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MILGAMMA

Reviews
Acta Diabetol. 2001;38(3):135-8.
Benfotiamine is similar to thiamine in correcting endothelial cell defects induced by high glucose.
Pomero F, Molinar Min A, La Selva M, Allione A, Molinatti GM, Porta M.
WHO Collaborating Centre for Diabetes-Related Blindness, Department of Internal Medicine, University of Turin, Italy.

We investigated the hypothesis that benfotiamine, a lipophilic derivative of thiamine, affects replication delay and generation of advanced glycosylation end-products (AGE) in human umbilical vein endothelial cells cultured in the presence of high glucose. Cells were grown in physiological (5.6 mM) and high (28.0 mM) concentrations of D-glucose, with and without 150 microM thiamine or benfotiamine. Cell proliferation was measured by mitochondrial dehydrogenase activity. AGE generation after 20 days was assessed fluorimetrically. Cell replication was impaired by high glucose (72.3%+/-5.1% of that in physiological glucose, p=0.001). This was corrected by the addition of either thiamine (80.6%+/-2.4%, p=0.005) or benfotiamine (87.5%+/-8.9%, p=0.006), although it not was completely normalized (p=0.001 and p=0.008, respectively) to that in physiological glucose. Increased AGE production in high glucose (159.7%+/-38.9% of fluorescence in physiological glucose, p=0.003) was reduced by thiamine (113.2%+/-16.3%, p=0.008 vs. high glucose alone) or benfotiamine (135.6%+/-49.8%, p=0.03 vs. high glucose alone) to levels similar to those observed in physiological glucose. Benfotiamine, a derivative of thiamine with better bioavailability, corrects defective replication and increased AGE generation in endothelial cells cultured in high glucose, to a similar extent as thiamine. These effects may result from normalization of accelerated glycolysis and the consequent decrease in metabolites that are extremely active in generating nonenzymatic protein glycation. The potential role of thiamine administration in the prevention or treatment of vascular complications of diabetes deserves further investigation.

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Drug information

Product Name: MILGAMMA dragee

Substance (drage): 250 mcg cyancobalaminum, 50 mg benfotiaminum.
Substance (injection): 1 mg cyancobalaminum, 100 mg pyridoxinum chloratim, 100 mg thiaminium chloratum, 20 mg lidocainium chloratum / 2 ml
Substance (capsules): 250 mcg cyancobalaminum, 40 mg benfotiaminum, 90 mg pyridoxinium chloratum

1. Other Components: Highly disperse silicon dioxide, microcrystalline cellulose, carboxymethyl cellulose sodium, polyvidone, talcum, higher-chained partial glycerides, shellac, saccharose, macrogol 6000, calcium carbonate, gum Arabic, maize starch, glycerol 85%, polysorbate 80, colouring material E 171, montan glycol wax, gluten-free, contains no lactose.

2. Fields of Application: Diseases of the nervous system (neurological system diseases) resulting from a shown deficiency of vitamin B1 and B6.

3. Contraindications: If hypersensitiveness is suspected towards any of the ingredients, otherwise there are no known contraindications. No indications of deformations (teratogenicity) or changes to the genome (mutagenicity), no reservations during breast-feeding within the stated dose range. There is no information available with respect to the application of milgamma in children and the elderly.

4. Precautions and Warnings: No special precautions are required. What precautions must be taken when operating a motor vehicle, working with machines or in locations without a guard? No special precautions are required.

5. Interactions: There are interactions with INH, D-penicillamine, cycloserine. Therapeutic doses of vitamin B6 may weaken the effect of L-dopa.

6. Dosage Instructions, Type and Duration of the Application: The following information applies unless you have been given different instructions with respect to milgamma by your doctor. Please adhere to the dosage instructions as otherwise milgamma will not have the desired effect! 1 milgamma dragee up to 3 times daily. The dragees should be taken with adequate amounts of liquid. The dragees may be taken at any time. After four weeks of therapy the doctor should decide whether further therapeutic measures are required.

7. Incorrect Use and Overdose: If any symptoms occur the doctor should be contacted. Continue to take milgamma as previously at the usual times and ensure that the dose is taken regularly in future. If the treatment is interrupted you are jeopardising its chances of success! If you notice any unpleasant side-effects, please speak to your doctor about future treatment.

8. Side-effects: In individual cases there may be allergic hypersensitiveness reactions with skin reactions, urticaria (nettle rash) or states of shock. If you observe any side-effects which are not listed in these instructions, please inform your doctor or pharmacist. In the case of systemic hypersensitiveness reactions it may be necessary to initiate emergency measures. In case of side-effects please contact your doctor.

9. Information on the Shelf-Life of the Medication: The use-by date is printed on this pack. The medication should not be used after this date! milgamma should be stored away from light and heat!

