natgillin/translations-raw huggingface dataset:
Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis
Občasni pankreatitis (vključno s kroničnim)*, hematemeza, otekanje ustnic*, obstrukcija prebavil (vključno z obstrukcijo tankega črevesa, ileusom)*, neprijeten občutek v trebuhu, razjede v ustih*, enteritis*, gastritis*, krvavitev iz dlesni, gastroezofagealna refluksna bolezen*, kolitis (vključno s kolitisom, povzročenim s clostridium difficile)*, ishemični kolitis
Corneal lesion*, Exophthalmos, Retinitis, Scotoma, Eye disorder (inc. eyelid) NOS, Dacryoadenitis acquired, Photophobia, Photopsia, Optic neuropathy
Redki poškodba roženice*, ekzoftalmus, vnetje mrežnice, skotom, očesne bolezni (vključno z vekami) NOS, pridobljen dakrioadenitis, fotofobija, fotopsija, optična nevropatija
• storage precautions for reconstituted solution • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
• Možna tveganja napak pri uporabi zdravila, vključno z informacijami o prevelikem odmerjanju,
Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Redki hipermagneziemija*, acidoza, motnje ravnovesja elektrolitov*, čezmerno nabiranje tekočine, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, presnovne motnje, pomanjkanje vitaminov B kompleksa, pomanjkanje vitamina B12, protin, zvečan apetit, neprenašanje alkohola
• advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
in s.c. uporabi in, da je treba pri s.c. uporabi menjavati mesta injiciranja.
Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Bortezomib je v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom indiciran za zdravljenje odraslih bolnikov z limfomom plaščnih celic, ki še niso prejemali zdravljenja in pri katerih presaditev krvotvornih matičnih celic ni mogoča.
Immune system disorders Common
Bolezni imunskega sistema
b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Bolniki, ki dosežejo vsaj delni odgovor po 4 ciklih, lahko prejmejo do 6 ciklov zdravljenja.
9/l • Non-haematological toxicities should have resolved to grade 1 or baseline
• Ne-hematološke toksičnosti se morajo povrniti na 1. stopnjo ali na stanje pred začetkom zdravljenja.
Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock)
Pogosti fibrilacija srca (vključno z atrijsko), aritmija*, srčno popuščanje (vključno s popuščanjem levega in desnega prekata)*, ishemija miokarda, moteno delovanje prekatov*
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
deksametazon (40 mg peroralno na 1. do 4. dan in 8. do 11. dan) in talidomid (50 mg na dan peroralno na 1. do 14. dan, povečan odmerek 100 mg na 15. do 28. dan in potem povečan odmerek 200 mg na dan).
Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
b Ocena razmerja tveganja na osnovi Coxovega modela, stratificiranega IPI tveganjem in stopnjo bolezni.
Therefore, caution must be used during handling and preparation.
Bortezomib je citotoksičen, zato je potrebna previdnost med njegovo pripravo in ravnanjem.
> 1.0 x −1.5 x ULN
> 1,0 x - 1,5 x ULN katera koli ni potrebna zmerna
IV on day 1; cyclophosphamide 750 mg/m
750 mg/m ciklofosfamida, 50 mg/m doksorubicina i.v.
Discontinue bortezomib
Druga zdravila in bortezomib
You must read the package leaflets of all medicinal products to be taken in combination with bortezomib for information related to these medicines before starting treatment with bortezomib.
Preden začnete zdravljenje z bortezomibom preberite tudi navodila za uporabo zdravil, ki jih jemljete skupaj z bortezomibom.
Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage
Občasni pljučni embolizem, plevralni izliv, pljučni edem (vključno z akutnim), pljučna alveolarna krvavitev
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; BTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; OR=odds ratio * Primary endpoint a
CI = interval zaupanja; CR = popoln odgovor; nCR = skoraj popoln odgovor; ITT = populacija, ki so jo nameravali zdraviti; RR = stopnja odgovora; BTDx = bortezomib, talidomid, deksametazon; TDx = talidomid, deksametazon; PR = delni odgovor; OR = razmerje verjetnosti; * primarna ocena učinkovitosti a OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja verjetnosti za stratificirane preglednice; p vrednosti Cochran Mantel-Haenszelovega testa.
Peripheral neuropathy in combination regimens Multiple myeloma
Periferna nevropatija pri kombiniranem zdravljenju Diseminirani plazmocitom
SN:
LDH.
Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Občasni duševne motnje*, halucinacije*, psihotične motnje*, zmedenost*, nemir
Then, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m to
Nato lahko ponovno uvedete bortezomib v odmerku, ki je eno stopnjo manjši od prejšnjega (z 1,3 mg/m na 1 mg/m ali z 1 mg/m na
• If platelet counts ≤ 30 x 10
• Število trombocitov mora biti ≥ 70 x 10
Cycles 1 to 4
B+Dx cikel 1 do 4
• dosing instructions and examples: how to calculate the body surface area of a patient and the
• Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega bortezomiba (za i.v.
Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Redki rabdiomioliza, sindrom temporomandibularnega sklepa, fistula, izliv v sklep, bolečina v čeljusti, bolezni kosti, okužbe in vnetja mišično-skeletnega sistema in vezivnega tkiva*, sinovialna cista
Any
Ali
• that bortezomib is to be given only by IV or SC injections; no other route of administration is allowed
ali s.c., nobena druga pot uporabe ni dovoljena.
No new safety concerns were observed when bortezomib was added to the standard pediatric pre B cell ALL chemotherapy backbone.
Pri dodatku bortezomiba standardni pediatrični pre B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
It is recommended that patients receive 2 cycles of bortezomib following a confirmation of a complete response.
Priporočamo, da bolniki po potrjenem popolnem odgovoru prejmejo še 2 cikla zdravljenja z bortezomibom.
Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline).
• Shingles (localised including around the eyes or spread across the body)
• pasasti izpuščaj (herpes zoster (lokaliziran, vključno s področjem okoli oči, ali razširjen po telesu))
When bortezomib is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration.
Pri sočasni uporabi bortezomiba z drugimi zdravili glejte Povzetke glavnih značilnosti teh zdravil za navodila za odmerjanje.
Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Bortezomib je v kombinaciji z melfalanom in prednizonom indiciran za zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih pred presaditvijo krvotvornih matičnih celic kemoterapija v velikih odmerkih ni primerna.
Adverse reaction hypotension
Občasni anafilaktična reakcija
Hazard ratio b
14,0 mesecev razmerje tveganja b
Therefore, caution should be used during handling and preparation of bortezomib.
Opozorilo: Bortezomib je citotoksično zdravilo, zato je med pripravo in ravnanjem z njim potrebna previdnost.
Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction,
Občasni krvavitev iz nožnice, bolečina v spolovilih*, erektilna disfunkcija
Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Bortezomib je v kombinaciji z deksametazonom ali deksametazonom in talidomidom indiciran za indukcijsko zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih.
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Pojavnost periferne nevropatije pri kombiniranem zdravljenju v študiji LYM-3002 z bortezomibom, skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BR-CAP), je navedena v spodnji preglednici:
In cycles 1-4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
V ciklih 1-4 se bortezomib daje dvakrat na teden, na 1., 4., 8., 11., 22., 25., 29. in 32. dan, v ciklih 5-9 pa enkrat na teden, na 1., 8., 22. in 29. dan.
Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Bortezomib je indiciran za zdravljenje napredujočega diseminiranega plazmocitoma v monoterapiji ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali z deksametazonom pri odraslih bolnikih, ki so prejeli najmanj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev pri njih ni mogoča.
The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following singleor repeated-dose intravenous administration of 1.0 mg/m or 1.3 mg/m to patients with multiple myeloma.
Porazdelitev Po enkratnem ali večkratnem intravenskem dajanju odmerkov 1,0 mg/m2 ali 1,3 mg/m2 bolnikom z diseminiranim plazmocitomom je bil povprečni volumen porazdelitve (Vd) 1,659 l do 3,294 l. To nakazuje, da se bortezomib v veliki meri porazdeljuje v periferna tkiva.
Bortezomib powder has to be dissolved before administration.
Bortezomib je v obliki praška, ki ga je potrebno raztopiti pred injiciranjem.
Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib treatment cycle.
Deksametazon boste jemali peroralno v odmerku 40 mg na 1., 2., 3., 4., 8., 9., 10. in 11. dan 28- dnevnega cikla zdravljenja z bortezomibom.
Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors e
Razmerje tveganja manjše kot 1 kaže prednost zdravljenja z VMP. c Nominalna p-vrednost na osnovi stratificiranega log-rank testa, prilagojena na osnovi stratifikacijskih dejavnikov: β2-micikllobulin, albumin in regija.
Progression-free survival Events n (%)
Preživetje brez napredovanja bolezni dogodki n (%) mediana a
43.1 mo
< 0,001a
• In cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and
- V ciklih 1 do 4 se bortezomib daje dvakrat na teden,1., 4., 8., 11., 22., 25., 29. in 32. dan. - V ciklih 5 do 9 pa enkrat na teden, 1., 8., 22. in 29. dan.
