部分中文INFUVITE  PEDIATRIC处方资料（仅供参考）
小儿多种维生素，本品是同时含有9种水溶性维生素和4种脂溶性维生素的多种维生素注射液，注射液已经在国外上市多年。临床应用明显优于目前国内市场上销售的注射用12种复合维生素、注射用水溶性维生素、注射用脂溶性维生素(I)、注射用脂溶性维生素(II)和复方维生素注射(4)等复合维生素针剂品种。
中文名称：小儿多种维生素注射液
处方组成：本品每瓶中同时含有9种水溶性维生素和4种脂溶性维生素
商品名为：INFUVITE  PEDIATRIC
用法用量：
必须稀释后进行静脉输注。直接加入到500ml的输液中，最好是1000ml。配伍溶液可是：葡萄糖、氯化钠等相关输液中。将成人多种维生素注射液（13）加入到静脉注射用液体中之后，适宜立即使用。
适应症：
本品适应于接受胃肠外营养多种维生素每日所需剂量以及在其他情形下静脉常规需要量，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。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激反应和组织营养缺乏的情况。
特点：
目前最全的同时含有脂溶性维生素与水溶性维生素注射用剂型（含有维生素K1）；
药理学：
一般药理试验
1.对中枢神经系统的影响
1)对犬自主行为的影响10例比格犬(2/组)
采用隐静脉注射给药新配制的CernivitTM-12或加热分解的CernivitTM-12混合微胶粒，给药容量为0.1、0.3和1ml/kg，给药速度为5ml/min。比格犬再次给药的时间间隔为4周。动物给药后观察自主行为的变化。
比格犬上述给药容量未见自主行为的异常变化。1例比格犬新配制的CernivitTM-12以1ml/kg静脉注射期间唾液分泌过多，未见一般症状的异常变化。
2)对小鼠戊四氮诱发痉挛或最大电休克痉挛的影响
雌性小鼠静脉注射给药新配制的CernivitTM-12或加热分解的CernivitTM-12混合微胶粒和丙二醇，给药容量为0.1、0.3、1.O和3.0ml/kg，对电休克(50Hz 10mA达0.2sec)或戊四氮(120mg/kg IP)诱导的强直性痉挛均无影响。
2.对心血管系统的影响
1)新配制的CernivitTM-12或加热分解的CernivitTM-12混合微胶粒对清醒血压正常的犬收缩期血压、心率和自主行为的影响8例雌性杂种犬分组，每组为4只采用静脉注射给药新配制的CernivitTM-12或加热分解的CernivitTM-12混合微胶粒，给药容量为0.01、0.03、0.1和0.3ml/kg。比格犬再次给药的时间间隔为4周。动物给药后观察自主行为的变化。
犬静脉注射给药后，血压轻度和非持续性血压下降，0.3ml/kg剂量组给药后60min达最大效应为8mmHg。最高剂量组给药后心率增加，最大效应心率增加为18次/min。上述效应持续5-10min。部分陈旧CernivitTM-12混合微胶粒，犬收缩期血压、心率和自主行为未见异常的变化。本品口服吸收后，经门静脉到达肝脏，然后进入肝细胞，在细胞内转换成活性三磷酸盐。本品的5’三磷酸化合物低浓度时，能竞争性地抑制D-HBV编码的DNA聚合酶，结合到新合成的HBV DNA中，这种结合使DNA链的延长终止，从而抑制病毒DNA的复制。
适应症：
本品适用于成人接受胃肠外营养多种维生素每日所需剂量以及在其他情形下静脉常规需要量，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。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激反应和组织营养缺乏的情况。
不良反应：
很少有采用胃肠外多种维生素治疗后产生过敏反应报告。也很少有采用大剂量静脉输入维生素B1后发生过敏反应的报告。维生素B1与其他的B族维生素合用时，其过敏反应是可以忽略的。没有使用多种维生素注射制剂产生致命过敏反应的报告。
保存：需要在2－8℃保存。
MULTI VITAMIN INFUSION PEDIATRIC - ascorbic acid, retinol, ergocalciferol, thiamine hydrochloride, riboflavin 5'-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, biotin, folic acid, cyanocobalamin and phytonadione injection, powder, lyophilized, for solution
Hospira Worldwide, Inc.
