natgillin/translations-raw huggingface dataset:
Nedsatt leverfunksjon: Behandling bør initieres med halvparten av anbefalt dose til pasienter med fastslått moderat nedsatt leverfunksjon med serum-albumin 25-35 g/L. Erfaring hos slike pasienter begrenser seg til pasienter med cirrhose.
Hepatic impairment: Treatment should be initiated at half the recommended dose in patients with established moderate liver impairment with a serum albumin of 25-35 g/l.
i de første dagene etter at behandling med celekoksib initieres eller celekoksib-dosen endres (se pkt. 4.4).
Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with celecoxib is initiated or the dose of celecoxib is changed (see 4.4).
slag) var 3,4 (95% CI 1,4-8,5) for den høyeste dosen og 2,5
The relative risk (RR) for the composite endpoint (cardiovascular death, MI or stroke) was 3.4 (95% CI 1.4 - 8.5) for the higher dose and 2.5 (95% CI 1.0 - 6.4) for the lower dose of celecoxib, compared to placebo.
i ni dager, uten at dette har gitt klinisk signifikante bivirkninger.
mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse effects.
Spania
Spain
Celekoksib utskilles i morsmelk hos diegivende rotter i konsentrasjoner omtrent
Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
til pasienter med tidligere hjertesvikt, venstre ventrikkeldysfunksjon eller hypertensjon, og hos pasienter med preeksisterende ødem av annen årsak, ettersom prostaglandinhemming kan medføre forverring av nyrefunksjon og væskeretensjon.
Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention.
Svært sjeldne: forverret epilepsi, aseptisk meningitt, ageusi, anosmi
Very rare: aggravated epilepsy, meningitis aseptic, ageusia, anosmia
Tsjekkia
Czech Republic
Det er liten erfaring med celekoksib til pasienter med nedsatt nyrefunksjon.
There is little experience of celecoxib in renal impairment.
Den kliniske
Clinical 2
Østerrike
Austria
som hemmer prostaglandinsyntesen, er væskeretensjon og ødem observert hos pasienter som tar celekoksib.
As with other drugs known to inhibit prostaglandin synthesis fluid retention and oedema have been observed in patients taking celecoxib.
Sjeldne: duodenal-, ventrikkel-, øsofageal- og intestinalsårdannelse, sårdannelse i tykktarm, dysfagi, intestinal perforasjon, øsofagitt, melena
Rare: duodenal, gastricoesophageal, intestinal and colonic ulceration, dysphagia, intestinal perforation, oesophagitis, melaena
som er kjent å ha langsom metabolisme via CYP2C9 bør behandles med forsiktighet. (Se pkt.
Patients known to be CYP2C9 poor metabolisers should be treated with caution (see 5.2.
Mindre vanlige: økning i ASAT og ALAT, økning av serum-kreatinin og urinstoff
Investigations Uncommon: increased SGOT and SGPT, increased creatinine, BUN increased
Alvorlig nedsatt nyrefunksjon er kontraindisert.
Severe renal impairment is contraindicated.
4.6 og 5.3).
Breast feeding (See 4.6 and 5.3).
Pfizer H.C.P. Corporation Representation Office in Lithuania A.
Corporation Representation Office in Lithuania A. Gostauto 40 a
23-25, avenue du Docteur Lannelongue
Pfizer Holding France 23-25, avenue du Docteur Lannelongue 75668 Paris Cedex 14
tegn på inflammasjon.
Inflammatory bowel disease.
Alvorlige overfølsomhetsreaksjoner (anafylakse og angioødem) er rapportert hos pasienter
Serious hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients receiving celecoxib (see 4.8).
5. FARMAKOLOGISKE EGENSKAPER
5 PHARMACOLOGICAL PROPERTIES
Vanlige: utslett
Uncommon: urticaria
sikkerhet mellom selektive COX-2-hemmere + acetylsalisylsyre og NSAIDs + acetylsalisylsyre er
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in longterm clinical trials (see 5.1).
Pasienter med vesentlige risikofaktorer for kardiovaskulære hendelser (f.eks. hypertensjon,
- Addition of a warning for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia (high cholesterol levels), diabetes and smoking.
