Descrizione Clinica
B12 500 MG/2 MG POLVER AND SOLVENT FOR ORAL SUSPENSION
active ingredients
A cap contains: Active ingredient: Cobamamide 2 mg. One bottle contains: Active ingredient: L-Carnitine internal salt 500 mg. Excipients with known effects: 70% solution sorbitol (E420). 4,075 g, sucrose 1.5 g, benzoate sodium 0.048 (E211) g. For the complete list of excipients, see paragraph 6.1.Excellent
The cap contains: polyethyleneglycol 4000, mannitol powder. The bottle contains: 70% solution sodium benzoate, black cherry juice, orzate juice, sucrose, demineralized water q.b.Therapeutic indications
Pediatrics: All states of malnutrition of children, infants and premature, delays of increase, weightlessness, distrophy, anorexia, disability from any cause, post-infectious debilitation states. Internal medicine: Pathological differences of any etyology, magrecy without apparent cause, inappetence, astenia, convalescence, as an antitabolic in protracted cortisonic therapies and in thyrotoxicosis, in the hypoproteinmies of hepatopathies and nephrosis.Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.Population
Milky and premature: a bottle per day diluted in water. Children and teenagers: 1-2 bottles a day diluted in water. Adults: 2-3 bottles a day. Special popularity. Senior Patients: Changes in CoCarnitin B12 dosing in elderly patients are not required. Patients with kidney failure: Patients with severe impairment of kidney function should not be treated with the administration of high doses of L-Carnitine for prolonged periods orally because it can induce an accumulation of potentially toxic metabolites, see paragraph 4.4. No data is available for the use of Vitamin B12 in patients with kidney failure. Patients with liver failure: Data is not available in patients with liver failure. The characteristics of CoCarnitin B12 can be altered by exposure to light and if it is not used immediately after mixing with liquids or food.Conservation
Do not store at temperature above 25°C.Warnings
Chronic oral administration of high doses of L-Carnitine in patients with severe renal failure can induce a accumulation of potentially toxic metabolites: trimethylamine (TMA) and trimethylamine-N oxide (TMAO). Very rare cases of increase of the IR (International Normalized Ratio) in patients subjected to concomitant therapy with L-Carnitine and cumarinic drugs. The INR or other appropriate coagulation tests - must be checked weekly until the stabilization of values and subsequently monthly, in patients taking anticoagulants together with L-Carnitine. Convulsions were reported in patients, with or without prior convulsive activity, who had received L-Carnitine or intravenous. In patients with underlying conditions, treatment with L-Carnitine can trigger convulsive crises. CoCarnitin B12 contains 4,075 g bottle sorbitol. Sorbitol can cause gastrointestinal disorders and have a slight laxative effect. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. Patients with hereditary fructose intolerance should not be given this medicine. CoCarnitin B12 contains 1.5 g sucrose for bottle. Sucrose can be harmful to your teeth. Patients suffering from rare fructose intolerance problems, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. CoCarnitin B12 contains 0.048 g benzoate sodium for bottle. The increase in bilirubinemia following its detachment from albumin can increase the neonatal hetero that can evolve in kernittero (deposits of bilirubin not conjugated in the brain tissue). This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’. Given the particular lability and photosensitivity of Cobamamide, the possible solution of the product in liquids or its mixing in other foods must take place immediately before the time of administration. The drug does not give addiction or addiction. Products containing Cobamamide should not be administered to anemic subjects except on the basis of investigations aimed at establishing the exact nature of anemia.Interactions
Oral anticoagulants: Very rare cases of increase of the IR (International Normalized Ratio) in patients subjected to concomitant therapy with L-Carnitine and cumarinic drugs (see paragraph 4.4). The INR or other appropriate coagulation tests must be checked weekly until the stabilisation of values and subsequently monthly, in patients taking L-Carnitine along with cumarinic drugs (see paragraph 4.4). Other interactions: Concurrent administration of L-Carnitine with drugs that induce hypocarnitinemia due to a greater loss of renal carnitine (Valproic acid, pharmacies containing pivalic acid, cephalosporine, cisplatin, carboplatin and ifosfamide) can reduce the availability of L-Carnitine. Vitamin B12 interactions with other drugs are not known.Effects
Adverse reactions from any source (clinical studies, clinical data published for individual active ingredients and post-marketing data from CoCarnitin B12) are listed 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: Kefalea. Gastrointestinal disease. Not common: Abdomen, gastrointestinal pain, Vomito; City: Abdominal pain, Diarrhea, Nausea. Convulsions were reported in patients, with or without prior convulsive activity, who had received L-Carnitine or intravenous (see paragraph 4.4).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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Overdosing
No overdose cases have been reported. Pregnancy:
L-Carnitine crosses the placenta. The levels of carnitine in newborns reflect those of the mother. Clinical studies are not available with the administration of vitamin B12 or CoCarnitin B12 in pregnant women. Nursing:
L-Carnitine is the normal component present in breast milk. There are no clinical studies in women during lactation with supplements containing L-Carnitine or CoCarnitin B12. Fertility:
Clinical fertility studies with L-Carnitine have not reported security issues. Clinical fertility studies with vitamin B12 are not available.
Source: Farmadati
