natgillin/translations-raw huggingface dataset:
Velphoro is indicated for the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD).
Zdravilo Velphoro je indicirano za uravnavanje ravni fosforja v serumu pri odraslih s kronično ledvično boleznijo (KLB) in bolnikih na hemodializi (HD) ali peritonealni dializi (PD).
Method of administration - Velphoro should only be taken by mouth.
Način uporabe - Zdravilo Velphoro se jemlje samo peroralno (skozi usta).
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti ne kažejo posebnega tveganja za človeka.
Mean serum phosphorus levels were 2.5 mmol/L at baseline and 1.8 mmol/L at week 12 for Velphoro (reduction by 0.7 mmol/L).
Povprečne ravni fosforja v serumu so bile v izhodišču 2,5 mmol/l in 1,8 mmol/l v 12. tednu pri zdravilu Velphoro (zmanjšanje za 0,7 mmol/l).
Velphoro contains potato starch and pregelatinised maize starch.
Zdravilo Velphoro vsebuje krompirjev škrob in predgelatinizirani koruzni škrob.
Velphoro works by binding phosphorus from food in your digestive tract (stomach and intestines).
Zdravilo Velphoro veže fosfor iz hrane v prebavnem traktu (želodcu in črevesju).
Serum phosphorus levels are reduced as a consequence of the reduced dietary phosphate absorption.
Raven fosforja v serumu se zmanjša kot posledica zmanjšane absorbcije fosfata iz prehrane.
The recommended starting dose of Velphoro is 1,500 mg iron (3 tablets) per day, divided across the meals of the day.
Priporočeni začetni odmerek zdravila Velphoro je 1500 mg železa (3 tablete) na dan porazdeljeno na dnevne obroke.
How to take Velphoro
Kako jemati zdravilo Velphoro
PHARMACEUTICAL FORM AND CONTENTS 30 × 1 chewable tablets
FARMACEVTSKA OBLIKA IN VSEBINA 30 × 1 žvečljiva tableta
LIST OF EXCIPIENTS Contains sucrose, potato starch and pregelatinised maize starch.
Vsebuje saharozo, krompirjev škrob in predgelatinizirani koruzni škrob.
100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex France
100-101 Terrasse Boieldieu Tour Franklin La Défense 8 92042 Paris la Défense Cedex Francija
MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/001 30 chewable tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/943/001 30 žvečljivih tablet
Velphoro is for oral administration only and must be taken with meals.
Zdravilo Velphoro je samo za peroralno uporabo in ga je treba jemati s hrano.
Velphoro is a medicine that contains the active substance sucroferric oxyhydroxide, which is made up from iron, sugar (sucrose) and starches.
Velphoro je zdravilo, ki vsebuje učinkovino železov(III) oksihidroksid saharozni kompleks, ki je sestavljena iz železa, sladkorja (saharoza) in škroba.
(listed in section 6) - if you have a history of abnormal iron build-up in your organs (haemochromatosis) - if you have any other disorder associated with too much iron.
- če ste alergični na železov(III) oksihidroksid saharozni kompleks ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če se vam je kdaj v preteklosti v organih kopičila prevelika količina železa (hemokromatoza); - če imate drugo motnjo, ki je povezana s preveč železa.
Your doctor will advise you whether Velphoro should be used during pregnancy, based on benefit and risk assessment for use during pregnancy.
Vaš zdravnik vam bo na podlagi ocene koristi in tveganj uporabe med nosečnostjo povedal, ali lahko zdravilo Velphoro jemljete med nosečnostjo.
There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.
Kliničnih podatkov o uporabi železovega(III) oksihidroksid saharoznega kompleksa pri nosečnicah ni na voljo.
In rats, there was a slightly increased incidence of benign C-cell adenoma in the thyroid of male rats given the highest dose of sucroferric oxyhydroxide.
Pri podganjih samcih, ki so dobivali največji odmerek železovega(III) oksihidroksid saharoznega kompleksa, so opazili nekoliko povečan pojav benignega C­celičnega adenoma v ščitnici.
