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

otsuka america pharmaceutical, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - abilify (aripiprazole) oral tablets, orally-disintegrating tablets, and oral solution are indicated for the treatment of: - schizophrenia - acute treatment of manic and mixed episodes associated with bipolar i disorder - adjunctive treatment of major depressive disorder - irritability associated with autistic disorder - treatment of tourette's disorder abilify injection is indicated for the treatment of: - agitation associated with schizophrenia or bipolar mania abilify is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including abilify, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhea

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

otsuka pharmaceuticals (u.k. - aripiprazole - solution for injection - 7.5mg/1ml

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

otsuka pharmaceuticals (u.k. - aripiprazole - powder and solvent for suspension for injection - 400mg

Singapore - English - HSA (Health Sciences Authority)

luen wah medical company (singapore) private limited - calcium chloride dihydrate; potassium chloride; sodium chloride - injection - 0.33g/1l - calcium chloride dihydrate 0.33g/1l; potassium chloride 0.3 g/1000 ml; sodium chloride 8.6 g/1000 ml

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

otsuka america pharmaceutical, inc. - decitabine (unii: 776b62cq27) (decitabine - unii:776b62cq27) - decitabine 50 mg in 20 ml - dacogen is indicated for treatment of adult patients with myelodysplastic syndromes (mds) including previously treated and untreated, de novo and secondary mds of all french-american-british subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international prognostic scoring system groups. none. risk summary based on findings from human data, animal studies, and the mechanism of action, dacogen can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)] . limited published data on dacogen use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities). in animal reproduction studies, administration of decitabine to pregnant mice and rats during organogenesis caused adverse developmental outcomes including malformations and embryo-fetal lethality starting at doses approximately 7% of the recommended human dose on a mg/m2 basis (see data) . advise pregnant women of the potential risk to a fetus. 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. the estimated background risk of major birth defects and miscarriage in the u.s. general population is 2% to 4% and 15% to 20% of clinically recognized pregnancies, respectively. data human data a single published case report of decitabine pregnancy exposure in a 39-year old woman with a hematologic malignancy described multiple structural abnormalities after 6 cycles of therapy in the 18th week of gestation. these abnormalities included holoprosencephaly, absence of nasal bone, mid-facial deformity, cleft lip and palate, polydactyly and rocker-bottom feet. the pregnancy was terminated. animal data in utero exposure to decitabine causes temporal related defects in the rat and/or mouse, which include growth suppression, exencephaly, defective skull bones, rib/sternabrae defects, phocomelia, digit defects, micrognathia, gastroschisis, micromelia. decitabine inhibits proliferation and increases apoptosis of neural progenitor cells of the fetal cns and induces palatal clefting in the developing murine fetus. studies in mice have also shown that decitabine administration during osteoblastogenesis (day 10 of gestation) induces bone loss in offspring. in mice exposed to single ip (intraperitoneal) injections (0, 0.9 and 3.0 mg/m2 , approximately 2% and 7% of the recommended daily clinical dose, respectively) over gestation days 8, 9, 10 or 11, no maternal toxicity was observed but reduced fetal survival was observed after treatment at 3 mg/m2 and decreased fetal weight was observed at both dose levels. the 3 mg/m2 dose elicited characteristic fetal defects for each treatment day, including supernumerary ribs (both dose levels), fused vertebrae and ribs, cleft palate, vertebral defects, hind-limb defects and digital defects of fore- and hind-limbs. in rats given a single ip injection of 2.4, 3.6 or 6 mg/m2 (approximately 5%, 8%, or 13% the daily recommended clinical dose, respectively) on gestation days 9-12, no maternal toxicity was observed. no live fetuses were seen at any dose when decitabine was injected on gestation day 9. a significant decrease in fetal survival and reduced fetal weight at doses greater than 3.6 mg/m2 was seen when decitabine was given on gestation day 10. increased incidences of vertebral and rib anomalies were seen at all dose levels, and induction of exophthalmia, exencephaly, and cleft palate were observed at 6.0 mg/m2 . increased incidence of foredigit defects was seen in fetuses at doses greater than 3.6 mg/m2 . reduced size and ossification of long bones of the fore-limb and hind-limb were noted at 6.0 mg/m2 . the effect of decitabine on postnatal development and reproductive capacity was evaluated in mice administered a single 3 mg/m2 ip injection (approximately 7% the recommended daily clinical dose) on day 10 of gestation. body weights of males and females exposed in utero to decitabine were significantly reduced relative to controls at all postnatal time points. no consistent effect on fertility was seen when female mice exposed in utero were mated to untreated males. untreated females mated to males exposed in utero showed decreased fertility at 3 and 5 months of age (36% and 0% pregnancy rate, respectively). follow up studies indicated that treatment of pregnant mice with decitabine on gestation day 10 was associated with a reduced pregnancy rate resulting from effects on sperm production in the f1-generation. risk summary there are no data on the presence of decitabine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions from dacogen in a breastfed child, advise women not to breastfeed while receiving dacogen and for at least 2 weeks after the last dose. pregnancy testing conduct pregnancy testing of females of reproductive potential prior to initiating dacogen. contraception females dacogen can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception while receiving dacogen and for 6 months following the last dose. males advise males with female partners of reproductive potential to use effective contraception while receiving treatment with dacogen and for 3 months following the last dose [see nonclinical toxicology (13.1)] . infertility based on findings of decitabine in animals, male fertility may be compromised by treatment with dacogen. the reversibility of the effect on fertility is unknown [see nonclinical toxicology (13.1)]. the safety and effectiveness of dacogen in pediatric patients have not been established. of the total number of patients exposed to dacogen in the controlled clinical trial, 61 of 83 patients were age 65 years and over, while 21 of 83 patients were age 75 years and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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

sergeant's pet care products, inc - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - benzalkonium chloride 0.13 g in 118 ml - fast relief. effective. soothing. non-stinging. alcohol-free.  petarmor for dogs hot spot skin remedy kills topical bacteria, fungus and viruses associated with hot spots. remedy for superficial cuts, scrapes, and abrasions. other hot spot signs:  biting and skin flaking.

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

lundbeck australia pty ltd - aripiprazole, quantity: 400 mg (equivalent: aripiprazole monohydrate, qty 416.07 mg) - injection, powder for - excipient ingredients: carmellose sodium; mannitol; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - for the acute and maintenance treatment of schizophrenia in adults. for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar i disorder in adult patients as monotherapy.

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

lundbeck australia pty ltd - aripiprazole, quantity: 300 mg (equivalent: aripiprazole monohydrate, qty 312.05 mg) - injection, powder for - excipient ingredients: carmellose sodium; mannitol; monobasic sodium phosphate monohydrate; sodium hydroxide; water for injections - for the acute and maintenance treatment of schizophrenia in adults. for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar i disorder in adult patients as monotherapy.

Kenya - English - Pharmacy and Poisons Board

claris otsuka private limited village - vasna chacharwadi tal. sanand - amino acids anhydrous glucose bp soybean oil usp - injection - 10% amino acid + 10% dextrose + 20% fat emulsion - intravenous solutions: solutions for parenteral

Singapore - English - HSA (Health Sciences Authority)

lundbeck singapore pte. ltd. - sterile aripiprazole monohydrate 416mg/vial equivalent to anhydrous aripiprazole - injection, powder, for suspension, extended release - sterile aripiprazole monohydrate 416mg/vial equivalent to anhydrous aripiprazole 400mg/vial