natgillin/translations-raw huggingface dataset:
In the pooled Combo 450 population, uveitis was reported in 4.4% (12/274) of patients, and was Grade 1 in 0.4% (1/274), Grade 2 in 3.6% (10/274) and Grade 3 in 0.4% (1/274). 
Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je bil pojav vnetja uvee opažen pri 4,4 % (12/274) bolnikov, in sicer 1. stopnje pri 0,4 % (1/274), 2. stopnje pri 3,6 % (10/274)
Arthralgia* Myalgiag Pain in extremity Back pain 
Bolečine v mišicahg Bolečine v okončinah Bolečine v hrbtu
• Recurrent Grade 3 adverse reactions 
• Ponovni pojav neželenih učinkov 3. stopnje
Renal failure * 
Okvara ledvic*
• Recurrent Grade 3 (AST or ALT > 5x ULN and blood bilirubin > 2x ULN) 
• Ponovni pojav 3. stopnje (AST ali ALT > 5-kratnika ULN in krvni bilitubin > 2kratnika ULN)
Talk to your doctor, pharmacist or nurse before taking Braftovi, about all of your medical conditions, particularly if you have any of the following: - heart problems including alteration of the electrical activity of your heart (QT interval prolongation) - bleeding problems or if you are taking medicines that may cause bleeding - eye problems - liver or kidney problems 
- težave s srcem, vključno s spremembami v električni aktivnosti srca (podaljšanje intervala QT), - težave s krvavitvami ali če jemljete zdravila, ki lahko povzročijo krvavitve, - težave z očmi,
Encorafenib should be permanently discontinued if patient is unable to tolerate 100mg once daily. 
Če bolnik ne more prenašati odmerka 100 mg enkrat dnevno, je treba jemanje enkorafeniba trajno prekiniti.
Rash led to discontinuation in 0.4% (1/274) patients and to dose interruption or dose modification in 1.1% (3/274) of patients. 
Zaradi izpuščaja se je pri 0,4 % (1/274) bolnikov prenehalo zdravljenje, pri 1,1 % (3/274) bolnikov pa se je odmerjanje prekinilo ali se je odmerek spremenil.
In the pooled Combo 450 population, facial paresis occurred in 0.7% (2/274) of patients including Grade 3 in 0.4% (1/274) of patients. 
Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 je prišlo do pareze obraza pri 0,7 % (2/274) bolnikov, vključno s 3. stopnjo pri 0.4% (1/274) bolnikov.
Facial paresisc 
Pareza obrazac
The hard capsule (capsule) has a flesh coloured opaque cap and white opaque body, with a stylised “A” printed on the cap and “LGX 75mg” printed on the body. 
Braftovi 75 mg trde kapsule Trda kapsula (kapsula) ima pokrovček neprozorne kožne oranžne barve in telo neprozorne bele barve z natisnjeno stilizirano črko »A« na pokrovčku in napisom »LGX 75mg« na telesu.
Effects of encorafenib on other medicinal products CYP substrates 
Vplivi enkorafeniba na druga zdravila
Braftovi 75 mg: Each hard capsule contains 75 mg encorafenib. 
Braftovi 75 mg: Ena trda kapsula vsebuje 75 mg enkorafeniba.
Braftovi 75 mg hard capsules Each hard capsule contains 75 mg of encorafenib. 
Braftovi 75 mg trde kapsule Ena trda kapsula vsebuje 75 mg enkorafeniba.
Arthralgia* 
Artralgija*
RPED has also been reported in patients treated with encorafenib in combination with binimetinib (see section 4.8). 
Pri bolnikih, zdravljenih z enkorafenibom v kombinaciji z binimetinibom, so poročali tudi o odstopu retinalnega pigmentnega epitelija (RPED) (glejte poglavje 4.8).
Braftovi 50 mg hard capsules Each hard capsule contains 50 mg of encorafenib. 
Braftovi 50 mg trde kapsule Ena trda kapsula vsebuje 50 mg enkorafeniba.
Uveitis * 
Driska*
The half maximal inhibitory concentration (IC50) of encorafenib against BRAFV600E, BRAF and CRAF enzymes was determined to be 0.35, 0.47 and 0.30 nM, respectively. 
in CRAF je bila ugotovljena v količini 0,35, 0,47 in 0,30 nM za vsakega od navedenih.
