PROSULF Solution for injection Ref.[9525] Active ingredients: Protamine

Too rapid administration of protamine sulfate may cause severe hypotension and anaphylactoid reactions. Facilities for resuscitation and treatment of shock should be available.

Protamine sulfate is not suitable for reversing the effects of oral anticoagulants. 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 cardio-pulmonary by-pass 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.

None known.

As with most drugs, to be used only if clearly indicated in pregnancy and with caution during lactation.

None.

Blood and lymphatic system disorders: anticoagulant effect (when used at doses in excess of that required to neutralise the anticoagulant effect of heparin).

Immune system disorders: hypersensitivity reactions, including angioedema anaphylactoid reactions and fatal anaphylaxis, have been reported.

Cardiac disorders: bradycardia.

Vascular disorders: sudden fall in blood pressure, pulmonary and systemic hypertension, transitory flushing and a feeling of warmth, severe, acute pulmonary vasoconstriction with cardiovascular collapse.

Respiratory, thoracic and mediastinal disorders: Dyspnoea. There have been rare instances of noncardiogenic pulmonary oedema with prolonged hypotension, with significant morbidity and mortality.

Gastrointestinal disorders: nausea and vomiting.

Musculoskeletal and connective tissue disorders: back pain.

General disorders and administration site conditions: lassitude.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Protamine sulfate is incompatible with certain antibiotics, including several cephalosporins and penicillin.