通用中文 | 门冬胰岛素 | 通用外文 | Insulin Aspart, insulin Aspart Protamin |
品牌中文 | 品牌外文 | Novomix 30 Flexpen | |
其他名称 | 胰岛素天冬氨酸 | ||
公司 | 诺和诺德(novo nordisk) | 产地 | 丹麦(Danmark) |
含量 | 100iU/ml(3 ml) | 包装 | 5支/盒 |
剂型给药 | prefilled syringe | 储存 | 2度-8度(冰箱冷藏,禁止冷冻) |
适用范围 | 胰岛素依赖的糖尿病患者 |
通用中文 | 门冬胰岛素 |
通用外文 | Insulin Aspart, insulin Aspart Protamin |
品牌中文 | |
品牌外文 | Novomix 30 Flexpen |
其他名称 | 胰岛素天冬氨酸 |
公司 | 诺和诺德(novo nordisk) |
产地 | 丹麦(Danmark) |
含量 | 100iU/ml(3 ml) |
包装 | 5支/盒 |
剂型给药 | prefilled syringe |
储存 | 2度-8度(冰箱冷藏,禁止冷冻) |
适用范围 | 胰岛素依赖的糖尿病患者 |
活性物质胰岛素天冬氨酸双相
ATX codeA10AD05胰岛素天冬氨酸
药理组物质降钙素
低血糖药物,中等持续时间或长短作用的胰岛素类似物的组合[胰岛素]
香精分类(ICD-10)
E10胰岛素依赖型糖尿病
碳水化合物代谢的减少,糖尿病,糖尿病胰岛素糖,1型糖尿病,糖尿病酮症酸中毒,胰岛素依赖性糖尿病,胰岛素依赖性糖尿病,昏迷高渗性非酮症酸性糖尿病不规则形式,违反碳水化合物代谢,1型糖尿病,I型糖尿病,胰岛素依赖性糖尿病,1型糖尿病
E11非胰岛素依赖型糖尿病
糖尿病糖尿病,碳水化合物代谢的减少,糖尿病胰岛素不依赖糖,糖尿病糖2型,2型糖尿病,非胰岛素依赖性糖尿病,非胰岛素依赖性糖尿病,非胰岛素依赖性糖尿病,胰岛素抵抗,胰岛素抵抗糖尿病,糖尿病乳酸菌,违反碳水化合物代谢,2型糖尿病,II型糖尿病,成年糖尿病,老年糖尿病,糖尿病胰岛素不依赖,2型糖尿病,糖胰岛素依赖型糖尿病II型
组成
NovoMix®30Penfill®
用于皮下给药的悬浮液1ml
活性物质:
胰岛素天冬氨酸天冬氨酸(30%)和天冬氨酸鱼精蛋白(70%)胰岛素晶体100单位(3.5mg)
辅助物质:甘油 - 16 mg; 苯酚 - 1.5mg; 甲酚 - 1.72mg; 锌(以氯化锌的形式) - 19.6μg; 氯化钠 - 0.877毫克; 磷酸氢二钠二水合物 - 1.25mg; 硫酸鱼精蛋白 - 约0.32毫克; 氢氧化钠 - 约2.2mg; 盐酸约1.7毫克; 注射用水 - 高达1毫升
1个墨盒(3毫升)含有300个单位
NovoMix®30FlexPen®
用于皮下给药的悬浮液1ml
活性物质:
胰岛素天冬氨酸天冬氨酸(30%)和天冬氨酸鱼精蛋白(70%)胰岛素晶体100单位(3.5mg)
辅助物质:甘油 - 16 mg; 苯酚 - 1.5mg; 甲酚 - 1.72mg; 锌(以氯化锌的形式) - 19.6μg; 氯化钠 - 0.877毫克; 磷酸氢二钠二水合物 - 1.25mg; 硫酸鱼精蛋白 - 约0.32毫克; 氢氧化钠 - 约2.2mg; 盐酸约1.7毫克; 注射用水 - 高达1毫升
1个预充注射器笔(3毫升)包含300个单位
剂型说明
均匀悬浮白色,不含肿块。 样品中可能会出现片状物。
静置后,将悬浮液分层以形成白色沉淀和无色或几乎无色的上清液。
当搅拌沉淀物时,应根据医疗说明书中描述的程序形成均匀的悬浮液。
药理作用
药理作用 - 低血糖。
药效学
NovoMix®30Penfill®/FlexPen®是由可溶性天冬氨酸天冬氨酸(30%短效胰岛素类似物)和天冬氨酸鱼精蛋白的胰岛素晶体(平均持续时间的70%胰岛素类似物)组成的两相悬浮液。 活性物质NovoMix®30Penfill®/FlexPen®是通过使用酿酒酵母菌株的重组DNA的生物技术生产方法产生的胰岛素门冬胰岛素。
胰岛素天冬氨酸是基于摩尔浓度指数的等位可溶性人胰岛素。
由于胰岛素门冬胰岛素与肌肉和脂肪组织的胰岛素受体结合后的细胞内转运增加,肝脏的葡萄糖产生同时抑制,血糖水平降低。 在推出NovoMix®30Penfill®/FlexPen®之后,效果将在10-20分钟内发生。 在注射后1〜4小时范围内观察到最大效果。 药物持续时间达24小时。
在早餐和晚餐之前,在接受NovoMix®30Penfill®/FlexPen®和双相人胰岛素30次,每天2次的1型和2型糖尿病患者的三个月比较临床试验中,显示NovoMix® 30 Penfill®/ FlexPen®强烈降低餐后血糖水平(早餐和晚餐后)。
来自涉及1型和2型糖尿病患者的9项临床试验数据的Meta分析表明,NovoMix®30Penfill®/FlexPen®在早餐和晚餐前给药时,可以更好地控制餐后血糖(平均膳食血糖水平升高早餐,午餐和晚餐后),与人类双相胰岛素相比较30.尽管使用NovoMix®30Penfill®/FlexPan®的患者的空腹血糖较高,但一般来说NovoMix®30Penfill®/FlexPen®已经呈现出同样的效果糖化血红蛋白(HbA1c)的浓度,以及双相人胰岛素30。
在涉及341例2型糖尿病患者的临床研究中,患者随机分为仅与NovoMix®30Penfill®/FlexPan®,NovoMix®30Penfill®/FlexPen®联合二甲双胍和二甲双胍与磺酰脲衍生物联合使用。 在使用NovoMix®30Penfill®/FlexPin®联合二甲双胍治疗的患者和接受二甲双胍联合磺酰脲衍生物的患者中,治疗16周后的HbA1c浓度没有差异。 在本研究中,57%的患者基线HbA1c浓度高于9% 在这些患者中,使用NovoMix®30Penfill®/FlexPen®与二甲双胍联合治疗,导致HLA1c浓度比接受二甲双胍与磺酰脲衍生物联合使用的患者更为显着。
另一项研究中,将不服用血糖控制服用口服降血糖药物的2型糖尿病患者随机分为以下组:每天接受Novomix®30次(117例),每天接受甘精胰岛素(116例)。 施用28周后,NovoMix®30Penfill®/FlexPan®组的HbA1c浓度平均下降为2.8%(初始平均值为9.7%)。 在66%和42%的使用NovoMix®30Penfill®/FlexPen®的患者中,HbA1c值在研究结束时分别低于7%和6.5%。 平均空腹血糖降低约7mmol / l(从研究开始时的14mmol / L降至7.1mmol / L)。
