MANNITOL Solution for infusion (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Mannitol 15% w/v Solution for infusion.
Qualitative and quantitative composition
Mannitol: 150 g/l Each ml contains 150 mg mannitol. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for infusion. Clear, colourless solution, free from visible particles. Osmolarity: 823 mOsm/l (approx) pH: 4.5- 7.0
Therapeutic indications
Mannitol 15% w/v Solution for infusion is indicated for use as an osmotic diuretic in the following situations: Promotion of diuresis in the prevention and/or treatment of the oliguric phase of acute renal ...
Posology and method of administration
Posology The choice of the specific mannitol concentration, dosage and rate of administration depends on the age, weight and clinical condition of the patient and concomitant therapy. Adults and adolescents ...
Contraindications
Mannitol 15% w/v Solution for infusion is contra-indicated in patients presenting with: Pre-existing plasma hyperosmolarity Severe dehydration Established anuria Severe heart failure Severe pulmonary congestion ...
Special warnings and precautions for use
Hypersensitivity Anaphylactic/anaphylactoid reactions, including anaphylaxis, as well as other hypersensitivity/infusion reactions have been reported with mannitol. Fatal outcome has been reported (see ...
Interaction with other medicinal products and other forms of interaction
Effect Potentialisation Concurrent use of other diuretics may potentiate the effects of mannitol and dose adjustments may be required. Effect Inhibition Mannitol promotes urine flow, which will mainly ...
Fertility, pregnancy and lactation
There are no relevant published data from the use of mannitol in pregnant women. There are no relevant published data from animal studies with respect to mannitol effect on pregnancy and/or embryo/foetal ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The following adverse reactions have been reported in post-marketing experience. The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data. Immune system ...
Overdose
Signs and symptoms of overdose with mannitol may include acute renal failure, electrolyte imbalance, hypervoalaemia, CNS toxicity. Prolonged administration or rapid infusion of large volumes of hyperosmotic ...
Pharmacodynamic properties
Pharmacotherapeutic group: solutions producing osmotic diuresis ATC code: B05BC01 Mannitol, a carbohydrate, is confined to the extracellular compartment. It has an osmotic effect which causes fluid to ...
Pharmacokinetic properties
When administered intravenously, mannitol is eliminated largely unmetabolised through the glomeruli. Only 10% is reabsorbed back from the kidney tubule. The elimination half-life in adults is approximately ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to that already included in other sections of SPC.
List of excipients
Water for injections
Incompatibilities
Additives may be incompatible with Mannitol 15% w/v Solution for infusion. Incompatibility of the medicinal product to be added with the solution in the Viaflo container must be assessed before addition. ...
Shelf life
<u>Unopened:</u> 100 and 250 ml containers: 2 years. 500 ml containers: 3 years. <u>After opening, with or without additives:</u> From a microbiological point of view, the product should be used immediately. ...
Special precautions for storage
Do not refrigerate or freeze.
Nature and contents of container
The bags, known as Viaflo, are composed of polyolefin/polyamide co-extruded plastic (PL 2442) and contain Mannitol solution. The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene ...
Special precautions for disposal and other handling
Use administration sets with a final in-line filter because of the potential for mannitol crystals to form. For instructions on precautions to be taken before administration, in case of crystallization ...
Marketing authorization holder
Baxter Healthcare, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
Marketing authorization number(s)
PL 00116/0650
Date of first authorization / renewal of the authorization
01/04/2010 Renewal: 20/06/2015
Date of revision of the text
Jan 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
