Product information

Intended purpose and treatment areas

Mode of action. Injected into joints as a visco-supplement for the reduction of pain symptoms and improved functioning of the joints.

Indication. Indicated for pain and joint function disorders as a result of degenerative deficits as a single injection treatment course. After the injection hyaluronic acid forms a layer on the surface of the joint cartilage and improves the pain symptoms.

Treatment areas. Osteoarthritis of knee or hip.

The instructions for use name knee and hip joints only, for both variants. Use in other joints is not covered by the intended purpose.

Contraindications

Crespine Gel must not be used in the event of:

• autoimmune illnesses
• incompatibility with gram-positive bacteria
• active inflammation or infection processes
• anticoagulant therapies
• known allergy to hyaluronic acid
• patients with multiple allergies should be excluded from treatment

Warnings and precautions

• Only intended for intra-articular injection and must not be injected into blood vessels. This could lead to an occlusion of the vessels and embolism.
• No clinical data is available on administration during pregnancy or lactation, or to adolescents under 18 years of age.
• Must not be used in patients with existing infections and inflammation processes in the vicinity of the implantation site.
• Patients should not take anticoagulant medication (such as aspirin), steroids or high doses of vitamin E before treatment.

Adverse effects

Caused by the injection

As with any other injection, patients may suffer from the following. These reactions normally disappear within 2 to 5 days of the injection.

• temporary erythema
• slight swelling
• pain
• sensation of heat

Caused by the medical device

Hypersensitivity to hyaluronic acid after the injection occurs in less than 1 % of cases, manifesting as extensive erythema and swelling. These reactions can occur immediately after the injection or up to 2 to 4 weeks later. The clinical data show that these hypersensitivity reactions are mild or moderate and last for a maximum of two weeks.

Wording taken from the instructions for use, date of information 05.2019 (BP_CrespineGel_BPZ_009, BP_CrespineGelPlus_BPZ_011). The version supplied with the product prevails.

Application

• A full anamnesis must be performed before treatment, in order to rule out any contraindications.
• The practitioner has to advise the patient of all precautions and possible adverse effects prior to treatment.
• The area to be treated must be carefully prepared with an antiseptic.
• The needles used for implantation have to be selected according to their suitability for intra-articular injection.
• To minimize the likelihood of intravascular injection, aspiration should be performed before the application. If blood is aspirated, the needle must be repositioned. The absence of blood does not ensure the avoidance of intravascular injection.
• The injection technique is of decisive importance for the final outcome.
• Must only be used by authorised medical personnel in agreement with the regional legal regulations.
• It is possible to treat several joints at the same time.

Packaging and storage

Supplied in a 2 ml syringe with integrated Luer Lock adapter in a blister pack for single use only. The contents are sterile (steam sterilisation). A label is given to the patient to guarantee traceability of the product.

Store at room temperature (2 °C – 25 °C). Do not freeze or expose to extreme heat. Must not be re-sterilised, mixed with other injection materials or decanted. Do not use if the packaging or blister pack is damaged.