Consumer medicine information

Protamine Sulfate

Protamine sulfate

BRAND INFORMATION

Brand name

Protamine Sulfate Injection BP (Solution for injection)

Active ingredient

Protamine sulfate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Protamine Sulfate.

What is in this leaflet

This leaflet answers some common questions about PROTAMINE SULFATE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of giving you PROTAMINE SULFATE against the benefits they expect it will have for you.

If you have any concerns about receiving this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What PROTAMINE SULFATE is used for

The active ingredient of PROTAMINE SULFATE is the protein protamine sulfate. Protamine sulfate is used in hospitals to counteract the effect of heparin given before and after surgery and after dialysis. Heparin is used to prevent blood clots from forming. Protamine sulfate is given when there is excessive bleeding from heparin administration.

Your doctor may have prescribed PROTAMINE SULFATE for another reason. Ask your doctor if you have any questions about why

PROTAMINE SULFATE has been prescribed for you.

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

PROTAMINE SULFATE is not recommended for use in children.

Before you are given PROTAMINE SULFATE

When you must not be given it

You must not receive PROTAMINE SULFATE if you have a severe allergy to PROTAMINE SULFATE or an allergy to any of the ingredients listed at the end of this leaflet under Product Description.

Your doctor, nurse and pharmacist will ensure that you are not given PROTAMINE SULFATE after the expiry date (EXP) printed on the pack.

If you are given this medicine after the expiry date has passed, it may not work as well.

Your doctor, nurse and pharmacist will ensure that you are not given PROTAMINE SULFATE if the packaging is torn or shows signs of tampering.

If you are not sure whether you should start being given PROTAMINE SULFATE, contact your doctor or pharmacist.

Before you are given it

Tell your doctor, nurse or pharmacist if you have allergies to:

  • any other medicines
  • any other substances, such as foods, in particular fish, preservatives or dyes

Tell your doctor, nurse or pharmacist if you are pregnant or intend to become pregnant.

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

Tell your doctor, nurse or pharmacist if you are breast-feeding or plan to breast-feed.

Your doctor or pharmacist will discuss the possible risks and benefits of using PROTAMINE SULFATE during breast-feeding.

Tell your doctor, nurse or pharmacist if you have or have had any medical conditions, especially the following:

  • Heart surgery
  • Diabetes and you have received protamine insulin
  • You are male and have had a vasectomy or are infertile.

Taking other medicines

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

How PROTAMINE SULFATE is given

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

While you are receiving PROTAMINE SULFATE

Things you must do

If you develop itching with swelling or skin rash, difficulty breathing, dizziness or abnormal heart beats while you are receiving PROTAMINE SULFATE tell your doctor or nurse immediately.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while receiving PROTAMINE SULFATE.

All medicines have side effects. Sometimes they may be serious, most of the time they are not. You may need urgent treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or nurse immediately if you notice any of the following:

  • Red or itchy skin with swelling, skin rash or difficulty breathing.

Tell your doctor or nurse if you notice any of the following and they worry you:

  • Abnormal heart beats
  • Dizziness
  • Flushing and/or a feeling of warmth
  • Back pain
  • Stomach disturbances
  • Weakness or generally feeling unwell

Other side effects not listed above may occur in some patients. Tell your doctor, nurse or pharmacist if you notice anything that is making you feel unwell.

Do not be alarmed by the list of possible side effects.

You may not experience any of them.

After using PROTAMINE SULFATE

Storage

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

Product description

What it looks like

A clear, colourless solution in a clear glass ampoule.

Ingredients

Each 5mL ampoule contains protamine sulfate 50mg, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Distributor

sanofi-aventis australia pty ltd
12-24 Talavera Road,
Macquarie Park, NSW 2113
Australia

Australian registration number:

AUST R 27971

This leaflet was prepared in May 2016.

protamine-ccsiv1-cmiv4-may16

BRAND INFORMATION

Brand name

Protamine Sulfate Injection BP (Solution for injection)

Active ingredient

Protamine sulfate

Schedule

S4

 

1 Name of Medicine

Fisons Protamine Sulfate solution for injection.

6.7 Physicochemical Properties

CAS number.

9009-65-8.

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.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

No data available.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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.

4.3 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.

No data available.

Paediatric use.

Safety and efficacy in children have not been established, therefore use in children is not recommended.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
There are limited data available from the use of protamine in pregnant women. Therefore, Fisons Protamine Sulfate is not recommended during pregnancy unless the benefit outweighs the risk.
It is unknown whether Fisons Protamine Sulfate or its metabolites are excreted in human milk. A risk to the breast-fed child cannot be excluded. Therefore, Fisons Protamine Sulfate should not be used during breast feeding.

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.

Cases of thrombocytopenia have been reported and in some cases reported with antibody formation.

Cardiac disorders.

Bradycardia, a sudden fall in blood pressure.

Immune system disorders.

Hypersensitivity reactions (including shock) and fatal anaphylaxis have been reported (see Section 4.4 Special Warnings and Precautions for Use).

Vascular disorders.

Hypotension, acute pulmonary arterial hypertension and systemic hypertension, transitory flushing and a feeling of warmth.

Respiratory, thoracic and mediastinal disorders.

Non cardiogenic pulmonary oedema, sometimes fatal has been reported. Dyspnoea.

Injury, poisoning and procedural complications.

Post procedural haemorrhage has been reported.

Gastrointestinal disorders.

Nausea and vomiting.

Musculoskeletal and connective tissue disorder.

Back pain.

General disorders and administration site conditions.

Lassitude.

Reporting suspected adverse reactions.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New Zealand).

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.

4.7 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.

4.9 Overdose

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

Symptoms.

Overdosage may cause hypotension, bradycardia and dyspnoea with a sensation of warmth, nausea, vomiting, lassitude and transitory flushing.

Treatment.

Includes monitoring of coagulation tests, respiratory ventilation and symptomatic treatment. If bleeding is a problem, fresh frozen plasma or fresh whole blood should be given.
For information on the management of overdose, contact the Poisons Information Centre, on 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766 (New Zealand).

7 Medicine Schedule (Poisons Standard)

S4.

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.

Summary Table of Changes