Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Glucose; Sodium chloride
B. Braun Medical Limited
B05BB; B05BB02
Glucose; Sodium chloride
0.18 and 4 percent weight/volume
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions affecting the electrolyte balance; electrolytes with carbohydrates
Marketed
1983-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER B. Braun Melsungen AG · 34209 Melsungen, Germany 0.18% w/v Sodium Chloride and 4% w/v Glucose Intravenous Infusion BP SOLUTION FOR INFUSION (SODIUM CHLORIDE, GLUCOSE) 378/12261629/0118 schwarz Format = 210 x 297 mm (A4) 2 Seiten Lätus IE___378 378/12261629/0118 GIF – IL Production site: Melsungen Font size: 9 pt. G 111301 B|BRAUN Your levels of blood sugar, electrolytes (especially potassium) and acid- base and water balance will be checked to make sure that these are cor- rect before and during infusion. After major operations or severe injuries (post-traumatic and post-oper- ative conditions or in the presence of tissue oxygen deficiency, abnor- mally high level of acid in the blood or organ failure) you may not be able to metabolise glucose properly (impaired glucose tolerance). Your blood sugar level will then be regularly monitored. Please note: If this solution is used to dilute or dissolve medicines that are to be given to you by a drip into your vein, your doctor will take into account the safety information of the additive. OTHER MEDICINES AND 0.18% W/V SODIUM CHLORIDE AND 4% W/V GLUCOSE Tell your doctor if you are using, have recently used or might use any other medicines. Your doctor will adjust your dosage if you receive corticosteroids. Corti- costeroids may cause an accumulation of sodium and fluid in your body. PREGNANCY, BREAST-FEEDING AND FERTILITY If you are pregnant or breast-feeding, think you may be pregnant or are plan- ning to have a baby, ask your doctor for advice before taking this medicine. PREGNANCY Your doctor will decide carefully whether or not you should receive this solution if you are pregnant. Thus special care will be taken if you have a specific disorder that may occur during pregnancy, called eclampsia, with the following symptoms: high blood pressure, cramps, swelling. Blood sugar levels will be checked regularly. BREAST-FEEDING This medicine can be given while you are breast-feeding. DRIVING AND USING MACHINES 0.18% w/v Sodium C Soma hati kamili
Health≙Products≙Regulatory≙Authority 10≙September≙2019 CRN0099LK Page≙1≙of≙8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 0.18≙%≙w/v≙Sodium≙Chloride≙and≙4≙%≙w/v≙Glucose≙Intravenous≙Infusion≙BP,≙Solution≙for≙Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000≙ml≙of≙the≙solution≙for≙infusion≙contain: Sodium≙chloride ≙1.8≙g Glucose≙monohydrate ≙44.00≙g equivalent≙to glucose ≙40.00≙g _Electrolyte concentrations:_ Sodium≙31≙mmol/l Chloride≙31≙mmol/l For≙the≙full≙list≙of≙excipients,≙see≙section≙6.1. 3 PHARMACEUTICAL FORM Solution≙for≙infusion Clear,≙colourless,≙upto≙faintly≙straw-coloured≙aqueous≙solution. Energy ≙668kJ/l≙≙ 160kcal/l Theoretical≙osmolarity: ≙282mOsm/l Acidity≙(titration≙to≙pH7.4): ≙<0.5mmol/l≙pH: ≙3.5–5.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS § ≙Hypertonic≙dehydration § ≙Partial≙coverage≙of≙energy≙requirements § ≙Vehicle≙solution≙for≙compatible≙electrolyte≙concentrates≙and≙medicinal≙products _PAEDIATRIC POPULATION_ This≙product≙should≙only≙be≙used≙in≙paediatric≙specialist≙settings≙(such≙as≙renal,≙hepatic≙and≙cardiac≙units,≙high≙dependency≙ units≙and≙intensive≙care≙units)≙for≙intravenous≙fluid≙therapy≙requiring≙the≙use≙of≙0.18%≙sodium≙chloride≙and≙4%≙glucose≙to≙ maintain≙fluid≙and≙electrolyte≙balance. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The≙dose≙is≙adjusted≙according≙to≙the≙individual≙requirements≙of≙fluid,≙electrolyte≙and≙energy.≙Thus≙the≙patient’s≙age,≙weight,≙ clinical≙and≙biological≙(acid-base≙balance)≙conditions≙and≙concomitant≙therapy≙should≙be≙taken≙into≙account.≙Fluid≙balance,≙ serum≙glucose,≙serum≙sodium≙and≙other≙electrolytes≙may≙need≙to≙be≙monitored≙before≙and≙during≙admi Soma hati kamili