ZEDBAC Powder for solution for infusion (2022)
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Περιεχόμενα
Name of the medicinal product
Zedbac 500 mg powder for solution for infusion.
Qualitative and quantitative composition
Each vial contains 500 mg of azithromycin (equivalent to 524.1 mg of azithromycin dihydrate), which after reconstitution results in a 100 mg/ml azithromycin solution. The concentrate should be further ...
Pharmaceutical form
Powder for solution for infusion. Free white powder.
Therapeutic indications
Azithromycin as powder for solution for infusion is indicated for the treatment of community-acquired pneumonia due to susceptible microorganisms, (see Section 5.1) in adult patients where initial intravenous ...
Posology and method of administration
Posology The recommended dose of Azithromycin (azithromycin as powder for solution for infusion) for the treatment of adult patients with community-acquired pneumonia due to the indicated susceptible microorganisms ...
Contraindications
Azithromycin is contraindicated in patients with a known hypersensitivity to azithromycin, erythromycin or any of the macrolide or ketolide antibiotics, or to any of the excipients (listed in Section 6.1). ...
Special warnings and precautions for use
Hypersensitivity As with erythromycin and other macrolides, rare serious allergic reactions including angioneurotic oedema and anaphylaxis (rarely fatal), dermatologic reactions including acute generalised ...
Interaction with other medicinal products and other forms of interaction
<u>Antacids:</u> In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with oral azithromycin, no effect on overall bioavailability was seen, although peak serum ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of azithromycin in pregnant women. In reproduction toxicity studies in animals, azithromycin was shown to pass the placenta, but no teratogenic effects ...
Effects on ability to drive and use machines
There is no evidence to suggest that azithromycin may have an effect on a patients ability to drive or operate machinery.
Undesirable effects
The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing ...
Overdose
Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, Macrolides ATC code: J01FA10 Mechanism of action Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is constructed ...
Pharmacokinetic properties
Absorption Bioavailability after oral administration is approximately 37%. Peak plasma concentrations are attained 2 to 3 hours after taking the medicinal product. The administration of azithromycin capsules ...
Preclinical safety data
Phospholipidosis (intracellular phospholipid accumulation) has been observed in several tissues (e.g. eye, dorsal root ganglia, liver, gallbladder, kidney, spleen, and/or pancreas) of mice, rats, and dogs ...
List of excipients
Anhydrous citric acid Sodium hydroxide 30% (for pH adjustment)
Incompatibilities
Azithromycin reconstituted solution can be diluted according to the instructions and compatible solutions for infusion, indicated in Section 6.6 Special precautions for disposal and other handling. This ...
Shelf life
3 years. Concentrated solution after reconstitution (according to the instructions): azithromycin as powder for solution for infusion is chemically and physically stable during 24 hours, when stored below ...
Special precautions for storage
This medicinal product does not require any special storage conditions prior to reconstitution. For storage conditions after reconstitution and dilution of the medicinal product, see Section 6.3.
Nature and contents of container
Azithromycin is packed in 12 ml glass (type I) vials with bromobutyl rubber stopper and sealed with aluminium/plastic flip-off cap. Pack sizes of 1 vial with powder for solution for infusion.
Special precautions for disposal and other handling
Azithromycin as powder for solution for infusion is supplied in single dose vials. Preparation of reconstituted solution The initial reconstituted solution is prepared by adding 4.8 ml of sterile water ...
Marketing authorization holder
Aspire Pharma Ltd, Unit 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom
Marketing authorization number(s)
PL 35533/0026
Date of first authorization / renewal of the authorization
19/09/2012
Date of revision of the text
21/02/2022
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