Ambene^® Visco Midi (Intra-articular agent) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Contact Information

PROMOMED RUS LLC (Russia)

Dosage Form

Ambene® Visco Midi

Intra-articular agent 1.5%: 2 ml syringes 1 or 2 pcs.

Dosage Form, Packaging, and Product Composition

Intra-articular agent in the form of a colorless, viscous solution, free from foreign inclusions.

Excipients: physiological phosphate-saline buffer – to a volume of 1 ml.

2 ml – single-use prefilled syringes with a volume of 2.25 ml (1) – contour cell packaging* (1) – cardboard boxes.
2 ml – single-use prefilled syringes with a volume of 2.25 ml (1) – contour cell packaging** (2) – cardboard boxes.

* complete with sterile single-use injection needles 18G 1 ¹/₂ (1.2×38 mm) (1 pc.) and 21G 1 ¹/₂ (0.8×38 mm) (1 pc.), a sticker (1 pc.).
** complete with sterile single-use injection needles 18G 1 ¹/₂ (1.2×38 mm) (2 pcs.) and 21G 1 ¹/₂ (0.8×38 mm) (2 pcs.), stickers (2 pcs.).

Therapeutic Category

Medical device for the treatment of musculoskeletal system diseases

Properties

The intra-articular agent Ambene^® Visco Midi 1.5% is a synovial fluid joint prosthesis in prefilled syringes.

It is used against the background of degenerative changes in the cartilage surface to improve joint mobility, reduce pain, decrease inflammatory reactions, and restore homeostasis in the cartilage.

Ambene^® Visco Midi 1.5% is a sterile, viscous, high molecular weight (molecular mass is not less than 3 MDa) solution of the sodium salt of hyaluronic acid (sodium hyaluronate).

Hyaluronic acid is an essential component of the extracellular matrix, present in high concentrations in cartilage and synovial fluid.

Hyaluronic acid provides viscosity and elasticity to the synovial fluid.

Intra-articular administration of hyaluronic acid leads to an improvement in the functional state of the joint.

It prevents friction of the articular surfaces, which helps eliminate pain and inflammation, and also protects against premature wear and destruction of cartilage, provides mobility, and has shock-absorbing capacity (dampens external shocks, protecting the joint components from damage).

The sodium hyaluronate solution is distributed locally in the joint cavity, where it undergoes local transformations, exerting a lubricating effect.

Extraction or replacement of the agent is not applicable, as it mixes inseparably with the joint synovial fluid.

Based on a review of studies of products with a similar composition, the duration of the therapeutic effect is up to 6 months or more, depending on the site of administration, the severity of the disease, and individual characteristics of the body.

Scope of Application

Of the product Ambene^® Visco Midi

• To increase joint mobility and eliminate pain caused by osteoarthritis/osteoarthrosis, as well as other degenerative-dystrophic or post-traumatic joint changes;
• For rehabilitation after orthopedic joint surgery and arthroscopy;
• For individuals with increased stress on damaged joints.

ICD codes

Dosage Regimen

Intra-articularly. The administration regimen into the joints is determined by the doctor individually, taking into account the severity of degenerative or traumatic changes in the joint.

Into the knee joint, the contents of one filled syringe should be administered once a week, in a course of up to 3 injections according to the standard technique described below.

Usually, a 21G needle is used for the knee joint; for other joints, it is recommended to use a needle of the necessary size (from 17 to 22G) depending on the joint.

If necessary, a repeated course of injections can be carried out after consultation with a doctor.

Administration technique

Before the procedure, the patient should be informed about the indications of the medical device, as well as its contraindications and possible undesirable side effects.

Before use, make sure that the packaging of the product is not damaged and sterility is not compromised, and the product’s expiration date has not passed.

Do not reuse. There is a risk of infection or bloodborne contamination upon reuse.

The agent should be administered only by doctors who have undergone special training.

Rules of asepsis and antisepsis should be observed during the procedure.

The injection site must be properly disinfected.

Do not use disinfectants containing quaternary ammonium compounds, as hyaluronic acid precipitates in the presence of these substances.

It is recommended to warm the agent to room temperature before use.

The agent should be injected precisely into the joint cavity using standard techniques, considering anatomical features.

Before administering the agent, effusion (if present) should be removed from the joint capsule.

The same needle, inserted once before aspiration, can be used to remove effusion and administer the agent.

In this case, the syringe with the agent is attached to the needle freed from the syringe.

