Infuvite Pediatric
Generic: MULTIPLE VITAMINS INJECTION
Basic Information
Manufacturer
Sandoz Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
6d06546e-8b0a-4490-82d9-397bd902a044
Indications & Usage
1 INDICATIONS AND USAGE INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition ( 1 )
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
INFUVITE PEDIATRIC is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections 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 PEDIATRIC.
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.
Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 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 PEDIATRIC.
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.
Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis, rash, erythema, pruritis, headache, dizziness, agitation, anxiety, diplopia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.