92.肝灵

出处:按学科分类—医药、卫生 军事医学科学出版社《临床常用进口药物手册》第516页(5675字)

【中文释文】:

注射液

肝灵为一种复方冻干注射剂,其主要成分为按精确计算比率配伍的4种核苷酸,维生素B12及肾上腺皮质提取物等。肝灵的这些成分在细胞代谢及蛋白质合成方面具有极为关键的作用,可以促进细胞功能恢复,纠正代谢紊乱。

〔成分〕

每安瓿冻干结晶内含有:

腺苷 10mg

胞苷 50mg

尿苷 50mg

鸟苷 10mg

维生素B12 1000μg

肾上腺皮质活性物 20活性单位(CDU)

(相当于氢化可的松剂的皮质甾醇60 μg)

抗菌剂 1mg

注射用溶剂每支含:

盐酸利多卡因 10mg

注射用水 2ml

〔适应证〕

肝灵主要用于肝脏疾病、血液疾病、衰弱及功能缺损性综合征的治疗,还用于中毒及感染恢复期的辅助治疗。

临床上的主要适应证有:

肝脏疾病:急、慢性肝炎、黄疸性肝炎,肝硬变、脂肪肝、肝功能障碍、病毒性肝炎等。

血液疾病:溶血性贫血、巨幼红细胞性贫血、黄疸性贫血、慢性肝疾引起的贫血等。

其它:慢性疾病、手术或感染引起的衰弱、疲劳、营养不良等。

〔用法与用量〕

肌肉注射,每日1次,每次1安瓿或遵医嘱。

〔禁忌证〕

1.对维生素B12有过敏史的病人禁用。

2.本品注射用溶剂中含利多卡因,6岁以下儿童以及对利多卡因有禁忌证的病人禁用此注射用溶剂。

〔注意事项〕

1.本品为含有维生素B12的复方非肠道药制剂,疑对维生素B12过敏者应作过敏试验后才可决定能否使用。

2.本品中的肾上腺皮质活性物虽具糖皮质激素作用,但临床上需要用糖皮质激素治疗的病人,不能用本品作为皮质激素,或促皮质激素的替代品。

〔不良反应〕

1.本品无一般剂量皮质激素的全身副作用,对肾上腺体功能无抑制作用。

2.本品中所含各组成分引起的不良反应十分罕见,但有可能出现以下不良反应:注射部位疼痛,轻度的心率及呼吸频率增加,瘙痒等。

〔包装贮存〕

每盒装冻干结晶10安瓿,附注射用溶剂10安瓿,贮藏于阴凉干燥处。

〔有效期〕

见包装盒。

〔生产厂家〕

米兰生命制药公司,意大利

附:

肝灵中的肾上腺皮质提取物具有以下药理特点:

1.含有的活性物作用比可的松强。

2.在内源性肾上腺皮质激素存在的情况下,与合成皮质激素相比,能发挥更强的替代作用。

3.对垂体-肾上腺轴没有阻断作用。

4.不具有矿物化作用。

5.对细胞膜两端的势能差有特异作用。

【外文释文】:

Upasr is a freeze-dried(lyophilized)product for injection.

Each ampoule contains,in carefully compounded proportions,four ribonucleosides,vitamine B12 and adrenal cortical extract.These components play an essential role in cell metabolism and protein synthesis.They can also promote the recovery of cell function and correct metabolic alterations.

Active ingredients per ampoule:

Adenosine 10 mg

Cytidine 50 mg

Uridine 50 rng

Guanosine 10 mg

Vit.B12 1000 μg

Adrenal Cortical Extract 20 CDU

(equivalent 60μg of total corticosteroids

expressed as hydrocortisone)

Septocombin 1 mg

Solvent ampoule:

Lidocaine Hydrochloride 10 mg

Distilled water for injection to 2 ml

Indications

Upase is mainly indicated in the treatment of hepatopathy,haematopathy,asthenia,and hypofunction syndrome.It is also employed as an adjuvant in the treatment of the course of toxi-infectious processes.

The clinical indications are:

Hepatopathy:acute and chronic hepatitis,icterohepatitis,cirrhosis,fatty liver,hepatic dysfunction,virus hepatitis,etc.

Haematopathy:Haemolytic anaemia,jaundice anaemia,macrocytic anaemia and anaemia caused by chronic liver diseases.It is also used in treating asthenia,fatigue,and malnutrition due to chronic disease,operation or infection.

Application and dosage

Usually give one ampoule daily,by intramuscular injection,or adhere to the instruction of the physician.

Contraindications

1.This preparation must not be used in patients with Vit.B12 allergic history.

2.Due to the presence of lidocaine in the solvent,never give the product to children younger than 6 years old and patients in whom lidocaine is not indicated.

Precautions

1.As Upase is a parenteral preparation containing Vit.B12,allergy test should be performed in suspected hypersensitive individuals before administration.

2.Although the product contains adrenocortical extract,it should not be used as the surrogate of glucocorticoid or adrenocorticotropic hormone for patient who need to be treated with glucocorticoid.

Side-effects

1.No systemic side-effects are seen in administration with usual dose of cortical hormone.No inhibition occurs to adrenal function.

2.Side-effects caused by the ingredients of this product are extremely rare.The following side-effects may occur:pain at the injected site,heart rate and respiratory rate slight increase,itching,etc.

Package and storage

Each box contains 10 ampoules of lyophilized product and 10 ampoules of solvent for injection.

Keep in cool and dry place.

Validity:printed on the box.

Appendix

The pharmacological properties of adrenal cortical extract in Upase are as follow:

1.The activity is greater than cortisone.

2.During the condition with endogenous adrenocortical hormone low level,the replacement effect is superior to that exerted by synthetic corticosteroids.

3.No inhibitory effects was found on the pituitary-adrenal axis.

4.No mineralactive effect.

Manufacturer

Lifepharma S.P.A.,Milano Italy

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