Cervarix Vaccine

Cervarix Vaccine is used for: Human Papillomavirus infection, Premalignant cervical lesions and cervical cancer, Adenocarcinoma in situ, Cervical intraepithelial neoplasia

Intramuscular Injections Cervical Cancer Prevention Indicated for prevention of cervical precancers and cervical cancer associated with oncogenic HPV types 16 and 18. The vaccination schedule depends on the age of the subject. Children and Adults aged 9 through 26 years HPV vaccination can be given starting at age 9 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated. Age 9 to and including 14 years 2 doses each of 0.5 ml by intramuscular injection. The second dose given between 5 and 13 months after the first dose or 3 doses each of 0.5 ml by intramuscular injection at 0, 1, 6 months. Age from 15 years and above 3 doses each of 0.5 ml by intramuscular injection at 0, 1, 6 months *If the second vaccine dose is administered before the 5th month after the first dose, a third dose should always be administered. **If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose. The necessity for a booster dose has not been established Adults aged >26 years Catch-up HPV vaccination is not recommended for all adults aged >26 years. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated. 3 doses each of 0.5 ml by intramuscular injection at 0, 1, 6 months

Child: Not recommended for use in girls below 9 yr of age. Intramuscular Cervical Cancer Prevention Indicated for prevention of cervical precancers and cervical cancer associated with oncogenic HPV types 16 and 18. The vaccination schedule depends on the age of the subject. Children Age 9 to and including 14 years 2 doses each of 0.5 ml by intramuscular injection. The second dose given between 5 and 13 months after the first dose or 3 doses each of 0.5 ml by intramuscular injection at 0, 1, 6 months. Age from 15 years and above 3 doses each of 0.5 ml by intramuscular injection at 0, 1, 6 months *If the second vaccine dose is administered before the 5th month after the first dose, a third dose should always be administered. **If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose. The necessity for a booster dose has not been established

This is for intramuscular injection in the deltoid region. This vaccine should under no circumstances be administered intravascularly or intradermally. No data are available on subcutaneous administration of this vaccine.

Known hypersensitivity to any component. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of this vaccine. Postpone admin in patient suffering from an acute febrile illness.

Vaccination cannot replace the routine cervical cancer screening or other measures to prevent HPV infection and sexually transmitted diseases. Therefore, routine cervical cancer screening remains extremely important as recommended by the relevant health administrative departments. Prior to the vaccination, medical personnel should inquire and review the vaccinee's medical history (especially the prior vaccination history and any prior adverse reaction related to vaccination), and conduct clinical examination to evaluate the benefits and risks of vaccination. It is not recommended for populations other than those described in of the package insert. Like other vaccines for injection, appropriate medical emergency measures and monitoring methods should be prepared to ensure that those who develop allergic reactions after the injection. Syncope (fainting) may occur after any dose of vaccine, leading to falls and injuries, especially in adolescents and young adults. Therefore, it is recommended that the observation on site be conducted for at least 30 minutes after each injection as required in the vaccination procedures. It has been reported that syncope associated with tonic-clonic seizures and other epileptiform seizures may occur after the vaccination with similar products overseas. Syncope associated with tonic-clonic seizures is usually transient, and it can be resolved spontaneously when the vaccinee is placed in a supine or head-down position and the cerebral perfusion is restored. Some vaccinees may experience psychogenic reactions before/after the vaccination, and measures should be taken to avoid injury from the syncope. Like other vaccines, the vaccination should be postponed in vaccinees with acute serious febrile illness. In case of current or recent fever symptoms, whether to postpone the vaccination depends mainly on the severity of the symptoms and their etiology. Low-grade fever and mild upper respiratory tract infection are not absolute contraindications to vaccination. The vaccine should be used with caution in vaccinees with thrombocytopenia or any coagulation disorder. Like any other vaccine, vaccination with HPV vaccine may not ensure the protective effect for all vaccinees. It is only used for preventive purposes, but not indicated for the treatment of existing HPV-related lesions or preventing the progression of lesions. It cannot prevent lesions caused by all high-risk types HPV infections. It has not been proved that it can prevent the lesions caused by the infection of non-vaccine types of HPV as well as the diseases not caused by HPV infection. There has been no data on the use of HPV vaccine in vaccinees with impaired immune system (such as receiving the medication of immunosuppressive agents). Like other vaccines, vaccination in immunocompromised people may not induce adequate immune response.

At present, there has been no independent study conducted to systematically evaluate the effect on pregnant women. The very limited data from the clinical trial showed that the accidental vaccination during pregnancy does not cause abnormal pregnancy outcomes and neonatal health conditions, and no adverse effects on pregnancy rate, pregnancy outcomes and neonatal health conditions were observed after the vaccination of HPV vaccine. However, the data are not sufficient to determine whether pregnant women are at risk of adverse pregnancy (including spontaneous abortion) after the vaccination. In animal experiments, no direct or indirect adverse effects on reproduction, pregnancy, embryo/fetus development, parturition or postnatal development are observed after the vaccination. Vaccination should be avoided during pregnancy. If a woman is pregnant or preparing for pregnancy, it is recommended to postpone or interrupt the vaccination procedure, and the vaccination can be conducted after the end of pregnancy. Lactation: There has been no relevant study data to HPV vaccine. As many drugs can be secreted in breast milk, HPV vaccine should be used with caution in lactating women.

Immunosuppressive therapies e.g. irradiation, cytotoxic drugs and corticorsteroids may reduce a patient's immune response to the vaccine.

Side effects of Human Papilloma virus Bivalent (Types 16 and 18) Vaccine, Recombinant : Human papillomavirus bivalent (Types 16 and 18) vaccine is generally well tolerated. Most of the above adverse reactions are mild to moderate. >10% The most common local adverse reactions were pain, redness, and swelling at the injection site. The most common general adverse events were fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia. Systemic Adverse Reactions Very common: Fever (>37.1 °C) Common: Headache, fatigue, cough, muscle pain, nausea, diarrhea, dizziness and vomiting Occasional: Hypersensitivity, allergic dermatitis, rash, dizziness and pruritus Local Adverse Reactions Very common: Pain at the injection site Common: Pruritus, induration, swelling and erythema at injection site Occasional: Rash and discomfort at injection site

Human Papillomavirus (HPV) type 16 and 18 cause about 70% of cervical cancer. HPV bivalent (types 16 and 18) vaccine is a non-infectious vaccine produced by recombinant technology, which contains virus-like particles (VLP) of the major capsid L1 protein of oncogenic HPV types 16 and 18. Efficacy of vaccine may be mediated by the production of IgG neutralizing antibodies against the HPV-L1 capsid proteins.

Cervarix 0.5ml Vaccine manufactured by Glaxo SmithKline Biological S.A.,Belgium. Its generic name is Human Papilloma virus Bivalent (Types 16 and 18) Vaccine, Recombinant. Cervarix is availble in Bangladesh. Farmaco BD drug index information on Cervarix Vaccine is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.