Anfarm Hellas S.A. #Digestive_system #Other #HEALTH_CARE
Product description
The preparation Almiba is used to treat primary and secondary carnitine deficiency in adults and children, including newborns and infants. Secondary carnitine deficiency in patients undergoing hemodialysis.
Suspected secondary carnitine deficiency in patients undergoing hemodialysis in the following cases:
- Severe and persistent muscle spasms and / or hypotensive episodes during dialysis;
- Energy deficit, which leads to a significant negative impact on the quality of life;
- Muscle weakness and / or myopathy;
- Cardiopathy;
- Anemia, does not respond to erythropoietin treatment, or requires high doses of erythropoietin;
- Loss of muscle mass.
Compound
Active substance: levocarnitine;
1 ampoule (5 ml) contains levocarnitine - 1 g.
Excipients: hydrochloric acid, water for injection.
Mode of application
The preparation is administered intravenously slowly over 2-3 minutes.
Application for congenital metabolic disorders. During therapy, it is advisable to control the level of carnitine and acylcarnitine in both blood plasma and urine. The required dose depends on the specificity of the congenital metabolic disorder and the severity of the manifestations of the disease. In the case of acute decompensation, the recommended dose may be up to 100 mg / kg per day in 3-4 injections. Higher doses can be used if necessary, although side effects such as diarrhea may increase.
Secondary carnitine deficiency in patients undergoing hemodialysis. Before starting therapy, it is necessary to monitor the level of carnitine in the blood plasma. Secondary carnitine deficiency is diagnosed when the ratio of acylcarnitine to free carnitine in blood plasma is more than 0.4 and / or when the concentration of free carnitine is less than 20 μmol / L. A dose of 20 mg / kg should be given as an intravenous bolus at the end of each dialysis session. The overall response should be determined by monitoring plasma levels of acylcarnitine and free carnitine and evaluating the patient's condition. Normalization of the carnitine content in muscle tissue and cardiomyocytes occurs approximately 3 months after reaching the normal concentration of carnitine in the blood plasma. If the introduction of carnitine is stopped, its level will certainly begin to decline again. The need for a repeated saturating course of treatment is determined by quantitative determination of carnitine in blood plasma at regular intervals and by monitoring the patient's condition.
Hemodialysis is a supportive therapy. After a saturating course of administration of levocarnitine, a maintenance dose is used - 1 g of the preparation per day orally. On the day of dialysis, the preparation is administered orally at a dose of 1 g immediately after the completion of the next session.
Application features
Pregnant
Given the serious consequences of carnitine deficiency for a pregnant woman, the risk of interruption to treatment for the mother is considered greater than the theoretical risk to the fetus if treatment is continued.
Overdose
There have been no reports of overdose toxicity of levocarnitine. To treat an overdose, supportive therapy should be given. Large doses can cause diarrhea. Levocarnitine is easily removed from blood plasma by dialysis. Treatment: take measures to remove the preparation from the digestive tract when ingested, conduct symptomatic and supportive therapy. No cases of overdose that were life-threatening were reported.
Side effects
Moderate gastrointestinal distress has been observed with long-term use of oral levocarnitine, including fleeting nausea and vomiting, abdominal pain, and diarrhea. Reducing the dose often reduces or eliminates gastrointestinal symptoms. With long-term administration of oral levocarnitine, it is necessary to control the specific body odor (reducing the dose weakens or eliminates the odor caused by the preparation). When taking levocarnitine with coumarin anticoagulants, an increase in the international normative ratio of INR is possible. It is necessary to carefully monitor the tolerance of the preparation during the first week of administration and after any dose increase. Intravenous administration of levocarnitine is generally well tolerated.
Interaction
The simultaneous use of glucocorticoids leads to the accumulation of levocarnitine in body tissues (except for the liver). Other anabolic agents enhance the effect of Almiba.
In some cases, when taking levocarnitine with coumarin anticoagulants, an increase in the international normative ratio of INR is possible, therefore, their simultaneous use requires a reservation. INR or other coagulation tests should be checked weekly until they stabilize, and monthly thereafter in patients taking such anticoagulants with levocarnitine.
Storage conditions
Store at a temperature not exceeding 25 ° C, out of the reach of children.
Shelf life is 4 years.
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