GIALGAN RANSOM

Active material: Hyaluronic acid
When ATH: M09AX01
CCF: Substitute of synovial fluid
ICD-10 codes (testimony): M15, M25.5
When CSF: 16.05.03
Manufacturer: HAS FARMACEUTICI S. p. A. (Italy)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Solution for intra-articular introduction colorless, clear, Coupling.

Excipients: sodium chloride, disodium dodekagidrat phosphate, sodium dihydrogen phosphate dihydrate, water d / and.

2 ml – colorless glass vials (1) – packs cardboard.
2 ml – colorless glass vials (5) – packs cardboard.

Solution for intra-articular introduction colorless, clear, Coupling.

Excipients: sodium chloride, disodium dodekagidrat phosphate, sodium dihydrogen phosphate dihydrate, water d / and.

2 ml – syringes of colorless glass (1) – packings Valium planimetric (1) – packs cardboard.
2 ml – syringes of colorless glass (1) – packings Valium planimetric (5) – packs cardboard.

Pharmacological action

Stimulator of reparative processes. Phidias is a sterile Gialgan, free, viscous buffer aqueous solution of sodium salt gialuronoj acid fractions high purity with a molecular weight of 500 to 730 kDal′ton. Hyaluronic acid – a necessary component of extracellular matrix, is present in high concentrations in the composition of the joint cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity of synovial fluid, as well as it is necessary for the formation of proteoglycans in articular cartilage.

Osteoartroze marked deficiency of qualitative changes of hyaluronic acid in composition of the synovial fluid and cartilage. Intra-articular hyaluronic acid on degenerative changes of the surface sinovial′nogo of cartilage and synovial fluid pathology improves the functional condition of the hip.

When applying Phidias Gialgana have improved the clinical course of osteoarthritis throughout 6 months after treatment, developing anti-inflammatory and analgeziruty effect.

Pharmacokinetics

Absorption and distribution

With the introduction of vnutrisustavnom sodium salt of hyaluronic acid netted from synovial fluid within 2-3 days. Pharmacokinetic studies have demonstrated rapid distribution of substances in the synovial membrane. C_max labeled hyaluronic acid found in synovial fluid and articular capsule, smaller concentrations – in the synovial membrane, ligaments and surrounding muscles.

Metabolism and excretion

Hyaluronic acid in composition of the synovial fluid is not subjected to significant metabolic changes. On experimental models the main metabolism occurs in periarticular tissues and liver, excretion is mainly kidneys.

Testimony

— for cupping pain and improve mobility of Synovial joints, When osteoarthritis and post-traumatic changes;

— as an adjuvant in orthopedic surgery.

Dosage regimen

The drug is intended for intra-articular introduction.

In the knee and hip joints, the drug is injected in a dose 20 mg 1 once a week (contents 1 bottle 20 mg/2 ml or syringe filled). The course consists of 3-5 injection.

Rules of administration

You must abide by the rules of aseptics and antiseptics when performing the procedure.

Before the introduction of Phidias Gialgana should remove effusion of joint bags. Enter the drug should be exactly in the joint cavity by standard methods, given the anatomical features. To remove the effusion and drug administration you can use one and the same needle, Once you've entered before aspiration. When the syringe with a drug should be attached to the needle, liberated from the fluid by syringe. To confirm the finding needles in the joint cavity should be aspirirovat′ an affordable amount of synovial fluid before the slow introduction of the drug. The introduction of the drug in the joint cavity should stop when you see the pain during injection.

Avoid getting air in the syringe with medication.

The remaining product in the syringe is not storage.

Side effect

Local reactions: rarely – moderate pain, edema, increase in the joint cavity exudates, fever and redness in the area of injection. These reactions are transitory in nature and usually go away after 24 no (If you experience these symptoms, we recommend that you offload the affected joint and apply ice).

Allergic reactions: in a few cases – itch, rash, hives, anaphylactic reactions.

Contraindications

- Severe liver disease;

-infection or damage to the skin in the area of injection;

- Hypersensitivity to the drug;

-hypersensitivity to avian proteins.

Pregnancy and lactation

Nor should designate product during pregnancy and lactation (breast-feeding) due to the lack of clinical data on the use of this category of patients.

Cautions

For the first 2 days after the procedure it is recommended that you do not overload the joint, in particular, you should avoid prolonged activity.

When receiving the aspiration of fluids before the introduction of the drug should carry out appropriate studies to exclude bacterial etiology of arthritis.

Use in Pediatrics

Due to the lack of clinical data for use in Pediatrics the drug should not be appointed for children.

Effects on ability to drive vehicles and management mechanisms

Phidias Gialgan does not affect the ability to drive and to other potentially hazardous activities, require high concentration and psychomotor speed reactions.

Overdose

Currently, the cases of overdose not mentioned.

Drug Interactions

Phidias Gialgan should not appoint simultaneously with other drugs for intra-articular introduction due to the lack of sufficient clinical experience.

You should not use disinfectants, containing quaternary ammonium salt, Since hyaluronic acid is precipitated in the presence of these substances.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children, dark place at a temperature no higher than 25 ° C; Do not freeze. Shelf life – 3 year when stored in the original packaging.

You should not use the drug Gialgan of Phidias with damaged or opened packing.