Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

clinect pty ltd - periciazine, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: wheat starch; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate - severe anxiety and tension states and the maintenance treatment of the psychotic patient. it is useful in controlling such symptoms as impulsiveness and aggression.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

biomarin pharmaceutical australia pty ltd - cerliponase alfa, quantity: 30 mg/ml - injection, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride; magnesium chloride hexahydrate; calcium chloride dihydrate; water for injections; monobasic sodium phosphate monohydrate - brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (cln2) disease, also known as tripeptidyl peptidase 1 (tpp1) deficiency.

Ευρωπαϊκή Ένωση - Αγγλικά - EMA (European Medicines Agency)

sloan pharma s.a.r.l - botulinum toxin type b - torticollis - muscle relaxants - neurobloc is indicated for the treatment of cervical dystonia (torticollis).see section 5.1 for data on efficacy in patients responsive / resistant to botulinum toxin type a.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

life molecular imaging, ltd - florbetaben f-18 (unii: tla7312toi) (florbetaben f-18 - unii:tla7312toi) - florbetaben f-18 135 mci in 1 ml - neuraceq is indicated for positron emission tomography (pet) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for alzheimer’s disease (ad) and other causes of cognitive decline. a negative neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of ad at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to ad. a positive neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with ad, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. neuraceq is an adjunct to other diagnostic evaluations. limitations of use • a positive neuraceq scan does not establish the diagnosis of ad or any other cognitive disorder. • safety and effectiveness of neuraceq have not been established for:    o predicting development of dementia or other neurologic conditions;    o monitoring responses to therapies. none risk summary there are no available data on neuraceq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.  animal reproduction studies have not been conducted with neuraceq. all radiopharmaceuticals, including neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. if considering neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  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 are no data on the presence of florbetaben f 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben f 18 injection on milk production. exposure of neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see clinical considerations ]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for neuraceq and any potential adverse effects on the breastfed child from neuraceq or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of neuraceq. neuraceq is not indicated for use in pediatric patients. of the 872 subjects in clinical studies of neuraceq, 603 (69%) were 65 years or over, while 304 (35%) were 75 years or over. no overall differences in safety were observed between these subjects and younger subjects.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

general injectables and vaccines, inc - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 0.2 g in 5 ml - neut (4% sodium bicarbonate additive solution) is indicated for use asa an additive to raise the ph of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. not for use as a systemic alkalizer. none known.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

biomarin pharmaceutical inc. - cerliponase alfa (unii: x8r2d92qp1) (cerliponase alfa - unii:x8r2d92qp1) - cerliponase alfa 150 mg in 5 ml - brineura is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (cln2), also known as tripeptidyl peptidase 1 (tpp1) deficiency. brineura is contraindicated in patients with: - any sign or symptom of acute, unresolved localized infection on or around the device insertion site (e.g. cellulitis or abscess); or suspected or confirmed cns infection (e.g. cloudy csf or positive csf gram stain, or meningitis) [see warnings and precautions (5.1)] . - any acute intraventricular access device-related complication (e.g., leakage, extravasation of fluid, or device failure) [see warnings and precautions (5.2)] . - ventriculoperitoneal shunts. risk summary there are no available data on brineura use in pregnant women to inform a drug-associated risk of pregnancy-related outcomes. animal reproduction studies have not been conducted using cerliponase alfa. the estimated background risk of major birth defects and miscarr

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

hospira, inc. - sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 0.2 g in 5 ml - neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the ph of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. not for use as a systemic alkalizer. none known.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

cardinal health - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - sodium bicarbonate 0.2 g in 5 ml - neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the ph of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. not for use as a systemic alkalizer. none known.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

cardinal health - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the ph of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. not for use as a systemic alkalizer. none known.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

hospira, inc. - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20, sodium cation - unii:lyr4m0nh37) - neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the ph of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion. not for use as a systemic alkalizer. none known.