Poltech dtpa
Poland
Table of Contents
Package leaflet: Information for the user
PoltechDTPA, 13.25 mg, kit for the preparation of a radiopharmaceutical preparation
Monohydrate sodium diethylenetriaminepentaacetate (DTPA)
Please read carefully all the information contained in this leaflet before the product is used, as it contains important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any doubts or questions, please contact your attending physician or the nuclear medicine specialist supervising the examination.
- If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform the nuclear medicine specialist immediately.
Table of contents
- What PoltechDTPA kit is and what it is used for
- Important information before using PoltechDTPA kit
- How to use PoltechDTPA kit
- Possible side effects
- How to store PoltechDTPA kit
- Contents of the pack and other information
1. What PoltechDTPA kit is and what it is used for
PoltechDTPA is a radiopharmaceutical preparation intended exclusively for diagnostic use.
The radiopharmaceutical (radiopharmaceutical agent) PoltechDTPA, after radiolabelling (i.e. binding) with radioactive technetium isotope (Tc), is used in imaging diagnostics (scintigraphy) of the kidneys (in dynamic scintigraphy to assess glomerular filtration rate - GFR for each kidney and to evaluate urinary outflow disturbances), in GFR assessment using plasma samples, as well as in angioscintigraphy and brain scintigraphy.
Due to its binding with radioactive technetium isotope (Tc), the use of PoltechDTPA involves exposure to a small dose of radiation. Your attending physician and the nuclear medicine specialist have determined that the benefits derived from the diagnostic procedure outweigh the potential risks associated with ionizing radiation.
2. Important information before using PoltechDTPA kit
When not to use PoltechDTPA
Do not administer PoltechDTPA if the patient is allergic to the active substance or to any of the
other ingredients of this medicinal product (listed in section 6).
Warnings and precautions
Please inform the nuclear medicine specialist physician in the following cases:
- if the patient has impaired kidney function,
- if the patient is pregnant or suspects she may be pregnant,
- if the patient is breastfeeding.
Administration of radiopharmaceuticals poses a risk of external ionizing radiation exposure or contamination (e.g. from urine spills) to other individuals. Therefore, basic personal hygiene measures should be observed and bodily excretions (e.g. urine residues) should be properly cleaned up for the time period recommended by the physician.
Special care must be taken when handling radiopharmaceuticals to avoid unnecessary exposure of medical staff and patients.
Before administration of PoltechDTPA:
- drink plenty of water and ensure adequate hydration prior to the procedure, in order to promote frequent urination during the first hours following the examination.
Children and adolescents
Please inform the nuclear medicine specialist physician if the patient is under 18 years of age.
PoltechDTPA and other medicines
Inform the attending physician or the nuclear medicine specialist supervising the procedure about all medications currently taken or recently taken, including those obtained without a prescription, as well as any medications the patient plans to take.
Diagnostic use of captopril, furosemide, and certain psychotropic drugs may affect the function of the organ being examined.
Food and drink with PoltechDTPA
No special precautions are recommended.
Pregnancy and breastfeeding
Before administration of the medicinal product, inform the nuclear medicine specialist physician if:
- pregnancy is suspected,
- menstruation has not occurred at the expected time,
- the patient is breastfeeding. In case of uncertainty, consultation with the attending physician or the nuclear medicine specialist supervising the examination is required.
If the patient is pregnant, it is important to inform the physician. The use of radiopharmaceuticals during pregnancy must be carefully considered. The physician will refer the patient for a radiopharmaceutical-based examination during pregnancy only if absolutely necessary.
If the patient is breastfeeding and a radiopharmaceutical must be administered, the physician may recommend interrupting breastfeeding for 4 hours and expressing milk during this period. The possibility of resuming breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.
Driving and operating machinery
It is considered unlikely that Tc-DTPA will affect the ability to drive or operate machinery.
PoltechDTPA contains sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per vial; at this level, the product can be considered "sodium-free".
