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SPC: ALDARA Cream (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ALDARA 5% cream.

Qualitative and quantitative composition

Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5%). 100 mg of cream contains 5 mg of imiquimod. Excipients with known effects: Methyl hydroxybenzoate (E218) 2.0 mg/g cream Propyl hydroxybenzoate ...

Pharmaceutical form

Cream. White to slightly yellow cream.

Therapeutic indications

Imiquimod cream is indicated for the topical treatment of: External genital and perianal warts (condylomata acuminata) in adults. Small superficial basal cell carcinomas (sBCCs) in adults. Clinically typical, ...

Posology and method of administration

Posology The application frequency and duration of treatment with imiquimod cream is different for each indication. External genital warts in adults Imiquimod cream should be applied 3 times per week (example: ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

External genital warts, superficial basal cell carcinoma and actinic keratosis Avoid contact with the eyes, lips and nostrils. Imiquimod has the potential to exacerbate inflammatory conditions of the ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. This includes studies with immunosuppressive drugs. Interactions with systemic drugs would be limited by the minimal percutaneous absorption of imiquimod cream. ...

Fertility, pregnancy and lactation

Pregnancy For imiquimod no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...

Effects on ability to drive and use machines

Aldara cream has no or negligible influence on the ability to drive and use machines.

Undesirable effects

a) General Description External genital warts In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions judged to be probably or possibly related to imiquimod ...

Overdose

When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal percutaneous absorption. Studies in rabbits reveal a dermal lethal dose of greater than 5 g/kg. Persistent dermal ...

Pharmacodynamic properties

Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals ATC Code: D06BB10 Imiquimod is an immune response modifier. Saturable binding studies suggest a membrane receptor for imiquimod ...

Pharmacokinetic properties

External genital warts, superficial basal cell carcinoma and actinic keratosis Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects. ...

Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity and teratogenicity. In a four-month rat dermal toxicity study, significantly decreased ...

List of excipients

Isostearic acid Benzyl alcohol Cetyl alcohol Stearyl alcohol White soft paraffin Polysorbate 60 Sorbitan stearate Glycerol Methyl hydroxybenzoate (E218) Propyl hydroxybenzoate (E216) Xanthan gum Purified ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 25°C. Sachets should not be re-used once opened.

Nature and contents of container

Boxes of 12 or 24 single-use polyester/aluminium foil sachets, containing 250 mg of cream. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Meda AB, Pipers väg 2A, 170 73, Solna, Sweden

Marketing authorization number(s)

EU/1/98/080/001-002

Date of first authorization / renewal of the authorization

Date of first authorisation: 18/09/1998 Date of last renewal: 03/09/2008

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