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

astrazeneca pty ltd - chadox1-s, quantity: 100000000000 vp/ml - injection, solution - excipient ingredients: histidine; magnesium chloride hexahydrate; sucrose; disodium edetate; polysorbate 80; sodium chloride; histidine hydrochloride monohydrate; ethanol absolute; water for injections - vaxzevria has provisional approval for the indication:,active immunisation of individuals greater than or equal to 18 years old for the prevention of coronavirus disease 2019 (covid-19) caused by sars-cov-2.,the use of this vaccine should be in accordance with official recommendations.,the decision has been made on the basis of short term efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

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

viiv healthcare pty ltd - cabotegravir, quantity: 30 mg (equivalent: cabotegravir sodium, qty mg) - tablet, film coated - excipient ingredients: titanium dioxide; magnesium stearate; hypromellose; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; macrogol 3350 - vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults who are virologically suppressed (hiv-1 rna <50 copies/ml) and have no known or suspected resistance to either cabotegravir or rilpivirine (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties, clinical trials) for: ? oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection. ? oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.

United States - English - NLM (National Library of Medicine)

antibacterial wet wipes - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antibacterial wet wipes for hand sanitizing to decrease bacteria on the skin,kills 99.9% common germs stop use and ask a doctor if irritation or redness develop

United States - English - NLM (National Library of Medicine)

antibacterial wet wipes - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - antibacterial wet wipes for hand sanitizing to decrease bacteria on the skin,kills 99.9% common germs stop use and ask a doctor if irritation or redness develop

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - tisagenlecleucel (unii: q6c9whr03o) (tisagenlecleucel - unii:q6c9whr03o) - tisagenlecleucel 2000000 - kymriah is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: patients up to 25 years of age with b-cell precursor acute lymphoblastic leukemia (all) that is refractory or in second or later relapse. adult patients with relapsed or refractory (r/r) large b-cell lymphoma after two or more lines of systemic therapy including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high grade b-cell lymphoma and dlbcl arising from follicular lymphoma. limitation of use: kymriah is not indicated for treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory (r/r) follicular lymphoma (fl) after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary there are no available data with kymriah use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with kymriah to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if kymriah has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including b-cell lymphocytopenia. therefore, kymriah is not recommended for women who are pregnant, and pregnancy after kymriah administration should be discussed with the treating physician. report pregnancies to novartis pharmaceuticals corporation at 1-888-669-6682.  in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there is no information regarding the presence of kymriah in human milk, the effect on the breastfed infant, and the effects on milk production. a risk to the breastfed infant cannot be excluded. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kymriah and any potential adverse effects on the breastfed infant from kymriah or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually-active females of reproductive potential should have a pregnancy test prior to starting treatment with kymriah. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with kymriah. infertility there are no data on the effect of kymriah on male and female fertility. the safety and efficacy of kymriah have been established in pediatric patients with r/r b-cell all. use of kymriah is supported by a single-arm trial [see clinical studies (14.1)] that included 61 pediatric patients with r/r b-cell precursor all in the following age groups: 40 children (ages 2 years to less than 12 years) and 21 adolescents (ages 12 years to less than 17 years). no differences in efficacy or safety were observed between the different age subgroups or in comparison to the young adults in the trial. the safety and efficacy of kymriah in pediatric patients with r/r dlbcl and r/r fl have not been established. the safety and effectiveness of kymriah have not been established in geriatric patients with r/r b-cell all. clinical studies of kymriah did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

aft pharmaceuticals pty ltd - ceftriaxone sodium, quantity: 2.159 g (equivalent: ceftriaxone, qty 2 g) - injection, powder for - excipient ingredients: - for the treatment of the following infections when caused by susceptible aerobic organisms: = lower respiratory tract infections caused by s. pneumoniae, streptococcus species (excluding enterococci), methicillin sensitive s. aureus, h. influenzae, h. parainfluenzae, klebsiella species (including k. pneumoniae), e. coli, e. aerogenes, proteus mirabilis and serratia marcescens. = skin and skin structure infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, streptococcus group g, streptococcus pyogenes, streptococcus viridans, streptococcus species (excluding enterococci), peptostreptococcus species, e. coli, e. cloacae, klebsiella species (including k. pneumoniae, k. oxytoca), proteus mirabilis, morganella morganii, serratia marcescens. = urinary tract infections (complicated and uncomplicated) caused by e. coli, proteus mirabilis, proteus vulgaris, m. morganii and klebsiella species (including k. pneumoniae). = uncomplicated gonorrhoea (cervical/urethral and rectal) caused by neisseria gonorrhoea, including both penicillinase and non penicillinase producing strains. = bacterial septicemia caused by s. pneumoniae, e. coli and h. influenzae. = bone infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, enterobacter species, p. mirabilis and k. pneumoniae. = joint infections caused by methicillin sensitive s. aureus, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, p. mirabilis, k. pneumoniae and enterobacter species. = meningitis: the initial treatment, as a single agent, of meningitis in children and immunocompetent adults when presumed or proven to be caused by haemophilus influenzae type b, neisseria meningitidis, streptococcus pneumoniae or enterobacteriaceae pending culture and sensitivity results. = surgical prophylaxis: the preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of post-operative infections in patients undergoing vaginal or abdominal hysterectomy or cholecystectomy in high risk patients, surgical procedures which are classified as contaminated or potentially contaminated and patients undergoing coronary artery bypass surgery. = although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted. = susceptibility testing: before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing.

