Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Fresenius Kabi Manufacturing SA (Pty) Ltd, 6 Gibaud Road, Korsten, Port Elizabeth 6020, South Africa
1. The treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of Bacteroides and including other species for which metronidazole is bactericidal, such as fusobacteria, eubacteria, Clostridia and anaerobic Streptococci.
Trichazole has been used successfully for anaerobic infections in the following indication: pelvic inflammatory disease and postoperative wound infections. Combined therapy is often indicated as there are usually mixed infections.
2. For the prevention of postoperative abdominal and pelvic infections due to anaerobic bacteria:
100 ml (500 mg) by intravenous infusion eight hourly. The injection should be infused intravenously at the rate of 25 mg per minute (5 ml per minute), but may be administered alone or concurrently (but separately), with other bacteriologically appropriate antibacterial medicines in parenteral dosage forms.
Oral medication with 400 mg 8 hourly should be substituted as soon as this becomes feasible. Treatment for seven days should be satisfactory for most patients but, depending upon clinical and bacteriological assessments, the physician might decide to prolong treatment, e.g. for the eradication of infection from sites which cannot be drained or are liable to endogenous recontamination by anaerobic pathogens from the gut, oropharynx or genital tract.
As for adults, but the single intravenous dose is based on 1,5 ml/kg body mass (7,5 mg metronidazole/kg body mass) and the oral dose of 7 mg/kg body mass.
100 ml (500 mg) by intravenous infusion immediately before, during or after an operation, followed by the same dose eight hourly until oral medication (200-400 mg 8 hourly) can be given.
As for adults, but the single intravenous dose is based on 1,5 ml/kg body mass (7,5 mg metronidazole/kg body mass) and the oral dose of 7 mg/kg body mass.
In infants and other patients maintained on intravenous fluids, Trichazole may be diluted with appropriate volumes of normal saline, dextrose saline, dextrose 5% m/v or potassium chloride injections (20 mmol and 40 mmol/litre).
In cases of overdose in adults, the clinical symptoms are usually limited to nausea, vomiting and neurotoxic effects, including ataxia, slight disorientation, confusion, seizures and peripheral neurophathy.
There is no specific treatment for gross overdosage. Trichazole infusion should be discontinued.
The treatment is symptomatic and supportive.
PVC bags: 36 months.
freeflex bags: 24 months.
Protect from light.
PVC bags: Store at or below 25°C.
freeflex bags: Store at or below 30°C.
100 ml freeflex or PVC bags.
Pack size: 1, 40 or 50.
Not all pack sizes may be marketed.
Trichazole is compatible with the following injection:
Sodium chloride injection 0,9% m/v (normal saline injection)
Dextrose 5% m/v injection
Sodium chloride 0,18% and dextrose 4% m/v injection
Potassium chloride injection 20 mmol/litre
Potassium chloride injection 40 mmol/litre
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