Ocular events 
Očesni dogodki
Avoid driving or using machines if you have any problems with your vision, or have any other side effects that can affect your ability to drive or use machines (see section 4), while taking Braftovi. 
Če imate težave z vidom ali se pojavljajo drugi neželeni učinki, ki lahko vplivajo na vašo sposobnost upravljanja vozil in strojev
In Study CMEK162B2301-Part 2, in the Combo 300 arm, anaemia was observed in 9.7% (25/257) of patients with Grade 3-4 reported in 2.7% (7/257) patients. 
V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, anemijo opazili pri 9,7 % (25/257) bolnikov, pri čemer je pri 2,7 % (7/257) bolnikov prišlo do dogodkov 3.-4. stopnje.
In the pooled Combo 450 population, rash occurred in 19.7% (54/274) of patients. 
Pri združeni populaciji bolnikov v okviru zdravljenja s kombinacijo 450 se je izpuščaj razvil pri 19,7 % (54/274) bolnikov.
Administration of encorafenib should be undertaken with caution at a reduced dose in patients with mild hepatic impairment (see section 4.2). 
Pri bolnikih z blago jetrno okvaro je potrebna previdnost in uporabiti nižji odmerek enkorafeniba (glejte poglavje 4.2).
The pharmacokinetics of encorafenib have not been studied in patients with severe renal impairment. 
Pri bolnikih z resno okvaro ledvic farmakokinetika enkorafeniba ni bila preučena.
Braftovi 50 mg: Each hard capsule contains 50 mg encorafenib. 
Braftovi 50 mg: Ena trda kapsula vsebuje 50 mg enkorafeniba.
Encorafenib should be maintained and supportive measures such as topical therapy should be instituted. 
Vnašanje enkorafeniba je treba nadaljevati in uvesti podporne ukrepe,
LVD defined as symptomatic or asymptomatic decreases in ejection fraction has been reported when encorafenib is used in combination with binimetinib. 
Pri uporabi enkorafeniba v kombinaciji z binimetinibom so poročali o LVD, opredeljeni kot simptomatično ali asimptomatično zmanjšanje iztisnega deleža.
Amylase and lipase elevations were reported in 3.3% (9/274) and 5.1% (14/274) of patients, respectively. 
3,3 % (9/274) in 5,1 % (14/274) bolnikov.
Shellac (E904) Iron oxide black (E172) Propylene glycol (E1520) 
Šelak (E904) Črni železov oksid (E172)
How to store Braftovi 
Shranjevanje zdravila Braftovi
Encorafenib should be used with caution in patients with severe renal impairment. 
Pri bolnikih s hudo ledvično okvaro je ob uporabi enkorafeniba potrebna previdnost.
Fatal gastric ulcer haemorrhage, with multiple organ failure as a concurrent cause of death, occurred in one patient. 
Vzrok smrti enega bolnika je bila krvavitev iz želodčne razjede s sočasno odpovedjo več organov.
In Study CMEK162B2301-Part 2, in the Combo 300 arm, fatigue was observed in 33.5% (86/257) of patients with 1.6% (4/257) Grade 3-4 events. 
V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, utrujenost opazili pri 33,5 % (86/257) bolnikov, pri čemer je pri 1,6 % (4/257) bolnikov prišlo do dogodkov 3.-4. stopnje.
Encorafenib should be withheld (see monitoring in section 
Vnašanje enkorafeniba je treba prekiniti (glejte spremljanje v poglavju 4.4.
A thorough QT study to evaluate the QT prolongation potential of encorafenib has not been conducted. 
Pri bolnikih, zdravljenih z inhibitorji BRAF, je bilo opaženo podaljšanje intervala QT. Podrobna študija intervala QT, ki bi ocenila podaljšanje intervala QT pri zdravljenju z enkorafenibom, ni bila izvedena.
New primary melanoma has been observed in patients treated with BRAF inhibitors including encorafenib (see section 4.8). 
Pri bolnikih, zdravljenih z inhibitorji BRAF, vključno z enkorafenibom, so poročali o nastanku novih primarnih melanomov (glejte poglavje 4.8).
