Products

Presentation:

Papilovax : Each 0.5 ml contains Human Papillomavirus Vaccine (rDNA) BP consisting of recombinant human papillomavirus type 16 L1 protein 40 µg and recombinant human papillomavirus type 18 L1 protein 20 µg. Papilovax is a mixture of two-aluminum hydroxide adjuvant-absorbed
recombinant L1 capsid proteins of human papillomavirus (HPV) type-16 and type-18 each self-assembled into virus-like particles (VLPs). The HPV-16 and HPV-18 L1 antigens are expressed in Escherichia coli by recombinant DNA technology.

Description:

Papilovax is a suspension for injection in a prefilled syringe. Upon storage, a fine white deposit with a clear colorless supernatant can be observed. Papilovax would be a suspension after thorough agitation. Papilovax does not contain any preservative.
Excipients: Aluminum hydroxide, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Sodium chloride, Polysorbate 80 & Water for injection.

Indications:

Papilovax is indicated for women aged 9-45 years. It is used for preventing the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and/or 18-
- Cervical cancer
- Cervical intraepithelial neoplasia Grade 2 or 3 (CIN2/3) and adenocarcinoma in-situ (AIS)
- Cervical intraepithelial neoplasia Grade 1 (CIN1) and persistent infections of HPV types 16 and/or 18
The risk of exposure to HPV increases with age, especially with sexual debut. Therefore, it is recommended to vaccinate as early as possible. It would be more beneficial to receive the vaccine at the earlier time between ages 9-45 years.

Dosage and Administration:

It is recommended to receive 3 doses of 0.5-ml each, by intramuscular injection according to the following schedule: 0, 1, and 6 months.
If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2 months after the first dose and third dose between 5 and 8 months after the first dose. On the basis of the clinical trial results and refer to the recommendations in Human Papillomavirus Vaccines: WHO Position Paper (2017), female aged 9-14 years can also choose a vaccination schedule of two doses at 0 month and 6 month (0.5-ml per dose, with an interval of not less than 5 months).
At present, it has not been determined whether the booster vaccination is required.

Side Effects:

Human papillomavirus bivalent (Types 16 and 18) vaccine is generally well tolerated. 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
Most of the above adverse reactions are mild to moderate.

Precautions:

- 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.
- 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.
- 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 vaccine is placed in a supine or head-down position and the cerebral perfusion is restored. Some vaccines 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 vaccines.
- 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.

Contraindications:

-Hypersensitivity to the active substances or to any component of the excipients of vaccine.
-Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of this vaccine.

Use in Pregnancy and Lactation:

Pregnancy: 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.

Over Dosage:

Not applicable

Storage:

-Keep out of the reach and sight of children
-Store at +2 ºC to +8 ºC. Transportation should also be at +2 ºC to +8 ºC
-Do not freeze. Discard vaccine if frozen
-Protect from light.

Commercial Pack:

Papilovax Each box contains 0.5 ml of suspension Human Paillomavirus Vaccine (rDNA) BP in a prefilled syringe and 1 needle.