Chloromycetin 0.5% w/v Redidrops Eye Drops, Solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Chloramphenicol

Dostupné z:

Mercury Pharmaceuticals Ltd

ATC kód:

S01AA; S01AA01

INN (Medzinárodný Name):

Chloramphenicol

Dávkovanie:

0.5 percent weight/volume

Forma lieku:

Eye drops, solution

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Antibiotics; chloramphenicol

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1974-12-20

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chloromycetin 0.5% w/v Redidrops Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of the drops contains 5mg of chloramphenicol (0.5%w/v)
Excipient with known effect: Phenylmercuric nitrate 0.002% w/v.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye drops, solution
A clear, colourless, sterile, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chloramphenicol is a broad spectrum antibiotic for the treatment of
bacterial conjunctivitis caused by chloramphenicol
susceptible organisms including:_ Escherichia coli, Haemophilus
influenzae, Staphylococcus aureus, Streptococcus_
_haemolyticus, Morax-axenfeld,_ Klebsiella/Enterobacter species and
others.
Chloramphenicol is indicated in both adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children:
The recommended dosage for adults and children is two drops to be
applied to the affected eye every 3 hours or more
frequently if required. Treatment should be continued for at least 48
hours after the eye appears normal.
Elderly (over 65 years):
As for adults. Chloramphenicol has been used successfully at normal
dosages in elderly patients. The pattern and
incidence of adverse effects does not appear to differ from younger
adults.
Paediatric population
Dosage adjustment may be necessary in newborn infants because of
reduced systemic elimination due to immature
metabolism and the risk of dose-related adverse effects. The maximum
duration of treatment is 10-14 days.
Method of administration
Topical administration to the eye only.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Chloromycetin Redidrops should not be administered to patients with
a known personal or family history of blood dyscrasias including
aplastic anaemia.
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