Gardasil IM Injection 0.5 ml/pre-filled syringe

Gardasil IM Injection 0.5 ml/pre-filled syringe Uses, Dosage, Side Effects, Food Interaction and all others data.

Gardasil IM Injection 0.5 ml/pre-filled syringe
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Gardasil IM Injection 0.5 ml/pre-filled syringe
Generic	Human Papillomavirus Quadrivalent
Weight	0.5 ml/pre-filled syringe
Type	IM Injection
Therapeutic Class	Vaccines, Anti-sera & Immunoglobulin
Manufacturer	Healthcare Pharmaceuticals Ltd.
Available Country	Bangladesh
Last Updated:	October 19, 2023 at 6:27 am

Uses

Gardasil IM Injection 0.5 ml/pre-filled syringe is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine: Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18. ... Read more

Dosage

Gardasil IM Injection 0.5 ml/pre-filled syringe dosage

9 through 14 years: 2-dose: 0, 6 to 12 months. If the second dose is administered earlier than 5 months after the first dose, a dminister a third dose at least 4 months after the second dose. 3-dose: 0, 2, 6 months. 15 through 45 years: 3-dose: 0, 2, 6 months. For intramuscular use only. Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. Gardasil IM Injection 0.5 ml/pre-filled syringe should not be diluted or mixed with other vaccines. After thorough agitation, Gardasil IM Injection 0.5 ml/pre-filled syringe is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored. Gardasil IM Injection 0.5 ml/pre-filled syringe should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. Syncope has been reported following vaccination with Gardasil IM Injection 0.5 ml/pre-filled syringe and may result in falling with injury; observation for 15 minutes after administration is recommended.

Side Effects

The most common (≥10%) local and systemic adverse reactions reported: 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 women 27 through 45 years of age: injection-site pain (82.8%), injection-site swelling (23.3%), injection-site erythema (16.9%), and headache (13.6%) 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%).

Precaution

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 vaccination with Gardasil IM Injection 0.5 ml/pre-filled syringe. 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.

Interaction

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 & Breastfeeding use

Pregnancy Category B. Reproduction studies have been performed in female rats at doses equivalent to the recommended human dose and have revealed no evidence of impaired female fertility or harm to the fetus due to Gardasil IM Injection 0.5 ml/pre-filled syringe. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Gardasil IM Injection 0.5 ml/pre-filled syringe should be used during pregnancy only if clearly needed. It is not known whether Gardasil IM Injection 0.5 ml/pre-filled syringe is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Gardasil IM Injection 0.5 ml/pre-filled syringe is administered to a nursing woman.

Contraindication

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Gardasil IM Injection 0.5 ml/pre-filled syringe.

Special Warning

Pediatric Use: Safety and effectiveness have not been established in pediatric patients below 9 years of age.Geriatric Use: The safety and effectiveness of Gardasil IM Injection 0.5 ml/pre-filled syringe have not been evaluated in a geriatric population, defined as individuals aged 65 years and over.

Acute Overdose

There have been reports of administration of higher than recommended doses of Gardasil IM Injection 0.5 ml/pre-filled syringe. In general, the adverse event profile reported with overdose was comparable to recommended single doses of Gardasil IM Injection 0.5 ml/pre-filled syringe.

Storage Condition

Store refrigerated at 2 to 8°C. Do not freeze. Protect from light. Gardasil IM Injection 0.5 ml/pre-filled syringe should be administered as soon as possible after being removed from refrigeration.