To confirm the needle is in the joint cavity, a small amount of synovial fluid should be aspirated before slow administration.

Avoid getting air into the syringe.

Administration of the agent into the joint cavity should be stopped if pain occurs during the injection.

When inserting the needle, especially for injections into the hip joint, the use of local anesthesia is recommended.

It is recommended to perform joint injections under ultrasound or fluoroscopic control.

Procedure for working with the syringe

1. Open the contour cell packaging under aseptic conditions.
2. Unscrew the cap from the syringe tip.
3. Firmly attach the needle to the syringe. Screw the needle onto the syringe until it has passed the thread path and is seated tightly.
4. Visually ensure that the needle has passed the thread path to the end.
5. Remove the cap from the needle with a straight motion. Ensure that the needle is not unscrewed.
6. Expel residual air from the system by holding the syringe barrel with one hand and gently pressing the plunger rod with the other until solution appears at the needle tip.

The solution should be administered slowly, applying minimal necessary pressure.

If the needle is blocked, do not increase pressure on the plunger rod. Instead, stop administering the solution and replace the needle.

Unused residue of the agent is not subject to storage.

The biodegradation period of the medical device is up to 6 months or more.

Precautions for use

Do not use Ambene^® Visco Midi 1.5% with damaged or opened packaging.

Avoid hitting blood vessels with the needle during the manipulation.

Side effects

Possible: moderate soreness, swelling, increased temperature and redness at the injection site, increased exudate content in the joint cavity.

The above symptoms are transient and usually disappear within 24 hours.

If these symptoms occur, it is recommended to unload the affected joint and apply ice.

Extremely rarely allergic reactions.

Contraindications

• Hypersensitivity to the components of the agent;
• Presence of infection or skin lesions in the injection area;
• Acute synovitis;
• Children under 18 years of age (due to lack of clinical data).

Use during pregnancy and breastfeeding

It is not recommended to use the agent during pregnancy and breastfeeding due to the lack of clinical data.

Prescription of the agent during pregnancy and breastfeeding is at the discretion of the attending physician.

Special instructions

Sodium hyaluronate is obtained by fermentation of Streptococcus equi bacteria and is thoroughly purified.

Nevertheless, the physician should consider the potential risk associated with the injectable administration of any biological substances.

During the first 2 days after the procedure, it is recommended not to overload the joint, especially avoiding prolonged stress.

Ambene^® Visco Midi 1.5% is not prescribed to patients with inflammatory diseases, in particular, Bechterew’s disease and rheumatoid arthritis.

Not intended for children.

For single use only.

The kit includes 2 or 4 (depending on the number of syringes in the package) sterile single-use injection needles to enable the doctor to choose a needle of the necessary caliber/size depending on the joint into which the agent will be injected.

Attention must be paid to the expiration date of the needle indicated on its label.

For safe use and disposal of used needles, national and regional rules and regulations must be observed.

Medical device safety requirements

The agent is non-toxic and does not have a harmful effect on the human body when handled.

The agent does not form toxic compounds in the air or in wastewater and does not lead to sanitary-hazardous environmental pollution.

The agent must meet biological safety requirements in accordance with GOST R 52770 and the GOST ISO 10993 series of standards.

Sterilization information

The components of the agent are pre-mixed and packaged into syringes.

The filled syringes are sterilized by steam sterilization in an autoclave in accordance with GOST R ISO 17665-1, GOST R 56893/ISO/TS 17665-2.

Disposal

Used materials are disposed of according to the hazard class specified in SanPiN 2.1.3684.

In accordance with SanPiN 2.1.3684

• The syringe with needles, according to the hazard classification, belongs to Class B;
• Packaging materials, cardboard box, and blister, according to the hazard classification, belong to Class A.

The syringe with needles must be disposed of immediately after use, even if the contents were not used completely.

Effect on the ability to drive vehicles and mechanisms

Ambene^® Visco Midi 1.5% does not affect a person’s ability to drive motor vehicles, engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Ambene^® Visco Midi 1.5% should not be prescribed simultaneously with other intra-articular injections.

Do not use disinfectants containing quaternary ammonium compounds, as hyaluronic acid precipitates in the presence of these substances.

Storage Conditions

The agent should be stored and transported in the packaging at a temperature from +2°C (35.6°F) to +30°C (86°F) and relative air humidity up to 80% in a place protected from direct sunlight, out of reach of children.

Shelf Life

Shelf life – 36 months. Do not use after the expiration date.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.