natgillin/translations-raw huggingface dataset:
- progressiv multifokal leukoencefalopati (PML) så som konfusion, problemer med at tænke, hukommelsestab, uklart syn eller synstab, nedsat styrke, nedsat kontrol eller følelse i en arm eller et ben, en forandring i måden at gå på eller tab af balance (for nærmere informationer, se punkt 2) (forekommer hos færre end 1 ud af 100 personer).
Tell your doctor straight away if you notice any of the following symptoms because some of them may be signs of a serious or possibly fatal condition: - progressive multifocal leukoencephalopathy (PML) symptoms such as confusion, trouble thinking, memory loss, blurred or loss of vision, decreased strength, decreased control or sensation in one arm or leg, a change in the way of walking, or loss of balance (for more detailed information, see section 2) (affects less than 1 in 100 people) - symptoms of inflammation of the pancreas (pancreatitis) such as severe and persistent stomach pain, with or without nausea and vomiting (may affect up to 1 in 100 people).
(6,1-204,0) 18,8 mdr.
18.7 mo (6.1-204.0)
Rygsmerter
Refractory
Den anbefalede startdosis til patienter med let nedsat leverfunktion er 0,9 mg/kg administreret som en intravenøs infusion over 30 minutter hver 2. uge.
The recommended starting dose in patients with mild hepatic impairment is 0.9 mg/kg administered as an intravenous infusion over 30 minutes every 2 weeks.
2,4 hætteglas
2.4 vials
Af de 8 sALCL-patienter blev 3 genbehandlet to gange, hvilket giver 11 genbehandlinger i alt. Genbehandling med ADCETRIS medførte 6 CR (55 %) og 4 PR (36 %), dvs. en ORR på 91 %.
Retreatment with ADCETRIS resulted in 6 CRs (55%) and 4 PRs (36%), for an ORR of 91%.
Tabel 13 viser en oversigt over patient- og sygdomskarakteristika ved baseline.
Table 13 provides a summary of the baseline patient and disease characteristics.
Dosisjustering
Dose adjustments
Antal hændelser
Number of Risk Factors
Primær refraktær på førstelinjebehandling Refraktært på den seneste behandling Baseline B-symptomer Stadium III ved initiel diagnose Stadium IV ved initiel diagnose a. Primært refraktær HL defineres som manglende opnåelse af komplet remission efter primær behandling eller progression inden for 3 måneder efter afslutning af denne.
One patient had a baseline ECOG status of 2, which was prohibited by protocol and is captured as Inclusion Criteria Not Met. b. Primary refractory sALCL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Figur 3: Kaplan-Meier-plot af PFS iht.
Figure 3: Kaplan-Meier Plot of PFS per IRF in Patients with ≥ 2 Risk Factors
Sygdomskarakteristika
Disease Characteristics
Immunsystemet Ikke almindelig:
Febrile neutropenia Immune system disorders Uncommon:
Tumorlyse-syndrom
Tumour lysis syndrome
IRF (HR = 0,58 [95 % CI (0,41; 0,81)]).
An updated analysis conducted after 3 years of follow-up showed a sustained PFS improvement per IRF (HR = 0.58 [95% CI (0.41, 0.81)]).
6.6) indeholder hver ml 5 mg brentuximab vedotin.
Each vial contains 50 mg of brentuximab vedotin
Den anbefalede startdosis for patienter med svært nedsat nyrefunktion er 1,2 mg/kg administreret som intravenøs infusion over 30 minutter hver 3. uge.
The recommended starting dose in patients with severe renal impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
I det puljede datasæt for ADCETRIS som monoterapi i studier af HL, sALCL og CTCL (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 og C25007, se pkt.
In the pooled dataset of ADCETRIS as monotherapy across HL, sALCL and CTCL studies (SG035-0003, SG035-0004, SGN35-005, SGN35-006, C25001 and C25007, see section 5.1) the most frequent adverse reactions (≥ 10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain.
Visse infektioner kan være alvorlige og kan skyldes virus, bakterier eller andet, der kan være livstruende.
Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening experience a whistling sound during breathing (wheezing)/difficulty breathing, hives, itching, or swelling (signs of an infusion reaction).
Grad 2 (<1500-1000/mm
9/L) or Grade 2 (< 1500-1000/mm < 1.5-1.0 x 10
Det skal du vide, før du begynder at få Adcetris
What you need to know before you are given Adcetris
144 mg
80 kg 144 mg
investigator var 0,41 (95 % CI [0,29; 0,58]) (se fig. 3 og 4).
