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Introduction About GARDASIL INJECTION
GARDASIL INJECTION contains Human Papilloma Virus Vaccine Quadrivalent, which belongs to the group of medicines called Vaccines. It is used in children and adolescents from 9 years of age and adults to protect against diseases such as pre-cancerous lesions and cancers of the female genitals (cervix, vulva, and vagina), pre-cancerous lesions and cancers of the anus, and genital warts in males and females caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
If you are pregnant, think that you may be pregnant or are planning to have a baby. Ask your doctor for advice before you receive this vaccine. GARDASIL INJECTION may be given to women who are breastfeeding or intend to breastfeed.
The safety and efficacy of GARDASIL INJECTION in children under 9 years of age and the elderly population aged 65 years and above have not been established.
The most common side effects of receiving GARDASIL INJECTION are pain, swelling, redness at the injection site, and headache. Consult your doctor if any of the side effects worsen.
Uses Of GARDASIL INJECTION
- To protect against diseases caused by human papillomavirus (HPV)
How GARDASIL INJECTION Works
When an individual is vaccinated with GARDASIL INJECTION, the immune system (the body’s natural defense system) stimulates the production of antibodies against the nine vaccine HPV types to help protect against the diseases caused by these viruses.
How to use GARDASIL INJECTION
GARDASIL INJECTION will be administered by a doctor as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh). Your doctor will decide the correct dose and duration for you depending on your age, body weight, and disease condition.
Side Effects Of GARDASIL INJECTION
Common
- pain, swelling, redness, bruising, and itching at the injection site
- headache
- fever
- tiredness
- dizziness
- nausea
Uncommon
- swollen glands (neck, armpit, or groin)
- hives (urticaria)
- fainting, sometimes accompanied by shaking or stiffening
- vomiting
- joint pain, aching muscles
- unusual tiredness or weakness
- chills, generally feeling unwell
Rare
- Allergic reactions
How To Manage Side Effects
Dizziness Or Drowsiness
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol. Consult your doctor if your dizziness worsens.
Headache
Rest and relax. Keep yourself hydrated by drinking plenty of fluids, such as water or electrolytes. Applying a pain-relieving balm to your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
Nausea And Vomiting
Take GARDASIL INJECTION with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. Consult your doctor if your nausea worsens.
Warning & Precautions
Pregnancy
Consult your doctorIf you are pregnant, think that you may be pregnant or are planning to have a baby. Ask your doctor for advice before you receive this vaccine. If you are pregnant or if you become pregnant during vaccination, it is recommended to postpone or interrupt vaccination until completion of pregnancy.
Breastfeeding
SafeGARDASIL INJECTION may be given to women who are breastfeeding or intend to breastfeed.
Driving and Using Machines
Use with CautionGARDASIL INJECTION may affect the ability to drive or operate machines.
Allergy
ContraindicatedGARDASIL INJECTION is not recommended for use if you or your child is allergic to Human Papilloma Virus Vaccine Quadrivalent or to any other ingredients of this medicine.
Use In Pediatrics
Consult your doctorThe safety and efficacy of GARDASIL INJECTION in children under 9 years of age have not been established.
Use In Geriatrics
Consult your doctorThe safety and effectiveness of GARDASIL INJECTION have not been evaluated in an elderly population aged 65 years and above.
Others
GARDASIL INJECTION is not recommended for use if you or your child have:
- developed an allergic reaction after receiving a dose of GARDASIL INJECTION
Before receiving GARDASIL INJECTION, inform your doctor if you or your child:
- has a bleeding disorder (Ex. Haemophilia)
- has a weakened immune system (Ex. due to a genetic defect, HIV infection, or medicines that affect the immune system)
- suffer from an illness with high fever
- has previous history of fainting after receiving GARDASIL INJECTION
Interactions
A. Drug-Drug Interactions:
Tell your doctor if you or your child are taking, have recently taken, or might take any other medicines, including prescription, non-prescription, or herbal medicines.
- medicines that suppress the immune system.
B. Drug-Food interactions:
NA
Overdose:
GARDASIL INJECTION will be given to you only by a doctor in a hospital, and so it is unlikely to result in an overdose.
Synopsis
| Drug | : | Human Papilloma Virus Vaccine Quadrivalent |
| Pharmacological Category | : | Vaccines |
| Therapeutic Indication | : | To protect against diseases caused by human papillomavirus (HPV) |
| Dosage Forms | : | Injection |
More Information
Storage
- Keep GARDASIL INJECTION out of reach of children
- Store GARDASIL INJECTION in a refrigerator (2 °C–8 °C). Do not freeze.
