natgillin/translations-raw huggingface dataset:
Фулвестрант трябва да се прилага с повишено внимание при пациенти с леко до умерено чернодробно увреждане (вж. точки 4.2, 4.3 и 5.2).
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).
Сравнение между групите (Фулвестрант 500 mg/
Comparison between groups (Fulvestrant 500 mg/Fulvestrant 250 mg)
Понижен брой на тромбоцитите (тромбоцитопения)
• Decreased levels of platelets (thrombocytopenia)
Фаза 3 е приключило при 736 постменопаузални жени с авансирал рак на гърдата, с рецидив по време на или след адювантна ендокринна терапия или с прогресия след ендокринна терапия за авансирало заболяване.
A Phase 3 clinical study was completed in 736 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Фулвестрант плюс палбоциклиб (N=141)
Fulvestrant plus palbociclib (N=141)
a Предпочитаните термини (ПТ) са изброени съгласно MedDRA 17.1. б „Инфекции“ включва всички ПТ, които са част от системо-органния клас „Инфекции и инфестации“. в „Неутропения“ включва следните ПТ: неутропения, намален брой на неутрофилите.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Фулвестрант 250 mg (N=374)
Fulvestrant 250 mg (N=374)
Криви на Каплан-Майер за преживяемост без прогресия (оценка на изследователя, intent-to-treat популация) ─ проучване FALCON
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat Population) ─ FALCON Study
Фулвестрант 500 mg (N=230)
Fulvestrant 500 mg (N=230)
За всяка от двете спринцовки:
All other side effects:
В подгрупата пациентки, при които заболяването е ограничено до невисцерални метастази (n=208), коефициентът на риск (HR) е 0,592 (95 % CI: 0,419; 0,837) в рамото на фулвестрант, в сравнение с рамото на анастрозол.
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.
Фулвестрант 500 mg (N=362)
Fulvestrant 500 mg (N=362)
Фаза 3 с фулвестрант 500 mg спрямо анастрозол 1 mg е проведено при постменопаузални жени с ER-позитивен и/или PgR-позитивен локално авансирал или метастатичен рак на млечната жлеза, които предходно не са били лекувани с хормонална терапия.
A Phase 3, randomised, double-blind, double-dummy, multicentre study of fulvestrant 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Изходните демографски и прогностични характеристики на пациентите в рамото на фулвестрант плюс палбоциклиб и рамото на фулвестрант плюс плацебо са сходни.
Patients were well matched for baseline demographics and prognostic characteristics between the fulvestrant plus palbociclib arm and the fulvestrant plus placebo arm.
Изчакайте да чуете щракване и погледнете дали върхът на иглата е покрит напълно.
Listen for click and visually confirm needle tip is fully covered.
Фулвестрант + палбоциклиб (N=345)
Fulvestrant + Palbociclib (N=345)
Една прозрачна спринцовка от стъкло клас 1, предварително напълнена с полипропиленово бутало, снабдено със затваряща капачка, съдържаща 5 ml Фулвестрант Mylan инжекционен разтвор.
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.
Също така, има данни, че фулвестрант 500 mg, приложен при пациенти с тумори на гърдата, в условията на неоадювантно лечение, потиска експресията на ER и на маркера на пролиферация Ki67 в поголяма степен, отколкото фулвестрант 250 mg.
It has also been shown that fulvestrant 500 mg downregulates ER and the proliferation marker Ki67, to a greater degree than fulvestrant 250 mg in breast tumours in postmenopausal neoadjuvant setting.
възпаление на лигавицата, болка в устата, орофарингеален дискомфорт, орофарингеална болка, стоматит.
Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Чернодробна недостатъчноств,е хепатите, повишаване на ГГТе
Hepatic failurec,f, hepatitis f, elevated gamma-GT f
Алергични реакции (реакции на свръхчувствителност), включително подуване на лицето,
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat
Етанол, безводен
Renal impairment
Фулвестрант + плацебо (N=172)
Fulvestrant + placebo (N=172)
Обривд
ORRd
Какво трябва да знаете, преди да използвате
What you need to know before you use Fulvestrant Mylan
(АЕ-подгрупа) и 313 пациенти, които са имали рецидив или прогресия по време на терапия с ароматазен инхибитор (АИ-подгрупа).
The study included 423 patients whose disease had recurred or progressed during anti-estrogen therapy (AE subgroup) and 313 patients whose disease had recurred or progressed during aromatase inhibitor therapy (AI subgroup).
