Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Dosage and Administration** The dose of intravenous PERSANTIN as an adjunct to thallium myocardial perfusion imaging should be adjusted according to the weight of the patient. The recommended dose is 0.142 mg/kg/minute (0.567 mg/kg total) infused over 4 minutes. The maximum dose is 0.84 mg/kg infused over 6 – 10 minutes. Exceeding the maximum dose is not recommended. Prior to intravenous administration, i.v. PERSANTIN should be diluted in at least a 1:2 ratio with sodium chloride 0.45% or 0.9% or glucose 5% for a total volume of approximately 20 to 50 ml. Infusion of undiluted PERSANTIN may cause local irritation. Thallium-201 should be injected within 5 minutes following the 4-minute infusion of PERSANTIN. PERSANTIN should not be mixed with other drugs in the same syringe or infusion container. Safety and effectiveness in children have not been established. Use is not recommended.
INTRAVENOUS, INTRAMUSCULAR
Medical Information
**Indications** I.v. PERSANTIN is indicated as an alternative to exercise testing in myocardial perfusion Thallium and stress-echocardiography imaging for the evaluation of coronary artery disease, particularly in patients who cannot exercise adequately. The sensitivity and specificity of exercise thallium imaging and PERSANTIN thallium imaging is almost identical.
**Contraindications** Hypersensitivity to any of the components of the product. Patients already receiving treatment with regular oral PERSANTIN should not receive additional intravenous PERSANTIN for the purposes of stress testing.
B01AC07
dipyridamole
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
BOEHRINGER INGELHEIM ESPANA S.A.
Active Ingredients
Documents
Package Inserts
Persantin SG_PI.pdf
Approved: October 6, 2020