DAJVONEKS

Active material: Calcipotriol
When ATH: D05AX02
CCF: The drug with antiproliferative activity for the treatment of psoriasis
ICD-10 codes (testimony): L40
When CSF: 29.13.01.01
Manufacturer: LEO PHARMACEUTICAL PRODUCTS (Denmark)

Pharmaceutical form, composition and packaging

Cream for external application uniform, white.

1 g
kalьcipotriola Gidran52.2 g,
equivalent calcipotriol50 g

Excipients: macrogol cetostearyl ether, cetostearyl alcohol, hloralilgeksamina chloride, disodium эdetat, sodium hydrogen phosphate, glycerol 85%, Liquid paraffin, White paraffin, Purified water.

30 g – aluminum tuba (1) – packs cardboard.
100 g – aluminum tuba (1) – packs cardboard.

Ointment for external application translucent, uniform, from white to white with a yellowish tint.

1 g
calcipotriol50 g

Excipients: disodium эdetat, sodium hydrogen phosphate, a-токоферол, Liquid paraffin, poliэtilenglikolya stearate, propylene glycol, White paraffin, Purified water.

30 g – aluminum tuba (1) – packs cardboard.
100 g – aluminum tuba (1) – packs cardboard.

The solution for outdoor applications clear, colorless, slightly viscous.

1 ml
kalьcipotriola Gidran52.2 g,
equivalent calcipotriol50 g

Excipients: hydroksypropyltsellyuloza, isopropanol, levomenthol, propylene glycol, sodium citrate, Purified water.

60 ml – plastic bottles (1) – packs cardboard.

 

Pharmacological action

Calcipotriol is a vitamin D analogue. It stimulates the morphological differentiation and suppresses proliferation of keratinocytes, that underlies its therapeutic effect for psoriasis.

Calcipotriol is a potent inhibitor of T-lymphocyte activation, I induced by interleukin.

Effect on calcium metabolism of calcipotriol in 100 times weaker, than with the hormonally active form of vitamin D3.

 

Pharmacokinetics

Transdermalynaya absorption kalytsipotriola sostavlyaet, depending on the applied dose, from 1% to 5%. Calcipotriol undergoes rapid biotransformation in the liver with the formation of pharmacologically inactive metabolites.

T1/2 very short.

 

Testimony

- Psoriasis vulgaris (incl. chronic psoriasis of the scalp).

 

Dosage regimen

Ointment

To Adult the maximum daily dose should not exceed 15 g, the maximum dose per week – no more 100 g. The ointment is applied in a thin layer to the affected skin 2 times / day. The therapeutic effect is usually observed through 1-2 weeks of treatment. The duration of treatment – no more 6-8 weeks.

To childrenolder 12 years the maximum dose per week must not exceed 75 g. The ointment is applied in a thin layer to the affected skin 2 times / day.

To children aged 6 to 12 years the maximum dose per week – no more 50 g. The ointment is applied in a thin layer to the affected skin 2 times / day.

Cream

To Adult the maximum daily dose should not exceed 15 g, the maximum dose per week – no more 100 g. The cream is applied in a thin layer to the affected skin 2 times / day. The therapeutic effect is observed after 1-2 weeks of treatment. The duration of treatment – no more 6-8 weeks.

Solution

To Adult The maximum total dose per week must not exceed 60 ml. A small amount of solution is applied to affected areas of the scalp 2 times / day (in the morning and in the evening).

 

Side effect

Dermatological reactions: the most common – local skin irritation; typical – erythema, and itching of the skin; untypical – dermatitis (incl. dermatitis, perioral skin and the application of the solution), exacerbation of psoriasis; very rare – giperpigmentatsiya, photosensitivity.

Metabolism: very rare – hypercalciuria, hypercalcemia.

Allergic reactions: in some cases – angioneurotic edema and swelling of the face (when using the drug in solution form).

 

Contraindications

- Diseases, accompanied by disturbance of calcium metabolism;

- Hypersensitivity to the drug.

FROM caution use in patients with hypercalcemia, hypercalciuria, hypervitaminosis D, nephrolithiasis, children in the appointment of a cream and solution (aged 6 years – the appointment of an ointment) due to lack of experience with; in patients over 65 years.

 

Pregnancy and lactation

Avoid the use of the drug during pregnancy and lactation. The safety of the drug during pregnancy and lactation has not been established. Unknown, whether it is allocated calcipotriol in breast milk.

 

Cautions

Before use, consult with your doctor.

Do not apply ointment, cream and a solution of the drug on the face.

In order to avoid contact of the product with the skin, hands should be washed thoroughly after each application of ointment, cream or solution.

Hypercalcemia develops in excess of the maximum dose of calcipotriol per week. When you remove the drug concentration of calcium in the blood quickly normalized.

In the case of the solution with an ointment or cream should be considered, that the total dose should not exceed calcipotriol 5 mg per week, corresponding 60 ml and 40 g ointment or cream, or 40 ml and 60 g ointment or cream (1 corresponds ml 1 g ointment or 1 g cream).

During treatment Dayvoneks® Doctors advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UV light only if the physician and patient consider, that the potential benefits outweigh the potential risks.

Effects on ability to drive vehicles and management mechanisms

Dajvoneks® It does not affect the ability to drive vehicles and management mechanisms.

 

Overdose

Symptoms: when using the drug in doses, exceeding recommended, may increase the concentration of calcium in blood.

Treatment: removal of the drug.

 

Drug Interactions

Dajvoneks® should not be used in conjunction with topical preparations, containing salicylic acid.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

Conditions and terms

The drug should be stored at temperatures above 25 ° C out of reach of children. Shelf life – 2 year.

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