natgillin/translations-raw huggingface dataset:
Paediatric patients weighing 75 kg or more should be administered ORENCIA following the adult dosing regimen, not to exceed a maximum dose of 1,000 mg.
Pri pediatričnih bolnikih s telesno maso 75 kg ali večjo je treba upoštevati režim odmerjanja zdravila ORENCIA za odrasle, vendar pa odmerek ne sme preseči največjega odmerka, to je 1.000 mg.
Paediatric patients with body weight at least 32.6 kg, should be administered 10 ml (0.5 mg) of the oral solution or one 0.5 mg tablet once daily.
Pediatrični bolniki s telesno maso vsaj 32,6 kg morajo jemati 10 ml (0,5 mg) peroralne raztopine ali eno 0,5 mg tableto enkrat na dan.
Paediatric patients with chronic renal failure Correction Phase
Pediatrični bolniki s kronično odpovedjo ledvic Obdobje korekcije
Paediatric patients with juvenile idiopathic arthritis.
Otroci z juvenilnim idiopatskim artritisom
Paediatric patients with plaque psoriasis
Otroci s psoriazo v plakih
Paediatric patients with the complete deletion/large rearrangement genotype have a high probability of developing antibodies, including neutralizing antibodies, in response to exposure to idursulfase.
Pri pediatričnih bolnikih z genotipom s popolno delecijo/obsežno preureditvijo je velika verjetnost, da bodo kot odziv na izpostavljenost idursulfazi razvili protitelesa, vključno z nevtralizirajočimi protitelesi.
Paediatric patients with very low initial haemoglobin (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than patients whose initial haemoglobin is higher (> 6.8 g/dl or > 4.25 mmol/l).
Pediatrični bolniki z zelo majhno začetno koncentracijo hemoglobina (< 6,8 g/dl ali < 4,25 mmol/l) lahko potrebujejo večje vzdrževalne odmerke kot bolniki z večjo začetno koncentracijo hemoglobina (> 6,8 g/dl ali > 4,25 mmol/l).
Paediatric patients:
Otroci:
Paediatric patients:
Pediatrična populacija
Paediatric Patients:
Pediatrični bolniki:
Paediatric patients: In children and adolescents, neuro-psychological retardation can be observed during mitotane treatment.
Pediatrični bolniki: Pri otrocih in mladostnikih lahko v času zdravljenja z mitotanom opazimo nevro- psihološko nazadovanje.
Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, non- randomised phase III trial, and were treated with Glivec (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Pediatrični bolniki: V odprto, nerandomizirano, multicentrično preizkušanje faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do 22 let) s Ph+ ALL in jih zdravili z zdravilom Glivec (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, non- randomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy. imatinib was administered intermittently in cohorts
Pediatrični bolniki: V odprto, nerandomizirano, multicentrično študijo faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do 22 let) s Ph+ ALL in jih zdravili z imatinibom (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
Paediatric patients: In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, non-randomized phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
Pediatrični bolniki: V odprto, nerandomizirano, multicentrično preizkušanje faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do 22 let) s Ph+ ALL in jih zdravili z imatinibom (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
Paediatric patients: Pylobactell is not recommended for use in children and adolescents below the age of 18 years due to insufficient data on efficacy.
Pediatrični bolniki: Zaradi nezadostnih podatkov o učinkovitosti uporaba testa Pylobactell pri otrocih in mladostnikih pod 18 let ni priporočljiva
Paediatric patients: sJIA Patients
Pediatrični bolniki Bolniki s sJIA
Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children with PAH aged from 1 year to 15 years were on average lower than in adult patients and were not increased by increasing the dose of STAYVEER above 2 mg/kg body weight or by increasing the dosing frequency from twice daily to three times daily (see section 5.2).
Podatki pediatrične farmakokinetike so pokazali, da so bile povprečne koncentracije bosentana v plazmi pri otrocih s PAH, starih od 1 do 15 let, nižje kot pri odraslih bolnikih in da se z zvišanjem odmerka zdravila STAYVEER nad 2 mg/kg telesne mase ali s povečanjem pogostnosti odmerjanja z dvakrat dnevno na trikrat dnevno niso zvečale (glejte poglavje 5.2).
Paediatric pharmacokinetic data have shown that bosentan plasma concentrations in children with PAH aged from 1 year to 15 years were on average lower than in adult patients and were not increased by increasing the dose of Tracleer above 2 mg/kg body weight or by increasing the dosing frequency from twice daily to three times daily (see section 5.2).
