natgillin/translations-raw huggingface dataset:
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) 
Manje često (može se javiti u do 1 na 100 osoba) - vrsta raka kože, kao što je bazocelularni karcinom - upala oka (uveitis) - upala gušterače (pankreatitis) koja izaziva jaku bol u abdomenu
• If improved to Grade 0 or 1 or to baseline levels, then it should be resumed at a reduced dose level. 
• Ako je došlo do poboljšanja na stupanj 0 ili 1 ili na početne vrijednosti, treba nastaviti sa smanjenom razinom doze.
In the pooled Combo 450 population, fatigue occurred in 43.8% (120/274) of patients including Grade 3 in 2.9% (8/274) of patients. 
U ukupnoj populaciji kombinirane terapije 450, umor se javio u 43,8% (120/274) bolesnika, uključujući i stupanj 3 u 2,9% (8/274) bolesnika.
Shellac (E904) Iron oxide black (E172) Propylene glycol (E1520) 
Željezov oksid, crni (E172) Propilenglikol (E1520)
If during treatment LVD occurs, see section 4.2 of binimetinib SmPC. 
Ako se tijekom liječenja pojavi disfunkcija lijeve klijetke (LVD), vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib.
Caution should be exercised if a moderate CYP3A inhibitor is co-administered with encorafenib. 
Nužan je oprez pri istodobnoj primjeni umjereno jakih inhibitora CYP3A s enkorafenibom.
In the pooled encorafenib 300 population, facial paresis was observed in 7.4% (16/217) of patients. 
U ukupnoj populaciji enkorafeniba 300, facijalna pareza se javila u 7,4% (16/217) bolesnika.
Encorafenib dose when used in combination with binimetinib 
Doziranje enkorafeniba kad se primjenjuje u kombinaciji s binimetinibom
Nausea Vomiting* Constipation 
konstipacija mučnina povraćanje*
The embryo-foetal development study in rats indicated that encorafenib induced foetal toxicity with lower foetal weights and delays in skeletal development. 
Ispitivanje embriofetalnog razvoja kod štakora pokazalo je da enkorafenib izaziva toksičnost u fetusa,
Muscle problems: Braftovi, when taken with binimetinib, can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include: - muscle pain, cramps, stiffness or spasm - dark urine 
(rabdomioliza) koje može prouzročiti oštećenje bubrega i može biti opasno po život; znakovi i simptomi mogu uključivati: - bol u mišićima, grčeve, ukočenost ili spazam - tamno obojena mokraća
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. 
Tvrda kapsula (kapsula) ima neprozirnu kapicu boje mesa i neprozirno tijelo bijele boje, sa stiliziranim „A” tiskanim na kapici i „LGX 75mg” na tijelu kapsule.
Rash led to discontinuation in 0.4% (1/274) patients and to dose interruption or dose modification in 1.1% (3/274) of patients. 
Osip je doveo do obustavljanja liječenja u 0,4% (1/274) bolesnika i privremenog prekida ili prilagodbe doze u 1,1%
Uncommon (may affect up to 1 in 100 people) - weakness and paralysis of face muscles - inflammation of the pancreas (pancreatitis) causing severe abdominal pain 
Manje često (može se javiti u do 1 na 100 osoba) - slabost ili paraliza mišića lica
Dose interruption or dose modification occurred in 1.1% (3/274) of patients. 
Do privremenog prekida ili prilagodbe doze došlo je u 1,1% (3/274) bolesnika.
An additional secondary endpoint included PFS of Combo 450 compared with Enco 300. 
Dodatna sekundarna mjera ishoda uključuje preživljenje bez progresije (PFS) u skupini bolesnika liječenih kombiniranom 450 terapijom u usporedbi sa skupinom liječenom enkorafenibom 300.
Concomitant agents that are substrates of UGT1A1 (e.g. raltegravir, atorvastatin, dolutegravir) may have increased exposure and should be therefore administered with caution. 
Lijekovi koji su supstrati UGT1A1 (npr. raltegravir, atorvastatin,
HRa (95% CI) (vs Vem) 
HRa (95 % CI) (naspram vemurafeniba)
Overall response rate, n (%) 
Stopa ukupnog odgovora, n (%) (95 % CI)
Common cuSCC a New Primary Melanoma* 
Često planocelularni karcinom kožea novi primarni melanom*
Side effects when Braftovi and binimetinib are taken together 
Nuspojave pri istodobnoj primjeni lijeka Braftovi i binimetiniba
Encorafenib should be withheld (see monitoring in section 
Treba prekinuti enkorafenib (vidjeti praćenje u dijelu 4.4).