10. For the Information of our Patients: milgamma dragees contain benfotiamine and pyridoxine hydrochloride. Benfotiamine is a fat-soluble form of vitamin B1, representing a further development of this vitamin. It is absorbed by the organism many times better than equal quantities of the traditional water-soluble vitamin B1. After being taken up by the intestine, benfotiamine is converted in the body to the active substance vitamin B1. Pyridoxine hydrochloride is also designated vitamin B6. These two vitamins are micronutrients which are essential for life. If they are not taken in by the body in sufficient quantities, they may in time result in deficiency syndromes such as neurological system diseases. These diseases are usually accompanied by functional disturbances in the metabolism of the nerves. The consequences may be pains and sensory disturbances, above all in the feet.

Product Name: MILGAMMA N inj.

2 ml of the injection solution contains:
Pharmaceutically active ingredients
Thiamine chloride hydrochloride 100 mg
Pyridoxine hydrochloride 100 mg
Cyanocobalamin 1000 mg


PHARMACEUTICAL FORM: Injection solution

1. Therapeutic indications: Nervous diseases of various origins, neuritides, neuralgias, polyneuropathies (e.g. diabetic, alcoholic, etc.), myalgias, radicular syndromes, retrobulbar neuritis, herpes zoster, facioplegia and as a roborant.

2. Dosage, method and duration of administration: Single and daily doses In severe and acutely painful cases, initially 1 injection (2 ml) daily in order to quickly achieve a high blood level. After the acute stage has subsided, and in cases of less severe diseases, 1 injection 2-3 times a week.

3. Method and duration of administration: The injection solution is injected deeply into a muscle (i.m.). In the injection interval, for after-treatment and in less severe cases, 1 milgamma N capsule up to 3-4 times daily.

4. Contraindications: Hypersensitivity to one of the components of the medicine. The medicine should not be used in cases of severe conduction disturbances or acutely decompensated cardiac insufficiency. Owing to its benzyl alcohol content, milgamma N should not be administered to neonates, in particular to immature infants. Daily vitamin B6 doses of up to 25 mg can be taken during pregnancy and while breast-feeding without any reservations. However, as the preparation contains 100 mg of vitamin B6 per 2 ml ampoule, this medicine should not be used during pregnancy and while breast-feeding. Special warnings and precautions for use Owing to its benzyl alcohol content, milgamma N should not be administered to neonates, in particular to immature infants.

5. Interactions with other medicinal products and other forms of interaction: Thiamine is decomposed completely by sulphite-containing solutions. Other vitamins may be inactivated in the presence of vitamin B1 decomposition products. Therapeutic doses of vitamin B6 may weaken the effect of L-dopa. Further interactions exist with INH, D-penicillamine and cycloserine. In the parenteral application of lidocaine there may be an increase in cardiac side effects if epinephrine or norepinephrine are administered at the same time. There are also further interactions with sulphonamides. In cases of overdose with local anesthetics, epinephrine and norepinephrine must not be administered additionally.

6. Pregnancy and lactation: Daily vitamin B6 doses of up to 25 mg can be taken during pregnancy and while breast-feeding without any reservations. However, as the preparation contains 100 mg of vitamin B6 per 2 ml ampoule, this medicine should not be used during pregnancy and while breast-feeding. Effects on ability to drive No special precautions are required.

7. Side effects: In individual cases there have been reports of profuse perspiration, tachycardia, acne, skin reactions with itching and urticaria. In rare cases there may be hypersensitivity reactions (e.g. skin rash, respiratory distress, shock, angioedemas). Systemic reactions are possible through rapid flooding (unintentional intravenous injection, injection in tissue with high blood supply) or through overdose. Vertigo, vomiting, bradycardia, arrhythmias, obnubilation and cramps may occur.

8. Overdose: Not applicable.

9. Pharmacodynamic properties: The neurotropic vitamins of the B complex have a favorable effect on inflammatory and degenerative diseases of the nerves and locomotor's apparatus. They are used not only to remedy deficiencies, but in high doses also have pharmacological properties, which explains the analgesic, antiallergic and circulation-promoting effects which can be attained with milgamma N. Vitamin B1 is also designated an antineuritic vitamin. In its phosphorylated form (TPP) as cocarboxylase, it regulates the breakdown of carbohydrates and is used against acidotic metabolic disturbances. Vitamin B6 regulates protein, fat and carbohydrate breakdown. Its neurotropic effect is used, for example, in isonicotinic acid hydrazide therapy for the avoidance of neuritides. Its effects on the brain stem attenuate extra pyramidal symptoms. Vitamin B12 is essential for cell metabolism, normal blood formation and the functioning of the nervous system. It catalyses biological nucleic acid synthesis, and therefore the structure of new cell nuclei. In high doses vitamin B12 also shows analgesic, antiallergic and circulation-promoting properties. Owing to the complementarities of its components, the vitamin combination milgamma N, with its causal effect and good tolerance, has a wide range of uses far exceeding the treatment of acute and chronic neurological diseases.