In Study CMEK162B2301-Part 2, in the Combo 300 arm, headache was reported in 12.1% (31/257) of patients and was Grade 3 in 0.4% (1/257) of patients. 
V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, glavobol opazili pri 12,1 % (31/257) bolnikov, pri čemer je pri 0,4 % (1/257) bolnikov prišlo do dogodkov 3. stopnje.
In Study CMEK162B2301-Part 2, in the Combo 300 arm, RPED was observed in 12.5% (32/257) of patients with 0.4% (1/257) Grade 4 event. 
V 2. delu študije CMEK162B2301 so RPED pri bolnikih, zdravljenih v okviru kombinacije 300, opazili pri 12,5 % (32/257) bolnikov, pri čemer je pri 0,4 % (1/257) bolnikov prišlo do dogodka 4. stopnje.
Erythema* 
Disgevzija*
Braftovi 50 mg hard capsules 
Braftovi 50 mg trde kapsule
Pancreatitis led to dose interruption or adjustment in (0.4 %) 1/274 of patients. 
Zaradi pankreatitisa je bil pri (0,4 %) 1/274 bolnikov vnos prekinjen oziroma odmerek spremenjen.
In Study CMEK162B2301-Part 2, in the Combo 300 arm, nausea was observed in 27.2% (70/257) of patients and was Grade 3 in 1.6% (4/257) of patients. 
V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, slabost opazili pri 27,2 % (70/257) bolnikov, pri čemer je pri 1,6 % (4/257) bolnikov prišlo do dogodkov 3. stopnje.
1st dose reduction 300 mg once daily 2nd dose reduction 200 mg once daily Subsequent modification 
Odmerek enkorafeniba v kombinaciji z binimetinibom Začetni odmerek 450 mg enkrat dnevno 1. zmanjšanje odmerka
• First occurrence of Grade 3 adverse reactions 
• Prvi pojav neželenih učinkov
Braftovi 75 mg hard capsules 
Braftovi 75 mg trde kapsule
Very common (may affect more than 1 in 10 people): - reduced red blood cell count (anaemia) - problem with the nerves resulting in pain, loss of sensation or tingling in hands and feet - headache - dizziness - bleeding at various sites in the body - high blood pressure - problems with your vision (visual impairment) - stomach pain - diarrhoea - being sick (vomiting) - feeling sick (nausea) - constipation - itching - dry skin - hair loss or thinning (alopecia) - skin rash of various types - thickening of the outer layers of the skin - joint pain (arthralgia) - muscle pain, weakness or spasm - back pain - pain in the extremities - fever - swelling of the hands or feet (peripheral oedema), localised swelling - fatigue - abnormal blood test results for liver function - abnormal blood test results related to blood creatine kinase, indicating damage to the heart and muscle 
- zmanjšana količina rdečih krvničk (anemija), - težave z živci, ki lahko povzročijo bolečino, izgubo občutljivosti ali mravljinčenje v dlaneh in stopalih, - glavobol, - omotica, - krvavitve iz različnih predelov telesa, - visok krvni tlak, - težave z vidom (okvara vida),
Heart problems: Braftovi when taken with binimetinib can affect how well your heart works (left ventricular ejection fraction decrease); signs and symptoms can include: - feeling dizzy, tired or lightheaded - shortness of breath - feeling like your heart is pounding, racing or beating irregularly - swelling in the legs 
Težave s srcem: Zdravilo Braftovi ob sočasnem jemanju z binimetinibom lahko vpliva na delovanje srca (zmanjšanje iztisnega deleža levega prekata); znaki in simptomi lahko vključujejo:
In Study CMEK162B2301-Part 2, in the Combo 300 arm, haemorrhagic events were observed in 6.6% (17/257) of patients and were Grade 3-4 in 1.6% (4/257) of patients. 
V 2. delu študije CMEK162B2301 so pri bolnikih, zdravljenih v okviru kombinacije 300, krvavitve opazili pri 6,6 % (17/257) bolnikov, pri čemer je pri 1,6 % (4/257) bolnikov prišlo do dogodkov 3-4. stopnje.
