Injekcija Synvisc 16mg/2ml 3 švirkštai

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Prekė: Injekcija Synvisc 16mg/2ml 3 švirkštai. Kategorija: Sąnariai, kaulai, raumenys.

• Gamintojas: Sanofi
• Modelis: 3401078489921

SYNVISC HYLAN GF20 16mg/2ml x 3 amp.-syringe - treatment of pain associated with osteoarthritis.

SYNVISC HYLAN GF20 16mg/2ml - pain reduction, discomfort reduction, joint mobility increase!

GIFT: Set of patches for children

SYNVISC HYLAN GF20 16mg/2ml x 3 amp.-syringe + Set of patches for children

Synvisc Hylan GF20 16mg/2ml x 3 amp.-syringe Hylates are derivatives of hyaluronic acid sodium salt, which contain repetitive disaccharide units of N-acetyl-glucosamine and sodium glucuronide. Hylan A has an average molecular weight of approx. 6 000 000 Daltons, and Hylan B is a hydrated gel.

Synvisc Hylan G-F 20 16mg/2ml has a therapeutic effect through viscosupplementation – a process in which the physiological and rheological state of the tissues of the joint altered by inflammation is restored.

Indications for use:

• for the periodic replacement and replenishment of synovial fluid;
• in patients at different stages of osteoarthritis;
• in patients who actively and regularly use the joint covered by the disease;

Viscosupplementation with hylan G‐F 20 is designed to reduce pain and discomfort and increase joint mobility. In vitro studies have shown that hylan G‐F 20 protects cartilage cells from some physical and chemical damage.

SYNVISC can only be administered by a physician intraarticularly to treat pain associated with osteoarthritis of the knee, hip, ankle and shoulder joints.

Contraindications: Do not use in patients with hypersensitivity to hyaluronic acid and other ingredients contained in the product. Injections into the joint cavity are contraindicated for current or past skin disease infections in the injection area.

Do not inject intravenously or post-articularly.

Usage: Product to be used only by authorised healthcare professionals. Before use, read the information on the use of the medical device and consult a doctor.

• Use topically, in bulk.
• Do not use the SYNVISC medical device if the packaging has been opened or damaged before.
• The contents of the syringe should be used immediately after opening the pack.
• Remove synovial fluid or exudate from the knee before injecting Hylan G‐F 20
• Inject at room temperature.
• To remove the syringe from the blister (or tray), hold the syringe by the body without touching the plunger.
• Administer with strict aseptic technique, especially when removing the stopper from the vial.
• Before removing the grey safety cap, it must be turned. This will minimize the leakage of the medical device.
• To ensure tightness and prevent leakage, the needle should be firmly attached during feeding, while holding the Luer fitting firmly.
• Do not overtighten the needle or apply excessive pressure to the needle while applying or removing the needle cover, as this may break the tip of the syringe.
• The device should only be administered into the synovial gland if necessary using fluoroscopy, in particular before administration into the hip or shoulder joint.
• The contents of the syringe are for single use only.
• Do not reuse the syringe and/or needle – reuse of syringes, needles and/or medical device from the syringe used may result in loss of sterility, contamination of the device and/or incomplete treatment.
• Hylan G-F 20 should not be re-sterilized.

Recommended dosage: The recommended dosage depends on the joint to which SYNVISC (Hylan G‐F 20) is to be administered.

• Osteoarthritis knee joint: The recommended dosage is three injections of 2 ml into the knee joint with a one-week interval between each administration. In order to achieve the full therapeutic effect, it is important to administer all three doses. The maximum recommended dose is 6 injections over 6 months with at least a 4‐ week interval between administrations;
• osteoarthritis of the hip, ankle, shoulder joint: The recommended starting dose is 2 ml injection. If symptoms have not improved after the first administration, it is recommended to give another 2 ml injection.

Clinical data have shown benefit to the patient from the second injection if given between 1 and 3 months after the first administration. The duration of action of Hylan G‐F 20 affects only the joint within which the injection was given. It does not cause any effects at the systemic level.

Effects in responders were reported up to 26 weeks after administration of the medical device, but a shorter or longer duration of action was also observed. Clinical data from the treatment of osteoarthritis of the knee have shown efficacy. effects up to 52 weeks after a series of three injections of SYNVISC.

Packaging: 3 pre-filled syringes of 2 ml

Composition:

1 ml of G-F 20 hylan contains:

• hylan 8,0mg ,
• sodium chloride 8,5mg,
• disodium hydrogen phosphate 0,16mg,
• sodium diphosphate monohydrate 0,04mg,
• water for injections q.s.

Manufacturer: Genzyme Europe

Specifications

Group	Name	Value
Parametry	Condition	new
Parametry	Invoice	With VAT invoice
Parametry	Manufacturer code	3401078489921
Parametry	Product weight with unit packaging	0.01 kg
Parametry	Form	vial
Parametry	Number of pieces	3 pcs
Parametry	Volume	2 ml
Parametry	Brand	Sanofi
Parametry	Basic ingredient	hyaluronic acid
Parametry	Additional features	safe for breastfeeding women
Parametry	EAN (GTIN)	3401078489921