来自临床试验涉及2型糖尿病患者的数据的meta分析结果显示,与NovoMix®30Penfill®/FlexPen®相比,与两期人相比,夜间低血糖发作和严重低血糖发生总数减少胰岛素30.在这种情况下,用NovoMix®30Penfill®/FlexPan®治疗的患者白天低血糖的总体风险较高。
儿童和青少年。 进行16周的临床试验,比较30天(饭前),人胰岛素/双相人胰岛素30(饭前)和异烟醛 - 胰岛素(睡前给药)之间的血糖。 该研究涉及167例10至18岁的患者。 两组中HbA1c的平均值在整个研究中保持接近初始值。 此外,当使用NovoMix®30Penfill®/FlexPen®或两相人胰岛素30时,低血糖发生率无差异。
在6〜12岁的患者群中进行了双盲,横断面研究(共54例,每种治疗12周)。 使用NovoMix®30Penfill®/FlexPen®的患者组的低血糖发生率和餐后葡萄糖增加显着低于使用双相人胰岛素30的患者组。研究结束时HbA1c的值在双相组人胰岛素30中,显着低于使用NovoMix®30Penfill®/FlexPen®的患者组。
老年病人。 药物动力学NovoMix®30Penfill®/FlexPen®在老年和老年患者尚未研究。 然而,在19例年龄65-83岁(平均年龄70岁)的2型糖尿病患者的随机双盲交叉研究中,比较了胰岛素门冬胰岛素和可溶性人胰岛素的药效学和药代动力学。 老年患者胰岛素门冬胰岛素与人胰岛素的药代动力学(最大葡萄糖输注速率 - 最大葡萄糖输注速度 - 最大葡萄糖浓度和投药后120分钟内输注速率曲线下面积AUCGIR,0-120分钟)的差异分别为类似于健康志愿者和年轻的糖尿病患者。
临床前安全数据
根据普遍接受的药物安全性研究,再利用毒性,遗传毒性和生殖毒性的数据,临床前研究尚未发现对人类有任何危害。
在体外试验中,其包括结合胰岛素和IGF-1受体和对细胞生长的影响,显示胰岛素门冬胰岛素的性质与人胰岛素的性质相似。 研究结果还表明,胰岛素门冬胰岛素与胰岛素受体结合的解离等同于人胰岛素的结合。
药代动力学
在天冬氨酸的天冬氨酸中,用天冬氨酸替代位置B28的氨基酸脯氨酸降低了在可溶性人胰岛素中观察到的可溶性级分中的分子形成六聚体的趋势。 在这方面,天冬氨酸天门冬氨酸(30%)从皮下脂肪吸收比二相人胰岛素中含有的可溶性胰岛素更快。 剩余的70%归因于鱼精蛋白 - 胰岛素门冬胰岛素的结晶形式,其吸收速率与人NPH胰岛素的吸收速率相同。
施用NovoMix®30Penfill®/FlexPen®后血清中的C max胰岛素比两相人胰岛素30高50%,Tmax与两相人胰岛素30相比是一半。
在健康志愿者中,以0.2U / kg C max的速率给予Novomix 30后,血清中的门冬胰岛素在60分钟后达到(140±32)pmol / l。 NovoMix®30的T1 / 2的持续时间,反映了鱼精蛋白相关级分的吸收速率,为8-9小时。 给药后15-18小时血清胰岛素水平恢复到基线。 在2型糖尿病患者中,Cmax在给药后95分钟达到,并保持在基线以上至少14小时。
老年患者和老年人。 NovoMix®30在老年和老年患者中的药代动力学研究未进行。 然而,老年2型糖尿病(年龄65-83岁,平均70岁)胰岛素门冬胰岛素与人体可溶性胰岛素的药代动力学相似差异与健康志愿者和年龄较小的糖尿病患者相似。 在老年患者中,观察到吸收率的降低,导致T1 / 2减慢(82分钟四分位数范围 - 60-120分钟),而平均Cmax与年龄较小的患者类似2型糖尿病,略低于1型糖尿病患者。
肾功能受损的患者。 没有研究NovoMix®30Penfill®/FlexPen®在肾脏和肝脏功能受损患者中的药代动力学。 然而,随着肾脏和肝脏功能受损程度不同的患者药物剂量的增加,可溶性胰岛素门冬胰岛素的药代动力学没有变化。
儿童和青少年。 NovoMix®30Penfill®/FlexPen®在儿童和青少年中的药代动力学性质尚未研究。 然而,在1型糖尿病儿童(6至12岁)和青少年(13至17岁)中研究了可溶性胰岛素门冬胰岛素的药代动力学和药效学性质。 在两个年龄组中,门冬胰岛素的特征在于快速吸收和Tmax值与成人相似。 然而,两个年龄组的Cmax值不同,这表明个体选择胰岛素门冬胰岛素剂量的重要性。
适应症
糖尿病。
禁忌
增加对胰岛素门冬胰岛素或药物的任何成分的个体敏感性。
不推荐用于6岁以下的儿童。 关于使用NovoMix®30Penfill®/FlexPen®的临床研究尚未实施。
怀孕和哺乳期
怀孕期间NovoMix®30Penfill®/FlexPen®的临床经验有限。
关于在孕妇中使用NovoMix®30Penfill®的研究尚未进行。
然而,与可溶性人胰岛素相比,两项随机对照临床试验(157名和14名在基础推注方案中接受门冬胰岛素的孕妇)的数据显示怀孕期间或门诊/新生儿健康状况下胰岛素门冬胰岛素没有显着的副作用。 此外,在接受27名妊娠糖尿病妇女的临床随机试验中,他们接受了天门冬胰岛素和可溶性人胰岛素(14名妇女接受了天门冬胰岛素,13人胰岛素),证实了两种胰岛素类似的安全性。
在怀孕期间,在整个期间,有必要认真监测糖尿病患者的状况并监测血液中葡萄糖的浓度。 一般来说,胰岛素的需求在妊娠期减少,妊娠第二和第三个三个月逐渐上升。 出生不久后,胰岛素的需要迅速恢复到怀孕前的水平。
在母乳喂养期间,可以无限制地使用NovoMix®30Penfill®/FlexPen®。 向哺乳母亲引入胰岛素并不会对孩子构成威胁。 但是,可能需要调整NovoMix®30Penfill®/FlexPen®的剂量。
副作用
使用Novomix®30患者观察到的不良反应主要是由于胰岛素的药理作用。 使用胰岛素最常见的不良现象是低血糖症。 副作用在NovoMix®30背景下的发生率取决于患者群体,药物的剂量方案和血糖控制。
在胰岛素治疗的初始阶段,可能会发生屈光不正,水肿和注射部位的反应(包括疼痛,发红,荨麻疹,炎症,血肿,注射部位肿胀和瘙痒)。 这些症状通常是暂时的。 血糖控制的快速改善可导致急性疼痛神经病变的状态,这通常是可逆的。 胰岛素治疗的强化与碳水化合物代谢控制的显着改善可能导致糖尿病性视网膜病变的状态暂时恶化,而血糖控制的持续改善降低了糖尿病性视网膜病变进展的风险。