Braftovi 75 mg: Each hard capsule contains 75 mg encorafenib. 
Braftovi 75 mg: Jedna tvrda kapsula sadrži 75 mg enkorafeniba.
Rash led to discontinuation in 0.5% (1/217) of patients and to dose interruption or dose modification in 7.4% (16/217) of patients. 
Osip je doveo do obustavljanja liječenja u 0,5% (1/217) bolesnika i privremenog prekida ili prilagodbe doze u 7,4%
Decreased appetite 
- tamnjenje kože - gubitak apetita
Encorafenib has minor influence on the ability to drive or use machines. 
Enkorafenib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The hard capsule (capsule) has an orange opaque cap and flesh opaque body, with a stylised “A” printed on the cap and “LGX 50mg” printed on the body. 
Tvrda kapsula (kapsula) ima narančastu neprozirnu kapicu i neprozirno tijelo boje mesa, sa stiliziranim „A” tiskanim na kapici i „LGX 50mg” na tijelu kapsule.
Dose interruption or dose modification was reported in 0.4% (1/274) of patients. 
Privremeni prekid ili prilagodba doze zabilježeni su u 0,4% (1/274) bolesnika.
Pancreatitis led to dose interruption or adjustment in (0.4 %) 1/274 of patients. 
Upala gušterače dovela je do potrebe za prilagodbom doze ili obustavom liječenja u (0,4%) 1/274 bolesnika.
Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules 
Braftovi 50 mg tvrde kapsule Braftovi 75 mg tvrde kapsule
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. 
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, anemija je zapažena u 9,7% (25/257) bolesnika sa stupnjem 3 do 4 prijavljenim u 2,7% (7/257) bolesnika.
Braftovi 50 mg: Each hard capsule contains 50 mg encorafenib. 
Braftovi 50 mg: Jedna tvrda kapsula sadrži 50 mg enkorafeniba.
In the 13-week study, partial reversibility was noted at the highest dose level (60 mg/kg/d). 
13-tjednom ispitivanju, djelomična reverzibilnost zabilježena je pri najvišoj razini doze
It is recommended that left ventricular ejection fraction (LVEF) is assessed by echocardiogram or multi-gated acquisition (MUGA) scan before initiation of encorafenib and binimetinib, one month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment. 
Multi-Gated Acquisition) prije uvođenja enkorafeniba i binimetiniba, mjesec dana nakon uvođenja i potom u intervalima na približno svaka tri mjeseca ili češće ukoliko je to klinički indicirano tijekom liječenja.
Simulations of 450 mg encorafenib co-administered with probe substrates for CYP2B6, CYP1A2, CYP2C9, CYP2C19 and CYP2D6 on Day 1 and Day 15 all indicated no clinically relevant interactions are expected. 
Simulacije istodobne primjene 450 mg enkorafeniba sa supstratima za CYP2B6, CYP1A2, CYP2C9, CYP2C19 i
Muscular disorders/Myalgial Pain in extremity Back pain 
Vrlo često artralgija* mijalgijag bol u ekstremitetu bol u leđima artralgija* poremećaji mišićnog sustava/mijalgijal bol u ekstremitetu bol u leđima
RPED has also been reported in patients treated with encorafenib in combination with binimetinib (see section 4.8). 
Odvajanje pigmentnog epitela mrežnice (RPED) također je prijavljeno u bolesnika liječenih enkorafenibom u kombinaciji s binimetinibom (vidjeti dio 4.8).
Encorafenib should be discontinued if more than one recurrence. 
Treba trajno obustaviti enkorafenib ako se pojavi više nastupa produljenja.
Transaminase increased* Blood creatinine increased* Lipase increased 
Često povišenje transaminaza* povišenje kreatinina u krvi* povišenje lipaze povišenje alkalne fosfataze u krvi povišenje kreatinina u krvi* povišenje amilaze povišenje lipaze
Recommended dose modifications for encorafenib (when used in combination with binimetinib) 
Tablica 2: Preporučena prilagodba doze za enkorafenib (kada se primjenjuje u kombinaciji s binimetinibom) za određene nuspojave
In the pooled encorafenib 300 population, cuSCC was reported in 7.4% (16/217) patients. 
