Pneumococcal 13-Valent Conjugate Vaccine (Prevnar 13)

Trade Name : PREVNAR 13

Wyeth Pharmaceutical Division of Wyeth Holdings LLC

INJECTION, SUSPENSION, VACCINE

Strength 2.22.22.22.22.24.42.22.22.22.22.22.22.2 ug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mL

STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Conjugate [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pneumococcal 13-Valent Conjugate Vaccine (Prevnar 13) which is also known as PREVNAR 13 and Manufactured by Wyeth Pharmaceutical Division of Wyeth Holdings LLC. It is available in strength of 2.2; 2.2; 2.2; 2.2; 2.2; 4.4; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2; 2.2 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL per ml. Read more

Pneumococcal 13-Valent Conjugate Vaccine (Prevnar 13) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

In children 6 weeks through 5 years of age (prior to the 6 birthday), Prevnar 13 is indicated for:
In children 6 years through 17 years of age (prior to the 18 birthday), Prevnar 13 is indicated for:
In adults 18 years of age and older, Prevnar 13 is indicated for:
Limitations of Prevnar 13 Use and Effectiveness

Children 6 weeks through 5 years: The four-dose immunization series consists of a 0.5 mL intramuscular injection administered at 2, 4, 6, and 12u201315 months of age. ()
Children 6 through 17 years of age: a single dose. ()
Adults 18 years and older: a single dose. ()

Prevnar 13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes.
0.5 mL suspension for intramuscular injection, supplied in a single-dose prefilled syringe. ()

tttttttSevere allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine . tttttt
Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine. ()

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13, to infants born prematurely should be based on consideration of the individual infant's medical status, and the potential benefits and possible risks of vaccination. ()

Because clinical trials are conducted under widely varying conditions, adverse-reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.
To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

In infants and toddlers vaccinated at 2, 4, 6, and 12u201315 months of age in US clinical trials, the most commonly reported solicited adverse reactions (>5%) were irritability (>70%), injection site tenderness (>50%), decreased appetite (>40%), decreased sleep (>40%), increased sleep (>40%), fever (>20%), injection site redness (>20%), and injection site swelling (>20%). ()
In children aged 5 through 17 years, the most commonly reported solicited adverse reactions (>5%) were injection site tenderness (>80%), injection site redness (>30%), injection site swelling (>30%), irritability (>20%), decreased appetite (>20%), increased sleep (>20%), fever (>5%), and decreased sleep (>5%). ()
In adults aged 18 years and older, the most commonly reported solicited adverse reactions (>5%) were pain at the injection site (>50%), fatigue (>30%), headache (>20%), muscle pain (>20%), joint pain (>10%), decreased appetite (>10%), injection site redness (>10%), injection site swelling (>10%), limitation of arm movement (>10%), vomiting (>5%), fever (>5%), chills (>5%), and rash (>5%). ()

No data

Pediatric Use:
8.4

Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM Protein) is a sterile suspension of saccharides of the capsular antigens of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography. The polysaccharides are chemically activated to make saccharides, which are directly conjugated by reductive amination to the protein carrier CRM, to form the glycoconjugate. CRM is a nontoxic variant of diphtheria toxin isolated from cultures of strain C7 (u03b2197) grown in a casamino acids and yeast extract-based medium or in a chemically-defined medium. CRM is purified through ultrafiltration, ammonium sulfate precipitation, and ion-exchange chromatography. The individual glycoconjugates are purified by ultrafiltration and column chromatography and analyzed for saccharide to protein ratios, molecular size, free saccharide, and free protein.
The individual glycoconjugates are compounded to formulate Prevnar 13. Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates. Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 u00b5g of each of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides, 4.4 u03bcg of 6B saccharides, 34 u00b5g CRM carrier protein, 100 u00b5g polysorbate 80, 295 u00b5g succinate buffer and 125 u00b5g aluminum as aluminum phosphate adjuvant.
The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

