部分中文MVI-12 VIAL WO K处方资料（仅供参考）
【名称】：注射用13种复合维生素
【药效分类】：胃肠外营养补充剂
【适应症】：本品为静脉补充维生素用药，适用于经胃肠道营养摄取不足(如营养不良或胃肠道吸收障碍等)，或经胃肠营养禁忌者。
【用法用量】：本品用高能量静脉营养输液溶解后进行点滴。用量为通常成人每日1瓶。其它根据年龄、症状而酌情加减。
【特点】： 适合不同病人需求，稳定性好。
【适应证状况】：
本品为静脉补充维生素用药，使用于经胃肠道营养摄取不足的病人，包括外科手术、广泛烧伤、骨折和其他外伤，严重感染性疾病和昏迷的病人。本品可与已确定相容性和稳定性的碳水化合物、脂类、氨基酸、电解质及微量元素等肠外营养物混合使用。可用于连续发生的严重营养状态改变下机体新陈代谢的应急反应和组织营养缺乏的情况。本品可以提供必需维生素的摄入量以维持机体正常反应和修复，同时本品不应在人体缺乏维生素时才开始使用。
营养是机体生长发育、修复组织、产生抵抗力、维持正常生理功能的物质基础，它是生物正常生长、活动的源泉，是病人得以康复不可缺少的条件。
在人们健康时，各类营养素自然地维持平衡状态。当机体患病时常出现营养摄入不足或需求增加等现象而导致营养不良。尽管近年来医学发展很快，但在世界范围内，住院病人的营养不良问题一直是一个普遍存在的问题。国内临床流行病学调查显示我国有30%-70%的住院病人在入院时或住院期间即存在现营养不良。国外住院病人的营养不良发生率也有较多最新报道（如美国和荷兰普外科病人营养不良发生率分别为44%和50%）。根据北京协和医院肠外肠内营养研究中心的一项调查研究显示：综合性医院胃肠外科病人营养不良的发生率为30－40％，另有20％的病人存在继发性营养不良的隐患。ICU病人营养不良高达70-80%。此外，儿科、内科、妇科病人神经科等不能进食的病人中也存不同程度的营养不良，众多的临床经验表明：大部分病人都处于营养不良的风险之中。营养不良发生以后，可以导致更多的并发症，从而使死亡率增高，康复期延长，住院期延长，临床花费增加，加重了社会、医院及家庭的负担。及时给予合理的营养支持，可以改善患者的营养状况，减少并发症，降低死亡率，缩短康复期和住院期。可见临床营养支持十分重要和必要。
【该品的研究】
本品采用甘氨胆酸/磷脂混合胶束系统溶解脂溶性维生素，人体含有胆汁中本身就含有甘氨胆酸/磷脂，是一种生物相容性赋型剂。例如采用甘氨胆酸/磷脂混合胶束的注射用12种复合维生素Cernevit从1988年上市以来，已售1300万支，但仅报道了6例不良事件：2例荨麻疹、1例过敏、1例高钙分泌、1例高烧、1例注射部位疼痛；不良反应的发生率极低，说明采用甘氨胆酸/磷脂混合胶束系统来溶解脂溶性维生素是安全的。注射用13种复合维生素也是采用甘氨胆酸/磷脂来溶解脂溶性维生素。
注射用13种复合维生素与12种维生素肠外营养制剂相比，增加了维生素B1、维生素B6、维生素C和叶酸的用量和加入了维生素K1，更加适合临床病人对维生素的实际需求。由于本品是肠外营养制剂，从静脉直接给与普通病人其所缺乏的复合维生素，来满足病人对多种维生素的需求。
【保存】
需要在2－8℃保存。
【综合分析】   
维生素是胃肠外营养不可缺少的组成部分，维生素在动物体内既不是构成各种组织的主要原料，也不是体内的能量物质，它们的生理功能主要是对物质代谢过程起非常重要的调节作用，多数的维生素作为辅酶或辅基的组成成分参与体内的代谢过程。在病态情况下，由于维生素的丢失或者利用过量或者不能以肠内营养形式吸收而造成维生素缺乏。
目前，临床应用的肠外营养复合维生素制剂有注射用水溶性维生素、注射用脂溶性维生素、M.V.I-Adult、Infuvite-Adult等。
注射用13种维生素与12种维生素相比，改变了几种维生素的用量，以及增加了维生素K1，更加适合于不同病人的维生素需求。

MULTI VITAMIN INFUSION - retinol, ergocalciferol, ascorbic acid, niacinamide, thiamine, biotin, folic acid, cyanocobalamin, vitamin e, riboflavin 5'-phosphate sodium, pyridoxine hydrochloride and dexpanthenol injection, solution, concentrate
Hospira Worldwide, Inc.

