Emzovit-15_

INFUVITE ADULT is a combination of vitamins indicated for the prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE ADULT is a combination of vitamins indicated for prevention of vitamin deficiency in adults and children aged 11 and older receiving parenteral nutrition ( 1 )

• INFUVITE ADULT is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K 1 , folic acid, biotin, and vitamin B 12 • INFUVITE ADULT is for administration by intravenous infusion after dilution • Recommended daily dosage is 10 mL • INFUVITE ADULT is supplied as a single dose and as a pharmacy bulk package. o Single Dose : Add one daily dose of 10 mL (5 mL from Vial 1 and 5 mL from Vial 2) to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. o Pharmacy Bulk Package : Add the contents of Vial 1 to the contents of Vial 2
• This provides ten 10 mL daily doses
• Take 10 mL from Vial 2 and add to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. • After dilution in an intravenous infusion, refrigerate resulting solution unless used immediately
• Use solution within 24 hours after dilution • Monitor blood vitamin concentrations • See Full Prescribing Information for drug incompatibilities Important Dosage Instructions INFUVITE ADULT is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K 1 , folic acid, biotin, and vitamin B 12 . …

INFUVITE ADULT Single Dose: is an injection for intravenous administration consisting of two vials labeled Vial 1 (5 mL) and Vial 2 (5 mL). For the vitamin strengths [see Description ( 11 )]. INFUVITE ADULT Pharmacy Bulk Package : is an injection for intravenous administration consisting of two vials labeled Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). …

Safety and effectiveness in children below the age of 11 years have not been established.

Safety and effectiveness for geriatric use have not been established.

Instruct patients (if age appropriate) and caregivers: • To watch for signs of allergic reactions such as urticaria, shortness of breath, wheezing and angioedema since hypersensitivity reactions may occur to any of the vitamins or excipients contained in INFUVITE ADULT. • To watch for and immediately report nausea, vomiting, headache, dizziness, blurred vision, especially if patients have renal impairment, as these may be signs of hypervitaminosis A. • To report other adverse reactions such as rash, erythema, pruritus, headache, dizziness, agitation, anxiety, and diplopia. …

INFUVITE ADULT is contraindicated in patients who have • An existing hypervitaminosis, or • A history of hypersensitivity due to any vitamins or excipients contained in this formulation. • Hypersensitivity to any of the vitamins or excipients ( 4 ) • Existing hypervitaminosis ( 4 )

A number of interactions between vitamins and drugs have been reported. The following are examples of these types of interactions: Effect of INFUVITE ADULT on other drugs: • Antibiotics: Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid decrease activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin ( 7.1 ) • Bleomycin: Ascorbic acid and riboflavin may reduce the activity of bleomycin ( 7.1 ) • Levodopa: Pyridoxine may decrease blood levels of levodopa and levodopa efficacy may decrease ( 7.1 ) • Phenytoin: Folic acid may decrease phenytoin blood levels and increase risk of seizure activity ( 7.1 ) • Methotrexate: Folic acid may decrease response to m …

• Risk of Aluminum Toxicity: For at risk patients (renal failure or those with prolonged therapy), consider periodic monitoring of aluminum levels ( 5.1 ) • Allergic Reactions: To thiamine may occur ( 5.2 ) • Hypervitaminosis A : Patients with renal failure or liver disease may be at higher risk ( 5.3 ) • Decreased Anticoagulant Effect of Warfarin: Monitor INR ( 5.4 , 7.1 ) • Interferes with Megaloblastic Anemia Diagnosis: Avoid during testing for this disorder ( 5.5 ) • Risk of Vitamin Deficiencies or Excesses: Monitor blood vitamin concentrations ( 5.6 ) • False Negative Urine Glucose Tests: Due to vitamin C ( 5.7 ) 5.1 Aluminum Toxicity INFUVITE ADULT contains aluminum that may be toxic. …

The following adverse reactions are discussed in greater detail in other section of the labeling. • Allergic reactions to thiamine [see Warnings and Precautions ( 5.2 )] • Hypervitaminosis A [see Warnings and Precautions ( 5.3 )] The following adverse reactions have been identified during postapproval use of INFUVITE ADULT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. …

8.1 Pregnancy Risk Summary Administration of the approved recommended dose of INFUVITE ADULT in parental nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Pregnant patients should follow the U.S. Recommended Daily Allowances for pregnancy because their vitamin requirements may exceed those of nonpregnant patients. …

Signs and symptoms of acute or chronic overdosage may be those of individual INFUVITE ADULT component toxicity. In post-marketed surveillance, overdosage with INFUVITE ADULT at two times the prescribed dose did not result in toxicity.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.