PENTACIS Powder for solution for injection Ref.[49884] Active ingredients: Technetium ⁹⁹ᵐTc pentetic acid

Source: Health Products Regulatory Authority (IE)  Revision Year: 2016  Publisher: CIS Bio International, Route National 306, BP 32, 91192 Gif-Sur-Yvette Cedex, France

4.1. Therapeutic indications

This medicinal product is for diagnostic use only.

a) After reconstitution with sodium pertechnetate (99mTc) solution the agent may be used for:

Dynamic renal scintigraphy for perfusion, function and urinary tract studies.

Measurement of glomerular filtration rate.

Cerebral angiography and brain scanning. As an alternative method, when computed tomography and/or magnetic resonance imaging are not available.

b) After inhalation of the nebulized technetium (99mTc) labelled substance:

Lung ventilation imaging.

c) After oral administration of the technetium (99mTc) labelled substance:

Studies of gastro-oesophageal reflux and gastric emptying.

4.2. Posology and method of administration

In adults, the following administered doses are recommended (other doses may be justifiable):

For intravenous use:

Measurement of glomerular filtration rate from plasma: 1.8-3.7 MBq.

Measurement of glomerular filtration rate using gamma camera combined with sequential dynamic renal scanning: 37-370 MBq.

Sequential scanning should begin immediately after injection. Optimal static imaging time is 1 hour post injection.

Brain scanning: 185-740 MBq.

For cerebral examinations, static images are obtained 1 hour and, if necessary, several hours after injection. Sequential dynamic scanning should begin immediately after injection.

For inhalation:

Lung ventilation imaging: 500-1000 MBq in nebuliser.

50-100 MBq in lung.

For oral use:

Study of gastro-oesophageal reflux and gastric emptying: 10-20 MBq.

Dynamic recording should be performed during the first minutes (up to 120 minutes for gastroduodenal transit).

Pediatric dose. The dose for children is adjusted according to body weight:

Pediatric dose (MBq) = Adult dosage (MBq) X Child weight (Kg) / 70

In some circumstances, dose adjustment according to surface area may be appropriate.

Pediatric dosage (MBq) = Adult dosage (MBq) X Child body surface (m²) / 1.73

In very young children (up to 1 year) a minimum dose of 20 MBq is necessary in order to obtain images of sufficient quality, when technetium (99mTc) pentetate (DTPA) is used for kidney studies.

Dosimetry

(99mTc) technetium decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6 hours, to (99Tc) technetium which can be regarded as quasi stable.

For this product the effective dose equivalent resulting from:

  • an intravenous administered activity of 740 MBq to a patient with normal renal function is 3.6 mSv (per 70 kg individual).
  • an inhalation (nebuliser) of 100 MBq is 0.6 mSv (per 70 kg individual).
  • an oral administration of 20 MBq is 0.5 mSv (per 70 kg individual).

According to ICRP 53, 60, 80 (International Commission of Radiological Protection) the radiation doses absorbed by the patients are the following:

Normal renal function

ORGAN ABSORBED DOSE PER UNIT OF ADMINISTERED
ACTIVITY (mGy/MBq)
Adult 15 years 10 years 5 years 1 year
Adrenals
Bladder wall
Bone surfaces
Brain
Breast
Gall bladder
Gastrointestinal tract
Stomach
Small intestine
Colon
Upper large intestine wall
Lower large intestine wall

