- Approval Id
- e7a9aaa2197357cb
- Drug Name
- MYOVIEW FOR INJECTION 0.23 mg/vial
- Product Name
- MYOVIEW FOR INJECTION 0.23 mg/vial
- Approval Number
- SIN11820P
- Approval Date
- 2002-02-25
- Registrant
- GE HEALTHCARE PTE. LTD.
- Licence Holder
- GE HEALTHCARE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- **Dosage and administration**
**Paediatric Population**
Myoview is not recommended for use in children or adolescents as data are not available for these age groups.
**Adults**
**Myocardial Imaging**
Patients should be requested to fast overnight or to have only a light breakfast on the morning of the procedure.
For the diagnosis and localization of myocardial ischaemia the recommended procedure involves two intravenous injections of 99mTc-tetrofosmin. For adults and the elderly 185–250MBq is given at peak exercise, followed by 500–750MBq given at rest approximately 4 hours later. The activity administered should be restricted to 1000MBq in any one day.
As an adjunct in the diagnosis and localization of myocardial infarction, one injection of 99mTc-tetrofosmin (185–250MBq) at rest is sufficient.
Planar or preferably SPECT imaging should begin no earlier than 15 minutes post-injection. There is no evidence for significant changes in myocardial concentration or redistribution of 99mTc-tetrofosmin, therefore, images may be acquired up to at least four hours post-injection. For planar imaging the standard views (anterior, LAO 40°–45°, LAO 65°–70° and/or left lateral) should be acquired.
**Breast Imaging**
For the diagnosis and localization of suspected breast lesions, the recommended procedure involves a single intravenous injection of 99mTc-tetrofosmin between 500–750MBq. The injection should preferably be given in a foot vein or a site other than the arm on the side of the suspected breast lesion. The patient does not need to fast before the injection.
Breast imaging is optimally initiated 5–10 minutes post-injection with the patient in the prone position with the breast(s) freely pendant. A special imaging couch designed for nuclear medicine breast imaging is recommended. A lateral image of the breast suspected of containing the lesions should be obtained with the camera face as close to the breast as is practicable.
The patient should then be repositioned so that a lateral image of the pendant contralateral breast can be obtained. An anterior supine image may then be obtained with the patient’s arms behind her head.
**Procedure for the preparation of 99mTc-tetrofosmin**
Normal safety precautions for the handling of radioactive materials should be observed in addition to the use of aseptic technique to maintain sterility of the vial contents.
**Procedure for the preparation of 99mTc-tetrofosmin:**
Use aseptic technique throughout.
1. Place the vial in a suitable shielding container and sanitize the rubber septum with the swab provided.
2. Insert a sterile needle (the venting needle, see Note 1) through the rubber septum. Using a shielded, 10ml sterile syringe, inject the required activity of Sodium Pertechnetate \[99mTc\] Injection Ph. Eur. (appropriately diluted with 0.9% Sodium Chloride Injection BP) into the shielded vial (see Notes 2 to 4). Before removing the syringe from the vial, withdraw 5ml of gas from above the solution (see Note 5). Remove the venting needle. Shake the vial to ensure complete dissolution of the powder.
3. Incubate at room temperature for 15 minutes.
4. During this time assay the total activity, complete the user label provided and attach it to the vial.
5. Store the reconstituted injection at 2–25°C and use within 12 hours of preparation. Dispose of any unused material and its container via an authorised route.
**Notes:**
1. A needle of size 19G to 26G may be used.
2. The Sodium Pertechnetate \[99mTc\] Injection Ph. Eur. used for reconstitution should contain less than 5ppm aluminium.
3. The volume of diluted Sodium Pertechnetate \[99mTc\] Injection Ph. Eur. added to the vial must be in the range 4–8ml.
4. The radioactive concentration of the diluted Sodium Pertechnetate \[99mTc\] Injection Ph. Eur. must not exceed 1.5GBq/ml when it is added to the vial.
5. For preparation volumes of more than 6ml, the remaining vial headspace is less than the 5ml added air volume. In these cases, the withdrawal of a 5ml volume of gas ensures that all of the vial headspace is replaced by air.
6. The pH of the prepared injection is in the range 7.5–9.0.
7. Studies have demonstrated that satisfactory radiochemical purity is achieved when Myoview is reconstituted with Sodium Pertechnetate \[99mTc\] Injection Ph. Eur. eluted up to 6 hours previously from a generator last eluted within 72 hours.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **Indications**
This medicinal product is for diagnostic use only.
_Myocardial Imaging:_
Myoview is a myocardial perfusion agent indicated as an adjunct in the diagnosis and localization of myocardial ischaemia and/or infarction.
_Breast Tumour Imaging:_
Myoview is indicated as an adjunct to the initial assessments (e.g palpation, mammography, or alternative imaging modalities and/or cytology) in the characterisation of malignancy of suspected breast lesions where all these other recommended tests were inconclusive.
- Contraindications
- **Contra-indications**
Myoview is contraindicated in pregnancy and in patients with known hypersensitivity to tetrofosmin or any of the excipients.
- Atc Code
- V09GA02
- Atc Item Name
- technetium (99mTc) tetrofosmin
- Pharma Manufacturer Name
- GE HEALTHCARE PTE. LTD.
- Company Detail Path
- /organization/ge-healthcare-pte-ltd
