ABILIFY- aripiprazole tablet ABILIFY- aripiprazole solution ABILIFY- aripiprazole tablet, orally disintegrating ABILIFY- arip Združene države Amerike - angleščina - NLM (National Library of Medicine)

abilify- aripiprazole tablet abilify- aripiprazole solution abilify- aripiprazole tablet, orally disintegrating abilify- arip

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

Abilify Maintena 400mg powder and solvent for prolonged-release suspension for injection vials Velika Britanija - angleščina - MHRA (Medicines & Healthcare Products Regulatory Agency)

abilify maintena 400mg powder and solvent for prolonged-release suspension for injection vials

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

ARIPIPRAZOLE tablet Združene države Amerike - angleščina - NLM (National Library of Medicine)

aripiprazole tablet

mckesson corporation dba sky packaging - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole tablets are indicated for the treatment of: - schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify ® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole tablets are 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)]. teratogenic effects pregnancy category c pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs (including aripiprazole) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. adequate and well controlled studies with aripiprazole have not been conducted in pregnant women. animal reproduction studies were conducted with aripiprazole in rats and rabbits during organogenesis, and in rats during the pre-and post-natal period. oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses higher than the maximum recommended human dose (mrhd) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses higher than the maximum recommended human dose (mrhd) produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival. administer aripiprazole during pregnancy only if the potential benefit justifies the potential risk to the fetus. clinical considerations fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including aripiprazole) during the third trimester of pregnancy. these symptoms have varied in severity. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. monitor neonates for extrapyramidal and/or withdrawal symptoms. data animal data in animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the maximum recommended human dose [mrhd] on a mg/m 2 basis) of aripiprazole during the period of organogenesis. gestation was slightly prolonged at 30 mg/kg/day. treatment at the high dose of 30 mg/kg/day caused a slight delay in fetal development (decreased fetal weight), undescended testes, and delayed skeletal ossification (also seen at 10 mg/kg/day).  there were no adverse effects on embryofetal or pup survival. delivered offspring had decreased body weights (10 and 30 mg/kg/day), and increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia at 30 mg/kg (the other dose groups were not examined for these findings). postnatally, delayed vaginal opening  was  seen  at  10  and  30 mg/kg/day  and  impaired  reproductive  performance (decreased  fertility  rate,  corpora  lutea,  implants,  live  fetuses,  and  increased  post-implantation loss,  likely mediated through effects on  female offspring)  was  seen  at 30 mg/kg/day. some maternal toxicity was seen at 30 mg/kg/day however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. pregnant rabbits were treated with oral doses of 10, 30 , and 100 mg/kg/day (2 , 3, and 11 times human exposure at mrhd based on auc and 6, 19 , and 65 times the mrhd based on mg/m 2 ) of aripiprazole during the period of organogenesis. at the high dose of 100 mg/kg/day decreased maternal food consumption, and increased abortions were seen as well as  increased fetal mortality, decreased fetal weight (also seen at 30 mg/kg/day), increased  incidence  of   a   skeletal   abnormality  (fused   sternebrae)  (also   seen   at 30 mg/kg/day). in a study in which rats were treated peri- and post-natally with oral doses of 3, 10, and 30 mg/kg/day (1, 3, and 10 times the mrhd on a mg/m 2 basis) of aripiprazole from gestation day 17  through day 21 postpartum, slight maternal toxicity, slightly prolonged gestation  an  increase  in  stillbirths  and,  decreases  in  pup  weight  (persisting  into adulthood) and survival were seen at 30 mg/kg/day. the effect of aripiprazole on labor and delivery in humans is unknown. aripiprazole is present in human breast milk. because of the potential for serious adverse reactions in nursing infants from aripiprazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the pharmacokinetics of aripiprazole and dehydro-aripiprazole in pediatric patients, 10 to 17 years of age, were similar to those in adults after correcting for the differences in body weight [see clinical pharmacology (12.3)]. schizophrenia safety and effectiveness in pediatric patients with schizophrenia were established in a 6-week, placebo-controlled clinical trial in 202 pediatric patients aged 13 to 17 years [see  dosage and administration (2.1), adverse reactions (6.1), and clinical studies (14.1)]. although maintenance efficacy in pediatric patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. information describing a clinical study in which efficacy was not demonstrated in patients ages 6 to 17 years is approved for otsuka america pharmaceutical, inc.’s abilify ® (aripiprazole). additional pediatric use information in patients ages 6 to 18 years is approved for otsuka america pharmaceutical, inc.’s abilify ® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. juvenile animal studies aripiprazole in juvenile rats caused mortality, cns clinical signs, impaired memory and learning,  and  delayed  sexual  maturation when  administered at  oral  doses  of  10,  20, 40 mg/kg/day  from  weaning  (21  days  old)  through  maturity  (80  days   old).  at 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other cns signs were observed in both genders. in addition, delayed sexual maturation was observed in males. at all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. the changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. a no observed adverse effect level (noael) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (auc 0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. aripiprazole in juvenile dogs (2 months old) caused cns clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. a noael could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (auc 0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period. no dosage adjustment is recommended for elderly patients [see boxed warning, warnings and precautions (5.1), and clinical pharmacology (12.3)]. of the 13,543 patients treated with oral aripiprazole in clinical trials, 1073 (8%) were ≥65 years old and 799 (6%) were ≥75 years old. placebo-controlled studies of oral aripiprazole in schizophrenia, or other indications did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. aripiprazole is not approved for the treatment of patients with psychosis associated with alzheimer’s disease [see  boxed warningand warnings and precautions (5.1)]. dosage adjustment is recommended in known cyp2d6 poor metabolizers due to high aripiprazole concentrations. approximately 8% of caucasians and 3 to 8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm) [see  dosage and administration (2.7)and clinical pharmacology (12.3)]. no  dosage  adjustment for  aripiprazole  is  required  on  the  basis  of  a  patient’s  hepatic function (mild to severe hepatic impairment, child-pugh score between 5 and 15), or renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see clinical pharmacology (12.3)]. no dosage adjustment for aripiprazole is required on the basis of a patient’s sex, race, or smoking status [see clinical pharmacology (12.3)]. aripiprazole is not a controlled substance. aripiprazole has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of aripiprazole misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). in physical dependence studies in monkeys, withdrawal symptoms were observed upon abrupt cessation of dosing. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed.

