HEPARIN SODIUM 1000 I. U./ml Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Multiparin 1,000 I.U./ml solution for injection or concentrate for solution for infusion or Heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion.
Qualitative and quantitative composition
Heparin sodium 1,000 I.U./ml (5,000 I.U. in 5ml). For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection or concentrate for solution for infusion. A colourless or straw-coloured liquid, free from turbidity and from matter that deposits on standing.
Therapeutic indications
Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion. In extracorporeal circulation and haemodialysis.
Posology and method of administration
Route of Administration By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection. The intravenous injection volume of heparin injection should not ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Must not be given to premature babies or neonates (contains benzyl alcohol). Heparin should not be administered ...
Special warnings and precautions for use
Platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia. Heparin induced ...
Interaction with other medicinal products and other forms of interaction
Analgesics: Drugs that interfere with platelet aggregation e.g. aspirin and other NSAIDs should be used with care. Increased risk of haemorrhage with; Ketorolac Intravenous diclofenac (refer to section ...
Pregnancy and lactation
Heparin is not contraindicated in pregnancy. Heparin does not cross the placenta or appear in breast milk. The decision to use heparin in pregnancy should be taken after evaluation of the risk/benefit ...
Effects on ability to drive and use machines
None stated.
Undesirable effects
Blood disorders Haemorrhage (see also Special Warnings and Precautions and Overdosage Information). Thrombocytopenia has been observed occasionally (see also Special Precautions and Warnings). It has been ...
Overdose
A potential hazard of heparin therapy is haemorrhage, but this is usually due to overdosage and the risk is minimised by strict laboratory control. Slight haemorrhage can usually be treated by withdrawing ...
Pharmacodynamic properties
Heparin is an anticoagulant and acts by inhibiting thrombin and by potentiating the naturally occurring inhibitors of activated Factor X (Xa).
Pharmacokinetic properties
As heparin is not absorbed from the gastrointestinal tract and sublingual sites it is administered by injection. After injection heparin extensively binds to plasma proteins. Heparin is metabolised in ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.
List of excipients
Benzyl alcohol Methyl parahydroxybenzoate (E218) Water for injections Sodium hydroxide solution Hydrochloric acid
Incompatibilities
Heparin is incompatible with many injectable preparations e.g. some antibiotics, opioid analgesics and antihistamines. The following drugs are incompatible with heparin; Alteplase, amikacin sulfate, amiodarone ...
Shelf life
3 years. Following the withdrawal of the first dose the remainder should be used within 28 days. After this period, any unused material should be discarded.
Special precautions for storage
Do not store above 25°C. Store in the original package. Chemical and physical in use stability has been demonstrated for 28 days at 25°C. From a microbiological point of view, once opened, the product ...
Nature and contents of container
5ml multidose neutral glass (Type 1, Ph Eur) vial. Carton contains 10 vials.
Special precautions for disposal and other handling
Each multidose vial should be restricted to use in a single patient.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0109
Date of first authorization / renewal of the authorization
Date of first authorisation: 01/07/1991 Date of latest renewal: 20/09/2006
Date of revision of the text
28 September 2018
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