Hazard ratio (95% CI): 0.770 ( 0.603, 0.983)
Den anbefalede startdosis for patienter med nedsat leverfunktion er 1,2 mg/kg administreret som intravenøs infusion over 30 minutter hver 3. uge.
The recommended starting dose in patients with hepatic impairment is 1.2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks.
Figur 4: Kaplan-Meier-plot af PFS iht.
Figure 4: Kaplan-Meier Plot of PFS per Investigator in Patients with ≥ 2 Risk Factors
- har nyopstået eller forværret åndenød eller hoste, da disse kan være symptomer på en alvorlig og potentielt dødelig lungekomplikation (lungetoksicitet).
have abnormal liver test results as this may be related to a serious and potentially fatal liver injury (hepatotoxicity).
<nederste grænse af normalområdet (LLN)-1,5 x 10
Grade 1 (< LLN-1500/mm < LLN-1.5 x 10
Blod og lymfesystem Meget almindelig:
Frequency not known: Progressive multifocal leukoencephalopathy Blood and lymphatic system disorders Very common:
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - infektion i blodet (blodforgiftning) og/eller septisk shock (en livstruende form for blodforgiftning) - lungebetændelse - blærer, der kan danne skorpe eller sår - ømme, cremegule, hævede pletter i munden (trøske) - kløe - forhøjet blodsukker
Common side effects (may affect up to 1 in 10 people) - an infection in the blood (sepsis) and/or septic shock (a life-threatening form of sepsis);
108 mg
60 kg 108 mg
Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
This includes herbal medicines and other medicines you can obtain without a prescription.
Knogler, led, muskler og bindevæv Meget almindelig:
Musculoskeletal and connective tissue disorders Very common:
Vægttab
dizziness
96 mg
80 kg 96 mg
Levertoksicitet
Metabolism
Oversigt over indlægssedlen
VIAL LABEL
Samtidig administration af brentuximab vedotin og rifampicin, en stærk CYP3A4-induktor, ændrede ikke plasma-eksponeringen for brentuximab vedotin; Skønt der er begrænsede PK-data, syntes samtidig administration af rifampicin at reducere plasmakoncentrationer af de MMAE-metabolitter, der kunne bestemmes.
Co-administration of brentuximab vedotin with rifampicin, a strong CYP3A4 inducer, did not alter the plasma exposure to brentuximab vedotin.
IRF 0,49 (95 % CI [0,34; 0,71]), og hazard ratio for PFS iht.
At the time of the updated analysis (3 years of follow-up) for patients with 2 or more risk factors, the hazard ratio for PFS per IRF was 0.49 (95% CI [0.34, 0.71]) and the hazard ratio for PFS per investigator was 0.41 (95% CI [0.29, 0.58]) (see Figures 3 and 4).
72 mg
60 kg 72 mg
Hæn
Dizziness
Lungetoksicitet
Hepatotoxicity
investigator.
Median per Investigator
Tumorlysesyndrom
Pulmonary toxicity
ADCETRIS er indiceret til behandling af voksne patienter med recidiverende eller refraktært CD30+ Hodgkins lymfom (HL): 1.
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi -agent chemotherapy is not a treatment option.
Klargøring af infusionsvæsken
Preparation of Infusion Solution
97 M (59 %)/67 F
76M (46%)/89F (54%) 97M (59%)/67F (41%)
Hvis du oplever nogle af disse symptomer, skal du straks kontakte en læge.”
If you experience any one of these symptoms you must tell your doctor immediately.”
Der er evidens for, at højere doser og/eller kumulativ eksponering er risikofaktorer for udvikling af hjerteklappatologi.
There is evidence that higher dose and/or cumulative exposure are risk factors for development of valvular pathology.
Alle patienter bør gennemgå en kardiovaskulær vurdering, herunder ekkokardiografi, for at vurdere eventuel tilstedeværelse af en asymptomatisk hjerteklaplidelse.
All patients must undergo a cardiovascular evaluation, including echocardiogram, to assess the potential presence of asymptomatic valvular disease.
Hvis der opstår fibrotiske reaktioner, skal behandlingen afbrydes."
If fibrotic reactions occur treatment will have to be discontinued.”
