Drugs List

Therapeutic Indications

Uses

Plasma volume expansion

Administration

For intravenous infusion only.

Contraindications

Hyperkalaemia

Precautions and Warnings

Allergic disposition
Children under 18 years
Predisposition to circulatory overload
Predisposition to fluid retention
Restricted potassium intake
Restricted sodium intake
Asthma
Breastfeeding
Cardiac disorder
Cardiac failure
Hypertension
Oliguria
Pregnancy
Pulmonary oedema
Renal failure with anuria
Severe coagulopathy
Severe renal impairment

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

Pregnancy and Lactation

Pregnancy

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

There are no or limited amount of data from the use of gelatin (with acetate 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 acetate 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.

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

Use gelatin (with acetate and electrolytes) infusions with caution in breastfeeding.

The UK Drugs in Lactation Advisory Service states that 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. However, since risk to the suckling child cannot be excluded the manufacturer recommends making a decision whether to discontinue breastfeeding or discontinue therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

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

Abdominal pain
Allergic skin reactions
Anaphylactoid reaction
Angioedema
Chills
Collapse
Confusion
Cyanosis
Diaphoresis
Dizziness
Dyspnoea
Fever
Hypotension
Incontinence
Increased bleeding tendency
Loss of consciousness (transient)
Nausea
Oedema
Periorbital oedema
Respiratory difficulties
Rise in body temperature
Stridor
Tachycardia
Tightness of chest and/or throat
Urticaria
Vomiting
Wheezing

Presentation

Infusions of gelatin (with acetate and electrolytes)

Drugs List

Therapeutic Indications

Uses

Plasma volume expansion

Dosage

Adults

Elderly

Administration

For intravenous infusion only.

Contraindications

Hyperkalaemia

Precautions and Warnings

Allergic disposition
Children under 18 years
Predisposition to circulatory overload
Predisposition to fluid retention
Restricted potassium intake
Restricted sodium intake
Asthma
Breastfeeding
Cardiac disorder
Cardiac failure
Hypertension
Oliguria
Pregnancy
Pulmonary oedema
Renal failure with anuria
Severe coagulopathy
Severe renal impairment

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

Pregnancy and Lactation

Pregnancy

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

There are no or limited amount of data from the use of gelatin (with acetate 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 acetate 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.

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

Use gelatin (with acetate and electrolytes) infusions with caution in breastfeeding.

The UK Drugs in Lactation Advisory Service states that 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. However, since risk to the suckling child cannot be excluded the manufacturer recommends making a decision whether to discontinue breastfeeding or discontinue therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

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

Abdominal pain
Allergic skin reactions
Anaphylactoid reaction
Angioedema
Chills
Collapse
Confusion
Cyanosis
Diaphoresis
Dizziness
Dyspnoea
Fever
Hypotension
Incontinence
Increased bleeding tendency
Loss of consciousness (transient)
Nausea
Oedema
Periorbital oedema
Respiratory difficulties
Rise in body temperature
Stridor
Tachycardia
Tightness of chest and/or throat
Urticaria
Vomiting
Wheezing

Effects on Laboratory Tests

Laboratory blood tests such as determination of blood group or irregular antigens, are possible in patients who have received infusions of 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.

Gelatin (with acetate and electrolytes) may have an influence on the following:
Erythrocyte sedimentation rate
Specific gravity of urine
Unspecific protein assays, e.g. the biuret method

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.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 10 June 2015.

Summary of Product Characteristics: Gelaspan solution for infusion. B Braun Melsungen AG. Revised December 2014.

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