- Approval Id
- 5408e0af364b56d2
- Drug Approval Emc Name
- Vitamin B&C High Potency, Concentrate for solution for infusion
- Drug Name
- Vitamin B&C High Potency, Concentrate for solution for infusion
- Company Name
- Aspire Pharma Ltd
- Company Address
- 4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
- Company Website
- http://www.aspirepharma.co.uk
- Company Telephone
- +44 (0)1730 231148
- Company Medical Info Direct Line
- +44 (0)1730 231148
- Company Customer Care Direct Line
- +44 (0)1730 231148
- Atc Code
- A11EB
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
- Authorisation Number
- PL 35533/0195
- Authorisation Date
- 16/08/2024
- Instruction Authorisation Holder
- Aspire Pharma Limited
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
- Instruction Authorisation Number
- PL 35533/0195
- Instruction Authorisation Date
- 16/08/2024
- Instruction Composition
- Each carton contains pairs of 5 ml ampoules. Each pair of ampoules to be used in treatment is labelled No. 1 and No. 2.
| | | |
| --- | --- | --- |
| Each No. 1 ampoule contains: | 5 ml ampoule | |
| Thiamine Hydrochloride | 250 mg | |
| Riboflavin (as Sodium Phosphate Hydrate) | 4 mg | |
| Pyridoxine Hydrochloride | 50 mg | |
| Each No. 2 ampoule contains: | 5 ml ampoule | |
| Ascorbic Acid | 500 mg | |
| Nicotinamide | 160 mg | |
| Glucose (as Monohydrate) | 1000 mg | |
\*\*Excipients with known effect:\*\*
This medicinal product contains 79 mg sodium per 1 pair of 5 ml ampoules, equivalent to 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Concentrate for Solution for Infusion
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
This medicine is indicated in adults and children for rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C:
• particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy
• after acute infections
• post-operatively
• in psychiatric states
Also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.4.2 Posology and method of administration
\*Adults and elderly:\*
\*Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy\*
| | | |
| --- | --- | --- |
| \*\*10 ml solution from Ampoule Number 1\*\* | PLUS | \*\*10 ml solution from Ampoule Number 2\*\* |
| OR | | |
| \*\*15 ml solution from Ampoule Number 1\*\* | PLUS | \*\*15 ml solution from Ampoule Number 2\*\* |
2 to 3 pairs of 5 ml ampoules (1 pair = ampoule 1 + ampoule 2) diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) and administered over 30 minutes every 8 hours, or at the discretion of the physician.
\*Psychosis following narcosis or E.C.T; toxicity from acute infections\*
| | | |
| --- | --- | --- |
| \*\*5 ml Ampoule Number 1\*\* | PLUS | \*\*5 ml Ampoule Number 2\*\* |
1 pair of 5 ml ampoules diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) administered over 30 minutes twice daily for up to 7 days.
\*Haemodialysis\*
| | | |
| --- | --- | --- |
| \*\*5 ml Ampoule Number 1\*\* | PLUS | \*\*5 ml Ampoule Number 2\*\* |
1 pair of 5 ml ampoules diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) administered over 30 minutes once every two weeks at the end of dialysis.
\*Paediatric population\*
This medicine is rarely indicated for administration to children; however, suitable doses are as follows:
| | |
| --- | --- |
| Under 6 years | quarter of the adult dose |
| 6 - 10 years | third of the adult dose |
| 10 - 14 years | half to two thirds of the adult dose |
| 14 years and over | as for the adult dose |
\*Method of administration\*
Dilute before use.
This medicine should be administered by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50 ml to 100 ml physiological saline or 5% glucose and infused over 30 minutes (see sections 6.3 and 6.6).4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of this medicine, such rare occurrence of serious allergic reactions should not preclude the use of this medicine in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential.
Initial warning signs of a reaction to this medicine are sneezing or mild asthma and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever this medicine is administered. To minimise the risk of such events with this medicine this medicinal product should be administered by infusion over a period of 30 minutes.
\*\*This medicine is for injection into a vein only and should not be given by any other route.\*\*
Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended - reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.
In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.4.5 Interaction with other medicinal products and other forms of interaction
The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.4.6 Fertility, pregnancy and lactation
No adverse effects have been reported at recommended doses when used as clinically indicated.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Caution should be exercised when prescribing to pregnant women.4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However given the nature of the product, no effects are anticipated.4.8 Undesirable effects
Adverse reactions reported as possibly associated to this medicine are presented in the following table by MedDRA System Organ Class (SOC), Preferred Term and frequency. The following frequency categories are used:
Very common (>1/10);
Common (>1/100, <1/10);
Uncommon (>1/1,000, <1/100);
Rare (>1/10,000, <1/1,000);
Very rare (<1/10,000), including isolated reports.
Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure. Therefore it is not possible to estimate the true incidence of adverse reactions and the frequency is “unknown”.
\*\*Tabulated summary of adverse reactions\*\*
| | | |
| --- | --- | --- |
| \*\*SYSTEM ORGAN CLASS (SOC)\*\* | \*\*FREQUENCY\*\* | \*\*ADVERSE REACTION\*\* |
| \*\*Immune system disorders\*\* | Unknown | Hypersensitivity (including anaphylaxis, rash and urticaria) |
| \*\*Nervous system disorders\*\* | Unknown | Paraesthesia |
| \*\*Vascular disorders\*\* | Unknown | Hypotension |
| \*\*General disorders and administration site conditions\*\* | Unknown | Injection site reactions (including pain and swelling) |
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
In the unlikely event of over dosage, treatment is symptomatic and supportive.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
This medicine contains vitamins B1, B2, B6, nicotinamide, vitamin C and glucose.
ATC code: A11EB5.2 Pharmacokinetic properties
Not supplied.5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Edetic acid
Sodium hydroxide
Water for Injections6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.6.3 Shelf life
Before opening:
2 years
After opening:
Chemical and physical in-use stability of intravenous high potency vitamins B and C has been demonstrated in the following intravenous infusion fluids for the number of hours stated in the table below, at room temperature:
| | |
| --- | --- |
| \*\*Intravenous infusion fluid\*\* | \*\*In the light\*\* |
| Glucose 5% | 7 hours |
| Physiological saline (sodium chloride 0.9%) | 7 hours |
| Glucose 4.3% with sodium chloride 0.18% | 4 hours |
| Glucose 5% with potassium chloride 0.3% | 4 hours |
| Compound sodium lactate | 7 hours |
Although no further specific data are available, the solutions are expected to be stable for longer periods when protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
The diluted solutions should not be frozen.6.4 Special precautions for storage
Do not store above 25°C. Keep the container in the outer carton. Do not freeze. For storage conditions after dilution of the medicinal product, see section 6.3.6.5 Nature and contents of container
This medicine is supplied in pairs of amber glass ampoules of 5 ml. Packs contain either six or ten pairs of 5 ml ampoules.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
Compatibility of this medicine has been demonstrated with the following infusion fluids:
• Glucose 5%
• Physiological saline (sodium chloride 0.9%)
• Glucose 4.3% with sodium chloride 0.18%
• Glucose 5% with potassium chloride 0.3%
• Compound sodium lactate
Please refer to section 6.3 for details regarding storage following dilution in each of these fluids.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
Each carton contains pairs of 5 ml ampoules. Each pair of ampoules to be used in treatment is labelled No. 1 and No. 2.
| | | |
| --- | --- | --- |
| Each No. 1 ampoule contains: | 5 ml ampoule | |
| Thiamine Hydrochloride | 250 mg | |
| Riboflavin (as Sodium Phosphate Hydrate) | 4 mg | |
| Pyridoxine Hydrochloride | 50 mg | |
| Each No. 2 ampoule contains: | 5 ml ampoule | |
| Ascorbic Acid | 500 mg | |
| Nicotinamide | 160 mg | |
| Glucose (as Monohydrate) | 1000 mg | |
\*\*Excipients with known effect:\*\*
This medicinal product contains 79 mg sodium per 1 pair of 5 ml ampoules, equivalent to 4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Concentrate for Solution for Infusion
## Clinical Particulars
4.1 Therapeutic indications
This medicine is indicated in adults and children for rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C:
• particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy
• after acute infections
• post-operatively
• in psychiatric states
Also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.4.2 Posology and method of administration
\*Adults and elderly:\*
\*Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy\*
| | | |
| --- | --- | --- |
| \*\*10 ml solution from Ampoule Number 1\*\* | PLUS | \*\*10 ml solution from Ampoule Number 2\*\* |
| OR | | |
| \*\*15 ml solution from Ampoule Number 1\*\* | PLUS | \*\*15 ml solution from Ampoule Number 2\*\* |
2 to 3 pairs of 5 ml ampoules (1 pair = ampoule 1 + ampoule 2) diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) and administered over 30 minutes every 8 hours, or at the discretion of the physician.
\*Psychosis following narcosis or E.C.T; toxicity from acute infections\*
| | | |
| --- | --- | --- |
| \*\*5 ml Ampoule Number 1\*\* | PLUS | \*\*5 ml Ampoule Number 2\*\* |
1 pair of 5 ml ampoules diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) administered over 30 minutes twice daily for up to 7 days.
