Revision Year: 2016 Publisher: Mallinckrodt Medical B.V., Westerduinweg 3, 1755 LE Petten, The Netherlands
If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available.
For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.
Particular caution is required when administering technetium [99mTc] Macrosalb, as the effective dose per MBq is higher than in adults.
Special care should be exercised when administering technetium [99mTc] macrosalb injection to patients with significant right to left cardiac shunt, patients with pulmonary hypertension, or respiratory insufficiency. The number of particles must be kept as low as possible. In adults the number of particles can be reduced to between 100,000 and 200,000 particles without meaning that image quality for the detection of perfusion defects need suffer as a result. Non-homogenous distribution of activity can occur if the number of particles is reduced to less than 100,000 for an adult. If indications exist of the illnesses listed above, then Technescan LyoMAA may not be administered except after a careful benefit/risk analysis has been performed In order to minimise the possibility of microembolism to the cerebral and renal circulations Technetium [99mTc] macrosalb injection should be given by slow intravenous injection and the number of particles reduced by up 50%. Such precautions are also advised in patients with respiratory failure complicating pulmonary hypertension.
Contents of the vial are intended only for use in the preparation of technetium [99mTc] macrosalb injection and are not to be administered directly to the patient without first undergoing the preparative procedure.
The syringe should be gently swirled immediately prior to injection to homogenise the injectate. Blood should never be drawn into the syringe because that induces the formation of small clots. The medicinal product should not come into contact with air.
In order not to restrict the stability of the radioactively labelled medicinal product, technetium [99mTc] macrosalb aggregates are not permitted to be mixed with other medicinal products or components nor be administered together with them
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
It is strongly recommended that every time that Technescan LyoMAA is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Changes in the biological distribution of [99mTc]-MAA may be induced by different drugs.
There is no experience from the use of technetium [99mTc] macrosalb injection in pregnant women.
Radionuclide procedures carried out on pregnant women also involve radiation doses to the fetus. Only imperative investigations should therefore be carried out during pregnancy, when the likely benefit exceeds the risk incurred by the mother and the foetus.
When it is necessary to administer radioactive medicinal products to women 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 important that radiation exposure should be the minimum consistent with achieving the desired clinical information.
Alternative techniques which do not involve ionising radiation should be considered.
Before administering a radioactive medicinal product to a mother who is breastfeeding 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, bearing in mind the secretion of activity in breast milk. If the administration is considered necessary, breast feeding should be interrupted for 12 hours and the expressed feeds discarded. Breastfeeding can be restarted when the level in the milk will not result in a radiation dose to a child greater than 1 mSv.
No studies on the effects on ability to drive and use machines have been performed.
For safety with respect to transmissible agents see section 4.4.
The frequencies of undesirable effects are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Very rare: after intravenous administration of technetium [99mTc] macrosalb aggregates, hypersensitivity reactions appear such as urticaria, shivering fits, fever, nausea, reddening of the face and sweating as well as impairments of cardiac and circulatory functions in the form of changes in respiration, pulse, blood pressure and collapse which may be related to vascular occlusion.
Serious anaphylactoid reactions including shock with possible fatal outcome have been reported, but are very rare. The appearance of these reactions may also not be immediate. Local allergic reactions at the injection site have been observed.
If symptoms such as redness, itching, sneezing, coughing, sweating or feeling cold, difficulty breathing, nausea, vomiting, oedema, urticaria or other sensitivity reactions occur during injection, administration of the medicinal product must be interrupted immediately. Emergency equipment including the medicinal products necessary for treatment must be ready at hand.
Ionized radiation can cause cancer and genetic changes. As most nuclear medicine investigations are carried out with low effective doses of radiation of less than 20 mSv, the probability of these effects occurring should be regarded as being very slight. The effective dose after administration of the maximum recommended activity of this medicinal product is 2.2 mSv.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance; Earlsfort Terrace; IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6 or 12.
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