CLIVARIN Solution for injection Ref.[9374] Active ingredients: Reviparin

For subcutaneous use only.

The prefilled syringe is intended for single use of Clivarin only. It is ready for use once the needle shield has been removed. The residual volume of the prefilled syringe has been taken into account during the filling process. The injection is to be given into a pinched-up fold of the skin of the abdominal wall (between umbilicus and iliac crest) or on the front of the thigh. The needle should be inserted and removed perpendicularly and pulled straight out in the same manner. It has been designed so that aspiration prior to injection is not necessary.

Prophylaxis of venous thromboembolism in surgery

Surgery and immobilised trauma patients with normal risk for thromboembolic complications. The usual daily dose is 1432IU (0.25 ml) given subcutaneously once daily. The first injection should be given 2 hours before surgery or immediately when the patient is immobilised. The duration of therapy depends on the nature of the underlying disease and length of time the patient is at risk (immobilisation), and as such should be decided individually. Generally treatment until the patient is fully mobile is recommended. In general surgery, 7-14 days is the norm. Trauma patients with increased risk of thrombosis should receive prophylaxis as long as they are immobilised (experience is available regarding prophylaxis for 40-45 days until removal of circular plaster of the lower part of the legs). In clinical studies involving approximately 2600 patients, 877 (33.5%) received prophylaxis for four weeks or longer.

Surgery patients with increased risk for thromboembolic complications (i.e. orthopaedic surgery for total hip or knee replacement)

The usual daily dose is 3436IU (0.60ml) given subcutaneously once daily. The first injection should be given 12 hours before surgery. The prophylaxis should be administered until the patient is fully mobile, but it is recommended for at least for 14 days.

Treatment of venous thrombosis

A daily dose of 143 IU anti-Xa/kg body weight divided in two subcutaneous injections is recommended for the initial treatment of deep vein thrombosis). The maximum daily dose is 10,307 IU. Oral anticoagulation can be started at the same time with the goal of achieving a PK-INR (International Normalised Ratio) in the therapeutic target range of 2.0–3.0. Clivarin treatment should be given for at least 5-7 days.

In clinical studies the following dose scheme has proven to be effective:

For patients over 60 kg experience is available with the administration of 10,307 IU once daily (refer to the summary of product characteristics for Clivarin 17178 IU anti-Xa/ml, solution for injection).

Children

Reviparin is not indicated for use in children.

Renal impairment

Clivarin should be used with caution in patients with mild to moderate renal impairment (see section 4.4 and 5.2). The use of reviparin is contraindicated in patients with severe renal impairment (creatinine clearance less than 30ml/minute) (see section 4.3).

Hepatic impairment

Use of reviparin in patients with hepatic impairment has not been studied.

Overdosage of low molecular weight heparin results in hypocoagulability and thus in an increased risk of bleeding.

Slight bleeding or haematoma at the injection site may occur with normal doses but should not generally entail stopping treatment. Slow intravenous injection of the antidote protamine immediately and completely neutralises reviparin’s anti IIa activity while partly neutralising anti Xa activity. The protamine dose must be adjusted to the reviparin dose.

Treatment

About 17.5 mg protamine is required to neutralise a dose of reviparin (1432 IU). The half-life of low molecular weight heparin must be taken into account. 1mg of protamine netralises 81.8 IU anti-Xa ofreviparin. The bolus dose of protamine should not exceed 50 mg (refer to the manufacture’s instructions for protamine).

Shelf-life: 3 years.

No special precautions for storage.

Available in the following pack sizes:

Clivarin 1432 IU anti-Xa/0.25 ml, solution for injection in prefilled syringe:

2 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
5 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
10 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
20 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe
100 × 0.25 ml (0.25 ml = 1432 IU anti-Xa) – ungraduated syringe

Clivarin 5726 IU anti-Xa/ml solution for injection in prefilled syringe:

2 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe
5 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe*
10 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe*
20 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe*
100 × 0.6 ml (0.6 ml = 3436 IU anti-Xa) – graduated syringe*

2 × 0.9 ml (0.9 ml= 5153 IU anti-Xa) - graduated syringe*
5 × 0.9 ml (0.9 ml = 5153 IU anti-Xa) - graduated syringe*
10 × 0.9 ml (0.9 ml = 5153 IU anti-Xa) - graduated syringe*
20 × 0.9 ml (0.9 ml = 5153 IU anti-Xa) - graduated syringe*
100 × 0.9 ml (0.9 ml = 5153 IU anti-Xa) - graduated syringe*

Prefilled syringe (ungraduated and graduated) type I glass with a stainless steel needle. Inner needle shield of natural rubber (latex) or polyisoprene based rubber (latex free). Outer needle shield of polypropylene and a plunger of polypropylene or polycarbonate. Optional ultrasafe passive delivery system.

Not all pack sizes may be marketed.

* Syringe is marked with 0.05 ml graduations

For single use only any unused solution should be discarded.