Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: CIS bio international, R.N.306 Saclay B.P. 32, F 91192, Gif-sur-Yvette, Cedex, France
The possibility of hypersensitivity including serious, life-threatening, fatal anaphylactic/anaphylactoid reactions should always be considered. 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.
Special care should be exercised when administering technetium (99mTc) macrosalb to patients with pulmonary hypertension, respiratory insufficiency, possible or known right-to-left cardiac shunt or pulmonary transplant patients. In these cases, technetium (99mTc) macrosalb may not be administered except after a careful benefit/risk analysis.
In order to minimise the possibility of microembolism to the cerebral and renal circulations technetium (99mTc)‑macrosalb product should be given by slow intravenous injection. The particles number must be kept as low as possible.In adults the particles number can be reduced to between 100,000 and 200,000 particles without loss of image quality for detection of perfusion defects. Heterogeneous distribution of the radioactivity may occur when the number of particles is below 100.000 units.
Careful consideration of the benefit/risk ratio in these patients is required since an increased radiation exposure is possible (see section 4.2.).
For information on the use in paediatric population, see section 4.2. Careful consideration of the indication is required since the effective dose per MBq is higher than in adults (see section 11).
The patient should be well hydrated before the start of the examination and urged to void as often as possible during the first hours after the examination in order to reduce radiation.
A thyroid blockade prior to application of the technetium (99mTc) macrosalb injection suspension can help to reduce the radiation exposure of the thyroid by reducing the thyroid-uptake of technetium (99mTc) pertechnetate which develops in lesser amounts by the metabolism.
Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.
PULMOCIS contains human albumin.
It is strongly recommended that every time that PULMOCIS 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. 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 according to European Pharmacopoeia specifications by established processes.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.
For precautions with respect to environmental hazard, see section 6.6.
Changes in the biological distribution of technetium (99mTc) macrosalb may be induced by different medicinal products.
When it is necessary to administer radioactive medicinal products to women of childbearing potential, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.) alternative techniques not using ionising radiation (if there are any) should be offered to the patient.
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and the foetus.
Before administering radiopharmaceuticals to a mother who is breast-feeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breast-feeding and to what is the most appropriate choice of radiopharmaceuticals, 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.
No studies on fertility have been performed.
PULMOCIS has no or negligible influence on the ability to drive and use machines.
For safety information with respect to transmissible agents, see section 4.4.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 2.2 mSv, when the maximal recommended activity of 200 MBq is administered these adverse reactions are expected to occur with a low probability.
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).
Frequency not known: Hypersensitivity reactions such as urticaria, chills, fever, nausea, face erythema and sweating as well as impairments of cardiac and circulatory functions in the form of changes in respiration, pulse, blood pressure and chest pain, collapse which may be related to vascular occlusion.
Very rare: Serious anaphylactoid reactions including shock with possible fatal outcome have been reported. The appearance of these reactions may also not be immediate.
Frequency not known: Local allergic reactions at the injection site have been observed.
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 12.
The medicinal product should not come into contact with air.
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