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Apidra supply problem (glulisine insulin) Injectable solution in preloaded pen
Publication date: September 29, 2011
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Category: Human use medications, supply problems
Reference: SGICM (cont) psum, 5/2011
Apidra supply problems 100 units/ml Injectable solution in preloaded pen.
It is expected that the normal supply will resume in early 2012.
Apidra® preloaded feathers currently in the market can be used with total safety.
Sanofi Aventis Deutschland GmbH, head of the Marketing Authorization, has informed the European Medicines Agency (EMA) of an Apidra supply problem, medication for the treatment of diabetes mellitus, which affects in Spain the supply of the following medications:
Apidra 100 units/ml, Optiset Injectable solution in preloaded pen (CN: 651458) and
Apidra 100 units/ml, solostar injectable solution in preloaded pen (CN: 656073).
Apidra is a rapid action insulin analog (chemically modified insulin) that is used in combination with intermediate or prolonged action insulins, or other analogs of insulin.It can also be used in combination with other medications (oral route) to treat diabetes.
Sanofi-Aventis Deutschland GmbH, informed the European drug agency for an accidental discharge that occurred on July 11, 2011 at the plant where the medicine is manufactured in Frankfurt, Germany.The manufacture has been temporarily suspended while the corresponding internal investigations are carried out.This situation will result in a delay in the release of Apidra's lots in the European Union market.The problem of supply in Spain affects preloaded feathers, Optiset and Solostar.It does not affect Apidra vials or any other Sanofi insulin (Lantus).
The normal supply is expected to resume in early 2012. Until then supply problems are expected.
The preloaded feathers of Apidra currently in the market can be used with total safety.
The Committee of Human Use Medicines of EMA (CHMP) has developed recommendations for the management of this situation and ensure that patients continue to receive appropriate treatment during this temporary supply problem.Therefore, it has agreed that the company must send a letter to health professionals explaining the specific supply situation that will occur in each country, together with recommendations to handle the situation.
In Spain, taking into account the needs of each patient, the main recommendations, while this supply problem lasts, are the following:
Patients can move on to an alternative rapid insulin analogue treatment - for example, Insulina Lispr.blood.
In the event that the use of fast insulin action analogues is not appropriate, patient treatments could change to regular human insulin (standard) short action (Actrapid).As these insulins have a slower start of action and a longer duration of action that apidra, this change should be made under the direct supervision of a healthcare professional, with a more frequent control of blood glucose levels and dose adjustment,If it is considerednecessary.
At the hospital level, Apidra roads will continue to be available.
CHMP and national agencies are working in close collaboration with the company to guarantee the restoration of the normal supply as soon as possible for the benefit of patients.
Both the European Public Report on Apidra evaluation and the questions and answers published by the EMA on this matter, "Shortage of Apidra (Insuline Glulisine) Cartridges", can be consulted on your website www.ema.europa.eu .