Optimark

Optimark should only be administered by physicians experienced in clinical MRI practice. g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.

2 ml/kg (100 micromol/kg) body weight. 9 %) solution for injection. The imaging procedure should be completed within 1 hour of administration of the contrast medium. 2ml/kg (100 micromol/kg) may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.

The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly. The repeat dose is not recommended in these populations. Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of the dose of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.

Paediactric population No dose adjustment is considered necessary in children more than 2 years of age. 3). Use of Optimark is not recommended in children less than 2 years of age because the safety, efficacy, and impact of immature kidney function have not been studied in this age group.

Elderly (aged 65 years and above) No dose adjustment is considered necessary. 4). 3). 4). More than one dose should not be used during a scan. Medicinal product no longer authorised 4 Method of administration The agent should be administered as a bolus peripheral intravenous injection.

9 %) solution for injection. Insertion of a flexible in-dwelling venous catheter is recommended, see section

Summary of the safety profile Most of the adverse reactions were of mild to moderate intensity and transient in nature. The most common adverse reactions were dysgeusia, feeling hot, headache and dizziness. The majority of adverse reactions observed after the use of gadoversetamide were found to be adverse reactions of the nervous system, followed by general adverse reactions, gastrointestinal disorders/skin and subcutaneous tissue disorders.

Serious adverse reactions have been reported and include anaphylactic reactions, cardiovascular reactions, and allergic respiratory disorders. Medicinal product no longer authorised 7 Tabulated list of adverse reactions The following adverse reactions have been reported from clinical trials and from post-marketing use of gadoversetamide.

Medicinal product no longer authorised 8 System Organ Class (MedDRA) 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) Not known Immune System Disorders Anaphylactic reaction Metabolism and Nutrition Disorders Decreased appetite Psychiatric Disorders Anxiety, Sleep disorder, Confusion and disorientation Nervous System Disorders Headache, Dysgeusia Dizziness, Hypoaesthesia, Paraesthesia, Parosmia Convulsion, Tremor, Somnolence, Burning sensation Syncope Eye Disorders Erythema of eyelid, Eye pain, Vision blurred, Conjunctivitis, Ocular hyperaemia Ear and Labyrinth Disorders Tinnitus, Vertigo Cardiac Disorders Palpitations, AV block first degree, Extrasystoles, Tachycardia, Arrhythmia Vascular Disorders Flushing Hypotension, Hypertension Respiratory, Thoracic and Mediastinal Disorders Nasal congestion, Throat irritation Dyspnoea, Dysphonia, Rhinorrhoea, Throat tightness, Bronchospasm, Cough, Laryngeal/pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing Gastrointestinal Disorders Nausea, Diarrhoea Salivary hypersecretion,, Abdominal pain, Constipation, Dry mouth Vomiting Skin and Subcutaneous Tissue Disorders Pruritus, Rash Urticaria, Cold sweat, Erythema, Hyperhidrosis Periorbital oedema Nephrogenic systemic fibrosis (NSF) Renal and Urinary Disorders Blood creatinine increased, HaematuriaMedicinal product no longer authorised 9 System Organ Class (MedDRA) 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) Not known General Disorders and Administration Site Conditions Feeling hot Chest discomfort, Chest pain, Feeling cold (including peripheral coldness), Administration site reactions Chills, Pain, Face oedema, Asthenic conditions including asthenia, fatigue, and malaise, Fever, Oedema peripheral, Feeling abnormal Investigations Blood calcium abnormal ALT increased, Urine analysis abnormal, Urine electrolytes abnormal, albumin in urine, CPK Increased, Haemoglobin decreased Electrocardiogram QT prolongedMedicinal product no longer authorised 10 Local reactions have occurred at the injection site and may lead to local irritation type reactions.

4. 4). 6. 1. 4). 4 Special warnings and precautions for use As with any paramagnetic contrast agent, enhancement of MRI with gadoversetamide may impair the visualization of existing lesions. Some of these lesions may be seen on unenhanced, non-contrast MRI.

Therefore, caution should be exercised when contrast enhanced scan interpretation is made in the absence of a companion unenhanced MRI. Before the examination, care must be taken that patients are sufficiently hydrated. 8). Most of these reactions occur within half an hour after administering the contrast medium.

As with all other contrast media of the same class, late reactions may occur (after hours or days) in rare cases; however, none were reported in the completed clinical trials. If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately and intravenous treatment initiated, if necessary.

During the examination, supervision by a physician is necessary and insertion of a flexible in-dwelling catheter is recommended. g. epinephrine/adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.

g. allergies to seafood or medicinal products, hay fever, urticaria), whether they are hypersensitive to contrast media and whether they have bronchial asthma. Premedication with antihistamines and/or glucocorticoids may be considered.

Medicinal product no longer authorised 5 Patients with cardiovascular disease In this group of patients hypersensitivity reactions may be severe. g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate.

However, these were not evident from clinical trials with Optimark. Central nervous system disorders In patients suffering from epilepsy or brain lesions the likelihood of convulsions during the examination may be increased. g. monitoring of the patient) and the equipment and medicinal products needed for the rapid treatment of possible convulsions should be available.

1. 4).