ARIPIPRAZOLE tablet Združene države Amerike - angleščina - NLM (National Library of Medicine)

aripiprazole tablet

mckesson corporation dba sky packaging - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole oral tablets are indicated for the treatment of: • schizophrenia [see clinical studies ( 14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify ® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole tablets are 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 aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsycho

Amino acids (5%w/v) and Sorbitol (10%w/v) Solution For Injection Kenija - angleščina - Pharmacy and Poisons Board

amino acids (5%w/v) and sorbitol (10%w/v) solution for injection

claris otsuka private limited survey no. 199 to 201 & 208 to 210, village- - l-isoleucine usp l-leucine usp l-lysine… - solution for injection - 5%&10%w/v - intravenous solutions: solutions for parenteral

DNS - Sodium Chloride and Glucose Intravenous Infusion BP (0.9% wv & 5% wv) Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dns - sodium chloride and glucose intravenous infusion bp (0.9% wv & 5% wv)

biocare pharmaceutical (m) sdn. bhd. - sodium chloride; anhydrous glucose -

ABILIFY ASIMTUFII- aripiprazole injection, suspension, extended release Združene države Amerike - angleščina - NLM (National Library of Medicine)

abilify asimtufii- aripiprazole injection, suspension, extended release

otsuka america pharmaceutical, inc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - abilify asimtufii is indicated: - for the treatment of schizophrenia in adults - for maintenance monotherapy treatment of bipolar i disorder in adults abilify asimtufii is contraindicated in patients with a known hypersensitivity to aripiprazole, or any of the excipients. hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole [see adverse reactions (6.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, 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://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . risk summary neonates exposed to antipsychotic drugs, including abilify asimtufii, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms (see clinical considerations) . there are insufficient data with abilify asimtufii use in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 11 times, respectively, the maximum recommended human oral dose (mrhd) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses 10 times the oral mrhd produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival (see data) . consider the benefits and risks of abilify asimtufii and possible risks to the fetus when prescribing abilify asimtufii to a pregnant woman. advise pregnant women of potential fetal risk. the background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including oral aripiprazole, during the third trimester of pregnancy. these symptoms have varied in severity. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. monitor neonates exhibiting extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. data animal data no developmental toxicity studies were conducted with intramuscular aripiprazole suspension. in animal oral or intravenous studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits. pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the oral mrhd of 30 mg/day on mg/m2 basis of aripiprazole during the period of organogenesis. treatment at the highest dose caused a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight and undescended testes. delayed skeletal ossification was observed at 3 and 10 times the oral mrhd on mg/m2 basis. at 3 and 10 times the oral mrhd on mg/m2 basis, delivered offspring had decreased body weights. increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed in offspring from the highest dose group (the other dose groups were not examined for these findings). postnatally, delayed vaginal opening was seen at 3 and 10 times the oral mrhd on mg/m2 basis and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) along with some maternal toxicity were seen at the highest dose; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity. in pregnant rats treated with aripiprazole intravenously at doses of 3, 9, and 27 mg/kg/day, which are 1 to 9 times the oral mrhd on mg/m2 basis, during the period of organogenesis, decreased fetal weight and delayed skeletal ossification were seen at the highest dose which also caused maternal toxicity. in pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral mrhd based on auc and 6 to 65 times the oral mrhd of aripiprazole on mg/m2 basis during the period of organogenesis, decreased maternal food consumption and increased abortions were seen at the highest dose as well as increased fetal mortality. decreased fetal weight and increased incidence of fused sternebrae were observed at 3 and 11 times the oral mrhd based on auc. in pregnant rabbits receiving aripiprazole injection intravenously at doses of 3, 10, and 30 mg/kg/day, which are 2 to 19 times the oral mrhd on mg/m2 basis during the period of organogenesis, the highest dose caused pronounced maternal toxicity that resulted in decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification. the fetal no-effect dose was 5 times the human exposure at the oral mrhd based on auc and is 6 times the oral mrhd on mg/m2 basis. in rats treated with oral doses of 3, 10, and 30 mg/kg/day, which are 1 to 10 times the oral mrhd of