Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PANTOPRAZOLE SODIUM
Takeda Malaysia Sdn Bhd
PANTOPRAZOLE SODIUM
1 Vials
Takeda GmbH
CONTROLOC ® I.V. ACTIVE INGREDIENT: PANTOPRAZOLE SODIUM COMPOSITION One vial contains _Active ingredient _ Pantoprazole sodium 42.3 mg (equivalent to pantoprazole 40 mg) _Excipients _ Disodium edetate; sodium hydroxide PRODUCT DESCRIPTION Powder for preparation of an injection solution White to off-white powder. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic / indication group / action mechanism Selective proton pump inhibitor, substituted benzimidazole ATC Code: A02BC02 _Mechanism of action _ Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells. Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both basal and stimulated acid secretion. In most patients, freedom from symptoms is achieved within 2 weeks. As with other proton pump inhibitors and H2 receptor inhibitors, treatment with pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously. The fasting gastrin values increase under pantoprazole. On short-term use, in most cases they do not exceed the upper limit of normal. During long-term treatment, gastrin levels double in most cases. An excessive increase, however, occurs only in isolated cases. As a result, a mild to moderate increase in the number of specific endocrine (ECL) cells in the stomach is observed in a minority of cases during long-term treatment (simple to adenomatoid hyperplasia). However, according to th Olvassa el a teljes dokumentumot