Informations for option: Ultra-Technekow Fm, show other option

Select option:

1. Ultra-Technekow Fm
2. Ultra-Technekow Fm

Document: leaflet MAH GENERIC_PL 12288-0017 change

• leaflet MAH BRAND_PL 12288-0017
• leaflet MAH GENERIC_PL 12288-0017

---

DRN 4329 Ultra-TechneKow FM United Kingdom & Northern Ireland Page 1 of 4

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Trade name: UltraTechnekow FM

(Mallinckrodt Medical catalogue number: DRN 4329)

Non proprietary name: Technetium (^99mTc) generator.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Technetium (^99mTc) is produced by means of a (⁹⁹Mo/^99mTc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6 hours to technetium (⁹⁹Tc) which, in view of its long half-life of 2.13 x 10¹ years can be regarded as quasi stable.

A sterile generator containing the parent isotope ⁹⁹Mo, adsorbed to an aluminium oxide column. The ⁹⁹Mo on the column is in equilibrium with the formed daughter isotope ^99mTc. The generators are supplied with the following ⁹⁹Mo activity amounts:

At activity reference time:

GBq (mCi)		GBq	(mCi)
2.15	(58)	17.20	(465)
4.30	(116)	21.50	(581)
6.45	(174)	25.80	(697)
8.60	(232)	30.10	(814)
10.75	(291 )	34.40	(930)
12.90	(349)	43.00	(1162)

3. PHARMACEUTICAL FORM

Radionuclide generator.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

The eluate from the generator (Sodium Pertechnetate (^99mTc) Injection

Ph. Eur.) may be used as a reagent for labelling of various carrier

compounds supplied as kits or administered directly in-vivo.

When administered intravenously, the sterile sodium pertechnetate

(^99mTc) solution is used as a diagnostic aid in the following:

a)    Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in thyroid disease.

b)    Salivary gland scintigraphy: to assess salivary gland function and duct patency.

c)    Location of ectopic gastric mucosa: Meckel's diverticulum.

d)    Cerebral scintigraphy: to identify breaches in the blood-brain barrier caused by tumour, infarction, haemorrhage and oedema, when no other methods are available.

When used in conjunction with pre-treatment with a reducing agent to effect technetium (^99mTc)-labelling of red blood cells:

e)    Cardiac and vascular scintigraphy

•    angiocardioscintigraphy for:

•    evaluation of ventricular ejection fraction

•    evaluation of global and regional cardiac wall motion

•    myocardial phase imaging

•    organ perfusion or vascular abnormalities imaging

f)    Diagnosis and localisation of occult gastrointestinal bleeding.

Following instillation of sterile sodium pertechnetate (^99mTc) solution into the eye:

g)    Lacrimal duct scintigraphy: to assess patency of tear ducts.

4.2 Posology and Method of Administration

Sodium pertechnetate (^99mTc) is normally administered intravenously at activities which vary widely according to the clinical information required and the equipment employed. Pre-treatment of patients with thyroid blocking agents or reducing agents may be necessary for certain indications.

Recommended activities are as follows:

Adults and the elderly:

• Thyroid scintigraphy: 18.5-80 MBq

Scintigraphy performed 20 minutes after intravenous injection.

> Salivary gland scintigraphy: 40 MBq

Scintigraphy performed immediately after intravenous injection and at regular intervals up to 15 minutes.

•    Meckel's diverticulum scintigraphy: 400 MBq

Scintigraphy performed immediately after intravenous injection and at regular intervals up to 30 minutes.

•    Brain scintigraphy: 370-800 MBq

Rapid sequential images are taken immediately within the first minute after intravenous administration; static images 1 to 4 hours later. Thyroid and choroid plexus should be blocked to avoid non-specific ^99mTc uptake.

•    Cardiac and vascular scintigraphy: 740-925 MBq

Red cells are labelled in-vivo or in-vitro by pretreating with a reducing agent. Dynamic images are taken in the first minute after intravenous administration, followed by regular images over 30 minutes.

•    Gastrointestinal bleeding: 740-925 MBq

Red cells are labelled in vivo or in vitro by pretreating with a reducing agent. Dynamic images are taken in the first minute after intravenous administration, followed by regular images at appropriate intervals for up to 24 hours.

