It is also a weak anticoagulant protamines are simple protein principles obtained from the sperm of salmon and certain other species of fish. Each ampoule contains protamine sulphate 10 mgml in sodium chloride 0. It is used to counteract the anticoagulant effect of heparin before. Dobutamine in 5% dextrose injection, usp is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. Each mg of protamine sulfate protamine protamines s will neutralize approximately 90 usp units of heparin activity derived from beef lung tissue or about 115 usp units of heparin activity derived from porcine intestinal mucosa. Caution should be observed when administering protamine sulfate to patients who may be at increased risk of allergic reaction to protamine. Hemochron protamine response test prt package insert. Protamine sulfate injection, usp is a sterile, nonpyrogenic, isotonic solution of protamine sulfate in water for injection. Read all of this leaflet carefully before you start using. Protamine, a strongly basic compound, forms complexes with heparin sodium or heparin calcium, which are acidic compounds. Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with prostin vr pediatric sterile solution. Highlights of prescribing information these highlights do not include all the information needed to use humalog safely and effectively. Heparin is continuously excreted, thus dosage is to be reduced if more than 15 minutes.
The usual duration of lovenox therapy is 8 days or until hospital discharge. Read all of this leaflet carefully before you start. Impact of different dosage of protamine on heparin. These highlights do not include all the information needed to use cuvitru safely and effectively. Each ml contains 500 micrograms alprostadil in dehydrated alcohol. Apr 12, 2020 fragmin package insert pdf package leaflet. Protamine sulfate 1 mg will usually neutralise heparin 100 units. Protamine possesses weak anticoagulant effects when administered alone. All information was extracted from manufacturers package inserts.
Jun 10, 2019 protamine sulfate pharmacokinetics absorption onset. Information for the patient protamine sulphate leo pharma 1400 antiheparin iuml corresponds to 10 mgml solution for injection and infusion protamine sulphate read all of this leaflet carefully before you start using this medicine because it contains important information for you. Glycophos is indicated in adult patients and infants as a supplement in intravenous nutrition to meet the requirements of phosphate. Additionally, residual cells in the upper liquid were recultured and flocculated by protamine again, with a flocculation rate reaching 84. Protamine dosing guidelines guidelines for unfractionated heparin. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Protamine response test prt package insert english intended use the hemochron prt is designed for in vitro diagnostic protamine dose response evaluation. Special warnings and precautions for use too rapid administration of protamine sulphate may cause severe hypotension and anaphylactoid reactions. Glycophos is contraindicated in patients in a state of dehydration or with hypernatremia, hyperphosphatemia, severe renal insufficiency or shock. Dec 31, 2019 protamine sulfate injection should be given by very slow intravenous injection over a 10minute period in doses not to exceed 50 mg see warnings. Clinical study, study 9 in this file, referred to as nct00595270 in the national library. Protamine sulfate protamine protamines s injection, usp is indicated in the treatment of heparin overdosage dosage and administration. Protamine sulfate protamine sulfate dose, indications. Highlights of prescribing information these highlights do not include all the information needed to use aromasin safely and effectively.
Each mg of protamine sulfate neutralizes approximately 100 usp heparin units. Information for the patient protamine sulphate leo pharma 1400 antiheparin iuml corresponds to 10 mgml solution for injection and infusion protamine sulphate read all of this leaflet carefully before you start using this medicine because it contains important information for. Prozinc protamine zinc recombinant human insulin is. Protamine sulphate injection may be administered by slow intravenous injection over a period of 10 minutes. Create a clinical reminder order check for a protamine order on a patient whose chart shows any history of nph use or history of diabetes, which may imply previous use of nph to provide the message. If you need information about a lilly product or want to report an adverse event or product complaint, you may call us. This infusion rate is greatly in excess of the 50 mg10 min suggested in the protamine package insert.
The dose is dependent on the amount of heparin that has to be neutralised, the initial dose and timeframe. Dailymed protamine sulfate protamine sulfate injection. Formation of this complex can result in disruption of the heparinantithrombin iii complex responsible for the anticoagulant activity of heparin. List of drug master files dmf of protamine sulfate active pharmaceutical ingredient api submitted to the u. Read all of this leaflet carefully before you start using this medicine because it contains important. Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and nonqwave myocardial infarction, when concurrently administered with aspirin. Sulfuric acid andor dibasic sodium phosphate heptahydrate may have been added for ph adjustment. The development of antibodies reacting with nuclear antigens was studied in sera from vasectomized men and monkeys obtained at intervals of up to 2 and 4 years, respectively, after the operation, by means of a comparative fluorescence study on swollen nuclei of somatic cells, human and salmon spermatozoa. Protamine dosing guidelines guidelines for unfractionated. Protamine sulfate injection should be given by very slow intravenous injection over a 10minute period in doses not to exceed 50 mg see warnings. Aug 14, 2019 fragmin package insert pdf package leaflet.
