LIDBREE Intrauterine gel Ref.[49920] Active ingredients: Lidocaine

Posology

Cervical procedures

Apply 2 to 3 mL in a thick layer to the portio, and 3 mL into the cervical canal using the sterile applicator 5 minutes before start of procedure.

Intrauterine procedures

Using the sterile applicator, apply 1 to 2 mL to the anterior lip of the portio, and 2 to 3 mL into the cervical canal. Wait 2 minutes for the onset of effect at the inner meatus. Thereafter insert the applicator into the uterine cavity and introduce 3 to 5 mL, 5 minutes before the procedure. The applicator is marked with a centimetre scale. A smaller volume can be administered, e.g. in nulliparous patients, if the patient experiences discomfort before the whole volume has been given. A single intrauterine dose should not exceed a total of 10 mL.

Paediatric population from 15 years of age

In low-weight adolescents below 30 kg body weight the dose should be proportionally reduced, and a single dose should not exceed the maximum recommended parenteral dose (6 mg/kg lidocaine hydrochloride, corresponding to 5.2 mg/kg lidocaine base in Lidbree, i.e. 1.2 mL per 10 kg body weight). In adolescents with a body weight of 30 kg the maximum dose of Lidbree is 3.6 mL in total.

The safety and efficacy of Lidbree in infants and children below 15 years of age have not been established. Lidbree should not be used in children below 15 years of age because of safety concerns (see section 4.4 and 5.1).

Elderly

No dose reduction is necessary in elderly patients (see section 5.2).

Hepatic impairment

A reduction of a single dose is not necessary in patients with impaired hepatic function (see section 5.2).

Renal impairment

A dose reduction is not necessary in patients with impaired renal function.

Method of administration

For cervical and intrauterine use only. When administered, Lidbree should be a liquid. If it has formed a gel, it should be placed in a refrigerator until it becomes a liquid again. The air bubble visible in the syringe will then move if the syringe is tilted.

Assemble the product stepwise and apply the viscous liquid by use of the co-packed sterile applicator:

1) Check the appearance of the syringe while tilting it. The air bubble in the syringe will move when tilted if the product is in liquid state ready for use. If the air bubble does not move the product has formed a gel – then place in refrigerator until it becomes a liquid again.

2) Connect the plunger rod and applicator to the syringe and ensure they are tightly connected.

3) Extrude the air bubble and fill the applicator with gel by cautiously pushing the plunger of the syringe.

4) Use the applicator centimetre scale for positioning the Lidbree formulation.

With the applicator in place, 8.5 mL gel can be delivered from the syringe. One mL contains 42 mg lidocaine. Apply the gel stepwise (1 to 3) as illustrated in the figure.

Lidbree used as recommended is unlikely to cause toxic plasma concentrations of lidocaine. However, if other local anaesthetics are administered concomitantly the effects are additive and may cause an overdose, as may an unintentional intravascular injection (see section 4.4), with systemic toxic reactions.

Symptoms

Systemic toxic reactions primarily involve the central nervous system (CNS) and the cardiovascular system (CVS) and become increasingly apparent at increasing plasma concentration from 5,000 to 10,000 ng/mL. Signs of toxicity in the CNS generally precede cardiovascular toxic effects.

CNS toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are usually, circumoral paraesthesia, numbness of the tongue, light-headedness, hyperacusis, tinnitus and visual disturbances. Dysarthria, muscular twitching or tremors are more serious and precede the onset of generalised convulsions. Unconsciousness and grand mal convulsions may follow which may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with respiration and possible loss of functional airways. In severe cases apnoea may occur. Acidosis hyperkalaemia, hypocalcaemia and hypoxia increase and extend the toxic effects of local anaesthetics.

Recovery is due to redistribution of the local anaesthetic drug from the central nervous system and subsequent metabolism and excretion.

Cardiovascular system toxicity may be seen in severe cases and is generally preceded by signs of toxicity in the central nervous system. Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics, but in rare cases cardiac arrest has occurred without prodromal CNS effects.

Treatment

Severe CNS symptoms (convulsion, CNS depression) must promptly be treated with appropriate airway/respiratory support and the administration of anticonvulsants.

If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with vasopressor, chronotropic and or inotropic agents should be considered.

If circulatory arrest should occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.

3 years.

This medicinal product does not require any special storage conditions.

Lidbree 42 mg/mL intrauterine gel is provided in a sterile 10 mL prefilled syringe (cyclic olefin copolymer) with bromobutyl rubber tip-cap and stopper, packed in the same blister with the plunger rod. The syringe is graduated in mL. A sterile (polypropylene) applicator with a Luer lock fitting compatible with the prefilled syringe is provided in a separate bag within the carton. 8.5 mL can be extruded from the syringe-applicator.

Pack size: 1×10 mL intrauterine gel in pre-filled syringe.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.