Human Papillomavirus 9-Valent Vaccine, Recombinant (Gardasil 9)

Trade Name : GARDASIL 9

Merck Sharp & Dohme Corp.

INJECTION, SUSPENSION, VACCINE

Strength 304060402020202020 ug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mLug/.5mL

HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Human Papillomavirus Vaccine [EPC],Actively Acquired Immunity [PE],Papillomavirus Vaccines [CS],Vaccines, Inactivated [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Human Papillomavirus 9-Valent Vaccine, Recombinant (Gardasil 9) which is also known as GARDASIL 9 and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 30; 40; 60; 40; 20; 20; 20; 20; 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL per ml. Read more

Human Papillomavirus 9-Valent Vaccine, Recombinant (Gardasil 9) 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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About GNH

No data

GARDASIL 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases:
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
GARDASIL 9 is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases:
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
Limitations of Use and Effectiveness:

For intramuscular administration only. ()
Each dose of GARDASILu00a09 is 0.5-mL
Administer GARDASILu00a09 as follows: ()

GARDASIL 9 is a suspension for intramuscular administration available in 0.5-mL single-dose vials and prefilled syringes. See for the complete listing of ingredients.
0.5-mL suspension for injection as a single-dose vial and prefilled syringe. (, )

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL n
Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL. (, )

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. ()

The most common (u226510%) local and systemic adverse reactions reported:
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

In girls and women 16 through 26 years of age: injection-site pain (89.9%), injection-site swelling (40.0%), injection-site erythema (34.0%) and headache (14.6%). ()
In girls 9 through 15 years of age: injection-site pain (89.3%), injection-site swelling (47.8%), injection-site erythema (34.1%) and headache (11.4%). ()
In boys and men 16 through 26 years of age: injection-site pain (63.4%), injection-site swelling (20.2%) and injection-site erythema (20.7%). ()
In boys 9 through 15 years of age: injection-site pain (71.5%), injection-site swelling (26.9%), and injection-site erythema (24.9%). ()

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines .

Pregnancy registry: available at 1-800-986-8999. ()
Safety and effectiveness of GARDASIL 9 have not been established in the following populations:

Children below the age of 9 years. ()
Immunocompromised individuals. Response to GARDASIL 9 may be diminished. ()

GARDASIL 9, Human Papillomavirus 9-valent Vaccine, Recombinant, is a non-infectious recombinant 9-valent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The L1 proteins are produced by separate fermentations using recombinant and self-assembled into VLPs. The fermentation process involves growth of on chemically-defined fermentation media which include vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate or AAHS). The 9-valent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer.
GARDASIL 9 is a sterile suspension for intramuscular administration. Each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein.
Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein, and water for injection. The product does not contain a preservative or antibiotics.
After thorough agitation, GARDASIL 9 is a white, cloudy liquid.

HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Efficacy of GARDASIL 9 against anogenital diseases related to the vaccine HPV types in human beings is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.

GARDASIL 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility. GARDASIL 9 administered to female rats had no effects on fertility .

In these studies, seropositive is defined as anti-HPV titer greater than or equal to the pre-specified serostatus cutoff for a given HPV type. Seronegative is defined as anti-HPV titer less than the pre-specified serostatus cutoff for a given HPV type. The serostatus cutoff is the antibody titer level above the assay's lower limit of quantification that reliably distinguishes sera samples classified by clinical likelihood of HPV infection and positive or negative status by previous versions of competitive Luminex Immunoassay (cLIA). The lower limits of quantification and serostatus cutoffs for each of the 9 vaccine HPV types are shown in Table 5 below. PCR positive is defined as DNA detected for a given HPV type. PCR negative is defined as DNA not detected for a given HPV type. The lower limit of detection for the multiplexed HPV PCR assays ranged from 5 to 34 copies per test across the 9 vaccine HPV types.

No data

GARDASIL 9 is supplied in vials and syringes.
Carton of ten 0.5-mL single-dose vials. NDC 0006-4119-03
Carton of ten 0.5-mL single-dose prefilled Luer Lock syringes with tip caps. NDC 0006-4121-02
Store refrigerated at 2 to 8u00b0C (36 to 46u00b0F). Do not freeze. Protect from light.
GARDASIL 9 should be administered as soon as possible after being removed from refrigeration. GARDASIL 9 can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8u00b0C and 25u00b0C) does not exceed 72 hours. Cumulative multiple excursions between 0u00b0C and 2u00b0C are also permitted as long as the total time between 0u00b0C and 2u00b0C does not exceed 72 hours. These are not, however, recommendations for storage.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform the patient, parent, or guardian:

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
The trademarks depicted herein are owned by their respective companies.
Copyright u00a9 2006-2020 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
uspi-v503-i-2002r010

