Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aprepitant
Zentiva Pharma UK Ltd
A04AD12
Aprepitant
125mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 8594739231672
Page 1 of 3 1065019079_BOX_APREPITANT_80_125MG_CD_WAL1X1+2_GB.ai aprepitant 1 x 125 mg hard capsule and 2 x 80mg hard capsules Aprepitant Zentiva 125mg/80mg hard capsules Aprepitant Zentiva 125mg/80mg hard capsules Aprepitant Zentiva 125mg/80mg hard capsules Aprepitant Zentiva 125mg/80mg hard capsules 1 x 125 mg hard capsule and 2 x 80 mg hard capsule Aprepitant 125mg/80 mg hard capsules Each 80 mg capsule contains 80 mg of aprepitant. Each 125 mg capsule contains 125 mg of aprepitant. Contains sucrose and sodium Read the package leaflet before use. Oral use. Store in the original package in order to protect from moisture. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. PL 17780/0824 Zentiva Pharma UK Limited 12 New Fetter Lane London EC4A 1JP United Kingdom 1065019079 *WILL BE IMPLEMENTED NOT LATER THAN 2/2019 _Data matrix code_ _printed on the right _ _of the variable data _ _Tamper evidence sol._ Orders _with_ _serialization_ PC: SN: Batch No: EXP: Orders _without_ _serialization_ Batch No: EXP: aprepitant #125 mg/#80 mg 1065019079_BOX_APREPITANT_80_125MG_CD_WAL1X1+2_GB.pdf 1 6/2/2020 1:37:37 PM Page 3 of 3 1065019079_BOX_APREPITANT_80_125MG_CD_WAL1X1+2_GB.ai PMS 287 C • PMS 7528 C • PMS 568 C • PMS 339 C • PMS 2727 C KEYLINE • BRAILLE • VARNISH FREE Correction to the Braille text. Space is required bewteen the number and the units 'mg' in the braille text. This needs to be implemented in the next production run. Correction to the Braille text. Space is required bewteen the number and the units 'mg' in the braille text. This needs to be implemented in the next production run. aprepitant #125 mg/#80 mg aprepitant #125 mg/#80 mg N/A N/A Helvetica Neue LT Std 7 pt N/A N/A 100 x 24 x 145 mm Pharmaten RV 02.06.2020 V1 718149 APREPITANT 80;125MG; CD WAL1X1+2 Box 1065019079 REEL POSITION REEL POSITION TECHNICAL COLOURS TECHNICAL COLOURS COLOURS [ 5 ] COLOURS [ 5 ] TECHNICAL INFO TECHNICAL INFO GENERAL INFO GENERAL INFO REASON FOR CHANGE REASON FOR CHANGE BRAILLE TEXT: MATERIAL TYPE (TS): LOOK CODE: FONT + MI Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aprepitant Zentiva 125mg/80mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 125 mg capsule contains 125mg of aprepitant. Each 80 mg capsule contains 80 mg of aprepitant. Excipient with known effect Each 125mg capsule contains 125 mg of sucrose and 0.00026 mmol (0.006 mg) of sodium. Each 80 mg capsule contains 80 mg of sucrose and 0.00022 mmol (0.005 mg) of sodium. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard capsule (capsule) The 125mg hard capsules are presented as opaque hard gelatin capsules of size No 1, with a pink cap and white body, imprinted in black ink with “125mg” on the body. The 80 mg hard capsules are presented as opaque hard gelatin capsules of size No 2, with a white cap and white body, imprinted in black ink with “80mg” on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12. Aprepitant 125mg/80 mg is given as part of combination therapy (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Aprepitant is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose is 125mg orally once daily one hour before start of chemotherapy on Day 1 and 80 mg orally once daily on Days 2 and 3 in the morning. The following regimens are recommended in adults for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy: _Highly Emetogenic Chemotherapy Regimen _ Day 1 Day 2 Day 3 Day 4 Aprepitant 125mg orally 80mg orally 80mg orally none Dexamethasone 12mg orally 8mg orally 8mg orally 8mg orally 5-HT 3 antagonists Standard dose of 5-HT 3 antagonists. See the product information for selected 5-HT 3 antagonist for appropriate dosing information None None None Dexamethasone should be administered 30 minutes prior to chemotherapy treatment Perskaitykite visą dokumentą