Black stools may occur very commonly in patients taking Velphoro.
Pri bolnikih, ki jemljejo zdravilo Velphoro, se lahko zelo pogosto pojavi črno blato.
Velphoro contains a mixture of polynuclear iron(III)-oxyhydroxide (pn-FeOOH), sucrose and starches.
Zdravilo Velphoro vsebuje mešanico polinuklearnega železovega(III) oksihidroksida (pn­FeOOH), saharoze in škroba.
There are no available clinical data from the use of Velphoro in breast-feeding women.
Kliničnih podatkov o uporabi zdravila Velphoro pri doječih materah ni na voljo.
Velphoro contains starches.
Zdravilo Velphoro vsebuje škrob.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
Ena žvečljiva tableta vsebuje 500 mg železa v obliki železovega(III) oksihidroksid saharoznega kompleksa (sucroferric oxyhydroxide), ki je znan tudi kot mešanica polinuklearnega železovega(III) oksihidroksida, saharoze in škroba.
However, no evidence of hepatic impairment or significant alteration of hepatic enzymes were observed in the clinical studies with Velphoro.
Vendar pa v kliničnih študijah z zdravilom Velphoro niso opazili nobenih okvar jeter ali bistvenih sprememb jetrnih encimov.
Pack sizes of 30 × 1 or multipack of 90 (3 packs of 30 × 1) chewable tablets.
Velikost pakiranj: 30 × 1 žvečljiva tableta ali večje pakiranje po 90 žvečljivih tablet (3 pakiranja po 30 × 1).
Velphoro can cause black stools.
Zaradi uporabe zdravila Velphoro se lahko blato obarva črno.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/004
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/943/004
In the 55 weeks long term studies, the majority of these diarrhoea adverse reactions were transient, occurred early during treatment initiation and led to treatment discontinuation in 3.1% of the patients.
Pojavili so se kmalu na začetku zdravljenja, pri 3,1 % bolnikov pa je to privedlo do prekinitve zdravljenja.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/943/003
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/943/003
What Velphoro contains
Kaj vsebuje zdravilo Velphoro
No dose-dependent trends were observed in the adverse reaction profile of Velphoro.
V profilu neželenih učinkov zdravila Velphoro ni bilo opaženih učinkov, odvisnih od odmerka.
Serum phosphorus levels must be monitored and the dose of Velphoro up or down titrated in increments of 500 mg iron (1 tablet) per day every 2 - 4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring afterwards.
Raven fosforja v serumu je treba spremljati in vsake 2 - 4 tedne povečevati oziroma zmanjševati odmerek zdravila Velphoro v korakih po 500 mg železa (1 tableta) na dan.
Neohesperidin-dihydrochalcone Magnesium stearate
Neohesperidin dihidrokalkon
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - PLASTENKA S 30 IN 90 ŽVEČLJIVIMI TABLETAMI
Any potential bleeding from your digestive tract (stomach and gut) may be hidden by these black stools.
Takšno črno blato lahko prikrije morebitne krvavitve v prebavnem traktu (želodcu in črevesju).
Nausea Constipation Vomiting Dyspepsia Abdominal pain Flatulence Tooth discolouration
Navzea Zaprtje Bruhanje Dispepsija Bolečine v trebuhu Flatulenca Sprememba barve zob
- The active substance is iron as sucroferric oxyhydroxide also known as a mixture of polynuclear iron(III)-oxyhydroxide, sucrose, and starches.
- Učinkovina je železo v obliki železovega(III) oksihidroksid saharoznega kompleksa, ki je znan tudi kot mešanica polinuklearnega železovega(III) oksihidroksida, saharoze in škroba.
The active moiety of Velphoro, pn-FeOOH, is not metabolised.
Aktivna sestavina zdravila pn­FeOOH se ne presnavlja.
Velphoro can cause discoloured (black) stool.
Zaradi uporabe zdravila Velphoro lahko blato spremeni barvo (se obarva črno).
One phase 3 clinical study has been performed in patients with CKD on dialysis to investigate the efficacy and safety of Velphoro in this population.