•    Lacrimal dust scintigraphy: 2-4 MBq each eye

Drops are instilled into the eye and dynamic images are taken over 2 minutes, followed by static images at appropriate intervals over 20 minutes.

Children:

The activity for administration to children may be calculated from the recommended range of adult activity and adjusted according to body weight or surface area. However, the Paediatric Task Group of EANM recommends that the activity to be administered to a child should be calculated from the body weight according to the following table:

Fraction of adult dose:
03	kg	= 0,10	22	kg
04	kg	= 0,14	24	kg
06	kg	= 0,19	26	kg
08	kg	= 0,23	28	kg
10	kg	= 0,27	30	kg
12	kg	= 0,32	32	kg
14	kg	= 0,36	34	kg
16	kg	= 0,40	36	kg
18	kg	= 0,44	38	kg
20	kg	= 0,46	40	kg

In very young children (up to 1 year) a minimum dose of 20 MBq (10 MBq in thyroid scintigraphy) for direct administration or 80 MBq for red blood cell labelling is necessary in order to obtain images of sufficient quality.

4.3 Contra-Indications

None known.

4.4 Special Warnings and Special Precautions for Use

Radiopharmaceutical agents should be used only by qualified personnel with the appropriate government authorizations for the use and manipulations of radionuclides.

This radiopharmaceutical may be received, used and administered only by authorised personnel in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of local competent official organisations.

Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken complying with the requirements of Good Pharmaceutical Manufacturing Practice for radiopharmaceuticals.

4.5 Interaction with other Medicinal Products and other forms of Interaction

Drug interactions have been reported in brain scintigraphy where there can be increased uptake of (^99mTc) pertechnetate in the walls of cerebral ventricles as a result of methotrexate-induced ventriculitis. In abdominal imaging drugs, such as atropine, isoprenaline and analgesics, can result in a delay in gastric emptying and redistribution of pertechnetate.

4.6    Pregnancy and Lactation

^99mTc (as free pertechnetate) has been shown to cross the placental barrier.

When it is necessary to administer radioactive medicinal products to a woman of childbearing potential, information should always be sought about pregnancy. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. Where uncertainty exists, it is particularly important that the radiation exposure should be the minimum consistent with achieving the desired clinical information. Alternative techniques which do not involve ionising radiation should be considered.

Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only imperative investigations should be carried out during pregnancy, when the likely benefit exceeds the risk incurred by the mother and the foetus. Direct administration of 800 MBq sodium pertechnetate (^99mTc) to a patient results in an absorbed dose to the uterus of 6.5 mGy. Following pretreatment of patients with a blocking agent, administration of 800 MBq sodium pertechnetate (^99mTc) results in an absorbed dose to the uterus of 5.3 mGy. Administration of 925 MBq ^99mTc labelled red blood cells results in an absorbed dose to the uterus of 4.3 mGy. Doses above 0.5 mGy should be regarded as a potential risk to the foetus.

Before administering a radioactive medicinal product to a woman who is breast-feeding, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether the most appropriate choice of radiopharmaceutical has been made. If the administration is considered necessary, breast-feeding should be interrupted and the expressed feeds discarded. Breast-feeding can be restarted when the activity level in the milk will not result in a radiation dose to the child greater than 1 mSv.

4.7    Effects on Ability to Drive and Use Machines

Effects on ability to drive and use machines have not been described.

4.8    Undesirable Effects

Allergic reactions have been reported following intravenous injection of sodium pertechnetate (^99mTc) and include urticaria, facial oedema, vasodilution, pruritus, cardiac arrythmias and coma.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit. The activity administered must be such that the resulting radiation is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic or therapeutic result.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. For diagnostic nuclear medicine investigations, the current evidence suggests that these adverse effects will occur with low frequency because of the low radiation doses incurred.

For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered is less than 20 mSv EDE. Higher doses may be justified in some clinical circumstances.

This product contains no excipients that have a recognised action or effect, or knowledge of which is important for safe and effective use of the product.

4.9    Overdose

In the event of the administration of a radiation overdose with sodium pertechnetate (^99mTc), the absorbed dose should be reduced where possible by increasing the elimination of the radionuclide from the body. Measures to reduce possible harmful effects include frequent voiding of urine and promotion of diuresis and faecal excretion.

