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Rx Item-Twinrix hepatitis a and hepatitis b- recombinant vaccSyr 10X1Ml By Glaxo

Item No.: RX118594 118594 NDC No.58160081552 58160-815-52 5816081552 UPC No.:358160815522 358160-815522 3-58160-81552-2  NDC No.58160-0815-52 UPC/GTIN No.3-58160-81552-2 MPN 81552 Item No.: RX118594 118594 NDC No.58160081552 58160-815-52 5816081552 UPC No.:358160815522 358160-815522 3-58160-81552-2  NDC No.58160-0815-52 UPC/GTIN No.3-58160-81552-2 MPN 81552 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.

Rx Item-Twinrix hepatitis a and hepatitis b- recombinant vaccSyr 10X1Ml By Glaxo

$1453.80$1299.99

Item No.: RX118594 118594 NDC No.58160081552 58160-815-52 5816081552 UPC No.:358160815522 358160-815522 3-58160-81552-2 NDC No.58160-0815-52 UPC/GTIN No.3-58160-81552-2 MPN 81552 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.Rx118594 Twinrix 720/20/ml Syringe 10X1ml by Glaxosmithkline/Vaccines

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hepatitis a and hepatitis b- recombinant vaccine injection, suspension
Clinical Information
Gen. Code and Des.
62816 hepatitis A and B vaccine/PF INTRAMUSC SYRINGE 720-20/ML
GCN and Des.
98587 hepatitis A and B vaccine/PF INTRAMUSC SYRINGE 720-20/ML
Strength
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
80120000 VACCINES
Active Ingredients
3980 hepatitis A virus vaccine
8320 hepatitis B virus vaccine, recombinant
9870 preservative free
Inactive Ingredients
2551 polysorbates 9005645
8921 latex





TWINRIX- hepatitis a virus strain hm175 antigen (formaldehyde inactivated) and hepatitis b virus subtype adw2 hbsag surface protein antigen injection, suspension
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE

TWINRIX� is indicated for active immunization against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus. TWINRIX is approved for use in persons 18 years of age or older.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration


​ The vaccine should be re-suspended before use. When re-suspended, the vaccine will have a uniform hazy white appearance.

​ Upon storage, a fine white deposit with a clear colorless layer above may be present. Re-suspend the vaccine following the steps below.

​ 1. Hold the syringe upright in a closed hand.

​ 2. Shake the syringe by tipping it upside down and back upright again.

​ 3. Repeat this action vigorously for at least 15 seconds.

​ 4. Inspect the vaccine again:


If the vaccine appears as a uniform hazy white suspension, it is ready to use � the appearance should not be clear.

If the vaccine still does not appear as a uniform hazy white suspension, tip upside down and back upright again for at least another 15 seconds then inspect again.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 1-mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.
2.2 Administration
TWINRIX should be administered by intramuscular injection only as a 1-mL dose. Administer in the deltoid region. Do not administer in the gluteal region; such injections may result in a suboptimal response.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.3 Recommended Dose and Schedule
Standard dosing schedule consists of 3 doses (1 mL each), given intramuscularly at 0, 1, and 6 months. Alternatively, an accelerated schedule of 4 doses (1 mL each), given intramuscularly on Days 0, 7, and 21 to 30 followed by a booster dose at Month 12 may be used.

3 DOSAGE FORMS AND STRENGTHS

Suspension for injection available in 1-mL single-dose vials and prefilled TIP-LOK� syringes [see Description (11), How Supplied/Storage and Handling (16)].

4 CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing or hepatitis B-containing vaccine, or to any component of TWINRIX, including yeast and neomycin, is a contraindication to administration of TWINRIX [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Latex
The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

5.2 Syncope
Syncope (fainting) can occur in association with administration of injectable vaccines, including TWINRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

5.3 Preventing and Managing Allergic Vaccine Reactions
Prior to immunization, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. [See Contraindications (4).]

5.4 Moderate or Severe Acute Illness
To avoid diagnostic confusion between manifestations of an acute illness and possible vaccine adverse effects, vaccination with TWINRIX should be postponed in persons with moderate or severe acute febrile illness unless they are at immediate risk of hepatitis A or hepatitis B infection.

5.5 Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to TWINRIX.