U ukupnoj populaciji enkorafenib 300, planocelularni karcinom je prijavljen u 7,4% (16/217) bolesnika.
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 
Vrlo često (može se javiti u više od 1 na 10 osoba): - smanjen broj crvenih krvnih stanica (anemija) - problem sa živcima koji može uzrokovati bol, gubitak osjeta ili trnce u šakama i stopalima - glavobolja - omaglica - krvarenja s raznih mjesta u tijelu - visok krvni tlak - problemi s vidom (poremećaj vida) - bol u trbuhu - proljev
New primary melanoma has been observed in patients treated with BRAF inhibitors including encorafenib (see section 4.8). 
U bolesnika liječenih BRAF inhibitorima, uključujući i enkorafenib, zabilježeni su slučajevi novih primarnih melanoma (vidjeti dio 4.8).
Encorafenib should be used with caution in patients with severe renal impairment (see sections 4.4 and 5.2). 
Bolesnike s teškim oštećenjem bubrežne funkcije treba pomno nadzirati tijekom primjene enkorafeniba (vidjeti dijelove 4.4 i 5.2).
Recommended dose modifications for encorafenib (used in combination with binimetinib) for other adverse reactions Severity of adverse reaction Encorafenib 
Tablica 3: Preporučena prilagodba doze za enkorafenib (kad se primjenjuje u kombinaciji s binimetinibom) za druge nuspojave Težina nuspojave
HRa (95% CI) (vs Vem) Nominal p-value 
HRa (95 % CI) (naspram vemurafeniba) Nominalna p-vrijednost HRa (95 % CI) (naspram vemurafeniba) Nominalna p-vrijednost
Very common 
Često kolitisk
Skin papilloma* Melanocytic nevus 
- neke vrste benignih tumora kože, kao što su melanocitni nevus i papilom kože
Flesh coloured opaque cap and white opaque body, printed with a stylised “A” on the cap and “LGX 75mg” on the body. 
Neprozirna kapica boje mesa i bijelo neprozirno tijelo, sa stiliziranim „A” tiskanim na kapici i „LGX 75mg” na tijelu kapsule.
Effects of encorafenib on other medicinal products CYP substrates 
Učinak enkorafeniba na druge lijekove
Braftovi 50 mg capsules encorafenib 
Braftovi 50 mg kapsule enkorafenib
Pruritus* 
RPED*
Braftovi 75 mg capsules encorafenib 
Braftovi 75 mg kapsule enkorafenib
HRa (95% CI) (vs Vem) p-value (stratified log-rank)b 
HRa (95 % CI) (naspram vemurafeniba) p-vrijednost (stratificirani lograng)b
HR (95% CI) (vs Enco 300) p-value (stratified log-rank) 
HR (95 % CI) (naspram enkorafenib 300) p-vrijednost (stratificirani lograng)
In vitro experiments indicate encorafenib is a relatively potent reversible inhibitor of UGT1A1, CYP2B6, CYP2C9 and CYP3A4/5, as well as a time-dependent inhibitor of CYP3A4. 
UGT1A1, CYP2B6, CYP2C9 i CYP3A4/5, kao i inhibitor CYP3A4 ovisan o vremenu.
Braftovi 50 mg hard capsules 
Braftovi 50 mg tvrde kapsule
Braftovi 75 mg hard capsules 
Braftovi 75 mg tvrde kapsule
Arthritis * 
Često artritis*
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. 
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, RPED je zapažen u 12,5% (32/257) bolesnika s 0,4% (1/257) događaja stupnja 4.
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. 
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, glavobolja se javila u 12,1% (31/257) bolesnika i bila je stupnja 3 u 0,4% (1/257) bolesnika.
HR (95% CI) (vs Vem) p-value (stratified log-rank) 
HR (95 % CI) (naspram vemurafenib) p-vrijednost (stratificirani lograng)
Therefore, female patients using hormonal contraception are advised to use an additional or alternative method such as a barrier method (e.g. condom) during treatment with encorafenib and for at least 1 month following the last dose. 
Stoga se ženama u reproduktivnoj dobi koje koriste hormonsku kontracepciju savjetuje koristiti dodatnu ili alternativnu metodu kao što je metoda barijere
Agents that are CYP3A4 substrates should be co-administered with caution. 
Lijekove koji su supstrati CYP3A4 enzima treba veoma oprezno primjenjivati istodobno s enkorafenibom.
