Philippines - English - FDA (Food And Drug Administration)

phil shinpoong pharma inc.; distributor: better option pharmaceuticals, inc. - co-amoxiclav - film-coated tablet - 500mg / 125mg

Philippines - English - FDA (Food And Drug Administration)

phil shinpoong pharma, inc.; distributor: better option pharmaceuticals, inc. - cefuroxime (as sodium) - powder for injection (im/iv) - 750mg

Philippines - English - FDA (Food And Drug Administration)

metz pharmaceuticals, inc. - ascorbic acid , cholecalciferol , zinc - capsule classification: over-the-counter (otc) - 500 mg (equivalent to 562.43 mg sodium ascorbate) 1,000 iu/10 mg (equivalent to 70 mg zinc gluconate) dosage

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

sanofi-aventis australia pty ltd - haemophilus type b polysaccharide, quantity: 10 microgram; tetanus protein, quantity: 18 microgram - injection, powder for - excipient ingredients: trometamol; sucrose - for use in infants from 2 months to 5 years of age for active immunization against invasive disease caused by the haemophilus influenzae type b.

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

sanofi-aventis australia pty ltd - haemophilus type b polysaccharide, quantity: 10 microgram; tetanus protein, quantity: 18 microgram - injection, powder for - excipient ingredients: trometamol; sucrose - for use in infants from 2 months to 5 years of age for active immunization against invasive disease caused by the haemophilus influenzae type b.

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

merck sharp & dohme corp. - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen (unii: luy6p8763w) (haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen - unii:luy6p8763w) - haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen 1 g in 1 g

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

glaxosmithkline biologicals sa - haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen (unii: c9r35m8xv6) (haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen - unii:c9r35m8xv6) - haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - hiberix is indicated for active immunization for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. hiberix is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday). severe allergic reaction (e.g., anaphylaxis) after a previous dose of any h. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of hiberix [see description (11)] . safety and effectiveness of hiberix in children younger than 6 weeks and in children aged 5 to 16 years have not been established.

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

amgen inc - blinatumomab (unii: 4fr53sif3a) (blinatumomab - unii:4fr53sif3a) - blinatumomab 12.5 ug in 1 ml - blincyto is indicated for the treatment of cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1% in adult and pediatric patients. blincyto is indicated for the treatment of relapsed or refractory cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in adult and pediatric patients. blincyto is contraindicated in patients with known hypersensitivity to blinatumomab or to any component of the product formulation. risk summary based on its mechanism of action, blincyto may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of blincyto in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, a murine surrogate molecule administered to pregnant mice crossed the placental barrier (see data) . blinatumomab causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. in addition, based on expression of cd19 on b-cells and the finding of b-cell depletion in non-pregnant animals, blinatumomab can cause b-cell lymphocytopenia in infants exposed to blinatumomab in-utero. advise pregnant women of the potential risk to a fetus. 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 due to the potential for b-cell lymphocytopenia in infants following exposure to blincyto in utero , the infant's b lymphocytes should be monitored before the initiation of live virus vaccination [see warnings and precautions (5.11)] . data animal data animal reproduction studies have not been conducted with blinatumomab. in embryo-fetal developmental toxicity studies, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis. the surrogate molecule crossed the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. the expected depletions of b and t cells were observed in the pregnant mice, but hematological effects were not assessed in fetuses. risk summary there is no information regarding the presence of blinatumomab in human milk, the effects on the breastfed infant, or the effects on milk production. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from blincyto, including b-cell lymphocytopenia, advise patients not to breastfeed during treatment with blincyto and for 48 hours after the last dose. blincyto may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating blincyto treatment. contraception females advise females of reproductive potential to use effective contraception during treatment with blincyto and for 48 hours after the last dose. minimal residual disease (mrd)-positive b-cell precursor all the safety and efficacy of blincyto for the treatment of cd19-positive b-cell precursor acute lymphoblastic leukemia (all) in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0.1% have been established in pediatric patients. use of blincyto is supported by evidence from two randomized, controlled trials (study aall1331 nct02101853 and study 20120215 nct02393859) in pediatric subjects with first relapsed b-cell precursor all. both studies included pediatric patients with mrd-positive b-cell precursor all. the studies included pediatric patients treated with blincyto in the following age groups: 6 infants (1 month up to less than 2 years), 165 children (2 years up to less than 12 years), and 70 adolescents (12 years to less than 17 years). in general, the adverse reactions in blincyto-treated pediatric patients were similar in type to those seen in adult patients with mrd-positive all [see adverse reactions (6.1)] , and no differences in safety were observed between the different pediatric age subgroups. relapsed or refractory b-cell precursor all the safety and efficacy of blincyto have been established in pediatric patients with relapsed or refractory b-cell precursor all. use of blincyto is supported by a single-arm trial in pediatric patients with relapsed or refractory b-cell precursor all. this study included pediatric patients in the following age groups: 10 infants (1 month up to less than 2 years), 40 children (2 years up to less than 12 years), and 20 adolescents (12 years to less than 18 years). no differences in efficacy were observed between the different age subgroups [see clinical studies (14.2)] . in general, the adverse reactions in blincyto-treated pediatric patients with relapsed or refractory all were similar in type to those seen in adult patients with relapsed or refractory b-cell precursor all [see adverse reactions (6.1)] . adverse reactions that were observed more frequently (≥ 10% difference) in the pediatric population compared to the adult population were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%). in pediatric patients less than 2 years old (infants) with relapsed or refractory all, the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%). benzyl alcohol toxicity in neonates serious and fatal adverse reactions, including "gasping syndrome," can occur in very low birth weight (vlbw) neonates born weighing less than 1500 g, and early preterm neonates (infants born less than 34 weeks gestational age) treated with benzyl alcohol-preserved drugs intravenously. the "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high concentrations of benzyl alcohol and its metabolite in the blood and urine (blood concentration of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. the minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known [see warnings and precautions (5.12)] . use the preservative-free formulations of blincyto where possible in neonates. when prescribing blincyto (with preservative) in neonatal patients, consider the combined daily metabolic load of benzyl alcohol from all sources including blincyto (with preservative). the blincyto 7-day bag (with preservative) contains 7.4 mg of benzyl alcohol per ml [see warnings and precautions (5.12)] . benzyl alcohol administration may contribute to metabolic acidosis in pediatric patients, particularly those with immaturity of the metabolic pathway for alcohol, or those with underlying conditions or receiving concomitant medications that could predispose to acid base imbalance. monitor these patients during use of blincyto (with preservative) for new or worsening metabolic acidosis. of the total number of patients with all treated in clinical studies of blincyto, approximately 12% were 65 and over, while 2% were 75 and older. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. however, elderly patients experienced a higher rate of serious infections and neurological toxicities, including cognitive disorder, encephalopathy, and confusion [see warnings and precautions (5.2, 5.3)] .

Philippines - English - FDA (Food And Drug Administration)

glaxosmithkline philippines, inc. - haemophilus influenza type b conjugate vaccine - lyophilized powder for injection - 10mcg + 0.5ml

Philippines - English - FDA (Food And Drug Administration)

glaxosmithkline philippines, inc. - haemophilus influenza type b conjugate vaccine - lyophilized powder for injection - 10mcg + 0.5ml