Medicinal Products

ABELCET 5 mg / mL

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amphotericin B
laboratory: Acino France

Suspension to be diluted for IV infusion
Box of 10 bottles of 20 ml
All forms

Indication

Treatment of aspergillosis and systemic candidiasis:
- in subjects who have developed renal insufficiency under amphotericin B defined by:
. elevation of serum creatinine above 220 micromol / L or,
. lower creatinine clearance below 25 ml / min;
- in case of pre-existing and persistent deterioration of renal function defined by:
. serum creatinine greater than 220 micromol / L or,
. clearance of creatinine less than 25 ml / min.

Dosage ABELCET 5 mg / mL Concentrate to be diluted for infusion IV Box of 10 vials of 20 ml

- Abelcet is a sterile, pyrogen-free suspension to be diluted for intravenous infusion only.
- The recommended dose is 5.0 mg / kg / day for 14 to 21 days. Abelcet should be administered as an intravenous infusion at a rate of 2.5 mg / kg / hour.
- Given the allergic risks, an initial 1.0 mg test dose should be administered in slow IV (15 min) to demonstrate sensitivity.
- In case of worsening of renal function under Abelcet, continuation of treatment should be discussed according to the estimated benefit / risk ratio. In the absence of a validated dose adjustment regimen, it is proposed to lower Abelcet doses to 2.5 mg / kg transiently, or to temporarily space infusions.
- In the current state of knowledge, no scheme can guarantee both the efficacy and safety of treatment.
- A filter can be used on the infusion line to infuse Abelcet. The pore diameter should not be less than 5.0 microns.

Against indications

CONTRAINDICATED:
Abelcet is contraindicated in patients with known hypersensitivity to any of the components.
NOT RECOMMENDED :
This drug is generally not recommended with sultopride (see section interactions).

Abelcet side effects

Side effects that have been reported with conventional amphotericin B may occur with Abelcet.
- Premedication (eg with paracetamol) may be used to prevent the occurrence of infusion-related side effects. The main adverse effects encountered include chills, fever, nausea and vomiting.
- Generals:
Fever (sometimes accompanied by chills usually occurring 15 to 20 minutes after starting treatment), discomfort, weight loss, flush.
- Gastrointestinal:
Anorexia, nausea, vomiting, diarrhea, dyspepsia, gastric pain.
- Hematologic:
Normochromic normochromic anemia, agranulocytosis, coagulation defects, thrombocytopenia, leukopenia, eosinophilia.
- Local :
Pain at the injection site with or without phlebitis or thrombophlebitis.
- Locomotives:
Generalized pain, including muscle and joint pain.
- Neurological:
Headache, convulsions, hearing loss, tinnitus, transient vertigo, visual disturbances or diplopia, peripheral neuropathies, other neurological symptoms. Exceptional cases of leukoencephalopathy have been reported most often in subjects who have undergone total body irradiation.
- Renal:
Impairment of renal function: azotemia, increased serum creatinine, hypokalaemia, hypomagnesaemia, hyposthenuria, distal tubular acidosis and histological nephrocalcinosis, or even permanent renal failure if administration of large total doses.
- Allergic:
Anaphylactic reactions.
- Cardiovascular:
Cardiac arrest, arrhythmias (ventricular fibrillations), heart failure, hypertension, hypotension, shock.
- Dermatological:
Rash, especially maculopapular, pruritus.
- Lungs:
Dyspnoea, bronchospasm, non-cardiogenic pulmonary edema.

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