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Rx Item-Elaprase 6Mg Idursulfase IV 3 Ml Vial By Theracom Shire Elaprase

Item No.:RX601190 NDC No.54092070001 5409270001 54092-700-01 UPC No.:354092700011 NDC No. 54092-0700-01 UPC/GTIN No. 3-54092-70001-1 354092700011 354092-700011 MPN 70001Item No.:RX601190 NDC No.54092070001 5409270001 54092-700-01 UPC No.:354092700011 NDC No. 54092-0700-01 UPC/GTIN No. 3-54092-70001-1 354092700011 354092-700011 MPN 70001Only 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.

Rx Item-Elaprase 6Mg Idursulfase IV 3 Ml Vial By Theracom Shire Elaprase

$3763.00$3583.81

Item No.:RX601190 NDC No.54092070001 5409270001 54092-700-01 UPC No.:354092700011 NDC No. 54092-0700-01 UPC/GTIN No. 3-54092-70001-1 354092700011 354092-700011 MPN 70001 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx601190 Elaprase 6mg/3 ml Vial by Theracom/Shire / Elaprase Item No. 3601190 NDC

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Clinical Information
Gen. Code and Des.
61253 idursulfase INTRAVEN VIAL 6 MG/3 ML
GCN and Des.
97047 idursulfase INTRAVEN VIAL 6 MG/3 ML
Strength
6 MG/3ML
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
44000000 ENZYMES
Active Ingredients
11684 idursulfase 50936599
Inactive Ingredients
2551 polysorbates 9005645
FDA NDA Approved






ELAPRASE- idursulfase solution, concentrate
Shire US Manufacturing Inc.

WARNING: RISK OF ANAPHYLAXIS

? Life-threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after ELAPRASE infusions, regardless of duration of the course of treatment. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional monitoring [ see Warnings and Precautions (5.1, 5.3) and Adverse Reactions (6)].

1 INDICATIONS AND USAGE



? ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). ELAPRASE has been shown to improve walking capacity in patients 5 years and older.

? In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older.

? The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age [see Use in Specific Populations (8.4)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose
The recommended dosage regimen of ELAPRASE is 0.5 mg per kg of body weight administered once weekly as an intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Item No.:RX601190 NDC No.54092070001 5409270001 54092-700-01 UPC No.:354092700011 NDC No. 54092-0700-01 UPC/GTIN No. 3-54092-70001-1 354092700011 354092-700011 MPN 70001
RX ITEM-Elaprase 6Mg 3 Ml Vial By Therac
Item No.:RX601190 NDC No.54092070001 5409270001 54092-700-01 UPC No.:354092700011 NDC No. 54092-0700-01 UPC/GTIN No. 3-54092-70001-1 354092700011 354092-700011 MPN 70001

Item No.:RX601190 NDC No.54092070001 5409270001 54092-700-01 UPC No.:354092700011 NDC No. 54092-0700-01 UPC/GTIN No. 3-54092-70001-1 354092700011 354092-700011 MPN 70001
Elaprase 6Mg 3 Ml Vial By Theracom Shire
Item No.:RX601190 NDC No.54092070001 5409270001 54092-700-01 UPC No.:354092700011 NDC No. 54092-0700-01 UPC/GTIN No. 3-54092-70001-1 354092700011 354092-700011 MPN 70001

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
IDURSULFASE INTRAVEN VIAL
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.