Drugs List

Therapeutic Indications

Uses

Malnutrition
Parenteral nutritional support
Supplement in malabsorption syndromes

Administration

By slow intravenous injection over at least 10 minutes or by intravenous infusion in a solution of 5% glucose or 0.9% sodium chloride solution for infusion.

Contraindications

Children under 11 years
Hypervitaminosis A
Hypervitaminosis D
Restricted sodium intake
Breastfeeding
Hypersensitivity to arachis oil (peanuts)

Precautions and Warnings

Hepatic impairment
Pregnancy
Renal impairment

Contains more than 1 mmol (23 mg) sodium per dose
Contains soya or soya derivative
This preparation does not contain vitamin K
Do not mix with other drugs/substances unless compatibility known
Injection should be given by slow injection over not less than 10 minutes
Resuscitation facilities must be immediately available
Assess vitamin B12 status prior to administration
Monitor fat soluble vitamins during long term therapy
Monitor hepatic function
May cause anaphylactic / anaphylactoid reactions
May affect results of some laboratory tests
Discontinue if severe hypersensitivity reactions occur

Refeeding syndrome may result in severely undernourished patients. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent it. Should nutrient deficiencies occur, appropriate supplementation may be necessary.

Monitoring of hepatic function is recommended and closely in patients with hepatic jaundice or other evidence of cholestasis.

Hepatobiliary disorders including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis are known to develop in some patients on parenteral nutrition. Patients developing abnormal laboratory parameters or other signs of hepatobiliary disorders should be assessed early in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.

Patients with hepatic impairment may need individualised vitamin supplementation because the presence of liver disease is associated with increased susceptibility to vitamin A toxicity.

Patients with renal impairment may need individualised vitamin supplementation, depending on the degree of impairment and the presence of concomitant medical conditions.

In severe renal impairment ensure adequate vitamin D status is maintained and vitamin A toxicity prevented, which may develop in such patients with low-dose vitamin A supplementation or even without supplementation.

Cross-allergic reactions between soybean and peanut proteins have been observed.

Allow for vitamins from other sources.

Monitor blood vitamin concentrations in long term use to ensure maintenance of adequate levels and to avoid overdose and toxic effects.

The solution, infusion set and catheter should be periodically checked for precipitates.

Pregnancy and Lactation

Pregnancy

The preparation should be used with caution during pregnancy.

The vitamin requirements for pregnant women may exceed those of non-pregnant women. The manufacturer advises that pregnant women should follow recommended daily allowances for their condition. Careful consideration should be given to the potential risks and benefits for each specific patient before administering the preparation.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The preparation is contraindicated during breastfeeding.

The manufacturer advises that breastfeeding is not recommended because of the risk of vitamin A overdose in the neonate.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Alanine aminotransferase increased
Bile acids increased
Cardiac arrest
Chest discomfort
Diarrhoea
Dysgeusia
Epigastric discomfort
Erythema
Gamma glutamyl transferase (GGT) increased
General aches
Glutamate dehydrogenase increased
Hypersensitivity reactions
Increase in alkaline phosphatase
Increase in serum transaminases
Infusion related reaction
Local pain (injection site)
Nausea
Pruritus
Pyrexia
Rash
Respiratory distress
Retinol binding protein increased
Tachycardia
Tachypnoea
Throat tightness
Urticaria
Vitamin A increased
Vomiting

Presentation

Powder for solution for injection or infusion containing multivitamins

Drugs List

Therapeutic Indications

Uses

Malnutrition
Parenteral nutritional support
Supplement in malabsorption syndromes

Dosage

Adults

Elderly

Children

Administration

By slow intravenous injection over at least 10 minutes or by intravenous infusion in a solution of 5% glucose or 0.9% sodium chloride solution for infusion.

Contraindications

Children under 11 years
Hypervitaminosis A
Hypervitaminosis D
Restricted sodium intake
Breastfeeding
Hypersensitivity to arachis oil (peanuts)

Precautions and Warnings

Hepatic impairment
Pregnancy
Renal impairment

Contains more than 1 mmol (23 mg) sodium per dose
Contains soya or soya derivative
This preparation does not contain vitamin K
Do not mix with other drugs/substances unless compatibility known
Injection should be given by slow injection over not less than 10 minutes
Resuscitation facilities must be immediately available
Assess vitamin B12 status prior to administration
Monitor fat soluble vitamins during long term therapy
Monitor hepatic function
May cause anaphylactic / anaphylactoid reactions
May affect results of some laboratory tests
Discontinue if severe hypersensitivity reactions occur

Refeeding syndrome may result in severely undernourished patients. Careful monitoring and slowly increasing nutrient intakes while avoiding overfeeding can prevent it. Should nutrient deficiencies occur, appropriate supplementation may be necessary.

Monitoring of hepatic function is recommended and closely in patients with hepatic jaundice or other evidence of cholestasis.

Hepatobiliary disorders including cholestasis, hepatic steatosis, fibrosis and cirrhosis, possibly leading to hepatic failure, as well as cholecystitis and cholelithiasis are known to develop in some patients on parenteral nutrition. Patients developing abnormal laboratory parameters or other signs of hepatobiliary disorders should be assessed early in order to identify possible causative and contributory factors, and possible therapeutic and prophylactic interventions.

Patients with hepatic impairment may need individualised vitamin supplementation because the presence of liver disease is associated with increased susceptibility to vitamin A toxicity.

Patients with renal impairment may need individualised vitamin supplementation, depending on the degree of impairment and the presence of concomitant medical conditions.

In severe renal impairment ensure adequate vitamin D status is maintained and vitamin A toxicity prevented, which may develop in such patients with low-dose vitamin A supplementation or even without supplementation.

Cross-allergic reactions between soybean and peanut proteins have been observed.

Allow for vitamins from other sources.

Monitor blood vitamin concentrations in long term use to ensure maintenance of adequate levels and to avoid overdose and toxic effects.

The solution, infusion set and catheter should be periodically checked for precipitates.

Pregnancy and Lactation

Pregnancy

The preparation should be used with caution during pregnancy.

The vitamin requirements for pregnant women may exceed those of non-pregnant women. The manufacturer advises that pregnant women should follow recommended daily allowances for their condition. Careful consideration should be given to the potential risks and benefits for each specific patient before administering the preparation.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The preparation is contraindicated during breastfeeding.

The manufacturer advises that breastfeeding is not recommended because of the risk of vitamin A overdose in the neonate.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Alanine aminotransferase increased
Bile acids increased
Cardiac arrest
Chest discomfort
Diarrhoea
Dysgeusia
Epigastric discomfort
Erythema
Gamma glutamyl transferase (GGT) increased
General aches
Glutamate dehydrogenase increased
Hypersensitivity reactions
Increase in alkaline phosphatase
Increase in serum transaminases
Infusion related reaction
Local pain (injection site)
Nausea
Pruritus
Pyrexia
Rash
Respiratory distress
Retinol binding protein increased
Tachycardia
Tachypnoea
Throat tightness
Urticaria
Vitamin A increased
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2016

Reference Sources

Joint Formulary Committee. British National Formulary. 71st ed. London: BMJ Group and Pharmaceutical Press; 2016.

Summary of Product Characteristics: Cernevit. Baxter Healthcare Ltd. Revised March 2018.