DALACIN T Topical solution (2017)
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Περιεχόμενα
Name of the medicinal product
Dalacin T Topical Solution.
Qualitative and quantitative composition
One ml of Dalacin T Topical Solution contains the equivalent of 10 mg Clindamycin. Excipients with known effect: Propylene glycol 50 mg/ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Topical solution. Clear colourless aqueous solution.
Therapeutic indications
Dalacin T Topical Solution is indicated in the treatment of acne vulgaris.
Posology and method of administration
Apply a thin film of Dalacin T Topical Solution twice daily to the affected area. Shake well before use.
Contraindications
Topical clindamycin is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin or to any of the excipients listed in section 6.1. Clindamycin topical is contraindicated ...
Special warnings and precautions for use
Products containing benzoyl peroxide should not be used concurrently with Dalacin T Topical Solution. Oral and parenteral clindamycin, as well as most other antibiotics, have been associated with severe ...
Interaction with other medicinal products and other forms of interaction
Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving ...
Pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies in pregnant women during the first trimester. A moderate amount of data from clinical trials in pregnant women (between 300-1000 pregnancy outcomes) ...
Effects on ability to drive and use machines
The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.
Undesirable effects
The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. The frequency grouping is defined using the ...
Overdose
Topically applied clindamycin can be absorbed in sufficient amounts to produce systemic effects. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-infectives for treatment of acne ATC Code: DA10AF01 Mechanism of action Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis. It binds to the ...
Pharmacokinetic properties
Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are ...
Preclinical safety data
Impairment of fertility Fertility studies in rats treated orally with up to 300 mg/kg/day (72-fold the human exposure based on mg/m²) revealed no effects on fertility or mating ability. Pregnancy In oral ...
List of excipients
Isopropyl alcohol Propylene glycol Purified water Hydrochloric acid (10%) Sodium hydroxide (10%)
Incompatibilities
Not applicable.
Shelf life
24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Bottle: White high density polyethylene bottle containing 30 ml, 50 ml or 60 ml. Cap: Prolypropylene, linerless screw caps or Polypropylene screw caps lined with laminated films consisting of polyethylene, ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0962
Date of first authorization / renewal of the authorization
Date of first authorisation: 18<sup>th</sup> January 1988 Date of latest renewal of authorisation: 7<sup>th</sup> August 2009
Date of revision of the text
03/2017
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