【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。

【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

INFUVITE®
ADULT PHARMACY BULK PACKAGE
Multiple Vitamins for Infusion

DRUG DESCRIPTION
INFUVITE ADULT (PHARMACY BULK PACKAGE) is a sterile product consisting of 2 vials – 1 each of Vial 1 (50 mL) and Vial

2 (50 mL Fill in 100 mL Vial), provided as a pharmacy bulk package.

A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

Each 5 mL of Vial 1 contains:
Ascorbic acid (Vitamin C) ................... 200 mg
Vitamin A1 (as palmitate) ............... 3,300 IU
Vitamin D31 (cholecalciferol)............. 200 IU
Thiamine (Vitamin B1)
(as the hydrochloride) .......................... 6 mg
Riboflavin (Vitamin B2)
(as riboflavin 5-phosphate sodium)... 3.6 mg
Pyridoxine HCl (Vitamin B6) ................... 6 mg
Niacinamide.......................................... 40 mg
Dexpanthenol
(as d-pantothenyl alcohol) ................. 15 mg
Vitamin E1 (dl-α-tocopheryl acetate<) .... 10 IU
Vitamin K11...................................... 150 mcg

Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.

Each 5 mL of Vial 2 contains:
Folic acid ........................................... 600 mcg
Biotin .................................................. 60 mcg
Vitamin B12 (cyanocobalamin) ............. 5 mcg

Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection. “Aqueous” multiple vitamin preparation for intravenous infusion: INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.

Contains no more than 70 mcg/L of aluminum (combined vials 1 and 2).

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INDICATIONS
INFUVITE ADULT (PHARMACY BULK PACKAGE) is indicated as a daily multivitamin maintenance supplement for adults and children aged 11 and older receiving parenteral nutrition.

INFUVITE ADULT (PHARMACY BULK PACKAGE) is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states, which may provoke a “stress” situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients.

The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. INFUVITE ADULT (PHARMACY BULK PACKAGE) (administered in intravenous fluids under proper dilution) contributes intake of necessary vitamins toward maintaining the body's normal resistance and repair processes.

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.

Some patients do not maintain adequate levels of certain vitamins when a multiple vitamin preparation, such as INFUVITE ADULT (PHARMACY BULK PACKAGE) , in recommended amounts, is the sole source of vitamins. Blood levels of vitamins A, C, D, and folic acid may decline in patients receiving parenteral multivitamins as their sole source of vitamins for 4 to 6 months. Therefore, in patients for whom total parenteral nutrition will be continued for long periods of time blood vitamin concentrations should be monitored to ensure maintenance of adequate levels. If deficiencies appear to be developing, multiples of the formulation (1.5 to 3 times) may be needed for a period of time. When multiples of the formulation are used for more than a few weeks, vitamins A and D should be monitored occasionally to be certain that an excess accumulation of these vitamins is not occurring.

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DOSAGE AND ADMINISTRATION
INFUVITE ADULT (PHARMACY BULK PACKAGE) is ready for immediate use in adults and children aged 11 years and older when added to intravenous infusion fluids.

INFUVITE ADULT (PHARMACY BULK PACKAGE) should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.

Preparation of INFUVITE ADULT (PHARMACY BULK PACKAGE) for intravenous feeding should be done by transferring the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses. One daily 10 mL dose should be added directly to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion.

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

After INFUVITE ADULT (PHARMACY BULK PACKAGE) is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution. Some of the vitamins in this product, particularly A, D and riboflavin, are light sensitive; therefore, exposure to light should be minimized.

Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours. INFUVITE ADULT (PHARMACY BULK PACKAGE) IS A PHARMACY BULK PACKAGE. IT IS NOT INTENDED FOR DIRECT INFUSION. DISCARD UNUSED PORTION.

