AMGLIDIA Oral suspension (2023)
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Περιεχόμενα
Name of the medicinal product
AMGLIDIA 0.6 mg/mL oral suspension. AMGLIDIA 6 mg/mL oral suspension.
Qualitative and quantitative composition
<u>AMGLIDIA 0.6 mg/mL oral suspension:</u> Each mL contains 0.6 mg glibenclamide. <u>AMGLIDIA 6 mg/mL oral suspension:</u> Each mL contains 6 mg glibenclamide. <u>Excipient(s) with known effect:</u> Each ...
Pharmaceutical form
Oral suspension. White suspension.
Therapeutic indications
AMGLIDIA is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like AMGLIDIA have been shown to be effective in patients with mutations ...
Posology and method of administration
Glibenclamide suspension therapy should be initiated by a physician experienced in the treatment of patients with very early onset diabetes. Prescription instructions Care should be taken when prescribing ...
Contraindications
This medicinal product is contraindicated in the following cases: hypersensitivity to the active substance, other sulphonylureas or sulphonamides or to any of the excipients listed in section 6.1 in patients ...
Special warnings and precautions for use
Special care should be taken when calculating the dose. Before each administration, it should be verified that the correct strength and syringe are used. Glibenclamide should not be used in patients with ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed for the two oral suspensions of glibenclamide (0.6 mg/mL and 6 mg/mL). Hypoglycaemia may occur when taking other medicinal products. Highly protein-bound medicinal ...
Fertility, pregnancy and lactation
General aspects AMGLIDIA is indicated for the treatment of neonatal diabetes in newborns, infants and children. Women of childbearing potential Women of childbearing potential planning a pregnancy should ...
Effects on ability to drive and use machines
Glibenclamide has moderate influence on the ability to drive and use machines since it may increase the risk of hypoglycaemia. This may not be relevant for the target population. However, reduced alertness ...
Undesirable effects
Summary of the safety profile The most frequent adverse reactions are hypoglycaemia, transitory diarrhea and abdominal pain. The most serious adverse reaction is hypoglycaemia (see section 4.4). Overall, ...
Overdose
Overdose of sulphonamides can result in hypoglycaemia. The symptoms of moderate hypoglycaemia, without loss of consciousness or neurological signs, must be completely corrected by taking sugar, adjusting ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes, sulphonylureas <b>ATC code:</b> A10BB01 Mechanism of action Sulphonylureas act on pancreatic beta-cells by inhibiting ATP-sensitive potassium channels. ...
Pharmacokinetic properties
Absorption After oral administration, glibenclamide is absorbed rapidly and induces its effect within 2.5 hours with a duration of up to 15 hours, although the elimination half-life is 5 to 10 hours. The ...
Preclinical safety data
In repeated dose toxicity studies with oral administration of high doses of glibenclamide, effects on pancreatic beta-cells were observed (enlargement of the islets of Langerhans with irregularly configured ...
List of excipients
Hydroxyethylcellulose Lactic acid Purified water Sodium benzoate (E211) Sodium citrate Xanthan gum
Incompatibilities
Not applicable.
Shelf life
3 years. <u>After first opening:</u> 30 days. Keep the bottle tightly closed.
Special precautions for storage
Keep the bottle in the outer carton in order to protect from light. For storage conditions after first opening of the medicinal product, see section 6.3.
Nature and contents of container
Brown glass bottle (type III) with a child-resistant closure (polypropylene screw cap with polyethylene capsule inside) in a carton containing a 1 mL or 5 ml graduated oral syringe of LDPE and polypropylene ...
Special precautions for disposal and other handling
At the first use, the bottle should be opened by unscrewing the child-resistant closure while pressing downwards. The adaptor should be inserted firmly into the bottle while holding the bottle the right ...
Marketing authorization holder
AMMTeK, 8 rue Campagne Première, 75014 Paris, France, Tel: +33 (0)6 74 29 38 14
Marketing authorization number(s)
EU/1/18/1279/001 EU/1/18/1279/002 EU/1/18/1279/003 EU/1/18/1279/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 May 2018
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