所选不良反应的描述
过敏反应。 已经注意到非常罕见的广泛性超敏反应(包括广泛性皮疹,瘙痒,出汗增加,胃肠道疾病,血管性水肿,呼吸困难,心悸,降血压)。
低血糖症。 低血糖是最常见的副作用。 如果胰岛素的剂量相对于胰岛素的需要太高,可能会发展。 严重的低血糖可导致意识丧失和/或抽搐,脑功能的暂时或不可逆的破坏直到致命的结果。 低血糖症状往往突然发展。 它们可能包括冷汗,皮肤苍白,疲劳,紧张或震颤,焦虑感,异常疲劳或虚弱,定向受损,集中度降低,嗜睡,严重饥饿,视力障碍,头痛,恶心和心悸。 临床研究表明,低血糖发生率根据患者群体,给药方案和血糖控制而变化。 临床研究显示接受胰岛素门冬胰岛素治疗的患者和使用人胰岛素制剂的患者的低血糖发生总发生率无差异。
脂肪代谢障碍。 有报道称罕见的脂肪营养不良病例。 脂肪营养不良可以在注射部位发展。
相互作用
有一些影响胰岛素需求的药物。 胰岛素的低血糖作用增加口服降糖药物,MAO抑制剂,ACE抑制剂,碳酸酐酶抑制剂,非选择性β-肾上腺素阻滞剂,溴隐亭,磺胺类药物,合成代谢类固醇,四环素,氯贝丁酯,酮康唑,甲苯达唑,吡哆醇,茶碱,环磷酰胺,芬氟拉明,锂制剂,水杨酸。
胰岛素的降血糖作用由口服避孕药,GCS,甲状腺激素,噻嗪类利尿剂,肝素,三环抗抑郁药,拟交感神经药,生长激素,达那唑,可乐定,BCC,二氮嗪,吗啡,苯妥英,尼古丁减弱。
β受体阻滞剂可以掩盖低血糖症状。
奥曲肽/兰瑞肽可以增加和减少身体对胰岛素的需求。
酒精可以增加或降低胰岛素的降血糖作用。
不兼容。 由于尚未进行兼容性研究,因此NovoMix®30Penfill®/FlexPen®不应与其他药物混合使用。
给药和管理
NovoMix®30Penfill®/FlexPen®适用于蜡。 不要注入NovoMix®30Penfill®/FlexPen®IV。 这可能导致严重的低血糖。 您还应避免/ m引入NovoMix®30Penfill®/FlexPen®。 不要在胰岛素泵中使用NovoMix®30Penfill®/FlexPen®胰岛素输注(PPII)。
根据患者的需要,医生在每种情况下单独确定NovoMix®30Penfill®/FlexPen®的剂量。 要达到最佳血糖水平,建议监测血糖浓度和剂量调整。
2型糖尿病患者NovoMix®30Penfill®/FlexPen®可以在单一疗法中和口服降糖药联合使用,在那些仅通过口服降血糖药物不能充分调节血糖水平的情况下。
开始治疗
对于已经首次使用胰岛素的2型糖尿病患者,推荐的初始剂量NovoMix®30Penfill®/FlexPen®在早餐前为6单位,晚餐前为6单位。 晚上(晚餐前一天)也可以一天一次的服用12套NovoMix®30Penfill®/FlexPen®。
从其他胰岛素制剂转移患者
将患者从双相人胰岛素转移至NovoMix®30Penfill®/FlexPen®时,应开始相同的剂量和给药方案。 然后根据患者的个体需要调整剂量(参见下文中关于滴定药物剂量的建议)。 与往常一样,当将患者转移到新型胰岛素时,在患者转移期间和使用新药的头几周需要严格的医疗控制。
治疗强化
通过从单次日剂量切换到双剂量,可以加强NovoMix®30Penfill®/FlexPen®治疗。 建议在达到剂量30单位药物后,每天更换2次NovoMix®30Penfill®/FlexPen®,将早餐和晚餐(早餐和晚餐前)的剂量分为两等份。
每天3次过渡到NovoMix®30Penfill®/FlexPen®可以通过将早晨剂量分成两个相等的部分,并在早上和午餐时段(三次每日剂量)中引入这两个部分。
修正剂量
为了调整NovoMix®30Penfill®/FleksPen®的剂量,使用过去三天获得的最低空腹血糖浓度。
为了评估以前剂量的适宜性,请在下一顿饭之前使用血糖值。
剂量调整可以每周进行一次,直到目标HbA1c达到。 不要增加药物的剂量,如果在此期间观察到低血糖。
如果患者的身体活动增加,他的常规饮食改变,或者伴有疾病,可能需要调整剂量。
特殊病人群体
与使用胰岛素制剂一样,特殊群体的患者应更密切地监测血液中的葡萄糖浓度,并单独调整胰岛素的剂量。
老年患者和老年人。 NovoMix®30Penfill®/FlexPen®可用于老年患者,但75岁以上患者的口服降血糖药物经验有限。
患有肾脏和肝衰竭的患者。 在肾或肝功能不全的患者中,可以减少对胰岛素的需要。
儿童和青少年 。 当首选预混胰岛素时,NovoMix®30Penfill®/FlexPen®可用于治疗十岁以上儿童和青少年。 6-9岁儿童的临床资料有限(见药效学)。
NovoMix®30Penfill®/FlexPen®应注射到大腿或前腹壁。 如果需要,药物可以注射到肩部或臀部区域。
有必要改变解剖区域内的注射部位,以防止脂肪营养不良的发展。
与任何其他胰岛素制剂一样,NovoMix®30Penfill®/FlexPen®的持续时间取决于剂量,给药部位,血流强度,体温和身体活动水平。
与两相人胰岛素相比,NovoMix®30Penfill®/FlexPen®开始起作用更快,因此在服用婴儿前应立即注射。 如有必要,您可以在收到利基后立即进入NovoMix®30Penfill®/FlexPen®。
过量
症状。 胰岛素过量所需的一定剂量尚未建立,但如果根据患者的需要施用过高的剂量,低血糖可逐渐发展。
治疗。 容易患者低血糖可以消除自身,服用葡萄糖或含糖食物。 因此,鼓励糖尿病患者不断携带含糖食品。
在严重低血糖的情况下,当患者无意识时,您应该从0.5mg至1mg的胰高血糖素IM或SC(可由受过训练的人员)或IV葡萄糖(葡萄糖)溶液进入(只能由医学专业的 )。 如果患者在引入胰高血糖素后10-15分钟内没有恢复意识,还需要注射IV葡萄糖。 恢复意识后,建议患者摄取富含碳水化合物的食物,以防止低血糖症复发。
特别说明
在与时区变化相关的长途旅行之前,患者应咨询其主治医师,因为更改时区意味着患者应在另一时间服用食物并注射胰岛素。
高血糖。 剂量不足或停止治疗,特别是1型糖尿病,可导致高血糖或糖尿病酮症酸中毒的发展。 通常,高血糖症的第一症状在几小时或几天内逐渐出现。 高血糖症状在呼出的空气中口渴,尿频,恶心,呕吐,瞌睡,皮肤发红,干燥,口干,食欲不振以及丙酮气味。 没有适当的治疗,1型糖尿病患者的高血糖可导致糖尿病酮症酸中毒,这是一种潜在致命的病症。
