European Union - English - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vaccines - active immunisation against h5 subtype of influenza a virus

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

jazz pharmaceuticals, inc. - ziconotide acetate (unii: t2i226k69m) (ziconotide - unii:7i64c51o16) - ziconotide 25 ug in 1 ml - prialt (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. ziconotide was embryolethal in rats when given as a continuous intravenous infusion during the major period of organogenesis as evidenced by significant increases in post-implantation loss because of an absence or a reduced number of live fetuses. estimated exposure for embryolethality in the rat was approximately 700-fold above the expected exposure resulting from the maximum recommended human daily intrathecal dose of 0.8 mcg/hr (19.2 mcg/day). ziconotide was not teratogenic in female rats when given as a continuous intravenous infusion at doses up to 30 mg/kg/day or in female rabbits up to 5 mg/kg/day during the major period of organ development. estimated exposures in the female rat and rabbit were approxima

European Union - English - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - ziconotide - injections, spinal; pain - analgesics - ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (it) analgesia.

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

tersera therapeutics llc - ziconotide acetate (unii: t2i226k69m) (ziconotide - unii:7i64c51o16) - prialt (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. - prialt is contraindicated in patients with a known hypersensitivity to ziconotide or any of its formulation components. - prialt is contraindicated in patients with any other concomitant treatment or medical condition that would render intrathecal administration hazardous. contraindications to the use of intrathecal analgesia include the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of csf. - prialt is contraindicated in patients with a pre-existing history of psychosis. risk summary available data from postmarketing reports are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in an animal reproduction study, ziconotide did not cause embryo-fetal toxicity when administered to pregnant rats and rabbits during the period of organogenesis by continuous intravenous infusion at 400- and 940-times, respectively, the maximum recommended human dose (mrhd) of 19.2 mcg/day. in a pre- and post-natal development study, ziconotide did not affect pup development or reproductive performance when administered to rats by continuous intravenous infusion at 3800-times the mrhd (see data) . 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. data animal data ziconotide caused embryo-fetal mortality in rats when given as a continuous intravenous infusion during the major period of organogenesis as evidenced by significant increases in post-implantation loss because of an absence or a reduced number of live fetuses. estimated exposure for embryo-fetal mortality in the rat was approximately 700-fold above the expected exposure resulting from the maximum recommended human daily intrathecal dose of 0.8 mcg/hr (19.2 mcg/day). ziconotide did not result in malformations when administered to pregnant rats by continuous intravenous infusion at doses up to 30 mg/kg/day or to pregnant rabbits up to 5 mg/kg/day during the major period of organ development. estimated exposures in the female rat and rabbit were approximately 26,000-fold and 940-fold higher than the expected exposure resulting from the maximum recommended human daily dose of 0.8 mcg/hr (19.2 mcg/day) based on plasma exposure. maternal toxicity in the rat and rabbit, as evidenced by decreased body weight gain and food consumption, was present at all dose levels. maternal toxicity in the rat led to reduced fetal weights and transient, delayed ossification of the pubic bones at doses ≥ 15 mg/kg/day, which is approximately 8900-fold higher than the expected exposure resulting from the maximum recommended human daily intrathecal dose of 0.8 mcg/hr (19.2 mcg/day) based on plasma exposure. the no observable adverse effect level (noael) for embryo-fetal development in rats was 0.5 mg/kg/day and in rabbits was 5 mg/kg/day. estimated noael exposures in the rat and rabbit were approximately 400-fold and 940-fold higher than the expected exposure resulting from the maximum recommended human daily intrathecal dose of 0.8 mcg/hr (19.2 mcg/day) based on plasma exposure. in a pre- and post-natal study in rats, ziconotide given as a continuous intravenous infusion did not affect pup development or reproductive performance up to a dose of 10 mg/kg/day, which is approximately 3800-fold higher than the expected exposure resulting from the maximum recommended human daily intrathecal dose of 0.8 mcg/hr (19.2 mcg/day) based on plasma exposure. maternal toxicity, as evidenced by clinical observations, and decreases in body weight gain and food consumption were observed at all doses. risk summary there are no data on the presence of ziconotide in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. infants exposed to prialt through breast milk should be monitored for sedation which may result in respiratory depression and/or feeding problems. the developmental and health benefits of breastfeeding should be weighed against the mother´s clinical need for prialt and any potential adverse effect on the breastfed infant from prialt or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the total number of subjects in clinical studies of prialt, 22% were 65 and over, while 7% were 75 and over. in all trials, there was a higher incidence of confusion in older patients (42% for ≥ 65 year old versus 29% for < 65 year old subgroups). other reported clinical experience has not identified differences in responses between elderly and younger patients. in general, the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

intrapharm laboratories ltd - ziconotide acetate - solution for infusion - 100microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

intrapharm laboratories ltd - ziconotide acetate - solution for infusion - 100microgram/1ml

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

bodyshphere, llc - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987) - pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes. traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

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

bodyshphere, llc - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987) - pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes. traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

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

bodysphere, llc - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987) - pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes. traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

European Union - English - EMA (European Medicines Agency)

seqirus s.r.l.  - influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza, human; immunization; disease outbreaks - vaccines - active immunisation against h5n1 subtype of influenza-a virus.this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/turkey/turkey/1/05 (h5n1)-like strain.aflunov should be used in accordance with official recommendations.