Da bi preučili učinkovitost in varnost zdravila Velphoro v tej populaciji, so pri bolnikih s KLB na dializi opravili eno klinično študijo v 3 fazah.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACK) - 90 (3 PACKS OF 30) CHEWABLE TABLETS
ZUNANJOST ŠKATLE (VEČJE PAKIRANJE) - 90 (3 PAKIRANJA PO 30) ŽVEČLJIVIH TABLET
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON -30 CHEWABLE TABLETS (5 BLISTERS OF 6 CHEWABLE TABLETS)
ZUNANJA ŠKATLA - 30 ŽVEČLJIVIH TABLET (5 PRETISNIH OMOTOV S PO 6 ŽVEČLJIVIMI TABLETAMI)
NAME OF THE MEDICINAL PRODUCT Velphoro 500 mg chewable tablets iron as sucroferric oxyhydroxide
Navodilo za uporabo Velphoro 500 mg žvečljive tablete železo v obliki železovega(III) oksihidroksid saharoznega kompleksa (sucroferric oxyhydroxide)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE OF 30 AND 90 CHEWABLE TABLETS
PODATKI NA PRIMARNI OVOJNINI NALEPKA - PLASTENKA S 30 IN 90 ŽVEČLJIVIMI TABLETAMI
There is no clinical data available with Velphoro in patients with earlier stages of renal impairment.
Pri bolnikih z zgodnejšo fazo okvare ledvic ni na voljo kliničnih podatkov v zvezi z zdravilom Velphoro.
How to store Velphoro
Shranjevanje zdravila Velphoro
Colloidal anhydrous silica 6.2 Incompatibilities
Brezvodni koloidni silicijev dioksid
Diarrhoea* Faeces discoloured
Diareja* Sprememba barve blata
Tabulated list of adverse reactions
Povzetek neželenih učinkov v tabeli
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 6 CHEWABLE TABLETS
PRETISNI OMOT S 6 ŽVEČLJIVIMI TABLETAMI
Information about sucrose and starches (carbohydrates) Velphoro contains sucrose.
Zdravilo Velphoro vsebuje saharozo in škrob (ogljikovi hidrati)
Each chewable tablet contains 500 mg iron as sucroferric oxyhydroxide.
Ena žvečljiva tableta vsebuje 500 mg železa v obliki železovega(III) oksihidroksid saharoznega kompleksa.
Velphoro contains sucrose and starches (carbohydrates) If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
Discoloured stool
PODATKI NA ZUNANJI OVOJNINI
27 April 2010
27. aprila 2010
The final opinion was converted into a Decision by the European Commission on 27 April 2010.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 27. aprila 2010.
The referral procedure started on 14 July 2009.
Napotitveni postopek se je začel 14. julija 2009.
The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the reference Member State was Germany and the concerned Member States were Austria, Belgium, Denmark, Greece, Spain, Finland, Ireland, Italy, Luxemburg, the Netherlands, Norway, Portugal and Sweden.
Vloga je bila predložena v skladu s členom 6 Uredbe Komisije 1084/2003/ES, pri čemer je bila referenčna država članica Nemčija, zadevne države članice pa Avstrija, Belgija, Danska, Grčija, Španija, Finska, Irska, Italija, Luksemburg, Nizozemska, Norveška, Portugalska in Švedska.
EMA/183104/2010 Veterinary Medicines
EMA/183104/2010 Veterinarska zdravila
Article 6(12) of Regulation (EC) No 1084/2003.
Člen 6(12) Uredbe (ES) št. 1084/2003.
International non-proprietary name (INN): ramipril
Mednarodno nelastniško ime (INN): ramipril
The mutual recognition procedures (DE/V/0103/001/II/007, DE/V/0103/002/II/007 and DE/V/0103/004/II/007) started on 3 December
Postopki z medsebojnim priznavanjem (DE/V/0103/001/II/007, DE/V/0103/002/II/007 in DE/V/0103/004/II/007) so se začeli 3. decembra 2008.
The rapporteur and co-rapporteur appointed were Dr. R. Breathnach and Dr. M. Holzhauser-Alberti respectively.
