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部分中文Gelofusine Eco Bag处方资料（仅供参考）
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    佳乐施(Gelofusine)是一种琥珀酰明胶类血浆代用品,用于急性失血性休克的治疗.在不影响机体正常生理功能前提下，使用血浆代用品，能够较好维持循环血容量充足、维护血流动力学稳定、保证氧供/氧耗平衡.

【通用名称】琥珀酰明胶注射液

【适应症】用于低血容量性休克、手术创伤、烧伤及感染的血容量补充，手术前后及手术间的稳定血液循环，体外循环（血液透析，人工心肺机）血液稀释，脊髓及硬膜外麻醉后的低血压的预防。

【用法用量】经静脉输注，剂量和速度取决于病人的实际情况，如脉搏、血压、外周组织灌注量、尿量等，必要时可加压输注。快速输注时应加温液体，但不超过37oC。如果血液或血浆丢失不严重，或术前或术中预防性治疗，一般1~3小时内输注500~1000ml；低血容量休克，容量补充和维持时，可在24小时内输注10~15L（但红细胞压积不应低于25%，年龄大者不应低于30%同时避免血液稀释引起的凝血异常）；严重急性失血致生命垂危时，可在5~10min内加压输注500ml，进一步输注量视缺乏程度而定。

【不良反应】偶风过敏反应，可出现轻微荨麻疹。本品引起严重不良反应的发生率在1/6000和1/13000之间，由血管活性物质放引起。病人通常表现为变态反应。如病人已处于过敏状态，如哮喘，则出现反应的机会增加，程度也会加重，应慎用。一旦出现过敏反应，应立即停止输注，并根据病人情况做相应处理：更换容量替代液；抬高双腿；增加供氧；监测电解质；给予肾上腺素（1：1000浓度0.5-1.0ml肌注，必要时每15分重复一次或1：10000浓度5~10ml缓慢静滴）及大剂量肾上腺皮质激素（如泼尼松龙250-1000mg）；也可使用抗菌素组胺药（如：氯苯那敏10~20mg缓慢静滴）及钙剂（小心病人服过强心苷）；必要时可用利尿剂加快液体排出。

【禁忌】对本品有过敏反应的病人禁用。有循环超负荷、水潴留、严重肾功能衰竭、出血素质、肺水肿的病人禁用。

【注意事项】1．心力衰竭可能拌有循环超负荷者，此时输液时应缓慢进行。2．对水分过多、肾衰、有出血倾向、肺水肿、钠或钾缺乏以及对输液成分过敏等病人要慎用。3．失血量超过总量25%时，应输全血或红细胞。4．使用本品不会干扰交叉配血。5．本品含钙量、含钾量低，可用于洋地黄化的病人或肾功能较差的病人。6．输注本品期间下列化验指标可能不稳定：血糖、血沉、尿液比重、蛋白、双缩脲、脂肪酸、胆固醇、果糖、山梨醇脱氢酶。7．容器如有破裂或液体出现混浊应丢弃不用，瓶盖上之无菌封贴一经揭开，不宜再盖回，插入输液器前应消毒。8．本品一旦封口开启，应在4小时内使用，任何未用完之药液均不可再用。

Gelofusine
Indications
As a colloid volume replacement in hypovolaemia, for haemodilution, in an extracorporeal circulation system (heart-lung machine, artificial kidney), as prophylaxis against a possible hypotension following spinal or epidural anaesthesia and as a vehicle for insulin infusions (to prevent losses of insulin by absorption into containers and infusion tubing).

In the context of the replacement of specific components following blood loss, it is generally possible to avoid giving red cells until the losses amount to 20% of the total blood volume. If more than 2000-3000 mL of Gelofusine B

Braun are infused pre- and intraoperatively, it is recommended that the serum protein concentration will be checked postoperatively, especially if there are signs of tissue oedema. Under certain circumstances (eg, septic shock, where there may be a need for specific globulins) a human albumen preparation may be the appropriate choice for further volume expansion.

Gelofusine B Braun has no effect on blood coagulation or on renal function, even in large doses (up to 15 L in 24 hrs as part of massive transfusions). Particularly in cases of massive transfusion is it important to avoid disturbances of coagulation, other than those caused by a simple dilution effect. The simultaneous administration of blood through the same infusion set is possible. The low calcium content does not cause any coagulation of the citrated blood.
 
Dosage
The solution is administered IV. The duration and quantity of the infusion is to be determined individually on the basis of pulse, blood pressure, peripheral perfusion and diuresis. In cases of less severe blood or plasma losses, or as prophylaxis pre- and intraoperatively, it is usually sufficient to give 500-1000 mL over 1-3 hrs. For volume replacement and maintenance in shock it may be necessary to give 10-15 L within 24 hrs. (The haematocrit should not fall below 25% or in elderly patients better not below 30%, and coagulation disorders caused by dilution should be avoided.)

Further Notes: Gelofusine B Braun is effective in maintaining blood volume, but does not adequately replace protein deficiencies associated with blood or plasma losses.

