DIART INSTRUCTIONS FOR USE

Injectable Medical Device – based on Hyaluronic acid in syringe

QUALITATIVE AND QUANTITATIVE COMPOSITION.

Active substance: sodium hyaluronate. Excipients: succinic acid, sodium succinate, sodium chloride and water for injection.

CLASSIFICATION OF THE PRODUCT

Medical device – sterilized and pyrogen-free – Class III.

PACKAGE

1ml pre-filled disposable syringe which contains 1.1 % (11mg) of hyaluronic acid.

2ml pre-filled disposable syringe which contains 1.1 % (22mg) of hyaluronic acid.

1ml pre-filled disposable syringe which contains 1.8 % (18mg) of hyaluronic acid.

2ml pre-filled disposable syringe which contains 1.8 % (36mg) of hyaluronic acid.

! Only contents of the syringe are sterile.

! The medical device has been sterilized by steam sterilization.

Each Package contains:

Two hypodermic needles (0.80x50mm – Manufactured by Becton Dickinson and Company Limited – CE 0050) for injecting the medical device.
Two labels with variable data for the product (LOT number and EXP. date).

INDICATIONS

Hyaluronic acid is a natural polysaccharide and an important building block of the skin and connective tissues. DIART ® takes the form of a gel; it is a sterile, pyrogen-free, colorless and transparent hyaluronic acid of non-animal origin with optimum pH. Medical device DIART ® is intended to be injected in joints in order to temporarily restore the viscoelasticity of synovial fluid of the joints in the event of problems due to trauma, or diseases such as osteoarthritis.

WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Do not administer intravenously.
Do not use if the solution is not transparent and colorless.
Do not use if the package has been opened or is damaged.
The product must be used immediately afler opening and destroyed once it has been used.
Do not reuse. Once the product has been used for the first time, any residuals of the product are unsuitable for repeat use as the product is no longer sterile.
Do not resterilize. Repeated sterilization may cause cross-contamination for the patient and the surgeon.
Do not insert air in the syringe.
Do not freeze. Heating in a microwave oven is not recommended.
Solution must not be administered orally.
The product is intended for single use. After the first injection, the unused product is no longer sterile. Do not use product residuals.
Before treatment, put a slight pressure on the syringe plunger in order to create a drop on the needle tip, thus eliminating any air bubbles present in the product.

SPECIAL DIRECTIONS

You should always employ aseptic techniques when using the medical device.
Do not use the device on patients with known hypersensitivity to any of the product components.
Do not use in patients who have undergone thrombolytic therapy or anticoagulant therapy in the last two weeks.
Do not use in patients with symptoms of viral or bacterial infections, or similar.
Do not use together with disinfectants containing quaternary ammonium salts, such as benzalkonium chloride, for preparing the skin.
Do not heat or cool the injection point before the disappearance of redness or edema due to primary treatment.
Do not use the product in the presence of infections or serious infections, or of skin diseases or skin infections in the injection site.
Do not use in patients less than 18 years.
Do not use this product on patients who are pregnant or breastfeeding.

ADVERSE REACTIONS AND SIDE EFFECTS

Like any routine involving other injectable product, this medical procedure may cause discomfort in some patients. Skin rash (redness, swelling, edema, bruising, itching and minor pain at the site of injection) may occur as a result of the medical procedure. Usually these symptoms regress within 72hours. In rare cases, signs of solidification and temporary loss of sensation at the injection site may appear. In very rare cases described in the literature, signs of necrosis, papilla, granulomas, hypersensitivity and abscess formation may occur after injection with hyaluronic acid-based products. In the event of any of the mentioned cases, immediately contact your doctor and the manufacturer of the medical device.

ROUTE OF ADMINISTRATION AND DOSAGE

DIART® should only be administered by health care professionals trained in intra-articular injection techniques and should only be administered into the synovial space. Before treatment, it is necessary for the operator to be informed about the medical history of the patient and it is necessary that they inform the patient of the expected outcome of treatment and the potential side effects. DIART® may be administered for a period of 3-5 weeks with a 1-2-week interval between one treatment and the other, depending on the severity of the problem. DIART® is supplied in 1 ml or 2 ml syringes to be used based on the size of the injection site. The recommended treatment regimen is 3 intra-articular injections per joint. The treatment regimen may be repeated after 6 months of the initial treatment, if warranted by the patient’s symptoms and if prescribed by your doctor.

HOW TO USE

Check the expiration date indicated on the package. Do not use after the expiry date.
Attach the label with the product data (batch number and expiry date) to the Medical Record of the patient undergoing the procedure.
Open the sterile package.
Remove the stopper plug from the syringe connector.
Attach the needle to perform the procedure. Make sure that the needle is properly attached to the syringe.
Remove the needle cover.
Before treatment, put a slight pressure on the syringe plunger to create a drop on the needle tip, thus eliminating any air bubbles present in the product.
Give the injection and carry out the medical procedure.
Once the product has been used, dispose of it in line with the current state regulations

SHELF LIFE

2 years in an intact package.

HOW TO STORE

Store at a temperature of between 5 and 30 °C (inclusive), away from direct light and heat, and in adequately sealed packaging. The expiry date is applied to products which are correctly stored in an intact package.

	DIART® 1,8%				DIART® 1,1%
The amount of sodium succinate, mg per ml	16				16
The amount of hyaluronic acid, mg per ml	18				11
Destination	Osteoarthritis				Traumatic cartilage damage and arthroscopy
Treatment course	OA Stage I	OA Stage II		OA Stage III	Afler full vanishing of all inflammation symptoms and absence of exudate in a joint
	requires 64 mg of sodium succinate		requires 96 mg of sodium succinate		requires 64 mg of sodium succinate
	= Diart 1,8% — 2 ml №2 with 7-10 days interval		= Diart 1,8% — 2 ml №3 with 7-10 days interval		= Diart 1,1% — 2 ml №5 with 7-10 days interval
	1-2 times per year				once