Prevnar 13, comprised of pneumococcal polysaccharides conjugated to a carrier protein (CRM), elicits a T-cell dependent immune response. Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response.
Nonclinical and clinical data support opsonophagocytic activity, as measured by opsonophagocytic activity (OPA) antibody assay, as a contributor to protection against pneumococcal disease. The OPA antibody assay provides an in vitro measurement of the ability of serum antibodies to eliminate pneumococci by promoting complement-mediated phagocytosis and is believed to reflect relevant in vivo mechanisms of protection against pneumococcal disease. OPA antibody titers are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%.
In infants that have received Prevnar 13, opsonophagocytic activity correlates well with serotype specific anti-capsular polysaccharide IgG levels as measured by ELISA. A serum anti-capsular polysaccharide antibody concentration of 0.35 u00b5g/mL as measured by ELISA one month after the third dose as a single antibody reference concentration was used to estimate the effectiveness of Prevnar 13 against invasive pneumococcal disease (IPD) in infants and children. The assay used for this determination is a standardized ELISA involving pre-absorption of the test sera with pneumococcal C-polysaccharide and serotype 22F polysaccharide to reduce non-specific background reactivity. The single antibody reference value was based on pooled efficacy estimates from three placebo-controlled IPD efficacy trials with either Prevnar or the investigational 9-valent CRM conjugate pneumococcal polysaccharide vaccine. This reference concentration is only applicable on a population basis and cannot be used to predict protection against IPD on an individual basis. Functional antibodies elicited by the vaccine (as measured by a dribble opsonophagocytic activity [dOPA] antibody assay) were also evaluated in infants.
In adults, an antipolysaccharide binding antibody IgG level to predict protection against invasive pneumococcal disease or non-bacteremic pneumonia has not been defined. Noninferiority trials for Prevnar 13 were designed to show that functional OPA antibody responses (as measured by a microcolony OPA [mcOPA] antibody assay) for the Prevnar 13 serotypes are noninferior and for some serotypes superior to the common serotypes in the currently licensed pneumococcal polysaccharide vaccine (PPSV23). OPA antibody titers measured in the mcOPA antibody assay cannot be compared directly to titers measured in the dOPA antibody assay.

Prevnar 13 has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. In a study in rabbits, no vaccine-related effects were found regarding reproductive performance including female fertility .

No data

ClinicalTrials.gov identifiers for studies included below:

Prefilled Syringe, 1 Dose (10 per package) u2013 NDC 0005-1971-02.
Prefilled Syringe, 1 Dose (1 per package) u2013 NDC 0005-1971-05.
After shipping, Prevnar 13 may arrive at temperatures between 2u00b0C to 25u00b0C (36u00b0F to 77u00b0F).
Upon receipt, store refrigerated at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).
Do not freeze. Discard if the vaccine has been frozen.
Prevnar 13 is stable at temperatures up to 25u00b0C (77u00b0F) for 4 days. These data are not recommendations for shipping or storage, but may guide decisions for use in case of temporary temperature excursions.
The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

Prior to administration of this vaccine, inform the individual, parent, guardian, or other responsible adult of the following:
Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

US Govt. License No. 3
LAB-0469-18.0CPT Code 90670

NDC n- Rx
Pneumococcal 13-valent ConjugateVaccine(Diphtheria CRM Protein)
Prevnar 13
One Dose (0.5 mL)FOR IM USE ONLY
REFRIGERATEDO NOT FREEZESHAKE WELL
Wyeth Pharm. Inc.US Govt. License No. 3
LOT:
EXP:
PAA053716

NDC
Rx only
Pneumococcal 13-valent Conjugate Vaccine(Diphtheria CRM Protein)
Prevnar 13n
10 One-Dose (0.5 mL)Disposable Syringes
FOR INTRAMUSCULAR USE ONLY
Pfizer

NDC n- Rx only
Pneumococcal 13-valent Conjugate Vaccine(Diphtheria CRM Protein)
Prevnar 13
10 One-Dose (0.5 mL)Disposable Syringes
FOR INTRAMUSCULAR USE ONLY
Pfizer

NDC 0005-1971-05
Rx only
Pneumococcal 13-valent Conjugate Vaccine(Diphtheria CRM Protein)
Prevnar 13n
One Dose (0.5 mL)Disposable Syringe
FOR INTRAMUSCULAR USE ONLY
Pfizer

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Pneumococcal 13-Valent Conjugate Vaccine (Prevnar 13)

Trade Name : PREVNAR 13

INJECTION, SUSPENSION, VACCINE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Pneumococcal 13-Valent Conjugate Vaccine (Prevnar 13)

Trade Name : PREVNAR 13

INJECTION, SUSPENSION, VACCINE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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