FLEXdose Delivery Program - Sirtex · situations Offers the flexibility to modify treatment...

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FLEXibility as easy as 3-2-1 Time (SGT) GBq mCi 9 am 8.290 224.06 11 am 8.113 219.27 1 pm 7.939 214.58 3 pm 7.769 209.99 7 am 6.535 176.62 9 am 6.395 172.85 11 am 6.258 169.15 1 pm 6.125 165.53 3 pm 5.994 161.99 7 am 5.041 136.25 9 am 4.933 133.34 11 am 4.828 130.48 1 pm 4.725 127.69 3 pm 4.624 124.96 7 am 3.889 105.11 Day of Calibration 9 am 3.806 102.86 11 am 3.724 100.66 1 pm 3.645 98.50 3 pm 3.567 96.40 7 am 3.000 81.08 Post-Calibration 9 am 2.936 79.35 11 am 2.873 77.65 1 pm 2.812 75.99 3 pm 2.751 74.36 7 am 2.314 62.55 SIR-Spheres ® is a registered trademark of Sirtex SIR-Spheres Pty Ltd. Caution: SIR-Spheres® Y-90 resin microspheres may only be distributed to a duly licensed or accredited facility capable of handling therapeutic medical isotopes. This product is radioactive and should thus be handled in accordance with all applicable standards and regulations. SIR-Spheres® Y-90 resin microspheres are supplied for use in Singapore, Malaysia, Thailand, Vietnam, Hong Kong, Taiwan, South Korea, India, Australia and New Zealand. Intended Use / Indications For Use: This product is indicated for the treatment of patients with advanced non-operable liver cancer. Warnings / Precautions: Inadvertent delivery of the microspheres to locations other than the intended hepatic tumour may result in local radiation damage and serious side effects. Due to the radioactivity and the significant consequences of misplacing the microspheres in situ, this product must be implanted by physicians who have completed the Sirtex TEC training program. A SPECT scan of the upper abdomen immediately after implantation is recommended. Patients may experience abdominal pain immediately after administration and pain relief may be required. Gastric acid blocking agents may be administered the day before implantation and continued as needed to reduce gastric complications. Side effects: Common side effects are fever, mild to moderate abnormality of liver function tests, abdominal pain, nausea, vomiting, and diarrhoea. Potential serious effects due to exposure to high radiation include acute pancreatitis, radiation pneumonitis, acute gastritis, radiation hepatitis, and acute cholecystitis. Contraindications: SIR-Spheres® Y-90 resin microspheres are contraindicated in patients with markedly abnormal synthetic and excretory liver function tests; greater than 20% lung shunting of the hepatic artery blood flow or 30 Gy radiation absorbed dose to the lungs, as estimated by the 99mTc MAA scan. This device should not be implanted in patients determined via angiogram to have an abnormal vascular anatomy that would result in significant reflux of the hepatic arterial blood flow to the stomach, pancreas or bowel. Reference the Package Insert for each country for a complete listing of indications, contraindications, side effects, warnings and precautions. 1 DAY pre-calibration 3 DAYS pre-calibration FLEXdose Delivery Program 2 DAYS pre-calibration Sirtex Medical Singapore Pte Ltd 50 Science Park Road, #01-01, The Kendall, Singapore Science Park II, Singapore 117406 Tel: +65 6800 6500 Fax: +65 6778 9424 Sirtex Medical Limited Level 33, 101 Miller Street, North Sydney NSW 2060, Australia Tel: +61 2 99648400 Fax: +61 2 9964 8410 www.sirtex.com ©2019 Sirtex Medical Inc. ID 209-A-0719

Transcript of FLEXdose Delivery Program - Sirtex · situations Offers the flexibility to modify treatment...