Read this information with care before getting GARDASILu00ae9. You or your child (the person getting GARDASIL 9) will need 2 or 3 doses of the vaccine, depending on how old you are. It is important to read this information before getting each dose. This information does not take the place of talking with your health care professional about GARDASIL 9.
What is GARDASIL 9?
GARDASIL 9 is a vaccine (injection/shot) given to individuals 9 through 45 years of age to help protect against diseases caused by some types of Human Papillomavirus (HPV).
What diseases can GARDASIL 9 help protect against?
In girls and women 9 through 45 years of age, GARDASIL 9 helps protect against:
In boys and men 9 through 45 years of age, GARDASIL 9 helps protect against:
These diseases have many causes. Most of the time, these diseases are caused by nine types of HPV: HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL 9 only protects against diseases caused by these nine types of HPV.
People cannot get HPV or any of these diseases from GARDASIL 9.
What important information about GARDASIL 9 should I know?
GARDASIL 9:
GARDASIL 9 may not fully protect each person who gets it.
Who should not get GARDASIL 9?
Anyone with an allergic reaction to:
What should I tell the health care professional before getting GARDASIL 9?
Tell the health care professional if you or your child (the person getting GARDASIL 9):
The health care professional will help decide if you or your child should get the vaccine.
How is GARDASIL 9 given?
GARDASIL 9 is a shot that is usually given in the arm muscle. GARDASIL 9 may be given as 2 or 3 shots.
Make sure that you or your child gets all doses recommended by your health care professional so that you or your child gets the best protection. If the person getting GARDASIL 9 misses a dose, tell the health care professional and they will decide when to give the missed dose. It is important that you follow the instructions of your health care professional regarding return visits for the follow-up doses.
Fainting can happen after getting an HPV vaccine. Sometimes people who faint can fall and hurt themselves. For this reason, the health care professional may ask the person getting GARDASIL 9 to sit or lie down for 15 minutes after getting the vaccine. Some people who faint might shake or become stiff. The health care professional may need to treat the person getting GARDASIL 9.
Can I get GARDASIL 9 if I have already gotten GARDASIL?
If you have already gotten GARDASIL, talk to your health care professional to see if GARDASIL 9 is right for you.
Can I get GARDASIL 9 with other vaccines?
GARDASIL 9 can be given at the same time as:
What are the possible side effects of GARDASIL 9?
The most common side effects seen with GARDASIL 9 are:
Studies show that there was more swelling where the shot was given when GARDASIL 9 was given at the same time as Menactra and/or Adacel.
Tell the health care professional if you have any of these problems because these may be signs of an allergic reaction:
Additional side effects that have been reported during general use for GARDASIL 9 are shown below. Side effects reported during the general use of GARDASIL are also shown below. GARDASIL side effects are reported as they may be relevant to GARDASIL 9 since the vaccines are similar in composition.
GARDASIL 9
Additionally, these side effects have been seen with the general use of GARDASIL.
GARDASIL
You should contact your health care professional right away if you get any symptoms that bother you.
For a more complete list of side effects, ask the health care professional.
Call your health care professional for medical advice about side effects. You may also report any side effects to your doctor or directly to Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.
GARDASIL 9 was not studied in women who knew they were pregnant. A pregnancy registry is available. You are encouraged to contact the registry as soon as you become aware of your pregnancy by calling 1-800-986-8999, or ask your health care professional to contact the registry for you.
What is in GARDASIL 9?
GARDASIL 9 contains:
This document is a summary of information about GARDASIL 9.
To learn more about GARDASIL 9, please talk to the health care professional or visit www.GARDASIL9.com.

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
The trademarks depicted herein are owned by their respective companies.
Copyright u00a9 2006-2020 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
Revised: 02/2020
usppi-v503-i-2002r004

NDC 0006-4119-03
10 Single-dose 0.5-mL Vials
REFRIGERATE
Human Papillomavirus 9-valent Vaccine, Recombinant
GARDASIL 9
Suspension for intramuscular injection
Each 0.5-mL dose contains human papillomavirus L1 protein of each type adsorbed on amorphous aluminumhydroxyphosphate sulfate adjuvant as follows:Type 6 (30 mcg), Type 11 (40 mcg), Type 16 (60 mcg), Type 18 (40 mcg), Type 31 (20 mcg), Type 33 (20 mcg),Type 45 (20 mcg), Type 52 (20 mcg), Type 58 (20 mcg).
Vaccine is prepared from fermentation cultures of a recombinant strain of yeast n containing the genes for the human papillomavirus L1 protein of each type (6, 11, 16, 18, 31, 33, 45, 52, 58).
Contains no preservative or antibiotics.
Rx only

NDC 0006-4121-02
10 Single-dose 0.5-mL Syringes
REFRIGERATE
Human Papillomavirus9-valent Vaccine, Recombinant
GARDASIL 9
Suspension for intramuscular injection
Each 0.5-mL dose contains human papillomavirus L1 protein of each typeadsorbed on amorphous aluminum hydroxyphosphate sulfate adjuvantas follows:Type 6 (30 mcg), Type 11 (40 mcg), Type 16 (60 mcg), Type 18 (40 mcg),Type 31 (20 mcg), Type 33 (20 mcg), Type 45 (20 mcg), Type 52 (20 mcg),Type 58 (20 mcg).
Vaccine is prepared from fermentation cultures of a recombinant strain of yeastn containing the genes for the human papillomavirusL1 protein of each type (6, 11, 16, 18, 31, 33, 45, 52, 58).
Contains no preservative or antibiotics.
Rx only

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Human Papillomavirus 9-Valent Vaccine, Recombinant (Gardasil 9)

Trade Name : GARDASIL 9

INJECTION, SUSPENSION, VACCINE

Delivery Process

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Human Papillomavirus 9-Valent Vaccine, Recombinant (Gardasil 9)

Trade Name : GARDASIL 9

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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