INHIXA 2,000 IU Solution for injection in pre-filled syringe (2020)

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Περιεχόμενα

1. Name of the medicinal product

Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection.

2. Qualitative and quantitative composition

10,000 IU/mL (100 mg/mL) solution for injection: Each pre-filled 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 ...

3. Pharmaceutical form

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

4.1. Therapeutic indications

Inhixa 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 ...

4.2. 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. ...

4.3. 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 ...

4.4. 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 ...

4.5. 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 ...

4.6. 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. ...

4.7. Effects on ability to drive and use machines

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

4.8. 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 ...

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 agents, heparin group ATC code: B01AB05 Inhixa is a biosimilar medicinal product. Detailed information is available on the website of the European ...

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. IV (Bolus) Injection (for acute STEMI indication only): Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% ...

6.3. Shelf life

Pre-filled syringe: 3 years. Diluted medicinal product with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose: 8 hours.

6.4. Special precautions for storage

Store below 25°C. Do not freeze.

6.5. Nature and contents of container

0.2 mL of solution in: a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod. The ...

6.6. Special precautions for disposal and other handling

INSTRUCTIONS FOR USE: PRE-FILLED SYRINGE How to give yourself an injection of Inhixa Your pre-filled syringe has a needle guard attached to it in order to protect you from needle stick injury. If you are ...

7. Marketing authorization holder

Techdow Pharma Netherlands B.V., Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Netherlands

8. Marketing authorization number(s)

EU/1/16/1132/001 EU/1/16/1132/002 EU/1/16/1132/011 EU/1/16/1132/012 EU/1/16/1132/021 EU/1/16/1132/023 EU/1/16/1132/033 EU/1/16/1132/034 EU/1/16/1132/051 EU/1/16/1132/053 EU/1/16/1132/054 EU/1/16/1132/064 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 15/09/2016

10. Date of revision of the text

02/12/2020

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