Spikevax LP.8.1: Dosing, Side Effect & Interaction

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

Concise Prescribing Info

Contents

SARS-CoV-2 LP.8.1 mRNA [COVID-19 mRNA vaccine (nucleoside modified)]

Indications/Uses

Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals ≥12 yr.

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Dosage/Direction for Use

Administer intramuscularly, preferably into the deltoid muscle. Individual ≥12 yr w/ or w/o prior vaccination 1 dose (0.5 mL), administered at least 3 mth after the most recent dose of a COVID-19 vaccine. Individual ≥65 yr 1 dose (0.5 mL). 1 additional dose may be administered at least 3 mth after the most recent dose of a COVID-19 vaccine. Immunocompromised individual ≥12 yr w/ or w/o prior vaccination 1 dose (0.5 mL). Additional age-appropriate dose(s) may be administered at least 2 mth following the most recent dose of a COVID-19 vaccine.

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Overdosage

View Spikevax LP.8.1 overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity.

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Special Precautions

Do not administer intravascularly, subcutaneously or intradermally. Should not be mixed in the same syringe w/ any other vaccines or medicinal products. Anaphylactic reaction following vaccination. Closely observe for at least 15 min following vaccination. Subsequent doses should not be given to those who have experienced anaphylaxis to a prior dose of any Spikevax vaccine. Increased risk for myocarditis & pericarditis. Postpone vaccination in individuals suffering from acute severe febrile illness or acute infection. Should be given w/ caution in individuals receiving anticoagulant therapy or those w/ thrombocytopenia or any coagulation disorder (eg, haemophilia). Risk of capillary leak syndrome flare-ups. Not intended for childn <12 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Lymphadenopathy; decreased appetite; irritability/crying; headache, sleepiness; nausea/vomiting; myalgia, arthralgia; inj site pain/swelling/erythema, fatigue, chills, pyrexia. Diarrhoea; rash; inj site urticaria/rash, delayed inj site reaction.

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Drug Interactions

Different injectable vaccines should be given at different inj sites.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Spikevax LP.8.1 detailed prescribing information

Storage

View Spikevax LP.8.1 storage conditions for details to ensure optimal shelf-life.

Description

View Spikevax LP.8.1 description for details of the chemical structure and excipients (inactive components).

Action

View Spikevax LP.8.1 mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07BN01 - covid-19, RNA-based vaccine ; Belongs to the class of covid-19 vaccines.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Spikevax LP.8.1 dispersion for inj (pre-filled syringe) 50 mcg/dose (0.5 mL)

Packing/Price

10 × 1's

Spikevax LP.8.1

Manufacturer:

Moderna

Distributor:

Zuellig