Maintelyte Solution for Infusion

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

GLUCOSE ANHYDROUS, SODIUM CHLORIDE, SODIUM ACETATE, TRIHYDRATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, HEXAHYDRATE

제공처:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC 코드:

B05BB02

INN (국제 이름):

SODIUM ACETATE TRIHYDRATE 3.13 g GLUCOSE ANHYDROUS 50 g SODIUM CHLORIDE 1 g POTASSIUM CHLORIDE 1.5 g MAGNESIUM CHLORIDE HEXAHYDRATE 0.30 g

약제 형태:

SOLUTION FOR INFUSION

구성:

SODIUM ACETATE TRIHYDRATE 3.13 g GLUCOSE ANHYDROUS 50 g SODIUM CHLORIDE 1 g POTASSIUM CHLORIDE 1.5 g MAGNESIUM CHLORIDE HEXAHYDRATE 0.30 g

처방전 유형:

POM

치료 영역:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

승인 상태:

Authorised

승인 날짜:

2019-02-14

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
MAINTELYTE SOLUTION FOR INFUSION
Active substances: glucose, sodium chloride, sodium acetate
trihydrate, potassium chloride,
magnesium chloride hexahydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
Throughout this leaflet, Maintelyte solution for infusion will be
called Maintelyte.
WHAT IS IN THIS LEAFLET
1. What Maintelyte is and what it is used for
2. What you need to know before you are given Maintelyte
3. How you will be given Maintelyte
4. Possible side effects
5. How to store Maintelyte
6. Content of the pack and other information
1. WHAT MAINTELYTE IS AND WHAT IT IS USED FOR
Maintelyte is a solution of the following substances in water:
-
sugar (glucose)
-
sodium chloride
-
sodium acetate trihydrate
-
potassium chloride
-
magnesium chloride hexahydrate
Glucose is one of the body’s sources of energy. This solution for
infusion provides 200 kilocalories
per litre. Sodium, potassium, magnesium, chloride and acetate are
chemical substances found in the
blood.
Maintelyte is used to provide a source of fluid and chemical
substances and to give you some
carbohydrate (sugar) if you are unable to eat or drink normally.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MAINTELYTE
DO NOT RECEIVE MAINTELYTE IF YOU ARE SUFFERING FROM ANY OF THE
FOLLOWING CONDITIONS
-
higher levels of potassium in the blood than normal (hyperkalaemia)
-
severe problems with your kidneys (renal insufficiency) with a
reduction in the amount of urine
produced (oliguria) or no urine at all (anuria)
-
heart or lung failure (uncompensated cardiac or pulmonary failure)
-
diabetes that is not adequately treated, allowing your blood sugar
levels to rise above normal
(uncontr

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Maintelyte solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml of Maintelyte solution for infusion contains:
Glucose (as monohydrate)
50.00 g
Sodium Chloride
1.00 g
Sodium Acetate trihydrate
3.13 g
Potassium Chloride
1.50 g
Magnesium Chloride hexahydrate
0.30 g
Content of electrolytes per 1000 ml:
Na
+
40 mmol
K
+
20 mmol
Mg
2+
1.5 mmol
CH
3
COO
-
23 mmol
Cl
-
40 mmol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles
pH: 4.5-6.5
Osmolarity: 402 mOsm/l (approx)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supplement of water, carbohydrates and electrolytes to patients where
normal intake is
insufficient or when there is a deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage, rate, and duration of administration are to be individualised
and depend upon the
indication for use, the patient’s age, weight, clinical condition,
and concomitant treatment, and on
the patient’s clinical and laboratory response to treatment.
Fluid balance, blood glucose, and serum electrolytes should be
monitored before and during
administration (see sections 4.4, 4.5, 4.6 and 4.8).
Recommended dose for adults is 2-3 litres infusion fluid per day.
Maintelyte solution for infusion: 1000 ml administered intravenously
during 4 -12 hours (based
on a patient weighing 70 kg).
Infusion rate: 1.2 – 3.5 ml/kg/hour._ _
Buffering capacity: In order to increase pH of Maintelyte solution
from 5 to 7, approximately 7
mmol NaOH will be needed. In order to decrease the pH of Maintelyte
solution from 5 to 4,
approximately 13 mmol HCl will be needed.
Infusion rate should not exceed the patient’s glucose oxidation
capacities in order to avoid
hyperglycaemia. For information, the maximum glucose oxidation
capacities is 5mg/kg/min for
adults.
_Paediatric population: _
Currently, there are no dosing recommendations for use in children
(Please see section