Podatki pediatrične farmakokinetike so pokazali, da so bile povprečne koncentracije bosentana v plazmi pri otrocih s PAH, starih od 1 do 15 let, nižje kot pri odraslih bolnikih in da se z zvišanjem odmerka zdravila Tracleer nad 2 mg/kg telesne mase ali s povečanjem pogostnosti odmerjanja z dvakrat dnevno na trikrat dnevno niso zvečale (glejte poglavje 5.2).
Paediatric plaque psoriasis
Luskavica (psoriaza) v plakih pri pediatričnih bolnikih
Paediatric plaque psoriasis (12 years and older)
Pediatrični bolniki s psoriazo s plaki (stari 12 let in več)
Paediatric Plaque Psoriasis Outcomes at 12 Weeks
Rezultati po 12 tednih pri otrocih s psoriazo v plakih
Paediatric PNH and aHUS patients with body weight ≥ 40kg are treated with the adult dosing recommendations, respectively.
Pediatrične bolnike s PNH in z aHUS s telesno maso ≥ 40 kg zdravimo po priporočilih za odmerjanje za zdravljenje odraslih.
Paediatric population
Absorbcija
Paediatric population
IZ = interval zaupanja Pediatrična populacija
Paediatric population
Mladostniki
Paediatric population
Občasni: splošno slabo počutje Pediatrična populacija
Paediatric population
Pediatrija
Paediatric population
Pediatričn a populacija
Paediatric population
Pediatrična piopulacija
Paediatric population
Pediatrična polulacija
Paediatric population
Pediatrična populacija kontrolna skupina
Paediatric population
Pediatrična populacija s hemofilijo A
Paediatric population
Pediatrična populacija:
Paediatric population
Pediatrična uporaba
Paediatric population
Pediatrični bolniki)
Paediatric population
Pediatrični populacija
Paediatric population
Populacije, ki niso bile preučevane
Paediatric population
Preobčutljivost za lateks
Paediatric population
Preveliko odmerjanje
Paediatric population
Uporaba pri otrocih
Paediatric population ( pVTEp orthopaedic surgery)
Pediatrična populacija (pVTEp pri ortopedski operaciji)
Paediatric population (0 to 17 years)
Pediatrična populacija (0-17 let)
Paediatric population (12 to 17 years old)
Otroci (stari 12 do 17 let)
Paediatric population (2 months to <18 years of age)
Pediatrična populacija (2 meseca do < 18 let starosti)
Paediatric population (2 years of age and above)
Pediatrična populacija (od 2. leta dalje)
Paediatric population (2 years of age and above)
Pediatrična populacija(od 2. leta dalje)
Paediatric population (6 to 17 years of age)
Pediatrična populacija (od 6 do 17 let)
Paediatric population (6 years to less than 18 years of age)
Pediatrična populacija (6 let do 18 let)
Paediatric population (6 years to less than 18 years of age)
Pediatrična populacija (od 6 let do manj kot 18 let)
Paediatric population (6 years to less than 18 years of age)
Pediatrična populacija (od 6 let do manjk kot 18 let)
Paediatric population (< 18 years old)
Pediatrična populacija (< 18 let)
Paediatric population (age below 18 years)
Pediatrična populacija (bolniki stari manj kot 18 let)
Paediatric population (age below 18 years)
Pediatrična populacija (mlajši od 18 let)
Paediatric population (age below 18 years)
Pediatrična populacija (starost do 18 let)
Paediatric population (aged 1 to 17 years)
Pediatrična populacija (v starosti od 1 leta do 17 let)
Paediatric population (aged 6 years and above) – recommended dosage escalation and maintenance regimen
Pediatrična populacija (starost 6 let in več) – priporočeni režim stopnjevanja odmerka in vzdrževalnega odmerka
Paediatric population (aged 6 years and above) – recommended down-titration schedule
Pediatrična populaciija (starost 6 let in več) – priporočeni režim zmanjševanja odmerka
Paediatric population (below 2 years of age)
Pediatrična populacija (starost manj kot 2 leti)
Paediatric population (bitherapy only) – Dose to be administered
Pediatrična populacija (samo dvojna terapija) – odmerek za injiciranje
Paediatric population (DVT/PE prevention)
Pediatrična populacija (preprečevanje GVT/PE)
Paediatric population (DVT/PE treatment)
Pediatrična populacija (zdravljenje GVT/PE)
Paediatric population (infants less than one year of age)
Pediatrična populacija (dojenčki, mlajši od enega leta)
Paediatric population (less than 6 years of age)
Pediatrična populacija (do 6 let)
Paediatric population (less than 6 years of age)
Pediatrična populacija (mlajši do 6 let)
Paediatric population (pVTEp orthopaedic surgery)
Pediatrična populacija (pVTEp pri ortopedski operaciji)
Paediatric population (see section 4.2 and section 5.1)
Pediatrični bolniki (glejte poglavji 4.2 in 5.1)
Paediatric population (see section 4.2 and section 5.2)
Pediatrična populacija
Paediatric population (see section 4.2 and section 5.2)
Pediatrična populacija (glejte poglavji 4.2 in 5.2)
Paediatric population (see section 4.2 and section 5.2)
Pediatrični bolniki (glejte poglavji 4.2 in 5.2)
Paediatric population (see sections 4.2 and 5.1)
Pediatrična populacija (glejte poglavji 4.2 in 5.1)
Paediatric population (SPAF)
Pediatrična populacija (SPAF)
Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy
Otroci - Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba fondaparinuksa pri otrocih, mlajših od 17 let, ni priporočljiva.
