ERYTHROMYCIN Granules for oral suspension (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
Erythromycin 500mg/5ml Sugar Free Granules for Oral suspension.
Qualitative and quantitative composition
Each 5 ml of reconstituted suspension contains 500 mg of Erythromycin (as ethylsuccinate ester). Excipients with known effect: Each 5 ml of oral suspension contains 1.288 g of sorbitol. Each 5 ml of oral ...
Pharmaceutical form
Granules for oral suspension. Sugar free, orange flavour oral suspension.
Therapeutic indications
Erythromycin is indicated for the treatment/prophylaxis of infections caused by erythromycin-sensitive organisms: Upper and lower respiratory tract infections. Skin and soft tissue infections. Bone infections. ...
Posology and method of administration
Method of Administration For oral administration only. Posology Adults, including elderly, and children over 8 years 250–500 mg every six hours, up to 4 g daily for more severe infections. For acne vulgaris ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Erythromycin is contraindicated in patients taking simvastatin, tolterodine, mizolastine, amisulpride, astemizole, ...
Special warnings and precautions for use
As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued ...
Interaction with other medicinal products and other forms of interaction
Increases in serum concentrations of the following drugs metabolised by the cytochrome P450 system may occur when administered concurrently with erythromycin: acenocoumarol, alfentanil, astemizole, bromocriptine, ...
Pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies in pregnant women. However, observational studies in humans have reported cardiovascular malformations after exposure to medicinal products containing ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Blood and lymphatic system disorders: Eosinophilia. Immune system disorders: Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred. Psychiatric disorders: Hallucinations. ...
Overdose
Symptoms: hearing loss, severe nausea, vomiting and diarrhoea. Treatment: gastric lavage, general supportive measures. Erythromycin is not dialysable.
Pharmacodynamic properties
Pharmacotherapeutic group: Macrolides, Lincosamides and Streptogramins, Macrolides ATC code: J01FA01 Mechanism of action Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit ...
Pharmacokinetic properties
Absorption is facilitated if the stomach is empty. Peak blood levels normally occur within 1 hour of dosing of erythromycin ethylsuccinate granules. The elimination half life is approximately 2 hours. ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to that already included in the other sections of the SPC.
List of excipients
Colloidal anhydrous silica Sorbitol Riboflavin-5-sodium phosphate Orange flavour (contain propylene glycol) Glycerly mono and distearate (Atmer 122 (Atmos)) Anhydrous disodium hydrogen phosphate Carmellose ...
Incompatibilities
None know.
Shelf life
Shelf life Unopened: 3 years. Once reconstituted: 14 days.
Special precautions for storage
Granules: do not store above 25°C. Following reconstitution: store at 2°C-8°C (in a refrigerator). Do not freeze. When storing keep the cap tightly closed. The reconstituted granules have a shelf life ...
Nature and contents of container
Amber (Type III) glass bottles with tamper evident polypropylene cap (100 ml, 140 ml, and 150ml). White HDPE plastic bottles with wadded, tamper evident polypropylene cap (100 ml, 125 ml 140 ml and 150 ...
Special precautions for disposal and other handling
60 ml suspension: to reconstitute add 36 ml water and shake the bottle vigorously. The resulting suspension is yellow in colour. 100 ml suspension: to reconstitute add 60ml water and shake the bottle vigorously. ...
Marketing authorization holder
Pinewood Laboratories limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Marketing authorization number(s)
PL 04917/0050
Date of first authorization / renewal of the authorization
22/06/2009
Date of revision of the text
21/03/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
