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SPC, UK: INNOHEP 10,000 anti-Factor Xa IU/ml Solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

innohep 10,000 IU/ml.

Qualitative and quantitative composition

Tinzaparin sodium 10,000 anti-Factor Xa IU/ml. Excipients with known effect: Benzyl alcohol (10 mg/ml) and sodium (in total <23 mg/dose). For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. Vials of 2 ml filled with a colourless to straw coloured liquid, free from turbidity and from matter that deposits on standing.

Therapeutic indications

Prophylaxis of venous thromboembolism in adult patients undergoing surgery, particularly orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in non-surgical adult patients ...

Posology and method of administration

Posology Prophylaxis of thromboembolic events in adults Administration is by subcutaneous injection. Surgical patients at moderate risk of thromboembolic events: 3,500 anti-Xa IU given SC 2 hours before ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Current or history of immune-mediated heparin-induced thrombocytopenia (type II) (see section 4.4). Active major ...

Special warnings and precautions for use

Neuraxial anaesthesia Caution is advised when performing neuraxial anaesthesia or lumbar puncture in patients receiving prophylactic doses of innohep due to the risk of spinal haematomas resulting in prolonged ...

Interaction with other medicinal products and other forms of interaction

The anticoagulant effect of innohep may be enhanced by other drugs affecting the coagulation system, such as those inhibiting platelet function (e.g. acetylsalicylic acid and other non-steroidal anti-inflammatory ...

Fertility, pregnancy and lactation

Pregnancy Anticoagulant treatment of pregnant women requires specialist involvement. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. A large amount ...

Effects on ability to drive and use machines

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

Undesirable effects

The most frequently reported undesirable effects are haemorrhage events, anaemia secondary to haemorrhage and injection site reactions. Haemorrhage may present in any organ and have different degrees of ...

Overdose

Haemorrhage is the main complication of overdose. Due to the relatively short half-life of innohep (see section 5.2), minor haemorrhages can be managed conservatively following treatment discontinuation. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic Agents ATC code: B01AB10 innohep is an antithrombotic agent. It potentiates the inhibition of several activated coagulation factors, especially Factor Xa, its ...

Pharmacokinetic properties

The pharmacokinetics/pharmacodynamic activity of innohep is monitored by anti-Factor Xa activity. innohep has a bioavailability of around 90% following a subcutaneous injection. The absorption half-life ...

Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

List of excipients

Benzyl alcohol Sodium acetate Sodium hydroxide Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 2 years. The vial should be discarded 14 days after first opening.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

2 ml multi-dose glass vial containing 10,000 anti-Factor Xa IU/ml. Pack sizes: 1, 2, 5 or 10 vials. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Marketing authorization number(s)

PL 00043/0205

Date of first authorization / renewal of the authorization

Date of first authorisation: 30 September 1998 Date of latest renewal: 26 April 2004

Date of revision of the text

29/10/2018

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