natgillin/translations-raw huggingface dataset:
Two phase-3 clinical studies were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Zaključeni sta bili dve klinični študiji 3. faze na skupno 851 ženskah v pomenopavzi z napredovalim rakom dojke, pri katerih se je bolezen ponovila med ali po adjuvantnem endokrinem zdravljenju ali pa je prišlo do poslabšanja bolezni po endokrinem zdravljenju napredovale bolezni.
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena napolnjena injekcijska brizga vsebuje 250 mg fulvestranta v 5 ml raztopine.
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat Population) ─ FALCON Study
Kaplan-Meierjev prikaz preživetja brez napredovanja bolezni (po oceni raziskovalca, populacija z-namenom-zdravljenja) ─ študija FALCON
United Kingdom Generics [UK] Ltd Tel: +44 1707 853000
United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.
Fulvestrant plus palbociclib (N=141)
fulvestrant in palbociklib (N = 141)
How to use Fulvestrant Mylan
Kako uporabljati zdravilo Fulvestrant Mylan
Comparison between groups (Fulvestrant 500 mg/ Fulvestrant 250 mg) Hazard ratio
Primerjava med skupinami (fulvestrant 500 mg/fulvestrant 250 mg) razmerje ogroženosti
You must not breast-feed while on treatment with Fulvestrant Mylan.
Med zdravljenjem z zdravilom Fulvestrant Mylan ne smete dojiti.
Comparison between groups (Fulvestrant 500 mg/Fulvestrant 250 mg)
Primerjava med skupinami (fulvestrant 500 mg/fulvestrant 250 mg) absolutna razlika v %
OR 1.074 (0.716 - 1.614) p = 0.7290
RO 1,074 (0,716 - 1,614) p = 0,7290
Castor oil, refined
prečiščeno ricinusovo olje.
Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and pvalue
Preživetje brez napredovanja bolezni Število dogodkov PFS (%) Razmerje ogroženosti za PFS (95 % IZ) in vrednost p
Two clear type 1 glass pre-filled syringes with polypropylene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Fulvestrant Mylan solution for injection.
Dve napolnjeni injekcijski brizgi iz prozornega stekla tipa 1 s polipropilenskim potisnim batom z zaporko, ki ščiti pred posegom, od katerih vsaka vsebuje 5 ml Fulvestrant Mylan raztopine za injekcije.
• Check that the needle is locked to the Luer connector before moving out of the vertical plane.
• Pred premikom iz navpične ravnine preverite, ali je igla pričvrščena na nastavku Luer.
Figure 2 Kaplan-Meier plot of progression-free survival (investigator assessment, intentto-treat population) - PALOMA3 study
Kaplan-Meierjev prikaz preživetja brez napredovanja bolezni (po oceni raziskovalca, vključeni bolniki) - študija PALOMA3
No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥30 ml/min).
Pri bolnicah z blago do zmerno ledvično okvaro (kreatininski očistek ≥ 30 ml/min) ni priporočil za prilagoditev odmerka.
Other medicines and Fulvestrant Mylan
Shranjevanje zdravila Fulvestrant Mylan
What Fulvestrant Mylan contains - The active substance is fulvestrant.
Kaj vsebuje zdravilo Fulvestrant Mylan - Zdravilna učinkovina je fulvestrant.
The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral.
b Izraz reakcije na mestu injiciranja ne vključuje izrazov krvavitev na mestu injiciranja, hematom na mestu injiciranja, išias, nevralgija in periferna nevropatija.
A total of 335 patients in the fulvestrant plus palbociclib arm and 166 patients in the fulvestrant plus placebo arm completed the questionnaire at baseline and at least 1 post-baseline visit.
Vprašalnik je ob izhodišču in vsaj 1 obisku po izhodišču izpolnilo skupno 335 bolnic iz skupine s fulvestrantom in palbociklibom ter 166 bolnic iz skupine s fulvestrantom in placebom.
e
ali
For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 4).
Zaradi praktičnosti pri uporabi je prirezani del igle na strani ročice (glejte sliko 4).
Fulvestrant solution for injection and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
V študijah s ponavljajočimi odmerki so raztopino fulvestranta za injiciranje in druge oblike s fulvestrantom dobro prenašale vse živalske vrste.
4.4 Special warnings and precautions for use Fulvestrant should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Fulvestrant uporabljajte previdno pri bolnicah z blago do zmerno jetrno okvaro (glejte poglavja 4.2, 4.3 in 5.2).