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M.V.I. Pediatric®
Multi-Vitamin for Infusion
For dilution in intravenous
infusions only.
Rx only
DESCRIPTION
M.V.I. Pediatric® is a lyophilized, sterile powder intended for reconstitution and dilution in intravenous infusions. Each 5 mL of reconstituted product provides:
Ascorbic acid (vitamin C)………………………………………………………………………80 mg
Vitamin A* (retinol)………………………………………………………………………..0.7 mg (a)
Ergocalciferol*
(vitamin D)………………………………………………………………………………10 mcg (b)
Thiamine (vitamin B1)
(as the hydrochloride)………………………………………………………………………..1.2 mg
Riboflavin (vitamin B2) (as riboflavin-
5-phosphate sodium)…………………………………………………………………………...1.4 mg
Pyridoxine (vitamin B6)
(as the hydrochloride)………………………………………………………………………….1 mg
Niacinamide…………………………………………………………………………………….17 mg
Dexpanthenol
(d-pantothenyl alcohol)………………………………………………………………………...5 mg
Vitamin E* (dl-alpha
tocopheryl acetate)…………………………………………………………………………7 mg (c)
Biotin…………………………………………………………………………………………..20 mcg
Folic acid……………………………………………………………………………………..140 mcg
Cyanocobalamin
(vitamin B12)………………………………………………………………………………….1 mcg
Phytonadione*
(vitamin K1)………………………………………………………………………………...200 mcg
with 375 mg mannitol; sodium hydroxide for pH adjustment; 50 mg polysorbate 80; 0.8 mg polysorbate 20; 58 mcg butylated hydroxytoluene; 14 mcg butylated hydroxyanisole.
*Oil-soluble vitamins A, D, E and K1 water-solubilized with polysorbate 80.
(a) 0.7 mg vitamin A equals 2,300 USP units.
(b) 10 mcg ergocalciferol equals 400 USP units.
(c) 7 mg vitamin E equals 7 USP units.
Multivitamin Formula for Intravenous Infusion: M.V.I. Pediatric® (Multi- Vitamin for Infusion) provides a combination of important oil-soluble and water-soluble vitamins, formulated especially for incorporation into intravenous infusions after reconstitution. Through special processing techniques, the liposoluble vitamins A, D, E and K1 have been water solubilized with polysorbate 80, permitting intravenous administration of these vitamins.
INDICATIONS AND USAGE
This formulation is indicated as daily multivitamin maintenance dosage for infants and children up to 11 years of age receiving parenteral nutrition.
It 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.
M.V.I. Pediatric® (reconstituted and administered in intravenous fluids under proper dilution) contributes intake of these 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. Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as their sole source of vitamins for long periods of time.
CONTRAINDICATIONS
Known hypersensitivity to any of the vitamins or excipients in this product or a pre-existing hypervitaminosis.
Allergic reaction has 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 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 phosphate 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
General: Caution should be exercised when administering this multivitamin formulation to patients on warfarin sodium-type anticoagulant therapy. In such patients, vitamin K may antagonize the hypoprothrombinemic response to anticoagulant drugs. Therefore, periodic monitoring of prothrombin time is essential in determining the appropriate dosage of anticoagulant therapy.
Adequate blood levels of vitamin E are achieved when M.V.I. Pediatric® is given to infants at the recommended dosage. Larger doses or supplementation with oral or parenteral vitamin E are not recommended because elevated blood levels of vitamin E may result.
Studies have shown that vitamin A may adhere to plastic, resulting in inadequate vitamin A administration in the doses recommended with M.V.I. Pediatric®. Additional vitamin A supplementation may be required, especially in low birth weight infants.
