PAMECIL Powder for solution for injection or infusion Ref.[28317] Active ingredients: Ampicillin

Posology

For intramuscular administration: add 1.0ml, 1.8ml and 3.5ml of water for injections into the 250mg, 500mg and 1000mg vials respectively and shake well.

For intravenous administration: add 5ml of water for injections into 250mg and 500mg vials and 7.5 ml into 1000mg vials and shake well. Inject the solution slowly (over a period of 3 to 4 minutes). Pamecil may be added into compatible infusion fluids. It can also be injected after suitable dilution into the drip tube over a period of 3 to 4 minutes.

Usual adult dosage (including elderly patients)

• Septicaemia, endocarditis, osteomyelitis: 500 mg four to six times a day IM or IV for one to six weeks.
• Peritonitis, intra-abdominal sepsis: 500 mg four times a day IM or IV.
• Meningitis: Adult dosage: 2 g six hourly IV.
• Local use in abdominal surgery: 1 g sterile powder sprinkled into the wound extraperitoneally or into muscle layers to prevent wound infection post-operatively.

Paediatric population

Usual children’s dosage (under 10 years):

• Half adult routine dosage. All recommended dosages are a guide only. In severe infections the above dosages may be increased.
• Meningitis: 150 mg/kg daily IV in divided doses.

Renal impairment

In the presence of severe renal impairment (creatinine clearance <10 ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis an additional dose should be administered after the procedure.

Method of administration

For instructions on dilution of the product before administration, see section 6.6.

Symptoms

In case of overdosage gastrointestinal effects such as nausea, vomiting and diarrhea may be evident.

Treatment

Discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal functions impairment ampicillin-class antibiotics can be removed by haemodialysis but not by peritoneal dialysis.

3 years.

Use immediately after reconstitution.

Store below 25°C.

Clear glass (type III) vials sealed with grey chlorobutyl rubber stopper, type I and aluminium overcap. Packs of 10, 50, or 100 vials are available.

Not all pack sizes may be marketed.

Reconstitution of Pamecil should be performed under suitable conditions and with aseptic precautions.

For intramuscular administration: add 1.0ml, 1.8ml and 3.5ml of water for injections into the 250mg, 500mg and 1000mg vials respectively and shake well.

For intravenous administration: add 5ml of water for injection into 250mg and 500mg vials and 7.5ml into 1000mg and shake well. Inject the solution slowly (over a period of 3 to 4 minutes). Pamecil may be added into compatible infusion fluids. It can also be injected after suitable dilution into the drip tube over a period of 3 to 4 minutes.

Pamecil vials are for single use and any remaining liquid should e discarded following reconstitution and first usage.