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

boiron - phytolacca americana root (unii: 11e6vi8veg) (phytolacca americana root - unii:11e6vi8veg) - sore throat pain radiating to the ears* stop use and ask a doctor if symptoms persist for more than 3 days or worsen

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

boiron - phytolacca americana root (unii: 11e6vi8veg) (phytolacca americana root - unii:11e6vi8veg) - sore throat pain radiating to the ears* stop use and ask a doctor if symptoms persist for more than 3 days or worsen

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

boiron - phytolacca americana root (unii: 11e6vi8veg) (phytolacca americana root - unii:11e6vi8veg) - sore throat pain radiating to the ears* stop use and ask a doctor if symptoms persist for more than 3 days or worsen

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

boiron - phytolacca americana root (unii: 11e6vi8veg) (phytolacca americana root - unii:11e6vi8veg) - sore throat pain radiating to the ears* stop use and ask a doctor if symptoms persist for more than 3 days or worsen

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

boiron - phytolacca americana root (unii: 11e6vi8veg) (phytolacca americana root - unii:11e6vi8veg) - sore throat pain radiating to the ears* stop use and ask a doctor if symptoms persist for more than 3 days or worsen

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

boiron - phytolacca americana root (unii: 11e6vi8veg) (phytolacca americana root - unii:11e6vi8veg) - sore throat pain radiating to the ears* stop use and ask a doctor if symptoms persist for more than 3 days or worsen

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

butler animal health supply, llc dba covetrus north america - pramoxine hydrochloride (unii: 88ayb867l5) (pramoxine - unii:068x84e056), salicyloyl phytosphingosine (unii: u891j4jcnh) (salicyloyl phytosphingosine - unii:u891j4jcnh) - indications: for the temporary relief of itching and skin irritations. directions for use: shake well before use. use 2-3 times per week until symptoms subside or as directed by your veterinarian. after bathing with phyto p shampoo, apply this product. starting with the skin abormalities, massage a quarter-size amount of phyto p créme rinse into the fur to reach the skin. repeat until entire body is lightly coated. leave on for 10 minutes before rinsing with cool water. for a rinse-free solution between baths, ask your veterinarian about phyto p spray or mousse.

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

cipla usa inc. - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione injectable emulsion is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors ii, vii, ix and x when caused by vitamin k deficiency or interference with vitamin k activity: - anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; - hypoprothrombinemia due to antibacterial therapy; - hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin k, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; - other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin k metabolism, e.g., salicylates. phytonadione injectable emulsion is indicated for prophylaxis and treatment of vitamin k-deficiency bleeding in neonates. hypersensitivity to phytonadione or any other component of this medication [see warnings and precautions (5.1)] . risk summary phytonadione injectable emulsion contains benzyl alcohol, which has been associated with gasping syndrome in neonates. the preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants. if phytonadione injectable emulsion is needed during pregnancy, consider using a benzyl alcohol-free formulation [see warnings and precautions (5.2), use in specific populations (8.4)] . published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see data] . there are maternal and fetal risks associated with vitamin k deficiency during pregnancy [see clinical considerations] . animal reproduction studies have not been conducted with phytonadione. the estimated background risk 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 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with vitamin k deficiency hypoprothrombinemia may be at an increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. subclinical maternal vitamin k deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. data human data phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma. administration of vitamin k1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. however, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding. animal data in pregnant rats receiving vitamin k1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer. risk summary phytonadione injectable emulsion contains benzyl alcohol. if available, preservative-free phytonadione injectable emulsion is recommended when phytonadione injectable emulsion is needed during lactation [see warnings and precautions (5.2), use in specific populations (8.4)] . phytonadione is present in breastmilk. there are no data on the effects of phytonadione injectable emulsion on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the clinical need for phytonadione injectable emulsion and any potential adverse effects on the breastfed child from phytonadione injectable emulsion or from the underlying maternal condition. the safety and effectiveness of phytonadione injectable emulsion for prophylaxis and treatment of vitamin k deficiency have been established in neonates. use of phytonadione injection for prophylaxis and treatment of vitamin k deficiency is based on published clinical studies. serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels 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. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. when prescribing phytonadione injectable emulsion in infants consider the combined daily metabolic load of benzyl alcohol from all sources including phytonadione injectable emulsion (phytonadione injectable emulsion contains 9 mg of benzyl alcohol per ml) and other drugs containing benzyl alcohol. the minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see warnings and precautions (5.2)] . whenever possible, use preservative-free phytonadione formulations in neonates. the preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. premature and low-birth weight infants may be more likely to develop toxicity.

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

cipla usa inc. - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione injectable emulsion is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors ii, vii, ix and x when caused by vitamin k deficiency or interference with vitamin k activity: - anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; - hypoprothrombinemia due to antibacterial therapy; - hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin k, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; - other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin k metabolism, e.g., salicylates. phytonadione injectable emulsion is indicated for prophylaxis and treatment of vitamin k-deficiency bleeding in neonates. hypersensitivity to phytonadione or any other component of this medication

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

a-s medication solutions - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - mephyton is indicated in the following coagulation disorders which are due to faulty formation of factors ii, vii, ix and x when caused by vitamin k deficiency or interference with vitamin k activity. mephyton tablets are indicated in: hypersensitivity to any component of this medication.