Метвикс

General characteristics. Structure:

Active agent: метиламинолевулинат a hydrochloride - 200 mg (that corresponds to 160 mg of a metilaminolevulinat).

Excipients: glyceryl monostearate - 60 mg, cetostearyl alcohol - 40 mg, a macrogoal stearate - 30 mg, methylparahydroxybenzoate (Е 218) - 2 mg, пропилпарагидроксибензоат (Е 216) - 1 mg, dinatrium эдетат - 10 mg, глицерол - 60 mg, white soft paraffin - 70 mg, cholesterol - 10 mg, isopropyl myristate - 40 mg, a peanut oil - 30 mg, almonds oil - 20 mg, oleyl alcohol - 10 mg, the water purified - 417 mg.

Pharmacological properties:

Pharmacodynamics. After outside drawing a metilaminolevulinat in cells of the processed sites of the affected skin pro-active porphyrines collect. Intracellular pro-active porphyrines (including PpIX) are photoactive, fluorescent connections. After activation by light in the presence of oxygen, as a result of interaction with pro-active porphyrines oxygen passes into a singlet state, forming "singlet" oxygen which causes damage of components of a cell, in particular mitochondrions. Light activation of the accumulated pro-active porphyrines leads to photochemical reaction and, thus, to phototoxicity for the target cells irradiated with light. Pharmacokinetics
In the researches in vitro absorption of a radioactive metilaminolevulinat through skin was studied. In 24 hours after processing average total dermal absorption of the person made 0,26% of the put dose. In skin the depot of a metilaminolevulinat containing 4,9% of a dose forms.
It is shown that after processing of skin of the person Metviks® cream pro-active porphyrines collect in affected areas more than on sites of healthy skin. After putting cream for 3 hours and the subsequent lighting full photodecolouration happens incoherent light to the wavelength of 570-670 nanometers at a total dose of light of 75 J/cm, and the content of pro-active porphyrines is returned to initial value before processing of Metviksom®.

Indications to use:

- Thin layer or not pigmented and not being hyper keratinized a beam keratosis of the person and a pilar part of the head in cases when other methods are recognized as less reasonable.
- The superficial and/or nodular basal cell carcinoma of skin which is not subject to treatment by other methods because of the possible complications caused by treatment, and also because of unsatisfactory cosmetic effect, for example, at localization of defeats on a face and ears, on the skin which is strongly injured by the sun and also at extensive or recurrent defeats.
- An intra epidermal planocellular carcinoma cutaneum (planocellular cancer of in situ, Bowen's disease) when surgical treatment is recognized as less reasonable.

Route of administration and doses:

Outwardly.
Adults (including elderly people)
For treatment of the beam keratoz (BK) it is necessary to hold one session of photodynamic therapy. In three months after the session it is necessary to estimate results of treatment and if necessary to hold the second session.
For treatment of a basal cell carcinoma of skin (BKR) and Bowen's disease it is necessary to hold two sessions with 1 weeks interval between them.
Before treatment each center of defeat on skin has to be processed - it is necessary to remove all scales and crusts and to roughen a surface skin. At nodular defeats of BKR delete a layer of intact epidermis. The tumor periblast is carefully excised, without overstepping its bounds.
Then it is necessary to apply the Metviks® cream layer (thickness about 1 mm) on an affected area and surrounding 5-10 mm of healthy skin by means of the pallet and to cover the processed site with an occlusive bandage for 3 hours.
In 3 hours to remove a bandage, to clear the processed site of 0,9% solution of sodium of chloride and to immediately irradiate it with red light with a continuous spectrum of 570-670 nanometers that a total dose of the light radiation received by a surface of struck
the site made 75 J / see. It is possible to use the red light with narrower range providing the same activation of the accumulated pro-active porphyrines. 200 MW / should not exceed intensity of light impact on a surface of an affected area see.
It is necessary to use only the lamps with marking of "SE" supplied with necessary filters and/or the reflecting mirrors to minimize influence of heat, blue light and Uv-radiation. It is important to provide purpose of an appropriate exposure dose. The exposure dose is defined by a number of factors, including the size of the light field, distance between a lamp and the surface of skin and duration of radiation. These factors depend on lamp type therefore lamps should be used according to the corresponding instruction for use of a lamp. Whenever possible it is necessary to control a lighting dose by means of the suitable detector.
The patient and the operator have to observe the safety rule attached to a light source. For the period of the radiation session the operator and the patient have to put on the special glasses providing protection according to a lamp radiation spectrum.
During the session there is no need to protect the healthy, raw part of skin surrounding affected areas from radiation.
During one medical session it is possible to carry out processing of several centers of defeat.
The response to treatment should be estimated in 3 months after processing. At treatment of BKR and Bowen's disease it is recommended to confirm reaction to treatment by means of a biopsy and the subsequent histologic research. During such assessment affected areas with the incomplete response to treatment can be processed repeatedly (at will). In the subsequent long-term clinical observation with carrying out, in case of need, the histologic analysis is recommended.

