XYLOPROCT Ointment (2016)
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Περιεχόμενα
1. Name of the medicinal product
Xyloproct 5%/0.275% Ointment.
2. Qualitative and quantitative composition
Composition for: 100 g: Lidocaine 5 g Hydrocortisone Acetate micro Ph. Eur. 0.275 g <u>Excipients with known effect:</u> Cetyl alcohol (7.4 g per 100 g of ointment) Stearyl alcohol (0.9 g per 100 g of ...
3. Pharmaceutical form
Ointment.
4.1. Therapeutic indications
Xyloproct rectal ointment is indicated in adults and children of all ages for the relief of symptoms such as anal and peri-anal pruritus, pain and inflammation associated with haemorrhoids, anal fissure, ...
4.2. Posology and method of administration
<u>Route of administration:</u> Topical. To be applied several times daily according to the severity of the condition. For intrarectal use, apply the ointment with the special applicator. Cleanse the applicator ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to local anaesthetics of the amide type. Use on atrophic skin. Xyloproct Ointment should not be used in patients ...
4.4. Special warnings and precautions for use
Xyloproct is intended for use for limited periods. Excessive dosage of lidocaine or short intervals between doses, may result in high plasma levels of lidocaine and serious adverse effects. Patients should ...
4.5. Interaction with other medicinal products and other forms of interaction
Lidocaine should be used with caution in patients receiving anti-arrhythmic drugs, local anaesthetics or agents structurally related to local anaesthetics, since the toxic effects of these compounds are ...
4.6. Fertility, pregnancy and lactation
Pregnancy Xyloproct should not be used during pregnancy unless considered essential by the physician. Breast-feeding Lidocaine and hydrocortisone acetate are excreted into breast milk, but at therapeutic ...
4.7. Effects on ability to drive and use machines
Xyloproct has minor influence on the ability to drive and use machines. Depending on the dose local anaesthetics may have a very mild effect on mental function and coordination even in the absence of overt ...
4.8. Undesirable effects
Contact sensitivity to lidocaine has been reported after perianal use. Contact sensitivity may also occur after the use of topical hydrocortisone. In extremely rare cases amide-type local anaesthetic preparations ...
4.9. Overdose
Systemic absorption of lidocaine may occur from the rectum. When using the special applicator care should be taken to avoid instillation of excessive amounts of Xyloproct Ointment into the rectum. Lidocaine ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Hydrocortisone <b>ATC code:</b> C05AA01 Lidocaine exerts a local anaesthetic effect by stabilising the neural membrane and preventing the initiation and conduction of ...
5.2. Pharmacokinetic properties
The onset of action of lidocaine is 3-5 minutes on mucous membranes. Lidocaine can be absorbed following application to mucous membranes with metabolism taking place in the liver. Metabolites and unchanged ...
5.3. Preclinical safety data
Lidocaine and hydrocortisone acetate are well established active ingredients. In animal studies the toxicity noted after high doses of lidocaine consisted of effects on the central nervous and cardiovascular ...
6.1. List of excipients
Zinc oxide Aluminium acetate Stearyl alcohol Cetyl alcohol Water purified Macrogol (3350 and 400)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years when stored between 2°C and 8°C. 2 months when stored below 25°C.
6.4. Special precautions for storage
Store in a refrigerator (2°C-8°C). The patient may store the product at temperatures below 25°C for 2 months whilst in use. The remaining ointment should then be discarded.
6.5. Nature and contents of container
Aluminium tube 20 g.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PL 39699/0087
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 22 February 1972 Date of latest renewal: 03 April 2003
10. Date of revision of the text
November 2016
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