FAQs About GARDASIL INJECTION
Q: What is GARDASIL INJECTION used for?
A: GARDASIL INJECTION is used in children and adolescents from 9 years of age and adults to protect against diseases such as pre-cancerous lesions and cancers of the female genitals (cervix, vulva, and vagina), pre-cancerous lesions and cancers of the anus, and genital warts in males and females caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Q: How GARDASIL INJECTION is given?
A: GARDASIL INJECTION will be administered by a doctor as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh). Your doctor will decide the correct dose and duration for you depending on your age, body weight, and disease condition.
Q: How does GARDASIL INJECTION work?
A: When an individual is vaccinated with GARDASIL INJECTION, the immune system (the body’s natural defense system) stimulates production of antibodies against the nine vaccine HPV types to help protect against the diseases caused by these viruses.
Q: What if I forget to receive one dose of GARDASIL INJECTION?
A: If a scheduled injection is missed, your doctor will decide when to give the missed dose. It is important that you follow your doctor or nurse’s instructions regarding return visits for the follow-up doses. If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice. When GARDASIL INJECTION is given as your first dose, the completion of the vaccination course should be done with GARDASIL INJECTION and not another HPV vaccine.
Q: Does GARDASIL INJECTION treat HPV?
A: GARDASIL INJECTION is intended to inhibit these diseases. The vaccine is not used to manage HPV-related diseases. It does not have any effect on individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine. However, in individuals who are already infected with one or more of the vaccine HPV types, GARDASIL INJECTION can still protect against diseases associated with the other HPV types in the vaccine.
Q: Does GARDASIL INJECTION cause disease?
A: No, GARDASIL INJECTION does not cause HPV-related diseases.
Q: Can I receive GARDASIL INJECTION when I suffer from fever and cold?
A: Before receiving GARDASIL INJECTION, inform your doctor if you or your child suffers from an illness with a high fever. However, a mild fever or upper respiratory infection (for example, having a cold) itself is not a reason to delay vaccination.
Q: Is GARDASIL INJECTION safe during pregnancy?
A: If you are pregnant, think that you may be pregnant or are planning to have a baby; ask your doctor for advice before you receive this vaccine. If you are pregnant or if you become pregnant during vaccination, it is recommended to postpone or interrupt vaccination until completion of pregnancy.
Q: Who should avoid using GARDASIL INJECTION?
A: GARDASIL INJECTION is not recommended for use if you or your child is allergic to Human Papilloma Virus Vaccine Quadrivalent or have developed an allergic reaction after receiving a dose of GARDASIL INJECTION.
Q: Can GARDASIL INJECTION be used in children?
A: The safety and efficacy of GARDASIL INJECTION in children under 9 years of age have not been established.
Q: What precautions must be taken while using GARDASIL INJECTION?
A: Before receiving GARDASIL INJECTION, inform your doctor if you or your child has a bleeding disorder (Ex. Haemophilia), a weakened immune system (Ex. due to a genetic defect, HIV infection, or medicines that affect the immune system), or suffers from an illness with a high fever or a previous history of fainting after receiving GARDASIL INJECTION.
References
1. Soca Gallego L, Dominguez A, Parmar M. Human Papilloma Virus Vaccine. Stat Pearls. NIH, National Library of Medicine, National Centre for Biotechnology Information. February 2024. [Accessed on 6th September 2024] https://www.ncbi.nlm.nih.gov/books/NBK562186/
2. Merck Sharp & Dohme B.V. Electronic Medicines Compendium (EMC). [Revised in April 2024] [Accessed on 6th September 2024] https://www.medicines.org.uk/emc/files/pil.7330.pdf
https://www.medicines.org.uk/emc/product/7330/smpc#gref
3. Merck Sharp & Dohme LLC. GARDASIL 9. [Revised in March 2024] [Accessed on 6th September 2024] https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf
Useful Diagnostic Tests
- Complete Blood Count (CBC)/ Hemogram
- Human Papilloma Virus (Hpv) Quantitative
- Cytology -Pap
- Healthy Midlife Checkup
- Men Health Checkup - Advanced
- Complete Women Checkup
- Full Body Checkup - Gold
- Full Body Checkup – Silver
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