Mandatory text for non medical professionals —
Instillagel® 6 ml/11 ml
Composition:
| 6 ml/11 ml gel contains | 6 ml | 11 ml |
| Lidocaine hydrochloride 1 H2O | 125.40 mg | 230.00 mg |
|
Chlorhexidine digluconate |
3.14 mg | 5.75 mg |
| Methyl 4-hydroxybenzoate (Ph.Eur.) | 3.76 mg | 6.90 mg |
| Propyl 4-hydroxybenzoate (Ph.Eur.) | 1.57 mg | 2.87 mg |
Other ingredients: Hyetellose, propylene glycol, sodium hydroxide, purified water
Indications: As a gel for mucous membrane disinfection and for local anesthesia, e.g., during catheterization, probe insertion, including intra-operatively, all forms of endoscopy, fistula catheter replacement, intubation, including for ventilation, for the prevention of iatrogenic damage to the rectum and colon.
Instillagel® 6ml/11ml is suitable for use in adults and children aged 2 years and above.
For risks and side effects, read the package leaflet and ask your doctor or pharmacist.
Warnings: Methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate may trigger hypersensitivity reactions, including late reactions.
Propylene glycol may cause skin irritation.
FARCO-PHARMA GmbH, Cologne, Germany
Date 01/2025
Mandatory text for medical professionals —
Instillagel® 6 ml/11 ml
Composition:
| 6 ml/11 ml gel contains | 6 ml | 11 ml |
| Lidocaine hydrochloride 1 H2O | 125.40 mg | 230.00 mg |
|
Chlorhexidine digluconate |
3.14 mg | 5.75 mg |
| Methyl 4-hydroxybenzoate (Ph.Eur.) | 3.76 mg | 6.90 mg |
| Propyl 4-hydroxybenzoate (Ph.Eur.) | 1.57 mg | 2.87 mg |
Other ingredients: Hyetellose, propylene glycol, sodium hydroxide, purified water
Indications: As a gel for mucous membrane disinfection and for local anesthesia, e.g., during catheterization, probe insertion, including intra-operatively, all forms of endoscopy, fistula catheter replacement, intubation, including for ventilation, for the prevention of iatrogenic damage to the rectum and colon. Instillagel® 6 ml/11 ml is suitable for use in adults and children aged 2 years and above.
Contraindications:
Do not use Instillagel® 6 ml/11 ml:
- if you are allergic to lidocaine hydrochloride 1 H2O, chlorhexidine bis(D-gluconate), methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate or any of the other ingredients of this medicine listed in section 6,
- in case of known hypersensitivity to lidocaine and other
local anaesthetics of the amide type, - in patients with significant disorders of the conduction system,
- in children under 2 years of age.
Use in pregnancy and lactation: Lidocaine should not be used during the first three months of pregnancy unless absolutely necessary. It is unknown whether lidocaine is excreted in breast milk, for which reason breastfeeding should not take place for up to about 12 hours after administration.
Side effects:
- Not known: Corneal damage (damage to the surface of the eye) and permanent eye damage including permanent visual impairment (following accidental eye contact during head, face and neck surgery) in patients under general anaesthesia (deep painless sleep)
- Not known: in spite of the proven wide safety range of Instillagel® 6 ml/11 ml, systemic adverse effects of the local anesthetic lidocaine, such as anaphylactic shock, a fall in blood pressure, bradycardia or seizures, are possible in the case of severe urethral damage.
- Very rare: allergic reactions, including late reactions, due to chlorhexidine and/or methyl- or propyl-4-hydroxybenzoate.
- In very rare cases, allergic reactions (in the most serious cases, anaphylactic shock) to a local anesthetic of the amide type and/or to chlorhexidine may occur.
Use in children: The systemic absorption of lidocaine may be increased in children and caution is therefore required. In general, the maximum dose should not exceed 2.9 mg of lidocaine hydrochloride per kg of body weight in children between 2 and 12 years of age. This is equivalent to 1.5 ml of Instillagel 6 ml/11 ml per 10 kg of body weight.
Warning: Methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate may trigger hypersensitivity reactions, including late reactions. Propylene glycol may cause skin irritation.
FARCO-PHARMA GmbH, Cologne, Germany
Date 09/2024