara wara l- menopawża u li huwa dokumentat li għandhom mard tal- qalb koronarju jew li qegħdin f’ riskju ogħla li jkollhom xi problemi koronarji (RUTH), l- okkorrenza tal - vażodilatazzjoni (il- fwawar) kienet ta ’ 7. 8% f’ pazjenti kkurati b’ raloxifene u ta ’ 4. 7% f’ pazjenti kkurati bi plaċebo.
Across all placebo-controlled clinical trials of raloxifene in osteoporosis, venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis occurred at a frequency of approximately 0.8% or 3.22 cases per 1,000 patient years.
Tul il- provi kliniċi kollha ta ’ raloxifene fl- osteoporożi, ikkontrollati bl- użu tal- plaċebo, l- avvenimenti tromboembolitiċi fil- vini, inklużi t- trombożi tal- vini fondi, l- emboliżmu pulmonari u t- trombożi tal - vina tar- retina, okkorrew bi frekwenza ta ’ madwar 0. 8% jew 3. 22 każijiet għal kull 1, 000 sena ta ’ l - etajiet magħduda tal- pazjenti.
A relative risk of 1.60 (CI 0.95, 2.71) was observed in EVISTA treated patients compared to placebo.
Riskju relattiv ta ’ 1. 60 (CI 0. 95, 2. 71) kien osservat fil- pazjenti ittrattati 5 bl- EVISTA meta mqabbla ma ’ dawk fuq il- plaċebo.
The risk of a thromboembolic event was greatest in the first four months of therapy.
Ir- riskju ta ’ avvenimenttromboembolika kien l - akbar fl- ewwel erba ’ xhur tat- terapija.
Superficial vein thrombophlebitis occurred in a frequency of less than 1%.
It- tromboflebite tal- vini superfiċjali okkorriet bi frekwenza ta ’ inqas minn 1%.
In the RUTH study, venous thromboembolic events occurred at a frequency of approximately 2.0% or 3.88 cases per 1000 patient-years in the raloxifene group and 1.4% or 2.70 cases per 1000 patient-years in the placebo group.
Fl- istudju kliniku RUTH, l- avvenimenti tromboembolitiċi fil- vini okkorrew bi frekwenza ta ’ madwar 2. 0% jew 3. 88 każijiet għal kull 1, 000 sena ta ’ l- etajiet magħduda tal- pazjenti fil- grupp ta ’ raloxifene u 1. 4% jew 2. 70 każijiet għal kull 1000 sena ta ’ l- etajiet magħduda tal- pazjenti fil- grupp ta ’ plaċebo.
The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 – 1.95).
Ir - riskju ta ’ komplikazzjonijiet għal każijiet kollha ta ’ VTE fl- istudju RUTH kien ta ’ HR= 1. 44, (1. 06 – 1. 95).
Superficial vein thrombophlebitis occurred in a frequency of 1% in the raloxifene group and 0.6% in the placebo group.
It- tromboflebite tal- vini superfiċjali okkorriet bi frekwenza ta ’ 1% fil- grupp ta ’ raloxifene u ta ’ 0. 6% fil- grupp ta ’ plaċebo.
5 Another adverse reaction observed was leg cramps (5.5% for EVISTA, 1.9% for placebo in the prevention population and 9.2% for EVISTA, 6.0% for placebo in the treatment population).
Reazzjoni avversa oħra kienu l- bugħawwiġijiet fir- riġlejn (5. 5% għal EVISTA, 1. 9% għall- plaċebo fil - grupp tal- prevenzjoni u 9. 2% għal EVISTA, 6. 0% għall- plaċebo fil- grupp tal- kura).
In the RUTH study, leg cramps were observed in 12.1% of raloxifene-treated patients and 8.3% of placebo-treated patients.
Fl- istudju kliniku RUTH, il- bugħawwiġijiet fir- riġlejn kienu osservati f’ 12. 1% ta ’ pazjenti kkurati b’ raloxifene u f’ 8. 3% ta ’ pazjenti kkurati bi plaċebo.
Flu syndrome was reported by 16.2% of EVISTA treated patients and 14.0% of placebo treated patients.
Is- sindromu ta ’ l- influwenza kien irrapportat f’ 16. 2% f’ dawk ittrattati bl- EVISTA u 14% ta ’ dawk il - pazjenti ittrattati bil- plaċebo.
