• No animal origin• No chemically modified agent

Pure Sodium Hyaluronate

75 MONO INJECT ION75 MONO INJECT ION

is a new generation HA-based therapyfor treating OSTEOARTHRITIS in a safe,easy to use, single injection regimen

NEW MONO INJECTIONNEW MONO INJECTION

L C A P H A R M A C E U T I C A L

SODIUM HYALURONATE75mg/3ml

VISCVISC

ARTHRUM 75VISC

VISCVISC

ARTHRUM vISC 75MONO INjECTION

ARTHRUM vISC 75 MONO INjECTION

ARTHRUM vISC75 MONO INjECTION

N E w

ARTHRUM vISC 75 MONO INjECTION

DESCRIPTION

ARTHRUM vISC 75 MONO INjECTIONis a sterile viscoelastic devicewhose active ingredient is a naturalderivative of hyaluronic acid, sodiumhyaluronate, obtained by biofermentation,not chemically modified, with a very highmolecular weight of ≥ 2,800,000 Daltonsand a high concentration of 25mg/mL(75 mg per intra-articular injection).

The active ingredient of ARTHRUM vISC75 MONO INjECTION does not containany protein of avian origin and is notcross-linked by a chemical agent,eliminating any risk of allergy and potentialcytotoxicity and ensuring a perfecttolerability and safety during long-term use.

ARTHRUM vISC 75 MONO INjECTIONcomplies with the European Pharmacopoeia,ISO standards and EEC Directive 93/42,which guarantees the perfect safety andbio-compatibility of the implantabledevice.

The high molecular weightcombined with a highconcentration of sodiumhyaluronate in ARTHRUM vISC 75MONO INjECTION is the essentialfactor of long-term efficacy inthe symptomatic treatment ofosteoarthritis, by replacing forthe qualitative and quantitativeinsufficiency of sodiumhyaluronate in the synovialfluid of osteoarthritic joints.

PRESENTATION

ARTHRUM vISC 75 MONO INjECTIONis a sterile, transparent, homogeneousviscoelastic preparation, not chemically

modified, composed ofhighly purified sodiumhyaluronate obtained bybacterial fermentation,containing 75 mg of sodiumhyaluronate per 3-mL syringe.

ARTHRUM vISC 75 MONO INjECTION issupplied in a sterile disposable Luer-Loksyringe, prefilled with 3 mL, in one syringebox.

SODIUM HYALURONATE

NaHA 75 mg/3 mL

PROPERTIES

Sodium hyaluronate exists naturally in human body and is a majorconstituent of intercellular matrix.In joints, it is a structural component of cartilage and synovial fluidthat acts as a lubricant, a shock absorber, a filter and a metabolicagent. ARTHRUM vISC 75 MONO INjECTION is biologically similar to thesodium hyaluronate of the human body.

THE FUNCTIONS OF ARTHRUM vISC 75 MONO INjECTION ARE AS FOLLOwS :u Protective effect on cartilage• The lubricating properties of sodium hyaluronate molecules in synovialfluid allow the joint surfaces to slide against each other and protect themfrom mechanical damage.• By reducing the stress on weight-bearing joints, the elastic propertiesprotect cartilage from compressive forces.u Metabolism interface• Small molecules such as water, electrolytes and nutrients can diffusereadily in the direction of the cartilage and the synovial membrane.u Structure-modifying effect• Sodium hyaluronate provides a protective barrier, masking the pain receptorsof the synovial membrane.

The rheological properties of ARTHRUM vISC 75MONO INjECTION are as follows :

RHEOLOGICAL PROPERTIES ARTHRUM vISC 75 MONO INjECTION

Flow at 25°C

Dynamic viscosity (Pa.s)

viscoelasticity at 25°C

G' (Pa)

at2,5 Hz

G" (Pa)

at2,5 Hz

Frequency

Cutoff(Hz)

at0,01 s-1

at0,1 s-1

at1 s-1

at10 s-1

at100 s-1

at1000 s-1

848 496 159 33,7 4,79 0,571 407 160 0,11

The sodium hyaluronate is normallypresent in synovial fluid of healthy joints1

and is deteriorated both in terms ofconcentration and molecular weight inosteoarthritic joints2,3. In the treatment ofosteoarthritis, ARTHRUM vISC 75 MONO INjECTION therefore has the effect ofimproving the deficient rheologicalcharacteristics of the synovial fluid(viscosity and elasticity). Thesecharacteristics4 are important for shocksabsorption and lubrication andprotection of cartilage surfaces5. The rheological properties of 2.5 Hz ofARTHRUM vISC 75 MONO INjECTIONexceed those of healthy synovial fluid toanticipate dilution effect within joint. Theuse of a high molecular weight alsoincreases the residence time in the joint5.In addition, different beneficial biologicaleffects are attributed to hyaluronic acidin the joint, as have been expressed injournals6,7,8 extract from numerousscientific publications.

