Clexane pre-filled syringes (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | SANOFI |
|---|---|
| Διεύθυνση | 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK |
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Name of the medicinal product
Clexane Syringes.
Qualitative and quantitative composition
Pre-filled syringes 20 mg Injection: Enoxaparin sodium 20 mg (equivalent to 2,000 IU anti-Xa activity) in 0.2 mL Water for Injections 40 mg Injection: Enoxaparin sodium 40 mg (equivalent to 4,000 IU anti-Xa ...
Pharmaceutical form
Solution for injection. Clear, colourless to pale yellow solution.
Therapeutic indications
The prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthopaedic or general surgery. The prophylaxis of venous thromboembolism in medical patients ...
Posology and method of administration
Adults Prophylaxis of venous thromboembolism In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 ...
Contraindications
Contraindicated in patients with acute bacterial endocarditis, active major bleeding and conditions with a high risk of uncontrolled haemorrhage, including recent haemorrhagic stroke, thrombocytopenia ...
Special warnings and precautions for use
Low Molecular Weight Heparins should not be used interchangeably since they differ in their manufacturing process, molecular weights, specific anti Xa activities, units and dosage. This results in differences ...
Interaction with other medicinal products and other forms of interaction
It is recommended that agents which affect haemostasis should be discontinued prior to enoxaparin therapy unless their use is essential, such as: systemic salicylates, acetylsalicylic acid, NSAIDs including ...
Pregnancy and lactation
Pregnancy: Animal studies have not shown any evidence of foetotoxicity or teratogenicity. In the pregnant rat, the transfer of <sup>35</sup>S-enoxaparin across the maternal placenta to the foetus is minimal. ...
Effects on ability to drive and use machines
Enoxaparin has no effect on the ability to drive and operate machines.
Undesirable effects
The adverse reactions observed in clinical studies and reported in post-marketing experience are detailed below. Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon ...
Overdose
Orally administered enoxaparin is poorly absorbed and even large oral doses should not lead to any serious consequences. This may be checked by plasma assays of anti-Xa and anti-IIa activities. Accidental ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic agent, heparin group. ATC code: B01AB05 Enoxaparin is a low molecular weight heparin with a mean molecular weight of approximately 4,500 daltons. The drug substance ...
Pharmacokinetic properties
Enoxaparin is rapidly and completely absorbed following subcutaneous injection. The maximum plasma anti-Xa activity occurs 1 to 4 hours after injection with peak activities in the order of 0.16 IU/ml and ...
Preclinical safety data
No long-term studies in animals have been performed to evaluate the carcinogenic potential of enoxaparin. Enoxaparin was not mutagenic in in vitro tests, including the Ames test, mouse lymphoma cell forward ...
List of excipients
Water for Injections
Incompatibilities
Subcutaneous Injection: Clexane should not be mixed with any other injections or infusions. Intravenous (Bolus) Injection for acute STEMI indication only: Enoxaparin sodium may be safely administered with ...
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Clexane pre-filled syringes are single dose containers discard any unused product.
Nature and contents of container
Solution for injection in Type I glass pre-filled syringes fitted with injection needle and an automatic safety device in packs of 10.
Special precautions for disposal and other handling
See section 4.2 Posology and method of administration.
Marketing authorization holder
Sanofi-aventis One Onslow Street Guildford Surrey, GU1 4YS UK
Marketing authorization number(s)
PL 04425/0187
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 October 1990 Date of latest renewal: 8 August 2002
Date of revision of the text
19 December 2011