Фулвестрант + плацебо (N=174)
Fulvestrant plus placebo (N=174)
Анорексияа
Anorexiaa
При инжектирането на фулвестрант се съобщават събития на мястото на инжектиране, включващи ишиас, невралгия, невропатна болка и периферна невропатия.
Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection.
Актуализиран анализ (дата на заключване на базата данни 23 октомври 2015 г.)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 january 2018
Ако сте бременна, не трябва да използвате Фулвестрант Mylan.
You must not use Fulvestrant Mylan if you are pregnant.
Кръвоизлив на мястото на инжектиранее, хематом на мястото на инжектиранее, невралгияв а Включва нежелани лекарствени реакции, за които поради наличие на подлежащо заболяване не може да се определи с точност степента, в която фулвестрант допринася за развитието им.
Includes adverse drug reactions for which the exact contribution of fulvestrant cannot be assessed due to the underlying disease.
Фулвестрант плюс пацебо (N=105)
Fulvestrant plus placebo (N=105)
Не използвайте Фулвестрант Mylan
How to use Fulvestrant Mylan
Фулвестрант плюс пацебо (N=69)
Fulvestrant plus placebo (N=69)
Вагинален кръвоизливд
Vaginal haemorrhagee
Фулвестрант Mylan 250 mg инжекционен разтвор в предварително напълнена спринцовка фулвестрант
Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Гадене (повдигане)
• Nausea (feeling sick)
Една предварително напълнена спринцовка съдържа 250 mg фулвестрант в 5 ml разтвор.
QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Много чести Алопеция Обривз
Very common Hot flushese Common
е „Тромбоцитопения“ включва следните ПТ: тромбоцитопения, намален брой на тромбоцитите.
c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
Въпреки това фулвестрант трябва да се прилага внимателно при тези пациенти, тъй като е възможна повишена експозиция на фулвестрант.
However, as fulvestrant exposure may be increased, fulvestrant should be used with caution in these patients.
Повишена лакримация Замъглено зрение „Сухо око“ Респираторни, гръдни и медиастинални нарушения Чести Епистаксис Стомашно-чревни нарушения
Infections and infestations Very common Infectionsb Blood and lymphatic system disorders Very common Neutropeniac Leukopeniad Anaemiae Thrombocytopeniaf Uncommon Febrile neutropenia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Common Dysgeusia Eye disorders Common Lacrimation increased Vision blurred Dry eye Respiratory, thoracic and mediastinal disorders Common Epistaxis Gastrointestinal disorders Very common Nausea
Има данни, че при плъхове и зайци след еднократно интрамускулно приложение фулвестрант минава през плацентата.
Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Астенияа, реакции на мястото на инжектиранеб
Very common Astheniaa, injection site reactionsb Common
Докато сте на лечение с Фулвестрант Mylan, не трябва да кърмите.
You must not breast-feed while on treatment with Fulvestrant Mylan.
Намален брой тромбоцитид
Reduced platelet counte
Една предварително напълнена спринцовка съдържа 250 mg фулвестрант (fulvestrant) в 5 ml разтвор.
STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
СОПг
PFS
Говорете с Вашия лекар, фармацевт или медицинска сестра, преди да използвате
Check with your doctor or pharmacist if you are not sure.
Фулвестрант Mylan 250 mg инжекционен разтвор в предварително напълнена спринцовка
NAME OF THE MEDICINAL PRODUCT Fulvestrant Mylan 250 mg solution for injection in prefilled syringe
Проучването включва 423 пациенти, които са имали рецидив или прогресия по време на антиестрогенна терапия
Fulvestrant is indicated in patients whose disease had recurred or progressed on an anti-estrogen therapy.
Mylan EPD d.o.o. Tel: +385 1 23 50 599
Tel: +385 1 23 50 599
в
b
Комбинираният анализ на двете проучвания показва, че коефициентът на риск за преживяемост без прогресия при фулвестрант 250 mg спрямо анастрозол е 0,95 (95 % CI 0,82 до 1,10).
Combined analysis of both studies showed the hazard ratio of fulvestrant 250 mg to anastrozole for progression-free survival was
з „Обрив“ включва следните ПТ: обрив, макулопапулозен обрив, сърбящ обрив, еритематозен обрив,
h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular,
Инжекционен разтвор в предварително напълнена спринцовка.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
Чернодробно нарушение
• Liver failure
{INVENTED NAME} kan tas med eller uten mat.
{Invented name}may be taken with or without food.