Features of use:

It is necessary to appoint only in the presence of the doctor, the nurse or other health workers trained to carry out photodynamic therapy by Metviks® cream.
It is not necessary to apply treatment cream of the dense (hyper keratinized) beam keratosis.
There is no experience of treatment by Metviks® cream of the pigmented defeats, defeats with high extent of infiltration or located on genitalias, and also Bowen's diseases with a size of centers more than 40 mm. As well as at treatment of a disease of Bowen with cryotherapy use also ftoruratsit, the frequency of answers at the large centers (> 20 mm in the diameter) is lower, than at treatment of the centers of the small size. There is no experience of treatment of a disease of Bowen at the patients who transferred transplantation and receiving immunosuppressive therapy and also at patients is after exposure by arsenic. At contact with skin метиламинолевулинат can cause the sensitization leading to a Quincke's disease, developing of eczema and contact dermatitis in the field of putting cream. Excipients cetostearyl alcohol and a peanut oil in rare instances can cause local skin reactions (for example, contact dermatitis); methyl - and a propilparagidroksibenzoata (E218, E216) allergic reactions can cause (perhaps, the slowed-down type).
It is necessary to cancel any forms of therapy by UF-light before an initiation of treatment.
To avoid solar radiation of the processed affected areas and surrounding sites of skin within several days after putting cream.
Within 3 hours between putting Metviks® cream and radiation sensitivity of the processed site to action of light radiation increases (photosensitization). If in 3 hours after putting Metviks® cream the patient for any reasons cannot undergo radiation, the processed site it is necessary to clear 0,9% chloride sodium solution. The processed site should be protected from solar radiation and very bright light indoors (for example, operating and viewing medical lamps) within not less than 48 hours.

Side effects:

Interaction with other medicines:

Medicinal interactions are not known.
There is a probability that simultaneous use of other means with the photosensitizing action can strengthen a photosensitization at treatment by cream of Metviks.

Contraindications:

Hypersensitivity to drug components. Sklerodermopodobny basal cell carcinoma of skin. Porphyria.
Allergic reactions to peanut butter.

Experience of use for children: It is not recommended as experience of treatment of children is younger than 18 years is absent.

With care. It is necessary to avoid direct hit of Metviks® cream in eyes.

Pregnancy and period of a lactation:
Pregnancy. Clinical data on use of a metilaminolevulinat during pregnancy are absent therefore it is not recommended to apply cream during pregnancy.

Lactation. It is unknown what quantity of a metilaminolevulinat gets to breast milk after external use of cream. For lack of clinical experience breastfeeding should be cancelled for 48 hours after putting cream.

Overdose:

In case of more long influence of cream or use of light of much higher intensity pain, an erythema and a burning sensation can amplify.

Storage conditions:

At a temperature from 2 to 8 °C. To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Cream for external use of 16% on 2,0 g in the aluminum tuba covered outside with white enamel, inside - grade epoxy for foodstuff. The end of a tuba is closed by an aluminum membrane and the screwing-up cap with a punch. On 1 tuba together with the application instruction in a cardboard pack.