The dosageschedule of

ARTHRUMvISC 75 MONO

INjECTIONis ONE INTRA-ARTICULAR INjECTION in theknee. A secondinjection may berepeated betweenthe first and thirdmonth if this is

justified bythe painful

symptoms ofthe patient.

DOSAGE

INDICATIONS

ARTHRUM vISC 75 MONO INjECTION viscoelastic devices are indicated inthe symptomatic treatment of osteoarthritis of the knee, in particular forreducing pain and restoring joint mobility by replacing and supplementingthe elastoviscosity of the pathological synovial fluid in osteoarthritic joints.

The therapeutic indications are for all types of painful osteoarthitisof the knee :

- Primary osteoarthritis of the knee (Kellgren radiological stages I, II and III)- Osteoarthritis of the knee and associated systemic factors :

• Ineffectiveness of the usual treatments.• Intolerance and/or contraindication of NSAIDs or analgesics.• Use of anticoagulants, polymedication (hypertension, diabetes,

obesity, cardiovascular and gastrointestinal problems).• Contraindications related to the placement of a prosthesis :

young subjects and various contraindications related to thepatient’s condition.

- Incipient osteoarthritis of the knee of young subjects.- Knee osteoarthritis secondary to traumas and sequelae of joint fractures.

BIBLIOGRAPHICAL REFERENCES

1. HASCALL v.C., LAURENT T.C. : Hyaluronan : Structure and Physical Properties Glycoforum / Science ofHyaluronan 1 - http://www.glycoforum.gr.jp/hyaluronan

2. BALAZS E.A., wATSON D., DUFF I.F., ROSEMAN S. : Hyaluronic acid in synovial fluid. I. Molecular parametersof hyaluronic acid in normal and arthritis human fluids – Arthritis Rheum. 1767; 10 : 357-375

3. PASCARETTI C., MONROCHE A. : L’essor des acides hyaluroniques at usage intra- articulaire – Cinésiologie(La Revue Internationale des Médecins du Sport) 2004 Mai-Août ; n° 215-216. 27-30

4. wIK O., AGERUP B., BOTHNER wIK H. : Rheology of hyaluronan products (KENNEDY j., PHILLIPS G., wILLIAMSP., HASCALL v. editors) – woodhead Publishing Limited. 2002, volume 1, chapter 24. 201-204

5. LEvICK j.R., COLEMAN P.j., SCOTT D., MASON R.M. : Secretory Regulation in vivo. Molecular Reflection &Hydraulic Roles of Synovial Hyaluronan - Hyaluronan – Hyaluronan (KENNEDY j., PHILLIPS G., wILLIAMS P.,HASCALL v. editors) – woodhead Publishing Limited. 2002, volume 2, chapter 46. 329-336

6. MORELAND L.w. : Intra- articular hyaluronan (hyaluronic acid) and Hylans for the treatment ofostheoarthritis : mechanisms of action – Arthritis Research & Therapy 2003. 5 : 54-67 – http://arthritis-research.com/content/5/2/54

7. vITANZO C. jr, SENNET j. : Hyaluronans : is clinical effectiveness dependent on molecular weight? – Am jOrthop. 2006 Sept; 35(9) : 421-8

8. GHOSH P., GUIDOLIN D. : Potential mechanism of action of intra-articular therapy in osteoarthritis : are theeffects molecular weight dependenr? – Semin Arthritis Rheum, 2002 Aug; 32(1) : 10-37

ART

HRU

M V

ISC

75 -

EN -

2017

-04.

ARTHRUM 75VISC

SODIUM HYALURONATE

LCA S.A.9, Allée Prométhée, F-28000 Chartres, FranceTel. : +33 (0)2 37 33 39 30 - Fax : +33 (0)2 37 33 39 39E-mail : lca@lca-pharma.com