Keytruda Umoja wa Ulaya - Kroeshia - EMA (European Medicines Agency)

keytruda

merck sharp & dohme b.v. - Пембролизумаб - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastična sredstva - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacijenata sa egfr ili ala pozitivnih tumora mutacije također treba primili таргетную terapiju prije dobivanja Кейтруда. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Caspofungin Accord Umoja wa Ulaya - Kroeshia - EMA (European Medicines Agency)

caspofungin accord

accord healthcare s.l.u. - caspofungin acetat - candidiasis; aspergillosis - antimikotika za sustavnu uporabu - liječenje od invazivnog kandidijaze kod odraslih i pedijatrijska bolesnika. liječenje od invazivnog аспергиллеза kod odraslih i pedijatrijski pacijenti koji резистентны ili netrpeljivosti Амфотерицина u, липидные lijekovi Амфотерицина b i/ili itrakonazol. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. za empirijske terapije namjeravanog gljivične infekcije (npr. candida ili аспергилл) u grozničav, još неоткупоренных za odrasle i pedijatrijska bolesnika.

Vfend Umoja wa Ulaya - Kroeshia - EMA (European Medicines Agency)

vfend

pfizer europe ma eeig - vorikonazol - candidiasis; mycoses; aspergillosis - antimikotika za sustavnu uporabu - voriconazole, širokog spektra, триазольное противогрибковое alat i navodi u odraslih i djece u dobi od 2 i više godina na sljedeći način:liječenje od invazivnog аспергиллеза;liječenje u candidaemianon bolesnika s нейтропенией;liječenje flukonazol-rezistentnih ozbiljan invazivne candida infekcije (uključujući i. krusei);liječenje teške gljivične infekcije uzrokovane scedosporium spp i. i fusarium ѕрр. Вифенд treba propisati prvenstveno u bolesnika s прогрессирующим, možda i po život opasne infekcije. prevencija invazivne gljivične infekcije u grupi visokog rizika аллогенной transplantacije hematopoetski matičnih stanica (ТГСК) primatelja.

DODATNI PRIBOR ZA PRIMJENU INFUZIJSKIH OTOPINA I INVAZIVNO MJERENJE TLAKA Korasia - Kroeshia - HALMED (Agencija za lijekove i medicinske proizvode)

dodatni pribor za primjenu infuzijskih otopina i invazivno mjerenje tlaka

mediva d.o.o., zagreb - skretnice sa ili bez produžnih linija i beziglenih pripoja kao dodatni pribor za primjenu infuzijskih otopina i invazivno mjeren

Synflorix Umoja wa Ulaya - Kroeshia - EMA (European Medicines Agency)

synflorix

glaxosmithkline biologicals s.a. - pneumococcal polysaccharide serotype 23f, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19f - pneumococcal infections; immunization - cjepiva - aktivna imunizacija protiv invazivnih bolesti i akutnih otitis media uzrokovanih streptococcus pneumoniae kod dojenčadi i djece od šest tjedana do pet godina. pogledajte odjeljke 4. 4 i 5. 1 u informacijama o proizvodu za informacije o zaštiti od specifičnih pneumokoknih serotipova. primjena cjepivo synflorix mora odrediti na temelju službenih preporuka, uzimajući u obzir utjecaj invazivne bolesti u različitim dobnim skupinama, kao i varijabilnost серотип za epidemiologiju u različitim zemljopisnim područjima.

Trumenba Umoja wa Ulaya - Kroeshia - EMA (European Medicines Agency)

trumenba

pfizer europe ma eeig - neisseria meningitidis serotip b fhbp (rekombinantni lipidirani fhbp (protein koji veže faktor h)) podfamilija a; neisseria meningitidis serotip b fhbp (rekombinantni lipidirani fhbp (faktor vezanja h proteina)) podskupina b - meningitis, meningokokal - bacterial vaccines, meningococcal vaccines - trumenba je indicirana za aktivnu imunizaciju osoba starijih od 10 godina kako bi se spriječila invazivna meningokokna bolest uzrokovana neisseria meningitidis serotipom b. korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

Voriconazole Accord Umoja wa Ulaya - Kroeshia - EMA (European Medicines Agency)

voriconazole accord

accord healthcare s.l.u. - vorikonazol - aspergillosis; candidiasis; mycoses - Антимикотиков za sistemsku primjenu, derivat триазола - voriconazole обширн-spektra, триазольное противогрибковое alat i navodi u odraslih i djece u dobi od dvije i više godina na sljedeći način:liječenje od invazivnog аспергиллеза;liječenje candidaemia u bolesnika s нейтропенией;liječenje flukonazol-rezistentnih ozbiljan invazivne candida infekcije (uključujući i. krusei);liječenje teške gljivične infekcije uzrokovane scedosporium spp i. i fusarium ѕрр. voriconazole sporazuma treba primjenjivati prvenstveno u bolesnika s прогрессирующим, možda i po život opasne infekcije.

Voriconazole Hikma (previously Voriconazole Hospira) Umoja wa Ulaya - Kroeshia - EMA (European Medicines Agency)

voriconazole hikma (previously voriconazole hospira)

hikma farmaceutica (portugal) s.a. - vorikonazol - bacterial infections and mycoses; aspergillosis; candidiasis - antimikotika za sustavnu uporabu - voriconazole je širok raspon, триазольное противогрибковое alat i navodi u odraslih i djece u dobi od 2 i više godina na sljedeći način:liječenje od invazivnog аспергиллеза;liječenje candidaemia u bolesnika s нейтропенией;liječenje flukonazol-rezistentnih ozbiljan invazivne candida infekcije (uključujući i. krusei);liječenje teške gljivične infekcije uzrokovane scedosporium spp i. i fusarium ѕрр. voriconazole treba propisati prvenstveno u bolesnika s прогрессирующим, možda i po život opasne infekcije. prevencija invazivne gljivične infekcije u grupi visokog rizika аллогенной transplantacije hematopoetski matičnih stanica (ТГСК)primatelja.

Prevenar 13 Umoja wa Ulaya - Kroeshia - EMA (European Medicines Agency)

prevenar 13

pfizer europe ma eeig - pneumococcal polysaccharide serotype 1, pneumococcal polysaccharide serotype 3, pneumococcal polysaccharide serotype 4, pneumococcal polysaccharide serotype 5, pneumococcal polysaccharide serotype 6a, pneumococcal polysaccharide serotype 6b, pneumococcal polysaccharide serotype 7f, pneumococcal polysaccharide serotype 9v, pneumococcal polysaccharide serotype 14, pneumococcal polysaccharide serotype 18c, pneumococcal polysaccharide serotype 19a, pneumococcal polysaccharide serotype 19f, pneumococcal polysaccharide serotype 23f - pneumococcal infections; immunization - cjepiva - aktivna imunizacija za prevenciju invazivnih bolesti, pneumonije i akutnog otitis medija uzrokovana streptococcus pneumoniae kod dojenčadi, djece i adolescenata od 6 tjedana do 17 godina starosti. aktivna imunizacija za sprječavanje invazivnih bolesti uzrokovane streptococcus pneumoniae kod odraslih ≥18 godina i starije. pogledajte odjeljke 4. 4 i 5. 1 za informacije o zaštiti od specifičnih pneumokoknih serotipova. korištenje Превенар 13 mora biti definiran na temelju službenih preporuka, uzimajući u obzir rizik od invazivnih bolesti u različitim dobnim skupinama, leži u osnovi srodne bolesti, kao i varijabilnost серотипа za epidemiologiju u različitim zemljopisnim područjima.