CRUSIA Solution for injection (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

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 ...

2. Qualitative and quantitative composition

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 ...

3. Pharmaceutical form

Solution for injection in pre-filled syringes. CRUSIA is a clear, sterile solution, free from visible particulate matter.

4.1. Therapeutic indications

To reduce the risk of post-operative venous thrombosis and embolism in high-risk patients (e.g., orthopaedic surgery) and moderate-risk patients (e.g., abdominal surgery). To reduce the risk of venous ...

4.2. Posology and method of administration

To reduce the risk of post-operative venous thrombosis and embolism High Risk Patients In orthopaedic surgery, 40 mg (0,4 ml) once daily by subcutaneous injection. The first injection should be given, ...

4.3. Contraindications

CRUSIA is contraindicated in patients with: Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in ...

4.4. Special warnings and precautions for use

Spinal/Epidural anaesthesia Spinal/epidural anaesthesia or lumbar puncture must not be performed within 24 hours of administration of CRUSIA at therapeutic doses (see also section 4.3). There have been ...

4.5. Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended Medicines affecting haemostasis (see section 4.4) It is recommended that some medicines which affect haemostasis should be discontinued prior to CRUSIA therapy unless strictly ...

4.6. Pregnancy and lactation

Pregnancy In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester. ...

4.7. Effects on ability to drive and use machines

CRUSIA has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile It has been reported during clinical trials with enoxaparin sodium, that the enoxaparin sodium regimen administered varied depending on indications. The enoxaparin sodium ...

4.9. Overdose

Signs and symptoms Accidental overdose with enoxaparin sodium after IV, extracorporeal or SC administration may lead to haemorrhagic complications. Following oral administration of even large doses, it ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agent, heparin group ATC code: B01AB05 CRUSIA is a biosimilar medicine. Pharmacodynamic effects Enoxaparin sodium is a low molecular weight heparin ...

5.2. Pharmacokinetic properties

General characteristics The pharmacokinetic parameters of enoxaparin sodium have been studied primarily in terms of the time course of plasma anti-Xa activity and also by anti-IIa activity, at the recommended ...

5.3. Preclinical safety data

Besides the anticoagulant effects of enoxaparin sodium, there was no evidence of adverse effects at 15 mg/kg/day in the 13-week SC toxicity studies both in rats and dogs and at 10 mg/kg/day in the 26-week ...

6.1. List of excipients

Water for injections.

6.2. Incompatibilities

SC injection: Do not mix with other products.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store at or below 25°C. Do not freeze.

6.5. Nature and contents of container

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 ...

6.6. Special precautions for disposal and other handling

Pre-filled syringes are ready for immediate use. For method of administration see section 4.2. Use only clear, colourless solutions. Pre-filled syringes are supplied with or without an automatic safety ...

7. Marketing authorization holder

Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand 1685, South Africa

8. Marketing authorization number(s)

CRUSIA 20 550009 CRUSIA 40 550010 CRUSIA 60 550011 CRUSIA 80 550012 CRUSIA 100 550013

9. Date of first authorization / renewal of the authorization

19 April 2022

10. Date of revision of the text

To be allocated.

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