FORMULATION:
Each mL of Somazine 500 contains Citicoline.................125mg
(500mg Citicoline per 4mL ampoule)
Each mL of Somazine 1000 contains Citicoline..................250mg
(1000mg Citicoline per 4mL ampoule)
Citicoline, a naturally occurring endogenous nucleoside, is an intermediate compound in the major pathway for the biosynthesis of the structural phospholipids of cell membranes, including neurons.
PHARMACODYNAMICS:
When administered orally, it is absorbed almost completely, and its bioavailability is approximately the same when administered intravenously.
Once absorbed, the cytidine and choline disperse widely throughout the body, cross the blood-brain barrier, and reach the central nervous system (CNS), where they are incorporated into the phospholipids fraction of the cellular membrane and microsomes.
The concept that the administration of exogenous Citicoline can augment the synthesis of neural membrane phospholipids is attractive, because accelerated replacement or repair plays a critical role in maintaining the healthy function of numerous physiological processes. It has shown the therapeutic efficacy in a variety of diseases in which membrane disorder, dysfunction, or degeneration result in cellular and tissue ischaemia and necrosis.
PHARMACOLOGICAL PROPERTIES:
Citicoline activates the biosynthesis of structural phospholipids in the neuronal membrane, increases cerebral metabolism and increases the level of various neurotransmitters, including acetylcholine and dopamine. Citicoline has shown neuro-protective effects in situations of hypoxia and ischaemia, as well as improved learning and memory performance in animal models for the brain aging. Furthermore, it has been demonstrated that Citicoline restores the activity the activity of mitochondrial ATPase and of membranal Na+/K+ATPase, inhibits the activation of phospholipase A2 and accelerates the re-absorption of cerebral edema in various experimental models
INDICATIONS:
a. Cerebrovascular diseases - e.g. from ischaemia due to stroke, where Citicoline accelerates the recovery of consciousness and overcoming motor deficit. The clinical testing of Citicoline has challenged the historical concept that one can do nothing for a stroke patient after a certain period of time has transpired after the onset of the symptoms. The practicality of a drug that can be administered up to 24 hours after stroke is a key factor in evaluating the potential of Citicoline.
The results of a recent phase 3 clinical trials among patients suffering from ischaemia stroke demonstrated a statistically and clinically significant improvement in the neurological function of patients treated with optimal dose of Citicoline, 500mg daily. The potential of Citicoline as stroke therapy is underscored by the other key attributes: its oral dosage for, a 24-hour window of therapeutic opportunity following stroke, and an apparent absence of significant side effects. Preliminary evidence suggests that in a small sub-group of patients, Citicoline may reduce the size of the impact caused by stroke.
Treatment of Citicoline within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery in 3 months.
b. Head Trauma of varying severity: In a clinical trial, Citicoline accelerated the recovery from post-traumatic coma and the recuperation of walking ability, achieved a better final functional result and reduced hospital stay.
c. Cognitive disorders of diverse aetiology - e.g. senile cognitive impairment which is secondary to degenerative diseases (e.g. Alzheimer's disease) and to chronic cerebral vascular disease. Citicoline improves scores on cognitive evaluation scales and slowed the progression of Alzheimer's disease.
d. Parkinson's disease - Citicoline has also been shown to be effective as co-therapy for Parkinson's disease. Beneficial neuroendocrine, neuroimmunodulatory, and neurophysiological effects have been described. Considerable experimental evidence of effects of Citicoline on CNS dopaminergic system has accumulated. After treatment with Citicoline, regeneration of cells in rats with substantina nigra lesions has been demonstrated. Citicoline increases striatal dopamine and tyrosine hydroxylase synthesis
CONTRAINDICATIONS:
Must not be administered to patients with hypertonic of the parasympathetic.
USE IN PREGNANCY AND LACTATIONS:
There is inadequate evidence of safe use of Somazine in human pregnancy. Somazine should be used in pregnancy and lactation only if the potential benefits justify the potential risks.
PRECAUTIONS:
In case of persistent intracranial hemorrhage, the very slow administration (30 drops/minute) is recommended, the administration of larger doses could provoke an increase of the cerebral blood flow.
INCOMPATIBILITIES:
Somazine must not be administered in conjunction with medication containing meclofenoxate (also known as clophenoxate).
DRUG INTERACTIONS:
Somazine potentiates the effects of L-dopa.
SIDE EFFECTS:
Occasionally, citicoline may exert a stimulating action of the parasympathetic system, as well as a fleeting and discrete hypotensive effect.
