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Rx Item-BENLYSTA 200MG/ML SYRINGES, 4X1 ML by Glaxosmithkline Rx

NDC No. 49401-0088-47 UPC/GTIN No. 3-49401-08847-8  MPN 8847 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical TherapGlaxosmithkline/Rx 
NDC: 49401-0101-01   
 

UPC: 349401101016 
 
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 scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Benlysta 120mg Vial 1 by Glaxosmithkline Rx

Rx Item-BENLYSTA 200MG/ML SYRINGES, 4X1 ML by Glaxosmithkline Rx

$4779.74$4552.14

NDC No. 49401-0088-47 UPC/GTIN No. 3-49401-08847-8 MPN 8847 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 scope of practice can order this RX item. Rx Item No. Rx49401-0088-47 BENLYSTA 200MG/ML SYRINGES, 4X1 ML by Glaxosmithkline Rx Item No. 3099453 NDC No. 49401008847 4940108847 UPC No. 349401088478 349401-088478 Other Name Belimumab I

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BENLYSTA- belimumab injection, powder, lyophilized, for solution
Human Genome Sciences, Inc.
BENLYSTA� (belimumab) is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
2.1 Dosage Schedule
BENLYSTA is for intravenous infusion only and must be reconstituted and diluted prior to administration [see Dosage and Administration (2.3)]. Do not administer as an intravenous push or bolus.

The recommended dosage regimen is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Reconstitute, dilute, and administer as an intravenous infusion only, over a period of 1 hour. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction [see Contraindications (4), Warnings and Precautions (5.4)].
1. Remove BENLYSTA from the refrigerator and allow to stand 10 to 15 minutes for the vial to reach room temperature.

2. Reconstitute the BENLYSTA powder with Sterile Water for Injection, USP, as follows. The reconstituted solution will contain a concentration of 80 mg/mL belimumab.


Reconstitute the 120-mg vial with 1.5 mL Sterile Water for Injection, USP.

Reconstitute the 400-mg vial with 4.8 mL Sterile Water for Injection, USP.
3. The stream of sterile water should be directed toward the side of the vial to minimize foaming. Gently swirl the vial for 60 seconds. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved. Do not shake. Reconstitution is typically complete within 10 to 15 minutes after the sterile water has been added, but it may take up to 30 minutes. Protect the reconstituted solution from sunlight.

4. If a mechanical reconstitution device (swirler) is used to reconstitute BENLYSTA, it should not exceed 500 rpm and the vial swirled for no longer than 30 minutes.

5. Once reconstitution is complete, the solution should be opalescent and colorless to pale yellow, and without particles. Small air bubbles, however, are expected and acceptable.
Dilution Instructions

6. Dextrose intravenous solutions are incompatible with BENLYSTA. BENLYSTA should only be diluted in 0.9% Sodium Chloride Injection, USP. Dilute the reconstituted product to 250 mL in 0.9% Sodium Chloride Injection, USP (normal saline) for intravenous infusion. From a 250-mL infusion bag or bottle of normal saline, withdraw and discard a volume equal to the volume of the reconstituted solution of BENLYSTA required for the patient's dose. Then add the required volume of the reconstituted solution of BENLYSTA into the infusion bag or bottle. Gently invert the bag or bottle to mix the solution. Any unused solution in the vials must be discarded.

7. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard the solution if any particulate matter or discoloration is observed.

8. The reconstituted solution of BENLYSTA, if not used immediately, should be stored protected from direct sunlight and refrigerated at 2� to 8�C (36� to 46�F). Solutions of BENLYSTA diluted in normal saline may be stored at 2� to 8�C (36� to 46�F) or room temperature. The total time from reconstitution of BENLYSTA to completion of infusion should not exceed 8 hours.

9. No incompatibilities between BENLYSTA and polyvinylchloride or polyolefin bags have been observed.

3 DOSAGE FORMS AND STRENGTHS

Single-use vials of belimumab lyophilized powder for injection:


120 mg per vial

400 mg per vial
4 CONTRAINDICATIONS

BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab.

NDC No. 49401-0088-47 UPC/GTIN No. 3-49401-08847-8  MPN 8847 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap
BENLYSTA 200MG/ML SYRINGES, 4X1 ML by Gl
NDC No. 49401-0088-47 UPC/GTIN No. 3-49401-08847-8 MPN 8847 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therap

Glaxosmithkline/Rx 
NDC: 49401-0101-01   
 

UPC: 349401101016
Benlysta 120mg Vial 1 by Glaxo
Glaxosmithkline/Rx NDC: 49401-0101-01 UPC: 349401101016

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
BELIMUMAB AL 1
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

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

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

Benlysta 120mg Vial 1 by Glaxosmithkline Rx
Benlysta
Benlysta 120mg Vial 1 by Glaxosmithkline Rx