Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Caffeine citrate
Martindale Pharmaceuticals Ltd
N06BC01
Caffeine citrate
10mg/1ml
Solution for infusion
Oral; Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 04040000; GTIN: 5014124170858
COMPOSITION 1. Each 1ml contains 10mg of caffeine citrate, equivalent to 5mg of caffeine. Each 2ml contains 20mg of caffeine citrate, equivalent to 10mg of caffeine. It also contains Water for Injections, Sodium Hydroxide, Dilute Hydrochloric Acid, Sodium Chloride and Citric Acid CLINICAL PARTICULARS 2.1. THERAPEUTIC INDICATIONS Treatment of apnoea of prematurity. 2.2. POSOLOGY AND METHOD OF ADMINISTRATION The recommended doses of Caffeine Citrate 10mg/ml Solution for Injection are expressed below. Please note: (a) the dose expressed as caffeine citrate is twice the dose expressed as caffeine base. (b) given orally or intravenously, 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 2.4 below) (c) Caffeine Citrate 10mg/ml Solution for Injection is also effective when administered orally, and this route may be used alternatively without adjusting the dose. (d) because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment. (e) Infants must be of sufficient respiratory maturity not to require positive pressure ventilation. _Continued next column_ _2.2 Posology and Method of Administration (Continued) _ Treatment should be continued until the child has reached a gestational age of 37 weeks, by which time apnoea of prematurity usually resolves spontaneously. This limit may however be revised according to clinical judgement in individual cases depending on response to treatment, the continuing presence of apnoeic episodes despite treatment, or other clinical considerations. Caffeine Citrate 10mg/ml Solution for Injection should not be given intramuscularly; being acidic, i.m. injection is likely to be painful. When given intravenously, it should be given as a slow infusion rather than a bolus injectio Przeczytaj cały dokument
OBJECT 1 CAFFEINE CITRATE 10MG/ML SOLUTION FOR INJECTION Summary of Product Characteristics Updated 14-Jul-2017 | Martindale Pharma 1. Name of the medicinal product Caffeine Citrate 10mg/ml Solution for Injection 2. Qualitative and quantitative composition Caffeine Citrate 10mg/ml Each 1ml of solution contains, 10mg Caffeine Citrate, equivalent to 5mg of Caffeine. Each 2ml of solution contains, 20mg Caffeine Citrate, equivalent to 10mg of Caffeine. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for Injection Appearance: clear and colourless. 4. Clinical particulars 4.1 Therapeutic indications Treatment of apnoea of prematurity. 4.2 Posology and method of administration The recommended doses of Caffeine Citrate 10mg/ml Solution for Injection are expressed below. Please note: (a) the dose expressed as caffeine citrate is twice the dose expressed as caffeine base. (b) given orally or intravenously, 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) Caffeine Citrate 10mg/ml Solution for Injection is also effective when administered orally, and this route may be used alternatively without adjusting the dose. (d) because of the slow elimination of caffeine in this patient population, there is no requirement for dose tapering on cessation of treatment. (e) Infants must be of sufficient respiratory maturity not to require positive pressure ventilation. DOSE OF CAFFEINE CITRATE 10MG/ML SOLUTION FOR DOSE EXPRESSED AS CAFFEINE CITRATE DOSE EXPRESSED AS CAFFEINE BASE ROUTE FREQUENCY INJECTION LOADING DOSE SEE (B) ABOVE 2ML/KG 20 MG/KG 10MG/KG INTRAVENOUS** (OVER 30 MIN) OR ORAL ONCE MAINTENANCE DOSE 0.5-1ML/KG* 5-10MG/KG* 2.5-5.0MG/KG* INTRAVENOUS** (OVER 10 MIN) OR ORAL EVERY 24 HOURS*** * In some cases maintenance doses higher than 10mg/k Przeczytaj cały dokument