Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
THEOPHYLLINE
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
R03DA04
80 mg/15 ml
SYRUP
THEOPHYLLINE 80 mg/15 ml
ORAL
Prescription Only
Ensign Laboratories Pty Ltd
ACTIVE
1989-05-09
PLEASE NOTE: THIS IS A LOW RESOLUTION PDF & IS NOT TO BE USED AS FINAL ARTWORK Comments VERSION 0 5 10 20 30 40 50 60 70 80 95 100 Signatures 20.05.14 - New artwork build - Schee DATE .................................... 20.05.14 LEAD MARKETING COUNTRY.............. Australia ARTWORK SOFTWARE .................. Illustrator CC BRAND ................................................... Nuelin PRODUCT VARIANT ..................................... ...................................................Nueline Syrup CONSUMER UNIT CONTENT .................. 500mL COMPONENT ....................... Label + Leaflet PROJECT.......................................... XXXXX FILE NAME.. 69851_LT053901_Nuelin Syrup_500ml_Leaflet.ai IMPORTANT: PDF’s are for viewing only. They are NOT to be used for Final Artwork. Colour 100% BLACK LT053901 69851 LT053901 303mm 60mm Proposed annotated PI PLEASE NOTE: THIS IS A LOW RESOLUTION PDF & IS NOT TO BE USED AS FINAL ARTWORK Comments VERSION 2 5 10 20 30 40 50 60 70 80 95 100 Signatures 16.05.14 - New artwork build - Schee 16.06.14 - Add Revision Date - Schee 24.06.14 - Add Australia - Schee DATE .................................... 16.05.14 LEAD MARKETING COUNTRY.............. Australia ARTWORK SOFTWARE .................. Illustrator CC BRAND ................................................... Nuelin PRODUCT VARIANT ..................................... ....................................Nuelin Syrup Singapore CONSUMER UNIT CONTENT .................. 500mL COMPONENT ....................... Label + Leaflet PROJECT.......................................... XXXXX FILE NAME... 69772_LT053901_Nuelin Syrup SG_500ml_Label&Leaflet.ai IMPORTANT: PDF’s are for viewing only. They are NOT to be used for Final Artwork. Colour 100% PMS 285 C PMS 318C BLACK LT053901 69772 = 2.315 mm LT053901 MANUFACTURED BY: Ensign Laboratories Pty Ltd 490-500 Wellington Road, Mulgrave, VIC 3170, Australia Revision Date: Jun 2014 303mm 60mm Lesen Sie das vollständige Dokument
Black PMS 318 C PMS 285 C PMS 485 C ARTWORK COLOUR 100% JOB NO. : JB-03070 UIC : A7853 SKU : 100539 A7853_NUELIN SYRUP 500ML COMPONENT : FAF LABEL-LEAFLE COUNTRY : SG DIELINE REF: XXXXX EMO: ENSIGN PRINTER: Xxxxxx Xxxxxxxxxxxx V1 G247 FILE NAME: 103284_A7853_NUELIN SYRUP 500ML_SG_LL_V1 13.03.24 - V0 - Artwork build - Sunny 14.03.24 - V1 - Amends - Yuki Guide Varnish PLEASE NOTE THIS HI RES PDF IS NOT TO BE USED AS FINAL ARTWORK SUPPLIER INFORMATION MAY BE PRESENT ON THE PACKAGING EMO/PRINTING VENDOR: PLEASE SHARE THE ARTWORK PDF TO PRINTER FOR CHECKS ON: • COLOURS - NO. OF COLOURS, SEQUENCE, CMYK/PMS • TEXT - LINE THICKNESS, FONT SIZE • DIELINE - SIZE, EYEMARK, PRINT DIRECTION • CODING - SIZE, LOCATION, VFA, FORMAT BKG COLOUR MOVING FORWARD WHEN POSSIBLE ANY ADDITONAL INFORMATION AND TECHNICAL CHECK REQUIRED BY EMO ON THE ARTWORK BEFORE APPROVING. A7853 A7853 MANUFACTURED BY: Ensign Laboratories Pty Ltd 490-500 Wellington Road, Mulgrave, VIC 3170, Australia Revision Date: March 2024 ® ADVERSE REACTIONS The most common adverse reactions are gastric irritation, nausea, vomiting, anorexia, epigastric pain, reactivation of peptic ulcer, gastro-oesophageal reflux, haematemesis, tachycardia, palpitation, headache, CNS stimulation, reflex hyperexcitability, insomnia and tremor. Other possible reactions include diarrhoea, extrasystoles, flushing, hypotension, tachypnoea, potentiation of diuresis, albuminuria, haematuria, rash, hyperglycaemia, hypokalaemia, alopecia and inappropriate ADH secretion (high dose). More serious signs of high serum levels (usually above 30 µg/mL), such as cardiac arrhythmias and convulsions, may appear rarely without prior warning. DOSAGE AND ADMINISTRATION Desirable therapeutic levels are considered to be between 10-20 µg/mL (55-110 µmol/L). Higher levels may produce toxic effects. Toxic effects may also occur at therapeutic levels. When maximum response is required, dose levels should be individually titrated. Serum theophylline may be monitored to confirm that levels are within t Lesen Sie das vollständige Dokument