Instillagel® 6 ml/11 ml

Active ingredient: Lidocaine hydrochloride 1 H2O, chlorhexidine bis (D-gluconate), methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate

Composition:

6 ml/11 ml gel contains	6 ml	11 ml
Lidocaine hydrochloride 1 H2O	125.40 mg	230.00 mg
Chlorhexidine bis D-gluconate	3.14 mg	5.75 mg
Methyl 4-hydroxybenzoate	3.76 mg	6.90 mg
Propyl 4-hydroxybenzoate	1.57 mg	2.87 mg

Other ingredients: Hyetellose, propylene glycol, sodium hydroxide, purified water

Indications: As a gel for disinfecting mucous membranes and for local anesthesia, e.g., during catheterization, probing, including intraoperative use, all forms of endoscopy, changing fistula catheters, intubation, also during ventilation, to prevent iatrogenic injuries to the rectum and colon.

Instillagel^® 6ml/11ml is suitable for use in adults and children aged 2 years or older.

Contraindications:

Instillagel^® 6 ml/11 ml must not be used:

• in case of known hypersensitivity to lidocaine and other local anesthetics of the amide type,
• in patients with significant disorders of the conduction system, – if there is hypersensitivity (allergy) to lidocaine hydrochloride 1 H₂O, chlorhexidine bis (D-gluconate), methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, or any of the other ingredients of this medicinal product.
• for children under 2 years of age.

Use during pregnancy and breastfeeding: Lidocaine should only be used in the first three months of pregnancy if absolutely necessary. It is not known whether lidocaine passes into breast milk, so breastfeeding should be discontinued for up to approx. 12 hours after administration.

Side effects:

• Not known: Despite the proven wide safety range of Instillagel^® 6 ml/11 ml, adverse systemic effects of the local anesthetic lidocaine, such as anaphylactic shock, drop in blood pressure, bradycardia, or seizures, are possible in the case of severe urethral injuries.
• In very rare cases, allergic reactions (in the most severe cases, anaphylactic shock) may occur to a local anesthetic of the amide type and/or to chlorhexidine.
• Very rare: Allergic reactions, including late reactions, to chlorhexidine and/or methyl or propyl 4-hydroxybenzoate.

Use in children: The systemic absorption of lidocaine may be increased in children, so caution is advised. As a rule, the maximum dose for children aged between 2 and 12 years should not exceed 2.9 mg lidocaine hydrochloride per kg body weight. This corresponds to 1.5 ml Instillagel 6ml/11ml per 10 kg body weight.

Warnings: Methyl and propyl 4-hydroxybenzoate may cause hypersensitivity reactions, including delayed reactions. Propylene glycol may cause skin irritation.

FARCO-PHARMA GmbH, Gereonsmühlengasse 1-11, 50670 Cologne, Germany