CARNITENE OS 10FL 1G/10ML

CARNITENE

active ingredients

CARNITENE 1 g/5 ml injectable solution for intravenous use A vial contains: Active ingredient: L-carnitine interior room 1,00 g CARNITENE 2 g/5 ml injectable solution for intravenous use A vial contains: Active ingredient: L-carnitine interior room 2,00 g CARNITENE 1 g/10 ml oral solution A single-dose container contains: Active ingredient: L-carnitine interior room 1,00 g CARNITENE 2 g/10 ml oral solution A single-dose container contains: Active ingredient: L-carnitine interior room 2,00 g CARNITENE 1.5 g/ 5 ml oral solution 100 ml of solution contain: Active ingredient: L–carnitine salt inside 30 g Excipients with known effects: sucrose, sorbitol (E420), methyl para-hydroxybenzoate sodium (E219), propile para-hydroxybenzoate sodium (E217). CARNITENE 1 g chewing tablets A chewable tablet contains: Active ingredient: L–carnitine internal salt 1,00 g Excipient with known effects: sucrose. CARNITENE 1 g/100 ml solution for infusion with chloride sodium A bag contains: active component: L–carnitine salt inside g 1,00. Excipient with known effects: sodium chloride. CARNITENE 2.5 g/250 ml solution for infusion with chloride sodium A bag contains: active component: L–carnitine interior hall g 2.50. Excipient with known effects: sodium chloride. CARNITENE 1 g/100 ml solution for infusion with glucoseA bag contains: active component: L–carnitine salt inside g 1,00. Excipient with known effects: glucose CARNITENE 2.5 g/250 ml solution for infusion with glucose A bag contains: active component: L–carnitine interior hall g 2.50. Excipient with known effects: glucose For the full list of excipients see paragraph 6.1.

Excellent

Injectable solution for intravenous use water for injectable preparations. 1 g/10 ml oral solution: malic acid, benzoate sodium, sodium saccharin, purified water. 2 g/10 ml oral solution: malic acid, benzoate sodium, sodium saccharin, powder pineapple aroma, purified water. 1.5 g/5 ml oral solution: sucrose, 70 percent sorbitol (not crystallized), para-hydroxybenzoate sodium, propile para-hydroxybenzoate sodium, cherry aroma, bitter aroma, purified water. Chewable tablets aroma mint powder, aroma licorice powder, sucrose, magnesium stearate. Solution for infusion with chloride sodium sodium chloride, diluted hydrochloric acid, water p.p. injectable.Solution for infusion with glucose monohydrate glucose, water p.p. injectable.

Therapeutic indications

Primary and secondary deficiencies of carnitine.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. The solution for infusion with chloride sodium is contraindicated in patients with hypernatremia and hydrosaline pletor. The solution for infusion with glucose is contraindicated in diabetic patients.

Population

Oral solution – chewable tablets: Primary deficiencies and secondary deficiencies in genetic diseases The daily oral dose is based on age and weight; from 0 to 2 years are recommended 150 mg per kg body weight, from 2 to 6 years 100 mg per kg, from 6 to 12 years 75 mg per kg; over 12 years and in adults 2 – 4 grams according to the severity of the pathology and the judgement of the doctor.Secondary emodialysis deficiencies 2 – 4 grams per day. Oral solutions are to be taken only after dilution, that in monodose containers must be diluted in a glass of water. Injectable solution for intravenous use – Infusion solution Secondary emodialysis deficiencies 2 grams at the end of the dialysis session administered slowly intravenously. The 2.5 g dosage can be indicated in patients with dialysis age greater than 1 year. Fial 5 ml Endovenous administration should be done slowly (2–3 minutes). Bags of 100 ml and 250 ml The infusion must be 3 ml per minute, approximately 30 minutes for 100 ml bags and 1 hour and 20 minutes for 250 ml bags. Special popularity Patients with kidney failure Patients with severe impairment of kidney function should not be treated with chronic oral administration of high doses of levocarnitine because it can induce an accumulation of potentially toxic quarterlylamine (TMA) and trimetilamin–N–oxide (TMAO), see paragraph 4.4. Senior Patients No special precaution and modifications of the dosage CARNITENE are necessary in elderly patients. The security profile observed in clinical studies is similar in older and young adults. Diabetic Patients The administration of L–carnitine in diabetic patients in insulin treatment or oral hypoglycemizers, improving the use of glucose, could result in hypoglycemia. Therefore, in these subjects, blood sugar must be checked regularly in order to be able to provide, if necessary, the adjustment of hypoglycemic therapy (see paragraph 4.4).

Conservation

There are no special precautions for conservation. CARNITENE solution for infusion with glucose: Do not store at temperature above 25° C.