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

aft pharmaceuticals pty ltd - ceftriaxone sodium, quantity: 1.079 g (equivalent: ceftriaxone, qty 1 g) - injection, powder for - excipient ingredients: - for the treatment of the following infections when caused by susceptible aerobic organisms: = lower respiratory tract infections caused by s. pneumoniae, streptococcus species (excluding enterococci), methicillin sensitive s. aureus, h. influenzae, h. parainfluenzae, klebsiella species (including k. pneumoniae), e. coli, e. aerogenes, proteus mirabilis and serratia marcescens. = skin and skin structure infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, streptococcus group g, streptococcus pyogenes, streptococcus viridans, streptococcus species (excluding enterococci), peptostreptococcus species, e. coli, e. cloacae, klebsiella species (including k. pneumoniae, k. oxytoca), proteus mirabilis, morganella morganii, serratia marcescens. = urinary tract infections (complicated and uncomplicated) caused by e. coli, proteus mirabilis, proteus vulgaris, m. morganii and klebsiella species (including k. pneumoniae). = uncomplicated gonorrhoea (cervical/urethral and rectal) caused by neisseria gonorrhoea, including both penicillinase and non penicillinase producing strains. = bacterial septicemia caused by s. pneumoniae, e. coli and h. influenzae. = bone infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, enterobacter species, p. mirabilis and k. pneumoniae. = joint infections caused by methicillin sensitive s. aureus, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, p. mirabilis, k. pneumoniae and enterobacter species. = meningitis: the initial treatment, as a single agent, of meningitis in children and immunocompetent adults when presumed or proven to be caused by haemophilus influenzae type b, neisseria meningitidis, streptococcus pneumoniae or enterobacteriaceae pending culture and sensitivity results. = surgical prophylaxis: the preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of post-operative infections in patients undergoing vaginal or abdominal hysterectomy or cholecystectomy in high risk patients, surgical procedures which are classified as contaminated or potentially contaminated and patients undergoing coronary artery bypass surgery. = although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted. = susceptibility testing: before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing.

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

aft pharmaceuticals pty ltd - ceftriaxone sodium, quantity: 539 mg (equivalent: ceftriaxone, qty 500 mg) - injection, powder for - excipient ingredients: - for the treatment of the following infections when caused by susceptible aerobic organisms: = lower respiratory tract infections caused by s. pneumoniae, streptococcus species (excluding enterococci), methicillin sensitive s. aureus, h. influenzae, h. parainfluenzae, klebsiella species (including k. pneumoniae), e. coli, e. aerogenes, proteus mirabilis and serratia marcescens. = skin and skin structure infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, streptococcus group g, streptococcus pyogenes, streptococcus viridans, streptococcus species (excluding enterococci), peptostreptococcus species, e. coli, e. cloacae, klebsiella species (including k. pneumoniae, k. oxytoca), proteus mirabilis, morganella morganii, serratia marcescens. = urinary tract infections (complicated and uncomplicated) caused by e. coli, proteus mirabilis, proteus vulgaris, m. morganii and klebsiella species (including k. pneumoniae). = uncomplicated gonorrhoea (cervical/urethral and rectal) caused by neisseria gonorrhoea, including both penicillinase and non penicillinase producing strains. = bacterial septicemia caused by s. pneumoniae, e. coli and h. influenzae. = bone infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, enterobacter species, p. mirabilis and k. pneumoniae. = joint infections caused by methicillin sensitive s. aureus, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, p. mirabilis, k. pneumoniae and enterobacter species. = meningitis: the initial treatment, as a single agent, of meningitis in children and immunocompetent adults when presumed or proven to be caused by haemophilus influenzae type b, neisseria meningitidis, streptococcus pneumoniae or enterobacteriaceae pending culture and sensitivity results. = surgical prophylaxis: the preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of post-operative infections in patients undergoing vaginal or abdominal hysterectomy or cholecystectomy in high risk patients, surgical procedures which are classified as contaminated or potentially contaminated and patients undergoing coronary artery bypass surgery. = although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted. = susceptibility testing: before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing.

United States - English - NLM (National Library of Medicine)

industrial specialties, inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - anti-microbial hand sanitizer - helps reduce bacteria that potentially can cause disease - helps prevent cross contamination by hand contact - recommended for repeated use

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

csl behring australia pty ltd - fibrinogen, quantity: 900 mg - injection, powder for - excipient ingredients: sodium citrate; albumin; arginine hydrochloride; sodium chloride - treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia.