Armaviscon® (Intra-articular agent) Instructions for Use
Therapeutic Category
Medical device for the treatment of musculoskeletal system diseases
Properties
A medical device.
Hyaluronic acid has physical properties that make it possible to use this substance as a substitute for the synovial fluid impaired by the inflammatory process. Thus, by restoring the physical characteristics of the joint fluid, hyaluronic acid increases mobility and reduces pain in joints affected by osteoarthritis or periarthritis.
In addition, the drug induces the synthesis of high molecular weight hyaluronic acid, similar in structure to “normal” hyaluronic acid, in synovial joints affected by a chronic degenerative or inflammatory process. Without this stimulus, the molecular weight of hyaluronic acid synthesized by synoviocytes is below normal.
This mechanism of action explains the prolonged clinical effect of sodium hyaluronate, which is 10 times greater than the effect calculated from the intra-articular clearance and metabolism.
Intra-articular administration of this agent improves joint function, relieves pain caused by osteoarthritis of the knee and shoulder joints. It improves joint mobility and normalizes the composition of the synovial fluid. Furthermore, this agent is used for administration into the carpometacarpal joint in patients suffering from rhizarthrosis.
Scope of Application
Osteoarthritis of the knee and shoulder joints; osteoarthritis of the carpometacarpal joint of grades I, II, and III; pain and limited mobility of other synovial joints as a result of degenerative and post-traumatic changes.
ICD codes
| ICD-10 code | Indication |
| M17 | Gonarthrosis [arthrosis of the knee] |
| M18 | Arthrosis of the first carpometacarpal joint |
| M19 | Other arthrosis |
| M25.5 | Pain in joint |
| M25.6 | Stiffness of joint, not elsewhere classified |
| ICD-11 code | Indication |
| FA01.Z | Osteoarthritis of knee, unspecified |
| FA02.Z | Osteoarthritis of the wrist or hand joint, unspecified |
| FA0Z | Osteoarthritis, unspecified |
| ME82 | Pain in joint |
| ME85 | Joint stiffness |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Intra-articular agent
Generally, intra-articular administration once a week for 5 consecutive weeks is recommended.
It is administered directly into the cavity of the knee joint, the shoulder joint (joint cavity, subacromial bursa, or tendon sheath of the long head of the biceps), the carpometacarpal joint, or other affected synovial joints.
For the carpometacarpal joint, two administration methods are recommended depending on the severity of osteoarthritis: the lateral external approach (grade I rhizarthrosis) and the interdigital/into the first web space approach (grade II and III rhizarthrosis). The choice of a particular administration method for this agent depends on the individual characteristics of each patient.
Administration of the drug is best performed under endoscopic control. In any case, the dose selection depends on the severity of symptoms.
Side effects
Local reactions: urticaria and itching are possible; in some cases – transient pain after injection and swelling, as well as redness, burning sensation, and heaviness at the injection site.
General reactions: very rarely – shock reactions.
Contraindications
Hypersensitivity to sodium hyaluronate.
Use during pregnancy and breastfeeding
Although preclinical studies have not revealed teratogenic properties, the safety of this agent during pregnancy has not been studied. Therefore, during pregnancy or suspected pregnancy, this agent should be used with caution.
Sodium hyaluronate is secreted into the milk of animals, therefore, it is recommended to discontinue breastfeeding during the use of this agent.
Special instructions
The use of this agent may cause an exacerbation of the inflammatory process in patients with osteoarthritis. In this case, administration is recommended after the inflammatory symptoms have subsided.
To prevent the development of pain after injection, it is recommended to rest the affected joint.
Use with caution in patients with a burdened allergic history and in patients with impaired liver function.
Use with caution in elderly patients, as many physiological functions of the body are reduced in the elderly.
Since the safety of this agent in children has not been studied, it should be used with caution.
Drug Interactions
Mixing the drug with quaternary ammonium salts, including benzalkonium chloride, or with chlorhexidine is not allowed due to the development of precipitation.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Intra-articular agent 1%: 2 ml syringes 1 or 2 pcs.