aripiprazole on a mg/m2 basis, peri- and post-natally (from day 17 of gestation through day 21 postpartum), slight maternal toxicity and slightly prolonged gestation were seen at the highest dose. an increase in stillbirths and decreases in pup weight (persisting into adulthood) and survival were also seen at this dose. in rats treated with aripiprazole intravenously at doses of 3, 8, and 20 mg/kg/day which are 1 to 6 times the oral mrhd on mg/m2 basis from day 6 of gestation through day 20 postpartum, increased stillbirths were seen at 3 and 6 times the oral mrhd on mg/m2 basis, and decreases in early postnatal pup weight and survival were seen at the highest dose; these doses produced some maternal toxicity. there were no effects on postnatal behavioral and reproductive development. risk summary aripiprazole is present in human breast milk; however, there are insufficient data to assess the amount in human milk, the effects on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother's clinical need for abilify asimtufii and any potential adverse effects on the breastfed infant from abilify asimtufii or from the underlying maternal condition. safety and effectiveness of abilify asimtufii in pediatric patients have not been established. juvenile animal studies no juvenile animal studies were conducted with intramuscular aripiprazole suspension. a study with oral aripiprazole in juvenile rats caused mortality, cns clinical signs, impaired memory and learning, and delayed sexual maturation when administered at doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). at 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other cns signs were observed in both genders. in addition, delayed sexual maturation was observed in males. at all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. the changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. a no observed adverse effect level (noael) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (auc0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended oral pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies. aripiprazole in juvenile dogs (2 months old) caused cns clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. a noael could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (auc0-24 ) for aripiprazole or its major active metabolite in adolescents at the maximum recommended oral pediatric dose of 15 mg/day. all drug-related effects were reversible after a 2-month recovery period. clinical studies of abilify asimtufii did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience and pharmacokinetic data have not identified differences in responses between the elderly and younger patients. in general, 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. in single-dose and multiple-dose pharmacokinetic studies with oral aripiprazole, there was no detectable age effect in the population pharmacokinetic analysis in schizophrenia patients. no dosage adjustments are recommended based on age alone. abilify asimtufii is not approved for the treatment of patients with dementia-related psychosis [see also boxed warning and warnings and precautions (5.1)]. dosage adjustment is recommended in known cyp2d6 poor metabolizers due to high aripiprazole concentrations. approximately 8% of caucasians and 3% to 8% of black/african americans cannot metabolize cyp2d6 substrates and are classified as poor metabolizers (pm) [see dosage and administration (2.4)] . no dosage adjustment for abilify asimtufii is required on the basis of a patient's renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 ml/minute) [see dosage and administration (2.4)] . no dosage adjustment for abilify asimtufii is required on the basis of a patient's hepatic function (mild to severe hepatic impairment, child-pugh score between 5 and 15). abilify asimtufii (a-bil-i-fy ah-sim-tuh-fye) (aripiprazole) extended-release injectable suspension the following information is intended for medical or healthcare professionals only and should be read by the medical or healthcare professional in conjunction with the full prescribing information. - read the complete instructions for preparation and administration below before administering abilify asimtufii. - to be prepared and administered only by a healthcare professional once every two months. - abilify asimtufii pre-filled syringe is single-dose only . re-use may lead to infection or other illness/injury. - for gluteal intramuscular injection only. do not administer by any other route. - prior to administration, visually inspect abilify asimtufii pre-filled syringe for particulate matter and discoloration. the suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in color. do not use abilify asimtufii pre-filled syringe if the suspension is discolored, or particulate matter is present. contents of kit each kit contains one sterile pre-filled syringe containing abilify asimtufii (aripiprazole) 720 mg or 960 mg extended-release injectable suspension and two safety needles: - one sterile 1 ½ inch 22 gauge needle (in black packaging) - one sterile 2 inch 21 gauge needle (in green packaging) preparation prior to administration - remove the abilify asimtufii pre-filled syringe from the package. - tap the syringe on your hand at least 10 (ten) times (figure 1). - after tapping, shake the syringe vigorously for at least 10 (ten) seconds until the medication is uniform (figure 2). figure 1