Denne informasjonen vil bli oppdatert når endelige data er tilgjengelig.
This information will be updated as final data become available.
Kapsel, hard.
Capsule, hard.
Eliminasjonshalveringstiden er 8-12 timer.
Elimination half-life is 8-12 hours.
Den økte risikoen ble tydelig etter omtrent ett års behandling.
The increased risk became apparent after approximately 1 year of treatment.
Det finnes en genetisk polymorfi av dette enzymet.
There is a genetic polymorphism of this enzyme.
Via Robert Koch, 1-2 20152 Milano Italia
Via Robert Koch, 1-2 20152 Milano Italy
Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederland
Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
Mindre enn 1 % av dosen utskilles uforandret i urin.
Less than 1% of the dose is excreted unchanged in urine.
[Svært vanlige (>1/10), vanlige (≥1/100, <1/10), mindre vanlige (≥1/1000, <1/100), sjeldne (≥1/10 000, <1/1000), svært sjeldne (<1/10 000 inkludert isolerte tilfeller.)]
[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)]
Risikopotensialet ved graviditet hos mennesker er ukjent, men kan ikke utelukkes.
The potential for human risk in pregnancy is unknown, but cannot be excluded.
Mindre enn 1 % av befolkningen har langsom metabolisme og har enzym med nedsatt aktivitet.
Less than 1% of the population are poor metabolisers and have an enzyme with decreased activity.
76139 Karlsruhe Tyskland
76139 Karlsruhe Germany
Sjeldne: alopeci, fotosensitivitet
Rare: alopecia, photosensitivity
Dosering med mat (fettrik kost) forsinker absorpsjonen med ca. en time.
Dosing with food (high fat meal) delays absorption by about 1 hour.
Platehemmende behandling skal derfor ikke avsluttes (se pkt. 5.1).
Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Kjent overfølsomhet for sulfonamider.
Known hypersensitivity to sulphonamides.
183 25 Täby
183 25 Täby Sweden
Hjertesvikt (NYHA II-IV).
Congestive heart failure (NYHA II-IV).
4.5 Interaksjon med andre legemidler og andre former for interaksjon
4.5 Interaction with other medicinal products and other forms of interaction
LT-01112 Vilnius
LT-01112 Vilnius Lithuania
signifikansen av disse in vitro funnene er ukjent.
The clinical significance of this in vitro finding is unknown.
Pfizer ApS Lautrupvang 8 2750 Ballerup Danmark
Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark
ikke er økt behandlingseffekt etter to uker, skal andre behandlingsalternativer vurderes.
In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.
VEDLEGG I LISTE OVER NAVN, LEGEMIDDELFORMER, LEGEMIDDELSTYRKER, ADMINISTRASJONSVEI, OG INNEHAVERE AV MARKEDSFØRINGSTILLATELSER I MEDLEMSLANDENE OG NORGE OG ISLAND
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
Eldre (>65 år): Som hos yngre voksne, bør 200 mg daglig benyttes ved oppstart av behandling.
Elderly >65 years: As in younger adults, 200 mg per day should be used initially.
Likevel bør adekvat monitorering av metotreksat-relatert toksisitet overveies når disse to legemidlene brukes sammen.
However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two drugs.
Steady-state plasmakonsentrasjoner nås innen 5 dagers behandling.
Steady state plasma concentrations are reached within 5 days of treatment.
1515 Lefkosia
1515 Lefkosia Cyprus
For hjelpestoffer, se 6.1.
For excipients, see 6.1.
Kvinner som tar celekoksib skal ikke amme.
Women who take celecoxib should not breastfeed.
Davy Avenue
Davy Avenue Know Hill
NSAIDs kan redusere effekten av diuretika og antihypertensiva.
NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Farmakoterapeutisk gruppe: ATC-kode: M01A H01
Pharmacotherapeutic group: ATC code: M01AH01.
Celekoksib elimineres hovedsakelig via metabolisme.
Celecoxib is mainly eliminated by metabolism.
Dataene var ikke konsistente sammenlignet med diklofenak (150 mg per dag).
The data were inconsistent in comparison with diclofenac (150 mg per day).
Aktivt peptisk sår eller gastrointestinal (GI) blødning.
Active peptic ulceration or gastrointestinal (GI) bleeding.
ikke gjennomsiktlig (opaque) PVC blister eller kaldpresset aluminiumfolieblister. Pakninger på 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 (endose), 1x100
Pack of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose.
