Gardasil Injection 0.5ml

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 accomp
• 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 prescri
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.

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