| 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. |