CAUTION:
Food, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
DOSAGE:
Somazine 500 - 125mg/mL Injection: 1 to 2 injections daily
Somazine 1000 - 250mg/mL Injection:1 Injection daily
Dosage may be adjusted based on the seriousness of the disease. It can be administered Intramuscularly, intravenously (3 to 5 minute) injection and in intravenous drop perfusion (dripping speed 40-60 drops/minute). SOMAZINE is compatible with all intravenous isotonic solutions. It can also be mixed with hypertonic glucose serum. Direct administration in the vein, if it is not made very slowly, can produce hypotension.
AVAILABILITY:
SOMAZINE 500 - 125mg/mL (500mg/4mL ampoule): Box of 5 ampoules x 4mL
SOMAZINE 1000 - 250mg/mL (1000mg/4mL ampoule): Box of 5 ampoules x 4mL
STORE BELOW 25°C.
配方：
每500毫升含有Somazine ................. 125mg胞二磷胆碱
（每500毫克4毫升安瓿胞二磷胆碱）
每毫升含有1000 Somazine胞二磷胆碱.................. 250毫克
（每4毫升安瓿胞二磷胆碱1000毫克）
胞二磷胆碱，一种自然产生的内源性核苷，是在为细胞膜，包括神经元的结构磷脂合成中间化合物的主要途径。
药效：
当口服，它几乎完全被吸收，其生物利用度约为静脉注射时一样。
一旦吸收，分散和胆碱胞苷广泛整个身体，穿过血脑屏障，达到中枢神经系统（CNS），在那里他们进入细胞膜磷脂含量和微粒中。
这一概念的外源性磷胆碱管理可以增加神经细胞膜磷脂的合成是有吸引力的，因为加速更换或维修在维持众多生理过程的保健功能的关键作用。它表现出了多种疾病的治疗效果，其中膜障碍，功能障碍，或变性的细胞和组织缺血和坏死的结果。
药理特性：
胞二磷胆碱激活磷脂结构中的神经元细胞膜的合成，提高脑代谢，增加了各种神经递质，包括乙酰胆碱和多巴胺的水平。胞二磷胆碱已显示在缺血缺氧的情况和神经保护作用，以及改善学习和记忆的大脑衰老动物模型的性能。此外，已经证明，胞二磷胆碱恢复线粒体ATP酶的活性和membranal的Na + / K + ATP酶，活性抑制磷脂酶A2激活并加速各种实验模型的再吸收脑水肿
适应症：
答：脑血管疾病 - 例如从因中风缺血，胞二磷胆碱在加速运动的意识和克服赤字恢复。临床试验的胞二磷胆碱历史概念提出了挑战，人们可以做什么中风病人经过一段时间的蒸腾后出现症状。一个可管理的中风后24小时药物实用性是评价的胞二磷胆碱潜力的关键因素。
包括由缺血中风患者的近期第3期临床试验结果表明，在患者的神经系统与胞二磷胆碱治疗作用的最佳剂量，每日500毫克统计学和临床显着改善。作为中风治疗的胞二磷胆碱的潜力是突出了其他关键属性：其口服制剂的，一个治疗的机会24小时的窗口中风后，一个明显的副作用明显的缺乏。初步证据表明，在一个小的子组患者，胞二磷胆碱可降低中风所造成的影响大小。
治疗后24小时内的胞二磷胆碱在患者发病后中度至重度中风增加了3个月内完全恢复的可能性。
湾头部不同程度的创伤：在临床试验中，胞二磷胆碱加速创伤后昏迷和休养恢复行走能力，取得了较好的最终功能结果，并减少住院时间。
角不同病因的认知障碍 - 例如老年认知功能障碍是次要的（如阿尔茨海默氏病），慢性退行性疾病和脑血管疾病。胞二磷胆碱改善认知评估量表分数和减缓了阿尔茨海默氏病的进展。
四帕金森氏病 - 胞二磷胆碱，也被证明是作为共同为帕金森氏病治疗有效。有益的神经内分泌，neuroimmunodulatory，及神经生理学的影响进行了描述。相当大的对中枢神经系统多巴胺能系统胞二磷胆碱作用的实验证据积累。胞二磷胆碱治疗后，细胞再生与substantina黑质病变大鼠已被证明。胞二磷胆碱增加纹状体多巴胺和酪氨酸羟化酶合成
禁忌症：
不得加以管理的副交感神经与高渗患者。
利用妊娠和LACTATIONS：
有安全使用的Somazine在人类怀孕证据不足。 Somazine应该用在怀孕和哺乳期只有在潜在利益辩护的潜在风险。
注意事项：
在持久性颅内出血，很慢局（30滴/分钟）的情况下，建议，较大剂量能引起政府的脑血流增加。
不兼容性：
Somazine不得使用含有甲氯芬酯药物管理（也称为clophenoxate）一起使用。
药物相互作用：
Somazine potentiates的L -多巴的影响。
副作用：
有时，胞二磷胆碱可施加一定的刺激作用的副交感神经系统，以及一个稍纵即逝和离散降压作用。
注意：
食品，药品，器械和化妆品法案禁止无处方配药。
用量：
Somazine 500 - 125mg/mL注射：注射每日1到2
Somazine 1000 - 250mg/mL注射：1每天注射
可以调整剂量根据疾病的严重程度。它可以以肌肉注射，静脉注射（3至5分钟）注射及点滴灌注（滴水速度40-60滴/分钟）。 SOMAZINE与所有静脉注射等渗解决方案兼容。它也可以混合使用高渗葡萄糖血清。直接在静脉注射，如果不进行非常缓慢，可产生低血压。
可用性：
SOMAZINE 500 - 125mg/mL（500mg/4mL安瓿）：5盒X 4毫升安瓿
SOMAZINE 1000 - 250mg/mL（1000mg/4mL安瓿）：5盒X 4毫升安瓿
低于25 ° C的保存
在西班牙的信息
SAURAN 1000MG 3 AMPOLLAS 10ML 胞磷胆碱口服液
dicamento: SAURAN 100MG 30 COMPRIMIDOS.