5.6 Multiple Sclerosis
Results from 2 clinical studies indicate that there is no association between hepatitis B vaccination and the development of multiple sclerosis,1 and that vaccination with hepatitis B vaccine does not appear to increase the short-term risk of relapse in multiple sclerosis.2

5.7 Limitations of Vaccine Effectiveness
Hepatitis A and hepatitis B have relatively long incubation periods. The vaccine may not prevent hepatitis A or hepatitis B infection in individuals who have an unrecognized hepatitis A or hepatitis B infection at the time of vaccination. Additionally, vaccination with TWINRIX may not protect all individuals.
DESCRIPTION

TWINRIX [Hepatitis A & Hepatitis B (Recombinant) Vaccine] is a bivalent vaccine containing the antigenic components used in producing HAVRIX� (Hepatitis A Vaccine) and ENGERIX-B� [Hepatitis B Vaccine (Recombinant)]. TWINRIX is a sterile suspension for intramuscular administration that contains inactivated hepatitis A virus (strain HM175) and noninfectious hepatitis B virus surface antigen (HBsAg). The hepatitis A virus is propagated in MRC-5 human diploid cells and inactivated with formalin. The purified HBsAg is obtained by culturing genetically engineered Saccharomyces cerevisiae yeast cells, which carry the surface antigen gene of the hepatitis B virus. Bulk preparations of each antigen are adsorbed separately onto aluminum salts and then pooled during formulation.

A 1-mL dose of vaccine contains 720 ELISA Units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum in the form of aluminum phosphate and aluminum hydroxide as adjuvants, amino acids, sodium chloride, phosphate buffer, polysorbate 20, and Water for Injection. From the manufacturing process each 1-mL dose of TWINRIX also contains residual formalin (not more than 0.1 mg), MRC-5 cellular proteins (not more than 2.5 mcg), neomycin sulfate (an aminoglycoside antibiotic included in the cell growth media; not more than 20 ng), and yeast protein (no more than 5%).

TWINRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.

TWINRIX is formulated without preservatives.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Hepatitis A

The course of infection with hepatitis A virus (HAV) is extremely variable, ranging from asymptomatic infection to fulminant hepatitis.3

The presence of antibodies to HAV (anti-HAV) confers protection against hepatitis A disease. However, the lowest titer needed to confer protection has not been determined. Natural infection provides lifelong immunity even when antibodies to hepatitis A are undetectable. Seroconversion is defined as antibody titers equal to or greater than the assay cut-off (cut-off values vary depending on the assay used) in those previously seronegative.

Hepatitis B

Infection with hepatitis B virus (HBV) can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma.

Antibody concentrations ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection.4
PATIENT COUNSELING INFORMATION


Inform vaccine recipients of the potential benefits and risks of immunization with TWINRIX.

Emphasize, when educating vaccine recipients regarding potential side effects, that components of TWINRIX cannot cause hepatitis A or hepatitis B infection.

Instruct vaccine recipients to report any adverse events to their healthcare provider.

Inform that safety and efficacy have not been established in pregnant women.

Give vaccine recipients the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
TWINRIX, HAVRIX, ENGERIX-B, and TIP-LOK are registered trademarks of the GSK group of companies. The other brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, US License No. 1617

Distributed by GlaxoSmithKline

Research Triangle Park, NC 27709

Item No.: RX118594 118594 NDC No.58160081552 58160-815-52 5816081552 UPC No.:358160815522 358160-815522 3-58160-81552-2  NDC No.58160-0815-52 UPC/GTIN No.3-58160-81552-2 MPN 81552
RX ITEM-Twinrix 720 20 Ml Syringe 10X1Ml
Item No.: RX118594 118594 NDC No.58160081552 58160-815-52 5816081552 UPC No.:358160815522 358160-815522 3-58160-81552-2 NDC No.58160-0815-52 UPC/GTIN No.3-58160-81552-2 MPN 81552

Item No.: RX118594 118594 NDC No.58160081552 58160-815-52 5816081552 UPC No.:358160815522 358160-815522 3-58160-81552-2  NDC No.58160-0815-52 UPC/GTIN No.3-58160-81552-2 MPN 81552
Twinrix 720 20 Ml Syringe 10X1Ml By Glax
Item No.: RX118594 118594 NDC No.58160081552 58160-815-52 5816081552 UPC No.:358160815522 358160-815522 3-58160-81552-2 NDC No.58160-0815-52 UPC/GTIN No.3-58160-81552-2 MPN 81552

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
HEPATITIS A & B VACCINE/P
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.