Data Sheet
Zyderm Test
Purified bovine dermal collagen 35mg/mL and lignocaine 3mg/mL collagen test implant
NAME OF MEDICINE
ZYDERM™ Test Dose is a sterile device composed of highly purified bovine dermal collagen that is dispersed in phosphate-buffered physiological saline.
ZYDERM™ Test Dose (collagen test implant) contains purified bovine dermal collagen 35mg/mL and lignocaine 3mg/mL.
Presentation
ZYDERM™ Test Dose is supplied sterile in syringes, ready for implantation.
ZYDERM™ Test Dose has a whitish, opaque or semi-opaque appearance. In the event that a syringe contains material that is crystal clear (like water), the syringe must not be used.
Uses
Actions
ZYDERM™ Test Dose is indicated for intradermal administration into the volar forearm, to screen out individuals who might develop hypersensitivity to injectable bovine dermal collagen devices. When injected into an extravascular connective tissue space and warmed to body temperature, the implant undergoes a fibrous transformation evolving from an opalescent gel to a white opaque mass. A soft cohesive network of fibres is formed. Histological examination reveals infiltration of various cell types into the collagen matrix within 24 to 48 hours after implantation. This infiltration later becomes limited to the normal cell types of connective tissue, i.e. fibroblasts and adipocytes. A newly developed vascular network can also be observed in and around the implant.
Once in place, the collagen implant condenses; syneresis of the implant and the resulting absorption of the exuded saline result in a rapid (less than 24 hour) reduction of implant volume, which is followed by a further, but more gradual (two or more weeks) reduction as the implant stabilises. Approximately 25 to 30% of the ZYDERM™ Test Dose implant volume remains, although this volume varies among individual patients. When established, the implant is similar in response and appearance to the surrounding soft tissue and is subject to the same stresses and ageing processes.
Indications
ZYDERM™ Test Dose is indicated for intradermal administration into the volar forearm, to screen out individuals who might develop hypersensitivity to injectable bovine dermal collagen devices.
Dosage and Administration
Prior to implantation with ZYDERM™ Test Dose the patient should be fully apprised of the purpose of and evaluation criteria for the test implant.
- Initially, a complete medical history should be obtained to determine conditions which may influence the successful use of injectable collagen implants. Care is needed in medical history taking and examination. This clinical judgment and directed questioning should be performed by an adequately trained and experienced medical practitioner.
- After verifying that contraindications do not exist to the proposed
injectable collagen treatment, a test implantation must be administered to
ensure that the patient does not have a pre-existing allergy to bovine
collagen. After cleansing the site, 0.1mL volume should be implanted
intradermally into the volar forearm surface.
Administration of ZYDERM Test Dose is a skilled procedure. Care must be taken to inject superficially to ensure any reaction is observed. Reaction to deep test injections may be missed. Therefore, it is recommended that test doses be administered by the practitioner who will perform the subsequent treatment. - The results of the test implantation must be carefully evaluated for a
four week period prior to the initiation of treatment with injectable
collagens. Test sites should be palpated as well as visually inspected for
reactions. Clinical experience has shown that the value of the test as a
screening device cannot be overemphasized. However, a negative skin test
does not preclude the possibility of subsequently developing a delayed
hypersensitivity response to the implant material following additional
exposures.
Patients should be instructed to notify their physician of any untoward test response observed within the four week period. - Discard the syringe after administration of the test implantation. Partly used syringes are to be discarded. A syringe should not be used on more than one patient.
Contraindications
ZYDERM™ Test Dose must not be used in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
ZYDERM™ Test Dose must not be used in patients with a history of allergies to bovine collagen products.
ZYDERM™ Test Dose contains lignocaine and must not be used in patients with known lignocaine hypersensitivity.
ZYDERM™ Test Dose is contraindicated for use in breast augmentation, and for implantation into bone, tendon, ligament or muscle.
Warnings and Precautions
A test implantation must be administered and evaluated prior to soft tissue deficiency correction with ZYDERM™ Test Dose (see Dosage and Administration).
