注射用12种复合维生素(Cernevit)——唯一的复合维生素注射剂,适用于经胃肠道营养摄取不足者的新药
【药品名称】
商品名称:施尼维他 Cernevit 通用名称:注射用多种维生素(12) 英文名称:Multivitamin for Injection (12)
【性状】为橙黄色的块状物。
【药理毒理】 作为胃肠外营养静脉注射液,施尼维他为含有水溶性维生素和脂溶性维生素的复合维生素剂,可供成人和11岁以上的儿童补充维生素。
【适应症】为静脉补充维生素用药。适用于经胃肠道营养摄取不足者。 【用法用量】 成人及11岁以上儿童,每天给药一支。用注射器取5ml注射用水注入瓶中。所得溶液应通过静脉缓慢注射,或溶于等渗的盐水或5%葡萄糖溶液中静脉滴注。施尼维他可与那些已确定相容性和稳定性的碳水化合物、脂肪、氨基酸和电解质等肠外营养物混合使用。
【不良反应】 静脉直接注射时,可在某些患者中观察到单独的血清谷丙转氨水平增高(见[使用特别注意事项]) 由于施尼维他含有维生素B1,某些过敏体质者可能会产生过敏反应。 【禁忌】 1、已知对施尼维他任何成分过敏者,尤其是对B1过敏者。 2、新生儿,婴儿,11岁以下的儿童。 【注意事项】 A、 静脉直接输注时,在某些患有活动型炎症性小肠结肠炎的病人,可见有血清谷丙转氨水平的中度升高。停止给药后,升高的酶水平可迅速回落。对这种病人,建议应检测其转氨酶水平。 B、 因施尼维他含有甘氨胆酸,对于表现有肝脏来源的黄疸或试验检测有明显的胆汁郁积的病人需长期重复给药时,有必要仔细地检测其肝功能。 C、 因施尼维他含有叶酸,在同含有苯巴比妥,苯妥英,去氧苯巴比妥的抗癫痫药品使用时需特别注意,并应采取以下措施:临床监控,血浆水平控制。在补充叶酸时和补充叶酸后调整抗癜痫药制剂的剂量。 D、 需通过特别的补充来校正一种或多种维生素的缺乏。 E、 施尼维他不含有维生素K,如有需要应单独补充。 F、 在同其他溶液或注射液混合时需事先检验相容性。尤其是当施尼维他加入到含葡萄糖、电解质和氨基酸溶液的二元胃肠道外营养混合物时,以及含葡萄糖、电解质、氨基酸溶液和脂肪乳的三元胃肠道外营养混合物时需特别注意。
药剂学方面注意事项 A、 使用前需检查容器的完整性 B、 应在无菌条件下操作。 C、 一旦复溶,不要存储使用过颜色异常的容器或溶液。 【孕妇及哺乳期妇女用药】 如需要,且在监控适应症及剂量以防止过量反应时,施尼维他可在妊娠期使用,此时使用任何药品时应向药剂师或医生咨询。为防止新生儿维生素A过量,建议哺乳期妇女不要使用施尼维他。 【儿童用药】 11岁以下儿童禁用。 【老年用药】 无相关资料,尚不明确。 【药物间相互作用】因施尼维他含有盐酸吡哆醇,同左旋多巴合用会降低左旋多巴的药理活性。 因施尼维他含有叶酸,同含有苯巴比妥,苯妥英,去氧苯巴比妥的抗癫痫药使用时会促进其肝脏代谢,降低此类药的血药浓度,需特别注意。 【药物过量】如施尼维他过量使用,可能出现维生素A过多的症状。服用超过15000IU维生素A可能出现如下急性中毒症状:胃肠道紊乱、头痛、颅内压升高、易怒、视神经乳头水肿、精神失常、易激惹、甚至痉挛和迟发性脱皮。维生素A慢性中毒时会出现如下症状:颅内压升高,长骨皮层增厚和骨骺不成熟融合。指趾端轻微或疼痛的皮下肿胀,X线检查显示尺骨、腓骨、锁骨、肋骨的骨膜增厚。在出现急性或慢性过量反应时,应立即停止使用施尼维他,减少钙摄入,增加利尿作用。 【规格】 每盒1支装,10支装或20支装。 【贮存】 在25℃以下避光贮存(连同外包装) 施尼维他溶解后,其理化性质在25℃下保持稳定24小时,从微生物学考虑,施尼维他应在溶解后立即使用,或施尼维他在2-8℃贮存不得超过24小时。 【包装】 棕色玻璃瓶装。 【有效期】 三年。 【批准文号】 进口药品注册证号H20080263 【生产企业】比利时Baxter S.A.
Cernevit Cernevit is an injectable multivitamin supplement by Baxter labs. It consists of a mixture of vitamins that are soluble in water (vitamin C or vitamins in the B group) and vitamins that are soluble in fat (vitamin A). The medicine does not contain the vitamin K, which can be administered separately at a specialist doctor’s recommendation.
Indications Cernevit is used in cases when a vitamin supplement is needed. The oral administration is not recommended at all. There are many cases when the patients opt for this method, without actually knowing that this method of administration may cause malnutrition or faulty digestive absorption. It is indicated for adults and for children above eleven years of age.
Usage Cernevit is reconstituted from its powdered form. It can be administered through an IV or injected directly. It must first be diluted in distilled water or other parenteral fluids, following exactly the instructions on the packaging or those given by a specialist doctor. Even though it is a multivitamin supplement, you should consult with a doctor before getting it, especially since it is not administered orally.
Side Effects and Overdose While vitamins are beneficial to the human body and are naturally ingested in the food, there is a risk for overdoses and possible side effects when taking supplements. They tend to have a much higher dosage of these substances than those naturally found in food. While vitamins that are soluble in water are easily eliminated in the urine, fat soluble vitamins can build up and provoke severe effects on the human body. The adverse reactions and side effects of a Cernevit overdose are identical to those being associated with each respective fat-soluble vitamin. Intravenous administration of thiamine has been linked to severe allergic reactions and should be taken into account before initiating this treatment.
Contraindications Cernevit should not be given to patients that have a preexisting hypervitaminosis. It should also be avoided in patients with possible hypersensitivity to a specific vitamin or intolerance. Other conditions that can affect this medication are hyperthyroidism or impaired liver and kidney functions. Any possible allergies to the components of this medication should be thoroughly consulted with a doctor.
Storage Cernevit should be stored at the room temperature, below 25 degrees Celsius. It should not be frozen and kept away from light. It must be used immediately after reconstitution. The usage must be limited to a single patient at a time for each dose and if there is any reconstituted product left over, it should be discarded.
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