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Gialurom Tendon 40 mg / 2 ml 1’s solution for introduction into the tendon and okolosuhozhilnoe space in the syringe

$192.50

804570b37525

Description

The name of a product of medical purpose
Gialury Tendon, solution for introduction to a sinew and near-tendinous space of 40 mg / 2 ml, the prefilled syringe of 2 ml,

the No. 1 Structure and the description
of the product The Prefilled Syringe with solution for introduction to a sinew and near-tendinous space of 2 ml, No. 1.
2 ml of solution contain sodium hyaluronate of 40 mg, sodium chloride of 14 mg, sodium dihydrophosphate monohydrate of 0.11 mg, sodium hydrophosphate dodecahydrate of 1.22 mg, Mannitolum of 10 mg, 1M hydroxide sodium solution / 1M acid chlorohydrogen to pH 7.2-7.5 and water for injections to 2 ml.

Sterilization by damp heat.

Gialury Tendon is transparent viscous colourless solution.

Gialury Tendon is issued in the form of the prefilled syringe from colourless glass of the first hydrolytic class siliconized, equipped with an elastomeric cap, a rod of the piston and the flange for management which contains not less than 2 ml of sterile solution.
On each prefilled syringe paste the label.
On 1 prefilled syringe place in strip packaging from polyvinylchloride and polyethylene, with a covering from an unmarked polyethylene transparent film. On 1 strip packaging together with the instruction for medical use in the state and Russian languages in a folding cardboard box.

Name and (or) trademark
of the Rompharm Company manufacturing organization of S.R. L.

A scope
For treatment of pains and limited mobility in various diseases of sinews.
A sinew – the formation of connective tissue with fibrous structure intended for attachment of striated muscles to bones of a skeleton, transfer of muscular effort to a bone and load distribution during muscular contraction. Sinews can adjoin to fibrous structures, synovial membranes, perisukhozhilny fabrics, synovial bags. The overload or an inappropriate biomechanical stress can lead to inflammatory changes and/or degenerative changes of a sinew that, in turn, is the reason of appearance of pain and loss of function. Greasing of a sinew can reduce pain, improve its function and reduce risk of formation of commissures.
Gialury Tendon supports normal sliding of a sinew and physiological process of a reparation thanks to its greasing and viscoelastic properties. Besides, Gialury Tendon reduces free passing of inflammatory cells and molecules thanks to the macromolecular network.
Gialury Tendon – the transparent solution of sodium hyaluronate of high extent of cleaning received by fermentation, which is not containing animal protein.
Mannitolum which helps stabilization of chains of sodium hyaluronate due to neutralization of free radicals is Gialurom’s part of Tendon.

The route of administration
Gialury Tendon has to be entered only by the doctors taught technique of introduction to near-tendinous space or in a sinew.
Gialury Tendon enter into the area of the affected sinew or into a sinew once a week, the course makes 2 injections. It is at the same time possible to treat several sinews. As required repeated courses of treatment can be applied.
Contents of the syringe Gialurom Tendon are sterile.
Remove the ready syringe from sterile strip plastic packaging, turn off a protective cap, attach a needle of the suitable size (for example, 25-27 G) and record easy rotation. Before introduction it is necessary to remove vials of air if they are present.

The data necessary for the user for identification of a product of medical purpose
– a stroke the code on secondary packing
Completeness

No.

Components

the manufacturing Organization (manufacturer)

the Country

1

Prefilled syringe from 2 ml of solution for introduction to a sinew and near-tendinous space, No. 1.
2 ml of solution contain sodium hyaluronate of 40 mg, sodium chloride of 14 mg, sodium dihydrophosphate monohydrate of 0.11 mg, sodium hydrophosphate dodecahydrate of 1.22 mg, Mannitolum of 10 mg, 1M hydroxide sodium solution / 1M acid chlorohydrogen to pH 7.2-7.5 and water for injections to 2 ml.

The syringe with a capacity of 3 ml consists from:
The syringe body from the colourless

Piston Rod glass of the piston
the Flange for management

of BD Medical Pharmaceutical Systems

France

Storage conditions
At a temperature not higher than 25 of 0C, in original packing.
To store out of children’s reach!

3 years
not to apply an expiration date after expiry date.

It is necessary to check expiry date of the validity and integrity of the package before use.
Not to use after the expiry date specified on packing or if packing is damaged.
The used syringes have to be destroyed after each injection and should not be used for other injection.

The Rompharm Company manufacturing organization
S.R. L. Eroilor No. 1A St., Otopen, Romania

the Name of the normative document
the Specification on a product of medical purpose Gialury Tendon, solution for introduction to a sinew and near-tendinous space of 40 mg / 2 ml, the prefilled syringe of 2 ml, No. 1

Side effect
After introduction Gialury Tendon is possible emergence of local reactions, such as pain, caumesthesia, bruise, reddening or swelling.

Contraindications for use

hypersensitivity (including hypersensitivity in the anamnesis) to the Gialurom Tendon components

children and teenagers

pregnant women and the feeding women

It is necessary to take Measures (safety) with care Gialury Tendon for treatment of patients with the known hypersensitivity to medicines.
It is necessary to observe general measures of precaution at an injection in near-tendinous space or in a sinew. Gialury Tendon it is necessary to enter precisely into a sinew or about a sinew, if necessary using diagnostic imaging.
It is necessary to avoid hit of a needle in blood vessels and nerves!
It is not necessary to use Gialury Tendon if the prefilled syringe or the blister packing are damaged. The solution which is not used right after packing opening has to be utilized. Otherwise, the sterility of solution is not guaranteed.
The drug is administered only if solution is transparent.

Now there is no information on incompatibility Gialury Tendon with other medicines applied to treatment of diseases of sinews.

Measures of first-aid treatment at misuse or collateral influence.
Patients with painful consequences after introduction Gialury Tendon should see a doctor immediately. If pain amplifies during introduction, the procedure has to be stopped.

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