Expiration date: 11/2025
The composition and form of issue:
The intravenous solution. 5 ml contains:
Protamine sulphate 50 mg
in ampoules of 5 ml in a cardboard pack of 10 ampoules.
Description pharmaceutical form:
Colorless, transparent solution.
Feature:
Specific antagonist of heparin, 1 mg neutralises which is 80-120 UNITS of heparin in the blood.
Description pharmacological action:
Formed at/in the introduction of the complex Protamine-heparin can be destroyed with the release of heparin. After the on/in the introduction effect occurs instantly and lasts for 2 hours.
Indications:
Increased bleeding caused by an overdose of heparin before surgery patients receiving heparin after surgery on the heart and blood vessels with the use of extracorporeal circulatory gipergeparinemia.
Contraindications:
Hypersensitivity, idiopathic or congenital gipergeparinemia.
Application of pregnancy and breast-feeding:
Perhaps if the expected effect therapy outweighs the potential risk to the fetus.
Side effects:
Rapid intravenous injection may cause hypotension, bradycardia, feeling of heat and redness of the skin. Very rarely, urticaria and other hypersensitivity reactions.
Drug interactions:
Incompatible with solutions of cephalosporins and penicillin (not to be entered at the same time). Interactions with other drugs data no.
Method of application and dose:
In/in slow struino or drip. The rate of introduction of not more than 5 mg/min (example: 50 mg administered for 10 min), as more rapid infusion may cause anaphylactoid reaction. The dosage depends on the method of administration of heparin:
1. When bolus heparin injection, the dose is reduced depending on the time elapsed from the introduction of heparin, since the latter is continuously removed from the body.
Table
The dose of Protamine sulfate dependent on the time elapsed after the injection of heparin
| The time elapsed after the injection of heparin | The dose of Protamine sulfate per 100 IU of heparin |
| 15-30 min | 1-1,5 mg |
| 30-60 min | 0,5-0,75 mg |
| Above 2 h | 0,25-0,375 mg |
2. The on/in infusion of heparin should stop the infusion and enter 25-30 mg of Protamine sulfate.
3. When s/to the injections of heparin dose 1-1. 5 mg for every 100 IU of heparin. First of 25-50 mg of Protamine sulfate injected into/in slowly, and the remaining dose in/in drip for 8-16 h. Possible fractional introduction of a drug under the control of activated partial thromboplastin time (APTT). For example, if n/a entered 20000 IU of heparin, after 2 h there is resorption of heparin from Protamine complexes at 3333 IU of heparin, in this regard, the following dose of Protamine sulfate is 33 mg.
4. In the case of using extracorporeal circulation in surgical intervention, the dose is 1.5 mg for every 100 IU of heparin.
Precautions:
Possible manifestation of cross-sensitivity in patients with diabetes mellitus who receive Protamine-zinc insulin. Do not enter more than 150 mg of Protamine sulfate for 1 h.
In patients taking Protamine-zinc insulin for treatment of diabetes, a possible anaphylactic reaction to Protamine sulfate.
