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Monitoring of respiratory and cardiac function is essential during this phase, especially in patients with cardiopulmonary disease and respiratory muscle weakness or those being treated with benzodiazepine-type preparations or opiates, who are at higher risk of respiratory depressions. Patients who do not respond to a 100-microgram test dose must not be given further doses and are not eligible for continuous intrathecal infusions. Signs of severe overdose (coma) have been observed in an adult after a single test dose of 25 micrograms. There is much variability with regard to sensitivity to intrathecal baclofen.
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Patients are considered to be positive responders if they show a significant decrease in muscle tone and/or frequency and/or severity of spasms. Resuscitative equipment must be on hand during injection of the first dose. Low-dose ampoules (0.05 mg/ml) are available for this test phase. The dose must be injected over at least one minute via barbotage. The initial dose is generally 25 or 50 micrograms the dose is generally increased in increments of 25 micrograms at intervals of at least 24 hours, until a response lasting approximately 4 to 8 hours is obtained. Patients should be infection-free prior to screening, as the presence of a sistemic infection may prevent an accurate assessment of the response. Usually, a bolus test dose is administered via lumbar puncture or an intrathecal catheter, in order to provoke a response. Prior to administering baclofen as a continuous intrathecal infusion, patients must show a positive response to administration of an intrathecal test dose in an initial test phase. This system is connected to an intrathecal catheter that passes subcutaneously into the subarachnoid space. This is an implantable administration systems: a refillable reservoir is implanted beneath the skin, mostly into the abdominal wall. Specific instructions for implantation, programming and/or refilling of the implantable pump are given by the pump manufacturers, and must be strictly adhered to.Įfficacy of baclofen intrathecal has been demonstrated in controller randomised studies with an EU certified pump. Intrathecal administration of Baclofen Aguettant through an implanted delivery system should only be undertaken by physicians with the necessary knowledge and experience. Establishment of the optimum dose schedule requires that each patient undergoes an initial screening phase with intrathecal bolus, followed by a very careful individual dose titration prior to maintenance therapy. Date of first authorisation/renewal of the authorisationīaclofen Aguettant is intended for administration in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, in implantable pumps suitable for continuous administration of Baclofen Aguettant into the intrathecal space (EU certified pumps). 6.6 Special precautions for disposal and other handling.
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4.7 Effects on ability to drive and use machines.4.5 Interaction with other medicinal products and other forms of interaction.4.4 Special warnings and precautions for use.4.2 Posology and method of administration.Show table of contents Hide table of contents