Protamine sulphate injection is contraindicated in patients who are known to be hypersensitive to protamine or to any of the excipients listed in section 6. The date shown in the date column of the table is the edition date of the pi is use in february 2020. Individuals using assistive technology may not be able to. The structure of the sperm head is also related to protamine levels. Patient package insert patient information for novolin n novolin n novoelin nph, human insulin isophane suspension injection recombinant dna origin unitsml 100 important do not change the type of insulin you use unless told to do so by your healthcare provider. Postvasectomy autoimmunity to protamines in relation to the. Drug guideline guideline title nsw agency for clinical. Dose of protamine sulfate determined by dose of heparin received, route of. When clinical circumstances bleeding require reversal of the heparin effect, protamine sulfate 1% solution by slow infusion will neutralize heparin sodium.
If you need help accessing information in different file formats, see instructions for downloading viewers and players. Protamine sulfate occurs as fine white or offwhite amorphous or crystalline powder. However, the significance of these findings in routine clinical use is not known. Cardiovascular effects of protamine sulfate in man. Protamine sulphate leo pharma 1400 antiheparin iuml. Neutralization of heparin occurs protamine heparin complex or extravascular compartments.
Side effects of protamine protamines, warnings, uses. Patient information for protamine sulphate 10mgml solution for injection including dosage instructions and possible side effects. Protamine sulfate api dmfs us drug master file dmf. Zyprexa is used for the treatment of psychotic conditions such as schizophrenia and bipolar disorder. Feb 24, 2017 protamine sulfate should be given to a pregnant woman only if prescribed. No more than 50 mg should be administered, very slowly, in any 10 minute period. Protamine dosing guidelines page 1 of 2 guidelines for unfractionated heparin immediate reversal discontinue heparin infusion calculate total amount of heparin received over the preceding 3 hours stat protamine sulfate see dosing recommendations below time from last dose of heparin protamine sulfate dose if initiated within 30 minutes. May 28, 2019 fragmin package insert pdf package leaflet. Package insert protamine sulfate injection, usppiengv1. Protamine is not suitable for reversing the effect of oral anticoagulants. Special warnings and precautions for use too rapid administration of protamine sulphate may cause severe hypotension and.
The hemochron prt200 peach top and the prt400 red top test tubes are recommended for use in invasive cardiology procedures requiring protamine for neutralization of heparin anticoagulation. For additional information, consult the prescribing information for protamine sulfate injection, usp. Protamine sulfate protamines is a heparin antagonist and a weak anticoagulant indicated in the treatment of heparin a drug used to treat and prevent blood clots overdose. Dobutamine in 5% dextrose injection, usp flexible plastic. Nov 25, 2019 fragmin package insert pdf package leaflet. Exemestane showed no effects on ovarian function, mating behavior, and conception rate in rats given doses up to 20 mgkgday approximately 8 times the recommended human dose on a mgm 2 basis. The ratio of protamine 2 to protamine 1 and transition nuclear proteins has been found to change the sperm head shape in various species of mice, by altering the expression of protamine 2 via mutations in its promoter region. Flocculation activity of carp protamine in microalgal. Lovenox between 15 minutes before and 30 minutes after the start of. It is not known whether this drug passes into breast milk. Between january and march 2014 in 9 patients undergoing offpump coronary artery bypass, we evaluated the effect of a dose of protamine equal to 1 mg per 100 units of heparin total calculated dose on hemostasis as evaluated by means of thromboelastomery. Protamine is used therapeutically to reverse the activity of heparins. Federal law restricts this drug to use by or on the order of a licensed veterinarian. These highlights do not include all the information needed to use advate safely and effectively.
488 1216 116 1147 1020 755 703 608 181 1498 1515 1455 1282 762 23 1251 283 546 223 304 1394 687 1204 349 1139 372 406 323 491 494 240 1207 457 725 670 278 459 523 60 490 1150 549 726 1262 256