Hydroxyapatite

General characteristics. Structure:

Active ingredient: 1 g, 2 g, 5 g or 10 g of gel of a hydroxyapatite.

Pharmacological properties:

Pharmacodynamics. "Hydroxyapatite gel" - the medicine on the basis of a nanocrystal hydroxyapatite (phosphate calcium) intended for implantation in a bone tissue for the purpose of activation of osteoreparative processes.

Hydroxyapatite Gel medicine has the increased ability to be transformed in biological environments to calcium ions and phosphates that provides the best assimilation of the specified ions directly in "an interest zone" – a bone wound (a zone between fragments at changes, bone defect, a sequestral cavity, etc.).

Calcium reduces permeability of cellular membranes and a vascular wall, prevents development of inflammatory reactions. Calcium ions participate in transfer of nervous impulses, in fibrillation and other physiological processes.

"Hydroxyapatite gel" promotes optimization of healing of a bone wound, formation functionally and structurally full-fledged osteoregenerate as primary healing of a bone wound. Use of drug allows to reduce duration of the painful period at patients after operation and promotes the fastest elimination of hypostasis of soft tissues in this zone. Drug is most effective at treatment of not growing together changes and nearthroses of bones of extremities.

Pharmacokinetics. Special researches of parameters of pharmacokinetics of drug were not conducted in communication of c by low system availability of a hydroxyapatite. The hydroxyapatite is characterized by low solubility in biological environments and slow receipt of calcium ions on interstitial Wednesday and blood.

Indications to use:

Drug is used at patients preferential with disturbances of process of an osteoreparation (the slowed-down consolidation, not growing together change, a nearthrosis), use for patients with the fractures of bones of extremities demanding operational treatment as soon as possible after an injury is possible.

Route of administration and doses:

In traumatology and orthopedics:

- at the closed fractures of the long tubular bones demanding operational treatment (splintered changes, intra joint changes) - directly in a bone wound – once (by means of the syringe) for a break plane covering;

- at the complicated (open) fracture of a long tubular bone - directly in a bone wound in the volume adequate to mezhotlomkovy space (by means of the syringe);

- at complicated (opened with defect) a fracture of a long tubular bone (by means of the syringe) in 2-3 weeks in the absence of signs of a purulent complication, chreskozhno, the syringe, in the volume adequate to mezhotlomkovy space;

- at patients with the slowed-down consolidation of a fracture, not accrete fracture or a nearthrosis of long tubular bones during open reposition of fragments and an osteosynthesis - directly in a bone wound in the volume adequate to mezhotlomkovy space (by means of the syringe), during the closed osteosynthesis - in a mezhotlomkovy zone chreskozhno (by means of the syringe) under control of roentgenoscopy in the volume adequate to mezhotlomkovy space.

Use of drug is possible both is directly intraoperatsionno opened, and injektsionno in the next postoperative period (extra focal compression дистракционный an osteosynthesis) after stopping of the acute phenomena of an operational injury.

Drug is used in the following doses: at changes and disturbances of osteoregeneration of a femur – 2,0-3,0 ml, a tibial bone – 1,5-3,0 ml, bones of a forearm, a shoulder and a clavicle – 0,5-2,0 ml.

In stomatology:

- at the open (complicated) jawbone change – directly in a bone wound in the volume adequate to mezhotlomkovy space (by means of the syringe) during primary surgical treatment at the time of reposition and an immobilization of fragments. Repeatedly – in 1-2 weeks in the absence of signs of infection of the line of a change, chreskozhno, the syringe, under control of roentgenoscopy, in the volume adequate to mezhotlomkovy space;

- at formation of bone defects of jawbones after an ekskokhleation of high-quality new growths – directly in a bone wound in the volume adequate to bone defect (by means of the syringe or a dental gladilka) after processing of bone defect before mending of an operational wound;

- at formation of vertical bone defects in the field of an alveolus of a jawbone and the tooth which is in it when carrying out radical operations on periodontium fabrics – directly in bone defect in the volume adequate to defect (by means of the syringe or a dental gladilka) after removal from a bone pocket of pathological fabrics, processing of a bone pocket before mending of an operational wound;

- at chronic posttraumatic osteomyelitis of jaws after removal of sequesters in the conditions of an immobilization - directly in a sequestral cavity (a defect cavity) in the volume adequate to bone defect;

- at patients with the complicated splintered change, not accrete change or a nearthrosis of a jawbone during an open osteosynthesis - directly in a bone wound in the volume adequate to mezhotlomkovy space (by means of the syringe).

Features of use:

Safety of drug at use in pediatrics and at pregnancy is not established. So far there are no pharmacokinetic data on existence or lack of ability at active component of drug or its metabolites to get into breast milk. In this regard in need of use in the period of a lactation it is recommended to stop breastfeeding.

There are no data on a negative impact "Hydroxyapatite gel" on ability to manage vehicles and to be engaged in potentially dangerous types of activity requiring special attention and speed of psychomotor reactions.

Drug is produced sterile. Is not subject to repeated sterilization.

Side effects:

As a rule, drug is well transferred.

In rare instances development of the raised fabric reaction on site of implantation "Hydroxyapatite gel" (hypostasis, the hyperemia) caused by local surplus of calcium ions is possible. The specified reaction can be stopped by use of non-steroidal anti-inflammatory drugs, and if necessary - short-term use of glucocorticosteroids.

Interaction with other medicines:

The perversion or strengthening of effect of drugs which effect is exponentiated by surplus of calcium ions, including digitoxin and other cardiac glycosides, aritmogenny means is possible. These medicines for the short period after implantation of large numbers "Hydroxyapatite gel" can be cancelled or their doses are reduced.

Narcotic analgetics, non-steroidal anti-inflammatory drugs, antihistaminic drugs (дифенгидрамин), spasmolysants (a papaverine a hydrochloride), antibiotics (cefazolin, gentamycin, lincomycin a hydrochloride) can be applied along with "Hydroxyapatite gel".

Contraindications:

Hypercalcemia, hypercalcuria, pregnancy, feeding by a breast, individual intolerance of drug and its components.

Overdose:

Symptoms: at considerable exceeding of a dose of drug (2 g/kg of body weight) the development of system side effects connected with excess receipt in blood of soluble fraction of a hydroxyapatite is noted: general oppression (lethargy), weakness, increase in excitation thresholds of nervous and neuromuscular system, nausea, vomiting, polydipsia, polyuria.

Treatment: therapy of a giperkaltsiyemichesky syndrome.

Issue conditions:

According to the recipe

Packaging:

Gel for intra bone introduction in syringes for single application on 1,0; 2,0; 5,0; 10,0 g.