Filipini - engleski - FDA (Food And Drug Administration)

msd animal health (phils.), inc.; distributor: msd animal health (phils.), inc. - inactivated actinobacillus pleuropneumoniae vaccine (vet.) - suspension for injection (im) - each dose (2 ml) contains: actinobacillus pleuropneumoniae antigen concentrate...................600 mg antigen concentrate contains: outer membrane protein (omp) antigen (appl-l-452 strain)..............50 units apxl antigen (app hv169 strain) ..................50 units apxii antigen (app hv143 strain) ..................50 units apxii + apxiii antigen (app 2 strain) .................50 units antigens incorporated in aqueous adjuvant contains: dl-a-tocopherol acetate................150 mg polysorbate 80..................60 mg simethicone ...............100 mcg sodium chloride ..................11 mg formalin ................1.08 mg water ......2 ml 150 mg 60 mg 100 mcg 11 mg ... 1.08 mg ........ 2 ml

Australija - engleski - Department of Health (Therapeutic Goods Administration)

medison pharma australia pty ltd - tebentafusp, quantity: 0.2 mg/ml - injection, concentrated - excipient ingredients: citric acid monohydrate; water for injections; mannitol; trehalose dihydrate; polysorbate 20; dibasic sodium phosphate - kimmtrak is indicated for the treatment of hla-a02 01-positive adult patients with unresectable or metastatic uveal melanoma.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - sacituzumab govitecan, quantity: 180 mg - injection, powder for - excipient ingredients: 2-n-morpholinoethanesulfonic acid monohydrate; polysorbate 80; trehalose dihydrate - metastatic triple-negative breast cancer,trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mtnbc) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease.,hr+/her2- metastatic breast cancer,trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative (ihc 0, ihc 1+ or ihc 2+/ish?) breast cancer who have received endocrine-based therapy (including a cdk4/6 inhibitor) and at least two additional systemic therapies in the locally advanced or metastatic setting.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - lanadelumab, quantity: 300 mg - injection, solution - excipient ingredients: citric acid monohydrate; water for injections; dibasic sodium phosphate dihydrate; polysorbate 80; histidine; sodium chloride - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - isatuximab, quantity: 500 mg - injection, concentrated - excipient ingredients: water for injections; histidine hydrochloride monohydrate; sucrose; polysorbate 80; histidine - sarclisa is indicated:,? in combination with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi).,? in combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - isatuximab, quantity: 100 mg - injection, concentrated - excipient ingredients: histidine; histidine hydrochloride monohydrate; polysorbate 80; sucrose; water for injections - sarclisa is indicated:,? in combination with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma (mm) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (pi).,? in combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - guselkumab, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; histidine; sucrose; polysorbate 80; histidine hydrochloride monohydrate - plaque psoriasis,tremfya is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,tremfya is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior dmard therapy.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - guselkumab, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; sucrose; histidine hydrochloride monohydrate; histidine; polysorbate 80 - plaque psoriasis,tremfya is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,tremfya is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior dmard therapy.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - fosaprepitant dimeglumine, quantity: 245.3 mg (equivalent: fosaprepitant, qty 150 mg) - injection, powder for - excipient ingredients: dilute hydrochloric acid; polysorbate 80; lactose; disodium edetate; sodium hydroxide - fosaprepitant-aft, in combination with other antiemetic agents, is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of:,? highly emetogenic cancer chemotherapy (see section 4.2 dose and method of administration),? moderately emetogenic cancer chemotherapy (see section 4.2 dose and method of administration).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

recordati rare diseases australia pty ltd - dinutuximab beta, quantity: 4.5 mg/ml - solution - excipient ingredients: polysorbate 20; hydrochloric acid; sucrose; water for injections; histidine - qarziba is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response.