CURATODERM Ointment (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Curatoderm 4μg/g Ointment.
Qualitative and quantitative composition
One gram of ointment contains 4μg/g of tacalcitol (4.17μg/g of tacalcitol monohydrate). Excipients with known effect: Butylhydroxytoluene (E321) contained in the excipient Paraffin, white soft. For the ...
Pharmaceutical form
Ointment.
Therapeutic indications
Curatoderm ointment is indicated for the treatment of psoriasis vulgaris in adults.
Posology and method of administration
Posology Adults and the Elderly Apply sparingly, once daily to the affected areas, preferably at bedtime. The amount applied should not exceed l0g of ointment/day. Ointment). Normally duration of treatment ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with hypercalcaemia or other known disorders of calcium metabolism.
Special warnings and precautions for use
At the doctors discretion, in patients at risk of hypercalcaemia, or patients taking high Vitamin D preparations (in excess of 500 IU vitamin D) albumin corrected serum calcium levels should be closely ...
Interaction with other medicinal products and other forms of interaction
No interactions are likely in patients using multivitamin preparations with up to 500 IU vitamin D. UVB radiation can be combined with Curatoderm Ointment. This approach increases the efficacy of the treatment ...
Pregnancy and lactation
Pregnancy The safety of this medicinal product for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The data given for frequency of adverse reactions is based on the following categories: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to 1/1,000) Very rare ...
Overdose
Overdosing by ingestion of an ointment is very unlikely. It cannot be excluded that topical application of excessive amounts may lead to hypercalcaemia. In this case Curatoderm treatment and other possible ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antipsoriatics for topical use ATC code: D05AX02 Tacalcitol is a vitamin D<sub>3</sub> derivative, which inhibits keratinocyte hyper-proliferation and induces differentiation ...
Pharmacokinetic properties
Single or repeated application of tacalcitol ointment in humans results in less than 0.5% of the drug being systemically absorbed through psoriatic skin. Tacalcitol is completely bound to plasma proteins ...
Preclinical safety data
Tacalcitol is effective in very low concentrations. The no-effect-level following cutaneous application over 12 months in rat studies amounted to only 4 ng/kg daily. Toxicity is focused to the classic ...
List of excipients
Paraffin White soft Liquid paraffin Diisopropyl adipate
Incompatibilities
None known.
Shelf life
Shelf life: 36 months at up to 30°C. 6 months after first opening the tube.
Special precautions for storage
None.
Nature and contents of container
Aluminium tubes with internal lacquer, membrane-sealed opening and plastic screw cap, containing 5g, 20g, 30g or 100g.
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
Almirall Hermal GmbH, Scholtzstrasse 3, D-21465, Reinbek, Germany
Marketing authorization number(s)
PL 33016/0012
Date of first authorization / renewal of the authorization
13<sup>th</sup> July 2006
Date of revision of the text
09/2019
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