国: イスラエル
言語: 英語
ソース: Ministry of Health
PANTOPRAZOLE AS SODIUM
TAKEDA ISRAEL LTD
A02BC02
POWDER FOR SOLUTION FOR INJECTION
PANTOPRAZOLE AS SODIUM 40 MG/VIAL
I.V
Required
TAKEDA GMBH, GERMANY
PANTOPRAZOLE
PANTOPRAZOLE
For the treatment of duodenal ulcer, gastric ulcer, moderate and severe forms of reflux oesophagitis. Zollinger Ellison Syndrome.
2023-10-31
1 | P a g e TAKEDA ISRAEL LTD. IL/PANV/0919/0004 25 Efal st., P.O.B 4140, Petach-Tikva 4951125 Tel:+972- - 3- 33733140 Fax (local): + 972-3-3733150 וטקוא רב 2019 אפור / ה ה/דבכנ , חקור / ת דבכנ / ה , :ןודנה CONTROLOC ® I.V. 40 MG/VIAL קולורטנוק ™ . V . I 0 4 /ג"מ ) ןוקובקב לאיו ( ןכדעתה ,ןודנבש רישכתה לש אפורל ןולעה יכ םכעידוהל תשקבמ מ"עב לארשי הדקט תרבח ב רבמטפס 2019 . וכדעה ן הז בתכמב עיפומ הטמ , . עדימל ףסונ , שי ןייעל רגאמב תופורתה רתאבש דרשמ תואירבה . ,ןכ ומכ לבקל ןתינ קתעה ספדומ ןולעה לש ינכדעה ע ל - ידי :םושירה לעבל היינפ לעפא 'חר ,מ"עב לארשי הדקט 25 חתפ , - קת ו ,הו :'לט 03-3733140 . :לארשיב רישכתל תרשואמה היוותהה Controloc I.V. is indicated for the treatment of duodenal ulcer, gastric ulcer, moderate and severe forms of reflux oesophagitis, Zollinger Ellison Syndrome. ביכרמ ליעפ : Pantoprazole (as sodium) 40 mg/Vial הכרבב , ידרו בהי תחקור הנוממ הדקט לארשי עב " מ 2 | P a g e TAKEDA ISRAEL LTD. IL/PANV/0919/0004 25 Efal st., P.O.B 4140, Petach-Tikva 4951125 Tel:+972- - 3- 33733140 Fax (local): + 972-3-3733150 פורל ןולעב ןוכדעה וניה א ) טסקט ףסונש ןמוסמ ב לוחכ טסקט , הרמחה הווהמה בוהצב שגדומ ( : 4.8 UNDESIRABLE EFFECTS … Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience FREQUENCY SYSTEM ORGAN CLASS COMMON UNCOMMON RARE VERY RARE NOT KNOWN Gastrointestinal disorders Fundic gland polyps (benign) Diarrhoea; Nausea/ vomiting; Abdominal distension and bloating; Constipation; Dry mouth; abdominal pain and discomfort MICROSCOPIC COLITIS … 完全なドキュメントを読む
PRESCRIBING INFORMATION CONTROLOC ® I.V. 1. NAME OF THE MEDICINAL PRODUCT Controloc ® I.V. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains pantoprazole sodium 42.3 mg (corresponding to pantoprazole 40 mg) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications - duodenal ulcer - gastric ulcer - moderate and severe reflux oesophagitis - Zollinger-Ellison - Syndrome 4.2 Posology and method of administration This medicine should be administered by a healthcare professional and under appropriate medical supervision. Intravenous administration of Controloc ® I. V. is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. _ _ Therefore, as soon as oral therapy is possible, treatment with Controloc ® I.V. should be discontinued and 40 mg pantoprazole p.o. should be administered instead. Posology Duodenal ulcer, gastric ulcer, moderate and severe reflux oesophagitis _ _ The recommended intravenous dose is one vial of Controloc ® I.V. (40 mg pantoprazole) per day. Zollinger-Ellison- Syndrome _ _ For the long-term management of Zollinger-Ellison - Syndrome patients should start their treatment with a daily dose of 80 mg Controloc I.V . Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control. In case a rapid acid control is required, a starting dose of 2 x 80 mg Controloc ® I.V. is sufficient to manage a decrease of acid output into the target range ( < 10 mEq/h) within one hour in the majority of patients. Special populations : _Patients with hepatic impairment _ _ _ A daily dose of 20 mg pantoprazole (half a vial of 40 mg pantoprazole) sho 完全なドキュメントを読む