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Rx Item-Synagis 100Mg/Ml Vial By Medimmune Biologics

NDC 60574-4113-01 UPC/GTIN No.3-60574-41131-3 Mfg.Part No.411301BRAND: SYNAGIS NDC: 60574-4113-01,60574411301 UPC: 3-60574-41131-3,360574411313 Medimmune Biologics, IncOnly 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-Synagis 100Mg/Ml Vial By Medimmune Biologics

$3689.58$3513.89

Item No.: RX004907 NDC No.60574411301 UPC No.:360574411313 NDC No.60574-4113-01 UPC/GTIN No.3-60574-41131-3 MPN 411301 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.Rx004907 Synagis 100mg/ml Vial by Medimmune Biologics, Item No.3004907 NDC No.60574411301 UPC No.360574411313 Other Name Synagis, P

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SYNAGIS- palivizumab injection, solution
MedImmune, LLC
1 INDICATIONS AND USAGE

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

The following points should be considered when prescribing Synagis:


Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD) [see Clinical Studies (14)].

The safety and efficacy of Synagis have not been established for treatment of RSV disease.

2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information

The recommended dose of Synagis is 15 mg per kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season. In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities.

Synagis serum levels are decreased after cardio-pulmonary bypass [see Clinical Pharmacology (12.3)]. Children undergoing cardio-pulmonary bypass should receive an additional dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly as scheduled.

The efficacy of Synagis at doses less than 15 mg per kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.
DOSAGE FORMS AND STRENGTHS

Single-dose liquid solution vials: 50 mg per 0.5 mL and 100 mg per 1 mL.
DESCRIPTION

Palivizumab is a humanized monoclonal antibody (IgG1к) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of RSV. Palivizumab is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor and Cess. The human light chain sequence was derived from the constant domain of Cк and the variable framework regions of the VL gene K104 with Jк -4. The murine sequences were derived from a murine monoclonal antibody, Mab 1129, in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Palivizumab is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.

Synagis is supplied as a sterile, preservative-free liquid solution at 100 mg per mL to be administered by intramuscular injection. Thimerosal or other mercury-containing salts are not used in the production of Synagis. The solution has a pH of 6.0 and should appear clear or slightly opalescent.

Each 100 mg single-dose vial of Synagis liquid solution contains 100 mg of palivizumab and also contains chloride (0.5 mg), glycine (0.1 mg), and histidine (3.9 mg), in a volume of 1 mL.

Each 50 mg single-dose vial of Synagis liquid solution contains 50 mg of palivizumab and also contains chloride (0.2 mg), glycine (0.06 mg), and histidine (1.9 mg), in a volume of 0.5 mL.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action

Palivizumab is a recombinant humanized monoclonal antibody with anti-RSV activity [see Microbiology (12.4)].
Microbiology

Mechanism of Action

Palivizumab, a recombinant humanized monoclonal antibody which provides passive immunity against

RSV, acts by binding the RSV envelope fusion protein (RSV F) on the surface of the virus and blocking a critical step in the membrane fusion process. Palivizumab also prevents cell-to-cell fusion of RSV-infected cells.

NDC 60574-4113-01 UPC/GTIN No.3-60574-41131-3 Mfg.Part No.411301
RX ITEM-Synagis 100Mg/Ml Vial By Medimmu
NDC 60574-4113-01 UPC/GTIN No.3-60574-41131-3 Mfg.Part No.411301

BRAND: SYNAGIS NDC: 60574-4113-01,60574411301 UPC: 3-60574-41131-3,360574411313 Medimmune Biologics, Inc
Synagis 100Mg/Ml Vial By Medimmune Biolo
BRAND: SYNAGIS NDC: 60574-4113-01,60574411301 UPC: 3-60574-41131-3,360574411313 Medimmune Biologics, Inc

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
PALIVIZUMAB INTRAMUSC VIA
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

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