Pharmacia Ireland Limited
Pharmacia Ireland Limited Airways Industrial Estate Dublin 17
sår sammenlignet med naproxen (1000 mg per dag) og ibuprofen (2400 mg per dag).
In twelve week endoscopy studies celecoxib (100-800 mg per day) was associated with a significantly lower risk of gastroduodenal ulcers compared with naproxen (1000 mg per day) and ibuprofen (2400 mg per day).
som inkluderte placebo og/eller aktiv kontrollgruppe.
The following events have been reported in patients receiving celecoxib in 12 placebo and/or active controlled trials.
som bekrefter effekt og sikkerhet ved artrose og reumatoid artritt. Celekoksib ble evaluert for behandling av inflammasjon og smerte ved artrose i kne og hofte hos omlag 4200 pasienter i opptil 12 uker
Celecoxib was evaluated for the treatment of the inflammation and pain of OA of the knee and hip in approximately 4200 patients in placebo and active controlled trials of up to 12 weeks duration.
R. Manuel Ribeiro de Pavia, n.º1
Lab. Medinfar - Produtos Farmacêuticos S.A. R. Manuel Ribeiro de Pavia, n.º1 - Venda Nova 2700-547 Amadora
selektiv cyclooxygenase-2-(COX-2-)hemmer innenfor det kliniske doseområdet
Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily).
karbamazepin og barbiturater, kan redusere plasmakonsentrasjonen av celekoksib.
Concomitant use of inducers of CYP2C9 such as rifampicin, carbamazepine and barbiturates may reduce plasma concentrations of celecoxib.
Imidlertid hadde celekoksib ingen effekt på plateaggregering og blødningstid sammenlignet med placebo ved gjentatt dosering med 600 mg to ganger daglig (tre ganger den høyeste anbefalte dose) hos friske frivillige.
However, in healthy subjects, in small multiple dose studies with 600 mg BID (three times the highest recommended dose) celecoxib had no effect on platelet aggregation and bleeding time compared to placebo.
i vev omkring magesår hos menneske, men dets relevans for sårtilheling er ikke klarlagt.
COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.
Blødningstilfeller assosiert med økt protrombintid er rapportert, hovedsakelig hos eldre pasienter
Bleeding events in association with increases in prothrombin time have been reported, predominantly in the elderly, in patients receiving celecoxib concurrently with warfarin, some of them fatal.
14 Fankrike
4 CLINICAL PARTICULARS
Slovakia
Slovak Republic
som hemmer prostaglandinsyntesen, kan celekoksib forårsake svekkede rier og prematur lukking av ductus arteriosus i siste trimester. Celekoksib er kontraindisert ved graviditet og til kvinner
Celecoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.
Forskjellen i effekt på plateaggregering mellom enkelte COX-1 hemmende NSAIDs og selektive
The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
som besto av blødninger eller var av ukjent etiologi) 0,5 hendelser pr. 1000 i løpet av 3 år (sjelden).
In the same studies, the excess rate for clearly identified ischaemic stroke for the 400 mg daily dose (not including events that were haemorrhagic or of unknown aetiology) was 0.5 event per 1000 over 3 years (Rare).
sår eller andre gastrointestinale komplikasjoner ved samtidig bruk av lavdose acetylsalisylsyre, sammenlignet med bruk av celekoksib alene (se pkt.
In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see 5.1).
sjeldne: akutt nyresvikt, interstitiell nefritt
Renal and urinary disorders Very rare: acute renal failure, interstitial nephritis
Svært
Strength
som avbrøt behandling på grunn av bivirkninger var 7,1% for pasienter
Side-effects listed have a rate equal or greater than placebo, and the discontinuation rate due to side effects was 7.1% in patients receiving celecoxib and 6.1% in patients receiving placebo.
Svært sjeldne: forvirring, hallusinasjoner
Uncommon: anxiety, depression, tiredness Very rare: confusion, hallucinations.
