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SPC: PROTOPIC 0.03% Ointment (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Protopic 0.03% ointment.

Qualitative and quantitative composition

1 g of Protopic 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%). 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 0.03% ointment is indicated in adults, adolescents and children from the age of 2 years. Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic ...

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

*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

No special requirements. 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/1/02/201/001 EU/1/02/201/002 EU/1/02/201/005

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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