10. Pharmacokinetic properties: Thiamine is absorbed from the intestinal lumen by an active transport process. The absorption is limited to 8-15 mg per day. Approx. 1 mg of thiamine is broken down in the organism daily. Any excess thiamine is excreted with the urine. The tryptophan stress test is suitable for determining the vitamin B6 status. After the oral administration of 0.1 g of L-tryptophan per kilogram of body weight, xanthurenic acid excretion is generally less than 30 mg for each 24-hour period. Higher levels of xanthurenic acid excretion indicate vitamin B6 deficiency. Pyridoxine, pyridoxal and pyridoxamine are absorbed very quickly and phosphorylated and oxidized to pyridoxal-5 phosphate (PALP) and pyridoxal. The main excretion product is 4-pyridoxic acid. The vitamin B12 released from the food during the digestive process in the stomach is bound to the intrinsic factor (IF). This glycoprotein is formed by the parietal cells of the stomach. The vitamin B12-IF complex is resistant to proteolytic enzymes and passes into the distal ileum, where it is bound by specific receptors, thus ensuring that the vitamin is resorbed. Vitamin B12 is transferred through the mucosa to the capillary circulation, where it is bound to the transport protein transcobalamin. The liver, the bone marrow and other proliferating cells rapidly absorb this complex. Absorption is disturbed in patients with missing intrinsic factor, in patients suffering from malabsorption or diseases or changes to the intestine, after gastrectomy or in cases of autoimmune antibody formation. As a rule, only 1.5 - 3.5 µg of vitamin B12 is absorbed from the diet. Vitamin B12 is excreted in the gall and is subject to enterohepatic circulation. Vitamin B12 is transferred to the placenta.

11. Bioavailability: For determining the vitamin B1 status, measurements of TPP-dependent enzyme activities in the erythrocytes, such as transketolase and the degree to which they can be reactivated are suitable. The concentrations in the plasma are between 2 and 4 µg/100 ml. The mean serum value for PALP in adults is 1.2 µg/100 ml. The mean vitamin B6 concentration in the blood is 6 µmol/100 ml. Hypervitaminosis or other side effects have not been observed even after the administration of daily doses of more than 1 g over periods of weeks and months. Normally the plasma concentrations of vitamin B12 are 200-900 pg/ml, or <200 pg/ml in cases of deficiency. The circulating vitamin B12 corresponds to only 0.1 % of the total vitamin amount. The daily vitamin B12 requirement is approx. 1 µg. The vitamin B12 not circulating in the organism is mainly stored in the liver. With a "body-pool" of 3 - 5 mg, the amount contained in the liver is 50 - 90%. The resorption of vitamin B12 is inhibited by colchicine, ethanol and neomycin (here, a parenteral application is indicated). Oral antidiabetics of the biguanide type and p-amino salicylic acid, as well as chloramphenicol and vitamin C, interfere with vitamin B12 resorption. The biological half-life of cyanocobalamin in plasma is 123 hours.

12. Preclinical safety data: Mutagenic and tumor-producing potential There are indications that a metabolic product, 2.6-xylidine, produced from lidocaine in rats, and possibly in humans, might have a mutagenic effect. These indications result from in vitro tests in which this metabolite was used in very high, almost toxic concentrations. There is no reasons for believing at present that the parent substance, lidocaine, is itself mutagenic. In a cancerogenicity study with transplacental exposure and postnatal treatment of the animals over two years with 2.6-xylidine in rats, in a highly sensitive test system (transplacental exposure and postnatal treatment of the animals over two years with very high doses) malignant and benign tumors were observed, above all in the nasal cavities (ethmoturbinalia). It would not appear to be absolutely improbable that these findings are relevant for human beings. Therefore milgamma N should not be administered in high doses over a prolonged period.

- active components: lidocaine hydrochloride 20 mg
benzyl alcohol 40 mg

- other components:
water for injection
substances for physiological pH adjustment
potassium hexacyanoferrate III
sodium polyphosphate


13. Shelf life: Milgamma N injection solution can be stored 2 years.

14. Special precautions for storage: Milgamma N injection solution should be protected from heat and light, and must not be used after the expiry date. Nature and contents of container 5 ampoules each containing 2 ml solution

15. Instructions for use/handling: The injection solution is injected deeply into a muscle (i.m.).

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.

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MILGAMMA

Substance (drage): 250 mcg cyancobalaminum, 50 mg benfotiaminum.
Substance (injection): 1 mg cyancobalaminum, 100 mg pyridoxinum chloratim, 100 mg thiaminium chloratum, 20 mg lidocainium chloratum / 2 ml
Substance (capsules): 250 mcg cyancobalaminum, 40 mg benfotiaminum, 90 mg pyridoxinium chloratum

Dosage
Packing
Price
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mg
50 tabs
USD 43.00
mg
100 tabs
USD 69.00
mg
500 tabs
USD 294.00
2 ml
10 amp
USD 29.00
2 ml
30 amp
USD 68.00
mg
20 caps
USD 0.00
mg
50 caps
USD 43.00
mg
100 caps
USD 69.00
mg
500 caps
USD 294.00
 

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