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SPC, UK: AROVI 2,000 IU Solution for injection in pre-filled syringe (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Arovi 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe.

Qualitative and quantitative composition

2,000 IU (20 mg)/0.2 mL: Each prefilled syringe contains enoxaparin sodium 2,000 IU anti-Xa activity (equivalent to 20 mg) in 0.2 mL water for injections. For the full list of excipients, see section 6.1. ...

Pharmaceutical form

Solution for injection in pre-filled syringe (Injection). Clear, colourless to pale yellow solution.

Therapeutic indications

Arovi is indicated in adults for: Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer ...

Posology and method of administration

Posology Prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients Individual thromboembolic risk for patients can be estimated using validated risk stratification model. ...

Contraindications

Enoxaparin sodium 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 ...

Special warnings and precautions for use

General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and anti-IIa ...

Interaction with other medicinal products and other forms of interaction

Concomitant use not recommended Medicinal products affecting haemostasis (see section 4.4): It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium ...

Fertility, 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. ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile Enoxaparin sodium has been evaluated in more than 15,000 patients who received enoxaparin sodium in clinical trials. These included 1,776 for prophylaxis of deep vein thrombosis ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agent, heparin group ATC code: B01AB05 Arovi is a biosimilar medicinal product. Detailed information is available on the website of the Medicines and Healthcare ...

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 ...

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 ...

List of excipients

Water for injections

Incompatibilities

SC injection: Do not mix with other products. IV (Bolus) Injection (for acute STEMI indication only): Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water ...

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 25°C. Do not freeze.

Nature and contents of container

Solution for injection in Type I glass pre-filled syringes with chlorobutyl rubber stopper fitted with injection needle and with or without an automatic safety device. Prefilled syringes are stored in ...

Special precautions for disposal and other handling

The pre-filled syringe is ready for immediate use (see section 4.2). For syringes with safety device system the needle must be oriented away from the user and anyone else who is present. The safety system ...

Marketing authorization holder

Laboratorios Farmacéuticos ROVI, S.A., Julián Camarillo, 35, 2803, Madrid, Spain

Marketing authorization number(s)

PL 15406/0007

Date of first authorization / renewal of the authorization

24/03/2017

Date of revision of the text

12/11/2018

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