低血糖症。 跳餐或计划外的剧烈运动可导致低血糖。 如果胰岛素的剂量相对于患者的需要太高,低血糖也会发展(参见“副作用”和“过量”)。 与双相人胰岛素相比,NovoMix®30Penfill®/FlexPen®在给药后6小时内具有更显着的降血糖作用。 在这方面,在某些情况下,您可能需要调整胰岛素的剂量和/或营养的性质。
补充碳水化合物代谢后,例如,通过强化胰岛素治疗,他们的典型症状 - 低血糖前体可能在患者中发生变化,应通知患者。 常见的症状 - 前体可以随着糖尿病持续而消失。 患者中更严格的血糖控制可能会增加发生低血糖的风险,因此,在严格的医疗监督下,应增加“NovoMix®30Penfill®/FlexPan®”的剂量,如“给药方法和剂量”一节所述。 由于Novomix®30Penfill®/FlexPan®应与食物摄取直接相关,所以在治疗合并症或服用缓慢摄食的药物时,应考虑药物效应的高发生率。
伴随疾病,特别是传染性疾病,伴有发烧,通常会增加身体对胰岛素的需求。 如果患者伴随肾脏,肝脏,肾上腺,垂体或甲状腺疾病的疾病,也可能需要更换药物的剂量。
当将患者转移到其他类型的胰岛素时,与应用先前类型的胰岛素观察到的那些相比,早期症状 - 低血糖的前体可能改变或变得不那么显着。
从其他胰岛素制剂转移患者。 将患者转移到其他制造商的新型胰岛素或胰岛素制剂必须在严格的医疗监督下进行。 如果胰岛素制剂的浓度,类型,生产者和物种(人胰岛素,人胰岛素类似物)和/或生产方法改变,则可能需要剂量改变。 从其他胰岛素制剂转为NovoMix®30Penfill®/FlexPan®的患者可能要求与先前使用的胰岛素制剂相比,注射频率或剂量变化增加。 如果需要调整剂量,可以在药物的第一次给药或治疗的前几周或几个月内完成。
行政部门的反应。 与其他胰岛素制剂一样,注射部位的反应可以发展,其表现为疼痛,发红,荨麻疹,炎症,瘀伤,肿胀和瘙痒。 同一解剖学领域的注射部位的定期更换降低了这些反应的风险。 反应通常在几天到几周的时间内消失。 在极少数情况下,由于在管理现场的反应,可能需要取消NovoMix®30Penfill®/FlexPen®。
同时使用噻唑烷二酮组和胰岛素制剂的制剂。 已经报道了用于治疗噻唑烷二酮类与胰岛素制剂组合的患者的CHF病例,特别是如果这样的患者具有CHF的危险因素。 在使用噻唑烷二酮类和胰岛素制剂指定患者联合治疗时,应考虑到这一事实。 当这种联合疗法被规定时,有必要对患者进行身体检查,以确定CHF的体征和症状,体重增加和水肿。 患者心力衰竭症状恶化的情况下,应停止用噻唑烷二酮治疗。
胰岛素抗体 使用胰岛素可以形成抗体。 在极少数情况下,抗体的形成可能需要校正胰岛素的剂量,以防止高血糖或低血糖的病例。
对驾驶车辆和机械工作的能力的影响。 低血糖症患者聚焦和反应的能力可能受损,这在特别需要这些能力的情况下可能是危险的(例如驾驶车辆或使用机制时)。 建议患者采取措施,防止驾驶车辆或使用机制时的低血糖。 这对于缺乏或减少症状严重程度的患者尤其重要,即发生低血糖的前兆或频繁发生低血糖症的患者。 在这些情况下,应考虑驾驶车辆和进行此类工作的可取性。
问题形式
NovoMix®30Penfill®
用于皮下给药的悬浮液,100U / ml。 对于水解类玻璃I的药筒中的3ml药物,在一侧用溴丁基橡胶/聚异戊二烯塞子密封,另一侧用溴丁基橡胶的活塞密封。 玻璃球被放置在墨盒中,这有助于悬浮液的混合。 药筒被密封在多次注射的塑料多剂量一次性注射器笔中。 5个多剂量一次性注射器放置在纸板箱中。
NovoMix®30FlexPen®
用于皮下给药的悬浮液,100U / ml。 对于水解类玻璃I的药筒中的3ml药物,在一侧用溴丁基橡胶/聚异戊二烯塞子密封,另一侧用溴丁基橡胶的活塞密封。 玻璃球被放置在墨盒中,这有助于悬浮液的混合。 药筒被密封在多次注射的塑料多剂量一次性注射器笔中。 5个多剂量一次性注射器放置在纸板箱中。
药店的休假条款
处方。
储存条件
在2-8℃的温度下(在冰箱中)。 但不在冰柜旁边。 不要冻结 打开的墨盒:不要存放在冰箱里。 储存温度不超过30°C。使用4周内。 将墨盒存放在纸板箱中,以防止其受到光照。 应保护药物免受过热和过热。
放在儿童接触不到的地方。
保质期
2年。
NovoMix 30 FlexPen 3 mL Suspension for injection
Insulin, aspart (rys); Insulin, aspart (rys) protamine suspension
Brand Information
Brand name
NovoMix 30 FlexPen 3 mL Suspension for injection
Active ingredient
Insulin, aspart (rys); Insulin, aspart (rys) protamine suspension
Schedule
S4
Consumer medicine information (CMI) leaflet
Please read this leaflet carefully before you start using NovoMix 30 FlexPen 3 mL Suspension for injection.
What is in this leafletBefore you use NovoMix® 30 FlexPen®
How to use NovoMix® 30 FlexPen®
While you are using NovoMix® 30 FlexPen®
Things to be careful of
Side effects
After using NovoMix® 30 FlexPen®
Product description
Further information
Instructions For Use