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. Pediatric®.
In patients receiving parenteral multivitamins, blood vitamin concentrations should be periodically monitored to determine if vitamin deficiencies or excesses are developing.
Polysorbates have been associated with the E -Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis) in low birth weight infants.
M.V.I. Pediatric® should be aseptically transferred to the infusion fluid.
Drug-Drug Interactions
Physical Incompatibilities: M.V.I. Pediatric® is not physically compatible with alkaline solutions or moderately alkaline drugs such as Diamox (Acetazolamide), Diuril Intravenous Sodium (Chlorothiazide sodium), Aminophylline or sodium bicarbonate.
M.V.I. Pediatric® is not physically compatible with ampicillin and it may not be physically compatible with ACHROMYCIN (tetracycline HCl). It has also been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition of M.V.I. Pediatric® 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. Pediatric® 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.
Vitamin K may antagonize the hypoprothrombinemic effect of oral anticoagulants (see bolded statement).
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.
ADVERSE REACTIONS
There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactoid reactions have also been reported after large intravenous doses of thiamine. The risk, however, is negligible if thiamine is coadministered with other vitamins in the B group. There have been no reports of fatal anaphylactoid reactions associated with M.V.I. Pediatric®.
There have been rare reports of the following types of reactions:
Dermatologic - rash, erythema, pruritus
CNS - headache, dizziness, agitation, anxiety
Ophthalmic -diplopia
Allergic - urticaria, shortness of breath, wheezing, and angioedema
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
The single dose vial of M.V.I. Pediatric® is reconstituted by adding 5 mL of Sterile Water for Injection USP, Dextrose Injection USP 5%, or Sodium Chloride Injection to the 10 mL vial.
The vial may be swirled gently after the addition of the water to hasten reconstitution. Use of this product is restricted to a suitable work area, such as a laminar flow hood. The reconstituted solution is ready within three minutes for immediate use. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. The amount to be administered should be added to appropriate intravenous infusion fluids (see below).
The reconstituted M.V.I. Pediatric® should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation.
For a single dose, 5 mL of reconstituted M.V.I. Pediatric® should be added directly to not less than 100 mL of intravenous dextrose, saline or similar infusion solutions.
Infants weighing less than 1 kg: The daily dose is 30% (1.5 mL) of a single full dose (5 mL). Do not exceed this daily dose.
Infants weighing 1 to 3 kg: The daily dose is 65% (3.25 mL) of a single full dose (5 mL). Multiples of this recommended dose should not be given to infants weighing less than 3 kg. A supplemental vitamin A may be required for low birth weight infants.
Infants and children weighing 3 kg or more up to 11 years of age: The daily dose is 5 mL unless there is clinical or laboratory evidence for increasing or decreasing the dosage.
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 M.V.I. Pediatric® is reconstituted it should be immediately diluted into the intravenous solution. The resulting solution should be administered immediately. Some of the vitamins in this product, particularly vitamins A and D and riboflavin, are light-sensitive and exposure to light should be minimized.
HOW SUPPLIED
M.V.I. Pediatric® is available as:
NDC 61703-421-53, Single Dose Vial, Boxes of 10.
Store under refrigeration, 2 to 8°C (36 to 46°F).
附件：
201072300045011.pdf
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产地国家: 美国
原产地英文商品名:
M.V.I. PEDIATRIC 5ml/vial 10vials/box ( Infuvite replacement)
原产地英文药品名:
MVI, PEDI NO.1 WITH VIT K
中文参考商品译名:
小儿多种维生素 5毫升/瓶 10瓶/盒
中文参考药品译名:
多种维生素，PEDI NO.1和维生素K
生产厂家中文参考译名:
山德士
生产厂家英文名:
SANDOZ
该药品相关信息网址1:
http://www.flexyx.com/I/Infuvite%20Pediatric.html
该药品相关信息网址2:
http://www.rxlist.com/infuvite-pediatric-pharmacy-bulk-package-drug.htm