Skin Test Instructions for Use Instructions D`utilisation Du
Contents
1. This class of patient has a greater potential of ultimately exhibiting an allergic reaction to bovine collagen than do other patients sites in which an active inflammatory process skin eruptions such as cysts pimples rashes or hives or infection is present should be deferred until the underlying process has been controlled2. Alin eq pinoys 1uened leuejeuJ 1uejnund uep Aew M On Sn ea eno eDBuu s y esn jou op eoueJeedde Bu OP Il 96 0 epuojuo unipes 966 0 GTIvVTI38 HLIM LNSIALIV3HLL Bulmo jo Sunou pz uey aow Aynjereo eq SNU 159 UYS eu Jo y pJe2 S INSEeY 1S9 UNS olleg U9IUM UOH9 9J ird 0 TAa E Aatu Toco peii Jea o ney jou seop eDuu s 4ejynq ejeudsoud ueDejoo sJe dde 10 sunoy pz uey aJou JO Sinse eu eoepins uJeeJoJ JejoA y Jo Adoo e uM pepivoJud eq seu esuodseJ AjAnisuesjed u P ni NM e JEU JUSAS OU UJ eoue1eedde 9UIAOQ G E JO SISISUOO S9 UPJS De1e8J eq 1ou p nous 1s91 SjsisJed pue uonejuejduui GuiMoj oj e oui A euuepeaur peyuejduul pinoys 1uened eui jse UNS alllereg OU SUOISE290 9JEJ UQ U1e8J4g JO ONI VOIG3I WAaNns Jee 5 e sey jse UYS olleg aellljelleg uoe3 e ueDeljoo peyund jo puooes SIU ui esuodseij jesonnb jeyeipeuuuur szeedde ueo uoiuw eq pinous 189 UMS alliielleg eu peaejsiuruupe ueq 0 Joud sseujous 140 pue 1seuo ui sseujuDn Ajuo esn uejois ud 0 eorep SIU sjorjseJ MEJ EJ6pe UOTne 2 99 0 Surejuoo eDuu s Peal B8 48d JO ny sod e Dunensuouep snyunid NOUZI JO YY Butjjews 99 L O OUS y Duisuee o JOUV Dulureeuq AJnoyyip uorsueyod u jo 7 Oo l JZ3dH4 LON OQ senjejeduue eJ1 pejees euo ui s u S G JO z Jo ejnsodxe u w ze 1 S UdIIeg SY M p euonippe ue JO pue sseuJepuej uomeunpul JZd3dH4d LON OG senje1eduue seposide ejnoe Burpnjour sjuejduui E 1o1eJeDujeJ pyepueis 1e p
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5. implants hemostatic sponges and collagen based sutures because these patients are likely to have hypersensitivity to the Bellafill Skin Test Bellafill Skin Test is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies Bellafill Skin Test is an aseptically produced device composed of purified collagen gel Each Bellafill Skin Test consists of 3 5 bovine collagen 2 7 phosphate buffer 0 9 sodium chloride 0 396 lidocaine hydrochloride and 92 696 water for injection INDICATIONS Bellafill Skin Test is intended to be administered intradermally into the volar forearm to identify individuals who might show hypersensitivity to injectable bovine dermal collagen devices Patients so identified are ineligible for treatment with Bellafill lidocaine and is contraindicated for patients with known hypersensitivity to lidocaine Bellafill Skin Test is contraindicated for patients undergoing or planning to undergo desensitization injections to meat products as these injections can contain bovine collagen e If the Skin Test response is positive the patient must not be treated with Bellafill If the Skin Test response is equivocal it is recommended that a second Skin Test be administered in the opposite arm and evaluated prior to the initiation of treatment Some physicians have reported the occurrence of con
6. 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 2 be used when treating these patients including consideration for further skin testing Patients with a history of dietary beef allergy should be carefully examined before they are administered the Bellafill Skin Test since it is possible that the collagen component of the beef may be causing the allergy More than 1 Skin Test is highly recommended prior to treating these patients PRECAUTIONS As with all transcutaneous procedures Bellafill Skin Test injection carries a risk of infection The usual precautions associated with injectable materials should be followed Results of the skin test may be inaccurate if patients are on immunosuppressive therapy Bellafill Skin Test 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 Use of Bellafill amp Skin Test at specific sites in which an active inflammatory process skin eruptions such as cysts pimples rashes or hives or infection is present should be deferred until the underlying process has been controlled Rare anaphylactoid responses have been reported with collagen implants including acute e
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8. de and 92 696 water for injection Bellafill Skin Test syringes are appropriate only for testing prior to treatment with Bellafill Each syringe is sealed for single patient use The tip of the syringe is sealed with a tamper evidence cover The tray lid is also sealed with a tamper evidence cover Do not use if package is damaged or the cover is broken or removed Do not resterilize STORAGE DIRECTIONS Bellafill Skin Test syringes should be stored at standard refrigerator temperatures DO NOT FREEZE Bellafill Skin Test has a clear appearance In the event that a syringe does not have a clear appearance do not use the syringe and notify Suneva Medical at 1 858 550 9999 local Bellafill representative Outside the United States call 1 858 550 9999 Orders may also be sent by fax to 858 550 9997 or email to orders sunevamedical com Caution Federal law restricts this device to physician use only SUNEVA MEDICAL INC 5870 Pacific Center Blvd San Diego CA 92121 United States of America Outside the U S Phone 1 858 550 9999 Fax 858 550 9997 customersupport sunevamedical com www sunevamedical com www bellafill com 7193 REVO1 10 2014 ral 9r Gl ezi 49 s84 JOU OG peAouJaJ Jo uexoJq SI 49409 y JO pebewep si eDexoed VL gl y Jo Ayigissod y epnjoeud jou J BSN JOU OG 49409 eouepi e Jeduje ULIM pej ees osje s pi eJ eu 49409 eouepi e 1eduJe e ui pejees Seop 1s