M.V.I. − 12®

Pharmacy Bulk Package

(Multi-Vitamin Infusion without vitamin K)

For dilution in intravenous infusions only.

Rx only

DESCRIPTION

M.V.I.−12® is available as a sterile product consisting of two vials, labeled Vial 1 (50 mL) and Vial 2 (50 mL Fill) to provide ten 10 mL single doses.

Adult Formulation (intended for ages 11 and older)

Vial 1*
Ingredient	Amount per Unit Dose
Fat Soluble Vitamins**
Vitamin A (retinol)	1 mga
Vitamin D (ergocalciferol)	5 mcgb
Vitamin E (dl-alpha-tocopheryl acetate)	10 mgc
Water Soluble Vitamins
Vitamin C (ascorbic acid)	200 mg
Niacinamide	40 mg
Vitamin B2 (as riboflavin 5-phosphate sodium)	3.6 mg
Vitamin B1 (thiamine)	6 mg
Vitamin B6 (pyridoxine HCl)	6 mg
Dexpanthenol (d-pantothenyl alcohol)	15 mg
*WITH 30% PROPYLENE GLYCOL AND 2% GENTISIC ACID ETHANOLAMIDE AS STABILIZERS AND PRESERVATIVES; SODIUM HYDROXIDE FOR PH ADJUSTMENT; 1.6% POLYSORBATE 80; 0.028% POLYSORBATE 20; 0.002% BUTYLATED HYDROXYTOLUENE; 0.0005% BUTYLATED HYDROXYANISOLE. **Fat-soluble vitamins A, D, and E are water solubilized with polysorbate 80. (a) 1 mg vitamin A equals 3,300 USP units. (b) 5 mcg ergocalciferol equals 200 USP units. (c) 10 mg vitamin E equals 10 USP units.

Vial 2*
Biotin	60 mcg
Folic acid	600 mcg
Vitamin B12 (cyanocobalamin)	5 mcg
*WITH 30% PROPYLENE GLYCOL; AND CITRIC ACID, SODIUM CITRATE, AND SODIUM HYDROXIDE FOR PH ADJUSTMENT.

“Aqueous” multivitamin formula for intravenous infusion: M.V.I.−12® (Multi-Vitamin Infusion without vitamin K) makes available a combination of important fat-soluble and water-soluble vitamins in an aqueous solution, formulated specially for incorporation into intravenous infusions. Through special processing techniques, the liposoluble vitamins A, D, and E have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.

INDICATIONS AND USAGE

This formulation is indicated for the prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition who also receive warfarin-type anticoagulant therapy.

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.

Patients with multiple vitamin deficiencies or with markedly increased requirements may be given multiples of the daily dosage for two or more days as indicated by the clinical status. Clinical testing indicates that some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the sole source of vitamins.

CONTRAINDICATIONS

Known hypersensitivity to any of the vitamins in this product or a pre-existing hypervitaminosis. Allergic reaction has been known to occur following intravenous administration of thiamine. This formulation is contraindicated prior to blood sampling for detection of megaloblastic anemia, as the folic acid and the cyanocobalamin in the vitamin solution can mask serum deficits.

WARNINGS

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phospate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with M.V.I.−12®.

Where long-standing specific vitamin deficiencies exist, it may be necessary to add therapeutic amounts of specific vitamins to supplement the maintenance vitamins provided in M.V.I.−12®.

In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing.

M.V.I.−12® SHOULD BE ASEPTICALLY TRANSFERRED TO THE INFUSION FLUID.

