PROSULF Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Prosulf 10mg/ml Solution for Injection. Protamine Sulfate 10mg/ml Solution for Injection.
Qualitative and quantitative composition
Protamine Sulfate 10mg/ml.
Pharmaceutical form
Solution for injection. A clear, colourless solution.
Therapeutic indications
Protamine sulfate 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 ...
Posology and method of administration
Adults Prosulf should be administered by slow intravenous injection over a period of about 10 minutes. No more than 50mg of protamine sulfate should be given in any one dose. The dose is dependent on the ...
Contraindications
None known.
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
As with most drugs, to be used only if clearly indicated in pregnancy and with caution during lactation.
Effects on ability to drive and use machines
None.
Undesirable effects
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, ...
Overdose
Symptoms Protamine has weak anticoagulating properties and if given in the absence of heparin, or at doses in excess of those required to neutralise the anticoagulant effect of heparin, exerts its own ...
Pharmacodynamic properties
Although protamine is a potent antidote for heparin, its precise mechanism of action is unknown. However, when the strongly basic protamine combines with the strongly acid heparin, a stable salt is formed ...
Pharmacokinetic properties
The onset of action of protamine occurs within five minutes following intravenous administration. The fate of the protamine-heparin complex is unknown, but it may be partially degraded, thus freeing heparin. ...
Preclinical safety data
No data are available.
List of excipients
Sodium chloride Hydrochloric acid 3M Sodium hydroxide 3M Water for injections
Incompatibilities
Protamine sulfate is incompatible with certain antibiotics, including several cephalosporins and penicillin.
Shelf life
48 months.
Special precautions for storage
Store between 15°C and 25°C.
Nature and contents of container
5ml and 10ml neutral type 1 hydrolytic glass ampoules in pack sizes of 10 ampoules in cartons.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K
Marketing authorization number(s)
PL 29831/0180
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 May 1991 Date of latest renewal: 09 February 2009
Date of revision of the text
04 May 2018
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