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13. nective tissue diseases such as rheumatoid arthritis systemic lupus erythematosus SLE polymyositis PM and dermatomyositis DM subsequent to collagen injections in patients with no previous history of those disorders Also mediated and humoral immunity to various collagens has 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 Therefore caution should be used when treating these patients including consideration for further skin testing beef allergy should be carefully examined before they are administered the Bellafill8 Skin Test since it is possible that the collagen component of the beef may be causing the allergy More than 1 skin test is highly recommended prior to treating these patients As with all transcutaneous procedures Bellafill Skin Test injection carries a risk of infection The usual precautions associated with injectable materials should be followed e Results of the Skin Test may be inaccurate if patients are on immunosuppressive therapy e Bellafill Skin Test should be used with caution in patients who are atopic or have a history of allergies
14. oo uonnjos eun ue ejsisuoo i yejjeg eueino 1se1 enbeuj5 euyund eueBejoo ep jab un p esoduioo enbndese Jisodsip un 1se glljeieg ieuuondo euejno s9 97 NOILdld2S3Q epeue Skin Test Instructions for Use UN nyeeg 9ue1n sa nq uonesi an q suononuisu flueneq epeued epeued epeue epeued epeue epeue nyen g 9ue1 Ise nq uonesmnn suononasu uep eq bellafill SKIN TEST INSTRUCTIONS FOR USE Canada Canada Canada Canada Canada Canada DESCRIPTION Bellafill Skin Test contains lidocaine and collagen preparations Therefore caution should ADVERSE EVENTS be carefully evaluated for a 4 week period prior to TREATMENT WITH BELLAFILL IS HOW SUPPLIED To place an order contact Suneva Medical Inc or your The optional Bellafill Skin Test is an aseptically produced device composed of purified collagen gel Each Bellafill Skin Test consists of 3 5 bovine collagen 2 7 phosphate buffer 0 9 sodium chloride 0 3 lidocaine hydrochloride and 92 6 water for injection INDICATIONS The optional Bellafill Skin Test is intended to be administered intradermally into the volar forearm to identify individuals who might show hypersensitivity to injectable bovine dermal collagen devices Patients so identified are ineligible for treatment with Bellafill CONTRAINDICATIONS Bellafill Skin Test contains bovine collagen and is contraindicated for patients with a history of allergies to any bovine collagen products including bu
15. pisodes of hypotension difficulty breathing tightness in chest and or shortness of breath On rare occasions the hypersensitivity response has progressed to a cystic reaction that may drain purulent material DIRECTIONS FOR USE Note Bellafill Skin Test should be stored at standard refrigerator temperatures DO NOT FREEZE Prior to being administered the Bellafill Skin Test the patient should be provided with a copy of the Bellafill Skin Test Results Card The patient should be fully apprised of the purpose of and evaluation criteria for the Skin Test 1 After verifying that contraindications to the proposed Bellafill treatment do not exist a Bellafill Skin Test is administered At the time of the initial evaluation a complete medical history should be obtained 2 The Bellafill Skin Test syringe must be brought to room temperature before injection 3 After cleansing the site 0 1 cc Bellafill Skin Test should be implanted intradermally into a volar forearm surface The results of the skin test must the initiation of treatment with Bellafill Patients should be instructed to notify their physicians of any untoward test response observed within the 4 week period 4 Discard the syringe after administration of the Bellafill Skin Test a Positive Response A positive response consists of erythema of any degree induration tenderness and swelling with or without pruritus which can appear immediately follo
16. t not limited to collagen injectables except to verify questionable allergy collagen implants hemostatic sponges and collagen based sutures because these patients are likely to have hypersensitivity to the Bellafill amp Skin Test Bellafill amp Skin Test is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies is contraindicated for patients with known hypersensitivity to lidocaine Bellafill Skin Test is contraindicated for patients undergoing or planning to undergo desensitization injections to meat products as these injections can contain bovine collagen WARNINGS If the skin test response is positive the patient must not be treated with Bellafill If the skin test response is equivocal it is recommended that a second Skin Test 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 SLE polymyositis PM and dermatomyositis DM subsequent to collagen injections in patients with no previous history of those disorders Also an increased incidence of cell mediated and humoral immunity to various collagens has been found in systemic connective tissue diseases such as rheumatoid arthritis juvenile rheumatoid arthritis and progressive systemic sclerosis
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18. wing implantation and persists for more than 24 hours or appears more than 24 hours following implantation b Equivocal Response An equivocal response is one in which there is no localized skin reaction but the patient does elicit a possible systemic reaction such as a rash arthralgia aching joints or myalgia aching muscles that occurs at any time during the 4 week observation period If an equivocal response is observed a second injection in the opposite arm is required with observation for an additional 4 weeks Patients demonstrating a positive or equivocal response in this second test should not be treated CONTRAINDICATED IN ANY PATIENT EXHIBITING A POSITIVE RESPONSE OR 2 EQUIVOCAL RESPONSES Clinical experience has shown that the importance of screening by means of the optional Bellafill Skin Test cannot be overemphasized however it is at the physician s discretion to determine whether a Skin Test may be necessary A negative Skin Test does not preclude the possibility of the patient subsequently developing a delayed hypersensitivity response to the implant material following treatment exposure The Bellafill Skin Test is an aseptic product packaged in configurations of 2 or 5 syringes in one sealed tray per box Each syringe contains 0 3 cc of purified collagen gel Each Bellafill Skin Test consists of 3 596 bovine collagen 2 796 phosphate buffer 0 996 sodium chloride 0 396 lidocaine hydrochlori
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