MAINTELYTE Solution for infusion (2020)
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Περιεχόμενα
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 ...
3. Pharmaceutical form
Solution for infusion. Clear solution, free from visible particles. pH: 4.5-6.5 Osmolarity: 402 mOsm/l (approx).
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 patients age, weight, clinical condition, and concomitant treatment, and on the ...
4.3. Contraindications
The solution is contra-indicated in patients presenting: Hyperkalaemia Severe renal insufficiency (with oliguria/anuria) Uncompensated cardiac or pulmonary failure The solution is also contraindicated ...
4.4. Special warnings and precautions for use
Fluid balance / renal function Hyponatraemia Treatment with intravenous fluids having a lower sodium concentration than the patients serum sodium may cause hyponatraemia (see section 4.2). Children, patients ...
4.5. Interaction with other medicinal products and other forms of interaction
Interaction with sodium Corticoids/Steroids and carbenoxolone may cause retention of sodium and water (with oaedema and hypertension). Interaction with potassium Potassium-sparing diuretics (amiloride, ...
4.6. Fertility, pregnancy and lactation
When Maintelyte solution for infusion is administrated to pregnant women during labour, particularly if administered in combination with oxytocin, there may be an increased risk for hyponatraemia (see ...
4.7. Effects on ability to drive and use machines
Maintelyte solution has no or negligible influence on the ability to drive or use machines.
4.8. Undesirable effects
The following adverse reactions have been reported in the postmarketing experience, with unspecified Maintelyte solution, listed by MedDRA System Organ Class (SOC), then in order of severity, where feasible.The ...
4.9. Overdose
Too fast infusion may lead to water and sodium overload with a risk of oaedema, particularly when there is a defective renal sodium excretion. In this case renal dialysis may be necessary. Excessive administration ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Maintenance solution <b>ATC code:</b> B05BB02 The physiological balanced maintenance solutions cover the basal needs of fluid and electrolytes with a daily dose of 2000-3000 ...
5.2. Pharmacokinetic properties
fter intravenous administration glucose exhibits fast (approximately 20 minutes) and slow phases of equilibrium. Distribution is largely through extracellular water, and intracellular water of the liver. ...
5.3. Preclinical safety data
There is no preclinical data relevant to the prescribing doctor besides the one already described in the other sections of this Summary of Product Characteristics.
6.1. List of excipients
Hydrochloric acid, concentrated (for pH adjustment) Water for injections
6.2. Incompatibilities
Incompatibility of the medicinal product to be added with the solution in Viaflo container must be assessed before addition. In the absence of compatibility studies, this medicinal product must not be ...
6.3. Shelf life
Unopened: 3 years. In-use shelf-life: Chemical and Physical stability of any additive at the pH of Maintelyte solution in the Viaflo container should be established prior to use. From a microbiological ...
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic (PL 2442). The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene. Bag size: 1000 ...
6.6. Special precautions for disposal and other handling
After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. The solution should be inspected visually for particulate matter and discoloration ...
7. Marketing authorization holder
Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
8. Marketing authorization number(s)
PL00116/0666
9. Date of first authorization / renewal of the authorization
4th March 2019
10. Date of revision of the text
March 2020
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