Home > Package Inserts > Menitorix
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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