Qaialdo Den Europæiske Union - dansk - EMA (European Medicines Agency)

qaialdo

nova laboratories ireland limited - spironolacton - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 og 5.

PegIntron Den Europæiske Union - dansk - EMA (European Medicines Agency)

pegintron

merck sharp & dohme b.v. - peginterferon alfa-2b - hepatitis c kronisk - immunostimulants, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. der henvises til ribavirin og boceprevir produktresuméer (smpcs), når pegintron skal anvendes i kombination med disse lægemidler. adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. pegintron i kombination med ribavirin (bitherapy) er indiceret til behandling af chc-infektion hos voksne patienter, der er tidligere ubehandlet, herunder patienter med klinisk stabilt hiv co-infektion, og hos voksne patienter, der har undladt tidligere behandling med interferon-alfa (pegyleret eller non-pegyleret) og ribavirin kombination terapi eller alfa-interferon-monoterapi. interferon monoterapi, herunder pegintron, er indikeret primært i tilfælde af intolerance eller kontraindikation for ribavirin. der henvises til ribavirin spc, når pegintron er at blive brugt i kombination med ribavirin. paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna. når det besluttes ikke at udsætte behandlingen, indtil voksenalderen, det er vigtigt at overveje, at kombinationen af terapi-induceret vækst-hæmning, der kan være uoprettelige hos nogle patienter. beslutningen om at behandle en sag-for-sag. der henvises til ribavirin produktresumeet for kapsler eller oral opløsning, når pegintron er at blive brugt i kombination med ribavirin.

Spasmium Vet. 500 mg/ml+4 mg/ml injektionsvæske, opløsning Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

spasmium vet. 500 mg/ml+4 mg/ml injektionsvæske, opløsning

vetviva richter gmbh - hyoscinbutylbromid, metamizolnatrium - injektionsvæske, opløsning - 500 mg/ml+4 mg/ml - hest, hund, kvæg, svin

Sympagesic 500+4 mg/ml injektionsvæske, opløsning Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

sympagesic 500+4 mg/ml injektionsvæske, opløsning

dechra regulatory b.v. - hyoscinbutylbromid, metamizolnatriummonohydrat - injektionsvæske, opløsning - 500+4 mg/ml

Scintimun Den Europæiske Union - dansk - EMA (European Medicines Agency)

scintimun

cis bio international  - besilesomab - osteomyelitis; radionuclide imaging - diagnostiske radioaktive lægemidler - dette lægemiddel er til diagnostisk brug kun og den godkendte indikation er scintigrafi imaging, sammen med andre relevante billeddiagnostiske modaliteter, til at bestemme placeringen af betændelse/infektion i perifere knogle i voksne med formodede osteomyelitis. scintimun bør ikke anvendes til diagnosticering af diabetisk fodinfektion.

Tecentriq Den Europæiske Union - dansk - EMA (European Medicines Agency)

tecentriq

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastiske midler - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq som monoterapi er indiceret til behandling af voksne patienter med lokalt fremskreden eller metastatisk nsclc efter forudgående kemoterapi. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq som monoterapi er indiceret til behandling af voksne patienter med lokalt fremskreden eller metastatisk nsclc efter forudgående kemoterapi. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.