Za poročevalca je bil določen dr. R. Breathnach, za soporočevalca pa dr. M. Holzhauser-Alberti.
The products are currently authorised for use in dogs for the treatment of congestive heart failure (NYHA classification grade II, III and IV) due to chronic degenerative valvular heart disease or cardiomyopathy, with or without adjunct diuretic (furosemide) or cardiac glycoside (digoxin/methyldigoxin) therapy.
Zdravila so trenutno odobrena za uporabo pri psih za zdravljenje kongestivnega srčnega popuščanja (razreda II, III in IV po klasifikaciji NYHA) zaradi kroničnega obolenja srčnih zaklopk ali kardiomiopatije z dodatnim zdravljenjem z diuretikom (furosemidom) ali srčnim glikozidom (digoksinom/metildigoksinom) ali brez dodatnega zdravljenja.
On 2 July 2009 Belgium referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns whether the marketing authorisation should be varied by adding cats as a new target species by considering if a placebo group is deemed necessary in a clinical field trial to assess the efficacy of ramipril in cats to reduce systolic blood pressure.
Dne 2. julija 2009 je Belgija v skladu s členom 39 Direktive 2001/82/ES, kakor je bila spremenjena s sklicevanjem na člen 6(12) Uredbe (ES) št. 1084/2003, zadevo napotila na agencijo zaradi zadržkov glede spremembe dovoljenja za promet z dodatkom mačk kot nove ciljne živalske vrste, da bi ugotovila, ali je za vrednotenje učinkovitosti ramiprila za znižanje sistoličnega krvnega tlaka pri mačkah potrebna placebo skupina v kliničnem terenskem preskušanju.
tablet for dogs
za zdravilo Vasotop P tablete za pse
Written explanations were provided by the marketing authorisation holder on 17 August 2009.
Imetnik dovoljenja za promet z zdravilom je pisna pojasnila predložil 17. avgusta 2009, razlage v ustni obliki pa 11. novembra 2009.
Further to rapporteurs' assessment of the currently available data, the CVMP adopted on 8 December 2009 an opinion recommending that the variation application for the veterinary medicinal products Vasotop P 0.625 mg tablet for dogs, Vasotop P 1.25 mg tablet for dogs and Vasotop P 2.5 mg tablet for dogs and associated names does not satisfy the criteria for approval in respect of efficacy.
Na podlagi poročevalčeve ocene trenutno razpoložljivih podatkov je CVMP 8. decembra 2009 sprejel mnenje, v katerem priporoča, da vloga za spremembo zdravil za uporabo v veterinarski medicini Vasotop P 0,625 mg tablete za pse, Vasotop P 1,25 mg tablete za pse in Vasotop P 2,5 mg tablete za pse in z njim povezana imena glede učinkovitosti ne izpolnjuje meril za odobritev.
Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets are veterinary medicinal products that contain the active ingredient ramipril at concentrations of 0.625 mg, 1.25 mg and 2.5 mg respectively.
Zdravila Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg tablete so zdravila za uporabo v veterinarski medicini, ki vsebujejo zdravilno učinkovino ramipril v koncentracijah 0,625 mg, 1,25 mg in 2,5 mg. Ramipril je zaviralec angiotenzinske konvertaze (ACE).
The marketing authorisation holder (Intervet International B.V.) submitted applications for a type II variation subject to mutual recognition procedures for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets for dogs in order to include a new indication for cats as follows: For the reduction of elevated systolic blood pressure (between 160 and 230 mm Hg) and the control of associated clinical signs.
je predložil vloge za spremembo tipa II po postopkih z medsebojnim priznavanjem za zdravila Vasotop P 0,625 mg, Vasotop P 1,25 mg in Vasotop P 2,5 mg tablete za pse, da bi vključil novo indikacijo za mačke: Za znižanje povišanega sistoličnega krvnega tlaka (med 160 in 230 mm Hg) in obvladovanje povezanih kliničnih znakov.
