Gialgan Phidia (Hyalgan Fidia)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceHyaluronic acidHyaluronic acid
Similar drugsTo uncover
  • Gialgan Phidia
    solution in / Sust. 
    Phidia Pharmacyutzi SpA     Italy
    • Dosage form: & nbspsolution for intraarticular administration
    Composition:

    Each 2 ml of the preparation contains:

    active ingredient: sodium hyaluronate 20 mg;

    inactive ingredients: sodium chloride 17 mg, disodium hydrogen phosphate dodecahydrate 1.2 mg, sodium dihydrogen phosphate dihydrate 0.1 mg, water for injection up to 2 ml.

    Description:Colorless, clear viscous solution.
    Pharmacotherapeutic group:Reparation of tissue stimulant
    ATX: & nbsp

    M.09.A.X.01   Hyaluronic acid

    Pharmacodynamics:

    Gialgan Phidia is a sterile, pyrogen-free, viscous buffered aqueous solution of high-purity sodium hyaluronic acid fraction with a molecular weight of 500 to 730 kDaltons.

    Hyaluronic acid is a necessary component of the extracellular matrix, present in high concentrations in the articular cartilage and synovial fluid. Endogenous hyaluronic acid provides the viscosity and elasticity of the synovial fluid, and it is also necessary for the formation of proteoglycans in the articular cartilage. With osteoarthritis deficiency and qualitative changes of hyaluronic acid are noted in the synovial fluid and cartilage.Intra-articular introduction of hyaluronic acid against the background of degenerative changes in the surface of synovial cartilage and the pathology of synovial fluid leads to an improvement in the functional state of the joint.

    With the use of Gialgan Phidias, the clinical course of osteoarthritis has been improved for 6 months from the moment of treatment, anti-inflammatory and analgesic effect is observed.

    Pharmacokinetics:
    The sodium salt of hyaluronic acid with intra-articular administration is eliminated from the synovial fluid within 2-3 days. Pharmacokinetic studies have shown a rapid distribution of the substance in the synovial membrane. Highest concentrations of labeled hyaluronic acid acids are found in the synovial fluid and articular capsule, in a lower concentration - in the synovial membrane, ligaments and adjacent muscles. Hyaluronic acid in the synovial fluid is not subjected to significant metabolic changes. In experimental models, the main metabolism occurs in the periarticular tissues and liver, excretion is mainly carried out by the kidneys.
    Indications:

    To relieve pain and improve the mobility of synovial joints, with osteoarthritis and post-traumatic changes.

    As an aid in orthopedic surgery.

    Contraindications:

    Do not prescribe to patients with established hypersensitivity to the components of the drug or avian proteins, as well as severe liver disease.

    The administration of the drug is contraindicated in the presence of infection or damage to the skin in the area of ​​injection.

    Do not use during pregnancy, during feeding and in children due to lack of clinical data.

    Pregnancy and lactation:

    Do not use during pregnancy, during the period of feeding because of the lack of clinical data.

    Dosing and Administration:

    Intra-articular. In the knee and hip joints, the contents of one vial (20 mg / 2 ml) or a filled syringe (20 mg / 2 ml) should be administered once a week, with a course of five injections according to the standard procedure.

    Method of administration

    Before the introduction of Gialgan, Phidias should remove the effusion from the joint bag. Enter the drug should be exactly in the joint cavity by standard methods, taking into account anatomical features.To remove effusion and administer the drug, the same needle can be used, once injected before aspiration. In this syringe with the drug is attached to the needle, freed from the syringe with aspirated liquid. To confirm the location of the needle in the joint cavity, an available amount of synovial fluid should be aspirated before slow administration of the drug. Follow the rules of asepsis and antiseptics during the procedure. The introduction of the drug into the joint cavity should be stopped when pain occurs during the injection. Avoid getting air into the syringe with the drug. Unused until the end of the drug is not subject to storage.

    Side effects:
    Perhaps a rare occurrence of mild transient morbidity, edema, increased exudate content in the joint cavity, fever and redness in the area of ​​injection. The above symptoms are transient and usually disappear after 24 hours. If these symptoms occur, it is recommended to relieve the affected joint and apply ice.

    Single cases of allergic reactions (pruritus, rash, urticaria) and anaphylactic reactions to the drug have been noted.

    Overdose:

    There have been no cases of overdose.

    Interaction:

    Gialgan Phidia should not be administered concomitantly with other intra-articular injections, due to the lack of significant experience.

    Do not use disinfectants containing quaternary ammonium salts, since hyaluronic acid precipitated in the presence of these substances.

    Special instructions:

    During the first two days after the procedure, it is recommended not to overload the joint, especially prolonged activity should be avoided.

    When receiving the aspiration fluid before the introduction of the drug should be carried out appropriate studies to exclude the bacterial etiology of arthritis.

    Effect on the ability to drive transp. cf. and fur:

    Gialgan Fidia does not affect the ability of a person to drive motor vehicles, engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Solution for intraarticular administration, 10 mg / ml.
    Packaging:

    Bottles: on 2 ml in bottles from colorless borosilicate glass type I, ukuporennye rubber stoppers,lacquered aluminum caps and removable plastic seals.

    1 or 5 bottles with instructions for use are placed in a cardboard box.

    Syringes: 2 ml in sterile syringes from colorless borosilicate glass type I, with rubber stoppers. Polypropylene pistons are fixed on syringes. The syringes are equipped with luer-tip to protect the needle and restrictors for the return stroke of the syringe ("finger rest").

    1 or 5 syringes, each of which are placed in a contour mesh box made of PVC and paper, are placed in a cardboard box with instructions for use.

    Storage conditions:

    At a temperature of no higher than 25 ° C, in a place protected from light.

    Do not freeze.

    Do not use Gialgan Phidia with damaged or opened packaging.

    Keep out of the reach of children.
    Shelf life:

    3 years when stored in the original packaging.

    Do not use after the expiration date indicated.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006134/08
    Date of registration:01.08.2008 / 01.07.2009
    Expiration Date:Unlimited
    The owner of the registration certificate: Phidia Pharmacyutzi SpA Phidia Pharmacyutzi SpA Italy
    Manufacturer: & nbsp
    Information update date: & nbsp03.04.2017
    Illustrated instructions
      Instructions
      Up