Drugs List

Therapeutic Indications

Uses

Plasma volume expansion

Administration

For intravenous infusion only.

Contraindications

Hepatic impairment
Hyperkalaemia
Metabolic alkalosis

Precautions and Warnings

Allergic disposition
Predisposition to circulatory overload
Predisposition to fluid retention
Restricted potassium intake
Restricted sodium intake
Asthma
Cardiac failure
Oliguria
Pregnancy
Pulmonary disease
Renal failure with anuria
Renal impairment
Severe coagulopathy

Monitor blood pressure
Monitor fluid and electrolyte status
Monitor for hypersensitivity reactions during infusion
Monitor haematocrit. Do not allow level to fall below 25%.
Monitor urine output
May affect results of some laboratory tests
Discontinue if anaphylactoid reaction occurs

Pregnancy and Lactation

Pregnancy

Use gelatin (with lactate and electrolytes) infusions with caution in pregnancy.

There are no or limited amount of data from the use of gelatin (with lactate and electrolytes) in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Due to possible anaphylactic reactions with consecutive foetal and neonatal distress due to maternal hypotension, the use of gelatin (with lactate and electrolytes) should be avoided during pregnancy unless the clinical condition of the woman requires treatment with the medicinal product.

Schaeffer (2007) states that no specific embryo- or foetotoxic effects have been observed to date.

Isoplex may be used in the initial treatment of blood loss during pregnancy where plasma volume replacement is needed.

The use of Geloplasma should be avoided at the end of pregnancy.

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

Gelatin (with lactate and electrolytes) is considered safe for use in breastfeeding.

Plasma and plasma substitutes will present no risk to a breastfed infant due to their molecular size and mechanism of action in expanding plasma volume.

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

Allergic skin reactions
Anaphylactic shock
Anaphylactoid reaction
Chills
Decrease in heart rate
Dyspnoea
Hypertension
Hypotension
Hypoxia
Increased bleeding tendency
Pyrexia
Respiratory difficulties
Sweating
Tachycardia
Tremor
Urticaria
Wheezing

Presentation

Infusions of gelatin (with lactate and electrolytes).

Drugs List

Therapeutic Indications

Uses

Plasma volume expansion

Dosage

Adults

Children

Administration

For intravenous infusion only.

Contraindications

Hepatic impairment
Hyperkalaemia
Metabolic alkalosis

Precautions and Warnings

Allergic disposition
Predisposition to circulatory overload
Predisposition to fluid retention
Restricted potassium intake
Restricted sodium intake
Asthma
Cardiac failure
Oliguria
Pregnancy
Pulmonary disease
Renal failure with anuria
Renal impairment
Severe coagulopathy

Monitor blood pressure
Monitor fluid and electrolyte status
Monitor for hypersensitivity reactions during infusion
Monitor haematocrit. Do not allow level to fall below 25%.
Monitor urine output
May affect results of some laboratory tests
Discontinue if anaphylactoid reaction occurs

Pregnancy and Lactation

Pregnancy

Use gelatin (with lactate and electrolytes) infusions with caution in pregnancy.

There are no or limited amount of data from the use of gelatin (with lactate and electrolytes) in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Due to possible anaphylactic reactions with consecutive foetal and neonatal distress due to maternal hypotension, the use of gelatin (with lactate and electrolytes) should be avoided during pregnancy unless the clinical condition of the woman requires treatment with the medicinal product.

Schaeffer (2007) states that no specific embryo- or foetotoxic effects have been observed to date.

Isoplex may be used in the initial treatment of blood loss during pregnancy where plasma volume replacement is needed.

The use of Geloplasma should be avoided at the end of pregnancy.

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

Gelatin (with lactate and electrolytes) is considered safe for use in breastfeeding.

Plasma and plasma substitutes will present no risk to a breastfed infant due to their molecular size and mechanism of action in expanding plasma volume.

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

Allergic skin reactions
Anaphylactic shock
Anaphylactoid reaction
Chills
Decrease in heart rate
Dyspnoea
Hypertension
Hypotension
Hypoxia
Increased bleeding tendency
Pyrexia
Respiratory difficulties
Sweating
Tachycardia
Tremor
Urticaria
Wheezing

Effects on Laboratory Tests

Laboratory blood tests such as determination of blood group or irregular antigens, are possible in patients who have received up to 2 litres of liquid gelatin however interpretation may be more difficult due to haemodilution and it may be preferable to draw a sample for these tests before starting the infusion.

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: June 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 10 June 2015.

Summary of Product Characteristics: Geloplasma solution for infusion. Fresenius Kabi Limited. Revised May 2010.

Summary of Product Characteristics: Isoplex 4% w/v Solution for Infusion. Beacon Pharmaceuticals. Revised June 2010.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 7 September 2017

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 10 June 2015