Leaflet SIFICETINA 4mg / ml powder and solvent for ophthalmic solution

Indicated for: bacterial infections

Route of administration: ophthalmic

Substance: chloramphenicol (antibacterial antibiotic)

ATC: S01AA01 (Sensory organs | Antiinfectives | Antibiotics)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Chloramphenicol is a broad-spectrum antibiotic used to treat severe bacterial infections such as bacterial meningitis, typhoid fever, or eye infections (in the form of eye drops). It works by inhibiting bacterial protein synthesis, stopping the growth and multiplication of bacteria.

Chloramphenicol is used in cases where other antibiotics are ineffective or contraindicated. It is available in capsule, injectable solution, or eye drop forms.

Side effects may include nausea, vomiting, diarrhea, or allergic reactions. In rare cases, it can cause severe reactions such as aplastic anemia (a serious bone marrow condition) or gray baby syndrome in newborns. It is contraindicated in patients with hypersensitivity to chloramphenicol and should be used with caution in children and pregnant women.

General data about SIFICETINA 4mg / ml

  • Substance: chloramphenicol
  • Date of latest medicines list: 01-07-2020
  • Product code: W13143001
  • Concentration: 4mg / ml
  • Pharmaceutical form: powder and solvent for ophthalmic solution
  • Quantity: 1
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: S.I.F.I. S.P.A. - ITALIA
  • Holder: S.I.F.I. S.P.A. - ITALIA
  • Number: 8891/2016/01
  • Shelf life: 3 years

Concentrations available for chloramphenicol

  • 125mg
  • 1g
  • 250mg
  • 4mg/ml
  • 5%