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
 |
Armaviscon® | Intra-articular agent 1%: 2 ml syringes 1 or 2 pcs. |
Dosage Form, Packaging, and Composition
Intra-articular agent in the form of a colorless, viscous solution.
| 1 ml | |
| Sodium hyaluronate | 9-11 mg |
| Dynamic viscosity of solution >100 mPa·s Osmolality 250-350 mOsm/kg PH 6.5-7.5 |
Excipients: sodium chloride – 8.5 mg, disodium hydrogen phosphate dihydrate – 0.28 mg, sodium dihydrogen phosphate dihydrate – 0.044 mg, water for injections – up to 1 ml.
2 ml – syringes (1) – foil laminated film bags* (1) – cardboard boxes.
2 ml – syringes (1) – foil laminated film bags** (2) – cardboard boxes.
2 ml – syringes (1) – contour cell blisters* (1) – cardboard boxes.
2 ml – syringes (1) – contour cell blisters** (2) – cardboard boxes.
* Inclusion of 1 or 2 sterile single-use injection needles in the bag or contour cell blister is allowed.
** Inclusion of 2 or 4 sterile single-use injection needles in the bag or contour cell blister is allowed.
Inclusion of needles of the same or different sizes is allowed.
Information about the size of the included needle (needles) is indicated on the packaging.
18G 1 1/2 (1.2×40 mm) or 21G 1 1/2 (0.8×40 mm) – for the knee joint; 18G 2 (1.2×50 mm), 21G 2 (0.8×50 mm), 18G 4 (1.2×100 mm), 21G 4 3/4 (0.8×120 mm) or 21G 4 (0.8×100 mm) – for the hip joint.
Inclusion of 3 tracking labels (for 1 syringe) and 6 tracking labels (for 2 syringes) in the cardboard box is allowed.
Intra-articular agent 1%: 2 ml syringes 1 or 2 pcs.
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
|
Armaviscon® Vita | Intra-articular agent 1%: 2 ml syringes 1 or 2 pcs. |
Dosage Form, Packaging, and Composition
Intra-articular agent in the form of a colorless, viscous solution.
| 1 ml | |
| Sodium hyaluronate | 9-11 mg |
| Dynamic viscosity of solution >100 mPa·s Osmolality 250-350 mOsm/kg PH 6.5-7.5 |
|
Excipients: sodium chloride – 8.5 mg, disodium hydrogen phosphate dihydrate – 0.28 mg, sodium dihydrogen phosphate dihydrate – 0.044 mg, water for injections – up to 1 ml.
2 ml – syringes (1) – foil laminated film bags* (1) – cardboard boxes.
2 ml – syringes (1) – foil laminated film bags** (2) – cardboard boxes.
2 ml – syringes (1) – contour cell blisters* (1) – cardboard boxes.
2 ml – syringes (1) – contour cell blisters** (2) – cardboard boxes.
* Inclusion of 1 or 2 sterile single-use injection needles in the bag or contour cell blister is allowed.
** Inclusion of 2 or 4 sterile single-use injection needles in the bag or contour cell blister is allowed.
Inclusion of needles of the same or different sizes is allowed. Information about the size of the included needle (needles) is indicated on the packaging.
The syringe is equipped with a Luer-Lock type needle fixation system.
The kit may include a sterile single-use injection needle 18G 1 1/2 (1.2×40 mm) or 21G 1 1/2 (0.8×40 mm), or 21G 2 (0.8×50 mm) (RZN 2018/7086 dated 26.04.2018) or 18G 1 1/2 (1.2×40 mm), or 21G 1 1/2 (0.8×40 mm), or 21G 2 (0.8×50 mm), or 18G 2 (1.2×50 mm), or 18G 4 (1.2×100 mm), or 21G 4 3/4 (0.8×120 mm), or 21G 4 (0.8×100 mm) (FSZ 2007/00712 dated 03.12.2007). The needle has a silicone coating, an ultra-sharp lancet-type point, providing an almost painless injection.
Inclusion of 3 tracking labels (for 1 syringe) and 6 tracking labels (for 2 syringes) in the cardboard box is allowed.