Tolerance is unknown.
 
Overdosage
In case of overdose, problems can arise from haemodilutional effects of Gelofusine and they have to be treated accordingly to their nature.

Contraindications
Circulatory overload. Previous anaphylactoid reactions after administration.

Special Precautions
In heart failure there is a possibility of circulatory overload, in which case the infusion should be given slowly.

Caution in cases of overhydration, renal failure, haemorrhagic diatheses, pulmonary oedema, sodium or potassium

deficiency and known hypersensitivity to components of the solution.

Use in pregnancy & lactation: Pregnancy Category C: There is little information on the administration of Gelofusine B

Braun to pregnant or lactating women. No embryotoxic effect has, however, hitherto been observed, but there is a little risk of severe anaphylactoid reactions. Under these circumstances this preparation should only be prescribed when the potential advantage outweighs the potential risk to the foetus.
 
Side Effects
Severe anaphylactoid reactions following infusions of Gelofusine B Braun have been observed. The incidence is between 1 in 6000 and 1 in 13,000. Such reactions are caused by the release of vasoactive substances, and appear to occur with greater frequency and with greater severity in patients with known allergies.

Treatment: The Gelofusine infusion should be stopped immediately. Further treatment depends on the severity of the

anaphylactoid reaction: Alternative volume replacements; elevation of the legs administration of oxygen; immediate administration of adrenaline parenterally (eg, 0.5-1 mL of adrenaline 1:1000 IM, repeated if necessary, every 15 min, or 5-10 mL of adrenaline 1:10,000 slowly IV); administration of high-dose corticosteroids (eg, prednisolone 250-1000 mg); antihistamines (eg, chlorpheniramine 10-20 mg slowly IV); calcium (caution in patients being treated with cardiac glycosides); observation and treatment of the metabolic acidosis.
 
Drug Interactions
During Gelofusine B Braun infusions the results of the following clinical chemistry tests may be unreliable:Blood sugar, ESR, specific gravity of urine, protein, Biuret, fatty acids, cholesterol, fructose, sorbitol dehydrogenase.

Incompatibilities: Although electrolyte and carbohydrate solutions may be given together through the same cannula as the Gelofusine B Braun solution, this is not permitted for fat emulsions. The simultaneous administration of blood through the same infusion set is possible. The addition of drugs in aqueous solution (eg, vasoactive drugs, barbiturates, muscle relaxants, corticosteroids and antibiotics) is generally possible but not recommended.

Storage
Store at room temperature below 25°C.
Any container which has been pierced should be used within 4 hrs. Cloudy solutions should be discarded.

Shelf-Life: 5 years.
 
Description
Gelofusine B Braun is a plasma substitute of succinylated gelatin solution (modified fluid gelatin).
 
Mechanism of Action
Pharmacology: Gelofusine B Braun is an isotonic sterile and pyrogen-free 4% solution of succinylated gelatin. It has a volume effect comparable to the volume infused, and therefore does not have an intrinsic volume expander effect.
The infusion of Gelofusine B Braun increases the plasma volume. This produces an increase in venous return, cardiac output, arterial blood pressure and peripheral perfusion. The osmotic diuresis induced by Gelofusine B Braun has a substantial effect on the maintenance of renal function in shock.

The combination of the following effects of a Gelofusine B Braun infusion produces an improved oxygen supply to the tissues:

Haemodilution with Gelofusine B Braun which has a relative viscosity similar to plasma, reduces the relative viscosity of the blood. In addition, negative changes in the microcirculation are reversed, at least in part. The overall result is a considerably improved pattern of blood flow with an increased cardiac output.

Gelofusine B Braun infusion reduces the haematocrit and thereby the oxygen-carrying capacity of the blood. However, the reduction in blood viscosity and the positive changes in the microcirculation reduce the workload of the heart, so that the cardiac output can be increased without any increase in myocardial oxygen consumption. The overall effect of the Gelofusine B Braun infusion, taking into account this increase in cardiac output, is to increase the oxygen transport (if the haematocrit does not sink below about 25% or in elderly patients better not below 30 %).

Furthermore, the colloid osmotic properties of Gelofusine B Braun prevent or reduce the possibility of interstitial oedema, which may limit the oxygen supply to the tissues.

If there is a peripheral oxygen deficit, the release of oxygen from the haemoglobin is increased, with a useful effect on the total oxygen supply to the tissues.

Pharmacokinetics: Gelofusine B Braun has been shown to have a multi-phase elimination curve from the blood

circulation, with a half-life of about 9 hrs (determined by a graphical technique) and a volume effect of about 5 hrs.

It appears that some 75% of the infused succinylated gelatin molecules are excreted through the kidneys and about 15% in the faeces. In animal experiments, retention in the reticuloendothelial system for 24-48 hrs has been demonstrated.

The fraction which is not directly excreted is broken down by proteolysis. This breakdown process is so effective that there is no accumulation even in renal failure.

The dose administered is always determined by the goal of an adequate circulation. This applies even when renal excretion is reduced.

 
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于2010年5月25日更新