Heart
Kidneys
Liver
Lungs
Muscles
Oesophagus
Ovaries
Pancreas
Red marrow
Skin

Spleen
Testes
Thymus
Thyroid
Uterus

Other tissue

Effective dose (mSv/MBq) 		1.3E-03
6.2E-02
2.3E-03
8.4E-04
7.1E-04
1.5E-03

1.3E-03
2.5E-03
3.0E-03
2.1E-03
4.3E-03

1.1E-03
3.9E-03
1.2E-03
9.9E-04
1.6E-03
1.0E-03
4.2E-03
1.4E-03
1.4E-03
8.5E-04

1.2E-03
2.9E-03
1.0E-03
1.0E-03
7.9E-03

1.7E-03

4.9E-03		1.7E-03
7.8E-02
2.8E-03
1.0E-03
9.0E-04
2.0E-03

1.6E-03
3.1E-03
3.8E-03
2.7E-03
5.3E-03

1.4E-03
4.7E-03
1.5E-03
1.3E-03
2.0E-03
1.3E-03
5.3E-03
1.8E-03
1.8E-03
1.0E-03

1.6E-03
4.0E-03
1.3E-03
1.3E-03
9.5E-03

2.0E-03

6.2E-03		2.6E-03
9.7E-02
4.0E-03
1.7E-03
1.3E-03
3.6E-03

2.7E-03
4.5E-03
5.4E-03
4.0E-03
7.3E-03

2.1E-03
6.7E-03
2.4E-03
1.9E-03
2.8E-03
1.9E-03
6.9E-03
2.7E-03
2.6E-03
1.6E-03

2.4E-03
6.0E-03
1.9E-03
2.0E-03
1.3E-02

2.8E-03

8.2E-03		3.8E-03
9.5E-02
5.5E-03
2.7E-03
2.1E-03
4.6E-03

3.7E-03
5.7E-03
6.4E-03
5.4E-03
7.7E-03

3.2E-03
9.6E-03
3.5E-03
2.9E-03
3.7E-03
2.9E-03
7.8E-03
4.0E-03
3.3E-03
2.3E-03

3.6E-03
6.9E-03
2.9E-03
3.2E-03
1.3E-02

3.7E-03

9.0E-03		7.0E-03
1.7E-01
9.9E-03
4.8E-03
4.0E-03
6.0E-03

6.7E-03
9.8E-03
1.1E-02
9.0E-03
1.3E-02

5.8E-03
1.7E-02
6.3E-03
5.3E-03
6.7E-03
5.3E-03
1.3E-02
7.2E-03
5.6E-03
4.3E-03

6.6E-03
1.3E-02
5.3E-03
5.8E-03
2.2E-02

6.4E-03

1.6E-02

Abnormal renal function

ORGAN ABSORBED DOSE PER UNIT OF ADMINISTERED
ACTIVITY (mGy/MBq)
Adult 15 years 10 years 5 years 1 year
Adrenals
Bladder wall
Bone surfaces
Breast

Gastrointestinal tract
Stomach wall
Small intestine
Upper large intestine wall
Lower large intestine wall

Kidneys
Liver
Lungs
Ovaries
Pancreas

Red marrow
Spleen
Testes
Thyroid
Uterus

Other tissue

Effective dose (mSv/MBq) 		4.1E-03
2.2E-02
4.4E-03
3.0E-03

3.8E-03
4.7E-03
4.4E-03
4.7E-03
7.9E-03

3.8E-03
3.3E-03
4.9E-03
4.3E-03
5.2E-03

4.0E-03
3.3E-03
2.5E-03
6.3E-03
3.3E-03

4.9E-03

5.1E-03
2.7E-02
5.3E-03
3.0E-03

5.0E-03
5.6E-03
5.6E-03
6.2E-03
9.6E-03

4.6E-03
4.2E-03
6.3E-03
5.4E-03
6.3E-03

4.8E-03
4.5E-03
4.3E-03
7.5E-03
4.0E-03

6.2E-03

7.8E-03
4.0E-02
7.9E-03
4.3E-03

7.9E-03
8.6E-03
8.1E-03
9.6E-03
1.4E-02

7.1E-03
6.2E-03
9.4E-03
8.1E-03
9.0E-03

7.2E-03
6.9E-03
6.8E-03
1.1E-02
6.1E-03

9.3E-03

1.2E-02
5.8E-02
1.2E-02
6.9E-03

1.1E-02
1.3E-02
1.3E-02
1.4E-02
2.0E-02

1.1E-02
9.5E-03
1.4E-02
1.2E-02
1.3E-02

1.1E-02
1.1E-02
1.1E-02
1.7E-02
9.4E-03

1.4E-02

2.1E-02
1.1E-01
2.1E-02
1.3E-02

2.0E-02
2.3E-02
2.2E-02
2.5E-02
3.4E-02

1.9E-02
1.7E-02
2.4E-02
2.2E-02
2.2E-02

2.0E-02
2.0E-02
1.9E-02
2.9E-02
1.7E-02

2.5E-02

The radiation doses given to man on administration by aerosol of (99mTc) DTPA are the following:

