The ministry detected some practitioners do not administer the injections with the exact dose for anaphylactic shock.
The Spanish Agency for Medicines and Health Products (Competent Authority), under the Ministry of Health, Social Services and Equality, has ordered the recall of several lots of adrenaline autoinjector device Jext, used as a measure of support vital in case of anaphylactic shock in allergic patients after detecting a ‘possible quality defect’ on multiple devices.
The defect affects several batches of the drug in doses of 150 and 300 micrograms solution for injection in pre-filled pen 0.15 and 0.3 milliliters, and is a problem that causes no dosing, some cases being notified pharmacovigilance systems by health authorities in Denmark.
It is estimated that the units that may be affected are the 0.04% of the total. Although this probability is very low, as recognized Health, absence of appropriate dosing ‘presents a potential risk to the patient’s life.’
The Ministry notes that it is ‘very important’ that patients with affected units take these drugs to their pharmacy to get them process for the change of potential affected units of Jext other unaffected units or alternative medicines in case of lack of units of this first.
Alternative drugs in Spain are Altellus 150 micrograms or 300 micrograms children adults, both marketed by Meda Pharma.
Both contain Altellus Jext as adrenaline in two doses of 150 or 300 micrograms solution for injection as presenting as one distinct applicator, which makes them equivalent if used correctly, as the composition and shape pharmaceutical in both cases the same. However, ‘for proper use, the patients should be trained in their use.’
‘Management difference between the two devices may be relevant in clinical practice and patients’ safety,’ says Health Department, which states that the packaging will be replaced only if no Jext units.
In this case, authorizing that can dispense a corresponding medicine package ‘Altellus, to understand what is best for the patients to have some adrenaline device treatment lacking in an emergency situation.
The replacement will take place in the pharmacy for patients who delivered a package of lots of the affected Jext will have no charge to them, since Alk Abelló will bear the costs of these events. In fact, it reminds the patients not to dispose Jext units until they can get another alternative unit.
The Competent Authority has contacted the holders of marketing authorizations for these medicines in order to increase the units put in the market to make it possible to perform all the necessary substitutions.
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