Paediatric population <2 years
Pediatrična populacija, mlajša od 2 let
Paediatric population aged 1 to 5 years
Pediatričn bolniki stari od 1 do 5 let)
Paediatric population aged 1 to 5 years
Pediatrični bolniki, stari od 1 do 5 let
Paediatric population aged 2 to 18 years
Pediatrični bolniki stari od 2 do 18 let
Paediatric population aged 4 years or older and adults (including elderly)
Pediatrični bolniki, stari 4 leta ali več, in odrasli (vključno s starejšimi bolniki)
Paediatric population and young adults with open epiphyses
Pediatrična populacija in mladi odrasli z odprtimi epifizami
Paediatric population between 1 and less than 4 years of age
Pediatrična populacija, stara od 1 do manj kot 4 let
Paediatric population See section 4.2
Pediatrična populacija (glejte poglavje 4.2).
Paediatric population sJIA Patients Clinical efficacy
Pediatrična populacija Bolniki s sJIA Klinična učinkovitost
Paediatric population with chronic renal failure on haemodialysis
Pediatrična populacija s kronično ledvično odpovedjo, ki se zdravi s hemodializo
Paediatric population – children aged <3 years
Pediatrična populacija – otroci, mlajši od 3 let
Paediatric population – children and adolescents aged 3 years and older
Pediatrična populacija – otroci in mladostniki, stari 3 leta ali več
Paediatric population(see section 4.2 and section 5.2)
Pediatrična populacija (glejte poglavji 4.2 in 5.2)
Paediatric population.
Pediatrična populacija
Paediatric population:
Pediatrična populacija
Paediatric population: AZILECT is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
Pediatrična populacija: Uporaba zdravila AZILECT pri otrocih in mladostnikih ni priporočljiva zaradi nezadostnih podatkov o varnosti in učinkovitosti.
Paediatric population: Bosulif has not yet been studied in children less than 18 years of age.
Pediatrična populacija: Zdravila Bosulif še niso raziskovali pri otrocih, mlajših od 18 let.
Paediatric population: CoAprovel is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Pediatrična populacija: varnost in učinkovitost zdravila CoAprovel nista bili dokazani, zato uporaba pri otrocih in mladostnikih ni priporočljiva.
Paediatric population: Irbesartan Hydrochlorothiazide Zentiva is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Pediatrična populacija: varnost in učinkovitost zdravila Irbesartan Hydrochlorothiazide Zentiva nista bili dokazani, zato uporaba pri otrocih in mladostnikih ni priporočljiva.
Paediatric population: Karvezide is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Pediatrična populacija: varnost in učinkovitost zdravila Karvezide nista bili dokazani, zato uporaba pri otrocih in mladostnikih ni priporočljiva.
Paediatric population: No pharmacokinetic data are available in paediatric patients.
Pediatrična populacija: Farmakokinetičnih podatkov za pediatrične bolnike ni.
Paediatric population: Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Pediatrična populacija: Farmakokinetike in farmakodinamike prasugrela v pediatrični populaciji niso preučevali (glejte poglavje 4.2).
Paediatric population: Rasagiline ratiopharm is not recommended for use in children and adolescents due to lack of data on safety and efficacy.
Pediatrična populacija: Uporaba zdravila Razagilin ratiopharm pri otrocih in mladostnikih ni priporočljiva zaradi nezadostnih podatkov o varnosti in učinkovitosti.
