ArthramidVet

Company: Contura Vet US

Instruction for use

ArthramidVet Caution

Federal law restricts this device to sale by or on the order of a licensed veterinarian and it must be used under the supervision of a licensed veterinarian for intra-articular injection.

PRODUCT DESCRIPTION

ArthramidVet^® is a non-resorbable, biocompatible, injectable, transparent, hydrophilic gel intended for intra-articular injection in horses and dogs.

ArthramidVet^® consists of 2.5% cross-linked polyacrylamide and 97.5% non-pyrogenic water. The hydrogel is supplied in a sterile, pre-filled 1 mL syringe sealed with a Luer Lock fitting and a tip cap.

INDICATION

ArthramidVet^® is indicated for the management of non-infectious causes of joint disease in horses and dogs, including both early and late stages of osteoarthritis.

Contraindications

ArthramidVet^® is not to be injected into actively infected joints, infected soft tissues surrounding the joint or infected skin.

WARNINGS

● Do not inject ArthramidVet^® intravascularly. Injection into blood vessels may cause vascular occlusion leading to possible embolism.

● Do not mix ArthramidVet^® with any other product.

● No clinical data is available for using ArthramidVet^® in combination with other products intended for intra- articular injection.

● No clinical data is available for using ArthramidVet^® for a later secondary dose after initial partial treatment response.

● No clinical data is available for using ArthramidVet^® in pregnant and lactating animals.

● Do not use ArthramidVet^® if the package is opened or damaged.

● Do not re-sterilize ArthramidVet^®.

● Do not use ArthramidVet^® after the expiration date printed on the packaging.

PRECAUTIONS

ArthramidVet^® is not recommended for use in horses and dogs with acute/chronic diseases receiving treatment with intra-articular or systemic corticosteroids or antibiotics. Corticosteroids may mask a possible infection.

Medical history records addressing ongoing infections, concomitant medication, surgery, etc. must be considered before injection to minimize possible adverse events.

After use, syringes and needles should be handled as potential bio-hazards. Dispose in accordance with accepted medical practice and applicable local, state, and federal requirements.

METHOD OF ADMINISTRATION

ArthramidVet^® must be administered by a qualified veterinarian trained in intra-articular injections.

ArthramidVet^® is administered via percutaneous infiltration into the articular cavity of the affected joint, delivering the required dose as advised depending on the joint being injected.

DOSE RECOMMENDATION

The following dosage recommendations are based on observed clinical responses to administration:

HORSE

DOG

A single dose is normally considered adequate.

Concurrent treatment of multiple joints in the same animal is possible.

PROCEDURE

1. Sedate or restrain the animal according to normal practice.

2. Clip the hair overlaying the joint to be injected. For antisepsis, wash and disinfect thoroughly in a suitable area around the injection site.

3. ArthramidVet^® injection may be administered under local anesthesia.

4. An aseptic technique must be used to avoid contamination of the sterile ArthramidVet^® syringe and the injection site.

5. A sterile hypodermic needle (size 18-23G for horses and 21-23G for dogs) should be placed intra-articularly. Synovial fluid should be observed.

6. Care should be taken to avoid unnecessary damage of the intra-articular tissue, as this may result in diffuse swelling post procedural. Ultrasonography should be considered.

7. Remove the protective tip cap from the ArthramidVet^® syringe.

8. Once the clinician is confident of correct placement of the needle within the joint cavity, the syringe is firmly attached into the Luer Lock socket on the hypodermic needle. Make certain that the syringe is correctly mounted prior to injection.

9. If more than 1 mL of ArthramidVet^® is required for the joint, detach the empty ArthramidVet^® syringe from the hypodermic needle and repeat the process until the required dose is delivered.

10. Upon completion, withdraw the hypodermic needle and syringe and dispose in accordance with accepted medical practice and applicable local, state, and federal requirements.

11. Cover the injection site with a sterile non-adhesive dressing.

12. A cold pack can be applied on the injection site.

POST PROCEDURAL

Prophylactic non-steroidal anti-inflammatory drugs (NSAIDs) can be administered for pain relief.

The owner/trainer must be informed that the animal should be rested for 48 hours after the treatment, and the following 4 weeks be on a restricted exercise schedule.

COMPLICATIONS

As with any intra-articular procedure, ArthramidVet^® treatment carries a risk of infection.

In the event of infection, the use of broad-spectrum antibiotics is recommended. Any use of corticosteroids is contraindicated in case of infection.

Some animals can develop pain within the first few hours, post-administration. In addition, there is a minor risk of hematoma and mild edema at the site of injection. In case of edema, a cold pack should be applied on the injection site.

Within 1 - 2 weeks after treatment there is a minor risk that the animal may develop transient edema and tenderness in the treated joint. It is recommended to use maximum NSAID dosage to treat the symptoms.

INFORMATION TO THE OWNER/TRAINER

The owner/trainer of the animal should be informed about the indications, expected results, contraindications, precautions, warnings, and potential complications. The owner/trainer of the animal should be advised that in case of complications, the veterinarian who performed the ArthramidVet^® injections should be contacted immediately for necessary treatment.

COMPLAINTS

In case of questions, please contact Contura Vet at Info@conturavet.com.

In case of an adverse event and/or product complaint, please report to Contura Vet at complaints@contura.com.

STORAGE

ArthramidVet^® must be stored protected from direct sunlight. Do not freeze. Do not store unsealed syringes for later use. The expiry date is indicated on the package.

SYMBOLS USED ON PACKAGING