HPV 9-VALENT VACCINE

HPV 9-VALENT VACCINE  is a vaccine given to individuals 9 through 45 years of age to help protect against diseases caused by some types of Human Papillomavirus (HPV). 

In girls and women 9 through 45 years of age, HPV 9-VALENT VACCINE helps protect against: 

• Cervical cancer 

• Vulvar and vaginal cancers 

• Anal cancer 

• Certain head and neck cancers, such as throat and back of mouth cancers 

• Precancerous cervical, vulvar, vaginal and anal lesions 

• Genital warts 

In boys and men 9 through 45 years of age, HPV 9-VALENT VACCINE  helps protect against: 

• Anal cancer 

• Certain head and neck cancers, such as throat and back of mouth cancers 

• Precancerous anal lesions 

• Genital warts 

These diseases may have many causes, including HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. HPV 9-VALENT VACCINE only protects against diseases caused by these nine types of HPV. 

People cannot get HPV or any of these diseases from HPV 9-VALENT VACCINE. 

HPV 9-VALENT VACCINE : 

• Does not remove the need for screening for cervical, vulvar, vaginal, anal, and certain head and neck cancers, such as throat and back of mouth cancers as recommended by a health care professional; women should still get routine cervical cancer screening. 

• Does not protect the person getting HPV 9-VALENT VACCINE from a disease that is caused by other types of HPV, other viruses or bacteria. 

• Does not treat HPV infection. 

• Does not protect the person getting HPV 9-VALENT VACCINE from HPV types that he/she may already have. 

HPV 9-VALENT VACCINE may not fully protect each person who gets it. 

Tell the health care professional if you or your child (the person getting HPV 9-VALENT VACCINE): 

• Are pregnant or planning to get pregnant. 

• Have immune problems, like HIV or cancer. 

• Take medicines that affect the immune system. 

• Have a fever over 100°F (37.8°C). 

• Might have had an allergic reaction to a previous dose of HPV 9-VALENT VACCINE or HPV 4-VALENT VACCINE . 

• Take any medicines, even those you can buy over the counter. 

The health care professional will help decide if you or your child should get the vaccine. 

HPV 9-VALENT VACCINE is an injection that is usually given in the arm muscle. 

HPV 9-VALENT VACCINE may be given as 2 or 3 injections. 

For persons who are 

9 through 14 years old => 2 injections* 

Dose 1: first injection 

Dose 2: second injection given between 6 and 12 months after the first injection 

or 3 injections** 

Dose 1: first injection 

Dose 2: second injection given 2 months after the first injection 

Dose 3: third injection given 6 months after the first injection 

*If the second injection is given earlier than 5 months after the first injection, you will need to get a third injection at least 4 months after the second injection was given. 

**The need to use a 3-dose schedule instead of a 2-dose schedule will be determined by your health care professional. 

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 HPV 9-VALENT VACCINE 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. 

15 through 45 years old 3 injections =>  2=3 injections 

Dose 1: first injection 

Dose 2: second injection given 2 months after the first injection 

Dose 3: third injection given 6 months after the first injection 

Anyone with an allergic reaction to: 

• A previous dose of GARDASIL 9 

• A previous dose of GARDASIL® 

• Yeast (severe allergic reaction) 

• Amorphous aluminum hydroxyphosphate sulfate 

• Polysorbate 80 

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 HPV 9-VALENT VACCINE  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 HPV 9-VALENT VACCINE. 

If you have already gotten HPV 4-VALENT VACCINE, talk to your health care professional to see if HPV 9-VALENT VACCINE is right for you. 

Can I get HPV 9-VALENT VACCINE  with other vaccines? HPV 9-VALENT VACCINE can be given at the same time as: 

• Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] 

• Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)] 

The most common side effects seen with GARDASIL 9 are: 

• pain, swelling, redness, itching, bruising, bleeding, and a lump where you got the injection 

• headache 

• fever 

• nausea 

• dizziness 

• tiredness 

• diarrhea 

• abdominal pain 

• sore throat 

Studies show that there was more swelling where the injection 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: 

• difficulty breathing 

• wheezing (bronchospasm) 

• hives 

• rash 

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 

• vomiting 

• hives 

• lump where you got the injection 

The following side effects have been seen with the general use of GARDASIL 

GARDASIL 

• swollen glands (neck, armpit, or groin) 

• joint pain 

• unusual tiredness, weakness, or confusion 

• chills 

• generally feeling unwell 

• leg pain 

• shortness of breath 

• chest pain 

• aching muscles 

• muscle weakness 

• seizure 

• bad stomachache 

• bleeding or bruising more easily than normal 

• skin infection 

• lump where you got the injection 

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 Department of Drug and Food of the Ministry of Health of Cambodia via 012 673 268 / 089 498 863 or Email: pv.center@ezecom.com.kh or Website: www.ddfcambodia.com

បើមានប្រតិកម្មរំខានរបស់ផលិតផល សូមរាយការណ៍មកនាយកដ្ឋានឱសថ ចំណីអាហារ បរិក្ខារពេទ្យ និងគ្រឿងសំអាង តាមរយៈលេខទូរសព្ទ 012 673 268 / 089 498 863 ឬអ៊ីមែល pv.center@ezecom.com.kh ឬវេបសាយ www.ddfcambodia.com

GARDASIL 9 - HPV 9-VALENT VACCINE - was not studied in women who knew they were pregnant. Tell the doctor or health care professional if you or your child (the person getting GARDASIL 9), is pregnant or is planning to get pregnant. 

Available data are not sufficient to assess the effects of GARDASIL 9 on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GARDASIL 9 and any potential adverse effects on the breastfed child from GARDASIL 9 or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. 

The safety and effectiveness of GARDASIL 9 have not been evaluated in a geriatric population, defined as individuals aged 65 years and over. 

HPV 9-VALENT VACCINE  contains: 

• Proteins of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 

• Amorphous aluminum hydroxyphosphate sulfate 

• Yeast protein 

• Sodium chloride 

• L-histidine 

• Polysorbate 80 

• Sodium borate 

• Water