Other secondary efficacy comparisons between Combo 450 and either vemurafenib or Enco 300 included overall survival (OS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR) as assessed by BIRC and by investigator assessment. 
(engl. overall survival, OS), stopu objektivnog odgovora (engl. objective response rate, ORR), trajanje odgovora (engl. duration of response, DoR) i stopu kontrole bolesti (engl. disease control rate, DCR)
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. 
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, mučnina je zapažena kod 27,2% (70/257) bolesnika i bila je stupnja 3 u 1,6% (4/257) bolesnika.
Neuropathy peripheral* Dysgeusia* 
Poremećaji živčanog sustava Vrlo često glavobolja* periferna neuropatija* disgeuzija*
Haemorrhagei Hypertension * 
zatajenje bubrega*
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. 
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, događaji krvarenja zapaženi su u 6,6% (17/257) bolesnika i bili su stupnja 3-4 u 1,6% (4/257) bolesnika.
Tabulated list of adverse reactions 
Tablični sažeti prikaz nuspojava
Metabolism and nutrition disorders 
Poremećaji metabolizma i prehrane Vrlo često smanjeni apetit
This observation was similar to that described in humans as central serous-like chorioretinopathy or central serous retinopathy. 
kao što je središnja serozna korioretinopatija ili središnja serozna retinopatija.
Braftovi 50 mg hard capsules encorafenib 
Braftovi 50 mg tvrde kapsule enkorafenib
The incidences of liver laboratory abnormalities reported in the pooled Combo 450 population are listed below: 
Odstupanja od normalnih vrijednosti pretraga jetrene funkcije Incidencija odstupanja od normalnih vrijednosti pretraga jetrene funkcije u ukupnoj populaciji kombinirane terapije 450 je sljedeća:
Braftovi 75 mg hard capsules encorafenib 
Braftovi 75 mg tvrde kapsule enkorafenib
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) 
Često (može se javiti u do 1 na 10 osoba) - neke vrste tumora kože, kao što su papilom kože i bazocelularni karcinom - alergijska reakcija koja može uključivati oticanje lica i otežano disanje - promjene okusa - upala oka (uveitis) - krvni ugrušci - upala debelog crijeva (kolitis)
Dermatitis acneiform* PPES 
umor* pireksija* periferni edemm
PPES 
PFS
CK elevation and rhabdomyolysis occurred when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
Povišenje kreatin kinaze i rabdomioliza zabilježeni su pri primjeni enkorafeniba u kombinaciji s binimetinibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za binimetinib).
Hypertension was reported when encorafenib was used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
Hipertenzija je prijavljena tijekom primjene enkorafeniba u kombinaciji s binimetinibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za binimetinib).
See section 4. 
Tablicu 3 u dijelu 4.2).
VTE was reported when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
VTE je prijavljena kod primjene enkorafeniba u kombinaciji s binimetinibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za binimetinib).
Haemorrhagic events led to discontinuation of treatment in 1.1% (3/274) of patients. 
Krvarenja koja su dovela do obustavljanja liječenja javila su se u 1,1% (3/274) bolesnika.
Elderly 
Enkorafenib
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. 
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, umor je zapažen u 33,5% (86/257) bolesnika i bio je stupnja 3 i 4 u 1,6% (4/257) bolesnika.
Dermatitis acneiform was reported when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC). 
Akneiformni dermatitis zabilježen je kod primjene enkorafeniba u kombinaciji s binimetinibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za binimetinib).
Venous thromboembolism 
Venska tromboembolija (VTE)
Table 4: 
Tablica 4: Nuspojave
Fertility studies were not conducted with encorafenib. 
Nisu provedena posebna ispitivanja učinka enkorafeniba na plodnost.
Table 1: 
Tablica 5 i slika 1
Liver laboratory abnormalities should be managed with dose interruption, reduction or treatment discontinuation (see section 4.2). 
smanjenjem doze ili trajnom obustavom liječenja (vidjeti dio 4.2).
Liver laboratory abnormality 
- neuobičajeno vaginalno krvarenje
Colitis k 
BRAF-V600E ili K.
If during treatment patient develops RPED or RVO, see section 4.2 of binimetinib SmPC for guidance. 
Ako se uveitis, uključujući i iridociklitis i iritis, javi tijekom liječenja, vidjeti dio 4.2. Ako tijekom liječenja bolesnik razvije RPED ili RVO, za smjernice vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib.