Warnings

The administration of L–carnitine in diabetic patients in insulin treatment or oral hypoglycemizers, improving the use of glucose, could result in hypoglycemia. Therefore in these subjects blood sugar must be kept under frequent control in order to be able promptly to provide for the adjustment of hypoglycemizing therapy. Endovenous administration should be done slowly (2–3 minutes). CARNITENE solution for infusion should be used with great caution in patients with congestive heart failure, severe kidney failure and in clinical states where there is edema with salina retention, in patients in treatment with corticosteroid or corticotropin drugs. Continuous administration without addition of potassium can cause hypokalemia. Monitor fluid balance and electrolytes. In patients with previous convulsive activity the administration of L-carnitine can increase the incidence and/or severity of convulsive crises. In patients with predisposable conditions treatment with L–carnitine could trigger seizures. The safety and effectiveness of oral levocarnitine have not been demonstrated in patients with kidney failure. Chronic oral administration of high doses of levocarnitine in patients with severe impairment of renal function or kidney failure at the terminal stage (ESRD) and dialized can induce an accumulation of potentially toxic metabolites quarterethylamine (TMA) and trimetilamina–N–oxide (TMAO), as these metabolites are normally excreted with urine. This phenomenon does not occur with intravenous administration (see paragraph 5.2) Since L-carnitine a physiological product does not have any risk of addiction or addiction. Very rare cases of increase of the INR (International Normalized Ratio) have been reported in patients subjected to concomitant therapy with cumarinic drugs (see paragraphs 4.8 and 4.5). The INR – or other appropriate coagulation tests – should be checked weekly until the stabilisation of values and subsequently monthly, in patients taking anticoagulants together with CARNITENE. . CARNITENE 1.5 g/5 ml oral solution and CARNITENE 1 g chewable tablets contain sucrose: patients with rare hereditary problems of fructose intolerance, glucose–galactose mal absorption, or isomaltase sucrasis failure, should not take this medicine. It can be harmful to teeth. In addition, this is taken into account in diabetic patients and those subjected to hypocaloric dietary systems. CARNITENE 1.5 g/5 ml oral solution contains, sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. CARNITENE 1.5 g/5 ml oral solution contains para-hydroxy-benzoates (para-hydroxybenzoate and para-hydroxybenzoate propile) as preservatives: these can cause allergic reactions (also delayed). CARNITENE 1 g/100 ml infusion solution contains 15.2 mmol (or 350 mg) sodium per 100 ml bag and CARNITENE 2.5 g/250 ml infusion solution contains 38 mmol (or 875 mg) sodium for 250 ml bag. To be considered in people with reduced kidney function or following a low sodium diet. CARNITENE 1 g/100 ml glucose infusion solution contains 5.5 g glucose per dose (100 ml bag) and CARNITENE 2.5 g/250 ml solution for infusion with glucose contains 13,75 g glucose per dose (250 ml bag): patients suffering from rare hereditary problems of glucose–galactose disease, should not take this medicine. To consider in people with diabetes mellitus.

Interactions

An interaction between L-carnitine and cumarinic drugs cannot be excluded. Very rare cases of increase of the INR (International Normalized Ratio) have been reported in patients subjected to concomitant therapy with cumarinic drugs (see paragraphs 4.8 and 4.4). INR – or other appropriate coagulation tests – should be checked weekly until values are established and then monthly, in patients taking anticoagulants together with CARNITENE (see paragraph 4.4). Concurrent administration of CARNITENE with drugs that induce hypocarnitinemia due to increased loss of renal carnitine (Valproic acid, proarmacies containing pivalic acid, cephalosporine, cisplatin, carboplatin and ifosfamide) can reduce the availability of L–carnitine.

Effects

Adverse reactions from any source (clinical studies, literature and post-marketing) are listed in the table below according to the classification for MedDRA systems and organs. Within each class, adverse reactions are classified according to frequency. Within each frequency class, adverse reactions are classified in decreasing order of gravity. In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): very common (≥ 1/10), common (≥ 1/100,

Diseases of the nervous system
Not common:	Cefa
Notable:	Convulsions *, Capogiro
Heart disease
Notable:	Palpitations
Vascular diseases
Not common:	Hypertension, Hypotension
Respiratory, chest and mediastinic pathologies
Notable:	Dispense
Gastrointestinal diseases
City:	Vomito, Nausea, Diarrhea, Abdominal Pain
Not common:	Disgeusia, Dispepsia, Dry mouth
Pathologies of skin and subcutaneous tissue
Not common:	Odor of abnormal skin*
Notable:	Prurito, Skin rash
Diseases of musculoskeletal system and connective tissue
Not common:	Muscle spasms
Notable:	Miastenia [Bleep], muscle tension
Systemic pathologies and conditions for administration
Not common:	Thoracic pain, Feeling strange, Pyrexia, Reaction in Injection ****
Diagnostic examinations
Not common:	Increased blood pressure
Very rare:	Increase of the INR*****

* Convulsions were reported in patients, with or without prior convulsive activity, who had received L–carnitine or intravenous. L–carnitine administration can increase the incidence and/or severity of convulsive attacks. In patients with predisposable conditions treatment with L–carnitine could trigger seizures. ** In subjects with severely impaired renal function or dialysis, chronic oral administration of L–carnitine can result in TMA and TMAO accumulation in the blood resulting in quarterlylamminuria, pathological condition characterized by a strong "fish smell" present in the urine, breath and sweat of the patient (see paragraph 5.2) i.v. ***** There have been very rare cases of increase of the INR (International Normalized Ratio) in patients subjected to concomitant treatment with cumarinic drugs (see paragraphs 4.4 and 4.5). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Overdose and long-term administration of L–carnitine were associated with diarrhea. L–carnitine is easily removed from blood by dialysis.

Fertility In clinical studies conducted in fertility, favorable effects were identified and safety issues were not identified. Pregnancy Reproduction studies were conducted in rats and rabbits. There was no evidence of a teratogenic effect in both species. In the rabbit, but not in the rat, there was a greater number, statistically not significant, of post plant losses, to the maximum dose tested (600 mg/kg per day), than the control group. The importance of these results in man is unknown. No suitable clinical studies have been carried out in pregnant women. CARNITENE should be administered during pregnancy if the benefit for the mother exceeds potential risks to the fetus. Food L–carnitine is a normal component of human milk. The use of L–carnitine supplementation in nursing mothers has not been studied. CARNITENE should be used by the nursing mother if the benefit for the mother exceeds any potential risk for the child due to excessive exposure to carnitine.

Source: Farmadati