NEUROBION AMPOULES
Solution for Injection; multicomponent
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 ml ampoule contains: Thiamine hydrochloride (Vitamin B1) 100,0 mg Pyridoxine hydrochloride (Vitamin B6) 100,0 mg Cyanocobalamin (Vitamin B12) 1,0 mg Sugar free For a full list of excipients, see section 6.1
PHARMACEUTICAL FORM
Clear, red solution with no visible particles.
CLINICAL PARTICULARS
Therapeutic indications
NEUROBION AMPOULES are indicated for: • Restoring Vitamin B1, B6 and/or B12 levels. • The prevention and treatment of deficiencies in vitamin B1, B6 and B12. NEUROBION AMPOULES assist with the management of neuropathies.
Posology and method of administration
NEUROBION AMPOULES are preferably injected intramuscularly (deep intragluteal).
Contraindications
• Hypersensitivity to Vitamin B1, B6 and/or B12 or any of the excipients of NEUROBION AMPOULES (see section 6.1). • Children below the age of 14 years (due to the high doses of the active ingredients). NEUROBION AMPOULES should not be used in patients on Levodopa therapy.
Special warnings and precautions for use
NEUROBION AMPOULES should not be given for Vitamin B12 deficiency before a diagnosis has been fully established, because of the possibility of masking symptoms of subacute degeneration of the spinal cord. NEUROBION AMPOULES are not a suitable form of Vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of Vitamin B12. Neuropathies are described in the literature following long-term intake (6 - 12 months) of more than 50 mg mean daily dose of vitamin B6. Therefore, regular monitoring is recommended if NEUROBION AMPOULES are given over longer periods of time.
Interactions with other medicines and other forms of interaction
Fertility, pregnancy and lactation
The safety of this preparation in pregnancy and lactation has not been established. Vitamins B1, B6 and B12 (the components of NEUROBION AMPOULES) are secreted into human breast milk, but risks of overdose for the infant are not known. High doses of Vitamin B6, i.e. > 600 mg daily, may inhibit the production of breast milk. Mothers on NEUROBION AMPOULES should not breastfeed their infants.
Effects on ability to drive and use machines
No effects of the product on the ability to drive or use machines are known.
Undesirable effects
As most undesirable effects are based on post-marketing spontaneous reporting, frequency estimation is not possible. Immune system disorders Frequency not known: Hypersensitivity reactions, such as sweating, tachycardia, and skin reactions with itching and urticaria. Gastrointestinal disorders Less frequent: Gastrointestinal complaints, such as nausea, vomiting, diarrhoea and abdominal pain. Skin and subcutaneous tissue disorders Less frequent: Cases of acne or eczema have been reported after high doses of Vitamin B12. General disorders and administration site conditions Frequency not known: Injection site reactions. Renal and urinary disorders Less frequent: Chromaturia (“reddish urine”, appeared during the first 8 hours after an administration and typically resolves within 48 hours). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications:
https://www.sahpra.org.za/Publications/Index/8
Overdose
Sensorial neuropathy and other sensorial neuropathy syndromes which can be caused by long-term administration of high doses of pyridoxine improve gradually upon vitamin discontinuation.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
A.22.2 – Vitamins: Others Vitamins B1, B6 and B12 act as coenzymes and accordingly constitute substances essential for metabolism.