Hill Milton Keynes MK5 8PH
Milton Keynes MK5 8PH United Kingdom
Den signifikant lavere insidensen av denne hendelsen med celekoksib ble opprettholdt med eller uten bruk av acetylsalisylsyre.
The significantly lower incidence of this event with celecoxib was maintained with or without acetylsalicylic acid use.
Dosen kan, hvis nødvendig, senere økes til 200 mg to ganger daglig.
The dose may, if needed, later be increased to 200 mg twice daily.
Ingen studier foreligger om utskillelse av celekoksib i human morsmelk.
There are no studies on the excretion of celecoxib in human milk.
Hos noen pasienter, med utilstrekkelig lindring av symptomer, kan en økt dose på 200 mg to ganger daglig øke effekten.
In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy.
Den inter-individuelle variasjon ved eksponering av celekoksib er omlag 10-fold.
The inter-subject variability in the exposure of celecoxib is about 10-fold.
Maksimal anbefalt døgndose er 400 mg for begge indikasjoner.
The maximum recommended daily dose is 400 mg for both indications.
Dersom en kvinne blir gravid under behandling, skal celekoksibbehandlingen avsluttes.
If a woman becomes pregnant during treatment, celecoxib should be discontinued.
Diafragmabrokk ble også sett i en peri postnatal toksisitetsstudie hos rotter, som inkluderte eksponering i den organogenetiske periodne.
Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
2. KVALITATIV OG KVANTITATIV SAMMENSETNING Hver kapsel inneholder 100 mg eller 200 mg celekoksib
2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg or 200 mg celecoxib.
Det kan også ha en rolle ved sårtilheling.
It may also play a role in ulcer healing.
{INVENTED NAME, see Annex I} 200 mg kapsel, hard.
{INVENTED NAME, see Annex I } 200 mg capsule, hard.
Alvorlig nedsatt leverfunksjon (serum-albumin < 25 g/L eller Child-Pugh >10).
Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ³10).
En doseavhengig effekt på TxB2-dannelse er observert etter høye doser celekoksib.
A dose dependent effect on TxB2 formation has been observed after high doses of celecoxib.
Andre reaksjoner rapportert fra erfaring etter markedsføring hos >70 millioner behandlede pasienter inkluderte hodepine, kvalme, artralgi og reaksjonene listet som svært
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.
In vitro studier har vist et visst potensiale for celekoksib til å hemme CYP2C19 katalysert metabolisme.
In vitro studies have shown some potential for celecoxib to inhibit CYP2C19 catalysed metabolism.
Celekoksib absorberes bra, og maksimal plasmakonsentrasjon nås etter ca 2-3 timer.
Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
2870 Puurs Belgia
2870 Puurs Belgium
Ugjennomsiktige, hvite med to blå striper merket 7767 og 100 (INVENTED NAME 100 mg).
Opaque, white with two blue bands marked 7767 and 100 (INVENTED NAME 100 mg).
Pasienter med alvorlig nedsatt leverfunksjon (serum-albumin < 25 g/L) er ikke studert og celekoksib er kontraindisert for denne pasientgruppen.
Patients with severe hepatic impairment (serum albumin <25 g/l) have not been studied and celecoxib is contraindicated in this patient group.
Celekoksibs farmakokinetikk har ikke vært studert hos pasienter med nedsatt nyrefunksjon, men er trolig ikke markert forandret hos disse pasientene.
The pharmacokinetics of celecoxib has not been studied in patients with renal impairment but is unlikely to be markedly changed in these patients.
5a-B Pargas Str P.O.Box 22002
Markides & Vouros Ltd. 5a-B Pargas Str P.O.Box 22002
Dersom pasienten blir verre under behandlingen med tanke på funksjonen i noen av organsystemene beskrevet ovenfor, skal nødvendige tiltak iverksettes og seponering av behandlingen med celekoksib
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.
B-2870 Puurs Belgia
B-2870 Puurs Belgium
283, route d'Arlon, L-8011 Strassen,
Pfizer Luxembourg SARL, 283, route d'Arlon, L-8011 Strassen, Luksemburg
Medlemsland
Member State
De viktigste sirkulerende metabolittene har ingen detekterbar hemmende aktivitet på COX-1 eller
The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
Nedsatt nyrefunksjon: Erfaring med celekoksib hos pasienter med mild til moderat nedsatt nyrefunksjon er begrenset, derfor bør slike pasienter behandles med forsiktighet.
