Rx Item-Idelvion 1953 Unit Single Dose Vial By CSL Behring ASD Healthcare

IDELVION- coagulation factor ix recombinant human
CSL Behring Recombinant Facility AG
1 INDICATIONS AND USAGE
? IDELVION � , Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rIX-FP), a recombinant DNA-derived coagulation Factor IX concentrate, is indicated in children and adults with Hemophilia B (congenital Factor IX deficiency) for:

? On-demand treatment and control of bleeding episodes
? Perioperative management of bleeding
? Routine prophylaxis to reduce the frequency of bleeding episodes


Limitations of Use:

IDELVION is not indicated for immune tolerance induction in patients with Hemophilia B.

2 DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution only.

2.1 Dosage
Each vial of IDELVION contains the recombinant Factor IX potency in international units (IU) that is stated on the carton and vial label.
Dosage and duration of treatment with IDELVION depends on the severity of Factor IX deficiency, the location and extent of bleeding, and the patient�s clinical condition, age and recovery of Factor IX.
The calculation of the required dose of IDELVION is based on the empirical finding that one IU of IDELVION per kg body weight is expected to increase the circulating level of Factor IX by 1.3 IU/dL in patients ?12 years of age and by 1 IU/dL in patients <12 years of age. 3 DOSAGE FORMS AND STRENGTHS

IDELVION is a pale yellow to white lyophilized powder supplied in single-use vials containing nominally 250, 500, 1000, or 2000 IU of Factor IX potency. The actual factor IX potency is labeled on each vial and carton. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
IDELVION is a recombinant protein that temporarily replaces the missing coagulation Factor IX needed for effective hemostasis. IDELVION is comprised of genetically fused recombinant coagulation Factor IX and recombinant albumin. Fusion with recombinant albumin extends the half-life of Factor IX

RX ITEM-Idelvion 1953 Unit Single Dose V
NDC No. 69911-0867-02 UPC/GTIN No. MPN 86702

Idelvion 1953 Unit Single Dose Vial By
BRAND: IDELVION NDC: 69911-0867-02,69911086702 UPC: 3-63833-38702-2,363833387022 ASD Specialty Healthcare-Special Order

IDELVION- coagulation factor ix recombin
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.