Pharmacokinetic properties
Combined administration of vitamins B1, B6 and B12 is not expected to have a negative effect on the pharmacokinetics of the individual vitamins. Thiamine (Vitamin B1) The biological half-life of thiamine in humans is about 9,5 to 18,5 days, with an elimination half-life of approximately 4 hours. The reserve capacity is 4 to 10 days. The high turnover rate and limited storage of thiamine (20 – 30 mg, mainly in the heart, brain, liver, and kidneys) require an adequate daily thiamine intake to meet requirements. Deficiency can present within 2 - 3 weeks of intake ceasing. Pyridoxine (Vitamin B6) Vitamin B6 is phosphorylated mainly in the liver, forming the biologically active pyridoxal phosphate. To cross cell membranes, phosphorylated Vitamin B6 must be hydrolysed by alkaline phosphatase to free Vitamin B6. Transport into the cells is by simple diffusion followed by rephosphorylation. Peak concentrations are reached after 3,5 to 4 hours. The biological half-life of pyridoxal phosphate is about 15 - 25 days with an elimination half-life of approximately 3 hours. Cyanocobalamin (Vitamin B12) About 90 % of plasma cobalamin is bound to proteins (transcobalamins). Most of the vitamin B12 not circulating in the plasma is stored in the liver. Vitamin B12 is predominantly excreted via the bile and is largely reabsorbed via the enterohepatic circulation. If the body’s storage capacity is exceeded as a result of high-dose and, in particular, parenteral administration, the portion not retained is excreted in the urine.
Preclinical safety data
Not Applicable
PHARMACEUTICAL PARTICULARS
List of excipients
Potassium cyanide, Sodium hydroxide solution
Incompatibilities
Not Applicable
Shelf life
3 years
Special precautions for storage
Store between 2 - 8 °C in a refrigerator. Keep out of reach and sight of children.
Nature and contents of container
Boxes of 3 ampoules of 3 ml each.
Special precautions for disposal and other handling
No special requirements.
We are delighted to offer free shipping on all orders over R1500.
Delivery Services:
Lifestyle Health utilises The Courier Guy and Aramex for all our deliveries within South Africa. Once your order is dispatched, you will receive a tracking number to monitor the progress of your shipment.
Order Processing:
Orders are processed during regular business hours. If an order is placed on a weekend or public holiday, it will be processed on the next business day.
Orders are dispatched within 1-2 working days.
Delivery Timeframe:
Our goal is to ensure you receive your order as quickly as possible. Orders are typically delivered within 2-5 working days, depending on the delivery location within South Africa. We strive to process all orders promptly upon receipt.
Courier delivery takes 2 – 5 working days depending on the order's destination.
• Deliveries are made Monday to Friday between 9am – 5pm.
• There are no deliveries on weekends or public holidays.
• Main city centre delivery takes 2 – 5 working days.
• With remote areas deliveries can take up to 7 working days.
• Your delivery address should be at an address where somebody you trust will be available to accept your order at any time. Anyone at the delivery address can accept the delivery. In order for us to prove that delivery of an order has been completed, we do not have to prove that you personally received the goods, but rather that any person at the delivery address signed for the delivery.
Delivery Areas
Currently, we deliver exclusively within South Africa. We are working diligently to expand our reach and hope to serve international customers in the future.
Changes to Orders
If you need to make any changes to your order, please contact us immediately. We will do our best to accommodate your request, provided the order has not yet been dispatched.
Delivery Insurance
We offer the option of delivery insurance coverage at an additional cost. (Kindly inquire for a quote). The insurance will cover any loss or damage to your shipped products. Once your delivery has been shipped we cannot accept responsibility for lost, stolen, or damaged goods in transit. Any loss or damage without insurance will be at the loss or expense of the customer, so it is advised to accept insurance coverage.
Late Deliveries
Unforeseen circumstances e.g. adverse weather, closed roads, strikes etc. could prolong the delivery time. This is rare but it does happen, so 'late' delivery is not grounds for refund or cancellation of the order. However, if your delivery has not been delivered after the estimated times shown above please contact us with your order number so that we can follow up on the matter. We will also provide you with a tracking number so you can follow your order.
Collections:
If you have selected the “collection” option on checkout. Kindly allow 1-2 working days for the order to be processed. Once the order is ready you will be notified via email or WhatsApp that your order is ready for collection.
Please take note of our trading hours, we do not accommodate any collections after hours.
The provision of goods and services by Lifestyle Health is subject to availability. In cases of unavailability, Lifestyle Health will contact the customer with alternative options.
Thank you for choosing Lifestyle Health. We appreciate your business and look forward to serving your health needs!