Renal impairment: Experience with celecoxib in patients with mild or moderate renal impairment is limited, therefore such patients should be treated with caution.
4.9 Overdosering Det finnes ikke klinisk erfaring med overdose.
There is no clinical experience of overdose.
Plasmakonsentrasjonen av celekoksib er sannsynligvis markant forhøyet hos slike pasienter.
Plasma concentrations of celecoxib are probably markedly increased in such patients.
Ved celekoksib-behandling økte plasmakonsentrasjonen av CYP2D6-substratet dekstrometorfan med 136%.
During celecoxib treatment, the plasma concentrations of the CYP2D6 substrate dextromethorphan were increased by 136%.
I en interaksjonsstudie hadde celekoksib ingen klinisk relevante effekter på farmakokinetikken til orale antikonsepsjonsmidler (1mg noretisteron/35 mikrogram etinyløstradiol).
In an interaction study, celecoxib had no clinically relevant effects on the pharmacokinetics of oral contraceptives (1 mg norethistherone /35 microg ethinylestradiol).
Pasienter med kjent sulfonamidallergi eller annen legemiddelallergi kan ha større risiko for alvorlige hudreaksjoner eller overfølsomhetsreaksjoner (se pkt.
Patients with a history of sulphonamide allergy or any drug allergy may be at greater risk of serious skin reactions or hypersensitivity reactions (see 4.3).
Særlig forsiktighet skal utvises hos eldre med kroppsvekt lavere enn 50 kg (se pkt.
Particular caution should be exercised in elderly with a body weight less than 50 kg. (See 4.4 and 5.2).
Tjueto prosent av de inkluderte pasientene tok samtidig lavdose acetylsalisylsyre (≤ 325 mg /dag), primært
Twenty-two percent of enrolled patients took concomitant low-dose acetylsalicylic acid (£325 mg/day),
I en prospektiv langvarig sikkerhetsstudie (6 til 15 måneders varighet, CLASS-studie), fikk 5800 artrose- og 2200 RA-pasienter celekoksib 400 mg to ganger daglig (henholdsvis 4 ganger og 2 ganger anbefalt artrose- og RA-dose), ibuprofen 800 mg tre ganger daglig eller diklofenak 75 mg to ganger daglig (begge ved terapeutiske doser).
In a prospective long-term safety outcome study (6 to 15 month duration, CLASS study), 5,800 OA and 2,200 RA patients received celecoxib 400 mg BID (4-fold and 2-fold the recommended OA and RA doses, respectively), ibuprofen 800 mg TID or diclofenac 75 mg BID (both at therapeutic doses).
som kardiovaskulær profylakse.
primarily for cardiovascular prophylaxis.
Øvre gastrointestinale komplikasjoner (perforasjoner, sår eller blødninger (PUB's)), noen med fatale følger, har forekommet hos pasienter behandlet med celekoksib.
Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
Etablert iskemisk hjertesykdom, perifer arteriesykdom og/eller cerebrovaskulær sykdom.
Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
LEGEMIDLETS NAVN {INVENTED NAME, see Annex I} 100 mg kapsel, hard.
1 NAME OF THE MEDICINAL PRODUCT {INVENTED NAME, see Annex I} 100 mg capsule, hard.
Ingen kliniske data foreligger fra eksponering under graviditet for celekoksib.
No clinical data on exposed pregnancies are available for celecoxib.
Som for NSAIDs, kan risikoen for akutt nyreinsuffisiens, som vanligvis er reversibel, øke hos noen pasienter med nedsatt nyrefunksjon (f.eks. dehydrerte pasienter eller eldre) når ACE-hemmere eller angiotensin-II-reseptor antagonister kombineres med NSAIDs, inklusive celekoksib.
As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients)when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
Ugjennomsiktige, hvite med to gulfargete striper merket 7767 og 200 (INVENTED NAME 200 mg).
Opaque, white with two gold bands marked 7767 and 200 (INVENTED NAME 200 mg).
Siden celekoksib hovedsakelig metaboliseres via CYP2C9, bør det brukes halvparten av anbefalte dose hos pasienter
Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole.
Dyrestudier på rotter og kaniner har vist reproduksjonstoksisitet, inklusive misdannelser (se pkt.
Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see 4.3 and 5.3).
Legemiddelform Administrasjonsvei
Pharmaceutical Form Route of administration
ingen økt forekomst ved behandling med celekoksib sammenlignet med placebo.
For all strokes, there was no increased event rate with celecoxib compared with placebo.