CR+nCR+PR % (95% CI)
*RR (po presaditvi) CR+nCR CR+nCR+PR % (95% CI)
BR-CAP group compared with 18 months in the R-CHOP group.
Mediana trajanja popolnega odgovora je bila 42,1 meseca v skupini BR-CAP in 18 mesecev v skupini R-CHOP.
Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE.
Zdravilo Bortezomib Fresenius Kabi 3,5 mg prašek za raztopino za injiciranje je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
(95% CI)=0.63
(95 % CI) = 0,63 p-vrednost d mediana c(95 % CI) (meseci)
Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is for intravenous or subcutaneous use.
Zdravilo Bortezomib Fresenius Kabi 3,5 mg prašek za raztopino za injiciranje je za intravensko ali subkutano uporabo.
In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Pri vseh bolnikih, kot tudi pri bolnikih, ki so pred tem že prejeli eno vrsto terapije, je študija faze III zdravljenja z bortezomibom vodila do statistično značilno daljšega časa do napredovanja bolezni, statistično značilno podaljšanega preživetja in statistično značilno boljšega odziva na zdravljenje v primerjavi z zdravljenjem z deksametazonom (glejte preglednico 14).
Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy
Psihiatrične motnje Pogosti motnje spanja* Bolezni živčevja Zelo pogosti periferna senzorična nevropatija, disestezija *, nevralgija* Pogosti nevropatije*, motorična nevropatija*, izguba zavesti (vključno s sinkopo), encefalopatija*, periferna senzorična in motorična nevropatija, omotica*, disgevzija*, avtonomna nevropatija
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
(9 mg/m2) in prednizonom (60 mg/m2) prispeva k podaljšanju časa do napredovanja bolezni (Time To Progression-TTP) v primerjavi z zdravljenjem samo z melfalanom (9 mg/m2) in prednizonom
• need to handling the medicinal product in sterile setting
• Med ravnanjem z zdravilom je treba ves čas strogo upoštevati aseptično pripravo.
Neuropathic pain and/or peripheral neuropathy
periferna motorična nevropatija in periferna senzomotorična nevropatija.
Muscle spasms*, Pain in extremity, Muscular weakness
Zelo pogosti mišično-skeletna bolečina* Pogosti mišični krči*, bolečine v udih, mišična šibkost
Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
e Populacijo, pri kateri je prišlo do odziva, predstavljajo bolniki, pri katerih so lahko ovrednotili bolezen pred začetkom zdravljenja.
Reduce bortezomib to 1.0 mg/m or
Po intravenski aplikaciji bolusnega odmerka 1,0 mg/m in 1,3 mg/m
Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention
Zelo pogosti zmanjšan apetit Pogosti hipokalemija*, nenormalne koncentracije glukoze v krvi *, hiponatriemija *, sladkorna bolezen*, zastajanje tekočine
Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Najpogostejši neželeni učinki (vseh stopenj), ki so se pojavili pri najmanj 25 % bolnikov so bili trombocitopenija (55 %), nevropatija (40 %), anemija (37 %), diareja (35 %) in zaprtje (28 %).
T 200 mg a
T 200 mg a na dan na dan na dan na dan
• Infection of the outermost layer of the eye and the inner surface of the eyelids
• okužba veznice očesa in vek (konjuktivitis)
a p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm. b 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib c
a p-vrednost podpira hipotezo, da SC krak zadrži najmanj 60 % stopnje odziva IV kraka zdravljenja.
B=bortezomib; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
V 3. tednu 1. cikla se lahko odmerek talidomida poveča na 100 mg samo, če bolnik dobro prenaša odmerek 50 mg in na 200 mg v 2. ciklu, če bolnik dobro prenaša odmerek 100 mg.
Very common Hair disorder* Common
Pogosti okvara ledvic*
Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Za ugotavljanje učinkovitosti in varnosti ponovnega zdravljenja z bortezomibom so izvedli odprto, enokračno, študijo faze II MMY-2036 (RETRIEVE) pri stotrideset bolnikih (starih ≥ 18 let) z diseminiranim plazmocitomom.
Table 7 has been generated using Version 14.1 of the MedDRA. Post-marketing adverse reactions not seen in clinical trials are also included.
Preglednica 7 je pripravljena po klasifikaciji MedDRA, različica 14.1.
Table 4: Posology for bortezomib combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Preglednica 4: Odmerjanje kombiniranega zdravljenja z bortezomibom pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih je presaditev krvotvornih matičnih celic primerna.
-- -- -- -- rest period
-- -- -- -- pre mor
Antiviral prophylaxis was administered to 26% of the patients in the B+M+P arm.
