Promit®
`
`dextran 1
`
`Consumer Medicine Information
`
`1. Identification
`
`Promit® is an aqueous (water based)
`solution which contains dextran 1 (a
`sugar like material) and sodium
`chloride (salt). Promit is
`administered intravenously (into a
`vein, usually in the arm) and supplied
`in a 20 mL single dose polypropylene
`ampoule which contains 3 grams of
`dextran 1 and 120 mg of sodium
`chloride dissolved in water for
`injection. Each 20 mL (4
`teaspoonsful) ampoule is equivalent
`to one dose.
`
`Australian Registration Number
`80038
`
`2. What Promit® is used
`for and how it works
`
`Promit® is used to diminish the
`chance of patients suffering a severe
`allergic reaction to dextran- based
`fluids, such as dextran 40 or dextran
`70. When given before a dose one of
`these fluids, Promit dramatically
`reduces the chance of a patient
`suffering a severe reaction. Promit
`does not completely eliminate the
`chance of a reaction occurring
`(approximately 1/ 27000). Since
`Promit is also a dextran containing
`product, there is also a small risk of
`an allergic reaction from this product.
`
`Dextran 40 and dextran 70 are
`intravenous fluids which may be
`administered in large volumes
`(500mL) in cases of serious injury or
`during surgical procedures. In rare
`cases a patient may suffer allergic
`reactions to these dextran based
`products. Patients with an allergic
`sensitivity to dextran products have
`antibodies in their blood which can
`bind to dextran and form allergenic
`(allergic) complexes. When a
`sensitive patient is given Promit , the
`antibodies in their blood are belived
`to bind to the Promit instead and
`form inactive complexes. Because of
`this, if these patients are given either
`dextran 40 or dextran 70, there are
`less antibodies left in their blood to
`react with these dextran based fluids.
`
`Not all patients have an allergic
`sensitivity to dextran based fluids.
`Because it is not possible to
`definitely identify which patients are
`at risk of an allergic reaction to
`dextran based fluids your doctor may
`administer Promit as a precaution
`before using these fluids.
`
`3. Advice before using
`Promit®
`
`Since products such as Promit are
`only administered in a hospital
`setting your doctor will decide
`whether you will need an injection of
`a dextran based solution and
`therefore a pre- injection of Promit.
`
`However, Promit or any other
`dextran based product should not
`be given to patients with certain
`conditions and you should tell your
`doctor if you have ever had a
`reaction to a product containing
`dextran, have any type of:
`
`bleeding disorder
`take any blood thinning drugs
`have any heart or kidney disease
`You should also tell your doctor if
`you know or believe you may be
`pregnant or if you are currently
`breast feeding.
`
`4. How to use Promit®
`properly
`
`Promit is a prescription only medical
`product and is only administered
`under a doctor's supervision in a
`hospital setting. Only one injection of
`Promit is usually required. However,
`if more than 48 hours (2 days) passes
`between doses of a large volume
`dextran based solution, another pre-
`injection of Promit is needed.
`
`5. Further information
`
`Promit is a prescription only medical
`product.
`
`Promit®
`
`Published by MIMS/myDr April 2005
`
`1
`
`Pharmacosmos, Exh. 1027, p. 1
`
`

`
`9. Where to go for
`further information
`
`If you need further information on
`how or why Promit is used, possible
`unwanted effects or have any other
`questions you should contact your
`doctor, the marketing authorisation
`holder of the product Pharmalink AB
`(phone + 46 8 587 718 00) or the
`sponsor Medical Specialties
`Australia Pty Limited (phone 02
`9417 7955).
`
`10. Name and address
`of the Australian
`sponsor of the
`medicinal product
`
`Medical Specialties Australia Pty
`limited,
`ACN 003 624 155; ABN 75 880 043
`044;
`2 McCabe Place, Willoughby, NSW
`2068.
`
`11. Date of Information
`
`7 February 2003
`
`6. Unwanted effects
`
`As with any medicinal product
`unwanted effects can occur. Promit
`can, in rare cases, cause an
`anaphylactic (allergic) reaction.
`Other unwanted effects which have
`been associated with the use of
`Promit include hypotension (low
`blood pressure), bradycardia (slow
`heart rate), broncho spasm
`(temporary constriction of the
`bronchi, an air passage in the lung),
`fever, vomiting, dyspnoea (breathing
`difficulty), flushing, coughing, rash,
`pruritus (itching), tachycardia (rapid
`heart rate) and facial oedema (facial
`swelling).
`
`Your doctor is familiar with these
`possible unwanted effects and will
`carefully monitor your condition.
`However if you experience any
`unwanted effects even if it is not
`listed above you should tell your
`doctor.
`
`7. In case of overdose
`
`In the majority of cases only a single
`20 mL dose of Promit is used under
`medical supervision. This is much
`lower than the dose of Promit safely
`tolerated in clinical studies, and the
`risk of overdose is minimal.
`
`8. Storage conditions
`
`The Promit you will receive will be
`stored by the hospital pharmacy at
`the temperature recommended by the
`manufacturer, at or below 25 deg C
`and will be protected from freezing.
`Before use the solution will be
`examined by your doctor or nurse for
`any visible signs of deterioration and
`the expiry date checked.
`
`Promit®
`
`Published by MIMS/myDr April 2005
`
`2
`
`Pharmacosmos, Exh. 1027, p. 2