TINADERM Cream (2015)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Tinaderm Cream 1% w/w.
2. Qualitative and quantitative composition
Tolnaftate 1.0% w/w. <u>Excipients:</u> Also includes Chlorocresol 0.1%w/w, cetostearyl alcohol 7.2% w/w and Butylated hydroxytoluene (E321) 0.002% w/w. For a full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Cream. A smooth homogeneous white cream.
4.1. Therapeutic indications
Tinaderm is recommended in the topical treatment of Tinea pedia, Tinea crurus, Tinea corporis, tinea manuum, due to infection with Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, ...
4.2. Posology and method of administration
The cream should be applied topically to the affected area twice a day. When treating Athletes Foot, the feet should be thoroughly washed and dried before applying the cream. Symptomatic relief is usually ...
4.3. Contraindications
Use in patients hypersensitive to the ingredients.
4.4. Special warnings and precautions for use
Tinaderm Cream 1% is for external use only. This product should be kept away from the eyes and mucous membranes. In mixed infections supplementary anti-infective therapy is indicated. If there is no response ...
4.5. Interaction with other medicinal products and other forms of interaction
None Known.
4.6. Fertility, pregnancy and lactation
There is no evidence of safety of the drug in human pregnancy or during lactation, but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed during pregnancy, ...
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
Skin reactions occur rarely with tolnaftate and include irritation and contact dermatitis. If this occurs treatment should be stopped and referral made to GP. Reporting of suspected adverse reactions ...
4.9. Overdose
Not applicable.
5.1. Pharmacodynamic properties
<b>ATC code:</b> D01AE18 Tolnaftate is an effective fungicidal agent against cutaneous fungal infections.
5.2. Pharmacokinetic properties
As tolnaftate is applied topically, these data are not applicable.
5.3. Preclinical safety data
There is no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SmPC.
6.1. List of excipients
Chlorocresol Sodium Dihydrogen Phosphate Dihydrate White Soft Paraffin Macrogol cetostearyl Ether Cetostearyl Alcohol Paraffin Liquid Butylhydroxytoluene (E321) Phosphoric acid Sodium Hydroxide Purified ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Epoxy lined aluminium tubes with polyethylene caps containing 15 g.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland
8. Marketing authorization number(s)
PA1410/080/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 July 1983 Date of last renewal: 21 April 2007
10. Date of revision of the text
April 2015
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