3. How to use PoltechDTPA kit
Radiopharmaceuticals may be administered only by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals. The PoltechDTPA medicinal product is used exclusively under appropriate clinical conditions and only by appropriately qualified individuals. These individuals take special precautionary measures to ensure safe use of the medicinal product and will continuously report on their actions.
The medicinal product is intended for intravenous administration.
The nuclear medicine specialist supervising the procedure determines the dose of the medicinal product to be administered in a given case. This will be the minimum dose necessary to obtain the expected diagnostic information. Depending on the type of examination, the recommended dose ranges between 74 and 555 MBq (MBq = megabecquerel, a unit of radioactivity measurement); however, other doses may also be used, e.g. 1.8 – 3.7 MBq for glomerular filtration rate assessment only.
Use in children and adolescents
In children and adolescents, the amount of medicinal product to be administered is determined based on the patient's body weight.
Administration of the medicinal product and performance of the examination
The ready-to-use injection solution will be administered intravenously before the examination. The examination may take place within 1 hour or several hours after injection, depending on its type.
The radioactive preparation Tc-DTPA is intended for intravenous administration under strict supervision by qualified personnel.
During preparation and administration of the medicinal product, the regulations concerning occupational safety in conditions of exposure to ionizing radiation must be strictly observed.
Duration of the procedure
The physician will inform you about the standard duration of the procedure.
After administration of PoltechDTPA you should:
- avoid close contact with small children and pregnant women for 24 hours after injection,
- urinate frequently to help eliminate the medicinal product from the body.
The physician will inform you about the need to take special precautionary measures after administration of the medicinal product. In case of doubts, please contact your treating physician or nuclear medicine specialist.
Administration of a higher than recommended dose of PoltechDTPA
Overdose is practically impossible, as the dose administered to the patient is strictly controlled by the nuclear medicine specialist supervising the examination. However, in the event of an overdose, the physician may recommend increased fluid intake to help eliminate residual radiopharmaceutical from the body.
If you have any doubts regarding the use of the medicinal product, please contact your physician or the nuclear medicine specialist supervising the examination.
4. Possible adverse reactions
Like any medicinal product, PoltechDTPA may cause adverse reactions, although they do not occur in everyone.
Possible adverse reactions following administration of PoltechDTPA include: dizziness, hypotension, dyspnoea, flushing, urticaria, rash, pruritus.
These symptoms are very rare and usually have a mild course.
Administration of a radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with the risk of inducing cancer and hereditary disorders.
Current evidence indicates a low probability of such adverse reactions occurring in diagnostic procedures in nuclear medicine.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or a nuclear medicine specialist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.
5. How to store PoltechDTPA kit
The patient will not need to store this medicine.
Radiopharmaceuticals are stored exclusively by authorised personnel under appropriate clinical conditions. Storage of radiopharmaceuticals is carried out in compliance with local regulations concerning radioactive substances.
The following information is intended exclusively for professional medical staff.
Do not use the medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
6. Contents of the packaging and other information
What PoltechDTPA contains
- The active substance is sodium diethylenetriaminepentaacetate monohydrate.
- The other components are: tin(II) chloride dihydrate, sodium chloride, nitrogen.
What PoltechDTPA looks like and contents of the pack
Kit for the preparation of a radiopharmaceutical preparation.
White powder.
The kit is supplied in 10 ml glass vials closed with a rubber stopper and aluminium cap, packed in a cardboard box.
Pack sizes:
3 vials or 6 vials.
Each vial contains lyophilisate for the preparation of an injectable solution.
Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
7 Andrzeja Sołtana Street
05-400 Otwock
Phone: +48 22 7180700
Fax: +48 22 7180350
e-mail: [email protected]
For further information, please contact your doctor or a representative of the Marketing Authorisation Holder.
The full Product Characteristic Leaflet (SmPC) for PoltechDTPA is included as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.