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Product Line:

Cardiometabolism Line

Patient Product Information

Formulation:
For injection (IM and EV): Each ampule contains: L-Carnitine 1000 g.; Excipients  q.s; Solution: Each ampule contains: L-Carnitine 1.0000  g; Excipients  q.s

Therapeutical action:
stabilizer of the striated muscle cell metabolism: supplementary therapy in conditions with L-Carnitine deficit.

Indications:
Oral: treatment of primary carnitine deficiency. These patients have recurrent episodes of Reye-type encephalopathies, hypoketogenic hypoglycemia, and/or myocardiopathy. In some patients with carnitine deficit, especially those having myocardiopathy, the carnitine supplement produces a rapid relief of signs and symptoms. Treatment should include, together with the carnitine administration, complementary support therapy if it is required by the patient’s clinical condition.  
It is also indicated in the acute and chronic treatment of patients with congenital metabolism disorders producing secondary carnitine deficiency.  
For injection: acute and chronic treatment of the secondary carnitine deficiency derived from congenital errors of metabolism or from dialysis treatment in patients with terminal renal disease.

Dosage and Administration
For injection
Metabolic disorders
The recommended dose is 50 mg/kg in slow bolus (2-3 minutes) or infusion. A charge dose is often administered in patients with severe metabolic crisis, followed by an equivalent dose during the following 24 hours. It should be administered every 3-4 hours (minimum every 6 hours) by slow bolus or infusion. Subsequent daily doses of 50 mg/kg are recommended. The higher administered dose was 300 mg/kg.
It is recommended to measure the plasma carnitine concentration before beginning this parenteral therapy, and it is recommended a weekly and monthly monitoring subsequently. This monitoring should include humoral parameters, vital signs, global clinical evaluation and plasma carnitine levels (the plasma free carnitine should be between 35 and 60 umol/l).
Patients with chronic hemodialysis
The recommended initial dose is 10 to 20 mg/kg of dry weight administered as a slow bolus at the end of every dialysis session. Treatment in patients with low predialysis plasma concentrations of carnitine is recommended (less than 40-50 umol/l). The ulterior dose adjustments should be guided by the predialysis plasma levels of carnitine, and the dose has to be reduced at the third or fourth week of treatment. 
Drinking solution
Adults - The recommended dose is 1 to 3 g/day (10-30 ml/day) for a 50 kg subject, with an initial dose of 1 g/day, increasing it slowly according to tolerance and answer.
Children - The recommended dose is 50-100 mg/kg/day (0.5ml/kg/day), with an initial dose of 50 mg/kg/day, increasing it slowly up to a maximum of 3 g/day (30 ml/day), according to tolerance and answer.
General lab tests, vital signs, global clinical state and carnitine plasma concentration should be periodically monitored both in adults and children.
The drinking solution may be drunk alone or dissolved in beverage or liquid food, and the daily dose may be taken during the day, preferably near foods and it should be taken slowly to maximize the tolerance.

Contraindications:
unknown.

How-supplied:
ALBICAR for injection: packages containing 5 ampoules. ALBICAR Solution: packages containing 10 and 30 drinking vials.