Nombre: SAURAN 100MG 30 COMPRIMIDOS.
Sustancias: Citicolina.
Subgrupo Terapeutico: OTROS PSICOANALEPTICOS, EXCLUIDOS PREPARADOS ANTIOBESIDAD.
Subgrupo Terapeutico OMS: OTROS PSICOESTIMULANTES Y NOOTROPICOS.
Situación: BAJA GENERAL SIN CLASIFICAR.
Laboratorio: ABELLO, S.A..
Precio Laboratorio: 7.29 ?
Precio Actual: 11.63 ?
Precio de Referencia: 0 ?
Precio Comercial: 11.63 ?
Fecha de alta: 01/05/1981.
Fecha de baja: 01/04/1997.
Dosis Diaria Definida (unidades) y Origen: 400 (MG - MILIGRAMOS) INSALUD.
Dosis por unidad de contenido (unidades): 100 (MG - MILIGRAMOS).
Unidades posológicas: 30.
Unidades de contenido: COMPRIMIDO .
Vía de administración: ORAL.
Nº máximo de envases por receta: 1.
Forma Farmacéutica: COMPRIMIDOS.
Grupo: COMPRIMIDOS.
FORMA ORAL LIBERACION INMEDIATA. Per Os (oral) / Comprimidos / Ingerir
Principio Activo: CITICOLINA.
Sustancia Química: CITICOLINA (D.C.I.-P).
Autor del Codigo: ATC .
Dosis por unidad de contenido (unidades): 100 (MG - MILIGRAMOS).
Unidades posológicas: 30.
Unidades de contenido: COMPRIMIDO .
Vía de administración: ORAL.
Nº máximo de envases por receta: 1.
Forma Farmacéutica: COMPRIMIDOS.
Grupo: COMPRIMIDOS.
FORMA ORAL LIBERACION INMEDIATA. Per Os (oral) / Comprimidos / Ingerir
Principio Activo: CITICOLINA.
Sustancia Química: CITICOLINA (D.C.I.-P).
SAURAN 100MG 30 COMPRIMIDOS 胞磷胆碱片
Principio activo: COLINA CITIDIN-5-DIFOSFATO
Codigo Nacional: 660152
Codigo Registro: 69416
Nombre de presentacion: SOMAZINA 1000 mg solución oral, 10 sobres de 10 ml
Laboratorio: FERRER INTERNACIONAL, S.A.
Fecha de autorizacion: 2007-11-26
Estado: Autorizado
Fecha de estado: 2007-11-26
Prospecto
Toda la información del medicamento
1. NOMBRE DEL MEDICAMENTO
Somazina 100 mg/ml solución oral Somazina 1000 mg solución oral
2. COMPOSICIÓN CUALITATIVA Y CUANTITATIVA
Somazina 100 mg/ml solución oral, se envasa en frascos de vidrio de 30 ml. Cada mililitro contiene 100 mg de Citicolina (como sal sódica). Somazina 1000 mg solución oral, se envasa en sobres de 10 ml. Cada mililitro contiene 100 mg de Citicolina (como sal sódica). Excipientes: Ambas presentaciones contienen por ml de solución: 0,005 mg de Color rojo Ponceau 4R; 0,4 mg de Parahidroxibenzoato de propilo; 1,6 mg de Parahidroxibenzoato de metilo, 200 mg de Sorbitol líquido y otros excipientes en c.s. Para la lista completa de excipientes, ver sección 6.1.
3. FORMA FARMACÉUTICA
Solución oral. Somazina 100 mg/ml solución oral: Frascos de vidrio de 30 ml conteniendo una solución transparente de color rosa, con olor y sabor a fresa. Somazina 1000 mg solución oral: Sobres de 10 ml conteniendo una solución transparente de color rosa, con olor y sabor a fresa.
