BLISTEX COLD SORE Cream (2017)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | DDD Limited |
|---|---|
| Διεύθυνση | 94 Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ |
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
Name of the medicinal product
Blistex Cold Sore Cream (GSL).
Qualitative and quantitative composition
Each gram of cream contains 100 mg of docosanol. Excipient: 50 mg propylene glycol/gram cream. For a full list of excipients, see section 6.1.
Pharmaceutical form
Cream. White cream.
Therapeutic indications
Treatment of early stages (prodrome or erythema phase) of recurrent labial herpes simplex infection (cold sores) in immunocompetent adults.
Posology and method of administration
Route of Administration Cutaneous use. Posology Adults and adolescents aged 12 years and over Apply a thin film carefully over the entire cold sore 5 times a day (approximately every 3 hours during waking ...
Contraindications
Hypersensitivity to the active substance (docosanol) or to any of the excipients.
Special warnings and precautions for use
Avoid application close to or in the eyes. Should only be used for cold sores on the mouth and face. Must not be used to treat genital or ocular herpes infections Avoid transmitting the virus, particularly ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Therefore, Blistex Cold Sore Cream should not be used simultaneously with other topical medicinal products at the same application site.
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of docosanol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition ...
Effects on ability to drive and use machines
Due to its negligible absorption docosanol has no influence on the ability to drive and use machines.
Undesirable effects
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data). Results from clinical ...
Overdose
Adverse reactions related to overdose by topical application of Blistex Cold Sore Cream are unlikely because of negligible percutaneous absorption. Similarly, poor oral absorption makes the occurrence ...
Pharmacodynamic properties
Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals ATC code: D06BB11 The exact mechanism of the antiviral activity of docosanol is unknown. In vitro studies indicate that docosanol ...
Pharmacokinetic properties
Under conditions reflecting normal clinical use of Blistex Cold Sore Cream, docosanol could not be quantified (limit of quantification, LOQ = 10 ng/ml) in the plasma of treated patients. Ten women with ...
Preclinical safety data
Preclinical data revealed no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
List of excipients
Sucrose stearates (mono and distearate) Light mineral oil Propylene glycol (E1520) Benzyl alcohol (E1519) Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. After first opening the container: 6 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Epoxy-lined aluminium tubes closed with a polyethylene screw cap. Pack size: 2 g
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
DDD Limited, 94 Rickmansworth Road, Watford, Hertfordshire, WD18 7JJ
Marketing authorization number(s)
PL 00133/0236
Date of first authorization / renewal of the authorization
23/02/2017
Date of revision of the text
15/09/2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