B+M+P kraku študije je protivirusna zdravila prejelo 26 % bolnikov.
Patients in the BR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days
Bolniki v skupini BR-CAP so prejeli bortezomib (1,3 mg/m na
Psychiatric disorders
Bolezni jeter
Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 28-day treatment cycle.
Priporočeni odmerek je 1,3 mg/m telesne površine, dvakrat na teden dva tedna, na dan 1, 4, 8 in 11 v 28 dnevnem ciklu zdravljenja.
Bortezomib may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Uporaba tega zdravila je lahko povezana z utrujenostjo (zelo pogosto), omotico (pogosto), sinkopami (občasno) in ortostatsko oz. posturalno hipotenzijo ali zamegljenim vidom (pogosto), zato morajo biti bolniki pri vožnji ali upravljanju strojev previdni.
• volume of reconstituted bortezomib (both IV and SC use) required for different body surface areas (cross reference to Dosing Slide Rule)
in s.c. uporabo) glede na različne telesne površine (v povezavi z navodili za odmerjanje).
Gastrointestinal disorders Very common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Zelo pogosti bolezni las* Pogosti srbenje*, dermatitis*, izpuščaj*
Grade of hepatic impairment*
Pogosti okužba sečil *
Consider dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m in subsequent cycles based on patient tolerability.
Na osnovi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja a odmerka na 1,0 mg/m ali zmanjšanja odmerka na 0,5 mg/m
Renal impairment*
Pogosti vrtoglavica*
visual loss or disturbances and shortness of breath
omedlevica - težave s kašljem in dihanjem ali tiščanje v prsih
Six bortezomib cycles are recommended, although for patients with a response first documented at cycle 6, two additional bortezomib cycles may be given.
Priporočamo, da bolniki, ki dosežejo odgovor šele v 6. ciklu, prejmejo dva dodatna cikla zdravljenja.
Nervous system disorders Very common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Redki samomorilne misli*, motnje prilagajanja, delirij, zmanjšan libido Bolezni živčevja Zelo pogosti nevropatije*, periferna senzorična nevropatija, disestezija*, nevralgija*
Reduce bortezomib to 0.7 mg/m in the first treatment cycle.
Pri bolnikih z zmerno ali hudo jetrno okvaro je treba zdravljenje uvesti z manjšim odmerkom bortezomiba 0,7 mg/m na injekcijo v prvem ciklu zdravljenja.
* VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
* VN.U: vironevtralizirajoči titer protiteles po injiciranju cepiva pri morskih prašičkih.
Packaging Content Package Size
Pakiranje Vsebina Velikost pakiranja
Target Species Route of administration
Ciljna živalska vrsta
Withdrawal period
Način uporabe
EU/2/99/017/001 Bovalto Ibraxion gE deleted inactivated IBR virus, at least 0.75
5 odmerkov 10 ml steklenička
- If you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
- če ste kdaj imeli tuberkulozo ali če ste bili v tesnem stiku s kom, ki je imel ali ima tuberkulozo.
Postmarketing Studies
Postmarketinške študije
Folate supplementation was optional and only used in 10 % of patients.
Dodajanje folata je bilo fakultativno in uporabljeno le pri 10 % bolnikov.
Excretion data from the 14C study indicated that at least about 82 to 95 % of the dose is absorbed.
Podatki o ekskreciji iz študije 14C so pokazali, da se absorbira vsaj 82 do 95 % odmerka.
If this happens to you, do not drive or use machines.
Čese vam to zgodi, ne vozite oziroma ne upravljajte s stroji.
Repso tablets can be taken with or without food.
Tablete zdravila Repso lahko vzamete z ali brez hrane.
Children and adolescents Repso is not recommended for use in children and adolescents below 18 years of age.
Otroci in mladostniki Uporaba zdravila Repso ni priporočljiva pri otrocih in mladostnikih, ki so mlajši od 18 let.
Pharmacokinetic data in elderly people (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Farmakokinetični podatki pri starejših (> 65 let) so omejeni, vendar skladni s farmakokinetiko pri mlajših odraslih.
NSAIDs/Corticosteroids
NSAIDs/kortikosteroidi
For washout procedures and other recommended actions in case of desired or unintended pregnancy see section 4.6.
Za postopke izpiranja in druge priporočene ukrepe v primeru načrtovane ali nenačrtovane nosečnosti glejte poglavje 4.6.
Frequency groupings are defined according to the following convention: 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).
Skupine pogostnosti so opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
- If you are woman of child-bearing age and not using effective contraception.
- če ste ženska v rodni dobi in ne uporabljate učinkovite kontracepcije.