ZITHROMAX Capsule, hard (2018)
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Περιεχόμενα
Name of the medicinal product
ZITHROMAX 250 mg CAPSULES.
Qualitative and quantitative composition
Each capsule contains azithromycin dihydrate 262.05 mg equivalent to 250 mg azithromycin base. Excipients with known effect: Each capsule contains lactose anhydrous, and sulfur dioxide. For the full list ...
Pharmaceutical form
Capsule, hard. White, hard gelatin capsules marked Pfizer and ZTM 250.
Therapeutic indications
Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms (see section 5.1): Bronchitis. Community-acquired pneumonia. ...
Posology and method of administration
Posology Zithromax capsules should be given as a single daily dose. In common with many other antibiotics Zithromax Capsules should be taken at least 1 hour before or 2 hours after food. Children over ...
Contraindications
Zithromax is contra-indicated in patients with a known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipients (listed in section 6.1).
Special warnings and precautions for use
Hypersensitivity As with erythromycin and other macrolides, serious allergic reactions including angioneurotic oedema and anaphylaxis (rarely fatal), Acute Generalized Exanthematous Pustulosis (AGEP) and ...
Interaction with other medicinal products and other forms of interaction
Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with azithromycin, no effect on overall bioavailability was seen, although peak serum concentrations ...
Pregnancy and lactation
Pregnancy Animal reproduction studies have been performed at doses up to moderately maternally toxic dose concentrations. In these studies, no evidence of harm to the foetus due to azithromycin was found. ...
Effects on ability to drive and use machines
There is no evidence to suggest that Zithromax may have an effect on a patients ability to drive or operate machinery.
Undesirable effects
Zithromax is well tolerated with a low incidence of side effects. The section below lists the adverse reactions identified through clinical trial experience and postmarketing surveillance by system organ ...
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
General properties Pharmacotherapeutic group: Antibacterials for systemic use ATC code: J01FA10 Mode of action Zithromax 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. Distribution Orally administered azithromycin ...
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
Capsule content: Lactose anhydrous Magnesium stearate Maize starch Sodium lauryl sulfate Capsule shell: Gelatin Titanium dioxide (E171) Printing Ink: Black iron oxide (E172) Propylene glycol Shellac Sulfur ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Aluminium/PVC blister strips in carton boxes: 5 years Polythene capsule container with child resistant cap: 4 years
Special precautions for storage
None.
Nature and contents of container
Zithromax Capsules are available as: Packs of 2 capsules. Aluminium/PVC blister strips, 2 capsules per strip, 1 strip in a carton box. Packs of 4 capsules. Aluminium/PVC blister strips, 4 capsules per ...
Special precautions for disposal and other handling
No special requirements Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0335
Date of first authorization / renewal of the authorization
Date of first authorisation: 4 April 1991 Date of latest renewal: 7 September 1996
Date of revision of the text
08/2018
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