Very little supportive treatment can be undertaken in the event of an overdose of ^99mTc-labelled red blood cells since elimination is dependent on the normal haemolytic process. ¹

5.2    Pharmacokinetic Properties

The pertechnetate ion has similar biological distribution to iodide and perchlorate ions, concentrating temporarily in salivary glands, choroid plexus, stomach (gastric mucosa) and in the thyroid gland, from which it is released unchanged. The pertechnetate ion also tends to concentrate in areas with increased vascularisation or with abnormal vascular permeability, particularly when pre-treatment with blocking agents inhibits uptake in glandular structures.^99mTc is selectively excluded from the cerebrospinal fluid.

Following intravenous administration, pertechnetate (^99mTc) is distributed throughout the vascular system from which it is cleared by three main mechanisms:

•    Rapid removal, depending on the diffusion equilibrium with interstitial fluid

•    Intermediate rate of removal, depending on the concentration of the pertechnetate in glandular tissues, mainly thyroid, salivary and gastric fundus glands which have an ionic pump mechanism

•    Slow removal, by glomerular filtration by the kidneys, dependent on rate of urinary excretion.

Plasma clearance has a half-life of approximately 3 hours. Excretion during the first 24 hours following administration is mainly urinary (approximately 25%) with faecal excretion occurring over the next 48 hours. Approximately 50% of the administered activity is excreted within the first 50 hours.

When selective uptake of pertechnetate (^99mTc) in glandular structures is inhibited by the preadministration of blocking agents, excretion follows the same pathways but there is a higher rate of renal clearance.

When pertechnetate (^99mTc) is administered in association with pretreatment with reducing agents such as stannous/medronate which cause a "stannous loading" of red blood cells, up to approximately 95% of the administered activity is taken up by the red blood cells where it becomes bound within the cells. Any unbound pertechnetate (^99mTc) is cleared by the kidneys; radioactivity in the plasma normally constitutes less than 5% of the intravascular activity.

The fate of the technetium-99m follows that of the labelled erythrocytes themselves and the activity is cleared very slowly. A small level of elution of activity from the circulating red cells is thought to occur.

5.3    Pre-clinical Safety Data

a)    There is no information on acute, subacute and chronic toxicity from single or repeated dose administration. The quantity of sodium pertechnetate (^99mTc) administered during clinical diagnostic procedures is very small and apart from allergic reactions, no other adverse reactions have been reported.

b)    Reproductive Toxicity

Placental transfer of 99mTc from intravenously administered sodium pertechnetate (99mTc) has been studied in mice. The pregnant uterus was found to contain as much as 60% of the injected 99mTc when administered without perchlorate pre-administration. Studies performed on pregnant mice during gestation, gestation and lactation, and lactation alone showed changes in progeny which included weight reduction, hairlessness and sterility.

5.4    Dosimetry

According to ICRP 53, the radiation doses absorbed by a patient following direct administration of sodium pertechnetate (^99mTc) are as follows:

(I) Without pre-treatment with blocking agent:

Absorbed dose per unit activity administered (mGy/MBq)