This leaflet answers some common questions about NovoMix® 30 FlexPen®. It does not contain all the available information. It does not take the place of talking to your doctor, diabetes education nurse or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using NovoMix® 30 FlexPen® against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor, diabetes education nurse or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What NovoMix® 30 is used forThe insulin aspart (rys), or “NovoMix® 30”, in NovoMix® 30 FlexPen® is a mixture of rapid- and longer-acting insulin used to treat diabetes mellitus. Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level. Extra insulin is therefore needed.
There are two types of diabetes mellitus:
Type 1 diabetes – also called juvenile onset diabetes
Type 2 diabetes – also called maturity onset diabetes
Patients with type 1 diabetes always require insulin to control their blood sugar levels.
Some patients with type 2 diabetes may also require insulin after initial treatment with diet, exercise and tablets.
NovoMix® 30 lowers your blood sugar level after injection. When injected under your skin, NovoMix® 30 has a faster onset of action than soluble human insulin. It takes effect within 10 to 20 minutes. The maximum effect will occur between 1-4 hours after injection and the effect may last for up to 24 hours.
As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
NovoMix® 30 is a pre-mixed neutral suspension consisting of rapid-acting insulin aspart (rys) (30%) and longer-acting protamine insulin aspart (rys) (70%).
FlexPen® is a pre-filled dial-a-dose insulin pen able to deliver from 1 to 60 units in increments of 1 unit.
NovoMix® 30 FlexPen® can be used alone, or together with other medicines, for treating diabetes.
NovoMix® 30 is not addictive.
NovoMix® 30 FlexPen® is available only with a doctor’s prescription.
Ask your doctor, diabetes education nurse or pharmacist if you have any questions about why NovoMix® 30 FlexPen® has been prescribed for you.
Before you use NovoMix® 30 FlexPen®When you must not use itDo not use the medicine if:
you have an allergy to:
· any medicine containing insulin
· any of the ingredients listed in the ‘Ingredients’ section of this leaflet.
Some of the symptoms of an allergic reaction may include:
· redness, swelling, rash and itching at the injection site
· rash, itching or hives on the skin
· shortness of breath
· wheezing or difficulty breathing
· swelling of the face, lips, tongue or other parts of the body.
you are experiencing a low blood sugar level (a “hypo”) when the dose is due.
If you have a lot of hypos discuss appropriate treatment with your doctor.
If you are not sure whether you should start using this medicine, talk to your doctor.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Before you start to use itTell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any medical conditions, especially the following:
· kidney problems
· liver problems
· adrenal, pituitary or thyroid gland problems.
