Before diluting the preparation, the central part of the vial plug is treated with ethyl alcohol. The drug is dissolved by injecting into the vial 1-8 ml of 0.9% sodium chloride solution for injection by puncturing the plug with a sterile needle of 23 or 25 mm in length. Do not open the vial and remove the stopper. The drug solution is a clear, colorless liquid. The prepared injectable solution is injected with an insulin syringe with a non-removable needle, 0.27-0.29 mm in diameter. The position of the patient when injecting the drug into the muscles of the face - sitting on a chair, the back of the head is fixed.
Table 1. Concentrations of the preparation obtained by dilution of RELATOX® 50 U
| №№ pp | Volume of 0.9% solution of sodium chloride for injection, ml | The activity of the preparation (ED in 0.1 ml) |
| 1 | 1 | 5 |
| 2 | 2 | 2,5 |
| 3 | 2,5 | 2,0 |
| 4 | 4 | 1,25 |
Table 2. Concentrations of the preparation obtained by dilution of RELATOX® 100 U
| №№ pp | Volume of 0.9% solution of sodium chloride for injection, ml | The activity of the preparation (ED in 0.1 ml) |
| 1 | 2 | 5 |
| 2 | 4 | 2,5 |
| 3 | 5 | 2,0 |
| 4 | 8 | 1,25 |
Units of action of botulinum toxin in different preparations are not interchangeable.Recommended doses, expressed in units of action, for the drug PELATOKC® are different from those of other botulinum toxin preparations.
Doses, schemes and methods of administration of the drug in correcting facial wrinkles
Smoothing of interbrow wrinkles
In the process of formation, interbrowal wrinkles are involved m. corrugator supercilii (muscle, wrinkling eyebrow) and m. procerus (muscle of the proud).
To determine the injection site in order to eliminate inter-brow wrinkles, the patient is asked to frown, at that moment it is well palpated m. corrugator supercilii (the muscle wrinkling the eyebrow), and the point of the most pronounced muscular activity should be 0.5 cm up from the upper medial edge of the eyebrow. Similarly, markup on the other side is produced.
The needle is inserted into the abdomen, the direction of the needle - either at an angle of 45 ° from the front back, medially, or at an angle of 90 °. The depth of needle insertion is 7-10 mm. If the needle rests against the periosteum, it should be pulled 1 mm and then injected. The point of administration of the drug in m. procerus (muscle proud) is located in the center of the line connecting the medial edges of the eyebrows. Needle position - from front to back, depth of needle insertion - 2-3 mm.
At each marked point, RELATOX® is administered from 2.5 to 7.5 units, depending on the severity of wrinkles, age and sex. The total amount of the drug introduced into this area should not exceed 25 units.
The insertion points for smoothing interbrown wrinkles - withm. Fig. 1.
Smoothing of horizontal wrinkles in the forehead area
In the formation of horizontal wrinkles in the forehead region is involved m. epicranius (supracranial muscle). To smooth out frontal wrinkles, the patient is asked to raise his eyebrows and at the maximum of the amplitude, points with the most pronounced mimic activity are noted. To exclude ptosis of the eyebrow, the distance between the injection point and the upper edge of the eyebrow should be at least 2 cm. 5-10 points are used and in each enter from 1.25 ED to 2.5 units of the RELATOX® preparation (see Figure 2) .
With slightly pronounced wrinkles, 2.0-2.5 units are inserted into the middle of the frontal region of the right and left sides. If the patient wishes to save the movement of the tips of the eyebrows, the injection points can be placed V-shaped. If the patient has a very high forehead and folds are formed close under the hairline, you can additionally enter 1,25-2,5 ED at 2-3 points in parallel to the hair growth line.The total amount of the drug per given area should not exceed 20 units.
Smoothing wrinkles in the periorbital area
Wrinkles diverging radially around the eyes, the so-called "crow's feet", arise as a result of the activity of the circular muscle of the eye. To select a dose, the patient should be asked to laugh and at this time delineate the approximate boundaries of the skin area with the maximum number of folds.
To reduce the "crow's feet", several injections (2 to 4 on each side) must be made into the projection area m. orbicularis oculi (eye muscle circular) at a distance of not less than 1 cm from the outer corner of the eye, and also into the region of the lateral part of the lower eyelid in the places of maximum muscle activity (see Figure 3 - Points of reference to the periorbital region).
Calculation of the dose is based on the area of this surface at rest: at each point, 2.0-2.5 units of the drug is injected, diffusion from one point has a radius of 0.5-1.0 cm, therefore, the distance between injection points should be on average 1.0-2.0 see the maximum permissible amount of units entered into the periorbital region of not more than 25 units per side. In order not to violate the proportions of the face, it is necessary to carefully monitor the symmetry of the location of the insertion points.The drug in the field of "crow's feet" is not introduced very low, since it is possible to disrupt the symmetry of the corners of the mouth and the nasolabial fold due to the diffusion of the drug into the region m. zygomaticus major (the zygomatic muscle is large).
Smoothing wrinkles in the area of the back of the nose
In the presence of pronounced wrinkles in the region of the back of the nose, the drug is injected directly into the m. nasalis (nasal muscle) on each side of 2.5 units of the drug.
See Fig. 4 - Points of administration for smoothing the wrinkles of the back of the nose.
Smoothing wrinkles in the lower part of the face
- Wings of the nose. The drug is injected directly into the wing m. nasalis (nasal muscle) of 2.5 units on each side.
- Upper lip. Injections are made along the red rims of the upper lip directly into the wrinkles, directly from the edge by 2 mm, 1,25 units per point, the number of points from 4 to 6.
- The corners of the mouth. The drug is administered subcutaneously in an amount of 2.5 units directly into the m. depressor anguli oris (muscle that lowers the corner of the mouth).
- Chin. The drug is administered subcutaneously in an amount of 2.5 units directly into the m. mentalis (the muscle is chin).
Doses, regimens and route of administration of the drug in the treatment of blepharospasm
In the treatment of blepharospasm, the drug is injected superficially with an intramuscular syringe with a caliber 28-30 needle into the following points: twopoints on the upper eyelid, one point on the lateral half of the lower eyelid and one point at the lateral angle of the eye. At each point should be introduced 2.5-5.0 units. The average initial dose is 15-25 units per side.
See Fig. 5.6 - Points of administration for blepharospasm.
The maximum permissible amount of units introduced into the periorbital region is not more than 25 units per side.
The pronounced clinical effect from the administration of the drug is manifested in the interval from 2 to 14 days after the injection, depending on the individual characteristics of the organism, and lasts for 4-6 months.
If the first procedure is ineffective in any of the above described treatments, i. E. absence of significant clinical improvement in comparison with the baseline condition 1 month after drug administration:
- clinical confirmation of the toxin action on the injected muscle (muscle), which may include electromigraphic (EMG) research performed by an experienced specialist in a specialized department;
- Analysis of the reasons for the ineffectiveness of the procedure, for example; inadequate choice of injection points, insufficient dose, incorrect injection technique, signs of fixed contracture, weakness, antagonist muscles, formation of neutralizing antibody toxin;
- reassessment of the feasibility of treatment with botulinum toxin type A;
- in the absence of any undesirable effects associated with the first administration of the drug, the following conditions must be observed in the repeated procedure: correction of the dose, taking into account the reasons for the ineffectiveness of the previous procedure; EMG-control; the interval between the procedures should be at least 3 months.
If there is no effect from the introduction of the drug or a decrease in its severity after repeated injections, other methods of treatment should be recommended.