ORGAN ABSORBED DOSE PER UNIT OF ADMINISTERED
ACTIVITY (mGy/MBq)
Adult 15 years 10 years5 years 1 year
Adrenals
Bladder wall
Bone surfaces
Breast

Gastrointestinal tract
Stomach wall
Small intestine
Upper large intestine wall
Lower large intestine wall

Kidneys
Liver
Lungs
Ovaries
Pancreas

Red marrow
Spleen
Testes
Thyroid
Uterus

Other tissue

Effective dose (mSv/MBq) 		2.1E-03
4.7E-02
1.9E-03
1.9E-03


1.7E-03
2.1E-03
1.9E-03
3.2E-03

4.1E-03
1.9E-03
1.7E-02
3.3E-03
2.1E-03

2.7E-03
1.9E-03
2.1E-03
9.9E-04
5.9E-03

1.8E-03

6.3E-03

2.9E-03
5.8E-02
2.4E-03
1.9E-03


2.2E-03
2.6E-03
2.4E-03
4.2E-03

5.1E-03
2.5E-03
2.6E-02
4.1E-03
2.6E-03

3.4E-03
2.4E-03
3.1E-03
1.7E-03
7.2E-03

2.2E-03

8.5E-03

4.4E-03
8.4E-02
3.5E-03
3.3E-03


3.5E-03
4.1E-03
3.8E-03
6.3E-03

7.2E-03
3.7E-03
3.6E-02
6.1E-03
4.0E-03

4.7E-03
3.6E-03
5.2E-03
2.7E-03
1.1E-02

3.2E-03

1.2E-02

6.7E-03
1.2E-01
5.3E-03
4.8E-03


5.1E-03
6.3E-03
6.1E-03
8.8E-03

1.1E-02
5.5E-03
5.4E-02
8.9E-03
6.1E-03

6.2E-03
5.6E-03
7.9E-03
4.4E-03
1.6E-02

4.9E-03

1.8E-02

1.2E-02
2.3E-01
9.8E-03
7.8E-03


8.9E-03
1.1E-02
1.0E-02
1.5E-02

1.9E-02
9.7E-03
1.0E-01
1.5E-02
1.1E-02

9.6E-03
9.9E-03
1.5E-02
7.8E-03
2.7E-02

8.6E-03

3.3E-02

The radiation doses given to man on administration per os of (99mTc) DTPA are the following (D.J. GAMBINI, R. GRANIER : Manuel pratique de Médecine Nucléaire)

ORGAN ABSORBED DOSE PER UNIT OF
ADMINISTERED ACTIVITY (mGy/MBq)
Stomach
Small intestine
Red marrow
Ovaries
Testes
Effective dose equivalent
(mSv/MBq) 		8.6E-02
7.0E-02
1.2E-03
3.5E-03
1.7E-03

2.5E-02

After calculation according to ICRP 60, the effective dose is 2.6E-02 mSv/MBq.

4.9. Overdose

In the event of the administration of a radiation overdose with technetium (99mTc) pentetate (DTPA) the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by forced diuresis and frequent bladder voiding.

6.3. Shelf life

1 year.

After labelling, store at 2°C-8°C (in a refrigerator) and use within 4 hours with a maximum of 5 withdrawals per vial.

6.4. Special precautions for storage

Store at 2°C-8°C (in a refrigerator).

For storage conditions of the reconstituted medicinal product, see section 6.3.

Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

6.5. Nature and contents of container

15 ml, colourless, European Pharmacopoeia type I, drawn glass vials, closed with chlorobutyl rubber stoppers and aluminium caps.

Pack size: Kit of 5 multidose vials.

6.6. Special precautions for disposal and other handling

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused product or waste material should be disposed of in accordance with local requirements.

< Previous: Overview
Next: Precautions >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