Opinion following an Article 6(12) referral for Vasotop P tablet for dogs EMA/183104/2010
Mnenje v zvezi z napotitvijo v skladu s členom 6(12) za zdravilo Vasotop P tablete za pse
Including fatal outcome.
Vključno s smrtnimi izidi.
Also tell your doctor if you are taking or have recently taken any other medicines.
Zdravnika obvestite tudi, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo.
Very limited data are available.
Na voljo je zelo malo podatkov.
In Phase 2 studies, this increase was dose-dependent.
V študijah 2. faze je bilo to povečanje odvisno od odmerka.
Duration of follow-up ranged up to 55 months.
Obdobje spremljanja je trajalo do 55 mesecev.
Human IgG1 crosses the placental barrier.
Humani IgG1 prehaja preko placentarne bariere.
Table 9: Overall survival in observational studies
Preglednica 9: Celokupno preživetje v opazovalnih študijah
Number of Patients (%)
Število bolnikov (%)
a gp100 peptide vaccine is an experimental control.
Peptidno cepivo gp100 je eksperimentalna kontrola.
widespread/intense pruritus regardless of etiology
razširjeno/intenzivno srbenje ne glede na etiologijo
All patients were followed for at least 1 year.
Vse bolnike so spremljali najmanj 1 leto.
Do not try to treat your symptoms with other medicines.
Simptomov ne poskušajte zdraviti z drugimi zdravili.
No overall differences in safety or efficacy were reported between elderly (≥ 65 years) and younger patients (< 65 years).
O razlikah v varnosti in učinkovitosti med starostniki (≥ 65 let) in mlajšimi bolniki (< 65 let) niso poročali.
Responses are summarised in Table 11.
Povzetek odzivov je prikazan v preglednici 11.
The primary efficacy endpoint was 1-year survival rate.
Primarni opazovani dogodek učinkovitosti je bil delež 1-letnega preživetja.
Age ≥ 12 to 21 years
Starost ≥12 do 21 let
In CA184178, deaths were reported at least 90 days of the last dose.
V študiji CA184178 so o smrtnih izidih poročali najmanj 90 dni po zadnjem odmerku.
Age 12 to < 18 years
Starost 12 do < 18 let
Children younger than 12 years of age
Otroci, mlajši od 12 let
Tumor assessment was performed at Week 12.
Vrednotenje tumorja je bilo izvedeno v 12. tednu.
The most common clinical presentation includes headache and fatigue.
Najpogostejša klinična slika vključuje glavobol in utrujenost.
OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA samo za enkratno uporabo
The median age was 57 years.
Mediana starost je bila 57 let.
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe YERVOY are provided with the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo YERVOY, prejeli:
Adults and adolescents 12 years of age and older
Odrasli in mladostniki, stari 12 let in starejši
Treatment must be initiated and supervised by specialist physicians experienced in the treatment of cancer.
Zdravljenje mora uvesti in nadzirati zdravnik specialist z izkušnjami pri zdravljenju raka.
Permanent discontinuation of treatment or withholding of doses
Trajna ukinitev zdravljenja ali zadržanje odmerkov
Additional efficacy results are presented in Table 13.
Dodatni rezultati učinkovitosti so prikazani v preglednici 13.
Age (2-87 years) had no clinically important effect on the CL of ipilimumab.
Starost (2-87 let) ni imela klinično pomembnega vpliva na očistek ipilimumaba.
Data presented in those sections primarily reflect experience from a Phase 3 study, MDX010-20.
Podatki v teh poglavjih se v glavnem nanašajo na izkušnje iz študije 3. faze, MDX010-20.
a. Summary of the safety profile
a. Povzetek profila varnosti
The final concentration should range from 1 to 4 mg/ml.
Končna koncentracija mora biti v razponu od 1 do 4 mg/ml.
Deaths for pediatric patients are those with on-study events within 30 days of the last dose, except for “All Deaths,” which were >30 days after the last dose.
Smrtni izidi pri pediatričnih bolnikih so tisti dogodki med trajanjem študije, do katerih je prišlo v 30 dneh po zadnjem odmerku, razen za “Vsi smrtni izidi”, do katerih je prišlo v > 30 dneh po zadnjem odmerku.