\*Haemodialysis\*
| | | |
| --- | --- | --- |
| \*\*5 ml Ampoule Number 1\*\* | PLUS | \*\*5 ml Ampoule Number 2\*\* |
1 pair of 5 ml ampoules diluted with 50 ml to 100 ml infusion solution (physiological saline or glucose 5%) administered over 30 minutes once every two weeks at the end of dialysis.
\*Paediatric population\*
This medicine is rarely indicated for administration to children; however, suitable doses are as follows:
| | |
| --- | --- |
| Under 6 years | quarter of the adult dose |
| 6 - 10 years | third of the adult dose |
| 10 - 14 years | half to two thirds of the adult dose |
| 14 years and over | as for the adult dose |
\*Method of administration\*
Dilute before use.
This medicine should be administered by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50 ml to 100 ml physiological saline or 5% glucose and infused over 30 minutes (see sections 6.3 and 6.6).4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of this medicine, such rare occurrence of serious allergic reactions should not preclude the use of this medicine in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential.
Initial warning signs of a reaction to this medicine are sneezing or mild asthma and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever this medicine is administered. To minimise the risk of such events with this medicine this medicinal product should be administered by infusion over a period of 30 minutes.
\*\*This medicine is for injection into a vein only and should not be given by any other route.\*\*
Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended - reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.
In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.4.5 Interaction with other medicinal products and other forms of interaction
The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.4.6 Fertility, pregnancy and lactation
No adverse effects have been reported at recommended doses when used as clinically indicated.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Caution should be exercised when prescribing to pregnant women.4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However given the nature of the product, no effects are anticipated.4.8 Undesirable effects
Adverse reactions reported as possibly associated to this medicine are presented in the following table by MedDRA System Organ Class (SOC), Preferred Term and frequency. The following frequency categories are used:
Very common (>1/10);
Common (>1/100, <1/10);
Uncommon (>1/1,000, <1/100);
Rare (>1/10,000, <1/1,000);
Very rare (<1/10,000), including isolated reports.
Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure. Therefore it is not possible to estimate the true incidence of adverse reactions and the frequency is “unknown”.
\*\*Tabulated summary of adverse reactions\*\*
| | | |
| --- | --- | --- |
| \*\*SYSTEM ORGAN CLASS (SOC)\*\* | \*\*FREQUENCY\*\* | \*\*ADVERSE REACTION\*\* |
| \*\*Immune system disorders\*\* | Unknown | Hypersensitivity (including anaphylaxis, rash and urticaria) |
| \*\*Nervous system disorders\*\* | Unknown | Paraesthesia |
| \*\*Vascular disorders\*\* | Unknown | Hypotension |
| \*\*General disorders and administration site conditions\*\* | Unknown | Injection site reactions (including pain and swelling) |
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
In the unlikely event of over dosage, treatment is symptomatic and supportive.
## Pharmacological Properties
5.1 Pharmacodynamic properties
This medicine contains vitamins B1, B2, B6, nicotinamide, vitamin C and glucose.
ATC code: A11EB5.2 Pharmacokinetic properties
Not supplied.5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
## Pharmaceutical Particulars
6.1 List of excipients
Edetic acid
Sodium hydroxide
Water for Injections6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.6.3 Shelf life
Before opening:
2 years
After opening:
Chemical and physical in-use stability of intravenous high potency vitamins B and C has been demonstrated in the following intravenous infusion fluids for the number of hours stated in the table below, at room temperature:
| | |
| --- | --- |
| \*\*Intravenous infusion fluid\*\* | \*\*In the light\*\* |
| Glucose 5% | 7 hours |
| Physiological saline (sodium chloride 0.9%) | 7 hours |
| Glucose 4.3% with sodium chloride 0.18% | 4 hours |
| Glucose 5% with potassium chloride 0.3% | 4 hours |
| Compound sodium lactate | 7 hours |
Although no further specific data are available, the solutions are expected to be stable for longer periods when protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
The diluted solutions should not be frozen.6.4 Special precautions for storage
Do not store above 25°C. Keep the container in the outer carton. Do not freeze. For storage conditions after dilution of the medicinal product, see section 6.3.6.5 Nature and contents of container
This medicine is supplied in pairs of amber glass ampoules of 5 ml. Packs contain either six or ten pairs of 5 ml ampoules.
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
Compatibility of this medicine has been demonstrated with the following infusion fluids:
• Glucose 5%
• Physiological saline (sodium chloride 0.9%)
• Glucose 4.3% with sodium chloride 0.18%
• Glucose 5% with potassium chloride 0.3%
• Compound sodium lactate
Please refer to section 6.3 for details regarding storage following dilution in each of these fluids.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
