Drugs List

Therapeutic Indications

Uses

Adjunct to haemostasis on subcutaneous tissue surfaces
Improvement of haemostasis where surgical techniques insufficient
Tissue glue in gastrointestinal anastomoses
Tissue glue in neurosurgery where contact with CSF and dura matter possible
Tissue glue in plastic, reconstructive and burn surgery

Administration

For epilesional use.

Contraindications

None known

Precautions and Warnings

Children under 18 years
Elderly
History of treatment with aprotinin
Breastfeeding
Pregnancy

Not all available brands are licensed for all indications
Treatment to be initiated and supervised by a specialist
Derived from human proteins - transmission of infective agents possible
Cover all the tissue adjacent to the site of sealing before application
Record name and batch number of administered product
Remove solutions containing alcohol/iodine/heavy metals before application
Resuscitation facilities must be immediately available
Monitor blood pressure
Anaphylactic reactions may occur following repeated administration
Management of cases of shock should follow current medical standards
Discontinue if hypersensitivity reactions occur

Any application of pressurized gas is associated with a potential risk of air or gas embolism, tissue rupture or gas entrapment with compression, which may be life-threatening.

Artiss sealant
Once thawed, use within 14 days.

Tisseel Lyo
Use within 6 hours of reconstitution.

Tisseel Ready to use
Once thawed, use within 72 hours.

Pregnancy and Lactation

Pregnancy

Use fibrin sealant with caution in pregnancy.

The safety of fibrin sealants or haemostatics during human pregnancy has not been established.

Animal studies are not sufficient to assess safety in terms of reproduction, embryo/foetal development, gestation or peri/post natal development

No undesirable effects have been reported following the application of fibrin sealant during 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

Use fibrin sealant with caution in breastfeeding.

The safety of fibrin sealants or haemostatics during breastfeeding has not been established.

No undesirable effects have been reported following the application of fibrin sealant during lactation.

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 reaction
Anaphylactic shock
Anaphylactoid reaction
Anaphylaxis
Angioedema
Antibody formation
Bradycardia
Bronchospasm
Chest tightness
Chills
Dyspnoea
Embolism
Flushing
Headache
Hives
Hypotension
Intravascular coagulation (disseminated)
Irritation with burning (application site)
Lethargy
Nausea
Pruritus
Restlessness
Skin cysts
Skin graft failure
Tachycardia
Tingling sensation
Urticaria
Vomiting
Wheezing

Presentation

Artiss sealant
Prefilled double chamber syringe which contains sealer protein solution in one chamber and thrombin solution in the other chamber.

Tisseel Lyo sealant
A two component fibrin sealant kit consisting of:

1 vial containing powder for sealer protein solution (human)

1 vial containing thrombin powder for solution

1 vial containing aprotinin solution solvent

1 vial containing calcium chloride solution

1 kit for reconstitution and application

Tisseel Ready to use sealant
Prefilled double chamber syringe which contains sealer protein solution in one chamber and thrombin solution in the other chamber.

Drugs List

Therapeutic Indications

Uses

Adjunct to haemostasis on subcutaneous tissue surfaces
Improvement of haemostasis where surgical techniques insufficient
Tissue glue in gastrointestinal anastomoses
Tissue glue in neurosurgery where contact with CSF and dura matter possible
Tissue glue in plastic, reconstructive and burn surgery

Dosage

The required dose of fibrin sealant depends on the clinical needs of the patient, the type of surgical intervention, the size of the surface to be covered, the application method chosen and the number of applications required.

In clinical trials, individual doses have typically ranged from 0.2 to 20 ml depending on product used (see specific product literature). For some procedures, larger volumes have been used.

The initial amount applied should be sufficient to entirely cover the intended application area. The application may be repeated if necessary.

1 ml of fibrinogen solution plus 1 ml of thrombin solution will be sufficient to cover an area of at least 10 cm squared. If applied by spray application, the same quantity will be sufficient to coat considerably larger areas, depending on the specific indication and the individual case.

To avoid the formation of excess granulation tissue and to ensure gradual absorption of the solidified fibrin sealant, only a thin layer of the fibrinogen-thrombin solution or the individual components should be applied. This also avoids possible pressure on the brain, spinal cord, cranial, and/or spinal nerves.

Additional Dosage Information

Administration

For epilesional use.

Contraindications

None known

Precautions and Warnings

Children under 18 years
Elderly
History of treatment with aprotinin
Breastfeeding
Pregnancy

Not all available brands are licensed for all indications
Treatment to be initiated and supervised by a specialist
Derived from human proteins - transmission of infective agents possible
Cover all the tissue adjacent to the site of sealing before application
Record name and batch number of administered product
Remove solutions containing alcohol/iodine/heavy metals before application
Resuscitation facilities must be immediately available
Monitor blood pressure
Anaphylactic reactions may occur following repeated administration
Management of cases of shock should follow current medical standards
Discontinue if hypersensitivity reactions occur

Any application of pressurized gas is associated with a potential risk of air or gas embolism, tissue rupture or gas entrapment with compression, which may be life-threatening.

Artiss sealant
Once thawed, use within 14 days.

Tisseel Lyo
Use within 6 hours of reconstitution.

Tisseel Ready to use
Once thawed, use within 72 hours.

Pregnancy and Lactation

Pregnancy

Use fibrin sealant with caution in pregnancy.

The safety of fibrin sealants or haemostatics during human pregnancy has not been established.

Animal studies are not sufficient to assess safety in terms of reproduction, embryo/foetal development, gestation or peri/post natal development

No undesirable effects have been reported following the application of fibrin sealant during 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

Use fibrin sealant with caution in breastfeeding.

The safety of fibrin sealants or haemostatics during breastfeeding has not been established.

No undesirable effects have been reported following the application of fibrin sealant during lactation.

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 reaction
Anaphylactic shock
Anaphylactoid reaction
Anaphylaxis
Angioedema
Antibody formation
Bradycardia
Bronchospasm
Chest tightness
Chills
Dyspnoea
Embolism
Flushing
Headache
Hives
Hypotension
Intravascular coagulation (disseminated)
Irritation with burning (application site)
Lethargy
Nausea
Pruritus
Restlessness
Skin cysts
Skin graft failure
Tachycardia
Tingling sensation
Urticaria
Vomiting
Wheezing

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: April 2015

Reference Sources

Summary of Product Characteristics: Artiss Solutions for Sealant. Baxter Healthcare Ltd. Revised April 2014.

Summary of Product Characteristics: Tisseel Lyo Kit. Baxter Healthcare Ltd. Revised March 2013.

Summary of Product Characteristics: Tisseel Ready to use. Baxter Healthcare Ltd. Revised March 2013.