Orange opaque cap and flesh opaque body, printed with a stylised “A” on the cap and “LGX 50mg” on the body. 
Pokrovček neprozorno oranžne barve in telo kapsule neprozorno kožne barve z natisnjeno stilizirano črko »A« na pokrovčku in napisom »LGX 50mg« na telesu.
Common (may affect up to 1 in 10 people) - allergic reaction that may include swelling of the face and difficulty in breathing - weakness and paralysis of face muscles - fast heart beat - skin rash with a flat discoloured area or raised bumps like acne (dermatitis acneiform) - peeling or scaly skin - inflammation of joints (arthritis) - kidney failure - abnormal kidney test results (creatinine elevations) - increased skin sensitivity to sunlight - abnormal blood test result for pancreas function (lipase) 
- kožni izpuščaj z ravno površino spremenjene barve ali z bunčicami kot pri aknah (akneiformni dermatitis), - lupljenje kože ali luskasta koža - vnetje sklepov (artritis), - okvara ledvic, - nenormalni rezultati preiskav delovanja ledvic (dvig kreatinina),
It is used in adults in combination with another medicine containing binimetinib to treat a type of skin cancer called melanoma when it has - a particular change (mutation) in a gene responsible for producing a protein called BRAF, and - spread to other parts of the body, or cannot be removed by surgery 
V kombinaciji z drugim zdravilom, ki vsebuje binimetinib, se uporablja pri odraslih za zdravljenje vrste kožnega raka, ki se mu reče melanom,
Vomiting* Constipation Abdominal pain* Diarrhoea* 
- bolečine v trebuhu (abdominalne bolečine),
If during treatment LVD occurs, see section 4.2 of binimetinib SmPC. 
Če med zdravljenem pride do LVD, glejte poglavje 4.2
The length of the capsule is approximately 22 mm. 
Dolžina kapsule je približno 22 mm. Braftovi 75 mg trde kapsule
Common (may affect up to 1 in 10 people) - some types of skin tumours such as skin papilloma and basal cell carcinoma - allergic reaction that may include swelling of the face and difficulty breathing - changes in the way things taste - inflammation of the eye (uveitis) - blood clots - inflammation of the colon (colitis) - redness, chapping or cracking of the skin - inflammation of the fatty layer under the skin, symptoms include tender skin nodules - skin rash with a flat discoloured area or raised bumps like acne (dermatitis acneiform) - redness, skin peeling or blisters on hand and feet (palmar-plantar erythrodysesthesia or hand and foot syndrome) - kidney failure - abnormal kidney test results (creatinine elevations) - abnormal blood test results for liver function (blood alkaline phosphatase) - abnormal blood test results for pancreas function (amylase, lipase) - increased skin sensitivity to sunlight 
- rdeča koža, lupljenje kože ali žulji na rokah in stopalih (sindrom palmarno-plantarne eritrodisestezije na rokah in stopalih), - okvara ledvic, - nenormalni rezultati preiskav delovanja ledvic (dvig kreatinina), - nenormalni rezultati krvnih preiskav delovanja jeter (alkalna fosfataza v krvi), - nenormalni rezultati krvnih preiskav delovanja trebušne slinavke (amilaza, lipaza),
Braftovi 75 mg hard capsules encorafenib 
Braftovi 75 mg trde kapsule enkorafenib
CK elevation and rhabdomyolysis occurred when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
Pri jemanju enkorafeniba v kombinaciji z binimetinibom so poročali o dvigu CK in rabdomiolizi (glejte poglavje 4.8 Povzetka glavnih značilnosti zdravila binimetinib).
Braftovi 50 mg hard capsules encorafenib 
Braftovi 50 mg trde kapsule enkorafenib
Hypertension was reported when encorafenib was used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
Pri jemanju enkorafeniba v kombinaciji z binimetinibom so poročali o pojavu hipertenzije (glejte poglavje 4.8 Povzetka glavnih značilnosti zdravila binimetinib).
Creatinine elevation has been commonly reported with encorafenib as single agent or in combination with binimetinib. 
Pri bolnikih, zdravljenih z enkorafenibom v kombinaciji z binimetinibom ali kot samostojno učinkovino so pogosto poročali o povečanih količinah kreatinina.
