- Approval Id
- 33404dbaa66348fb
- Drug Name
- DOTAGRAF SOLUTION FOR INJECTION 0.5 MMOL/ML
- Product Name
- DOTAGRAF SOLUTION FOR INJECTION 0.5 MMOL/ML
- Approval Number
- SIN15973P
- Approval Date
- 2020-07-06
- Registrant
- BAYER (SOUTH EAST ASIA) PTE LTD
- Licence Holder
- BAYER (SOUTH EAST ASIA) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Posology</strong></p>
<p><u><strong>Adults</strong></u></p>
<p>The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg, in adults.</p>
<p><em>Special populations</em></p>
<p><u>Impaired renal function</u><br>
The adult dose applies to patients with mild to moderate renal impairment (GFR ≥ 30 ml/min/1.73m<sup>2</sup>).</p>
<p>Dotagraf should only be used in patients with severe renal impairment (GFR < 30 ml/min/1.73m<sup>2</sup>) and in patients in the perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic information is essential and not available with non-contrast enhanced MRI (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). If it is necessary to use Dotagraf, the dose should not exceed 0.1 mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of information on repeated administration, Dotagraf injections should not be repeated unless the interval between injections is at least 7 days.</p>
<p><u>Elderly (aged 65 years and above)</u><br>
No dosage adjustment is considered necessary. Caution should be exercised in elderly patients (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><u>Impaired hepatic function</u><br>
The adult dose applies to these patients. Caution is recommended, especially in the case of perioperative liver transplantation period (see above impaired renal function).</p>
<p><em>Paediatric population (2–18 years)</em></p>
<p>MRI of brain and spine / whole-body MRI: the recommended and maximum dose of Dotagraf is 0.1 mmol/kg body weight. More than one dose should not be used during a scan.</p>
<p><em>Method of administration</em><br>
The product is indicated for intravenous administration only.<br>
Intravascular administration of contrast media should, if possible, be done with the patient lying down. After the administration, the patient should be kept under observation for at least half an hour, since experience shows that the majority of undesirable effects occur within this time.</p>
<p>Prepare a syringe with a needle. Remove the plastic disk. After cleaning the stopper with a pad soaked in alcohol, puncture the stopper with the needle. Withdraw the quantity of product required for the examination and inject it intravenously.<br>
For single use only, any unused solution should be discarded.<br>
The solution for injection should be inspected visually prior to use. Only clear solutions free of visible particles should be used.</p>
<p><u>Paediatric population</u> <em>(2–18 years)</em><br>
Depending on the amount of Dotagraf to be given to the child, it is preferable to use Dotagraf vials with a single use syringe of a volume adapted to this amount in order to have a better precision of the injected volume.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>This medicinal product is for diagnostic use only.</p>
<p>Nuclear magnetic resonance imaging:</p>
<ul>
<li>Neuroradiology: tumour of the spine and the surrounding tissues, intracranial tumours.</li>
<li>Abdominal radiology: primary and secondary tumours.</li>
<li>Primary tumour of the bone and soft tissues.</li>
</ul>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to gadoteric acid, to meglumine or to any medicinal products containing gadolinium.</p>
- Atc Code
- V08CA02
- Atc Item Name
- gadoteric acid
- Pharma Manufacturer Name
- BAYER (SOUTH EAST ASIA) PTE LTD
