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Menitorix

Childhood vaccine given at 1 year old.

Intramuscular injection.

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Australia
Europe

Manufactured by GlaxoSmithKline

Not licensed in the USA

  • Haemophilus influenzae type b (Hib) and Meningococcal group C conjugate vaccine

1 dose (1.5 ml) also contains:

Trometamol - "is used as an excipient in the pharmaceutical industry and as a pH stabilizer for improving the solubility and stability of various substances (eg, contrast media, vaccines, eye drops, cosmetics). Although widely used, trometamol has rarely been involved in allergic reactions. In addition, its role in such reactions has not been assessed." (1)

 

Sucrose - table sugar. It is composed of glucose and fructose.

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Sodium chloride - commonly known as table salt.

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Water for injections

WARNINGS AND PRECAUTIONS

Genotoxicity and carcinogenicity

 

No studies were submitted, which is considered acceptable for this type of product.

Frequencies per dose are defined and colour coded as follows:

Very common - (≥1/10)

Common - ≥1/100 to <1/10

Uncommon - ≥1/1,000 to <1/100

Rare - ≥1/10,000 to <1/1,000

Very rare - <1/10,000

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Side effects that are not colour coded are of unknown frequency.

Side effects in trials
Side effects postmarketing

Eye disorders

Conjuctivitis

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Gastrointestinal disorders

Appetite lost

Diarrhoea

Vomiting

Constipation

Teething

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General disorders and administration site conditions

Fever (rectal ≥ 38°C)

Swelling

Pain

Redness

Injection site reaction

Fever (rectal > 39.5°C)

Malaise

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Infections and infestations

Bronchiolitis

Croup Infectious

Ear infection

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Injury, poisoning and procedural complications

Head injury

Joint dislocation

Limb injury

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Nervous system disorders

Drowsiness

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Respiratory, thoracic and mediastinal disorders

Asthma

Cough

Rhinorrhoea

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Psychiatric disorders

Irritability

Crying

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Skin and subcutaneous tissue disorders

Dermatitis atopic
Rash

Dermatitis diaper

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Blood and Lymphatic System Disorders

Lymphadenopathy

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General Disorders and Administration Site Conditions

Dizziness

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Immune system disorders

Allergic reactions (including urticaria and anaphylactoid reactions)

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Nervous system disorders

Headache

Febrile seizures

Hypotonia

*side effect list is a combination of Europe and Australia.

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Manufacturer's Pacakge Insert Side Effects*

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