Renero 5000

Renero 5000

cyanocobalamin

Manufacturer:

PT. Infion
Full Prescribing Info
Contents
Vitamin B-complex.
Description
Each Renero 5000 IM injection ampoule I contains Thiamine Hydrochloride 100 mg and Pyridoxine Hydrochloride 100 mg.
Each Renero 5000 IM injection ampoule II contains Cyanocobalamin 5000 mcg.
Renero 5000 contains a combination of Thiamine HCl, Pyridoxine HCl, and Cyanocobalamin as active substances available as intramuscular (IM) injection. Ampoule I liquid is clear, colorless to yellow, and free from foreign particles. Ampoule II liquid is clear, red and free from foreign particles. (See table.)


Click on icon to see table/diagram/image


Excipients/Inactive Ingredients: Ampoule I: Sodium hydroxide, Water for injection.
Ampoule II: Citric acid monohydrate, Disodium hydrogen phosphate dihydrate, Hydrochloride acid, Water for injection.
Action
Pharmacology: Renero 5000 is a combination of three essential neurotropic vitamins, i.e. Thiamine HCl, Pyridoxine HCl, and Cyanocobalamin in high dosage. Thiamine HCl, Pyridoxine HCl, and Cyanocobalamin are of special importance for the metabolism in the peripheral and central nervous system. Their effect on the regeneration of nerves has been shown in various investigations using the vitamins individually and in combination. Thiamine HCl functions in carbohydrate metabolism, in human body is converted to Thiamine Pirophosphate (active form) as a coenzyme in the decarboxylation of α-keto acids.
In human body, Pyridoxine HCl will be transferred to Pyridoxine Phosphate, co-enzyme reaction in carboxylation and transamination which are involved in protein and amino acid metabolism.
Cyanocobalamin is essential in nucleic acid and myelin synthesis, for cell growth and replication and maintaining the integrity of nervous tissue.
Indications/Uses
Treatment of Thiamine HCl, Pyridoxine HCl, and Cyanocobalamin deficiency in case of beri-beri, peripheral neuritis and neuralgia.
Dosage/Direction for Use
Renero 5000 is administered by intramuscular injection.
For initial treatment of severe cases, 1 pair ampoule is given until the acute symptoms subside. For follow up therapy 2-3 pairs ampoules are given per week.
The duration of treatment is determined by the doctor.
Overdosage
Prolonged overdose of Pyridoxine HCl, i.e. for longer than 2 months and more than 1 g per day, may lead to neurotoxic effects.
Contraindications
Renero 5000 must not be used in patients hypersensitive to any of the active ingredients or excipients of the product.
Special Precautions
In the literature neuropathies are described under long-term intake (6-12 months) of more than 50 mg mean daily dose of Pyridoxine HCl. Therefore, under long-term treatment regular monitoring is recommended.
This medication is used to treat a lack of vitamins (deficiency) when the form taken by mouth cannot be used or would not work as well as the injection.
Do not share this medication with others. This product is not a substitute for a proper diet. Remember that it is best to get vitamins from healthy foods.
Use In Pregnancy & Lactation
No risks have become known associated with the use of Renero 5000 during pregnancy at the recommended dosage.
Thiamine HCl, Pyridoxine HCl, and Cyanocobalamin are secreted into human breast milk, but risks of overdose for the infant are not known. In individual cases, high doses of Pyridoxine HCl i.e. >600 mg daily, may inhibit the production of breast milk.
Adverse Reactions
Hypersensitivity reactions to Thiamine HCl or Cyanocobalamin such as sweating, tachycardia (rapid heartbeat), and skin reactions with itching and urticaria may occur.
In single cases, conditions of shock have been observed after treatment with Thiamine HCl or Cyanocobalamin injections.
Gastrointestinal complaints, such as nausea, vomiting, diarrhoea or abdominal pain may occur.
Individual cases of acne have been reported after high parenteral dose of Cyanocobalamin.
Injection site reactions may occur.
Speak to a doctor, if such symptoms or other unwanted effects occur.
Drug Interactions
L-dopa: The effect of L-dopa may be reduced when Pyridoxine HCl is administered concomitantly.
Pyridoxine HCl-antagonists, e.g. lsoniazid (INH), Cycloserine, Penicillamine, Hydralazine: The efficacy of Pyridoxine HCl may be decreased.
Loop diuretics, e.g. Furosemide: In long-term use, the blood level of Thiamine HCl may be reduced.
Caution For Usage
Incompatibility: It is not recommended to use Renero 5000 injection solution together with other medicinal products in a "mixed injection" or infusion.
Thiamine HCl is completely degraded sulfite-containing infusion solutions.
Other vitamins, especially Cyanocobalamin, may be inactivated in the presence of Thiamine HCl degradation products.
Storage
Store below 30°C, protect from light.
MIMS Class
Vitamin B-Complex / with C
ATC Classification
A11DB - Vitamin B1 in combination with vitamin B6 and/or vitamin B12 ; Used as dietary supplements.
Presentation/Packing
Form
Renero 5000 inj
Packing/Price
((1 mL) Amp 2) 12's
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