Paediatric population: Resolor should not be used in children and adolescents younger than 18 years (see section 5.1)
Pediatrična populacija: zdravilo Resolor se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let (glejte poglavje 5.1).
Paediatric population: Study 189 is an ongoing study of the efficacy and safety of entecavir among 180 nucleoside-treatment-naïve children and adolescents from 2 to < 18 years of age with HBeAg- positive chronic hepatitis B infection, compensated liver disease, and elevated ALT.
Pediatrična populacija: Študija 189, ki še poteka, je študija učinkovitosti in varnosti entekavirja pri 180 z nukleozidi predhodno še nezdravljenimi otroci in mladostniki, starimi od 2 do < 18 let, s HBeAg pozitivno kronično okužbo z virusom hepatitisa B, kompenzirano boleznijo jeter in povečano vrednostjo ALT.
Paediatric Population: The pharmacokinetics of cinacalcet have been studied in 12 paediatric patients (6-17 years) with CKD receiving dialysis following a single, oral, 15 mg dose.
Pediatrična populacija: Farmakokinetiko cinakalceta po enem peroralnem odmerku 15 mg so raziskali pri 12 pediatričnih bolnikih (starih 6-17 let) s kronično boleznijo ledvic, zdravljenih z dializo.
Paediatric population: the pharmacokinetics of maraviroc in paediatric patients have not been established (see section 4.2).
Pediatrična populacija: Farmakokinetika maraviroka pri pediatričnih bolnikih ni ugotovljena (glejte poglavje 4.2).
Paediatric population: The recommended dose of Emtriva 10 mg/ml oral solution is 6 mg/kg up to a maximum of 240 mg (24 ml) once daily.
Pediatrična populacija: Priporočeni odmerek peroralne raztopine Emtriva 10 mg/ml je 6 mg/kg do maksimalno 240 mg (24 ml) enkrat dnevno.
Paediatric population: the safety and efficacy of Aprovel in children aged 0 to 18 has not been established.
Pediatrična populacija: varnost in učinkovitost zdravila Aprovel pri otrocih, starih od 0 do 18 let, nista bili dokazani.
Paediatric population: The safety and efficacy of AVONEX in adolescents aged 12 to 16 years have not yet been established.
Pediatrična populacija: Varnost in učinkovitost zdravila AVONEX pri otrocih, starih od 12 do 16 let, še nista bili ugotovljeni.
Paediatric population: The safety and efficacy of erlotinib in patients under the age of 18 years has not been established.
Pediatrična populacija: varnost in učinkovitost erlotiniba pri otrocih, mlajših od 18 let, še nista bili dokazani.
Paediatric population: the safety and efficacy of Irbesartan Zentiva in children aged 0 to 18 has not been established.
Pediatrična populacija: varnost in učinkovitost zdravila Irbesartan Zentiva pri otrocih, starih od 0 do 18 let, nista bili dokazani.
Paediatric population: the safety and efficacy of Karvea in children aged 0 to 18 has not been established.
Pediatrična populacija: varnost in učinkovitost zdravila Karvea pri otrocih, starih od 0 do 18 let, nista bili dokazani.
Paediatric population: The safety and efficacy of Truvada in children under the age of 18 years have not yet been established (see section 5.2).
Pediatrična populacija: Varnost in učinkovitost zdravila Truvada pri otrocih, mlajših od 18 let, še nista bili dokazani (glejte poglavje 5.2).
Paediatric population: There have been no specific studies in paediatric patients.
Pediatrična populacija: Specifičnih študij pri otrocih niso izvedli.
Paediatric population: There is no relevant use of Exelon in the paediatric population in the treatment of Alzheimer’s disease.
Pediatrična populacija: Zdravilo Exelon ni primerno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
Paediatric population: There is no relevant use of Prometax in the paediatric population in the treatment of Alzheimer’s disease.
Pediatrična populacija: Zdravilo Prometax ni primerno za uporabo pri pediatrični populaciji za zdravljenje Alzheimerjeve bolezni.
Paediatric population: There is no relevant use of Rivastigmine 3M Health Care Ltd. in the paediatric population in the treatment of Alzheimer’s disease.
Pediatrična populacija: Zdravila Rivastigmin 3M Health Care Ltd. ni smiselno uporabljati za zdravljenje Alzheimerjeve bolezni pri pediatrični populaciji.