Fulvestrant plus palbociclib (N=206)
Nevisceralna bolezen fulvestrant in palbociklib (N = 206)
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema pogosti zmanjšanje števila trombocitove
Fulvestrant plus placebo (N=105)
fulvestrant in placebo (N = 105)
• alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
• Zdravilo Fulvestrant Mylan se uporablja ali:samo, za zdravljenje žensk po menopavzi s posebno vrsto raka dojke (t.i. rakom dojke s pozitivnimi estrogenskimi receptorji), ki je lokalno napredoval ali se je razširil v druge dele telesa (je metastatski), ali
Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Fulvestrant Mylan 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi fulvestrant
Mylan EPD d.o.o.
Mylan Hrvatska d.o.o.
Fulvestrant 250 mg
250 mg).
Fulvestrant plus placebo (N=69)
fulvestrant in placebo (N = 69)
One clear type 1 glass pre-filled syringe with polypropylene plunger rod, fitted with a tamper-evident closure, containing 5 ml Fulvestrant Mylan solution for injection.
Eno napolnjeno injekcijsko brizgo iz prozornega stekla tipa 1 s polipropilenskim potisnim batom z zaporko, ki ščiti pred posegom, vsebuje 5 ml Fulvestrant Mylan raztopine za injekcije.
Fulvestrant plus placebo (N=174)
fulvestrant in placebo (N = 174)
No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
Pri bolnicah z blago do zmerno jetrno okvaro ni priporočil za prilagoditev odmerka.
Very common Hypersensitivity reactionse Uncommon
Bolezni imunskega sistema zelo pogosti preobčutljivostne reakcijee občasni anafilaktične reakcije
See the package leaflet for further information.
Za nadaljnja navodila glejte navodilo za uporabo.
Fulvestrant + placebo (N=172)
fulvestrant in placebo (N = 172)
Adverse reactions by system organ class and frequency Infections and infestations
Neželeni učinki glede na pogostnost in organski sistem Bolezni kože in podkožja zelo pogosti izpuščaje
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection.
Po injiciranju fulvestranta so poročali o učinkih, povezanih z mestom injiciranja, med njimi o išiasu, nevralgiji, nevropatski bolečini in periferni nevropatiji.
Fulvestrant Mylan has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
V pakiranju je bodisi 1 napolnjena injekcijska brizga iz prozornega stekla ali pa sta v pakiranju 2 napolnjeni injekcijski brizgi.
• Liver failure
Ledvična okvara
For the subgroup of patients with disease limited to non-visceral metastasis (n=208), the HR was 0.592 (95% CI: 0.419, 0.837) for the fulvestrant arm compared to the anastrozole arm. For the subgroup of patients with visceral metastasis (n=254), the HR was 0.993 (95% CI: 0.740, 1.331) for the fulvestrant arm compared to the anastrozole arm.
V podskupini bolnic z boleznijo, omejeno na nevisceralne metastaze (n = 208), je bilo razmerje ogroženosti (hazard ratioHR) v skupini s fluvestrantom v primerjavi s skupino z anastrozolom 0,592 (95 % IZ: 0,419; 0,837).
117 Allée des Parcs 69800 SAINT-PRIEST FRANCE
69800 SAINT-PRIEST FRANCIJA
f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
f Trombocitopenija vključuje naslednja PTs: trombocitopenija, zmanjšano število trombocitov.
Non-visceral Disease
Preživetje brez napredovanja bolezni
Patients were well matched for baseline demographics and prognostic characteristics between the fulvestrant plus palbociclib arm and the fulvestrant plus placebo arm.
Bolnice v skupini, ki je prejemala fulvestrant in palbociklib, so bile po izhodiščnih demografskih značilnosti in značilnostih prognoze bolezni dobro usklajene z bolnicami v skupini, ki je prejemala fulvestrant in placebo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
IME ZDRAVILA IN POT(I) UPORABE Fulvestrant Mylan 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi fulvestrant i.m.
g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration,
g Stomatitis vključuje naslednje PTs: aftozni stomatitis, heilitis, glositis, glosodinija, razjede v ustih, vnetje sluznice, bolečine v ustih, nelagodje v orofarinksu, bolečine v orofarinksu, stomatitis.
Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Znano je, da pri podganah in kuncih fulvestrant po enkratnih intramuskularnih odmerkih prehaja v placento.
