Euroopan unioni - slovakki - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozín propándiol monohydrát - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lieky používané pri cukrovke - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. okrem iných liekov na liečbu diabetes mellitus 2. typu. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 a 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Euroopan unioni - slovakki - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozín propándiol monohydrát - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lieky používané pri cukrovke - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. okrem iných liekov na liečbu diabetes mellitus 2. typu. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 a 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Euroopan unioni - slovakki - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - diabetes mellitus, typ 2 - lieky používané pri cukrovke - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 a 5.

Euroopan unioni - slovakki - EMA (European Medicines Agency)

viiv healthcare bv - abacavir, lamivudine - hiv infekcie - antivirals for treatment of hiv infections, combinations, antivirals for systemic use - kivexa je indikovaná v kombinovanej antiretrovírusovej liečbe na liečbu infekcie vírusom ľudskej imunodeficiencie (hiv) u dospelých, dospievajúcich a detí s hmotnosťou najmenej 25 kg. pred začatím liečby s abacavir, vyšetrenie na prepravu hla-b*5701 alely by mala byť vykonaná v akomkoľvek hiv-infikovaných pacientov, bez ohľadu na rasový pôvod. abacavir by sa nemali používať u pacientov známe vykonávať hla-b*5701 alely.

Euroopan unioni - slovakki - EMA (European Medicines Agency)

teva b.v. - ribavirin - hepatitída c, chronická - antivirotiká na systémové použitie - ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) in adults (see sections 4. 2, 4. 4 a 5. ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4. 2, 4. 4 a 5.

Euroopan unioni - slovakki - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv infekcie - antivirotiká na systémové použitie - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Euroopan unioni - slovakki - EMA (European Medicines Agency)

janssen-cilag international n.v. - darunavir, cobicistat - hiv infekcie - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - rezolsta je indikovaný v kombinácii s inými antiretrovírusovými liekmi na liečbu infekcie vírusom ľudskej imunodeficiencie 1 (hiv 1) u dospelých vo veku 18 rokov a starších. genotypic testovanie by sa malo riadiť použitie rezolsta.

Euroopan unioni - slovakki - EMA (European Medicines Agency)

teva pharma b.v. - pioglitazón hydrochlorid - diabetes mellitus, typ 2 - lieky používané pri cukrovke - pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: , in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. , pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. po začatí liečby s pioglitazone, pacienti by mali byť preskúmané po 3 až 6 mesiacov na posúdenie primeranosti odpoveď na liečbu (e. zníženie hba1c). u pacientov, ktorí nedokážu zobraziť primeranú odpoveď, pioglitazone by mali byť ukončené. z hľadiska potenciálnych rizík s dlhodobou liečbou, prescribers by mal potvrdiť na následné bežné recenzie, ktoré v prospech pioglitazone je zachovaná.

Euroopan unioni - slovakki - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Slovakia - slovakki - ŠÚKL (Štátny ústav pre kontrolu liečiv)

krka, d.d., novo mesto, slovinsko - sitagliptín - 18 - antidiabetica (vrÁtane inzulÍnu)