One further change was seen which was not statistically significant (p > 0.05), but which did show a significant dose trend.
Bidla oħra kienet innotata, li ma kenitx statistikament sinifikanti (p > 0. 05), iżda li wriet inċidenza sinifikanti relatata mad- doża.
This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1% for EVISTA and 1.9% for placebo; and in the treatment population occurred at an incidence of 7.1% for EVISTA and 6.1% for placebo.
Din kienet l- edema periferali li okkorriet fil- grupp ta ’ prevenzjoni b’ inċidenza ta ’ 3. 1% għal EVISTA u 1. 8% għall- plaċebo; u fil- grupp ta ’ trattament l- inċidenza kienet ta ’ 7. 1% għall- EVISTA u 6. 1% għall- plaċebo.
In the RUTH study, peripheral oedema occurred in 14.1% of the raloxifene-treated patients and 11.7% of the placebo-treated patients, which was statistically significant.
Fl- istudju kliniku RUTH, l- edema periferali okkorriet f’ 14. 1% ta ’ pazjenti kkurati b’ raloxifene u fi 11. 7% ta ’ pazjenti kkurati bi plaċebo u dan kien statistikament sinifikanti.
Slightly decreased (6-10%) platelet counts have been reported during raloxifene treatment in placebo- controlled clinical trials of raloxifene in osteoporosis.
Ġie rrappurtat li l- għadd tal- plejtlits naqas ftit (6- 10%) waqt il- kura b’ raloxifene fi studji kliniċi kkontrollati bi plaċebo ta ’ raloxifene fl- osteoporożi
Rare cases of moderate increases in AST and/ or ALT have been reported where a causal relationship to raloxifene can not be excluded.
Każijiet rari ta ’ żidiet moderati fl- AST u/ jew l- ALT kienu irrapportati meta r- relazzjoni kawżali ma ’ raloxifene ma tistax tkun eskluża.
A similar frequency of increases was noted among placebo patients.
Inċidenza simili ta ’ żidiet kienet innotata fil- pazjenti fuq il- plaċebo.
In a study (RUTH) of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, an additional adverse reaction of cholelithiasis occurred in 3.3% of patients treated with raloxifene and 2.6% of patients treated with placebo.
Fi studju kliniku (RUTH) ta ’ nisa wara l- menopawża u li huwa dokumentat li jbatu minn mard tal- qalb koronarju jew li qegħdin f’ riskju ogħla li jkollhom xi problemi koronarji, reazzjoni avversa addizzjonali ta ’ kolelitjażi seħħet f’ 3. 3% ta ’ pazjenti kkurati b’ raloxifene u f’ 2. 6% ta ’ pazjenti kkurati bi plaċebo.
Cholecystectomy rates for raloxifene (2.3%) were not statistically significantly different from placebo (2.0%).
Ir- rati ta ’ koleċistektomija għal raloxefine (2. 3%) ma kienux differenti b’ mod statistikament sinifikanti minn dawk ta ’ plaċebo (2. 0%).
EVISTA (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
EVISTA (n=317) kienet imqabbla ma ’ terapija kontinwa (n=110) ta ’ sostituzzjoni bl- ormoni (HRT) jew dik ċiklika (n=205) f’ xi ftit provi kliniċi.
The incidence of breast symptoms and uterine bleeding in raloxifene treated women was significantly lower than in women treated with either form of HRT.
L- inċidenza ta ’ sintomi fis- sider u t- tnixxija ta ’ demm mill- utru fin- nisa ittrattati b’ raloxifene kienet inqas b’ mod sinifikanti minn dawk in- nisa li ħadu tip jew ieħor tal- HRT.
The adverse reactions reported in post-marketing experience and are presented in the table below.
Ir- reazzjonijiet avversi li ġew irrappurtati wara li l- prodott tpoġġa fuq is- suq huma ppreżentati fit - tabella hawn taħt.
Blood and lymphatic system disorders Very rare: thrombocytopenia Gastrointestinal disorders Very rare:
Disturbi tad- demm u tas- sistema limfatika Rari ħafna: tromboċitopenija Disturbi gastro- intestinali Rari ħafna:
Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, dyspepsia General disorders and administration site conditions Rare: peripheral oedema Investigations Very rare:
Sintomi gastrointestinali bħal dardir, remettar, uġigħ addominali u dispepsja Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Rari: edema periferali Investigazzjonijiet Rari ħafna: