SUMMARY CMI

FISONS PROTAMINE SULFATE^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I being given FISONS PROTAMINE SULFATE?

FISONS PROTAMINE SULFATE contains the active ingredient protamine sulfate. FISONS PROTAMINE SULFATE is used to counteract the effect of heparin. It is given when there is excessive bleeding from heparin administration.

For more information, see Section 1. Why am I being given FISONS PROTAMINE SULFATE? in the full CMI.

2. What should I know before I am given FISONS PROTAMINE SULFATE?

Do not use if you have ever had an allergic reaction to protamine sulfate or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I am given FISONS PROTAMINE SULFATE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FISONS PROTAMINE SULFATE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is FISONS PROTAMINE SULFATE given?

• FISONS PROTAMINE SULFATE is injected or infused into a blood vessel.
• The dose your doctor gives you of FISONS PROTAMINE SULFATE will depend on the amount of heparin that needs to be neutralised.

More instructions can be found in Section 4. How is FISONS PROTAMINE SULFATE given? in the full CMI.

5. What should I know while using FISONS PROTAMINE SULFATE?

For more information, see Section 5. What should I know while using FISONS PROTAMINE SULFATE? in the full CMI.

6. Are there any side effects?

Less serious side effects include bleeding and bruising, dizziness, flushing and/or a feeling of warmth, back pain, nausea, vomiting, weakness or generally feeling unwell. Serious side effects include signs of allergic reaction (e.g. shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin), bleeding, coughing up blood, slow or abnormal heartbeats.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

FISONS PROTAMINE SULFATE^®

Active ingredient(s): protamine sulfate

Consumer Medicine Information (CMI)

This leaflet provides important information about using FISONS PROTAMINE SULFATE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using FISONS PROTAMINE SULFATE.

Where to find information in this leaflet:

1. Why am I being given FISONS PROTAMINE SULFATE?
2. What should I know before I am given FISONS PROTAMINE SULFATE?
3. What if I am taking other medicines?
4. How is FISONS PROTAMINE SULFATE given?
5. What should I know while using FISONS PROTAMINE SULFATE?
6. Are there any side effects?
7. Product details

1. Why am I being given FISONS PROTAMINE SULFATE?

FISONS PROTAMINE SULFATE contains the active ingredient protamine sulfate. Protamine sulfate is a protein used to counteract the effect of heparin. Heparin is used to prevent blood clots from forming.

FISONS PROTAMINE SULFATE is given in hospitals when there is excessive bleeding from heparin administration before and after surgery or after dialysis.

2. What should I know before I am given FISONS PROTAMINE SULFATE?

Warnings

You should not be given FISONS PROTAMINE SULFATE if:

• you are allergic to protamine sulfate, protamine contained in insulin NPH (Neutral Protamine Hagedorn), or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• are allergic to any other medicines, or substances, such as foods, in particular fish, preservatives or dyes
• take any medicines for any other condition
• have or have had diabetes and you have received protamine insulin
• have any other medical conditions.

Tell your doctor if you:

• have had heart surgery
• are male and have had a vasectomy or are infertile.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Your doctor will discuss the possible risks and benefits of using FISONS PROTAMINE SULFATE during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is not known whether FISONS PROTAMINE SULFATE passes into breast milk. Therefore, it should not be given during breastfeeding.

Children

FISONS PROTAMINE SULFATE is not recommended for use in children.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect FISONS PROTAMINE SULFATE.

4. How is FISONS PROTAMINE SULFATE given?

How much is given

FISONS PROTAMINE SULFATE is injected or infused into a blood vessel. The dose your doctor gives you of FISONS PROTAMINE SULFATE will depend on the amount of heparin that needs to be neutralised.

If you are given too much FISONS PROTAMINE SULFATE

As FISONS PROTAMINE SULFATE is given to you in hospital under the supervision of a healthcare professional, it is very unlikely that you will receive an overdose. Symptoms of a protamine sulfate overdose include low blood pressure, slow heartbeat, nausea, vomiting, fatigue, temporary flushing, and difficulty breathing with a sensation of warmth. If you think that you have been given much FISONS PROTAMINE SULFATE, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using FISONS PROTAMINE SULFATE?

Things you should do

Tell your doctor or nurse straight away if you:

• develop itching with swelling or skin rash, difficulty breathing, dizziness or abnormal heart beats while you are receiving FISONS PROTAMINE SULFATE.

Looking after your medicine

PROTAMINE SULFATE should be stored in the pharmacy or on the ward. The injection should be kept where the temperature stays below 25°C.

It will be kept where young children cannot reach it.

The expiry date will be checked by your doctor, nurse or pharmacist that it has not passed.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What FISONS PROTAMINE SULFATE contains

Do not receive this medicine if you are allergic to any of these ingredients.

What FISONS PROTAMINE SULFATE looks like

FISONS PROTAMINE SULFATE is a clear, colourless solution in a clear glass ampoule (Aust R 27971).

Who distributes FISONS PROTAMINE SULFATE

Distributed by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Email: [email protected]

This leaflet was prepared in November 2024.

protamine-ccsiv1-cmiv5-12nov24

Published by MIMS February 2025

1 Name of Medicine

Fisons Protamine Sulfate solution for injection.

2 Qualitative and Quantitative Composition

A sterile, pyrogen-free, clear, colourless 1% solution of Protamine Sulfate (Salmine) in Sodium Chloride Intravenous Infusion B.P. (0.9% w/v) adjusted to a pH of 2.5 to 3.5 and supplied in 5 mL glass ampoules.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

See Section 2 Qualitative and Quantitative Composition.

4 Clinical Particulars

4.1 Therapeutic Indications

Protamine is a basic protein which combines with heparin to form a stable, inactive complex. It is used to counteract the anticoagulant effect of heparin before surgery; after renal dialysis; after open-heart surgery; if excessive bleeding occurs and when an overdose has inadvertently been given.

4.2 Dose and Method of Administration

Fisons Protamine Sulfate Injection should be administered by slow intravenous injection over a period of about 10 minutes. The dose is dependent on the amount of heparin to be neutralised. 1 mg of Fisons Protamine Sulfate will usually neutralise at least 100 international units of mucous heparin or 80 units of lung heparin. Since heparin is being continuously excreted, the dose of Fisons Protamine Sulfate should be reduced if more than 15 minutes have elapsed since the heparin injection. Ideally, the dose required to neutralise the action of heparin should be calculated from the results of determinations of the amount required to produce an acceptable blood clotting time in the patient. In gross excess, protamine itself acts as an anticoagulant.

4.3 Contraindications

Hypersensitivity to protamine (including protamine contained in insulin NPH [Neutral Protamine Hagedorn]) or to any excipients.

4.4 Special Warnings and Precautions for Use

Too rapid administration of protamine sulfate may cause severe hypotension and anaphylactoid reactions. Rapid administration may also influence the severity of symptoms in a sensitized individual. For this reason, protamine sulfate should be administered by slow intravenous injection over a period of about 10 minutes. Facilities for resuscitation and treatment of shock should be available.
Not more than 50 mg Fisons Protamine Sulfate (5 mL) - 1 ampoule should be given at any one time. Protamine is not suitable for reversing the effect of oral anticoagulants.
Fatal cases of anaphylactic reactions have been reported. Caution should be observed when administering protamine sulfate to patients who may be at increased risk of allergic reaction to protamine. These patients include those who have previously undergone procedures such as coronary angioplasty or cardiopulmonary bypass, which may include use of protamine, diabetics who have been treated with protamine insulin, patients allergic to fish, and men who have had a vasectomy or are infertile and may have antibodies to protamine.
Patients undergoing prolonged procedures involving repeated doses of protamine should be subject to careful monitoring of clotting parameters. A rebound bleeding effect may occur up to 18 hours post-operatively which responds to further doses of protamine.
To ensure sufficient neutralisation, careful monitoring of clotting parameters is necessary.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

When used at doses in excess of that required to neutralise the anticoagulant effect of heparin, protamine sulfate exerts its own anticoagulant effect.
Following injection of protamine sulfate the following effects have been observed:

Blood and lymphatic system disorders.

Cardiac disorders.

Immune system disorders.

Vascular disorders.

Respiratory, thoracic and mediastinal disorders.

Injury, poisoning and procedural complications.

Gastrointestinal disorders.

Musculoskeletal and connective tissue disorder.

General disorders and administration site conditions.

Reporting suspected adverse reactions.

4.9 Overdose

Protamine overdose causes a haemorrhagic syndrome because of the anticoagulant activity of protamine.

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, hydrochloric acid, sodium hydroxide, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

10 X 5 mL ampoules: 10 mg/mL.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes