natgillin/translations-raw huggingface dataset:
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version J/ 11-00-03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt za obvladovanje tveganja Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici J/ 11- 00- 03 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganj, s katerimi soglaša CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini je treba posodobljeni načrt za obvladovanje tveganja posredovati hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
10  Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached  At the request of the EMEA
Poleg tega je treba posodobljeni načrt za obvladovanje tveganja predložiti  ob prejemu novih informacij, ki bi lahko vplivale na trenutne specifikacije varnosti zdravila, farmakovigilančni načrt ali dejavnosti za zmanjšanje tveganja,  v 60 dneh od trenutka dosega pomembnega mejnika (farmakovigilančnega ali povezanega z zmanjševanjem tveganja), 10  na zahtevo EMEA.
Official batch release: in accordance with Article 114 Directive 2001/ 83/ EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s 114. členom Direktive 2001/ 83/ ES, kakor je bila spremenjena, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
Component 1:
Raztopina 1:
1 vial containing 1 ml of human clottable protein (50 – 90 mg/ ml) Component 2:
1 viala vsebuje 1 ml humane koagulacijske beljakovine (50 – 90 mg/ ml) Raztopina 2:
1 vial containing 1 ml of human thrombin (800 – 1200 IU/ ml).
1 viala vsebuje 1 ml humanega trombina (800 – 1200 i. e. / ml).
1 vial containing 2 ml of human clottable protein (50 – 90 mg/ ml) Component 2:
1 viala vsebuje 2 ml humane koagulacijske beljakovine (50 – 90 mg/ ml) Raztopina 2:
1 vial containing 2 ml of human thrombin (800 – 1200 IU/ ml).
1 viala vsebuje 2 ml humanega trombina (800 – 1200 i. e. / ml).
1 vial containing 5 ml of human clottable protein (50 – 90 mg/ ml) Component 2:
1 viala vsebuje 5 ml humane koagulacijske beljakovine (50 – 90 mg/ ml) Raztopina 2:
1 vial containing 5 ml of human thrombin (800 – 1200 IU/ ml).
1 viala vsebuje 5 ml humanega trombina (800 – 1200 i. e. / ml).
Human Fibrinogen: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, water for injections.
humani fibrinogen: argininijev klorid, glicin, natrijev klorid, natrijev citrat, kalcijev klorid, voda za injiciranje.
Human Thrombin: calcium chloride, human albumin, mannitol, sodium acetate, water for injections.
humani trombin: kalcijev klorid, humani albumin, manitol, natrijev acetat, voda za injiciranje.
1 vial containing 2 ml human clottable protein (50 – 90 mg/ ml) Component 2:
1 viala vsebuje 2 ml humane koagulacijske beljakovine (50 – 90 mg/ ml) Raztopina 2:
Store in the outer carton at -18°C or colder, to protect from light.
Shranjujte pri – 18 °C ali nižji temperaturi v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
After thawing, store unopened vials in the outer carton at 2-8°C for up to 30 days starting on:
Po odtalitvi shranjujte neodprte viale v zunanji škatli pri 2– 8 °C do 30 dni po:
200 Chaussée de Waterloo B-1640 Rhode-St-Genèse
200 Chaussée de Waterloo B- 1640 Rhode- St- Genese
GENERAL CLASSIFICATION FOR SUPPLY
Izdaja zdravila je le na recept.
Justification for not including Braille accepted
Sprejeta je utemeljitev, zakaj Braillova pisava ni potrebna.
Human fibrinogen:
humani fibrinogen:
Human clottable protein 50 – 90 mg/ ml
Raztopina 1: humana koagulacijska beljakovina 50 – 90 mg/ ml
To be used as two-components product with supplied device.
Za uporabo kot dvokomponentni izdelek s priloženim pripomočkom.
Human thrombin:
humani trombin:
Human thrombin 800-1200 IU/ ml
Raztopina 2: humani trombin 800 – 1200 i. e. / ml
EVICEL solutions for sealant Human fibrinogen, human thrombin
EVICEL raztopini za lepilo humani fibrinogen, humani trombin
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v
tell you doctor or pharmacist.
tem navodilu, obvestite svojega zdravnika ali farmacevta.
What EVICEL is and what it is used for 2.
Kaj je zdravilo EVICEL in za kaj ga uporabljamo 2.
Before you are treated with EVICEL 3.
Kaj morate vedeti, preden boste prejeli zdravilo EVICEL 3.
How to use EVICEL 4.
Kako uporabljati zdravilo EVICEL 4.
Possible side effects 5 How to store EVICEL 6.
Možni neželeni učinki 5 Shranjevanje zdravila EVICEL 6.
WHAT EVICEL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EVICEL IN ZA KAJ GA UPORABLJAMO
EVICEL is a Human Fibrin Sealant which is supplied as a package containing two separate vials, each containing 1 ml, 2 ml or 5 ml of solution (Fibrinogen and Thrombin respectively) Human Fibrinogen and Human Thrombin.
Vsaka vsebuje 1 ml, 2 ml ali 5 ml raztopine (fibrinogena oz. trombina) humanega fibrinogena oz. humanega trombina.
Fibrinogen is a concentrate of clottable protein and Thrombin is an enzyme that causes clottable protein to coalesce.
Fibrinogen je koncentrat koagulacijske beljakovine, trombin pa encim, ki vpliva na koagulacijsko beljakovino tako, da ta tvori strdke.
It is dripped or sprayed onto cut tissue where it forms a thin layer that seals the tissue and stops bleeding.
Zdravilo nakapamo ali razpršimo na tkivo, kjer tvori tanek sloj, ki zalepi tkivo in zaustavi krvavitev.
EVICEL can also be used in blood vessels surgery and in surgery taking place in the area between the bowels and the posterior abdominal wall.
Zdravilo EVICEL se lahko uporabi tudi pri kirurških posegih na ožilju in kirurških posegih v področju med črevesjem in zadnjo trebušno steno.
BEFORE YOU ARE TREATED WITH EVICEL
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO EVICEL
 if you are hypersensitive (allergic) to products made from human blood or to any of the other ingredients of EVICEL.
Če ste alergični (preobčutljivi) na zdravila, izdelana iz človeške krvi ali katero koli sestavino zdravila  EVICEL.
Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and breathing difficulties.
Znaki takšnih reakcij so med drugim koprivnica, izpuščaj, stiskanje v prsih, sopenje, padec krvnega tlaka in oteženo dihanje.
Take special care with EVICEL
Bodite posebno pozorni pri uporabi zdravila EVICEL
 When EVICEL is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue.
Ko kirurg uporabi zdravilo EVICEL med kirurškim posegom, mora paziti, da ga nanese samo na  površino tkiva.
EVICEL must not be injected into tissue or blood vessels because it would cause clots which could be fatal.  The use of EVICEL has not been studied in the following procedures, and there is therefore no information to show that it would be effective:
Pri v nadaljevanju naštetih postopkih uporabe zdravila EVICEL niso preučevali, zato ni podatkov, ki bi  dokazovali njegovo učinkovitost pri: lepljenju tkiv skupaj  kirurških posegih na možganih ali hrbtenjači  nadzoru krvavitev v želodcu ali črevesju z apliciranjem prek endoskopa (cevke)  lepljenju kirurških korekcij črevesja.  Bližnje površine je treba zaščititi, da bi zagotovili, da je zdravilo EVICEL naneseno le na zdravljene 
20
20 površine.
 Nearby areas should be protected to make sure that EVICEL is only applied onto the surface which is to be treated.  As with any product containing proteins, allergic type hypersensitivity reactions are possible.
Kot pri vseh zdravilih, ki vsebujejo beljakovine, so možne preobčutljivostne reakcije alergijskega tipa.  Znaki takih reakciji vključujejo koprivnico, izpuščaj, stiskanje v prsih, sopenje, padec krvnega tlaka in anafilaksijo.
 When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Pri zdravilih, ki se izdelajo iz človeške krvi ali plazme, se izvajajo določeni ukrepi za preprečevanje  prenosa okužb na bolnike.
These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of viruses/infections.
Ti ukrepi so med drugim natančna izbira darovalcev krvi in plazme, da se izključi osebe s tveganjem prenosa okužbe, in testiranje vsake odvzete enote in združene plazme za znake virusov/ okužb.
This also applies to any unknown or emerging viruses, or other types of infections.
Kljub temu pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni možno povsem izključiti možnosti prenosa povzročiteljev nalezljivih bolezni, tudi tistih, ki do danes še niso poznani, porajajočih se virusov ali drugih vrst okužb.
The measures taken in the manufacture of Fibrinogen and Thrombin are considered effective for lipid coated viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus and the non- enveloped virus, hepatitis A.
Ukrepi, ki se izvajajo pri izdelavi raztopin fibrinogena in trombina, se štejejo za učinkovite proti virusom z lipidno ovojnico, kot so humani virus imunske pomanjkljivosti (HIV), virus hepatitisa B in virus hepatitisa C, ter proti virusu hepatitisa A, ki je brez ovojnice.
The measures taken may be of limited value against parvovirus B19.
Ukrepi, ki se izvajajo, so morda manj učinkoviti proti parvovirusu B19.
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
Okužba s parvovirusom B19 je lahko resna pri nosečnicah (okužba ploda) in posameznikih z oslabljenim delovanjem imunskega sistema ali tistih, ki imajo določene vrste anemij (npr. srpastocelično anemijo ali hemolitično anemijo).
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta.
There is not enough information available to know whether any particular risks are associated with the use of EVICEL during pregnancy or whilst breast-feeding.
Nosečnost in dojenje Na voljo ni dovolj podatkov, da bi lahko ugotovili, ali obstajajo tveganja, ki so povezana z uporabo zdravila EVICEL med nosečnostjo ali v obdobju dojenja.
However, since EVICEL is used during a surgical operation, if you are pregnant or breast-feeding you should discuss the overall risks of the operation with your doctor.
Ker pa se zdravilo EVICEL uporablja med kirurškim posegom, se o splošnem tveganju posega med nosečnostjo oz. dojenjem posvetujte s svojim zdravnikom.
Pediatric use Data are too limited to support the safety and effectiveness of EVICEL in children.
Uporaba pri otrocih Podatkov za sklepanje o varnosti in učinkovitosti uporabe zdravila EVICEL pri otrocih je premalo.
HOW TO USE EVICEL
KAKO UPORABLJATI ZDRAVILO EVICEL
During your operation, your doctor will drip or spray EVICEL onto raw tissue during operations, using an application device.
Med posegom bo zdravnik nakapal ali razpršil zdravilo EVICEL na tkivo z aplikatorjem.
It will be dripped onto the tissue in short bursts or sprayed in very small amounts (0.1-0.2 ml), to produce a thin, even layer.
Zdravilo se nakapa na tkivo v kratkih razprških ali razprši v majhni količini (0, 1- 0, 2 ml), da nastane tanek, enakomeren sloj.
Like all medicines, EVICEL can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo EVICEL neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
EVICEL is a fibrin sealant.
EVICEL je fibrinsko lepilo.
Fibrin sealants in general may, in rare cases (1 to 10 patients in 10,000), cause an allergic reaction.
Fibrinska lepila lahko na splošno v redkih primerih (pri 1 do 10 bolnikih izmed 10. 000) povzročijo alergijsko reakcijo.
If you experience an allergic reaction you might have one or more of the following symptoms: skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting or wheezing.
Če se pri vas pojavi alergijska reakcija, imate lahko enega ali več od naslednjih simptomov: kožni izpuščaj, koprivnica, stiskanje v prsih, mrazenje, zardevanje, glavobol, nizek krvni tlak, stanje podobno globokemu spanju (letargija), slabost, nemir, pospešen utrip srca, mravljinčenje, bruhanje ali sopenje.
There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.
21 Obstaja teoretična možnost, da pri vas nastanejo protitelesa proti beljakovinam v zdravilu EVICEL, kar lahko moti strjevanje krvi.
In clinical studies with EVICEL some undesired events occurred for which a causal relation to the application of EVICEL could not be excluded.
Med kliničnimi študijami z zdravilom EVICEL je prišlo do nekaj neželenih dogodkov, za katere vzročne povezave z uporabo zdravila EVICEL ni mogoče izključiti.
After abdominal surgery some patients presented with an abscess, and in vascular surgery some cases of an occluded graft occurred which had do be re-operated.
Po abdominalnem operativnem posegu se je pri nekaj bolnikih pojavil absces, pri žilnih kirurških posegih pa je prišlo do nekaj primerov okluzije presadka, ki jih je bilo treba operirati še enkrat.
HOW TO STORE EVICEL
SHRANJEVANJE ZDRAVILA EVICEL
Store in a freezer at -18°C or colder.
Shranjujte v zamrzovalniku pri temperaturi - 18 °C ali nižji.
Do not use EVICEL after the expiry date which is stated on the label as well as the carton after EXP.
Zdravila EVICEL ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP.
