Pajjiż: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ondansetron (ondansetron hydrochloride dihydrate)
Hankook Korus Pharm Co.
A04AA01
ondansetron (ondansetron hydrochloride dihydrate)
2mg/ml
solution for i/m and i/v injection
(10) ampoules 4ml
Prescription
Registered
2017-07-10
To be prescribed Marketing Authorization Holder BSA < 0.6m 2 Day 1 5mg/m 2 IV plus 2mg syrup after 12 hours Days 2-6 2mg syrup Every 12 hours ≥ 0.6m 2 to ≤1.2m 2 ≤ 10 kg >1.2m 2 5mg/m 2 IV plus 4mg syrup or tablet after 12 hours 5mg/m 2 IV or 8mg IV plus 8mg syrup or tablet after 12 hours 4mg syrup or tablet every 12 hours 8mg syrup or tablet Every 12 hours Body Weight ≤ 10kg Day 1 Up to 3 doses of 0.15mg/kg IV every 4 hours Days 2-6 2mg syrup Every 12 hours > 10kg Up to 3 doses of 0.15mg/kg IV every 4 hours 4mg syrup or tablet every 12 hours 78, Daepungsandan-ro, Daeso-myeon, Eumseong-gun, Chungcheongbuk-do, Republic of Korea Woori Venture Tower #201, 70, Seonyu-ro, Yeongdeungpo-ku, Seoul, Republic of Korea SOLUTION FOR IM / IV INJECTION COMPOSITION Each ampoule contains Active ingredients :Ondansetron Hydrochloride …………………………………………………….. 4mg/2mL Ondansetron Hydrochloride …………………………………………………………………………. 8mg/4mL Inactive ingredient : Sodium Chloride, Citric Acid Monohydrate, Sodium Citrate, Water for injection DESCRIPTION Colorless, clear solution in transparent ampoule. INDICATIONS & USAGE _Adults_ Ondansetron-Asteria Inj. is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron-Asteria Inj. is also indicated for the prevention and treatment of post-operative nausea and vomiting. _Paediatric Population_ _Injection and oral formulations:_ Ondansetron-Asteria Inj. is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy. No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; IV injection is recommended for this purpose. ADMINISTRATION & DOSAGE Ondansetron is available for oral, parenteral and rectal use to allow the route of administration and dosing to be flexible. CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AN Aqra d-dokument sħiħ
Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Ondansetron-Asteria Inj. 8mg/4ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient No. Chemical Name Quantity/ampoule Use 1 Ondansetron hydrochloride 8mg (as Ondansetron) Active ingredient Excipient(s) No. Chemical Name Quantity/ ampoule Use 1 Sodium Chloride 20mg Inactive ingredient 2 Citric Acid monohydrate 1.0mg Inactive ingredient 3 Sodium citrate 0.6mg Inactive ingredient 4 Water for injection q.s Inactive ingredient 3. PHARMACEUTICAL FORM Solution for i/m and i/v injection 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Adults Ondansetron-Asteria Inj. is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Ondansetron-Asteria Inj. is also indicated for the prevention and treatment of post-operative nausea and vomiting. Paediatric Population Injection and oral formulations: Summary of Product Characteristics Ondansetron-Asteria Inj. is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy. No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; IV injection is recommended for this purpose. 4.2 Posology and method of administration Ondansetron is available for oral, parenteral and rectal use to allow the route of administration and dosing to be flexible CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV and RINV) The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge. Populations _CINV AND RINV IN ADULTS _ The recommended intravenous (IV) or intramuscular (IM) dose of ONDANSETRON-ASTERIA INJ. is 8 mg administered immediately before treatment. For highly emetogenic chemotherapy, a maximum initial ondansetron dose of 16 mg IV infused over 15 minutes may be used. A sing Aqra d-dokument sħiħ