INSTILLAGEL Gel Ref.[28230] Active ingredients: Chlorhexidine Lidocaine

Unless otherwise prescribed by a doctor:

a) Urethral sounding and catheterisation instill 6‑11 ml. After the usual cleaning of the glans and urethra and orifice, Instillagel is instilled into the urethra and the glans is pressed for a short time between the thumb and index finger until the anaesthetic effect begins. When narrow gauge catheters are being introduced, any blockage of the eye of the catheter by gel can either be eliminated, if the bladder is full, by light pressure on the hypogastrium producing discharge of urine, or be re-opened by means of the sterile disposable syringe and instillation of sterile saline solution.

b) Cystoscopy: With a view to considerate and painless introduction of instruments, the entire urethra including the external sphincter must be coated with a film of lubricant and anaesthetised. With a short penis and correspondingly narrow urethra, a dose of 11 ml is sufficient, in other cases an additional instillation of 6‑11 ml of Instillagel is recommended. A penis clamp is applied in the area of the coronary sulcus. The anaesthetic effect begins after 3‑5 minutes. In prograde ureterocystoscopy, the external sphincter, which is simultaneously anaesthetised, can distinctly be seen opening up when irrigated.

c) In urethral stenosis (meatotomy, bougienage): Instil 11 ml and, if necessary, a further 6 or 11 ml, than attach a penile clamp. The required urethral anaesthesia is achieved after 5‑10 minutes.

d) For disinfection spread (instil) 6 or 11 ml evenly over the mucous membrane.

For other indications

Slowly instil 6 or 11 ml into the relevant orifice, and/or spread the gel as evenly as possible over the catheter or instrument to be inserted.

Full local anaesthetic and disinfectant action develops in 5‑10 min.

Instillagel must not be used in children under 2 years.

In general, the maximum dose in children aged 2 to 12 years should not exceed 2.9 mg lidocaine hydrochloride per kg of body weight. This is equivalent to 1.5 ml Instillagel per 10 kg of body weight.

The systemic absorption of lidocaine can be increased in children and caution is accordingly required.

Symptoms

In the event of excessive absorption of lidocaine into the bloodstream, symptoms may include CNS effects (such as convulsions, unconsciousness and possibly respiratory arrest) and cardiovascular reactions (such as hypotension, myocardial depression, bradycardia and possibly cardiac arrest).

Treatment

Treatment of a patient suffering from systemic toxicity of lidocaine consists of arresting the convulsions and ensuring adequate ventilation with oxygen, if necessary by assisted or controlled ventilation (respiration). If convulsions occur, they must be treated promptly by intravenous injection of thiopentone (100 or 200 mg) or diazepam (5 to 10 mg). Alternatively, succinylcholine (50‑100 mg IV) may be used, providing the clinician is acceptable of performing endotracheal intubation and managing a fully paralysed patient. If ventricular fibrillation or cardiac arrest occurs, effective cardiavascular resuscitation must be instituted. Epinephrine in repeated doses and sodium bicarbonate should be given as rapidly as possible.

60 months.

Store below 25°C.

The disposable syringe is made of polypropylene with butyl rubber stopper and containing 6 or 11 ml of gel. The syringes are packed in boxes of 10 × 6/11 ml.

Not all pack sizes may be marketed.

The product is for single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The syringe and any unused gel should be disposed of in accordance with local requirements.