国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
caffeine, Quantity: 20 mg
Phebra Pty Ltd
Caffeine
Injection, intravenous infusion
Excipient Ingredients: sodium citrate dihydrate; water for injections; citric acid monohydrate
Intravenous
10 x 2 mL vials per carton
Not Scheduled after consideration by Committee
CAFNEA INJECTION is indicated for the short-term treatment of apnoea of prematurity in infants between 28 and 33 weeks gestational age.
Visual Identification: Colourless liquid, free of haze, obvious turbidity and precipitate; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2010-04-09
Cafnea Injection and Cafnea Oral Solution Page 1 of 3 _Version 05 _ CAFNEA ® INJECTION AND CAFNEA ® ORAL SOLUTION CAFFEINE CITRATE INJECTION AND ORAL SOLUTION CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cafnea Injection and Cafnea Oral Solution. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of your baby being given Cafnea Injection or Cafnea Oral Solution against the benefits this medicine is expected to have for your baby. IF YOU HAVE ANY CONCERNS ABOUT EITHER MEDICINE BEING GIVEN TO YOUR BABY, ASK YOUR DOCTOR. KEEP THIS LEAFLET IN A SAFE PLACE . You may need to read it again. WHAT CAFNEA INJECTION AND CAFNEA ORAL SOLUTION ARE USED FOR Cafnea Injection and Cafnea Oral Solution are used to help improve the breathing of premature infants suffering from apnoea of prematurity who have been born between 28 and less than 33 weeks gestation. Apnoea of prematurity is a condition where a baby stops breathing for short periods of time. Cafnea Injection and Cafnea Oral Solution work by stimulating breathing in premature babies. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CAFNEA INJECTION OR CAFNEA ORAL SOLUTION HAS BEEN PRESCRIBED FOR YOUR BABY. Your doctor may have prescribed it for another reason. BEFORE CAFNEA INJECTION OR CAFNEA ORAL SOLUTION IS GIVEN _WHEN THEY SHOULD NOT BE _ _GIVEN _ YOUR BABY SHOULD NOT BE GIVEN CAFNEA INJECTION OR CAFNEA ORAL SOLUTION IF THEY HAVE AN ALLERGY TO: • caffeine or citrate • any other similar medicine. YOUR BABY SHOULD NOT BE GIVEN CAFNEA INJECTION OR CAFNEA ORAL SOLUTION IF THE SOLUTION IS DISCOLOURED, CLOUDY, TURBID, OR A PRECIPITATE OR PARTICLES ARE PRESENT. The solutions are normally clear, and colourless. YOUR BABY SHOULD NOT BE GIVEN EITHER MEDICINE IF, WHEN MIXED WITH ANOTHER SOLUTION IT CAUSES THE SOLUTION, TO BECOME DISCOLOURED, CLOUDY, TURBID, PRECIPITATE OR FORM PARTICLES. T 完全なドキュメントを読む
PRODUCT INFORMATION Australian Product Information - Cafnea Injection and Cafnea Oral Solution Page 1 of 11 _Version 12 _ CAFNEA ® CAFFEINE CITRATE 1 NAME OF THE MEDICINE Caffeine citrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cafnea Injection contains 20 mg/mL caffeine citrate (equivalent to 10 mg/mL of caffeine base). Cafnea Oral Solution contains 5 mg/mL caffeine citrate (equivalent to 2.5 mg/mL of caffeine base). For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Both Cafnea Injection (Caffeine Citrate Injection 40 mg/2 mL) and Cafnea Oral Solution (Caffeine Citrate Oral Solution 25 mg/5 mL) are clear, colourless, preservative free sterile solutions adjusted to a pH of 4.2 - 5.2. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Cafnea Injection and Cafnea Oral Solution are indicated for the short-term treatment of apnoea of prematurity (AOP) in infants of gestational age 28 to less than 33 weeks. 4.2 D OSE AND METHOD OF ADMINISTRATION CAFNEA INJECTION AND CAFNEA ORAL SOLUTION ARE INTENDED TO BE USED IN NEONATAL SPECIALIST UNITS. THE PRODUCT IS FOR SINGLE USE IN ONE PATIENT ONLY. DISCARD ANY RESIDUE. NOTE: ▪ A prior check should be made to ensure that no other methylxanthine (e.g. theophylline and aminophylline) is being administered. ▪ Baseline serum levels of caffeine should be measured if mothers have consumed caffeine containing fluids prior to delivery, since caffeine readily crosses the placenta. ▪ The dose expressed as caffeine base is half the dose when expressed as caffeine citrate (e.g. 20 mg of caffeine citrate is equivalent to 10 mg of caffeine base). LOADING DOSE Caffeine citrate 20 mg/kg body weight intravenously using a syringe infusion pump over 30 minutes. PRODUCT INFORMATION CAFNEA ® INJECTION AND CAFNEA ® ORAL SOLUTION Australian Product Information - Cafnea Injection and Cafnea Oral Solution Page 2 of 11 _Version 12_ MAINTENANCE DOSE Caffeine citrate 5 mg/kg once a day until apnoea ceases or until treatment is considered to be no longe 完全なドキュメントを読む