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Kalbitor 10mg/ml(1) Vial 3 by ASD Healthcare

NDC 47783-0101-01 UPC/GTIN No.3-47783-10101-3 Mfg.Part No.35451ASD Specialty Healthcare-Special OrderThis Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).ASD Specialty Healthcare-Special OrderImage 4 of Kalbitor 10mg/ml(1) Vial 3 by ASD Healthcare

Kalbitor 10mg/ml(1) Vial 3 by ASD Healthcare

$45448.56$41767.23

NDC No. 47783-0101-01 UPC/GTIN No. 3-47783-10101-3 MPN 35451 Only Physician,Pharmacy or Licensed Facility can order this Rx Item No. Rx020418 Kalbitor 10mg/ml(1) Vial 3 by ASD Healthcare Item No. 3020418 NDC No. 47783010101 UPC No. 347783101013 Other Name Kalbitor, ecallantide injection Sq Therapeutic Code 923200 Therapeutic Class Complement C1 Esterase Inhibitor Item Class Non Controlled Rx. Case Qnty: 1 Therapeutic Code 923200 Complement C1 Esterase Inhibitor Info 923200 Common Group Ecallanti

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KALBITOR- ecallantide injection, solution
Dyax Corp.

WARNING: ANAPHYLAXIS

Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer KALBITOR to patients with known clinical hypersensitivity to KALBITOR. [ see Contraindications (4), Warnings and Precautions (5.1), and Adverse Reactions (6)]

1??INDICATIONS AND USAGE



KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

2??DOSAGE AND ADMINISTRATION

2.1??Recommended Dosing
The recommended dose of KALBITOR is 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If the attack persists, an additional dose of 30 mg may be administered within a 24 hour period.

2.2??Administration Instructions
KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema.

KALBITOR should be refrigerated and protected from the light. KALBITOR is a clear, colorless liquid; visually inspect each vial for particulate matter and discoloration prior to administration. If there is particulate matter or discoloration, the vial should not be used.

Using aseptic technique, withdraw 1 mL (10 mg) of KALBITOR from the vial using a large bore needle. Change the needle on the syringe to a needle suitable for subcutaneous injection. The recommended needle size is 27 gauge. Inject KALBITOR into the skin of the abdomen, thigh, or upper arm. Repeat the procedure for each of the 3 vials comprising the KALBITOR dose. The injection site for each of the injections may be in the same or in different anatomic locations (abdomen, thigh, upper arm). There is no need for site rotation. Injection sites should be separated by at least 2 inches (5 cm) and away from the anatomical site of attack.

The same instructions apply to an additional dose administered within 24 hours. Different injection sites or the same anatomical location (as used for the first administration) may be used.

3??DOSAGE FORMS AND STRENGTHS

KALBITOR is a clear, colorless liquid free of preservatives. Each vial of KALBITOR contains ecallantide at a concentration of 10 mg/mL.

NDC 47783-0101-01 UPC/GTIN No.3-47783-10101-3 Mfg.Part No.35451
Kalbitor 10mg/ml(1) Vial 3 by ASD Health
NDC 47783-0101-01 UPC/GTIN No.3-47783-10101-3 Mfg.Part No.35451

ASD Specialty Healthcare-Special Order

ASD Specialty Healthcare-Special Order

This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).
ECALLANTIDE SUB-Q VIAL 10
This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).

ASD Specialty Healthcare-Special Order
ASD Specialty Healthcare-Special Order

Image 4 of Kalbitor 10mg/ml(1) Vial 3 by ASD Healthcare