Rx Item-Hemangeol 4.28Mg/Ml Solution 120Ml By Pierre Fabre Pharma

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HEMANGEOL- propranolol hydrochloride solution
Pierre Fabre Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy.

2 DOSAGE AND ADMINISTRATION

Initiate treatment at ages 5 weeks to 5 months.

The recommended starting dose of HEMANGEOL is 0.15 mL/kg (0.6 mg/kg) (see Table 1) twice daily, taken at least 9 hours apart. After 1 week, increase the daily dose to 0.3 mL/kg (1.1 mg/kg) twice daily. After 2 weeks of treatment, increase the dose to 0.4 mL/kg (1.7 mg/kg) twice daily and maintain this for 6 months. Readjust the dose periodically as the child's weight increases.



To reduce the risk of hypoglycemia, administer HEMANGEOL orally during or right after a feeding. Skip the dose if the child is not eating or is vomiting [see Warnings and Precautions (5.1)].

Monitor heart rate and blood pressure for 2 hours after HEMANGEOL initiation or dose increases [see Warnings and Precautions (5.2)].

If hemangiomas recur, treatment may be re-initiated [see Clinical Studies (14)].

HEMANGEOL is supplied with an oral dosing syringe for administration. Administration directly into the child's mouth is recommended. Nevertheless, if necessary, the product may be diluted in a small quantity of milk or fruit juice, given in a baby's bottle.

RX ITEM-Hemangeol 4.28Mg/Ml Solution 120
Item No.:RX333161 NDC No.64370037501 64370-375-01 6437037501 UPC No.:364370375015 NDC No. 64370-0375-01 UPC/GTIN No. 3-64370-37501-5 364370-375015 364370375015 MPN 37501

Hemangeol 4.28Mg/Ml Solution 120Ml By Pi
Item No.:RX333161 NDC No.64370037501 64370-375-01 6437037501 UPC No.:364370375015 NDC No. 64370-0375-01 UPC/GTIN No. 3-64370-37501-5 364370-375015 364370375015 MPN 37501

PROPRANOLOL HCL ORAL SOLU
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Hemangeol 4.28Mg/Ml Solution 1
Item No.:RX333161 NDC No.64370037501 64370-375-01 6437037501 UPC No.:364370375015 NDC No. 64370-0375-01 UPC/GTIN No. 3-64370-37501-5 364370-375015 364370375015 MPN 37501