Australia - engleză - Department of Health (Therapeutic Goods Administration)

beckman coulter australia pty ltd - 48304 - hepatitis b virus core total antibody ivd, kit, chemiluminescent immunoassay - qualitative immunoassay integrated to the access immunoassay systems, for the detection of antibodies directed against hepatitis b core antigen in human serum or plasma the access hbc ab assay is a qualitative immunoassay integrated to the access immunoassay systems, for the detection of antibodies directed against hepatitis b core antigen in human serum or plasma.

Australia - engleză - Department of Health (Therapeutic Goods Administration)

bio-rad laboratories pty ltd - 48381 - hepatitis c virus antibody/antigen ivd, kit, enzyme immunoassay (eia) - monolisa? hcv ag-ab ultra v2 is a qualitative enzyme immunoassay for the detection of infection by the hepatitis c virus (hcv) based on the detection of anti-hcv antibodies and capsid antigen in serum or human plasma. this hepatitis c screening test can be used by diagnostic laboratories and blood banks. monolisa? hcv ag-ab ultra v2 is a qualitative enzyme immunoassay for the detection of infection by the hepatitis c virus (hcv) based on the detection of anti-hcv antibodies and capsid antigen in serum or human plasma. this hepatitis c screening test can be used by diagnostic laboratories and blood banks.

Australia - engleză - Department of Health (Therapeutic Goods Administration)

bio-rad laboratories pty ltd - 48445 - hiv1/hiv2 antigen/antibody ivd, kit, enzyme immunoassay (eia) - a qualitative enzyme immunoassay kit for the detection of hiv p24 antigen and antibodies to hiv-1 (groups m and o) and hiv-2 in human serum or plasma. the genscreen? ultra hiv ag-ab is a qualitative enzyme immunoassay kit for the detection of hiv p24 antigen and antibodies to hiv-1 (groups m and o) and hiv-2 in human serum or plasma. this kit can be used for both hiv ag and hiv ab screening

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

rare disease therapeutics, inc - centruroides fab2 antivenin (equine) (unii: dda050fcea) (centruroides fab2 antivenin (equine) - unii:dda050fcea) - centruroides fab2 antivenin (equine) 24 mg in 1 ml - anascorp® [centruroides (scorpion) immune f(ab')2 (equine) injection] is an equine-derived antivenom indicated for treatment of patients with clinical signs of scorpion envenomation. none. risk summary animal reproduction studies have not been conducted with anascorp. it is also not known whether anascorp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. anascorp should be given to a pregnant woman only if clearly needed. risk summary it is not known whether anascorp is excreted in human breast milk. because many drugs are excreted in human milk, caution should be exercised when anascorp is administered to a nursing woman. seventy-eight percent of the patients enrolled in the clinical studies were pediatrics subjects(1204/1534), with ages ranging from less than one month to 18.7 years of age. patient age groups were as follows: < 2 years of age, 29%, 2 to 5 years, 37%, 5 to 18 years, 34%. the efficacy and safety

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

strides pharma science limited - abacavir sulfate (unii: j220t4j9q2) (abacavir - unii:wr2tip26vs) - abacavir 300 - abacavir tablets in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv-1) infection. abacavir tablets are contraindicated in patients: - who have the hla-b*5701 allele [see warnings and precautions (5.1)]. - with prior hypersensitivity reaction to abacavir [see warnings and precautions (5.1)]. - with moderate or severe hepatic impairment [see use in specific populations (8.6)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir tablets during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the metropolitan atlanta congenital defects program (macdp) reference population (see data). the apr uses the macdp as

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

rare disease therapeutics, inc - pit viper (crotalinae) immune globulin antivenin (equine) (unii: 92vv7g83ed) (pit viper (crotalinae) immune globulin antivenin (equine) - unii:92vv7g83ed) - pit viper (crotalinae) immune globulin antivenin (equine) 24 mg in 1 ml - anavip [crotalidae immune f(ab')2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with north american pit viper envenomation.

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

rph pharmaceuticals ab - propylthiouracil - oral tablet - 50mg

Regatul Unit - engleză - MHRA (Medicines & Healthcare Products Regulatory Agency)

octapharma ltd - human plasma proteins - infusion - 57.5mg/1ml

Noua Zeelandă - engleză - Ministry for Primary Industries

nexan corporation limited - cobalt; abamectin; closantel as the sodium salt; selenium - cobalt 2.2 g/litre; abamectin 1 g/litre; closantel as the sodium salt 50 g/litre; selenium 0.5 g/litre - endoparasiticide

Australia - engleză - Department of Health (Therapeutic Goods Administration)

abbott australasia pty ltd diagnostic division - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - this assay is a two-step immunoassay for the qualitative detection of hiv-1 p24 antigen, antibodies to hiv-1 (group m and group o), and antibodies to hiv-2 in human serum and plasma using chemiluminescent microparticle immunoassay (cmia) technology. the alinity s hiv ag/ab combo assay is a chemiluminescent microparticle immunoassay (cmia) used for the simultaneous qualitative detection of human immunodeficiency virus (hiv) p24 antigen and antibodies to hiv type 1 (hiv-1 group m and group o) and/or type 2 (hiv-2) in human serum and plasma, including specimens collected up to 24 hours postmortem (non-heart-beating), on the alinity s system.