Reumatoid artritt: Anbefalt startdose er 200 mg daglig fordelt på to doser. Dosen kan, dersom nødvendig, senere økes til 200 mg to ganger daglig.
Rheumatoid arthritis: The initial recommended daily dose is 200 mg taken in two divided doses.
til tolbutamid (CYP2C9substrat) eller glibenklamid.
Celecoxib does not affect the pharmacokinetics of tolbutamide (CYP2C9 substrate), or glibenclamide to a clinically relevant extent.
Vanlige: perifert ødem/væskeretensjon Undersøkelser
General disorders and administration site conditions Common: peripheral oedema/ fluid retention
Vanlige: faryngitt, rhinitt
Common: rash
Celekoksib er vist å kunne forårsake misdannelser hos de to dyrearter
Celecoxib has been shown to cause malformations in the two animal species studied (See 4.6 and 5.3).
Vanlige: søvnløshet
Common: dizziness
6. FARMASØYTISKE OPPLYSNINGER
6 PHARMACEUTICAL PARTICULARS
tidlig embryonutvikling preimplantasjons- og postimplantasjonstap. Disse effektene er forventet ved hemming av prostaglandinsyntese.
In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
Mindre vanlige: hyperkalemi
Metabolism and nutrition disorders Uncommon: hyperkalaemia
skal monitoreres etter initiering av samtidig behandling med celekoksib og ACE-hemmere eller angiotensin-II-reseptor antagonister. Denne overveielsen skal foretas jevnlig under behandlingen.
- Addition of a warning for prescribers to exercise caution when prescribing NSAIDs, including celecoxib, in combination with ACE inhibitors or angiotensin II receptor antagonists.
1000 pasient (sjelden) hos pasienter behandlet med celekoksib 200 eller 400 mg daglig sammenlignet med placebo.
*In a pooled analysis of 20 placebo-controlled studies with duration greater than 2 weeks up to 1 year in patients with OA and RA, the excess rate of myocardial infarction in patients treated with celecoxib 200 or 400 mg daily over placebo was 0.7 events per 1000 patients (Rare) and there was no excess of strokes.
Hellas
Greece
Basert på konvensjonelle toksisitetsstudier, genotoksitet eller karsinogenisitet, ble det
Based on conventional studies, genotoxicity or carcinogenicity, no special hazard for humans was observed, beyond those addressed in other sections of the SmPC.
Sjeldne: ataksi, smaksforandring
Uncommon: blurred vision, hypertonia, paraesthesia Rare: ataxia, taste alteration
Nevrologiske sykdommer Vanlige:
Psychiatric disorders Common: insomnia
Hos pasienter
Clinical 5
Holdbarhet
Description
Midlertidige data fra to studier i pasienter med kolorektale polypper behandlet med celekoksib 400
Ongoing Clinical Trials: Preliminary safety information from three long-term studies involving patients with Sporadic Adenomatous Polyps or who were predisposed to developing Alzheimer's disease treated with celecoxib is available.
i magen, klinisk overvåkning og, om nødvendig, instituere symptomatisk behandling.
To continue to make available emerging clinical and epidemiological data through publications and, where possible, in scientific congresses.
9. MT-DATO FOR FØRSTE GANG/SISTE FORNYELSE
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted or renewed.]
Sjeldne: iskemisk slag*
Rare: ischaemic stroke* Very rare: vasculitis.
skal kun behandles med celekoksib etter nøye vurdering (se 5.1).
Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see 5.1).
Copalia HCT се приема през устата под формата на една таблетка веднъж дневно по едно и също време на деня и за предпочитане сутрин.
Copalia HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Пълният текст на EPAR за Copalia HCT може да се намери на уебсайта на Агенцията: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Copalia HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Copalia HCT.
This is a summary of the European public assessment report (EPAR) for Copalia HCT.
За повече информация относно лечението с Copalia HCT прочетете листовката (също част от EPAR) или попитайте Вашия лекар или фармацевт.
For more information about treatment with Copalia HCT, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Трите активни вещества в Copalia HCT са антихипертензивни лекарства, които вече са в употреба в Европейския съюз (ЕС).