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. 
U ukupnoj populaciji kombinirane terapije 450, facijalna pareza se javila u 0,7% (2/274) bolesnika,
HRa (95% CI) (vs Enco 300) p-value (stratified log-rank)b 
Nominalna p-vrijednost HRa (95 % CI) (naspram enkorafeniba 300) p-vrijednost (stratificirani lograng)b
Neoplasms benign, malignant and unspecified 
Dobroćudne, zloćudne i nespecificirane novotvorine Vrlo često papilomi kože* melanocitni nevusi
Cerebral haemorrhage was reported in 1.5% (4/274) of patients, with fatal outcome in 3 patients. 
Krvarenje u mozgu prijavljeno je u 1,5% (4/274)
If you wish you may take a glass of water with it. 
Ako želite, možete je uzeti s čašom vode.
The recommended dose is one tablet a day. 
Preporučena doza je jedna tableta na dan.
Date of first renewal: 06 February 2015 
Datum prve obnove: 06 veljače 2015
The duration of the treatment in these studies ranged from 6 to 60 months. 
Dužina trajanja liječenja u tim ispitivanjima iznosila je od 6 do 60 mjeseci.
• Flu syndrome. 
• sindrom gripe.
In one of these trials the women had previously undergone hysterectomy. 
jednom od tih istraživanja žene su ranije imale histerektomiju.
The tablet can be taken at any time of the day without regard to meals. 
Tableta se može uzeti u bilo koje doba dana neovisno o obroku.
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. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
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. 
Nije važno u koje doba dana uzimate tabletu, međutim, uzimanje tablete svakoga dana u isto vrijeme može Vam pomoći da ne zaboravite uzeti lijek.
This adverse reaction was most common in the first 6 months of treatment, and seldom occurred de novo after that time. 
Ta nuspojava najčešća je unutar prvih 6 mjeseci terapije i rijetko se događa de novo nakon toga.
Renal insufficiency - Less than 6 % of the total dose is eliminated in urine. 
Insuficijencija bubrega - manje od 6 % ukupne doze eliminira se urinom.
Talk to your doctor or pharmacist before taking Raloxifene Teva: 
Obratite se svom liječniku ili ljekarniku prije nego uzmete Roloksifen Teva:
- 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. 
− Ako ste imali cerebrovaskularni događaj (npr. moždani udar), ili ako Vam je liječnik rekao da imate visok rizik od takvog događaja.
• Swelling of hands, feet and legs (peripheral oedema). 
• otečene ruku, stopala i noge (periferni edem).
Pack sizes of 14, 28 and 84 tablets. 
Veličine pakiranja sa 14, 28 i 84 tablete.
Forty five women with osteoporosis or 15 women with osteoporosis with an existing fracture would need to be treated with raloxifene for 3 years to prevent one or more vertebral fractures. 
Četrdeset i pet žena s osteoporozom ili 15 žena s osteoporozom s postojećim prijelomom morale bi se liječiti raloksifenom tijekom 3 godine da bi se spriječio nastanak jednog ili više prijeloma kralježaka.
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). 
(≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000 do < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
It is important that you continue taking Raloxifene Teva for as long as your doctor prescribes the medicine. 
Važno je da nastavite uzimati Raloksifen Teva onoliko dugo koliko je liječnik propisao lijek.
If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines. 
Ako zbog srca uzimate lijekove koji sadrže digitalis ili antikoagulanse poput varfarina za razrjeđivanje krvi, liječnik će Vam možda trebati prilagoditi doze tih lijekova.
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years. 
U nekim kliničkim istraživanjima davane su dnevne doze do 600 mg tijekom 8 tjedana i 120 mg tijekom 3 godine.
The Cmax of digoxin increased by less than 5 %. 
Cmax digoksina povećan je za manje od 5 %.
Very common: Vasodilation (hot flushes) 
Vrlo često: vazodilatacija (navale vrućine)
Raloxifene Teva could harm your unborn child. 
Raloksifen Teva može naškoditi Vašem nerođenom djetetu.
From the 4 
Od 4. do
- If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness. 
Ako ste neko vrijeme nepokretni, na primjer, ako se koristite invalidskim kolicima, trebate biti primljeni u bolnicu ili trebate ostati u krevetu radi oporavka nakon kirurškog zahvata ili neočekivane bolesti.