Vaginal moniliasis f, leukorrhea f
Motnje reprodukcije in dojk pogosti krvavitev iz nožnicee občasni nožnična kandidiaza f, levkoreja f
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
NAVEDBA ENE ALI VEČ UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 250 mg fulvestranta v 5 ml raztopine.
h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular,
h Izpuščaj vključuje naslednje PTs: izpuščaj, makulo-papulozen izpuščaj, pruritični izpuščaj, eritematozni izpuščaj, papulozni izpuščaj, dermatitis, akneiformni dermatitis, toksične erupcije na koži.
NAME OF THE MEDICINAL PRODUCT Fulvestrant Mylan 250 mg solution for injection in prefilled syringe
IME ZDRAVILA Fulvestrant Mylan 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Reproductive system and breast disorders Common
Infekcijske in parazitske bolezni pogosti okužbe sečil
A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of fulvestrant 500 mg plus palbociclib 125 mg versus fulvestrant 500 mg plus placebo was conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo) adjuvant or metastatic setting.
Študija je zajela ženske, ki so imele HR-pozitivnega, HER2-negativnega lokalno napredovalega raka dojke, neprimernega za resekcijo ali radioterapijo s kurativnim namenom, ali metastatskega raka dojke, ne glede na menopavzalni status, pri katerih je bolezen napredovala med predhodnim endokrinim zdravljenjem v okviru (neo)adjuvantnega ali metastatskega zdravljenja bolezni.
A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to fulvestrant plus palbociclib or fulvestrant plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Skupno 521 žensk pred menopavzo, v perimenopavzi ali po menopavzi, pri katerih je bolezen napredovala med ali v 12 mesecih po dokončanem adjuvantnem endokrinem zdravljenju ali med
Solution for injection.
NALEPKA NA NAPOLNJENI INJEKCIJSKI BRIZGI
This medicinal product contains 500 mg benzyl alcohol in each 5 ml.
Zdravilo Fulvestrant Mylan vsebuje benzilalkohol, To zdravilo vsebuje 500 mg benzilalkohola v 5 ml Benzilalkohol lahko povzroči alergijske reakcije.
Very common Joint and musculoskeletal paind Common
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti sklepna in mišično-skeletna bolečinad pogosti bolečine v križua
Combined analysis of both studies showed the hazard ratio of fulvestrant 250 mg to anastrozole for progression-free survival was
Kombinirana analiza obeh študij je pokazala razmerje ogroženosti za preživetje brez napredovanja bolezni med fulvestrantom 250 mg in anastrozolom 0,95 (95 % IZ 0,82 do 1,10).
Very common Elevated hepatic enzymes (ALT, AST, ALP) a
Bolezni jeter, žolčnika in žolčevodov zelo pogosti zvišanje jetrnih encimov (ALT, AST, ALP)a pogosti zvišanje bilirubinaa občasni odpoved jeterc,f, hepatitisf, zvišanje gama-GTf
Very common Hot flushese Common
Žilne bolezni zelo pogosti vročinski oblivie pogosti venska trombembolijaa
{Invented name}may be taken with or without food.
{Izmišljeno ime} se lahko jemlje s hrano ali brez nje.
Invented name
IZMIŠLJENO IME
On 23 June 2005, the CHMP concluded that:
Dne 23. junija je CHMP zakljucil da:
Elimination half-life is 8-12 hours.
Eliminacijski razpolovni cas je od 8 do 12 ur.
The increased risk became apparent after approximately 1 year of treatment.
Vecje tveganje je postalo ocitno po približno 1 letu zdravljenja..
Final study reports will be shared with Agencies when available.
Zakljucna porocila o študijah bodo posredovana agencijam, ko bodo na voljo.
LT-01112 Vilnius Lithuania
LT-01112 Vilnius Litva
To provide final study reports for the following long-term trials APC/PreSAP/ADAPT in full, when available.
Da bo predložil zakljucna porocila za sledeca dolgorocna preizkušanja APC/PreSAP/ADAPT v celoti, ko bodo na voljo.
Via Robert Koch, 1-2 20152 Milano Italy
Via Robert Koch, 1-2 20152 Milano Italija
Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nizozemska
Dosing with food (high fat meal) delays absorption by about 1 hour.
Uporaba s hrano (zelo masten obrok) upocasni absorpcijo za približno 1 uro.
[Very Common (>1/10), Common (³1/100, <1/10) Uncommon (³1/1000, <1/100) Rare (³1/10,000, <1/1000) Very rare (<1/10,000 including isolated cases)]
[Zelo pogosti (> 1/10), pogosti (³ 1/100, < 1/10), obcasni (³ 1/1.000, < 1/100), redki (³ 1/10.000, < 1/1.000), zelo redki (< 1/10.000, vkljucno s posameznimi primeri)]
Less than 1% of the dose is excreted unchanged in urine.