If the test implantation response is positive, the patient must not be treated with injectable collagen implants. If the test implantation response is equivocal, it is recommended that a second test implantation be administered in the opposite arm and evaluated prior to the initiation of treatment.
Some physicians have reported the occurrence of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis (DM), and polymyositis (PM) subsequent to collagen injections, in patients with no previous history of these disorders. A comparison of the observed number of cases of PM/DM in the collagen treated population with an estimate of the expected number of cases suggests an association between collagen injections and PM/DM; i.e. there appears to be a higher than expected incidence of PM/DM in the collagen treated population. However, a causal relationship between collagen injection and the onset of autoimmune disease or systemic connective tissue disease has not been established.
Also, an increased incidence of cell-mediated and humoral immunity to various collagens have been found in systemic connective tissue diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, and progressive systemic sclerosis (scleroderma). Patients with these diseases may thus have an increased susceptibility to hypersensitivity responses and/or accelerated clearance of their implants when injected with bovine dermal collagen preparations.
ZYDERM™ Test Dose must not be implanted into blood vessels. Collagen can initiate platelet aggregation and implantation of ZYDERM™ Test Dose into dermal vessels may cause vascular occlusion, infarction or embolic phenomena.
Injectable bovine collagen should be used with caution in patients who are atopic or have a history of allergies. This class of patient has a greater potential of ultimately exhibiting an allergic reaction to bovine collagen than do other patients.
The use of ZYDERM™ Test Dose at specific sites in which an active inflammatory process or infection is present should be deferred until the underlying process has been controlled.
Adverse Effects
Adverse reactions have occurred in approximately 3% of patients.
Rare anaphylactoid responses have been reported with injectable collagen implants including acute episodes of hypotension, difficulty in breathing, tightness in chest and/or shortness of breadth.
On rare occasions, the hypersensitivity response has progressed to a cystic reaction which may drain purulent material. The incidence and severity of this type of hypersensitivity response reported to date has been greater with ZYPLAST™ (cross-linked) collagen implant than with non-cross-linked ZYDERM™ 1 or ZYDERM™ 2 or ZYDERM™ Test Dose. In some cases, this reaction has been associated with increased titres of anti-bovine collagen antibodies. These reactions develop weeks to months following injection and may result in induration and/or scar formation. This type of reaction can occur as multiple and/or recurrent sterile abscesses which tend to be persistent and resistant to drug therapy; careful incision and drainage has been a useful treatment.
Systemic complaints have been reported by fewer than 0.5% of patients. During clinical testing and subsequent monitoring of patient complaints following treatment with injectable collagen implants, a variety of systemic complaints have been reported. These reports have included flu-like symptoms (fever, myalgia, neuralgia, headache, nausea, malaise or dizziness); pruritus; rash; transient visual disturbances including blurred vision; tingling and numbness; transient polyarthralgia; and various systemic diseases including immune-mediated diseases.
Persistent swelling and scarring associated with injectable collagen implantation may occur despite a four week problem-free interval after the test dose.
Pharmaceutical Precautions
Shelf-life is 36 months when stored at 2°C to 10°C. Refrigerate. Do not freeze.
Medicine Classification
Prescription Medicine
Package Quantities
ZYDERM™ Test Dose is supplied sterile in syringes, ready for implantation. Each syringe is packaged with a sterile fine-gauge needle. If the syringe cap is dislodged, or if the package is not intact, sterility cannot be assured and the syringe should not be used. In the event that a syringe contains material that is crystal clear (like water), the syringe must not be used.
ZYDERM™ Test Dose: 6 x 0.1mL
Caution: The technique of the practitioner is essential to the success of the medical treatment. This medical device can only be used by or under the supervision of a medical doctor.
Name and Address
Allergan New Zealand Limited
Cnr Manu Tapu Drive & Joseph Hammond Place,
Auckland International Airport,
Mangere
Auckland 1
New Zealand
Toll free telephone: 0800 659 912
Date of Preparation
December 2007