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1. Drug name
Rovit H5000
2. Drug formula ingredients
Each 3 ml tube contains:
Vitamin B1 (Thiamine HCl) 100 mg, Vitamin B6 (Pyridoxine HCl 100 mg), Vitamin B12 (Cyanocobalamin) 1 mg
Excipients: q.s 5 ml
3. Dosage form
Injectable solution.
4. Route of administration
Intramuscular.
5. Indications
- Treatment of neurological disorders and other disorders caused by vitamin B deficiency, including diabetic polyneuritis, alcoholic peripheral neuritis, polyneuropathy in pregnancy, and sadness. Nausea and vomiting in pregnant women.
- Supplement vitamins B1, B6, B12 in cases of neurological disorders and cases of deficiency of these vitamins.
6. Administration, dosage
Dosage
Depending on the treatment purpose, there are different dosage indications, specifically as follows (dosage calculated according to cyanocobalamin)
Support for the treatment of neurological diseases: Inject intramuscularly at a dose of 500 - 1000 mcg each time, 2-3 times per week.
Pernicious anemia, body weakness: Intramuscular injection dose of 100-200 mcg every 24 hours.
Administration
The drug is administered by intramuscular injection (note: absolutely not intravenous injection).
Injection technique ensures sterility and is performed by medical staff.
7. Contraindications
Contraindicated in subjects allergic to any ingredient of the drug.
Should not be used to treat megaloblastic anemia during pregnancy unless it can be demonstrated that the anemia is due to vitamin B12 deficiency.
Not to be used to treat amblyopia caused by taking Neo-Cyclamen.
Patients with allergies such as asthma and eczema.
Patients with malignant tumors.
8. Special warnings and precautions for use
Be careful if you drink a lot of alcohol, have or have ever had optic nerve atrophy or kidney disease.
Avoid using the drug in patients with allergic conditions (asthma, eczema) because some cases of immune reactions have been reported. Stop taking the drug immediately if there are signs of allergy.
Do not use the drug when there is intolerance to one of the drug's components through other routes of administration.
9. Fertility, pregnancy and lactation
Use with caution. However, there have been no reports of problems occurring when used at the recommended daily dose. Therefore, you should carefully consider the risks and benefits when using it for these subjects.
10. Effects on ability to drive and use machines
The drug does not affect the ability to drive and operate machinery.
11. Drug interactions and incompatibilities
Vitamin B1 enhances the effects of neuromuscular blocking drugs.
Antihistamines and most antibiotics , Methotrexate makes the drug ineffective.
Vitamin B6 reduces the effectiveness of Levodopa , however when used with drugs that inhibit the enzyme dopa decarboxylase, this interaction will not occur.
When used with oral contraceptives, plasma concentrations of the drug may be reduced, but this interaction is of little clinical significance.
When used in combination with other medications, consult your doctor to avoid adverse interactions that negatively affect your health.
12. Undesirable effects
During the process of taking medication, it is inevitable that you may encounter some unwanted effects, possibly due to the medication, or possibly due to the infusion technique of the medical staff.
Some unwanted effects that may be encountered when using the drug include:
Hypersensitivity reactions: Skin allergy (itching, rash).
Anaphylaxis.
Fever, chills, hot flashes, malaise.
Vomiting, nausea.
Pain, inflammation at the injection site, necrosis at the injection site.
13. Overdose and treatment
In general, overdosage with Rovit H5000 is unlikely. No significant effects are expected if overdose should occur.
However, treatment will be symptomatic.
No adverse effects of an overdose of water soluble vitamins have been reported, with the exception of cases of extremely high parenteral doses. Overdoses caused by parenteral preparations for nutritional supplement of water soluble vitamins have not been reported. Volume overload is a possibility resulting in pulmonary however, it is rare to have an overdose reaction due to water soluble vitamins.
14. Pharmacodynamic properties
Pharmacotherapeutic Group: Vitamins
ATC Code: B05XC
Thiamine HCl (Vitamin B1): Thiamine itself has no pharmacological effects even at high doses. Therefore, in the body it is converted into thiamine pyrophosphate, a substance with pharmacological effects. Thiamine pyrophosphate is a coenzyme involved in carbohydrate metabolism, decarboxylation of alpha - ketoacid and alpha - ketoglutarate, participating in the hexose cycle. Prolonged vitamin B1 deficiency will cause beri beri with symptoms such as muscle fatigue, muscle weakness, and inflammation of peripheral nerves. More severe cases can lead to heart failure and edema, personality disorders, depression, poor memory, and Wernicke's encephalopathy.
- Pyridoxine HCl (Vitamin B6): Pyridoxine HCl is one of three forms of vitamin B6, they will be transformed into pyridoxal phosphate and pyridoxamine phosphate after entering the body. These are two coenzymes that play a major role in Amino acid metabolism . In addition, it also participates in carbohydrate and fat metabolism, participates in the synthesis of hemoglobin and GABA in the central nervous system.
Vitamin B6 needs for children are 0.3 - 2mg/day, adults are 1.6 - 2mg/day and pregnant and lactating women are 2.1 - 2/2mg/day. Most bodies already absorb enough vitamin B6 through their diet. However, deficiency can occur in subjects with absorption disorders and metabolic disorders. When the body lacks vitamin B6, it can lead to dermatitis, glossitis, itching, and neurological disorders.
- Cyanocobalamin (Vitamin B12): Cyanocobalamin is one of two forms of vitamin B12 - a vitamin that has blood-forming effects. After being absorbed into the body, they are converted into Methylcobalamin and 5-deoxyadenosylcobalamin, two coenzymes that play an important role in cell replication and growth, especially for cells with strong growth rates such as hematopoietic tissue, small intestine, uterus. In particular, methylcobalamin is necessary to create methionine from homocysteine, while 5-deoxyadenosylcobalamin plays a role in the process of converting L-methylmalonyl CoA to succinyl CoA. Therefore, lack of Vitamin B12 will cause hematological abnormalities, impaired function of some essential forms of Folic Acid in cells, and demyelination of nerve fibers.
15. Pharmacokinetic properties
- Thiamine HCl (Vitamin B1): Thiamine is rapidly absorbed after intramuscular injection and then quickly widely distributed into body tissues and into breast milk. The drug is excreted in urine in intact or metabolized form.
- Pyridoxine HCl (Vitamin B6): After injection, pyridoxine is rapidly absorbed and converted into the active form pyridoxal phosphate. Pyridoxal phosphate is stored mainly in the liver, then metabolized to 4-pyridoxic acid and other inactive metabolites and finally excreted mainly through the kidneys. Pyridoxine crosses the placenta and enters breast milk.
- Cyanocobalamin (Vitamin B12): The drug is quickly absorbed after intramuscular injection and reaches maximum concentration in the blood after about 1 hour. The drug then binds to plasma proteins to leave the blood and distribute to tissues. The drug is metabolized in the liver and eliminated mainly through bile.
16. Packaging specifications
Box of 6 tubes x 3 ml with instructions for use.
17. Storage conditions, expiration date, and quality standards of the drug
Storage conditions: Cool and dry place, protected from light, temperature not exceeding 30 o C.
Expiry date: 36 monthsfrom the date of manufacture.
Quality standards of drugs: IN HOUSE
18. Name and address of the drug manufacturing facility
Euro Santé Pharmaceutical Joint Stock Company
Song Cung industrial site, Dong Thap commune, Dan Phuong district, Hanoi city, Vietnam.
