WARTICON Topical cream (2019)
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Περιεχόμενα
Name of the medicinal product
Warticon 0.15% w/w Cream.
Qualitative and quantitative composition
Podophyllotoxin 1.5 mg/g (0.15% w/w). Excipients with known effect: Methyl parahydroxybenzoate (E218) 0.100% w/w Propyl parahydroxybenzoate (E216) 0.030% w/w Sorbic acid 0.120% w/w Stearyl alcohol 2.000% ...
Pharmaceutical form
Topical Cream. A homogenous white cream.
Therapeutic indications
<u>Route of administration:</u> Topical. For the topical treatment of condylomata acuminata affecting the penis or the external female genitalia.
Posology and method of administration
The affected area should be thoroughly washed with soap and water, and dried prior to application. Using a fingertip, the cream should be applied twice daily morning and evening (every 12 hours) for 3 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Open or bleeding wounds. Concomitant use with other podophyllotoxin containing preparations.
Special warnings and precautions for use
Where the area of treatment is greater than 4 cm², it is recommended that treatment takes place under the direct supervision of a healthcare professional. Avoid applying the cream to warts occurring on ...
Interaction with other medicinal products and other forms of interaction
None presently known.
Pregnancy and lactation
Pregnancy There are limited data from the use of podophyllotoxin in pregnant women. Although there is very limited systemic absorption from topically applied podophyllotoxin, antimitotic products such ...
Effects on ability to drive and use machines
None presently known.
Undesirable effects
The frequency of adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare ...
Overdose
While serious systemic effects have not been reported with the recommended dosage of topical podophyllotoxin, topical overdosage would be expected to increase systemic absorption of the drug and increase ...
Pharmacodynamic properties
Pharmaco-therapeutic group: Chemotherapeutics for topical use, Antivirals ATC code: D06BB Podophyllotoxin is a metaphase inhibitor in dividing cells binding to at least one binding site on tubulin. Binding ...
Pharmacokinetic properties
Systemic absorption of podophyllotoxin after topical application of 100 mg of 0.3% cream or 100 μL of 0.5% solution has been studied (extravaginally in 10 females, and within the preputial cavity in 10 ...
Preclinical safety data
Carcinogenesis/Mutagenesis Podophyllotoxin was not carcinogenic following dietary administration up to 0.3 mg/kg/day for 104 weeks in rats and 80 weeks in mice. Podophyllotoxin was not mutagenic in in ...
List of excipients
Purified water Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216 Sorbic acid Phosphoric acid Stearyl alcohol Cetyl alcohol Isopropyl myristate Paraffin, liquid Triglycerides, medium chain ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
A collapsible aluminium tube with imperforate nozzle membrane and internally coated with a protective lacquer. Tube cap of polyethylene with a spike on the upper end aimed to perforate the membrane when ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Phoenix Labs, Suite 12, Bunkilla Plaza, Bracetown Business Park, Clonee, County Meath, IRELAND
Marketing authorization number(s)
PL 35104/0023
Date of first authorization / renewal of the authorization
Date of first authorisation: 26<sup>th</sup> April 1999 Date of last renewal: 17<sup>th</sup> January 2010
Date of revision of the text
December 2019
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