Starting dose 
Zmanjšanje teka
LVD was reported when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
Pri jemanju enkorafeniba v kombinaciji z binimetinibom so poročali o pojavu LVD (glejte poglavje 4.8 Povzetka glavnih značilnosti zdravila binimetinib).
Uncommon (may affect up to 1 in 100 people) - type of skin cancer such as basal cell carcinoma - inflammation of the eye (uveitis) - inflammation of the pancreas (pancreatitis) causing severe abdominal pain - abnormal blood test result for pancreas function (amylase) 
- povišana telesna temperatura, - nekatere vrste benignih kožnih tumorjev, kot so melanocitni nevus in kožni papilom, - nenormalni rezultati preiskav krvi, povezanih s preiskavami delovanja jeter,
Dermatitis acneiform was reported when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
Pri jemanju enkorafeniba v kombinaciji z binimetinibom so poročali o pojavu akneiformnega dermatitisa (glejte poglavje 4.8 Povzetka glavnih značilnosti zdravila binimetinib).
Missed doses 
Nedermalni malignomi
Additionally, your doctor needs to check for squamous cell carcinoma on your head, neck, mouth and lymph glands, and you will have CT scans regularly. 
Poleg tega vam mora zdravnik pregledati glavo, vrat,
Gamma-glutamyl transferase (GGT) increased* 
Zvišana vrednost gamaglutamiltransferaze (GGT)*
VTE was reported when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
Pri jemanju enkorafeniba v kombinaciji z binimetinibom so poročali o pojavu VTE (glejte poglavje 4.8 Povzetka glavnih značilnosti zdravila binimetinib).
Ocular toxicities 
FARMAKOLOŠKE LASTNOSTI
No NOAEL could be established for the 4-week study. 
Za 4-tedensko študijo ni bilo mogoče določiti odmerka brez opaznega neželenega učinka (angl. No Observed Adverse Effect
The duration of the treatment in these studies ranged from 6 to 60 months. 
Zdravljenje v teh študijah je trajalo od 6 do 60 mesecev.
If you wish you may take a glass of water with it. 
Če želite, jo lahko popijete s tekočino.
The tablet can be taken at any time of the day without regard to meals. 
Tableto se lahko vzame ob katerem koli času dneva, ne glede na obroke.
The recommended dose is one tablet daily.Due to the nature of this disease process, raloxifene is intended for long term use. 
Priporočen odmerek je ena tableta na dan. Zaradi narave tega bolezenskega procesa je raloksifen namenjen za dolgotrajno uporabo.
TEVA Pharmaceutical Works Private Limited Company Pallagi ùt 13, 4042 Debrecen Hungary 
TEVA Pharmaceutical Works Private Limited Company Pallagi ùt 13, 4042 Debrecen Madžarska
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. 
Pred začetkom jemanja zdravila natančno preberete navodilo, ker vsebuje za vas pomembne podatke!
- 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. 
- Če ste že imeli cerebrovaskularni dogodek (npr. možgansko kap) ali če vam je vaš zdravnik povedal, da imate visoko tveganje za tak dogodek.
• Headache including migraine 
• glavobol, vključno z migreno
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicines. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• Swelling of hands, feet and legs (peripheral oedema). 
• otekanje dlani, stopal in nog (periferni edem)
- If you have severe kidney problems. 
- Če imate hude težave ledvicami.
If you do have liver problems and your doctor still recommends treatment, then you may need some blood tests during treatment. 
Če imate težave z jetri, zdravnik pa vam kljub temu priporoča zdravljenje, boste med zdravljenjem utegnili imeti dodatne krvne preiskave.
Pack sizes of 14, 28 and 84 tablets. 
Velikosti pakiranj s po 14, 28 in 84 tabletami.
A similar increase in BMD was seen in the treatment population who received raloxifene for up to 7 years. 
Podobno povečanje BMD so ugotovili pri zdravljeni populaciji, ki je prejemala raloksifen do 7 let.
The table below gives the adverse reactions and frequencies observed in treatment and prevention studies involving over 13,000 postmenopausal women along with adverse reactions arising from postmarketing reports. 