Manj kot 1 % odmerka se nespremenjenega izloci v urinu.
Avenida de Europa, 20-B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Spain
Avenida de Europa, 20-B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Španija
Pharmacotherapeutic group: ATC code: M01AH01.
Farmakoterapevtska skupina: oznaka ATC: M01AH01.
4.8 Undesirable effects
4.8 Neželeni ucinki
Lagoas Park, Edifício n.º 10 2740-244 Porto Salvo Portugal
Lagoas Park, Edifício n.º 10 2740-244 Porto Salvo Portugalska
To continue to make available emerging clinical and epidemiological data through publications and, where possible, in scientific congresses.
Da bo še naprej objavljal nove klinicne in epidemiološke podatke ali jih, kjer je mogoce, predstavil na znanstvenih kongresih.
This USR was initiated on 16 February 2005 and finalised on 17 February 2005.
Nujen varnostni ukrep se je zacel 16. februarja 2005 in zakljucil 17. februarja 2005.
Capsule, hard.
Kapsula, trda
76139 Karlsruhe Germany
76139 Karlsruhe Nemcija
1324 Lysaker Norway
1324 Lysaker Norveška
In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.
V kolikor po dveh tednih zdravljenja ni izboljšanja, je treba razmisliti o drugih možnostih zdravljenja.
1515 Lefkosia Cyprus
1515 Lefkosia Ciper
The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes.
CHMP je potrdil spremembe informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto maja 2005, po februarskem nujnem varnostnem ukrepu in zahteval še nadaljnje spremembe.
Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Zato antiagregacijskega zdravljenja ne smemo ukiniti (glejte poglavje 5.1.
Milton Keynes MK5 8PH United Kingdom
Milton Keynes MK5 8PH Velika Britanija
Rare: alopecia, photosensitivity
Redki: alopecija, fotosenzibilnost
Congestive heart failure (NYHA II-IV).
Kongestivno srcno popušcanje (NYHA II-IV).
It may also play a role in ulcer healing.
Morda ima doloceno vlogo tudi pri celjenju ulkusov.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK TER JAKOSTI ZDRAVILA, POT UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH CLANICAH TER NORVEŠKA IN ISLANDIJA
This information will be updated as final data become available.
Ti podatki bodoposodobljeni, kakor hitro bodo na voljo dokoncni podatki.
The corresponding values in patients with moderate hepatic impairment were 41% and 146% respectively.
Ustrezni vrednosti pri bolnikih z zmerno okvaro jeter sta bili 41 % in 146 %.
The maximum recommended daily dose is 400 mg for both indications.
Maksimalni priporoceni dnevni odmerek je 400 mg za obe indikaciji..
The inter-subject variability in the exposure of celecoxib is about 10-fold.
Variabilnost v interindividualni izpostavljenosti celekoksibu je približno 10-kratna.
Children: Celecoxib is not indicated for use in children.
Otroci: Celekoksib ni indiciran za uporabo pri otrocih.
- Addition of a more detailed description of the first signs of skin reactions leading to discontinuation of the treatment.
- dodan je podrobnejši opis zacetnih znakov kožnih reakcij, zaradi katerih se zdravljenje prekine.
Less than 1% of the population are poor metabolisers and have an enzyme with decreased activity.
Manj kot 1 % populacije z njim slabo presnavlja; te osebe imajo encim z zmanjšano aktivnostjo.
Known hypersensitivity to sulphonamides.
Znana preobcutljivost za sulfonamide.
- In the posology section it is recommended to use of the lowest effective dose, for the shortest possible duration, and that the need for pain relief should be re-evaluated frequently.
- v poglavju o odmerjanju je priporoceno, naj se uporablja najnižji ucinkovit odmerek za najkrajši cas delovanja ter da je potrebo po lajšanju bolecin potrebno pogosto ponovno oceniti.
Therefore, this SPC may not necessarily represent the current text.
Zaradi tega ta Povzetek glavnih znacilnosti zdravila ne predstavlja nujno sedanjega besedila.
Particular caution should be exercised in elderly with a body weight less than 50 kg. (See 4.4 and 5.2).
Posebna previdnost je potrebna pri starejših osebah, pri katerih je telesna masa nižja od 50 kg (glejte poglavji 4.4 in 5.2).
To submit an analysis of spontaneous reports for all serious skin reactions from the analysis of the RegiSCAR database and further discuss results with Rapporteur following submission.