Wrapping the cardboard box with polymer film is allowed.
Intra-articular agent 1.5%: 2 ml syringes 1 or 2 pcs.
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
|
Armaviscon® Plus | Intra-articular agent 1.5%: 2 ml syringes 1 or 2 pcs. |
Dosage Form, Packaging, and Composition
Intra-articular agent in the form of a colorless, viscous solution.
| 1 ml | |
| Sodium hyaluronate | 13.5-16.5 mg |
| Dynamic viscosity of solution >500 mPa·s Osmolality 250-350 mOsm/kg PH 6.5-7.5 |
Excipients: sodium chloride – 8.5 mg, disodium hydrogen phosphate dihydrate – 0.22 mg, sodium dihydrogen phosphate dihydrate – 0.044 mg, water for injections – up to 1 ml.
2 ml – syringes (1) – foil laminated film bags * (1) – cardboard boxes.
2 ml – syringes (1) – foil laminated film bags** (2) – cardboard boxes.
2 ml – syringes (1) – contour cell blisters* (1) – cardboard boxes.
2 ml – syringes (1) – contour cell blisters** (2) – cardboard boxes.
* Inclusion of 1 or 2 sterile single-use injection needles in the bag or contour cell blister is allowed.
** Inclusion of 2 or 4 sterile single-use injection needles in the bag or contour cell blister is allowed.
Inclusion of needles of the same or different sizes is allowed.
Information about the size of the included needle (needles) is indicated on the packaging.
18G 1 1/2 (1.2×40 mm) or 21G 1 1/2 (0.8×40 mm) – for the knee joint; 18G 2 (1.2×50 mm), 21G 2 (0.8×50 mm), 18G 4 (1.2×100 mm), 21G 4 3/4 (0.8×120 mm) or 21G 4 (0.8×100 mm) – for the hip joint.
Inclusion of 3 tracking labels (for 1 syringe) and 6 tracking labels (for 2 syringes) in the cardboard box is allowed.
Intra-articular agent 3%: 3 ml syringes 1 pc.
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
|
Armaviscon® Platinum | Intra-articular agent 3%: 3 ml syringes 1 pc. |
Dosage Form, Packaging, and Composition
Intra-articular agent in the form of a colorless, viscous solution.
| 1 ml | |
| Sodium hyaluronate | 25.5-33 mg |
| Dynamic viscosity of solution >15000 mPa·s Osmolality 270-370 mOsm/kg PH 6.5-7.5 |
|
Excipients: sodium chloride – 8 mg, disodium hydrogen phosphate dihydrate – 0.33 mg, sodium dihydrogen phosphate dihydrate – 0.06 mg, water for injections – up to 1 ml.
3 ml – syringes (1) – foil laminated film bags* (1) – cardboard boxes.
3 ml – syringes (1) – contour cell blisters* (1) – cardboard boxes.
* Inclusion of 1 or 2 sterile single-use injection needles in the bag or contour cell blister is allowed.
Inclusion of needles of the same or different sizes is allowed. Information about the size of the included needle (needles) is indicated on the packaging.
The syringe has a Luer-Lock type connection for needle fixation.
The kit may include a sterile single-use injection needle 18G 1 1/2 (1.2×40 mm) or 21G 1 1/2 (0.8×40 mm), or 21G 2 (0.8×50 mm) (RZN 2018/7086 dated 26.04.2018) or 18G 1 1/2 (1.2×40 mm), or 21G 1 1/2 (0.8×40 mm), or 21G 2 (0.8×50 mm), or 18G 2 (1.2×50 mm), or 18G 4 (1.2×100 mm), or 21G 4 3/4 (0.8×120 mm), or 21G 4 (0.8×100 mm) (FSZ 2007/00712 dated 03.12.2007). The needle has a silicone coating, an ultra-sharp lancet-type point, providing an almost painless injection.
Inclusion of 3 tracking labels (for 1 syringe) in the cardboard box is allowed.
Wrapping the cardboard box with polymer film is allowed.
Product for peritendinous and intra-articular administration: 2 ml syringes 1 pc.
