Cervarix-IMInjection

Generic

Human Papillomavirus Bivalent

Indications

Papillomavirus vaccination is recommended for girls aged 9 and up to prevent chronic infection, premalignant cervical lesions, and cervical cancer (squamous cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV).

Pharmacology

Human Papillomavirus (HPV) types 16 and 18 are responsible for around 70% of cervical cancer cases. The HPV bivalent (types 16 and 18) vaccine is a non-infectious vaccine made with recombinant technology that includes virus-like particles (VLP) of the main capsid LI protein of carcinogenic HPV types 16 and 18. The vaccine's efficacy might be mediated by the development of IgG neutralizing antibodies against HPV-L1 capsid proteins.

Dosage & Administration

Adult: Females 10-25 yr (or between 10-45 yr in some countries): 3 doses of 0.5 ml each given at 0,1 and 6 mth, preferably administered into deltoid muscle.

Child: Not recommended for use in girls beiow 9 yr of age.

Interaction

Immunosuppressive treatments, such as irradiation, cytotoxic medicines, and corticosteroids, may suppress a patient's immunological response to the vaccination.

Contraindications

Any component is known to cause hypersensitivity. In the case of a patient suffering from a severe febrile sickness, administration should be postponed.

Side Effects

Pain, erythema, and inflammation at the injection site Fatigue, headache, myalgia, gastrointestinal problems, and arthralgia.

Pregnancy & Lactation

B is the pregnancy category. Animal reproduction studies have failed to show a harm to the fetus, and no appropriate and well-controlled trials in pregnant women have been conducted. OR Although animal studies have indicated a negative effect, sufficient and well-controlled trials in pregnant people have failed to establish a harm to the baby in any trimester. It is unknown whether this substance is found in breast milk.

Precautions & Warnings

Observe the patient for 15 minutes following administration since syncope, occasionally followed by brief tonic clonic movements and other seizure-like behavior, may occur during recovery. Patients with thrombocytopenia or other clotting problems should exercise caution since IM administration might result in hemorrhage. It should not be given intravenously, subcutaneously, or intradermally. Immunocompromised people may have a reduced immunological response to the vaccination. Despite the fact that vaccination will not prevent against every HPV infection or existing HPV infections, routine cervical screening should be undertaken. Not advised during pregnancy; use with caution during breastfeeding.

Therapeutic Class

Vaccines, antisera, and immunoglobulins

Storage Conditions

Keep refrigerated between 2 and 8°C. Do not get paralyzed. Keep out of direct sunlight. Human Papillomavirus Bivalent should be given as soon as possible after it has been taken from the refrigerator.

Pharmaceutical Name

Glaxo Smithkline Bangladesh Limited