PRILOTEKAL

4). g. maintaining the patency of the airways and administering oxygen, must be immediately available, since in rare cases severe reactions, sometimes with a fatal outcome, have been reported after using local anaesthetics, even in the absence of individual hypersensitivity in the patient’s case history.

4). Posology Posology must be established on an individual basis in accordance with the characteristics of the specific case. When determining the dose, take into consideration the patient’s physical condition and the concomitant administration of other medicinal products.

The lowest possible dose should be chosen. The duration of action is dose-dependent. The indications relating to recommended doses are valid in adults of average height and weight (approximately 70 kg) for obtaining an effective block with one single administration.

There are wide individual variations with regard to extent and duration of action. The experience of the anaesthetist and knowledge of the patient’s general condition are essential for establishing the dose.

With regard to posology the following guidelines are applied:

Adults population ml mg Average duration of action (minutes)Extension of sensory blockade required T10 2-3 40-60 Approx. 100-130 As a general guideline, the maximum recommended dose is 80 mg of prilocaine hydrochloride (= 4 ml Prilotekal).

Paediatric population The safety and efficacy of Prilotekal in paediatric population have not been established. No data are available. g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy) a reduced dose is indicated. In the case of compromised liver or kidney function a lower dosage range is recommended.

Method of administration Due to the glucose content Takipril is only to be used for spinal anaesthesia. It is not recommended for the use in epidural anaesthesia Inject Prilotekal via intrathecal route into the intervertebral space L2/L3, L3/L4 and L4/L5.

Administer the injection slowly, after having aspirated a minimum quantity of CSF to confirm the correct position and check the patient’s vital functions extremely carefully maintaining continuous verbal contact. 4). If the patient is in a seated position, the injected solution diffuses mainly in a caudal direction (in the direction of the sacrum); if the patient is lying down, the anaesthetic diffuses by gravity according to the patient’s position (Trendelenburg and anti-Trendelenburg ).

The possible undesirable effects due to the use of Prilotekal are generally similar to the undesirable effects of other local anaesthetics for spinal anaesthesia from the amide group. g. g. g. g. post-spinal headache). The frequency of onset of undesirable effects is classified as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Frequency Undesirable Effect Blood and lymphatic system disorders Rare Methemoglobinemia, Cyanosis Immune system disorders Rare Anaphylactic shock, Anaphylactic reactions, Allergic reactions, Itching Common Paresthesia, Dizziness Uncommon Signs and symptoms of CNS toxicity (convulsions, circumoral paresthesia, loss of consciousness, shaking, feeling of numbness affecting the tongue, speech problems, hearing problems, tinnitus, visual problems) Nervous system Disorders Rare Arachnoiditis, Neuropathy, Lesions of peripheral nerves Eye disorders Rare Diplopia Uncommon BradycardiaCardiac disorders Rare Cardiac arrest, Arrhythmia Very common HypotensionVascular disorders Uncommon Hypertension Respiratory, thoracic Rare Respiratory depression and mediastinal disorders Musculoskeletal and connective tissue disorders Uncommon Back pain, temporary muscle weakness Very common NauseaGastrointestinal disorders Common Vomiting The signs of intoxication from local anaesthetics are similar for any injected preparation, both in the way in which they manifest, and in their treatment.

In spite of the demonstrated high clinical tolerability of Prilotekal, undesirable toxic effects cannot be excluded in the presence of plasma levels above a critical threshold. These undesirable effects mainly manifest as symptoms affecting the central nervous and cardiovascular system.

The most effective prophylactic measures are scrupulous compliance with the recommended posology for Prilotekal, with it being essential for the doctor to check its action (visual and verbal contact with the patient), as well as careful aspiration prior to injecting the solution.

Due to the glucose content Prilotekal is only to be used for spinal anaesthesia. It is not recommended for the use in epidural anaesthesia. 5). Spinal anaesthesia must only be administered by (or under the supervision of) specialist medical personnel with the necessary knowledge and experience.

The doctor in charge is responsible for taking the measures needed to avoid an intravascular injection. In addition, it is essential for the doctor to know how to recognize and treat undesirable effects, systemic toxicity and other complications.

9). Some patients require special attention in order to reduce the risk of serious undesirable effects, even when locoregional anaesthesia constitutes the optimum choice for the surgical intervention: - Patients with total or partial heart block, since local anaesthetics can suppress myocardial conduction.

- Patients with high grade cardiac decompensation. 8). - Patients with advanced liver or kidney damage. - Elderly patients and patients in reduced general condition. g. amiodarone). 5). - In patients with acute porphyria, Prilotekal should only be administered when there is a compelling indication for its use, as Prilotekal may potentially precipitate porphyria.

Appropriate precaution should be taken in all patients with porphyria. Ensuring the presence of reliable venous access is recommended. As with all local anaesthetics, a drop in arterial pressure may occur and cardiac frequency may slow.

In high risk patients, the recommendation is to improve their general condition prior to the intervention. A rare, but serious, undesirable effect of spinal anaesthesia is high or total spinal block, with consequent cardiovascular and respiratory depression.

Cardiovascular depression is induced by an extended block of the sympathetic nervous system, which may induce severe hypotension and bradycardia to the point of cardiac arrest. Respiratory depression is induced by the block of the respiratory musculature and the diaphragm.

1, - serious problems with cardiac conduction, - severe anaemia, - decompensated cardiac insufficiency, - cardiogenic and hypovolemic shock, - congenital or acquired methemoglobinemia. - concomitant anticoagulant therapy general and specific contraindications for the technique of subarachnoid anaesthesia.

The use of Prilotekal in children younger than 6 months is contraindicated due to a higher risk of of developing methemoglobinemia The intravascular injection of Prilotekal is contra-indicated. Prilotekal must not be injected into infected areas.