Organ	Adult	15 Year	10 Year	5 Year	1 Year
Adrenals	3.6E-03	4.7E-03	7.1E-03	1.1E-02	1.9E-02
Bladder wall	1.9E-02	2.3E-02	3.4E-02	5.1E-02	9.1E-02
Bone surfaces	3.9E-03	4.7E-03	6.9E-03	1.0E-02	1.9E-02
Breast	2.3E-03	2.3E-03	3.5E-03	5.7E-03	1.1E-02
Gl tract
Stomach wall	2.9E-02	3.6E-02	5.0E-02	8.1E-02	1.5E-01
Small intestine	1.8E-02	2.2E-02	3.4E-02	5.2E-02	9.0E-02
ULI wall	6.2E-02	7.7E-02	1.3E-01	2.1E-01	3.9E-01
LLI wall	2.2E-02	2.8E-02	4.6E-02	7.4E-02	1.4E-01
Kidneys	5.0E-03	6.0E-03	8.7E-03	1.3E-02	2.1E-02
Liver	3.9E-03	4.8E-03	8.0E-03	1.3E-02	2.2E-02
Lungs	2.7E-03	3.4E-03	5.1E-03	7.9E-03	1.4E-02
Ovaries	1.0E-02	1.3E-02	1.9E-02	2.7E-02	4.5E-02
Pancreas	5.9E-03	7.2E-03	1.1E-02	1.6E-02	2.7E-02
Salivary glands	9.3E-03	1.2E-02	1.7E-02	2.4E-02	3.9E-02
Red marrow	6.1E-03	7.1E-03	9.8E-03	1.3E-02	2.0E-02
Spleen	4.4E-03	5.3E-03	7.9E-03	1.2E-02	2.1E-02
Testes	2.7E-03	3.7E-03	5.9E-03	9.3E-03	1.7E-02
Thyroid	2.3E-02	3.7E-02	5.6E-02	1.2E-01	2.3E-01
Uterus	8.1E-03	1.0E-02	1.6E-02	2.4E-02	4.0E-02
Other tissue	3.4E-03	4.0E-03	6.0E-03	9.3E-03	1.7E-02
Effective Dose	Equivalent
(mSv/MBq)	1.3E-02	1.6E-02	2.5E-02	4.0E-02	7.3E-02

(II) With pre-treatment with blocking agent:
Absorbed dose	per unit activity (mGy/MBq) when blocking
agents are given
Organ	Adult	15 Year	10 Year	5 Year	1 Year
Adrenals	3.3E-03	4.1E-03	6.3E-03	9.5E-03	1.7E-02
Bladder wall	3.2E-02	3.9E-02	5.7E-02	8.4E-02	1.5E-01
Bone surfaces	3.8E-03	4.5E-03	6.7E-03	1.0E-02	1.8E-02
Breast	2.5E-03	2.5E-03	3.6E-03	5.7E-03	1.1E-02
Gl tract
Stomach wall	3.2E-03	4.1E-03	6.6E-03	9.3E-03	1.7E-02
Small intestine	4.1E-03	4.9E-03	7.6E-03	1.1E-02	2.0E-02
ULI wall	3.8E-03	4.9E-03	7.1E-03	1.1E-02	1.9E-02
LLI wall	4.5E-03	5.9E-03	9.2E-03	1.3E-02	2.3E-02
Kidneys	4.7E-03	5.7E-03	8.2E-03	1.2E-02	2.1E-02
Liver	3.1E-03	3.8E-03	5.9E-03	9.0E-03	1.6E-02
Lungs	2.8E-03	3.5E-03	5.2E-03	7.9E-03	1.4E-02
Ovaries	4.7E-03	6.0E-03	8.9E-03	1.3E-02	2.3E-02
Pancreas	3.5E-03	4.4E-03	6.7E-03	1.0E-02	1.8E-02
Red marrow	4.5E-03	5.4E-03	7.8E-03	1.1E-02	1.8E-02
Spleen	3.2E-03	3.9E-03	5.9E-03	9.0E-03	1.6E-02
Testes	3.2E-03	4.4E-03	6.8E-03	1.1E-02	1.9E-02
Thyroid	2.1E-03	3.5E-02	5.7E-03	9.0E-03	1.6E-02
Uterus	6.6E-03	7.9E-03	1.2E-02	1.8E-02	3.0E-02
Other tissue	2.9E-03	3.5E-03	5.3E-03	8.2E-03	1.5E-02
Effective Dose	Equivalent
(mSv/MBq)	5.3E-03	6.6E-03	9.8E-02	1.5E-02	2.6E-02

The effective dose equivalent resulting from an administered activity of 800 MBq sodium pertechnetate (^99mTc) is 10.4 mSv. Following pretreatment of patients with a blocking agent, administration of 800 MBq sodium pertechnetate (^99mTc) results in an effective dose equivalent of 4.24 mSv.

