Infuvite Adult
Generic: MULTIPLE VITAMINS INJECTION
Basic Information
Manufacturer
Sandoz Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
14c7bfc5-07e8-400f-b8ff-5e4794dd2805
Indications & Usage
1 INDICATIONS AND USAGE 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 )
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 )
Adverse Reactions
6 ADVERSE REACTIONS 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.
Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis and anaphylactoid reactions including shortness of breath, wheezing and angioedema, 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 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.
Dermatologic: rash, erythema, pruritis CNS: headache, dizziness, agitation, anxiety Ophthalmic: diplopia Adverse reactions have included anaphylaxis and anaphylactoid reactions including shortness of breath, wheezing and angioedema, 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 .