Spodnja tabela prikazuje neželene učinke in pogostnosti, ki so jih opazili v študijah zdravljenja in preprečevanja, v katerih je sodelovalo več kot 13.000 postmenopavzalnih žensk, vključno z neželenimi učinki iz poročil v obdobju trženja.
After 3 years therapy raloxifene decreased fibrinogen (6.71 %). 
Po 3 letih terapije z raloksifenom je znižana vrednost fibrinogena (6,71 %).
Raloxifene may affect the development of the baby. 
Raloksifen lahko vpliva na dojenčkov razvoj.
Very common: Vasodilation (hot flushes) 
Zelo pogosti: vazodilatacija (vročinski oblivi)
It does not matter at what time of the day you take your tablet but taking the tablet at the same time each day will help you remember to take it. You may take it with or without food. 
Priporočen odmerek je ena tableta na dan. Ni pomembno, ob katerem času dneva jo vzamete, vendar vam bo jemanje vsak dan ob istem času pomagalo, da se spomnite, da morate vzeti zdravilo.
Raloxifene should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied. 
Raloksifena ne bi smeli uporabljati pri bolnicah, ki kažejo znake ali simptome raka endometrija, saj varnost zdravila pri tej skupini bolnic še ni bila zadosti raziskana.
• Flu syndrome. 
• sindrom gripe
Any uterine bleeding during raloxifene therapy is unexpected and should be fully investigated by a specialist. 
Vsakršna krvavitev iz maternice med terapijo z raloksifenom je nepričakovana in jo mora v celoti raziskati specialist.
• Decrease in the number of the platelets in the blood 
• zmanjšanje števila krvnih ploščic v krvi
Raloxifene 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. 
Uporaba raloksifena je bila povezana z zmanjšano resorpcijo kostnega tkiva in s srednjim pozitivnim premikom ravnotežja kalcija za 60 mg na dan, kar je bilo predvsem posledica zmanjšane izgube kalcija z urinom.
Date of first renewal: 06 February 2015 
Datum pridobitve dovoljenja za promet: 29.04.2010 Datum zadnjega podaljšanja: 06 februar 2015
14 film-coated tablets 28 film-coated tablets 84 film-coated tablets 
filmsko obložena tableta 14 filmsko obloženih tablet 28 filmsko obloženih tablet 84 filmsko obloženih tablet
Effects on prothrombin time may develop over several weeks if raloxifene treatment is started in patients who are already on coumarin anticoagulant therapy. 
Vplivi na protrombinski čas se lahko pokažejo šele čez nekaj tednov, če zdravljenje z raloksifenom uvedemo pri bolnicah, ki so že na kumarinski antikoagulantni terapiji.
Endometrial biopsies taken after six months therapy with raloxifene 60 mg daily demonstrated non-proliferative endometrium in all patients. 
Biopsija endometrija po šestih mesecih terapije z raloksifenom v odmerku 60 mg na dan je pri vseh bolnicah pokazala neproliferativni endometrij.
Store in the original package to protect from moisture. 
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
ii) Bone Mineral Density (BMD): The efficacy of raloxifene once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period. 
ii) Mineralna kostna gostota (BMD): Učinkovitost zdravljenja z raloksifenom enkrat dnevno so ugotavljali pri ženskah po menopavzi, starih do 60 let, z maternico ali brez nje, in sicer med 2-letnim zdravljenjem s tem zdravilom.
Raloxifene Teva could harm your unborn child. 
Zdravilo Raloksifen Teva lahko poškoduje vašega nerojenega otroka.
Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine. 
Obvestite zdravnika, če jemljete holestiramin, ki se uporablja predvsem kot zdravilo za zniževanje koncentracij lipidov v krvi.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov, našteto v poglavju 6.1.
- If you have any unexplained vaginal bleeding. 
- Če imate kakršno koli nerazložljivo krvavitev iz nožnice.
Bone loss is particularly rapid for the first 10 years after menopause when the compensatory increase in bone formation is inadequate to keep up with resorptive losses. 
Izguba kostne mase je še posebej hitra v prvih 10 letih po menopavzi, ko proces kompenzacijskega povečanja tvorbe kostnega tkiva ne zadostuje,