Paediatric population<12 years of age
Pediatrična populacija starosti < 12 let
Paediatric Psoriasis Dose
Odmerek pri pediatričnih bolnikih s psoriazo
Paediatric psoriasis study (CADMUS)
Študija pediatrične psoriaze (CADMUS)
Paediatric SCN patients
Pediatrični bolniki s hudo kronično nevtropenijo
Paediatric studies
Študije pri otrocih
Paediatric trials with REYATAZ capsules
Preskušanja, izvedena z zdravilom REYATAZ v obliki kapsul pri pediatrični populaciji
Paediatric Ulcerative colitis
Pediatrični ulcerozni kolitis
Paediatric use
Uporaba pri otrocih
Paediatric use
Uporaba pri otrocih in mladostnikih
Paediatric Use: Safety and effectiveness in paediatric patients have not been established.
Uporaba v pediatriji: Varnosti in učinkovitosti uporabe pri pediatričnih bolnikih niso ugotavljali.
Paediatric use: There is no experience in children with CML below 2 years of age (see section 5.1).
Pediatrična uporaba: Izkušenj pri otrocih s KML, mlajših od 2 let, ni (glejte poglavje 5.1).
Paediatric use: There is no experience in children with CML below 2 years of age (see section 5.1).
Uporaba v pediatriji: Izkušenj pri otrocih s KML, mlajših od 2 let, ni (glejte poglavje 5.1).
Paediatric uveitis
Uveitis pri pediatričnih bolnikih
Paediatric:
Otroci:
Paediatrics
Pediatrična populacija
Paediatrics and older people (65 years age and above)
Otroci in starejši ljudje (stari 65 let ali več)
PAES: In order to further confirm the efficacy of olaparib in patients with platinum sensitive relapsed BRCA mutated high grade serous ovarian cancer, the MAH should submit the results of study D0816C00002, a phase III randomised double-blind
PAES: Za dodatno potrditev učinkovitosti olapariba pri bolnicah z recidivom na platino občutljivega slabo diferenciranega seroznega raka jajčnikov in mutacijo gena BRCA, mora imetnik dovoljenja za promet predložiti rezultate študije D0816C00002, randomizirane dvojno slepe, s placebom kontrolirane multicentrične študije III. faze.
PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed somatic BRCA mutated high grade serous ovarian cancer, the MAH should conduct and submit the results of a phase IV, open label, single arm, non- randomised, multicentre study in patients with relapsed platinum sensitive ovarian cancer who are in complete or partial response following platinum based chemotherapy and who carry loss of function germline or somatic BRCA mutation(s).
PAES: Za dodatno potrditev učinkovitosti olapariba pri bolnicah z recidivom na platino občutljivega slabo diferenciranega seroznega raka jajčnikov in mutacijo gena BRCA, mora imetnik dovoljenja izvesti in predložiti rezultate odprte, nerandomizirane multicentrične študije IV. faze z eno skupino pri bolnicah z recidivom na platino občutljivega raka jajčnikov, ki so po kemoterapiji na osnovi platine v popolnem ali delnem odzivu in so nosilke izgube funkcije ene ali več mutacij gena BRCA germinalno ali somatsko.
PAES: In order to further define the long term efficacy of olaparib in patients with platinum sensitive relapsed BRCA mutated high grade serous ovarian cancer, the MAH should submit the final Overall Survival (OS) analysis of study D0810C00019, a phase II randomised, double blind, multicentre study.
Študija učinkovitosti po izdaji dovoljenje za promet (PAES): Za dodatno opredelitev dolgoročne učinkovitosti olapariba pri bolnicah z recidivom na platino občutljivega slabo diferenciranega seroznega raka jajčnikov in mutacijo gena BRCA, mora imetnik dovoljenja za promet predložiti končno analizo celokupnega preživetja v študiji D0810C00019, randomizirani dvojno slepi multicentrični študiji II. faze.
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Stran 5 (znotraj desno) Stran 6 (hrbtna stran)
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Page of barcode labels and sticker
List z etiketami s črtno kodo in nalepko
Page of labels and sticker
List z etiketami in nalepko
PAGE OF LABELS AND STICKERS
STRAN Z ETIKETAMI IN NALEPKO
Paget’s disease
Pagetova bolezen
Paget’s disease
pri Pagetovi bolezni;
Paget’s disease of the bone
Pagetova bolezen kosti
Paget’s disease:
Pagetova bolezen
Paglitaz can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy’).
Zdravilo Paglitaz se lahko uporablja tudi v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora, ali v kombinaciji s sulfonilsečnino (drugo vrsto zdravila proti sladkorni bolezni), če metformin ni primeren (dvojno zdravljenje).