Page 1: FLEXdose Delivery Program - Sirtex · situations Offers the flexibility to modify treatment planning The FLEXibility to deliver the required activity with the desired number of microspheres

FLEXibility as easy as 3-2-1

Time (SGT) GBq mCi

9 am 8.290 224.06

11 am 8.113 219.27

1 pm 7.939 214.58

3 pm 7.769 209.99

7 am 6.535 176.62

9 am 6.395 172.85

11 am 6.258 169.15

1 pm 6.125 165.53

3 pm 5.994 161.99

7 am 5.041 136.25

9 am 4.933 133.34

11 am 4.828 130.48

1 pm 4.725 127.69

3 pm 4.624 124.96

7 am 3.889 105.11

Day of Calibration

9 am 3.806 102.86

11 am 3.724 100.66

1 pm 3.645 98.50

3 pm 3.567 96.40

7 am 3.000 81.08

Post-Calibration

9 am 2.936 79.35

11 am 2.873 77.65

1 pm 2.812 75.99

3 pm 2.751 74.36

7 am 2.314 62.55

SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd.

Caution: SIR-Spheres® Y-90 resin microspheres may only be distributed to a duly licensed or accredited facility capable of handling therapeutic medical isotopes. This product is radioactive and should thus be handled in accordance with all applicable standards and regulations. SIR-Spheres® Y-90 resin microspheres are supplied for use in Singapore, Malaysia, Thailand, Vietnam, Hong Kong, Taiwan, South Korea, India, Australia and New Zealand. Intended Use / Indications For Use: This product is indicated for the treatment of patients with advanced non-operable liver cancer. Warnings / Precautions: Inadvertent delivery of the microspheres to locations other than the intended hepatic tumour may result in local radiation damage and serious side effects. Due to the radioactivity and the significant consequences of misplacing the microspheres in situ, this product must be implanted by physicians who have completed the Sirtex TEC training program. A SPECT scan of the upper abdomen immediately after implantation is recommended. Patients may experience abdominal pain immediately after administration and pain relief may be required. Gastric acid blocking agents may be administered the day before implantation and continued as needed to reduce gastric complications. Side effects: Common side effects are fever, mild to moderate abnormality of liver function tests, abdominal pain, nausea, vomiting, and diarrhoea. Potential serious effects due to exposure to high radiation include acute pancreatitis, radiation pneumonitis, acute gastritis, radiation hepatitis, and acute cholecystitis. Contraindications: SIR-Spheres® Y-90 resin microspheres are contraindicated in patients with markedly abnormal synthetic and excretory liver function tests; greater than 20% lung shunting of the hepatic artery blood flow or 30 Gy radiation absorbed dose to the lungs, as estimated by the 99mTc MAA scan. This device should not be implanted in patients determined via angiogram to have an abnormal vascular anatomy that would result in significant reflux of the hepatic arterial blood flow to the stomach, pancreas or bowel.

Reference the Package Insert for each country for a complete listing of indications, contraindications, side effects, warnings and precautions.

1 DAY

pre-calibration

3 DAYS

pre-calibration

FLEXdose Delivery Program

2 DAYS

pre-calibration

Sirtex Medical Singapore Pte Ltd50 Science Park Road,#01-01, The Kendall,Singapore Science Park II,Singapore 117406Tel: +65 6800 6500Fax: +65 6778 9424

Sirtex Medical LimitedLevel 33, 101 Miller Street,North Sydney NSW 2060,AustraliaTel: +61 2 99648400Fax: +61 2 9964 8410

www.sirtex.com ©2019 Sirtex Medical Inc. ID 209-A-0719

Page 2: FLEXdose Delivery Program - Sirtex · situations Offers the flexibility to modify treatment planning The FLEXibility to deliver the required activity with the desired number of microspheres

FLEXdose Delivery Program

3 DaysPre-calibration

6.5*

GBq

2 DaysPre-calibration

5.0*

GBq

1 DayPre-calibration

3.8*

GBq

Day of Calibration

Dose Delivery Options

Activity

Dose Draw

2.2 GBq

2.2 GBq(example)

Personalising treatment with additional calibration options

SIR-Spheres® Y-90 resin microspheres is the only SIRT that offers the following:

• Customised dosing for each clinical situation Allows you to administer tailored activity for your patient-specific needs

• Same day dose draw Enables you to draw the appropriate patient-specific activity on the day of treatment

• Supports time-sensitive clinical situations Offers the flexibility to modify treatment planning

The FLEXibility to deliver the required activity with the desired number of microspheres

**Day of calibration at 7am SGT*All activity based on procedure time at 7am SGT

**3.0GBq

The activity you want. The coverage you need.