Flebogamma DIF (previously Flebogammadif) Europska Unija - hrvatski - EMA (European Medicines Agency)

flebogamma dif (previously flebogammadif)

instituto grifols s.a. - imunoglobulina osoba normalan - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - imuni serumi i homologna, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Ig Vena 50 g/l otopina za infuziju Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

ig vena 50 g/l otopina za infuziju

kedrion s.p.a., ai conti, castelvecchio pascoli, barga (lucca), italija - imunoglobulin normalni, ljudski, intravenski - otopina za infuziju - 50 g/l - urbroj: 1 ml otopine sadrži: imunoglobulin normalni, ljudski, intravenski 50 mg (čistoće od najmanje 95% igg)

Fluenz Europska Unija - hrvatski - EMA (European Medicines Agency)

fluenz

medimmune llc - Реассортанта virusa gripe (live аттенуированная) sljedećih sojeva:a/california/7/2009 pdm09 (Н1n1)kao soj a/victoria/361/2011 (Н3n2), kao što su napon, b/ma/2/2012 kao soj - influenza, human; immunization - cjepiva - profilaksa gripe kod osoba od 24 mjeseca do 18 godina starosti. korištenje fluenz mora se temeljiti na službenim preporukama.

Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) Europska Unija - hrvatski - EMA (European Medicines Agency)

pandemic influenza vaccine h5n1 astrazeneca (previously pandemic influenza vaccine h5n1 medimmune)

astrazeneca ab - reassortant virus gripe (uživo oslabljenim) sljedeće soja: soja a/vijetnam/1203/2004 (h5n1) - gripa, ljudska - cjepiva - profilaksa influence u službeno deklariranoj pandemijskoj situaciji kod djece i adolescenata od 12 mjeseci do 18 godina starosti. cjepivo protiv pandemijskog gripa h5n1 АстраЗенека mora se koristiti u skladu sa službenim vodstvom.

Palforzia Europska Unija - hrvatski - EMA (European Medicines Agency)

palforzia

aimmune therapeutics ireland limited - defatted powder of arachis hypogaea l., semen (peanuts) - peanut hypersensitivity - allergens - palforzia is indicated for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. palforzia may be continued in patients 18 years of age and older. palforzia should be used in conjunction with a peanut-avoidant diet.

Enjaymo Europska Unija - hrvatski - EMA (European Medicines Agency)

enjaymo

sanofi b.v. - sutimlimab - hemolysis; anemia, hemolytic, autoimmune - imunosupresivi - enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (cad).

Jayempi Europska Unija - hrvatski - EMA (European Medicines Agency)

jayempi

nova laboratories ireland limited - azathioprine - odbacivanje transplantata - imunosupresivi - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Amifampridine SERB Europska Unija - hrvatski - EMA (European Medicines Agency)

amifampridine serb

serb sa - amifampridine phosphate - lambert-eaton myasthenic syndrome; paraneoplastic syndromes, nervous system; nervous system neoplasms; paraneoplastic syndromes; nervous system diseases; autoimmune diseases of the nervous system; neurodegenerative diseases; neuromuscular diseases; neuromuscular junction diseases; immune system diseases; autoimmune diseases; autoimmune diseases of the nervous system; cancer; neoplasms - ostali lijekovi protiv živčanog sustava - simptomatsko liječenje lambert-eaton miasteničnog sindroma (lems) u odraslih osoba.

Nplate Europska Unija - hrvatski - EMA (European Medicines Agency)

nplate

amgen europe b.v. - romiplostim - purpura, trombocitopenična, idiopatska - antihemorrhagics - adults:nplate is indicated for the treatment of primary immune thrombocytopenia  (itp) in adult patients who are refractory to other treatments (e. kortikosteroidi, imunoglobulini). paediatrics:nplate is indicated for the treatment of chronic primary immune thrombocytopenia (itp) in paediatric patients one year of age and older who are refractory to other treatments (e. kortikosteroidi, imunoglobulini).

Revolade Europska Unija - hrvatski - EMA (European Medicines Agency)

revolade

novartis europharm limited - eltrombopag - purpura, trombocitopenična, idiopatska - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 i 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 i 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.