(III) The radiation doses absorbed by a patient following intravenous injection of ^99mTc labelled red blood cells are as follows:

Absorbed dose per unit activity administered (mGy/MBq)

Organ	Adult	15 Year	10 Year	5 Year	1 Year
Adrenals	8.7E-03	1.1E-02	1.7E-02	2.7E-02	4.9E-02
Bladder wall	9.2E-03	1.2E-02	1.7E-02	2.5E-02	4.6E-02
Bone surfaces	9.2E-03	1.3E-02	2.3E-02	3.9E-02	7.8E-02
Breast	4.3E-03	4.5E-03	7.2E-03	1.1E-02	1.9E-02
Gl tract
Stomach wall	4.8E-03	6.1E-03	9.5E-03	1.4E-02	2.4E-02
Small intestine	4.4E-03	5.3E-03	8.1E-03	1.2E-02	2.2E-02
ULI wall	4.3E-03	5.5E-03	7.9E-03	1.3E-02	2.1E-02
LLI wall	3.9E-03	5.3E-03	8.0E-03	1 .1 E-02	2.1E-02
Heart	2.3E-02	2.8E-02	4.1E-02	6.2E-02	1.1E-01
Kidneys	1.0E-02	1.2E-02	1.9E-02	3.0E-02	5.5E-02
Liver	7.5E-03	8.8E-03	1.4E-02	2.1E-02	3.8E-02
Lungs	1.4E-02	1.8E-02	2.9E-02	4.5E-02	8.5E-02
Ovaries	4.2E-03	5.4E-03	7.9E-03	1.2E-02	2.1E-02
Pancreas	6.2E-03	7.5E-03	1.1E-02	1.7E-02	2.9E-02
Red marrow	7.3E-03	8.8E-03	1.3E-02	2.0E-02	3.5E-02
Spleen	1.5E-02	1.8E-02	2.8E-02	4.4E-02	8.4E-02
Testes	2.7E-03	3.7E-03	5.4E-03	8.3E-03	1.5E-02
Thyroid	4.9E-03	7.1E-03	1.2E-02	1.9E-02	3.5E-02
Uterus	4.7E-03	5.7E-03	8.5E-03	1.3E-02	2.2E-02
Other tissue	3.7E-03	4.4E-03	6.4E-03	9.8E-03	1.8E-02
Effective Dose	Equivalent
(mSv/MBq)	8.5E-03	1.1E-02	1.6E-02	2.5E-02	4.6E-02

The effective dose equivalent resulting from an administration of 925 MBq ^99mTc-labelled red blood cells is 7.86 mSv.

(IV) The radiation dose absorbed by the lens of the eye following administration of sodium pertechnetate (^99mTc) for lacrimal duct scintigraphy is estimated to be 0.038 mGy/MBq. This results in an effective dose equivalent of less than 0.01 mSv for an administered activity of 4 MBq.

6. PHARMACEUTICAL PARTICULARS

6.1    List of Excipients

None.

6.2    Incompatibilities

To date no incompatibilities are known.

6.3    Shelf-Life

The expiry date for this product is 9 days after activity reference time.

6.4    Special Precautions for Storage

Do not store above 25 °C. Do not refrigerate.

Generators must be kept in an UltraTechnekow^® Safe (with at least 57 mm of lead protection) or behind an adequate laboratory shield.

Storage should be in accordance with national regulations for radioactive materials.

6.5    Nature and Content of Container

Generator

The generator consists of a cartridge containing an aluminiumoxide column charged with ⁹⁹Mo and locked between two filters. One side of the cartridge is connected to the shielded, sterile supply needle in the eluent holder. The other side is connected to the similarly shielded, sterile outlet needle in the elution station. A second sterile needle in the eluent holder serves to eliminate the underpressure in the eluent vial under sterile conditions.

The generator column is shielded by 28 to 56 mm of lead, depending on the ⁹⁹Mo activity. The shielded generator with the built-in station and the eluent holder are packed in an hermetically sealed tin, which is also the package.

Elution occurs by placing the eluent vial on the needles in the eluent holder, followed by complete or partial filling of evacuated vials.

Elution yield: > 80% (vials of 11 and 25 ml)

> 75% (vial of 5 ml).

Each UltraTechnekow® FM is supplied with:

•    7 TechneVials, sterile, evacuated vials of 5, 11 or 25 ml

•    1 Sterile vial is provided with the elution set.

