Rx Item-Riastap 1068 Mg Vial By ASD Healthcare

RIASTAP- fibrinogen human injection, powder, lyophilized, for solution
CSL Behring GmbH

1 INDICATIONS AND USAGE

RiaSTAP� , Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

2 DOSAGE AND ADMINISTRATION



For intravenous use only.

2.1 Treatment of Congenital Fibrinogen Deficiency
RiaSTAP dosing, duration of dosing and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.

RiaSTAP dose when baseline fibrinogen level is known.

Dose should be individually calculated for each patient based on the target plasma fibrinogen level based on the type of bleeding, actual measured plasma fibrinogen level and body weight, using the following formula [see Clinical Pharmacology (12.3)]:

[Target level (mg/dL) -- measured level (mg/dL)]
1.7 (mg/dL per mg/kg body weight)
RiaSTAP dose when baseline fibrinogen level is not known.

If the patient's fibrinogen level is not known, the recommended dose is 70 mg per kg of body weight administered intravenously.

Monitor patient's fibrinogen level during treatment with RiaSTAP. Maintain a target fibrinogen level of 100 mg/dL until hemostasis is obtained.

2.2 Preparation and Reconstitution
The procedures below are provided as general guidelines for preparation and reconstitution of RiaSTAP.

Use aseptic technique when preparing and reconstituting RiaSTAP.

Reconstitute RiaSTAP at room temperature as follows:

Remove the cap from the product vial to expose the central portion of the rubber stopper.
Clean the surface of the rubber stopper with an antiseptic solution and allow it to dry.
Using an appropriate transfer device or syringe, transfer 50 mL of Sterile Water for Injection into the product vial.
Gently swirl the product vial to ensure the product is fully dissolved. Do not shake the vial.
After reconstitution, the RiaSTAP solution should be colorless and clear to slightly opalescent. Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Discard partially used vials.

RiaSTAP is stable for 8 hours after reconstitution when stored at 20-25�C; administer within this time period.

2.3 Administration
Do not mix RiaSTAP with other medicinal products or intravenous solutions. Administer through a separate injection site.

Use aseptic technique when administering RiaSTAP.

Administer RiaSTAP at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute.

3 DOSAGE FORMS AND STRENGTHS

RiaSTAP is available as a single-use vial containing 900 mg to 1300 mg lyophilized fibrinogen concentrate powder for reconstitution with 50 mL of Sterile Water for Injection.

The actual fibrinogen potency for each lot is printed on the vial label and carton.

RX ITEM-Riastap 1068 Mg Vial By ASD Heal
NDC 63833-0891-51 UPC/GTIN No.3-63833-89151-2 Mfg.Part No.43894

Riastap 1068 Mg Vial By ASD Healthcare
BRAND: RIASTAP NDC: 63833-0891-51,63833089151 UPC: 3-63833-89151-2,363833891512 ASD Specialty Healthcare-Special Order

FIBRINOGEN INTRAVEN EACH
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