1. Name Of The Medicinal Product
Dermidex Dermatological Cream.
2. Qualitative And Quantitative Composition
Dermidex Dermatological Cream contains:
Lidocaine 1.20% w/w
Alcloxa 0.25% w/w
Chorobutanol 1.00% w/w
Cetrimide 0.50% w/w
For excipients, see 6.1
3. Pharmaceutical Form
Cream. A smooth white cream, free from lumps, non greasy with an even distribution of emulsion droplets.
4. Clinical Particulars
4.1 Therapeutic Indications
Antiseptic, anaesthetic, anti-irritant, and emollient agent. For the treatment of mild pain caused by minor skin cuts, scratches and grazes (chapping) and soreness caused by detergents, soaps, deodorants and jewellery and bites and stings.
4.2 Posology And Method Of Administration
Adults, Children (age 4 and above) and the Elderly:
Apply to the affected area every 3 hours
Not suitable for children aged less than 4 years.
Route of administration: Cream for cutaneous use.
4.3 Contraindications
Dermidex Cream is contraindicated where there is hypersensitivity to cetrimide, chlorobutanol, lidocaine or other local anaesthetics of the amide type, or any of the other ingredients.
4.4 Special Warnings And Precautions For Use
For external use only. Keep out of reach and sight of children.
The product should not be used for longer than 7 days without seeking medical advice.
Avoid contact with the eyes.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Lidocaine crosses the placenta and is distributed into breast milk. As with all medicines use with care.
4.7 Effects On Ability To Drive And Use Machines
No or negligible influence.
4.8 Undesirable Effects
Occasionally there have been reports of skin reaction with all such preparations.
4.9 Overdose
Overdose is unlikely.
Accidental ingestion may result in anaesthesia of the upper respiratory tract, nausea, vomiting and abdominal discomfort. Ingestion of very large quantities could result in CNS and cardiovascular toxicity. Treatment should be symptomatic and supportive.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Other dermatologicals D11A
Not applicable.
5.2 Pharmacokinetic Properties
Not applicable
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Cetyl Alcohol
Glyceryl Monostearate
Isopropyl Myristate
Light Liquid Paraffin
Purified Water
Phenoxyethanol
Sorbitol Solution
Stearyl Alcohol 1895
Perfume Sport 14412C
6.2 Incompatibilities
None known
6.3 Shelf Life
36 months unopened
6.4 Special Precautions For Storage
None
6.5 Nature And Contents Of Container
Lacquered covex tube with a low or medium density Polyethylene cap in a carton. Aluminium tubes with a Polyamide internal lacquer, a membrane nozzle fitted with a full skirted, spiked white Polyethylene cap in a carton.
Pack sizes: 3g, 4g, 5g, 7.5g, 10g, 30g & 50g.
6.6 Special Precautions For Disposal And Other Handling
For external use only.
7. Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland.
8. Marketing Authorisation Number(S)
PL 30306/0068
9. Date Of First Authorisation/Renewal Of The Authorisation
2 December 2002
10. Date Of Revision Of The Text
17/10/11
11 DOSIMETRY (IF APPLICABLE)
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not Applicable
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