PROTOPIC 0.1% Ointment (2018)
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Περιεχόμενα
Name of the medicinal product
Protopic 0.1% ointment.
Qualitative and quantitative composition
1 g of Protopic 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%). Excipient with known effect: Butylhydroxytoluene (E321) 15 micrograms/g ointment. For the full list of excipients, ...
Pharmaceutical form
Ointment. A white to slightly yellowish ointment.
Therapeutic indications
Protopic 0.1% ointment is indicated in adults and adolescents (16 years of age and above). Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis ...
Posology and method of administration
Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment. ...
Contraindications
Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of ...
Interaction with other medicinal products and other forms of interaction
Formal topical drug interaction studies with tacrolimus ointment have not been conducted. Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions ...
Fertility, Pregnancy and lactation
Pregnancy There are no adequate data from the use of tacrolimus ointment in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3). The ...
Effects on ability to drive and use machines
Protopic ointment has no or negligible influence on the ability to drive and use machines.
Undesirable effects
In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application. Burning sensation and pruritus were very common, usually mild to ...
Overdose
Overdosage following topical administration is unlikely. If ingested, general supportive measures may be appropriate. These may include monitoring of vital signs and observation of clinical status. Due ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other dermatologicals ATC code: D11AH01 Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood. While ...
Pharmacokinetic properties
Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient. Absorption Data from healthy human subjects indicate ...
Preclinical safety data
Repeated dose toxicity and local tolerance Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and micropigs was associated with slight dermal changes such as ...
List of excipients
White soft paraffin Liquid paraffin Propylene carbonate White beeswax Hard paraffin Butylhydroxytoluene (E321) All-rac-α-tocopherol
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap. Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
LEO Pharma A/S, Industriparken 55 2750, Ballerup, Denmark
Marketing authorization number(s)
EU/1/02/201/003 EU/1/02/201/004 EU/1/02/201/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 February 2002 Date of latest renewal: 20 November 2006
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