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use:
4.3 Kontraindikationer
4.3 Contraindications:
Imidlertid er hjerteklaplidelser og fibrotiske reaktioner også set ved behandling med pergolid i doser lavere en 0,5 mg daglig.
However, valvulopathy and fibrotic reactions have been reported during treatment with pergolide at doses less than 0.5mg/day.
Fibrotiske lidelser kan være langsomt indtrædende, og patienter bør monitoreres jævnligt for mulige manifestationer af progressiv fibrose.
Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis.
Yderligere undersøgelser, som f.eks. erythrocyt sænkningsreaktion og måling af serumkreatinin bør om nødvendigt foretages for at understøtte en diagnose på fibrotisk lidelse”.
Additional appropriate investigations such as erythrocyte sedimentation rate, and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder.”
Der er set abnorm forhøjelse af erythrocyt-sænkningsreaktion (ESR) hos patienter med pleuraeffision/fibrose.
Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis.
Behovet for yderligere klinisk monitorering (f.eks. fysisk undersøgelse, hjertestetoskopi, røntgen, CT scanning) bør bestemmes efter en individuel vurdering.
The need for other clinical monitoring (e.g. physical examination including, cardiac auscultation, Xray, CT scan) should be determined on an individual basis.
Hjerteklapfibrose (og konstriktiv pericarditis) skal udelukkes, hvis sådanne symptomer opstår.
Therefore, valvular fibrosis (and constrictive pericarditis) should be excluded if such symptoms occur.
Lægen vil også foretage et ekkokardiogram (en ultralydsundersøgelse af hjertet) både før behandlingen begyndes og med jævne mellemrum under behandlingen.
He/she will also have an echocardiogram (an ultrasound test of the heart) taken before treatment is started and at regular intervals during treatment.
Før iværksættelse af langtidsbehandling:
Before initiating long-term treatment:
Afsnit 4 Bivirkninger
Section 4 “Possible side effects”:
De tidlige symptomer på dette viser sig ved en eller flere af følgende tilstande: åndedrætsbesvær, åndenød, smerter i brystet eller ryggen og hævede ben.
The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, chest or back pain and swollen legs.
Afsnit 2 ”Det skal De vide, før De begynder at tage [produktnavn]”
Section 2 “Before you take [product name]”.
4.8 Bivirkninger
4.8 Undesirable effects:
Herefter bør hyppigheden af ekkokardiografisk monitorering bestemmes efter en passende individuel klinisk vurdering med særlig opmærksomhed på de ovennævnte tegn og symptomer, men bør foretages mindst hver 6.-12. måned.
Following treatment initiation, the first echocardiogram must occur within 3-6 months, thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on the above-mentioned signs and symptoms, but must occur at least every 6 to 12 months.
Det kan være hensigtsmæssigt at udføre baseline monitorering af erythrocyt sænkningsreaktionen eller de andre inflammatoriske markører, lungefunktion/røntgen af thorax samt nyrefunktion inden behandlingen initieres
It is also appropriate to perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation of therapy.
Under langtidsbehandling:
During long-term treatment:
Følgende tilføjes under Hjerte: ”Meget almindelig: Hjerteklapfibrose (inklusivt tilbageløb) og relaterede lidelser (pericarditis og pericardieekssudat).”
The following should be included under Cardiac disorders: “Very common: cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion).”
”Fibrose og hjerteklaplidelser og relaterede kliniske fænomener
“Fibrosis and cardiac valvulopathy and possibly related clinical phenomena:
Før behandling initieres:
Before initiating treatment:
Hvis en fibrotisk klaplidelse påvises, bør patienten ikke behandles med pergolid (se pkt.
If fibrotic valvular disease is detected, the patient should not be treated with pergolide (see section 4.3).
Under behandling:
During treatment:
Risk-benefit af cabergolin-behandling bør overvejes ved hvert lægebesøg, for at afgøre om behandlingen skal fortsætte.
At each visit, the risk benefit profile of cabergoline treatment for the patient should be reassessed to determine the suitability of continued treatment with cabergoline.
Fibrotiske og serøse inflammatoriske tilstande, såsom pleuritis, pleuraeffusion, pleural fibrose, lungefibrose, pericarditis, pericardieekssudat, hjerteklaplidelser, som involverer en eller flere hjerteklapper (aorta, mitral og trikuspidal) eller retroperitoneal fibrose er set efter længerevarende brug af ergolinderivater med agonistisk aktivitet på serotonin 5HT2B-receptorer, som f.eks. pergolid.
Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as pergolide.
Vær ekstra forsigtig med at tage [produktnavn]”
Take special care with [product name]”
Fibrotiske og serøse inflammatoriske tilstande, såsom pleuritis, pleuraeffusion, pleural fibrose, lungefibrose, pericarditis, pericardieekssudat og hjerteklaplidelser, som involverer en eller flere hjerteklapper (aorta, mitral og trikuspidal) eller retroperitoneal fibrose, er set efter længerevarende brug af sekalealkaloider med agonistisk aktivitet på serotonin 5HT2B-receptorer, som f.eks. cabergolin.
Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as cabergoline.
Hvis der påvises en fibrotisk klaplidelse, bør patienten ikke behandles med cabergolin (se pkt.
If fibrotic valvular disease is detected, the patient should not be treated with cabergoline (see section 4.3).
Før behandling vil lægen normalt undersøge Deres hjerte, lunger og nyrer.
Before treatment your physician will check whether your heart, lungs and kidneys are in good condition.
BILAG III ÆNDRINGER TIL PRODUKTRESUMÉ OG INDLÆGSSEDDEL
ANNEX III AMENDMENTS TO THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Klinisk diagnostisk monitorering med henblik på udvikling af fibrotiske lidelser anbefales efter behov.
Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential.
“- hvis du har eller tidligere har haft fibrotiske reaktioner (arvæv), der har påvirket dit hjerte, dine lunger eller dit underliv."
“- If you have or had fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen.”
Graviditet skal udelukkes inden behandling med cabergolin påbegyndes.
“Before administration of cabergoline pregnancy should be excluded.
• Nyreinsufficiens eller obstruktion af kar i ureter/abdomen, som kan optræde med lænde-/sidesmerter og ødemer i underekstremiteterne samt evt. udfyldning eller ømhed i maven, som kan være tegn på retroperitoneal fibrose.
Renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank and lower limb oedema as well as any possible abdominal masses or tenderness that may indicate retroperitoneal fibrosis.
Pga. begrænset klinisk erfaring og cabergolins lange halveringstid bør kvinder, der ønsker, at blive gravide, seponere Dostinex mindst 4 uger før planlagt konception.
Because clinical experience is still limited and the product has a long half-life, as a precautionary measure it is recommended that once regular ovulatory cycles have been achieved women seeking pregnancy discontinue product name] one month before intended conception.”
“Ved langtidsbehandling: Tegn på hjerteklapbeskadigelse konstateret ved EKG før behandlingsstart.”
“For long-term treatment: Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
Hjerteklap- og perikardial fibrose manifesterer sig ofte som hjertesvigt.
Cardiac failure; cases of valvular and pericardial fibrosis have often manifested as cardiac failure.
I tilfælde af uforklarlig stigning i ESR og abnorme værdier anbefales røntgenundersøgelse af thorax.
Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values.
Derfor bør patienter behandles med den laveste effektive dosis.
Valvulopathy has been associated with cumulative doses, therefore, patients should be treated with the lowest effective dose.
I nogle tilfælde bedredes symptomerne eller manifestationerne på hjerteklaplidelsen efter seponering af pergoliod.
In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of pergolide.
I nogle tilfælde bedredes symptomerne eller manifestationerne på hjerteklaplidelsen efter seponering af cabergolin.
In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of cabergoline.
Klinisk diagnostisk monitorering for udvikling af hjerteklaplidelse eller fibrose anbefales efter behov.
Clinical diagnostic monitoring for development of valvular disease or fibrosis, as appropriate, is essential.
Pergolid bør seponeres, hvis ekkokardiografi viser ny eller forværret tilbageløb pga. hjerteklaplidelse, klapfunktionsindskrænkning eller fortykkelse af hjerteklap (se pkt.
Pergolide should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction or valve leaflet thickening (see Section 4.3).
Afsnit 3 ”Sådan skal De tage [produktnavn]”
Section 3 How to take [product name]
“- hvis du skal have langtidsbehandling med [produktnavn] og har eller tidligere har haft fibrotiske reaktioner (arvæv), der har påvirket dit hjerte.”
“-will be treated with [product name] for a long period and have or had fibrotic reactions (scar tissue) affecting your heart.”
