देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Caffeine citrate
Martindale Pharmaceuticals Ltd
N06BC01
Caffeine citrate
10mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04040000; GTIN: 5014124172852
WHAT IS IN THIS LEAFLET: 1. What Caffeine Citrate 10mg/ml Oral Solution is and what is it used for 2. What you need to know before your baby is given Caffeine Citrate 10mg/ml Oral Solution 3. How Caffeine Citrate 10mg/ml Oral Solution is used 4. Possible side effects 5. How to store Caffeine Citrate 10mg/ml Oral Solution 6. Contents of the pack and other information 1. WHAT CAFFEINE CITRATE 10MG/ML ORAL SOLUTION IS AND WHAT IT IS USED FOR • Caffeine belongs to a group of medicines known as methylxanthines • It is used in the treatment of interrupted breathing in premature babies (primary apnoea of premature newborns). These short periods when premature babies stop breathing are due to the baby’s breathing centres not being fully developed. This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns. 2. WHAT YOU NEED TO KNOW BEFORE YOUR BABY IS GIVEN CAFFEINE CITRATE 10MG/ML ORAL SOLUTION YOUR BABY SHOULD NOT BE GIVEN CAFFEINE CITRATE 10MG/ML ORAL SOLUTION • if allergic to caffeine citrate or to any of the other ingredients of this medicine listed in section 6. WARNINGS AND PRECAUTIONS Talk to your baby’s doctor before your newborn is given Caffeine Citrate 10mg/ml Oral Solution if your baby: • has liver or kidney disease • has had any unusual heart rhythms detected or heart disease. • suffers from seizures • has frequent regurgitation • produces more urine than usual • has a reduced weight gain or food intake • If you (the mother) consumed caffeine prior to delivery OTHER MEDICINES AND CAFFEINE CITRATE 10MG/ML ORAL SOLUTION Tell your baby’s doctor if your newborn is taking, have recently taken or might take any other medicines. As with most medicines, Caffeine Citrate 10mg/ml Oral Solution may interact with other medicines given at the same time. A premature baby may need many medicines, and any problems with caffeine are likely to be minor, but tell the doctor about any other medication they may not know about, particularly any other medi पूरा दस्तावेज़ पढ़ें
OBJECT 1 CAFFEINE CITRATE 10MG/ML ORAL SOLUTION Summary of Product Characteristics Updated 30-Oct-2017 | Martindale Pharma 1. Name of the medicinal product Caffeine Citrate 10mg/ml Oral Solution 2. Qualitative and quantitative composition Caffeine Citrate 10mg/ml Each 1ml of solution contains, 10mg Caffeine citrate, equivalent to 5mg of Caffeine. Excipients with known effect: Also, contains 3.02 mg of sodium per ml For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Solution Appearance: clear and colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Caffeine citrate 10 mg/ml Oral Solution is indicated in neonates for the treatment of apnoea of prematurity. 4.2 Posology and method of administration Treatment with caffeine citrate should be initiated under the supervision of a physician experienced in neonatal intensive care. Treatment should be administered only in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring. Posology NEONATES The recommended doses of Caffeine Citrate 10 mg/ml Oral Solution are expressed below. Please note: (a) the dose expressed as caffeine citrate is twice the dose expressed as caffeine base. (b) caffeine is clinically effective within 4 hours. If the patient fails to respond within this time, a second loading dose may be given. If there is no clinical response to the second loading dose, caffeine blood levels should be measured (see 'special warnings and precautions for use' section 4.4 below) (c) because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment. (d) Infants must be of sufficient respiratory maturity not to require positive pressure ventilation. DOSE OF CAFFEINE CITRATE 10MG/ML ORAL SOLUTION DOSE EXPRESSED AS CAFFEINE CITRATE DOSE EXPRESSED AS CAFFEINE BASE ROUTE FREQUENCY LOADING DOSE SEE (B) ABOVE 2ML/KG 20MG/KG 10 MG/KG ORAL ONCE MAINTENANCE DOSE 0.5-1ML/KG* 5-10MG/KG* 2.5-5.0MG/KG* ORAL E पूरा दस्तावेज़ पढ़ें