After thawing, unopened vials can be stored at 2-8°C and protected from light, for up to 30 days.
Po odtalitvi lahko neodprte viale shranjujete pri 2– 8 °C in zaščitene pred svetlobo do 30 dni.
The Fibrinogen and Thrombin components are stable at room temperature for up to 24 hours but once drawn up into the application device, they must be used immediately.
Raztopini s fibrinogenom in trombinom sta stabilni pri sobni temperaturi do 24 ur, po vnosu v aplikator pa ju morate porabiti nemudoma.
Human thrombin (800 - 1,200 IU/ml)
Raztopina 1: humana koagulacijska beljakovina (50 – 90 mg/ ml) Raztopina 2: humani trombin (800 – 1200 i. e. / ml)
Component 1: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride and water for injections.
Raztopina 1: argininijev klorid, glicin, natrijev klorid, natrijev citrat, kalcijev klorid in voda za injekcije.
Component 2: calcium chloride, human albumin, mannitol, sodium acetate and water for injections.
Raztopina 2: kalcijev klorid, humani albumin, manitol, natrijev acetat in voda za injekcije.
EVICEL is available in the following sizes:
Zdravilo EVICEL je na voljo v pakiranjih naslednjih velikosti:
2 x 1 ml, 2 x 2 ml and 2 x 5 ml.
2 x 1 ml, 2 x 2 ml in 2 x 5 ml.
All packs sizes may not be marketed in all countries.
Na trgu posameznih držav morda ni vseh navedenih pakiranj.
22 What EVICEL looks like and contents of the pack
Videz zdravila EVICEL in vsebina pakiranja
EVICEL is a Human Fibrin Sealant which is supplied as a package containing two separate vials, each containing 1 ml, 2 ml or 5 ml solution of Human Fibrinogen and Human Thrombin, respectively.
Vsaka vsebuje 1 ml, 2 ml ali 5 ml raztopine humanega fibrinogena oz. humanega trombina.
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.
Vsaka vsebuje enak volumen (1 ml, 2 ml ali 5 ml) zamrznjene, sterilne raztopine, ki je po odtalitvi brezbarvna ali rumenkasta.
Fibrinogen is a concentrate of clottable protein and Thrombin is an enzyme that causes clottable protein to coalesce.
Fibrinogen je koncentrat koagulacijske beljakovine, trombin pa je encim, ki povzroči strjevanje koagulacijske beljakovine.
For any information about this medicine, please contact the Manufacturer:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na izdelovalca:
Moshe Kamar, MD Head of PV and Medical Director Tel: +972-3-5316512 Fax: +972-3-5316590
Moshe Kamar, MD Head of PV and Medical Director Tel: +972- 3- 5316512 Faks: +972- 3- 5316590
This leaflet was last approved in {MM/YYY}
Navodilo je bilo odobreno {MM/ LLLL}
Read this before you open the package:
Preberite, preden odprete ovojnino:
Draw the contents of the two vials into the administration device, following the instructions in Figure 1.
Posesajte vsebino obeh vial v aplikator po navodilih na sliki 1.
23 Fibrinogen and Thrombin:
Fibrinogen in trombin:
Long term storage Store in a freezer at -18°C or colder.
Dolgoročno shranjevanje Shranjujte v zamrzovalniku pri temperaturi - 18 °C ali nižji.
Short term storage Store at 2C-8C (in a refrigerator) for no more than 30 days.
23 Shranjujte pri temperaturi med 2 C in 8 C (v hladilniku) do največ 30 dni.
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.
Raztopini fibrinogena in trombina sta stabilni pri sobni temperaturi do 24 ur, po vnosu v aplikator pa ju morate porabiti nemudoma.
Store separately from the Fibrinogen and Thrombin, at room temperature.
Shranjujte pri sobni temperaturi ločeno od raztopin fibrinogena in trombina.
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 (hladilnik): viale se odtalijo v 1 dnevu, 20– 25 °C (sobna temperatura): viale se odtalijo v 1 uri, 37 °C (npr. vodna kopel, z aseptično tehniko ali segrevanje v dlani): viale se odtalijo v 10 minutah; pri tej temperaturi jih ne smete pustiti dlje kot 10 minut oz. dokler se popolnoma ne odtalijo.
EVICEL can be sprayed using pressurised CO2 or compressed air.
Zdravilo EVICEL lahko pršite s komprimiranim CO2 ali komprimiranim zrakom.
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.