The three active substances in Copalia HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Пациентите получават Copalia HCT или една от трите комбинации, съдържащи само две от активните вещества, за период от осем седмици.
Patients received either Copalia HCT or one of the three combinations containing only two of the active substances for eight weeks.
Основното проучване показва ползата от най-високата концентрация Copalia HCT за понижаване на кръвното налягане.
The main study showed the benefit of the highest strength of Copalia HCT in lowering the blood pressure.
CHMP реши, че ползите от Copalia HCT са по-големи от рисковете, и препоръча да се издаде разрешение за употреба.
The CHMP therefore decided that Copalia HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Комитетът по лекарствените продукти за хуманна употреба (CHMP) е оценил лекарството, за да даде положително становище за разрешаване за употреба и препоръки за условията на употреба на Copalia HCT.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Copalia HCT.
За пълния списък на всички нежелани лекарствени реакции, съобщени при Copalia HCT, вижте листовката.
For the full list of all side effects reported with Copalia HCT, see the package leaflet.
Дозата Copalia HCT, която следва да се употребява, е същата като дозите на трите отделни активни вещества, които пациентът е приемал преди това самостоятелно.
The dose of Copalia HCT to be used is the same as the doses of three individual active substances that the patient was taking before.
Лечението с най-високата концентрация Copalia HCT е по-ефективно за лечението на хипертонията отколкото двойните комбинации, съдържащи което и да е от двете активни вещества.
Treatment with the highest strength of Copalia HCT was more effective at treating hypertension than dual combinations containing any of the two active substances.
При всички дози Copalia HCT отговоря на изискванията и показва, че е съпоставим с комбинациите от индивидуалните активни вещества, приемани поотделно.
For all doses, Copalia HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
При пациенти, приемащи Copalia HCT, средното понижаване на кръвното налягане е около 39,7/24,7 mmHg в сравнение с 32/19,7 mmHg, 33,5/21,5 mmHg и 31,5/19,5 mmHg при пациенти, приемащи съответно комбинациите валсартан/хидрохлоротиазид, валсартан/амлодипин и хидрохлоротиазид/амлодипин.
The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Copalia HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
В допълнение е проведено едно основно проучване при 2271 пациенти с умерена до тежка хипертония с най-високата концентрация Copalia HCT (320 mg валсартан, 10 mg амлодипин и 25 mg хидрохлоротиазид).
In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Copalia HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
CHMP отбеляза, че за пациентите, които вече са приемали трите активни вещества, могат да понесат лечение с Copalia HCT, съдържащ трите вещества в една таблетка.
The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Copalia HCT which combines the three substances in a single tablet.
Дневната доза Copalia HCT не трябва да превишава 10 mg амлодипин, 320 mg валсартан и 25 mg хидрохлоротиазид.
The daily dose of Copalia HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Copalia HCT е лекарство, което съдържа три активни вещества, амлодипин (amlodipine), валсартан (valsartan) и хидрохлоротиазид (hydrochlorothiazide).
Copalia HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Copalia HCT не трябва да се прилага при хора, които са свръхчувствителни (алергични) към активните вещества, сулфонамиди или към някоя от останалите съставки в Copalia HCT.
Copalia HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Copalia HCT.
Copalia HCT се използва за лечение на есенциална хипертония (високо кръвно налягане) при възрастни, при които е постигнат задоволителен контрол на кръвното налягане с комбинация от амлодипин, валсартан и хидрохлоротиазид.
Copalia HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
В заключение Copalia HCT не трябва да се използва при пациенти с хипокалемия (ниски нива на калий в кръвта), хипонатриемия (ниски нива на натрий в кръвта) и хиперкалциемия (високо съдържание на калций в кръвта), които не се повлияват от лечението, и при пациенти с хиперурикемия (повишаване на нивата на пикочната киселина в кръвта), която причинява симптоми.