•    1 Eluent vial, 100 ml of sterile, physiological salt solution

•    7 Disinfection swabs

•    7 Labels with the radioactivity symbol.

6.6 Instructions for Use, Handling and Disposal

Instructions for use

The elution must be carried out in an area capable of maintaining the sterility of the generator.

Preparation

1    Remove the seal, open the lever closing ring and store it together with the top cover.

2    Put the UltraTechnekow® FM in the UltraTechnekow® SAFE or behind any other suitable laboratory shielding with the elution station facing forward.

NB The needles are sterile beneath their covers and the generator underneath the top is clean therefore disinfection with liberal amounts of disinfectants containing alcohol is undesirable and moreover may influence the pertechnetate (^99mTc) yield unfavourably.

3    Remove the flip-off cover from the capsule of the eluent vial, disinfect the stopper, remove (and store) the plastic cover of the inlet needle and lower the eluent vial into its holder.

4    Remove the flip-off cover from the capsule of the sterile vial and put it into the sterile vial shielding.

5    Remove (and store) the rubber needle protection from the outlet needle and lower the shielded sterile vial into the elution station.

Elution

1    Remove the flip-off cover from the capsule of the required TechneVial, disinfect the stopper, let the disinfectant evaporate completely and put the vial into the UltraVial Shielding. (The TechneVial contains some residual water as a result of the sterilisation process.)

2    Replace the shielded sterile vial by the UltraVial Shield, ensure the lead glass window faces front.

3    Wait until the TechneVial is filled with at least 3% mililitres.

4    From this point, the process can be interrupted depending on the required elution volume (Pertechnetate (99mTc) concentration/ml) Elution is always ended by giving the UltraVial Shield a quarter turn, pushing it down and waiting for a few seconds (this causes the TechneVial to be filled with sterile air).

5    Replace the TechneVial Shielding by a shielded unused sterile vial.

Never interrupt elution by lifting the T echneVial Shield without

THE QUARTER TURN!

Eluates that are not clear or colourless must be rejected. Dispose of and return of the generator

1    Remove and dispose of the used sterile vial and the eluent vial.

2    Replace the original needle cover back on the inlet needles.

3    Elute the remaining mililitres of fluid from the generator (see under elution). The generator is now dry.

4    Replace the original outlet needle cover on the outlet needle.

5    Close the generator system with its top cover and lever closing ring.

6    Store the generator in a suitable place for decay to a level acceptable for disposal.

NB In some countries the possibility exists to return expired

generators. Consult the local representative for such a possibility or for details of dismantling.

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.

Waste must be disposed of in accordance with National Regulations for radioactive material.

7. MARKETING AUTHORISATION HOLDER

Covidien (UK) Commercial Ltd.

154 Fareham Road Gosport

Hampshire PO13 0AS United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 32873/0017

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

21 March 2001

10. DATE OF (PARTIAL) REVISION OF THE TEXT

05 November 2007

Ultra-TechneKow FM

radionuclide generator Active substance: technetium [^99mTc]

Read all of this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ultra-TechneKow FM is and what it is used for

2.    Before you use Ultra-TechneKow FM

3.    How to use Ultra-TechneKow FM

4.    Possible side effects

5.    How to store Ultra-TechneKow FM

6.    Further information

What Ultra-TechneKow FM is and what •^m it is used for

This medicine is for diagnostic use only.

Ultra-TechneKow FM is used through a scan to examine various body parts such as the:

•    thyroid glands

•    salivary glands

•    brain

•    heart

•    vessels

•    lining of the stomach or the eyes

•    stomach and/or bowel bleeding

This medicine is a generator containing a radioactive substance, from which another radioactive substance can be received. The latter can be mixed with a non-radioactive substance and when administered into the body it collects in certain organs.

The radioactive substance can be photographed from outside the body, using special cameras which take a scan. This scan shows the distribution of radioactivity within the organ and body. This also gives the doctor valuable information about the structure and function of that organ.

2. Before you use Ultra-TechneKow FM

Do not use Ultra-TechneKow FM

• No absolute limitations are known.

Take special care with Ultra-TechneKow FM

This medicine does involve treatment with radioactivity. Your doctor will only give you this medicine if the benefit outweighs the risk.