Afsnit 2 ”Det skal De vide, før De begynder at tage [produktnavn] Tag ikke pergolid
Section 2 “Before you take [product name]”: Do not take [product name] if you:
Cabergolin bør seponeres, hvis ekkokardiografi viser ny eller forværret tilbageløb pga. hjerteklaplidelse, klapfunktionsindskrænkning eller fortykkelse af hjerteklap (se pkt.
Cabergoline should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction or valve leaflet thickening (see Section 4.3).
Meget almindelig bivirkning (det sker hos mere end 1 ud af 10): lidelser i hjerteklapperne, f.eks. betændelse (perikardit) eller væskeansamlinger i hjertesækken (perikardieekssudat).
“Very common side effect (affecting more than one person in ten): heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion).
”Evidens for hjerteklaplidelse bestemt ved ekkokardiografi før start af behandling.”
“Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography.”
Det vides ikke, hvorvidt pergolidbehandling kan forværre den underliggende sygdom hos patienter med tilbageløb pga. hjerteklaplidelse.
In patients with valvular regurgitation, it is not known whether pergolide treatment might worsen the underlying disease.
Det vides ikke, hvorvidt cabergolinbehandling kan forværre den underliggende sygdom hos patienter med tilbageløb pga. hjerteklaplidelse.
In patients with valvular regurgitation, it is not known whether cabergoline treatment might worsen the underlying disease.
Tag ikke flere end 3 tabletter pr dag.
“Do not take more than 3 <if relevant include colour of the tablet> tablets (3 x 1000 microgram tablets) per day.”
• Pleuropulmonal sygdom, såsom dyspnø, kortåndethed, vedvarende hoste eller brystsmerter.
Therefore, during treatment, attention should be paid to the signs and symptoms of: Pleuro-pulmonary disease such as dyspnoea, shortness of breath, persistent cough or chest pain.
4.2 Dosering og indgivelsesmåde Følgende bør overvejes, hvis relevant:
4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of the maximum dose to 3 mg/day
ÆNDRINGER TIL RELEVANTE AFSNIT I INDLÆGSSEDLEN FOR PRODUKTER INDEHOLDENDE PERGOLID
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR PERGOLIDE CONTAINING MEDICINAL PRODUCTS
4.2 Dosering og indgivelsesmåde Følgende skal fremgå på passende måde:
4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of the maximum dose to 3 mg/day.
ÆNDRINGER TIL RELEVANTE AFSNIT I PRODUKTRESUMÉET FOR PRODUKTER INDEHOLDENDE PERGOLID
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR PERGOLIDE CONTAINING MEDICINAL PRODUCTS
ÆNDRINGER TIL RELEVANTE AFSNIT I PRODUKTRESUMÉ OG INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE CABERGOLIN
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR CABERGOLINE CONTAINING MEDICINAL PRODUCTS
ÆNDRINGER TIL RELEVANTE AFSNIT I INDLÆGSSEDDEL FOR PRODUKTER INDEHOLDENDE CABERGOLIN
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR CABERGOLINE CONTAINING MEDICINAL PRODUCTS
EMEA/CHMP/494917/2008
Ref. EMEA/CHMP/494914/2008
Proceduren blev indledt den 22. marts 2007.
The procedure started on 22 March 2007.
Indehaveren af markedsføringstilladelsen fremsendte supplerende oplysninger den 23. juli 2007.
The Marketing Authorisation Holder provided supplementary information on 23 July 2007.
Europa-Kommissionen vedtog en beslutning den 3. september 2008.
A Decision was issued by the European Commission on 3 September 2008.
London, den 3. september 2008 Ref. dok.
London, 3 September 2008 Doc.
Cozaar Comp og tilknyttede navne, 50/12,5 mg, 100/12,5 mg, 100/25 mg, filmovertrukne tabletter er en fastdosiskombination af losartan and hydrochlorothiazid.
Cozaar Comp and associated names, 50/12.5 mg; 100/12.5 mg; 100/25 mg, film coated tablets is a fixed dose combination of losartan and hydrochlorothiazide.
Losartan er en oralt aktiv angiotensin II (Ang-II) receptor-antagonist, der virker på AT1-receptor-undertypen og dermed blokerer for virkning af Ang-II i renin-angiotensin-systemets (RAS) kaskade.
Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN INDBRINGELSE I HENHOLD TIL ARTIKEL 30 Cozaar Comp og tilknyttede navne Internationalt fællesnavn (INN): losartan + hydrochlorothiazid
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Cozaar Comp and associated names International Non-Proprietary Name (INN): losartan + hydrochlorothiazide