Tell your doctor if you are pregnant or plan to become pregnant.
Pregnancy may make managing your diabetes more difficult. Insulin needs usually decrease during the first three months of pregnancy and increase during the last six months. Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you are breast-feeding or plan to breast-feed.
Your doctor or pharmacist can discuss with you the risks and benefits involved.
Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who are treated with thiazolidinediones in combination with insulin may develop heart failure.
If you have not told your doctor about any of the above, tell them before you start using this medicine.
Taking other medicinesTell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and NovoMix® 30 may interfere with each other and this may mean that your insulin dose has to change.
If you take any of the medicines below, your blood sugar may fall (hypoglycaemia):
· other medicines used to treat type 2 diabetes
· monoamine oxidase inhibitors (MAOI) - used for the treatment of depression
· alpha blockers - used to treat high blood pressure and to relieve difficulty in passing urine caused by an enlarged prostate
· non-selective beta blockers used to treat high blood pressure and certain heart conditions which may also mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia
· ACE inhibitors - used to treat high blood pressure, certain heart conditions or elevated protein/albumin in the urine
· salicylates e.g. aspirin - used to relieve pain and lower fever
· anabolic steroids – used to promote growth
· sulfonamides – used to treat bacterial infections
· quinine – used to treat malaria and relieve muscle cramps
· quinidine – used to treat heart problems.
If you take any of the medicines below, your blood sugar level may rise (hyperglycaemia):
· glucocorticoids (except when applied locally) – used to treat inflammatory conditions
· oral contraceptives (“the pill”) - used for birth control
· thiazides - used to treat high blood pressure or fluid retention (oedema)
· thyroid hormones - used to treat malfunction of the thyroid gland
· sympathomimetics such as salbutamol or terbutaline - used to treat asthma
· growth hormone – used to treat growth disorders
· danazol - used to treat endometriosis, menorrhagia, fibrocystic breast disease and hereditary angioedema
· oxymetholone – used to treat certain blood disorders
· diazoxide - used to treat high blood pressure
· nicotinic acid - used to treat high cholesterol levels in the blood
· asparaginase - used to treat leukaemia and lymph gland tumours.
If you take the following medicines, your blood sugar level may rise or fall:
· octreotide - used to treat gastrointestinal endocrine tumours and enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels
· lanreotide – used to treat enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal hormone levels.
Tell your doctor about any medicines that you are taking other than NovoMix® 30.
This is very important. Your doctor will advise you if it is all right to keep taking them or if you should stop taking them.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.
How to use NovoMix® 30 FlexPen®Your doctor, diabetes education nurse or pharmacist will have shown you how to use your medicine.
Carefully follow all the directions.
They may differ from the information contained in this leaflet.
Any change in dose or type of insulin should be made cautiously and only under medical supervision.
If you change the type of insulin that you use, you may have to use more or less than before. This may happen with the first dose or over a period of time.
If you do not understand the instructions, ask your doctor, diabetes education nurse or pharmacist for help.
How much to useYour doctor or diabetes education nurse will tell you how much of this medicine you need to use each day.
It is very important that you manage your diabetes carefully. Too much or too little insulin can cause serious effects.
When to use itNovoMix® 30 is normally used immediately (up to 10 minutes) before your meal. When necessary NovoMix® 30 may be used immediately after the meal.
How to use it· Inject NovoMix® 30 under the skin (subcutaneous injection) as shown to you by your doctor or diabetes education nurse. Never inject NovoMix® 30 into a vein or muscle.
· NovoMix® 30 may be injected into the abdomen, thighs, buttocks or upper arms.
· Remember to change your injection site regularly as shown to you by your doctor or diabetes education nurse.
· Take care not to drop or knock NovoMix® 30 FlexPen®.
· Do not use NovoMix® 30 in insulin pumps.
Checking your NovoMix® 30 FlexPen®:
Check your NovoMix® 30 FlexPen® before each preparation and injection. Make sure you are using the correct type and strength of insulin.
Do not use NovoMix® 30 FlexPen® if the medicine contains clumps of material or solid white particles sticking to the bottom or wall of the cartridge after resuspending.
Read the instructions printed at the end of this leaflet carefully in order to prepare and handle your NovoMix® 30 FlexPen® correctly.
How long to use itDo not stop using NovoMix® 30 FlexPen® unless your doctor tells you to.
If you use too much (overdose) – HypoglycaemiaYour blood sugar level may become too low (you may experience hypoglycaemia or a “hypo”) if you:
· accidentally use too much of this medicine
· have too much or unexpected exercise
· delay eating meals or snacks
· eat too little food
· are ill.
The first symptoms of mild to moderate hypos can come on suddenly. They may include:
· cold sweat, cool pale skin
· fatigue, drowsiness, unusual tiredness and weakness
· nervousness, anxious feeling, tremor, rapid heart beat
· confusion, difficulty concentrating
· excessive hunger
· vision changes
· headache, nausea.
Always carry some sugary food or fruit juice with you.
If you experience any of these symptoms of a hypo, immediately eat some sugary food or have a sugary drink e.g. lollies, biscuits or fruit juice, and measure your blood sugar level.
Tell your relatives, friends, close workmates or carers that you have diabetes. It is important that they recognise the signs and symptoms of a hypo.
Make sure they know to give you some sugary food or fruit juice for mild to moderate symptoms of a hypo.
If you lose consciousness, make sure they know:
· to turn you on your side and get medical help immediately.
· not to give you anything to eat or drink.
This is because you could choke.
An injection of the hormone glucagon may speed up recovery from unconsciousness. This can be given by a relative, friend, workmate or carer who knows how to give it.
If glucagon is used, eat some sugary food or have a sugary drink as soon as you are conscious again.
If you do not feel better after this, contact your doctor, diabetes education nurse, or the closest hospital.
If you do not respond to glucagon treatment, you will require medical attention.
See your doctor if you keep having hypo reactions, or if you have ever become unconscious after using insulin.
Your insulin dose may need to be changed.
If a severe hypo is not treated, it can cause brain damage and even death.