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
|
Armaviscon® MN | Product for peritendinous and intra-articular administration: 2 ml syringes 1 pc. |
Dosage Form, Packaging, and Composition
Agent for peritendinous and intra-articular administration in the form of a transparent, colorless, viscous solution.
| 1 ml | 1 syringe | |
| Sodium hyaluronate | 20 mg | 40 mg |
| Mannitol | 5 mg | 10 mg |
| Dynamic viscosity of solution >25000 mPa·s Osmolality 250-350 mOsm/kg PH 6.5-7.5 |
||
Excipients: sodium chloride – 8.55 mg, disodium hydrogen phosphate dihydrate – 0.33 mg, sodium dihydrogen phosphate dihydrate – 0.06 mg, water for injections – up to 1 ml.
2 ml – syringes (1) – foil laminated film bags* (1) – cardboard boxes.
2 ml – syringes (1) – contour cell blisters* (1) – cardboard boxes.
* Inclusion of 1 or 2 sterile single-use injection needles in the bag or contour cell blister is allowed.
Inclusion of needles of the same or different sizes is allowed. Information about the size of the included needle (needles) is indicated on the packaging.
The syringe is equipped with a Luer-Lock type needle fixation system.
The kit may include a sterile single-use injection needle 18G 1 1/2 (1.2×40 mm) or 21G 1 1/2 (0.8×40 mm), or 21G 2 (0.8×50 mm) (RZN 2018/7086 dated 26.04.2018), or 18G 1 1/2 (1.2×40 mm), or 21G 1 1/2 (0.8×40 mm), or 21G 2 (0.8×50 mm), or 18G 2 (1.2×50 mm), or 18G 4 (1.2×100 mm), or 21G 4 3/4 (0.8×120 mm), or 21G 4 (0.8×100 mm), or 25G 1 1/2 (0.5×40 mm), or 27G 1 1/2 (0.4×40 mm) (FSZ 2007/00712 dated 03.12.2007), or 18G 1 1/2 (1.2×40 mm), or 21G 1 1/2 (0.8×40 mm), or 25G 1 1/2 (0.5×40 mm), or 26G 1 1/2 (0.45×40 mm) (FSZ 2011/09101 dated 11.02.2011). The needle has a silicone coating, an ultra-sharp lancet-type point, providing an almost painless injection.
Inclusion of 3, 6, or 12 tracking labels in the cardboard box is allowed.
Intra-articular agent 2.3%: 3 ml syringes 1 pc.
Marketing Authorization Holder
Grotex, LLC (Russia)
Dosage Form
|
Armaviscon® Forte | Intra-articular agent 2.3%: 3 ml syringes 1 pc. |
Dosage Form, Packaging, and Composition
Intra-articular agent in the form of a colorless, viscous solution.
| 1 ml | |
| Sodium hyaluronate | 20.7-25.3 mg |
| Dynamic viscosity of solution >1500 mPa·s Osmolality 250-350 mOsm/kg PH 6.5-7.5 |
Excipients: sodium chloride – 8.55 mg, disodium hydrogen phosphate dihydrate – 0.33 mg, sodium dihydrogen phosphate dihydrate – 0.06 mg, water for injections – up to 1 ml.
3 ml – syringes (1) – foil laminated film bags* (1) – cardboard boxes.
3 ml – syringes (1) – contour cell blisters* (1) – cardboard boxes.
* Inclusion of 1 or 2 sterile single-use injection needles in the bag or contour cell blister is allowed.
Information about the size of the included needle (needles) is indicated on the packaging.
18G 1 1/2 (1.2×40 mm) or 21G 1 1/2 (0.8×40 mm) – for the knee joint; 18G 2 (1.2×50 mm), 21G 2 (0.8×50 mm), 18G 4 (1.2×100 mm), 21G 4 3/4 (0.8×120 mm) or 21G 4 (0.8×100 mm) – for the hip joint.
Inclusion of 3 tracking labels (for 1 syringe) in the cardboard box is allowed.
![Armaviscon® [Intra-articular agent] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Armaviscon® [Intra-articular agent] 2")