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Myobloc (Rimabotulinumtoxinb) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No long-term carcinogenicity studies in animals have been performed.

PREGNANCY

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with MYOBLOC. It is also not known whether MYOBLOC can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MYOBLOC should be given to a pregnant woman only if clearly needed.

OVERDOSAGE

Excessive doses of MYOBLOC may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis (see WARNINGS and PRECAUTIONS).Symptomatic treatment may be necessary.

Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or muscle paralysis.

In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100. More information can be obtained at http://cdc.gov/ncidod/srp/drugs/drug-service.html.

CONTRAINDICATIONS

MYOBLOC is contraindicated in patients with a known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

MYOBLOC is contraindicated for use in patients with infection at the proposed injection site(s).

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