Da bo predložil analizo spontanih porocil o vseh hudih kožnih reakcijah na podlagi analize podatkov iz zbirke podatkov RegiSCAR, ter da se bo o rezultatih po predložitvi še podrobneje pogovoril s porocevalcem.
Pfizer Hellas A. E. 5, Alketou Street 116 33 Athens Greece
Pfizer Hellas A. E. 5, Alketou Street 116 33 Athens Grcija
Where full study reports are not available to the MAH, it agrees to provide publications/manuscripts in lieu of the study report(s).
Kjer imetnik dovoljenja za promet ne bo imel na razpolago celotnih porocil o študijah, se strinja, da bo namesto porocil o študiji(ah) predložil publikacije/zapise.
Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark
Pfizer ApS Lautrupvang 8 2750 Ballerup Danska
Furthermore, the MAH commits to continue dialogue with EMEA/CHMP with regard to study design
Poleg tega se imetnik dovoljenja za promet zavezuje, da se bo v zvezi z nacrtom študije še naprej posvetoval z EMEA/CHMP.
Additional reactions reported from post-marketing experience in >70 million treated patients include headache, nausea and arthralgia, and the reactions included as very rare, in italics in the list below.
Med dodatnimi reakcijami, opisanimi v pomarketinškem obdobju pri > 70 milijonih zdravljenih bolnikov, so glavobol, navzeja in artralgija ter reakcije, ki so na spodnjem seznamu navedene v poševnem tisku kot zelo redke.
If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of celecoxib therapy should be considered.
Ce se med zdravljenjem poslabša delovanje kateregakoli organskega sistema opisanega zgoraj, je treba uvesti ustrezne ukrepe in razmisliti o ukinitvi zdravljenja s celekoksibom.
- Addition of a warning for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia (high cholesterol levels), diabetes and smoking.
- dodano je opozorilo za bolnike z dejavniki tveganja za srcne bolezni, kot so hipertenzija, hiperlipidemija (visoke ravni holesterola), sladkorna bolezen in kajenje.
Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia.
Previdnost je potrebna tudi pri bolnikih, ki dobivajo diuretike ali jih sicer ogroža hipovolemija.
Steady state plasma concentrations are reached within 5 days of treatment.
Koncentracija v plazmi v stanju dinamicnega ravnovesja je dosežena v 5 dneh zdravljenja.
In pregnancy and in women of childbearing potential unless using an effective method of contraception (See 4.5).
V casu nosecnosti in pri ženskah v rodni dobi, razen ce uporabljajo ucinkovito metodo kontracepcije (glejte poglavje 4.4).
The clinical significance of this in vitro finding is unknown.
Klinicni pomen tega izsledka in vitro ni znan.
Follow-up measures of the Marketing Authorisation Holder As requested by the CHMP, the MAH agreed to submit the follow-up measures as listed below:
Nadaljnji ukrepi imetnika dovoljenja za promet z zdravilom Glede na zahteve CHMP se je imetnik dovoljenja za promet strinjal, da bo izvedel nadaljnje ukrepe, kot so navedeni spodaj:
Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
Celekoksib se dobro absorbira in doseže najvecjo koncentracijo v plazmi po približno 2-3 urah.
The potential for human risk in pregnancy is unknown, but cannot be excluded.
Potencialno tveganje med nosecnostjo pri cloveku ni znano, a ga ni mogoce izkljuciti.
Patients with estimated creatinine clearance <30 ml/min.
Bolniki z ocenjenim ocistkom kreatinina <30 ml/min (0,5 ml/s).
Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment.
Kaže, da je tveganje za te reakcije najvecje kmalu po zacetku zdravljenja: v vecini primerov so reakcije nastopile v prvem mesecu zdravljenja.
Between November 2004 and June 2005, the MAH made oral explanations to the CHMP on cardiovascular and skin safety aspects for celecoxib on 18 January, 15 February, and 25 May 2005.
Med novembrom 2004 in junijem 2005 je imetnik dovoljenja za promet 18. januarja, 15. februarja in 25 maja 2005 pred CHMP ustno obrazložil kardiovaskularne in kožne varnostne vidike za celekoksib.
The CHMP agreed that an Urgent Safety Restriction (USR) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the SPC.
CHMP je soglasno ugotovil, da je potreben nujen varnostni ukrep (Urgent Safety Restriction, USR) v zvezi s kardiovaskularno varnostjo, da se dodajo nove kontraindikacije in okrepijo opozorila in podatki o neželenih ucinkih v Povzetku glavnih znacilnosti zdravila (SPC).