If you miss a dose – HyperglycaemiaIf you forget your insulin dose, test your blood sugar level as soon as possible.
If you are not sure what to do, talk to your doctor, diabetes education nurse or pharmacist.
Do not use a double dose of your insulin.
If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.
Otherwise, use it as soon as you remember – don’t forget to eat some carbohydrate within 10 minutes of your injection – and then go back to using it as you would normally.
Your blood sugar levels may become high (hyperglycaemia) if you:
· miss doses of insulin or use less insulin than you need
· have uncontrolled diabetes
· exercise less than usual
· eat more carbohydrates than usual
· are ill or stressed.
High blood sugar levels over a long period of time can lead to too much acid in the blood (diabetic ketoacidosis).
Contact your doctor immediately if your blood sugar level is high or you recognise any of the following symptoms.
Symptoms of mild to moderate hyperglycaemia include:
· drowsy feeling
· flushed face
· thirst, loss of appetite
· fruity odour on the breath
· blurred vision
· passing larger amounts of urine than usual
· getting up at night more often than usual to pass urine
· high levels of glucose and acetone in the urine.
Symptoms of severe hyperglycaemia include:
· heavy breathing
· fast pulse
· nausea, vomiting
· dehydration
· loss of consciousness.
Severe hyperglycaemia can lead to unconsciousness and in extreme cases death if untreated.
Discuss any worries you may have about this with your doctor, diabetes education nurse or pharmacist.
While you are using NovoMix® 30 FlexPen®Things you must doMeasure your blood sugar level regularly.
Make sure all friends, relatives, workmates or carers know that you have diabetes.
If your child has diabetes it is important to tell their carers.
Keep using your insulin even if you feel well.
It helps to control your condition, but does not cure it.
Tell your doctor if you often have hypos (low blood sugar levels).
Your doctor may need to adjust your insulin dose.
Always carry some sugary food or fruit juice with you.
If you experience any of the symptoms of a hypo, immediately eat some sugary food or have a drink e.g. lollies, biscuits or fruit juice.
Tell your doctor if you have trouble recognising the symptoms of hypos.
Under certain conditions, the early warning signs of hypos can be different or less obvious. Your doctor may need to adjust your insulin dose.
Make sure that you tell every doctor, dentist, pharmacist or other health care professional who is treating you that you have diabetes and are using insulin.
Tell your doctor, diabetes education nurse or pharmacist if you are travelling.
Ask your doctor for a letter explaining why you are taking injecting devices with you. Each country you visit will need to see this letter, so you should take several copies.
You may need to inject your insulin and eat your meals at different times because of time differences in and between countries.
You may not be able to get the same type of insulin in the country you are visiting.
Your doctor, diabetes education nurse or pharmacist can provide you with some helpful information.
Things you must not doDo not stop using your medicine unless your doctor tells you to.
Do not use the medicine if you think it has been frozen or exposed to excessive heat.
It will not work as well.
Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not share needles or pens.
Things to be careful ofBe careful driving or operating machinery until you know how the insulin affects you.
If your blood sugar is low or high your concentration and ability to react might be affected, and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car or operate a machine:
· if you have frequent hypos
· if you find it hard to recognise hypoglycaemia.
Tell your doctor if you drink alcohol.
Alcohol may mask the symptoms of hypos. If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.
Tell your doctor if you are ill.
Illness, especially with nausea and vomiting, may cause your insulin needs to change. Even if you are not eating, you still require insulin. You and your doctor should design an insulin plan for those times when you are sick.
Tell your doctor if you are exercising more than usual.
Exercise may lower your need for this medicine. Exercise may also speed up the effect of a dose of it, especially if the exercise involves the area of the injection site (e.g. the leg should not be used for injection prior to jogging or running).
Tell your doctor if your diet changes.
Changes in diet may cause your insulin needs to change.
Side effectsTell your doctor, diabetes education nurse or pharmacist as soon as possible if you do not feel well while you are using NovoMix® 30 FlexPen®.
This medicine helps most people for whom it is prescribed, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor, diabetes education nurse or pharmacist to answer any questions you may have.
The most common side effect when using insulin is low blood sugar levels (a hypo).
Tell your doctor if you notice any of the following and they worry you:
· hypos (mild to moderate).
· pain, redness, hives, bruising, swelling or itching at the injection site. Usually these symptoms disappear within a few weeks during continued use. If you have serious or continuing reactions, you may need to stop using NovoMix® 30 and use another insulin.
· a depression or thickening of the skin around the injection site (lipodystrophy).
· when you first start your insulin treatment you may get visual problems or swollen hands and feet.
This list includes the more common side effects of your medicine. They are usually mild and short-lived.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital.
More severe symptoms of low blood sugar levels, including:
· disorientation
· seizures, fits or convulsions
· loss of consciousness.
If a severe hypo is not treated, it can cause brain damage and death.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
· skin rashes over a large part of the body
· shortness of breath, wheezing
· swelling of the face, lips or tongue
· fast pulse
· sweating.
This list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Ask your doctor, diabetes education nurse or pharmacist to answer any questions you have.
After using NovoMix® 30 FlexPen®StorageStore NovoMix® 30 FlexPen® that are not being used between 2°C and 8°C in a refrigerator (away from the cooling element).
Resuspend the insulin in your NovoMix® 30 FlexPen® – whether it is to be used immediately or whether it is to be carried as a spare – upon removing it from the refrigerator.
Do not keep the NovoMix® 30 FlexPen® that you are using, or that you are carrying as a spare, in a refrigerator. You can use it up to 4 weeks at or below 30°C after taking it out of the refrigerator. Discard NovoMix® 30 FlexPen® after 4 weeks even if there is still some medicine left in it.
The medicine in your NovoMix® 30 FlexPen® must not be frozen, or exposed to excessive heat or light. Protect the medicine in NovoMix® 30 FlexPen® from light by keeping the cap on when not in use.
Never use NovoMix® 30 FlexPen® after the expiry date printed on the label and carton.
Never use NovoMix® 30 FlexPen® if NovoMix® 30 does not appear white and uniformly cloudy after resuspension.
Keep out of the reach of children.
DisposalDispose of used needles safely into a yellow plastic sharps container.
If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product descriptionWhat it looks likeNovoMix® 30 is a white, cloudy suspension for subcutaneous injection. NovoMix® 30 FlexPen® is a 3mL pre-filled glass cartridge contained in a dial-a-dose insulin pen.
IngredientsNovoMix® 30 contains soluble insulin aspart (rys) and protamine-crystallised insulin aspart (rys) 100 units per mL (100 U/mL) as the active ingredient, in the ratio of 30:70.
The abbreviation “rys” indicates the method of genetic engineering used to manufacture the insulin aspart.
NovoMix® 30 FlexPen® also contains the following inactive ingredients: glycerol, phenol, metacresol, zinc chloride, sodium chloride, dibasic sodium phosphate dihydrate, protamine sulfate (a fish product), sodium hydroxide, hydrochloric acid and water for injections.
SponsorNovoMix® 30 FlexPen® is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty. Ltd.
Level 3
21 Solent Circuit
Baulkham Hills NSW 2153
NovoMix® 30 FlexPen® is supplied in New Zealand by:
Novo Nordisk Pharmaceuticals Ltd.
58 Richard Pearse Drive
Airport Oaks
Mangere
New Zealand
NovoMix®, FlexPen®, NovoFine®, and NovoCare® are registered trademarks of Novo Nordisk A/S.
This leaflet was prepared on 13 June 2017.
Australian Registration Number:
AUST R 143166
© 2017
Novo Nordisk A/S
Further informationFor further information call the NovoCare® Customer Care Centre on 1800 668 626 (Australia) or 0800 733 737 (NZ).
www.novonordisk.com.au
www.novonordisk.co.nz
You can also get more information about diabetes and insulin from Diabetes Australia and Diabetes New Zealand:
· freecall helpline 1300 136 588 (Australia)
· www.diabetesaustralia.com.au
· www.diabetes.org.nz
Instructions For UseInstructionsPlease read the following instructions carefully before using your NovoMix® 30 FlexPen®. If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar levels.
Your FlexPen® is a prefilled, dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. FlexPen® is designed to be used with NovoFine® disposable needles up to a length of 8mm.
As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen® is lost or damaged.
Caring for your pen
Your FlexPen® must be handled with care. If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can lead to too high or too low blood sugar levels.
You can clean the exterior of your FlexPen® by wiping it with a medicinal swab. Do not soak, wash or lubricate it as this may damage the pen.
Do not refill your FlexPen®.
Preparing your NovoMix® 30 FlexPen®A
Check the name and coloured label of your pen to make sure that it contains the correct type of insulin. This is especially important if you take more than one type of insulin. If you inject the wrong type of insulin your blood sugar level may get too high or too low.
Every time you use a new pen
Let the insulin reach room temperature before you use it.
This makes it easier to resuspend.
Pull off the pen cap (see A).
B
Before your first injection with a new FlexPen®, you must resuspend the insulin:
Roll the pen between your palms 10 times – it is important that the pen is kept horizontal.
C
Then move the pen up and down 10 times between the two positions as shown, so the glass ball moves from one end of the cartridge to the other.
Repeat rolling and moving the pen until the liquid appears uniformly white and cloudy (resuspended).
For every subsequent injection:
Move the pen up and down between the two positions - as shown in Figure C - at least 10 times until the liquid appears uniformly white and cloudy. If the resuspension procedure alone is not enough to give a uniformly white and cloudy liquid, repeat the rolling and moving procedures (see B and C) until the liquid does appear uniformly white and cloudy.
Always make sure that you have resuspended the insulin prior to each injection. This reduces the risk of too high or too low blood sugar levels occuring. After you have resuspended the insulin, complete all the following steps of injection without delay.
· Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If there are fewer than 12 units left, use a new FlexPen®.
Attaching a needleD
Remove the paper tab from a new disposable needle.
Screw the needle straight and tightly onto your FlexPen®.
E
Pull off the big outer needle cap and keep it for later.
F
Pull off the inner needle cap and dispose of it. Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
· Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
· Be careful not to bend or damage the needle before use.
Checking the insulin flowPrior to each injection, small amounts of air may collect in the cartridge during normal use. To avoid injection of air and ensure proper dosing:
G
Turn the dose selector to select 2 units.
H
Hold your FlexPen® with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.
I
Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.
A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
· Always make sure that a drop appears at the needle tip before you inject. This makes sure that the insulin flows. If no drop appears you will not inject any insulin, even though the dose selector may move. This may indicate a blocked or damaged needle.
· Always check the flow before you inject. If you do not check the flow, you may get too little insulin or no insulin at all. The may lead to too high blood sugar levels.
Selecting your doseCheck that the dose selector is set at 0.
J
Turn the dose selector to select the number of units you need to inject. The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer. When turning the dose selector, be careful not to push the push-button as insulin will come out.
You cannot select a dose larger than the number of units left in the cartridge.
· Always use the dose selector and the pointer to see how many units you have selected before injecting the insulin.
· Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may get too high or too low. Do not use the residual scale, it only shows approximately how much insulin is left in your pen.
Making the injectionInsert the needle into your skin. Use the injection technique shown by your doctor or diabetes education nurse.
K
Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting. Turning the dose selector will not inject insulin.
L
Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds. This will make sure you get the full dose. Withdraw the needle from the skin, then release the pressure on the push-button.
Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar levels.
M
Guide the needle into the big outer needle cap without touching it, as shown. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.
Dispose of it carefully and put the pen cap back on.
· Always remove the needle after each injection and store your FlexPen® without the needle attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and inaccurate dosing.
Further important information· Caregivers must be very careful when handling used needles to reduce the risk of needle sticks and cross-infection.
· Dispose of your used FlexPen® carefully without the needle attached.
· Never share your FlexPen® or needles with other people. It might lead to cross-infection.
· Never share your pen with other people. Your medicine might be harmful to their health.
· Always keep your pen and needles out of sight and reach of others, especially children.