- inflammation of the eyes.
- vnetje oči.
Not reached (5.2, NE)
Ni dosežena (5,2; NE)
Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Korea
Samsung Biologics Co. Ltd 300, Songdo Bio Way (Daero) Yeonsu-gu, Incheon 21987 Koreja
The amount of YERVOY you will be given will be calculated based on your body weight.
Količina zdravila YERVOY, ki jo boste prejeli, se izračuna na osnovi vaše telesne mase.
if you have recently been prescribed Zelboraf (vemurafenib, another medicine for the treatment of skin cancer).
če so vam nedavno predpisali zdravilo Zelboraf (vemurafenib, drugo zdravilo za zdravljenje kožnega raka).
For instructions on the preparation and handling of the medicinal product before administration, see section 6.6.
Za navodila glede priprave in ravnanja z zdravilom pred dajanjem glejte poglavje 6.6.
Disease specific precautions
Za bolezen specifični previdnostni ukrepi
Table 3C:
Preglednica 3C:
The study enrolled 13 patients < 12 of age and 20 patients ≥ 12 years of age.
V študijo je bilo vključenih 13 bolnikov, starih < 12 let, in 20 bolnikov, starih ≥ 12 let.
If there are signs of adrenal insufficiency but the patient is not in adrenal crisis, further investigations should be considered including laboratory and imaging assessment.
Če so prisotni znaki insuficience nadledvične žleze, vendar pa bolnik ni v adrenalni krizi, je treba razmisliti o nadaljnjih preiskavah, vključno z laboratorijskimi in slikovnimi.
Date of first authorisation: 13 July 2011 Date of latest renewal: 21 April 2016
Datum zadnjega podaljšanja: 21. april 2016
In clinical trials, patients received up to 20 mg/kg without apparent toxic effects.
V kliničnih preskušanjih so bolniki zdravilo prejemali v odmerkih do 20 mg/kg brez očitnih toksičnih učinkov.
Median duration of responseg
Mediana trajanja odzivag
Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Pripravo raztopine za infundiranje mora izvesti ustrezno usposobljena oseba v skladu s pravili dobre prakse, še posebej glede aseptičnih pogojev.
Appropriate hormone replacement should also be initiated.
Začeti je treba tudi z ustreznim nadomeščanjem hormonov.
• Obligation to conduct post-authorisation measure
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
There are no data on the use of ipilimumab in pregnant women.
Podatkov o uporabi ipilimumaba pri nosečnicah ni.
Tapering should occur over a period of at least 1 month.
Odmerek je treba zmanjševati v obdobju vsaj enega meseca.
Long-term hormone replacement therapy may be necessary.
Morda bo potrebno dolgotrajno hormonsko nadomestno zdravljenje.
As the subgroups analysis includes only small numbers of patients, no definitive conclusions can be drawn from these data.
Ker je analiza po podskupinah vključevala le manjše število bolnikov, iz teh podatkov ni mogoče podati zanesljivih zaključkov.
Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 United States
Bristol-Myers Squibb Company 6000 Thompson Road East Syracuse, New York 13057 Združene države Amerike
The majority had received all 4 doses during induction.
Večina bolnikov je med indukcijo prejela vse 4 odmerke.
Rare proteinuriad
Redki proteinurijad
if you are taking any medicines that stop your blood from clotting (anticoagulants).
če jemljete katero koli zdravilo za preprečevanje nastanka krvnih strdkov (antikoagulanti).
No. at Risk mg/kg 965 429 127 73 41 29 28 12 8 4 0
Št. ogroženih oseb mg/kg 965 429 127 73 41 29 28 12 8 4 0
The development or maintenance of clinical activity following ipilimumab treatment was similar with or without the use of systemic corticosteroids.
Razvoj in vzdrževanje klinične aktivnosti po zdravljenju z ipilimumabom je bil podoben ob uporabi sistemskih kortikosteroidov ali brez.
The primary endpoints were safety and pharmacokinetics (PK).
Primarna opazovana dogodka sta bila varnost in farmakokinetika.