What Cleviprex contains
- The active substance is clevidipine 1 ml emulsion for injection contains 0.5 mg clevidipine. One vial of 50 ml of emulsion contains 25 mg of clevidipine One vial of 100 ml of emulsion contains 50 mg of clevidipine
- The other ingredients are soya-bean oil refined, glycerol, egg phospholipids, oleic acid, disodium edetate, water for injections and sodium hydroxide (for pH adjustment)
What Cleviprex looks like and contents of the pack
Cleviprex is a milky white emulsion in a glass vial
Cleviprex is available in cartons containing 10 vials of 50 ml and 10 vials of 100 ml.
Not all vial sizes may be marketed.
The Medicines Company | 25 June 2013 |
Clevidipine (EU Core for NL) | Module 1, 1.3.1.1 Product Information (English) |
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Marketing Authorisation Holder
The Medicines Company UK Ltd.
115L Milton Park
Abingdon
Oxfordshire
OX14 4SA
United Kingdon
Manufacturer
Hälsa Pharma GmbH
Nikolaus-Dürkopp-Str. 4A,
D-33602 Bielefeld,
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Cleviprex 0,5 mg/ml emulsion zur injektion
Belgium: Cleviprex 0,5 mg/ml émulsion injectable; Cleviprex 0,5 mg/ml, emulsie voor injectie; Cleviprex 0,5 mg/ml emulsion zur injektion
France: Cleviprex 0,5 mg/ml émulsion injectable Germany: Cleviprex 0,5 mg/ml emulsion zur injektion Italy: Cleviprex 0,5 mg/ml emulsione iniettabile Luxembourg: Cleviprex 0,5 mg/ml émulsion injectable Netherlands: Cleviprex 0,5 mg/ml, emulsie voor injectie Spain: Cleviprex 0,5 mg/ml emulsión inyectable Sweden: Cleviprex 0,5 mg/ml injektionsvätska, emulsion UK: Cleviprex 0.5 mg/ml emulsion for injection
This leaflet was last revised in 06/2013.
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The following information is intended for medical or healthcare professionals only:
The Medicines Company | 25 June 2013 |
Clevidipine (EU Core for NL) | Module 1, 1.3.1.1 Product Information (English) |
Confidential | Page 9 |
Cleviprex 0,5 mg/ml, emulsie voor injectie
Clevidipine
Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information.
Cleviprex is indicated for the rapid reduction of blood pressure in the perioperative setting. Safety and efficacy has not been established in children or pregnant women.
Instructions for use
For single use only.
Use strict aseptic technique. Once stopper is punctured, use within 12 hours; discard unused portion in accordance with local requirements.
Cleviprex is a sterile, white opaque emulsion. Visually inspect prior to use. Solutions that are discoloured or contain particulate matter should not be used.
Gently invert vial before use to ensure uniformity of the emulsion.
Cleviprex should be administered via a vented spike and infusion device. Do not dilute.
Lipid filters with a 1.2 micron pore size may be used when administering Cleviprex.
Cleviprex should not be administered in the same line as other medications; however, Cleviprex can be administered with the following:
- Water for injections
- Sodium Chloride (0.9%) Injection
- 5% glucose solution
- 5% glucose solution in Sodium Chloride (0.9%) Injection
- 5% glucose solution in Ringers Lactate Injection
- Lactated Ringers Injection
- 10% amino acid
Contraindications
Hypersensitivity to soybeans, soya-bean oil refined, soy products, peanut, eggs or egg products or to any of the other excipients. Clevidipine must not be used in patients with defective lipid metabolism (see section 4.3 of SmPC).
Special Warnings and Precautions
The Medicines Company | 25 June 2013 |
Clevidipine (EU Core for NL) | Module 1, 1.3.1.1 Product Information (English) |
Confidential | Page 10 |
Rapid pharmacologic reductions in blood pressure may produce systemic hypotension and reflex tachycardia. If either occurs, consider decreasing the dose by half or stopping the infusion. Full recovery of BP is achieved in 5-15 minutes (see section 5.1 of SmPC).
Clevidipine should be used with caution in patients who cannot compensate for reduced blood pressure such as those with left bundle-branch block or primary ventricular pacing or severe aortic stenosis (see section 4.4 of SmPC).
Drug-drug interaction: Clevipine is metabolized by esterases. At clinical doses, there is no potential for CYP interaction. Patients receiving oral or IV anti-hypertensive agents while on clevidipine should be observed closely for increased anti-hypertensive effects.
Hepatic or Renal Impairment: No dose adjustment required.
Administration
Clevidipine is for intravenous use. Titrate to achieve the desired blood pressure reduction
Initial dose: Initiate infusion at 4 ml/h (2 mg/h); the dose may be doubled as quickly as every 90 seconds. Continue titration until desired target range is achieved.
Maintenance dose: The desired therapeutic response for most patients occurs at doses of 8 – 12 ml/h (4 - 6 mg/h).
Maximum dose: The maximum recommended dose is 64 ml/h (32 mg/h). No more than 1000 ml of clevidipine infusion is recommended in the initial 24-hour period due to associated lipid load. There is limited experience with infusion durations beyond 72 hours at any dose.
Transition to an oral antihypertensive agent: Discontinue clevidipine or titrate downward while appropriate oral therapy is established.
Shelf life
2 years refrigerated (2-8ºC) of which 2 months may be below 25ºC
Do not return to refrigerated storage after beginning 25ºC storage
Do not freeze. The freezing point of Cleviprex is between -1°C and 0°C
The Medicines Company | 25 June 2013 |