Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
ROPIVACAINE HYDROCHLORIDE
PROPHARM LTD
N01BB09
SOLUTION FOR INJECTION
ROPIVACAINE HYDROCHLORIDE 2 MG / 1 ML
PERINEURAL, EPIDURAL
Required
ALTAN PHARMACEUTICALS S.A., SPAIN
ROPIVACAINE
Acute pain management :In adults and adolescents above 12 years of age for:- Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain- Field blocks- Peripheral nerve block via a continuous infusion or intermittent bolus injections, e.g. postoperative pain management
2019-09-04
1 1. NAME OF MEDICINAL PRODUCT ROPIVACAINE ALTAN 2 MG/ML, ROPIVACAINE ALTAN 10 MG/ML 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ROPIVACAINE ALTAN 2 MG/ML 1 ml solution for injection contains 2 mg ropivacaine hydrochloride. 1 ampoule of 10 ml solution for injection contains 20 mg ropivacaine hydrochloride ( equivalent to 21.16 mg of ropivacaine hydrochloride monohydrate ) . Excipient: Each ml contains 3.34 mg of sodium. ROPIVACAINE ALTAN 10 MG/ML 1 ml solution for injection contains 10 mg ropivacaine hydrochloride 1 ampoule of 10 ml solution for injection contains 100 mg ropivacaine hydrochloride ( equivalent to 105.80 mg of ropivacaine hydrochloride monohydrate). Excipient: Each ml contains3.03 mg of Sodium. For a full list of excipients see _section 6.1_ . 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution Ropivacaine Altan solution for injection is a sterile solution. The pH of the solution is adjusted to 4.5-5.8 with sodium hydroxide or hydrochloric acid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ROPIVACAINE ALTAN 10 MG/ML IS INDICATED IN ADULTS AND ADOLESCENTS AGED ABOVE 12 YEARS OF AGE FOR: Surgical Anaesthesia Lumbar epidural administration for surgery. ROPIVACAINE ALTAN 2MG/ML IS INDICATED IN ADULTS AND ADOLESCENTS ABOVE 12 YEARS OF AGE FOR: Acute pain management: a. Continuous epidural infusion or intermittent bolus administration during postoperative or labour pain. b. Field blocks. c. Peripheral nerve block via continuous infusion or intermittent bolus injections, e.g. postoperative pain management. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Ropivacaine Altan should only be used by or under the supervision of clinicians experienced in regional anaesthesia. _ADULTS AND ADOLESCENTS ABOVE 12 YEARS OF AGE:_ The following table is a guide to dosage for the more commonly used blocks. The smallest dose required to produce an effective block should be used. The clinician's experience and knowledge of the patient's physical status are of importance when deciding the dos Đọc toàn bộ tài liệu