Priključite ženski priključek luer- lock plinske cevke (z 0, 2- mikrometrskim bakteriostatičnim filtrom) na regulator tlaka, ki lahko zagotovi od 1, 0 do 2, 0 bara.
24  Disposal
 Odstranjevanje
Figure 1.
24 Slika 1.
Instructions for use of the administration device.
Navodilo za uporabo aplikatorja.
Ensure all connections are tight.
Pazite, da vse priključke dobro zatesnite.
Holding the syringe barrels with one hand, loosen the syringe pistons by sliding them back and forth.
V eno roko primite telesi brizg, z drugo roko pa razrahljate bata s premikanjem sem in tja.
Insert the two vials (Fibrinogen and Thrombin) into the two sterile vial cups.
Vstavite viali (fibrinogen in trombin) v sterilni posodici za viali.
The vial cups must be handled using sterile technique.
S posodicama za viali morate ravnati v skladu s sterilno tehniko.
Holding the vial cup, press the top of the vial into the vial connector which is attached to the applicator (as shown).
Primite za posodico in zgornji del viale potisnite v priključek za vialo na aplikatorju (kakor je prikazano).
Repeat with the second vial.
Ponovite z drugo vialo.
Holding the syringe barrels with one hand, aspirate both syringes slowly (vials facing up).
Z eno roko primite telesi brizg, z drugo roko pa počasi povlecite bata obeh brizg (viali sta obrnjeni na glavo).
If needed, inject back into vial and aspirate again to expel air.
Po potrebi injicirajte nazaj v vialo in ponovno aspirirajte, da odstranite zrak.
While holding the syringe barrels with one hand, gently turn the vial connector anti-clockwise with the other hand.
V eno roko primite telesi brizg, z drugo roko previdno obrnite priključek vial v nasprotni smeri urinih kazalcev.
The vial connector/vial/vial cup combination disconnects automatically.
Sestav priključka viale/ viala/ posodica za vialo se samodejno razstavi.
25 5 If spraying is required, connect the tubing to the pressure regulator.
Če boste zdravilo pršili, priključite cevi na regulator tlaka.
The applicator is now ready for use.
Aplikator je sedaj pripravljen za uporabo.
Raloxifene acts as an ‘ agonist ’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Raloksifen deluje kot agonist receptorjev estrogena (snovi, ki stimulira receptorje za estrogen) v nekaterih telesnih tkivih.
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%.
Pri preprečevanju osteoporoze se je pri ženskah, ki so prejemale zdravilo Evista, v dveh letih gostota kosti v kolkih ali hrbtenici povečala za 1, 6%, pri tistih, ki so prejemale placebo, pa se je zmanjšala za 0, 8%.
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.
Med štiriletnim zdravljenjem je zdravilo Evista v primerjavi s placebom zmanjšalo število novih zlomov vretenc za 46% pri ženskah z osteoporozo in za 32% pri ženskah z osteoporozo in že obstoječim zlomom kosti.
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).
Zdravila Evista ne smejo uporabljati ženske, ki: • bi lahko zanosile; • imajo ali so v preteklosti imele težave s krvnimi strdki, vključno s trombozo globokih ven in pljučno embolijo (krvni strdki v pljučih); • imajo obolenje jeter ali hudo obolenje ledvic, nepojasnjene krvavitve iz maternice ali raka endometrija (raka maternične sluznice).
The Committee decided that Evista’ s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women.
Odbor je sklenil, da so koristi zdravila Evista pri zdravljenju in preprečevanju osteoporoze pri ženskah po menopavzi večje od z njim povezanih tveganj.
Package size
peroralna uporaba
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
pretisni omot (PVC/ PE/ PCTFE)
blister (PVC/ PE/ PCTFE) blister (PVC/ PE/ PCTFE) blister (PVC/ PE/ PCTFE) bottle (HDPE)
pretisni omot (PVC/ PE/ PCTFE)
EVISTA 60 mg film coated tablets
EVISTA 60 mg filmsko obložene tablete
Excipient: each tablet contains lactose (149.40 mg).
Pomožna snov: vsaka tableta vsebuje laktozo (149, 40 mg).
For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi, glejte poglavje 6. 1.
Film coated tablet.
Filmsko obložena tableta.
Elliptically shaped, white tablets imprinted with the code ’ 4165’.
Eliptično oblikovane tablete bele barve, na katerih je odtisnjena šifra ’ 4165 ’.