Finally, Copalia HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Най-честите нежелани лекарствени реакции при Copalia HCT (наблюдавани при 1 до 10 на 100 пациенти) са хипокалемия (ниски нива на калий в кръвта), замаяност, главоболие, хипотензия (ниско кръвно налягане), диспепсия (киселини), полакиурия (абнормено често уриниране),
The most common side effects with Copalia HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Copalia HCT не трябва да се използва в комбинация с лекарства, съдържащи алискирен (използвани за лечение на есенциална хипертония), при пациенти с диабет тип 2 или с умерено или тежко бъбречно увреждане.
Copalia HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Какви ползи от Copalia HCT са установени в проучванията?
What benefit has Copalia HCT shown during the studies?
Какви са рисковете, свързани с Copalia HCT?
What is the risk associated with Copalia HCT?
Допълнителна информация за Copalia HCT:
Other information about Copalia HCT
Европейската комисия издава разрешение за употреба на Copalia HCT, валидно в Европейския съюз.
The European Commission granted a marketing authorisation valid throughout the European Union for Copalia HCT on 4 November 2009.
Какво представлява Copalia HCT?
What is Copalia HCT?
Как е проучен Copalia HCT?
How has Copalia HCT been studied?
За какво се използва Copalia HCT?
What is Copalia HCT used for?
Как се използва Copalia HCT?
How is Copalia HCT used?
Защо Copalia HCT е разрешен за употреба?
Why has Copalia HCT been approved?
Как действа Copalia HCT?
How does Copalia HCT work?
И ЛИСТОВКАТА
ANNEX III
ПРИЛОЖЕНИЕ III КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА, ОПАКОВКАТА
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
1 доза (0,5 ml) съдържа приблизително:
1 1 dose (0.5 ml) contains approximately:
Човешки папиломавирус тип 16 L1 протеин b,c (Human Papillomavirusa Type 16 L1 proteinb,c) 40 микрограма Човешки папиломавирус тип 18 L1 протеин b,c (Human Papillomavirusa Type 18 L1 proteinb,c) 20 микрограма aЧовешки папиломавирус = HPV. bL1 протеин под формата на вирусоподобни частици, произведени върху дрождеви клетки (Saccharomyces cerevisiae CANADE 3C-5 (Щам 1895)) чрез рекомбинантна ДНК технология.
Human Papillomavirusa Type 11 L1 proteinb,c 40 micrograms Human Papillomavirusa Type 16 L1 proteinb,c 40 micrograms Human Papillomavirusa Type 18 L1 proteinb,c 20 micrograms a Human Papillomavirus = HPV
20 микрограма b,c) 40 микрограма
20 micrograms
cадсорбирани върху аморфен алуминиев хидроксифосфат сулфат адювант (225 микрограма Al).
b L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology c adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al)
1 флакон предварително напълнена спринцовка предварително напълнена спринцовка + 1 игла флакон (стъкло) 0.5 ml предварително напълнени спринцовкаи
1 pre-filled syringe + 1 needle
Опаковка
1 vial
Какви мерки се предприемат, за да се гарантира безопасната и ефективна употреба на Lartruvo?
What measures are being taken to ensure the safe and effective use of Lartruvo?
Този протеин често се намира на повърхността на клетките, където играе роля за регулацията на клетъчното размножаване.
This protein is often found on the surface of cells where it plays a role in regulating cell multiplication.
Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Lartruvo.
This is a summary of the European public assessment report (EPAR) for Lartruvo.
Документът не е предназначен да предоставя практически съвети относно употребата на Lartruvo.
It is not intended to provide practical advice on how to use Lartruvo.
Комитетът по лекарствените продукти за хуманна употреба (CHMP) на Агенцията реши, че ползите от Lartruvo са по-големи от рисковете, и препоръча Lartruvo да бъде разрешен за употреба в ЕС.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Lartruvo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Поради малкия брой пациенти в основното проучване обаче са необходими допълнителни данни от фирмата, която предлага лекарството.
However, because of the small number of patients included in the main study, further data will be needed from the company that markets the medicine.
Препоръчителната доза на Lartruvo е 15 mg на килограм телесно тегло, прилагана два пъти за период от три седмици, на ден 1 и ден 8.
The recommended dose of Lartruvo is 15 mg per kilogram body weight, given twice over a period of three weeks, on days 1 and 8.