GLUCOSE 5% BP Solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Glucose 5% Intravenous Infusion BP.
Qualitative and quantitative composition
Glucose (as monohydrate): 50.0 g/l. Each ml contains 50 mg glucose (as monohydrate). Approximately 840 kJ/l (or 200 kcal/l). For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for infusion. Clear solution, free from visible particles. Osmolarity: 278 mOsm/l.(approx.) pH: 3.5–6.5
Therapeutic indications
Glucose 5% is indicated for the treatment of carbohydrate and fluid depletion. Glucose 5% is also used as a vehicle and diluent for compatible medicinal products for parenteral administration.
Posology and method of administration
Posology Adults, the Elderly and Children The concentration and dosage of Glucose 5% intravenous infusion is determined by several factors including the age, weight and clinical condition of the patient. ...
Contraindications
The solution is contraindicated in case of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma, hyperglycaemia, hyperlactataemia. Hypersensitivity ...
Special warnings and precautions for use
Glucose intravenous infusions are usually isotonic solutions. In the body, however, glucose containing fluids can become extremely physiologically hypotonic due to rapid glucose metabolization (see section ...
Interaction with other medicinal products and other forms of interaction
Both the glycaemic effects of Glucose 5% and its effects on water and electrolyte balance should be taken into account when using Glucose 5% in patients treated with other substances that affect glycaemic ...
Fertility, pregnancy and lactation
When a medicinal product is added, the nature of the drug and its use during pregnancy and lactation have to be considered separately. Intrapartum maternal intravenous glucose infusion may result in foetal ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Undesirable effects which occurred in patients treated with Glucose 5% from the post-marketing experience are tabulated below. The adverse drug reactions listed in this section are given following the ...
Overdose
Prolonged administration or rapid infusion of large volumes of Glucose 5% may cause hyperosmolarity and hyponatraemia, dehydration, hyperglycaemia, hyperglycosuria, osmotic diuresis (due to the hyperglycaemia) ...
Pharmacodynamic properties
Pharmacotherapeutic group: "Other IV Solution Additives" ATC code: B05BA03 The pharmacodynamic properties of this solution are those of glucose, which forms the principal source of energy in cellular metabolism. ...
Pharmacokinetic properties
Glucose is metabolized via pyruvic or lactic acid to carbon dioxide and water with the release of energy. The pharmacokinetics of the additive will depend on the nature of the drug used.
Preclinical safety data
The safety of glucose in animals is not relevant in view of its presence as a normal component in animal and human plasma. The safety of the additive should be considered separately.
List of excipients
Water for Injections.
Incompatibilities
As with all parenteral solutions compatibility of the additives with the solution must be assessed before addition. It is the responsibility of the physician to judge the incompatibility of an additive ...
Shelf life
Shelf life Shelf life as packaged: 50 ml bag: 15 months 100 ml bag: 2 years 250 and 500 ml bags: 2 years 1000 ml bags: 3 years In-use shelf life: Additives Chemical and physical stability of any additive ...
Special precautions for storage
50 and 100 ml bags: Do not store above 30°C. 250, 500 and 1000 ml bags: This medicinal product does not require any special storage conditions.
Nature and contents of container
Bag sizes: 50, 100, 250, 500 or 1000 mL. 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 ...
Special precautions for disposal and other handling
Discard after single use. Discard any unused portion. Do not store solutions containing additives. Do not reconnect partially used bags. Do not remove unit from overwrap until ready for use. The inner ...
Marketing authorization holder
Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Marketing authorization number(s)
PL 00116/0335
Date of first authorization / renewal of the authorization
10-May-2001 19-Mar-2006
Date of revision of the text
March 2019
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