Drug-Drug Interactions:

Physical Incompatibilities:

M.V.I.−12® (Multi-Vitamin Infusion without vitamin K) is not physically compatible with DIAMOX® (acetazolamide) 500 mg, DIURIL® Intravenous Sodium (chlorothiazide sodium) 500 mg, or aminophylline 125 mg, ampicillin 500 mg or moderately alkaline solutions. ACHROMYCIN® (tetracycline HCl) 500 mg may not be physically compatible with M.V.I.−12®. It has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Some of the vitamins in M.V.I.−12® may react with vitamin K bisulfite. Direct addition of M.V.I.−12® to intravenous fat emulsions is not recommended. Consult appropriate references for listings of physical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.

Several vitamins have been reported to decrease the activity of certain antibiotics. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin. Bleomycin is inactivated in vitro by ascorbic acid and riboflavin.

Some of the vitamins in M.V.I.−12® may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies.

Clinical Interactions:

A number of interactions between vitamins and drugs have been reported which may affect the metabolism of either agent. The following are examples of these types of interactions.

Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Conversely, phenytoin may decrease serum folic acid concentrations and, therefore, should be avoided in pregnancy. Folic acid may decrease the patient’s response to methotrexate therapy.

Pyridoxine may decrease the efficacy of levodopa by increasing its metabolism. Concomitant administration of hydralazine or isoniazid may increase pyridoxine requirements.

In patients with pernicious anemia, the hematologic response to vitamin B12 therapy may be inhibited by concomitant administration of chloramphenicol.

Consult appropriate references for additional specific vitamin-drug interactions.

Drug-Laboratory Test Interactions

ASCORBIC ACID IN THE URINE MAY CAUSE FALSE NEGATIVE URINE GLUCOSE DETERMINATIONS.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Carcinogenicity studies have not been performed.

Pregnancy:

Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women.

Nursing Mothers:

Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonlactating women.

Pediatric Use:

Safety and effectiveness in children below the age of 11 years have not been established.

ADVERSE REACTIONS

There have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine. The risk, however, is negligible if thiamine is co-administered with other vitamins in the B group. There have been no reports of fatal anaphylactoid reactions associated with M.V.I.−12®.

There have been rare reports of the following types of reactions:

Dermatologic — rash, erythema, pruritus

CNS — headache, dizziness, agitation, anxiety

Ophthalmic — diplopia

Allergic — urticaria, periorbital and digital edema

OVERDOSAGE

The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol. Therefore, vitamin A supplementation of renal failure patients should be undertaken with caution.

DOSAGE AND ADMINISTRATION

M.V.I.−12® is ready for immediate use in adults and children aged 11 years and above when added to intravenous infusion fluids.

Directions for Pharmacy Bulk Package:

Transfer the contents of Vial 1 into Vial 2. The mixed solution will provide ten 10 mL single doses. Each 10 mL single dose is ready for dilution in not less than 500 mL of infusion fluid. Utilize a suitable sterile transfer device or dispensing set, which allows measured distribution of the contents.

The withdrawal of container contents should be accomplished without delay. The solution should be used within 4 hours after dilution.

USE OF THIS PRODUCT IS RESTRICTED TO A SUITABLE WORK AREA, SUCH AS A LAMINAR FLOW HOOD.

M.V.I.−12® should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.

FOR INTRAVENOUS FEEDING, ONE DAILY DOSE OF M.V.I.−12® (10 ML) ADDED DIRECTLY TO NOT LESS THAN 500 ML, PREFERABLY 1,000 ML, OF INTRAVENOUS DEXTROSE, SALINE OR SIMILAR INFUSION SOLUTIONS.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

After M.V.I.−12® is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A and D and riboflavin, are light sensitive, and exposure to light should be minimized.

Store at 2-8°C (36-46°F).
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产地国家: 美国
原产地英文商品名:
MVI-12 VIAL WO K 50ml/vial 10vials/box
原产地英文药品名:
MVI, ADULT NO.2 WITHOUT VIT K
中文参考商品译名:
MVI-12 VIAL WO K 50毫升/瓶 10瓶/盒
中文参考药品译名:
多种维生素，ADULT NO.2不含维生素K
生产厂家中文参考译名:
HOSPIRA-MAYNE
生产厂家英文名:
HOSPIRA-MAYNE