Menactra Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Meningococcal (groups A, C, Y & W-135) polysaccharide diphtheria toxoid conjugate vaccine

Indications/Uses

Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y & W-135 in individuals 9 mth-55 yr.

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Dosage/Direction for Use

0.5 mL as single IM dose preferably in the anterolateral thigh or deltoid region. Primary vaccination Childn 9-23 mth travelling or living in endemic areas 2-dose series at least 3 mth apart. Individual 2-55 yr Single IM dose.

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Contraindications

Hypersensitivity after previous dose of meningococcal capsular polysaccharide-diphtheria toxoid or CRM₁₉₇-containing vaccine. Guillain-Barré syndrome. Postpone vaccination in case of febrile or acute disease. Pregnancy.

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Special Precautions

Do not administer IV, SC, or intradermally. Not for the prevention of meningitis caused by other microorganisms or invasive meningococcal disease caused by N. meningitidis serogroup B. Patient previously diagnosed w/ Guillain-Barré syndrome. Review the immunization history for possible vaccine sensitivity & previous vaccination-related AR prior to administration. Thrombocytopenia or bleeding disorders. Reduced immune response in individuals w/ altered immunocompetence including those receiving immunosuppressant therapy. Increased risk for invasive disease caused by N. meningitidis including invasive disease caused by serogroups A, C, Y & W-135 in patients w/ certain complement deficiencies & those receiving treatment that inhibits terminal complement activation (eg, eculizumab). Limitations of vaccine effectiveness. Syncope. Pregnancy & lactation. Infant <9 mth. Elderly >55 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Inj site reactions (tenderness, pain, redness, swelling), irritability, diarrhea, drowsiness, anorexia, headache, fatigue, fever ≥40°C. Lymphadenopathy; hypersensitivity reactions eg, anaphylaxis/anaphylactic reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension; Guillain-Barré syndrome, paresthesia, vasovagal syncope, dizziness, convulsion, facial palsy, acute disseminated encephalomyelitis, transverse myelitis; myalgia; large inj site reactions, extensive swelling of the injected limb.

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Drug Interactions

Do not mix w/ other vaccines in the same syringe. May reduce immune response to vaccines w/ immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, & corticosteroids (used in greater than physiologic doses).

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Storage

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Description

View Menactra description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07AH08 - meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated ; Belongs to the class of meningococcal bacterial vaccines.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Menactra vaccine (inj) 48 mcg/0.5 mL

Packing/Price

(vial) 1's (Rp753,024/boks); (vial) 5 × 1's

Menactra

vaccine, meningococcal

Manufacturer:

Kalventis Sinergi Farma