figure 2

figure 1 figure 2 select the appropriate needle needle selection is determined by patient body type. for gluteal intramuscular administration only. - for non-obese patients - 22-gauge, 1.5-inch (38 mm) safety needle with needle protection device (needle in black packaging) - for obese patients - 21-gauge, 2-inch (51 mm) safety needle with needle protection device (needle in green packaging) refer to table 1 below for needle information: attach the needle - twist and pull off the pre-filled syringe tip-cap (figure 3). - while holding the base of the needle, ensure the needle is firmly seated on the safety device with a push. gently twist clockwise until securely fitted (figure 3). figure 3 expel air - when you are ready to administer the injection of abilify asimtufii, hold the pre-filled syringe upright and remove the needle-cap straight up (figure 4). do not twist the needle-cap, as this may loosen the needle from the syringe. figure 4 - slowly advance the plunger rod upward to expel the air and until the suspension fills needle base (figure 5). figure 5 inject the dose - slowly inject the entire contents of the pre-filled syringe intramuscularly into the gluteal muscle of the patient (figure 6). do not administer by any other route. do not massage the injection site. figure 6 disposal procedure - after the injection, press the safety shield on a hard surface to cover and lock shield over the needle (figure 7 and 8) figure 7 figure 8 - immediately discard used syringe and the unused needle in an approved sharps container (figure 9). - the unused needle should not be saved for future use. figure 9

BUSULFEX® INJECTION 60 mgvial Singapur - angleščina - HSA (Health Sciences Authority)

busulfex® injection 60 mgvial

steward cross pte ltd - busulfan - injection, solution, concentrate - 60 mg/vial - busulfan 60 mg/vial

ARIPIPRAZOLE tablet Združene države Amerike - angleščina - NLM (National Library of Medicine)

aripiprazole tablet

sciegen pharmaceuticals inc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole tablets are indicated for the treatment of: additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole 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 aripiprazole, 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://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including aripi

ARIPIPRAZOLE tablet Združene države Amerike - angleščina - NLM (National Library of Medicine)

aripiprazole tablet

alembic pharmaceuticals inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole is indicated for the treatment of: •  schizophrenia •  irritability associated with autistic disorder •  treatment of tourette’s disorder additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole 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 aripiprazole, 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://womensmentalhealth.org/clinical-and-research-progr