Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand 1685, South Africa
CRUSIA 20, 2 000 IU (20 mg/0,2 ml) solution for injection in pre-filled syringes.
CRUSIA 40, 4 000 IU (40 mg/0,4 ml) solution for injection in pre-filled syringes.
CRUSIA 60, 6 000 IU (60 mg/0,6 ml) solution for injection in pre-filled syringes.
CRUSIA 80, 8 000 IU (80 mg/0,8 ml) solution for injection in pre-filled syringes.
CRUSIA 100, 10 000 IU (100 mg/1 ml) solution for injection in pre-filled syringes.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled syringes. CRUSIA is a clear, sterile solution, free from visible particulate matter. |
CRUSIA 20: Each pre-filled syringe contains enoxaparin sodium 2 000 IU anti-Xa activity (equivalent to 20 mg) in 0,2 ml water for injections.
CRUSIA 40: Each pre-filled syringe contains enoxaparin sodium 4 000 IU anti-Xa activity (equivalent to 40 mg) in 0,4 ml water for injections.
CRUSIA 60: Each pre-filled syringe contains enoxaparin sodium 6 000 IU anti-Xa activity (equivalent to 60 mg) in 0,6 ml water for injections.
CRUSIA 80: Each pre-filled syringe contains enoxaparin sodium 8 000 IU anti-Xa activity (equivalent to 80 mg) in 0,8 ml water for injections.
CRUSIA 100: Each pre-filled syringe contains enoxaparin sodium 10 000 IU anti-Xa activity (equivalent to 100 mg) in 1,0 ml water for injections.
For the full list of excipients, see section 6.1.
CRUSIA is sugar free.
Enoxaparin sodium is a biological substance obtained by alkaline depolymerisation of heparin benzyl ester derived from porcine intestinal mucosa.
| Active Ingredient | Description | |
|---|---|---|
| Enoxaparin |
Enoxaparin is a LMWH with a mean molecular weight of approximately 4,500 daltons, in which the antithrombotic and anticoagulant activities of standard heparin have been dissociated. The drug substance is the sodium salt and has a high anti-Xa activity. |
| List of Excipients |
|---|
|
Water for injections. |
CRUSIA solution for injection is packed in prefilled syringes.
CRUSIA is packed in clear, transparent Type I glass pre-filled syringes with black chlorobutyl rubber stopper fitted with injection needle with or without an automatic safety device for some presentations. The needle shield is made of synthetic rubber and a rigid cover of polypropylene.
Prefilled syringes are stored in plastic trays and carton boxes.
CRUSIA 20: 0,2 mL solution for injection in a 0,5 mL pre-filled syringe without scale. Pack sizes of 2, 10 and 50 syringes.
CRUSIA 40: 0,4 mL solution for injection in a 0,5 mL pre-filled syringe without scale. Pack sizes of 2, 10, 30 and 50 syringes.
CRUSIA 60: 0,6 mL solution for injection in a 1,0 mL graduated pre-filled syringe. Pack sizes of 2, 10 and 30 syringes.
CRUSIA 80: 0,8 mL solution for injection in a 1,0 mL graduated pre-filled syringe. Pack sizes of 2, 10 and 30 syringes.
CRUSIA 100: 1,0 mL solution for injection in a 1,0 mL graduated pre-filled syringe. Pack sizes of 2, 10 and 30 syringes.
Not all pack sizes may be marketed.
Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand 1685, South Africa
CRUSIA 20 – 550009
CRUSIA 40 – 550010
CRUSIA 60 – 550011
CRUSIA 80 – 550012
CRUSIA 100 – 550013
19 April 2022
| Drug | Countries | |
|---|---|---|
| CRUSIA | Austria, Germany, Ecuador, Estonia, Israel, New Zealand, Poland, Romania, South Africa |
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