Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - daptomycin - gram-positive bacterial infections; bacteremia; soft tissue infections; endocarditis, bacterial - antibatteriċi għal użu sistemiku, - cubicin huwa indikat għat-trattament ta 'l-infezzjonijiet li ġejjin. adulti u pedjatriċi (1-17-il sena) ta ' pazjenti b'infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob (cssti). pazjenti adulti bi dritt naħat endokardite infettiva (rie) minn staphylococcus aureus. huwa rakkomandat li d-deċiżjoni li jintuża daptomycin għandha tieħu in kunsiderazzjoni l-suxxettibilità antibatterika ta 'l-organiżmu u għandha tkun ibbażata fuq parir ta' espert. adulti u pedjatriċi (1-17-il sena) il-pazjenti bil-batterimja minn staphylococcus aureus (sab). fl-adulti, l-użu fl-batterimja għandha tkun assoċjata ma 'rie jew ma' cssti, filwaqt li fil-pazjenti pedjatriċi, l-użu fl-batterimja għandu jkun assoċjat ma ' cssti. daptomycin huwa attiv kontra batteri gram posittivi biss. imħallat ta 'l-infezzjonijiet fejn gram negattivi u/jew ċerti tipi ta' batterji anerobiċi huma suspettati, cubicin għandu jingħata flimkien ma ' sustanza anti batterjali xierqa(i). għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolactone - 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 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

accord healthcare s.l.u. - ibandronic acid - wounds and injuries; breast diseases; neoplastic processes; calcium metabolism disorders; water-electrolyte imbalance - drogi għat-trattament ta 'mard tal-għadam - ibandronic acid huwa indikat fl-adulti forprevention ta ' episodji skeletriċi (fratturi patoloġiċi, komplikazzjonijiet fl-għadam li jeħtieġu r-radjuterapija jew il-kirurġija) f'pazjenti b'kanċer tas-sider u metastażi fl-għadam. trattament ta ' iperkalċemja kkawżata minn tumuri bi jew mingħajr metastażi. it-trattament ta'l-osteoporożi f'nisa wara l-menopawża f'riskju miżjud ta'ksur (ara sezzjoni 5. tnaqqis fir-riskju ta ' ksur vertebrali ġie muri, l-effikaċja fuq il-ksur fl-għonq tal-femora ma ġietx stabbilita.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanedjol monohydrate, metformin hydrochloride - diabetes mellitus, tip 2 - drogi użati fid-dijabete - dijabete tat-tip 2 mellitusfor-trattament ta mhumiex ikkontrollati biżżejjed b'dijabete mellitus tip 2 bħala żieda mad-dieta u l-eżerċizzju. bħala monoterapija meta metformin huwa meqjus bħala mhux xierqa minħabba l-intolleranza. barra minn hekk għall-prodotti mediċinali oħra għat-trattament tad-dijabete tat-tip 2. għall-riżultati tal-istudju fir-rigward tal-kombinazzjoni ta ' terapiji, l-effetti fuq il-kontroll gliċemiku u episodji kardjovaskulari, u l-popolazzjonijiet studjati, ara sezzjonijiet 4. 4, 4. 5 u 5. dijabete tat-tip 1 mellitusedistride huwa indikat fl-adulti għall-kura ta mhumiex ikkontrollati biżżejjed dijabete mellitus tip 1 bħala kura aġġuntiva għall-insulina f'pazjenti b'bmi ≥ 27 kg/m2, meta l-insulina waħdu ma jipprovdux kontroll gliċemiku adegwat minkejja l-aħjar terapija ta'l-insulina.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - aġenti antineoplastiċi - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - metformin hydrochloride, dapagliflozin propanedjol monohydrate - diabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo huwa indikat fl-adulti għall-kura ta 'dijabete mellitus tip 2 bħala żieda mad-dieta u l-eżerċizzju:• f'pazjenti li mhumiex ikkontrollati biżżejjed dwar l-ogħla doża ttollerata ta' metformin waħdu • f'kombinazzjoni ma ' prodotti mediċinali oħra għall-kura tad-dijabete f'pazjenti li mhumiex ikkontrollati biżżejjed b'metformin u dawn il-prodotti mediċinali• fil-pazjenti li diġà qegħdin jiġu kkurati b'kumbinazzjoni ta dapagliflozin u metformin bħala pilloli separati. għall-riżultati tal-istudju fir-rigward tal-kombinazzjoni ta ' terapiji, l-effetti fuq il-kontroll gliċemiku u episodji kardjovaskulari, u l-popolazzjonijiet studjati, ara sezzjonijiet 4. 4, 4. 5 u 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozin propanediol monohydrate - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogi użati fid-dijabete - 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. barra minn hekk għall-prodotti mediċinali oħra għat-trattament tad-dijabete tat-tip 2. 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 u 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid - diabetes mellitus, tip 2 - drugs used in diabetes, sodium-glucose co-transporter 2 (sglt2) inhibitors - steglatro huwa indikat f'adulti ta '18-il sena u akbar b'dijabete mellitus tip 2 bħala żieda mad-dieta u l-eżerċizzju biex itejjeb il-kontroll gliċemiku:bħala monoterapija f'pazjenti li għalihom l-użu ta' metformin huwa kkunsidrat xieraq minħabba 'intolleranza jew ta' kontra-indikazzjonijiet. barra minn hekk oħra prodotti mediċinali għall-kura tad-dijabete.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogi użati fid-dijabete - type 2 diabetes mellitusdapagliflozin viatris 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 exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 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 u 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanedjol monohydrate - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - drogi użati fid-dijabete - qtern, taħlita fissa tad-doża ta saxagliptin u dapagliflozin, huwa indikat f'adulti ta ' 18-il sena u akbar b'dijabete mellitus tip 2:biex ittejjeb il-kontroll gliċemiku meta metformin u/jew mediċina tat-tip sulphonylurea (su) u waħda mill-monokomponenti tal-qtern ma jipprovdux kontroll gliċemiku adegwat,meta diġà qegħdin jiġu ttrattati bil-kombinazzjoni ħielsa ta dapagliflozin u saxagliptin. (ara sezzjonijiet 4. 2, 4. 4, 4. 5 u 5. 1 għall-dejta disponibbli dwar il-kombinazzjonijiet studjat.