47.肾灵片
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263页(4646字)
【中文释文】:
复方氨基酸片
〔薄膜衣片〕
每片含:(RS)-3-甲基-2-氧化戊酸67mg;DL异亮氨酸的α-酮基类似物,钙盐;
4-甲基-2-氧代戊酸101mg;亮氨酸的α-酮基类似物,钙盐;
2-氧代-3-苯基丙酸68mg;苯丙氨酸的α-酮基类似物,钙盐;
3-甲基-2-氧代丁酸86mg;缬氨酸的酮基类似物,钙盐;
RS-2-羟基-4-甲基硫代丁酸59mg;DL蛋氨酸的α-羟基类似物,钙盐;
L-赖氨酸醋酸酯105mg;
L-苏氨酸53mg;
L-色氨酸23mg;
L-组氨酸38mg;
L-酪氨酸30mg。
每片总氮含量36mg。
每片钙含量0.05g。
〔使用范围〕
预防和治疗由慢性肾机能不全时蛋白代谢障碍或蛋白代谢不足引起的损害,这与食物中每日蛋白限量40g(成人)或少于40g有关。也就是说本品一般用于肾小球滤过率(GFR)为约5ml/min和15ml/min的病人。
〔禁忌证〕
高钙血症、氨基酸代谢紊乱。
注意:迄今为止尚无用于妊娠和儿科的经验。
〔副作用〕
可能发生高钙血症。
注意:定期监测血清钙浓度。确保足够的热量供给。
〔与其他药相互作用〕
同时给予含钙药物(例如:Acetolyte)可能导致血清钙浓度病理性增加或强化。
服用复方氨基酸,由于尿毒症症状得到改善,可能应减少氢氧化铝剂量。请注意血清中磷酸盐的减少。
为了不干扰吸收,请勿将药物与可能与钙生成不溶性化合物(例如:四环素)的复方氨基酸片同时服用。
〔剂量与用法〕
口服,假使没有处方,请服4~8片,每日3次,饭时服用,整片吞下。该剂量用于体重70公斤的成人。
〔使用时间〕
只要肾小球滤过率在5~15ml/min就可长期给予复方氨基酸片。同时,食物中每日应含40g或低于40g蛋白质(成人)。
存放在儿童不能触及处!
〔包装〕
每盒100片薄膜衣片;
3×100薄膜衣片;
15×100薄膜衣片。
〔生产厂家〕
德国弗森尤斯股份公司
【外文释文】:
film-coated tablet contains
(RS)-3-methyl-2-oxovaleric acid 67mg
(α-ketoanalogous to DL-isoleucine),calcium salt
4-methyl-2-oxovaleric acid 101mg
(α-ketoanalogous to leucine),calcium salt
2-oxo-3-phenyl propionic acid 68mg
(α-Ketoanalogous to phenylalanine),calcium salt
3-methyl-2-oxobutyric acid 86mg
(α-Ketoanalogous to valine),calcium salt
(RS)-2-hydroxy-4-methyithiobutyric acid 59mg
(α-hydroxyanalogous to DL-methionine),calcium salt
L-Lysinen onoacetate 105mg
L-Threonine 53mg
L-Tryptophan 23mg
L-Histidine 38mg
L-Tyrosine 30mg
Total nitrogen content/tablet 36mg
Calcium/tablet 0.05 g
Fields of application
Prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein in food of 40g per day(for adults)and less,i.e.generally in patients with a glomerularfiltration rate(GFR)between 5 and about 15ml/minutes.
Contraindications
Hypercaleaemia,disturbed amino acid metabolism.
Note:No experience has been made so far with the application in pregnancy and paediatry”.
Side-effects
Hypercalcaemia may develop.
Notes:Monitor regularly the serum calcium level,ensure the sufficient supply with calories!
Interactions with other drugs
The simultaneous administration of medicaments containing calcimn(e.g.acetolyte)may lead to pathological increases of the serum calcium level or intensification.
As the uraemic symptoms improve under Ketosteril,a possible administration of aluminium hydroxide should be reduced,Pay attention to a reduction of serum phosphate.
In order not to interfere with absorption,do not take drugs together with Ketosteril that form sparingly soluble compounds with calcium(e.g.tetracylines).
Dosage and Application
For oral use.
If not otherwise prescribed,take 4 to 8 tablets three times a day during meale,swallow whole.
This dosage appiles to adults(70 kg/bw).
Duration of Application
Ketosteril tablets are given as long as the glomerular filtration rate is bwtween 5 and about 15ml/minute.Simultaneously food should contain 40g/day protein or less(adults).
Store not within reach of children!
Presentation
Pack containing 100 film-coated tablets
3×100 film-coated tablets
15×100 film-coated tablets
Manufacturer
Fresenius AG Fed.Rep.of Germany