INSTILLAGEL Gel (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Instillagel.
2. Qualitative and quantitative composition
One syringe of 6 ml gel contains: Lidocaine hydrochloride: 125.40 mg Chlorhexidine digluconate: 3.14 mg Methyl parahydroxybenzoate (E 218): 3.76 mg Propyl parahydroxybenzoate (E 216): 1.57 mg One syringe ...
3. Pharmaceutical form
Gel.
4.1. Therapeutic indications
Catheterisation, cystoscopy. Exploratory and intra-operative investigations, exchange of fistula catheters, protection against iatrogenic damage in the rectum and colon. For use during gynaecological investigation. ...
4.2. Posology and method of administration
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 ...
4.3. Contraindications
Instillagel is contraindicated in children under 2 years (see section 4.2). Instillagel must not be used in patients with known hypersensitivity to the active substances (amide-type anaesthetics, chlorhexidine ...
4.4. Special warnings and precautions for use
Products containing local anaesthetic should also be used with caution in patients with impaired cardiac conditions, hepatic insufficiency and in epileptics. Oropharyngeal use of Instillagel may cause ...
4.5. Interaction with other medicinal products and other forms of interaction
Lidocaine should be used with caution in patients receiving antiarrhythmic drugs.
4.6. Fertility, pregnancy and lactation
During the first three months of pregnancy, lidocaine should be used only if absolutely necessary. Since it is not known whether lidocaine passes into milk, breastfeeding should be suspended for 12 hours ...
4.7. Effects on ability to drive and use machines
The ability to drive and operate machinery may be slightly impaired after the use of Instillagel. If affected, patients should be advised not to drive or use machinery.
4.8. Undesirable effects
Undesirable effects are listed below by frequency convention and system organ class database. Frequencies are defined as: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare ...
4.9. Overdose
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anaesthetics, local <b>ATC code:</b> N01BB02 The anaesthetic ingredient of Instillagel is lidocaine, which stabilizes neuronal membranes and prevents initiation and conduction ...
5.2. Pharmacokinetic properties
After the products application to mucous membranes, lidocaine is absorbed, but its blood concentrations after the instillation of doses of up to 800mg into the urethra remain in the low range, below toxic ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
Hydroxyethylcellulose Sodium hydroxide Propylene glycol Purified water
6.2. Incompatibilities
None.
6.3. Shelf life
60 months.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
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.
6.6. Special precautions for disposal and other handling
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 ...
7. Marketing authorization holder
Farco-Pharma GmbH, Gereonsmühlengasse 1‑11, 50670 Köln, Germany, Tel: ++49 221 594061, Fax: ++49 221 593614
8. Marketing authorization number(s)
19988
9. Date of first authorization / renewal of the authorization
29th Dec. 2005
10. Date of revision of the text
17/07/2019
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