Directions For Dispensing FromPharmacy Bulk Vial
The Pharmacy Bulk Vial is intended for single puncture, multiple dispensing and for intravenous use only. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from Pharmacy Bulk Vial should be completed as soon as possible after initial entry.

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HOW SUPPLIED
INFUVITE ADULT (PHARMACY BULK PACKAGE) – NDC 54643-5649-2, is available in boxes containing 2 vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). Mix contents of Vial 1 with Vial 2 to provide 10 single doses.

Store under refrigeration, 2-8°C (36-46°F).

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SIDE EFFECTS
There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported following large intravenous doses of thiamine. However, the risk is negligible if thiamine is coadministered with other vitamins of the B group. There have been rare reports of the following types of reactions:
Dermatologic – rash, erythema, pruritis
CNS – headache, dizziness, agitation, anxiety
Ophthalmic – diplopia
Allergic – urticaria, shortness of breath, wheezing and angioedema.

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DRUG INTERACTIONS
Drug – Drug/Solution Interactions
Caution should be exercised when administering INFUVITE ADULT (PHARMACY BULK PACKAGE) to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs, such as warfarin and its congeners. Therefore, periodic monitoring of prothrombin/INR response is essential in determining the appropriate dosage of anticoagulant therapy.

INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion) is not physically compatible with alkaline solutions or moderately alkaline drugs such as acetazolamide, chlorothiazide sodium, aminophylline or sodium bicarbonate. Tetracycline HCl and ampicillin may not be physically compatible with INFUVITE ADULT (PHARMACY BULK PACKAGE). Also, it has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition 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. 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 activity. 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.

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.

Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement above).

Consult appropriate references for additional specific vitamin-drug interactions.

Some of the vitamins in INFUVITE ADULT (PHARMACY BULK PACKAGE) may react with vitamin K bisulfite or sodium bisulfite; if bisulfite solutions are necessary, patients should be monitored for vitamin A and thiamine deficiencies.

Drug-Laboratory Test Interactions
Ascorbic acid in the urine may cause false negative urine glucose determinations.

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WARNINGS
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 phosphate solution, 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.

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PRECAUTIONS
If this formulation is the only source of vitamins for long periods of time, blood concentration of each of the vitamins should be monitored, particularly vitamins A, C, D, and folic acid, to determine if deficiencies are occurring. If deficiencies are developing or when long-standing vitamin deficiencies are present, it may be necessary to add therapeutic amounts of certain vitamins to supplement the maintenance vitamins provided in INFUVITE ADULT (PHARMACY BULK PACKAGE).

Carcinogenesis, Mutagenesis, and Impairment of Fertility
Carcinogenicity, mutagenicity, and fertility studies have not been performed with INFUVITE ADULT (PHARMACY BULK PACKAGE).

Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with INFUVITE ADULT (PHARMACY BULK PACKAGE) (Multiple Vitamins for Infusion). INFUVITE ADULT (PHARMACY BULK PACKAGE) should be given to a pregnant woman only if clearly needed. Pregnant women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirements may exceed those of nonpregnant women. The use of INFUVITE ADULT (PHARMACY BULK PACKAGE) has not been studied in human pregnancy.

Nursing Mothers
Lactating women should follow the U.S. Recommended Daily Allowances for their condition, because their vitamin requirement may exceed those of nonlactating women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when INFUVITE ADULT (PHARMACY BULK PACKAGE) is administered to a nursing mother.

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

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OVERDOSE
The fat-soluble vitamins A, D, and E can accumulate to harmful levels. 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.

Water-soluble vitamins are readily excreted in the urine. Treatment of vitamin overdosage usually consists of withdrawal of the vitamin.

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CONTRAINDICATIONS
INFUVITE ADULT (PHARMACY BULK PACKAGE) is contraindicated where there is a preexisting hypervitaminosis, or a known hypersensitivity to any of the vitamins or excipients in the product.

Allergic reactions have been known to occur following intravenous administration of thiamine and vitamin K. The 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.