Ultra-TechneKow FM is given by specialists, who will take responsibility for any necessary precautions.

Your doctor will inform you if you need to take any special precautions after using this medicine. Contact your doctor if you have any questions.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines can particularly influence the Ultra-TechneKow FM examination:

•    methotrexate, a medicine to treat cancer, severe joint inflammations and psoriasis

•    atropine, used for example

-    to reduce stomach, bowel or gall bladder spasms

-    to reduce pancreas secretions

-    in ophthalmology

-    before administering an anaesthesia

-    to treat reduced heart beat or

-    as an antidote

•    isoprenaline, a medicine to treat reduced heart beat

•    pain killers

Pregnancy and breast-feeding

•    Pregnancy

Tell your doctor if you are pregnant or think you could be. Your doctor will only administer Ultra-TechneKow FM during pregnancy if it is absolutely necessary, as it could harm the unborn child.

•    Breast-feeding

Tell your doctor if you are breast-feeding as he may delay treatment until breast-feeding is finished. He may also ask you to stop breast-feeding and discard this milk, until the radioactivity is no longer in your body.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ultra-TechneKow FM is unlikely to impair the ability to drive and operate machinery.

3. How to use Ultra-TechneKow FM

Ultra-TechneKow FM will always be used in a hospital or similar setting. It will only be administered to you by qualified people trained to safe handle radioactive material.

Your doctor will decide the Ultra-TechneKow FM amount to be used. The dose administered will depend on the procedure.

The lowest dose possible will be used to produce adequate X-ray images.

The usual dose is:

Approximate doses for adults are:

•    2-925 MBq, injected into a vein or given as drops into the eye

MBq is the unit used to measure radioactivity, and defines the activity of a quantity of radioactive material.

Children under 18 years

Lower doses are used for children according to their body weight or body surface area.

How many scans

One injection is usually sufficient.

Drink and urinate as much as possible before and after treatment. This will prevent active substance gathering in the bladder.

If you use more Ultra-TechneKow FM than you should

It is unlikely that overdose will occur as this medicine is given under control by a doctor. However, if this happens you will receive appropriate treatment from your doctor.

If you have any further questions on the use of this product, ask you doctor.

6. Further information

What Ultra-TechneKow FM contains

•    The active substance is technetium [^99mTc] in form of a solution of sodium pertechnetate.

A system containing molybdenum [⁹⁹Mo] is supplied, from which technetium [^99mTc] can be derived and collected in a vial. Such a system can incorporate various amounts of radioactivity, ranging from 2150 to 43000 MBq. The exact amount of activity collected in the vial depends on the overall activity of the system and on the number of millilitres 'tapped'.

•    There are no other ingredients.

What Ultra-TechneKow FM looks like and contents of the pack

Ultra-TechneKow FM is a generator containing an aluminiumoxide column charged with molybdenum [⁹⁹Mo] and locked between two filters. The shielded generator with the built-in station and the outlet holder are packed in a hermetically sealed tin.

Marketing Authorisation Holder and Manufacturer

•    Marketing Authorisation Holder

Covidien (UK) Commercial Ltd.

154 Fareham Road, Gosport Hampshire, PO13 0AS United Kingdom

Tel: +44(0)1329224411, Fax: +44(0)1329224390 PL 32873/0017

•    Manufacturer

Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands

4.    Possible side effects

Like all medicines, Ultra-TechneKow FM can cause side effects, although not everybody gets them.

Frequency unknown, from the data available

•    allergic reactions, with symptoms such as

-    rash, hives, itching

-    swelling of the face

-    widening of blood vessels causing flushing or a drop in blood pressure

-    irregular heart beat

-    coma

Hospital staff will treat these reactions, if they occur.

•    cancer, however the risk is very low as low doses are used in this investigation

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Ultra-TechneKow FM

Do not use Ultra-TechneKow FM after the expiry date stated on the label.

Hospital staff will ensure correct storage temperature, between 1-25°C.

This leaflet was last approved in 10/2008.

04329006BYS05a.doc / 12 CON 4329 United Kingdom SPC 18052010 / 12 CON 4329 United Kingdom PIL 18052010

1

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

No pharmacological activity has been observed in the range of doses administered for diagnostic purposes.