Prescribing information.

Ropivacaine 2 mg/ml solution for infusion in administration system. Presentation: Ropivacaine is supplied in a dispensing device, the Ropivacaine ReadyfusOR infusion pump. One infusion pump contains 250 ml ropivacaine hydrochloride mono-hydrate solution for infusion, equivalent to 500 mg ropivacaine hydrochloride. 1 ml solution for infusion contains ropivacaine hydrochloride monohydrate, equivalent to 2 mg ropivacaine hydrochloride. Indications: Acute, postoperative pain management in adults. Maintenance of a continuous peripheral nerve block via a continuous infusion. Continuous wound infiltration. Dosage and administration: The Ropivacaine ReadyfusOR infusion pump delivers a flow rate of approximately 5 ml/h, equivalent to 10 mg/h, over a maximum of 48 hours. The fixed infusion rate of 5 ml (10 mg) per hour provides adequate analgesia with only slight and non-progressive motor block in most cases of moderate to severe postoperative pain. To maintain a continuous peripheral nerve block via a continuous perineural infusion, the following technique can be recommended: First, unless perioperatively instituted, a block is induced with ropivacaine 7.5 mg/ml. Analgesia is then maintained with Ropivacaine. For continuous wound infiltration a fenestrated catheter should be placed in wound during surgery. Depending on the patient’s clinical status, prescription of other oral analgesics (for patient-controlled analgesia), or additional bolus injections of a local anaesthetic should be considered. Children and adolescents (under 18 years of age): Not indicated. Contraindications: Hypersensitivity to the active substance or to other local anaesthetics of the amide type or to any of the excipients, intravenous regional anaesthesia, obstetric paracervical anaesthesia, intravascular use, intrathecal use, intracerebral use, intra-articular use. Warnings and precautions: Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available. The clinician responsible should be appropriately trained and familiar with diagnosis and treatment of side effects, systemic toxicity and other complications. Cardiovascular: Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring should be considered, since cardiac effects may be additive. Head and neck blocks: Certain local anaesthetic procedures, such as injections in the head and neck regions, may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used. Major peripheral nerve blocks: Major peripheral nerve blocks may imply the administration of a large volume of local anaesthetic in highly vascularised areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations. Hypersensitivity: A possible cross–hypersensitivity with other amide type local anaesthetics should be taken into account. Poor general health: Patients in poor general condition due to ageing or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention, although regional anaesthesia is frequently indicated in these patients. Hepatic and renal impairment: Ropivacaine is metabolised in the liver and should therefore be used with caution in patients with severe liver disease. Normally there is no need to modify the dose in patients with impaired renal function when used for single dose or short-term treatment. Acidosis and reduced plasma protein concentration, frequently seen in patients with chronic renal failure, may increase the risk of systemic toxicity. Acute porphyria: Ropivacaine is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available. Chondrolysis: There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics, including ropivacaine. Intra-articular continuous infusion is not an approved indication for Ropivacaine. Prolonged administration: Prolonged administration of ropivacaine should be avoided in patients concomitantly treated with strong CYP1A2 inhibitors, such as fluvoxamine and enoxacin. Excipients: This medicinal product contains 3.4 mg sodium per ml. See SmPC for full details. Interactions: Ropivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide type local anaesthetics, e.g. certain antiarrhythmics, such as lidocaine and mexiletine, since the systemic toxic effects are additive. Simultaneous use of Ropivacaine with general anaesthetics or opioids may potentiate each other’s’ (adverse) effects. Specific interaction studies with ropivacaine and anti-arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution is advised. Strong inhibitors of CYP1A2, such as fluvoxamine and enoxacin given concomitantly during prolonged administration of Ropivacaine, can interact with Ropivacaine. Prolonged administration of ropivacaine should be avoided in patients concomitantly treated with strong CYP1A2 inhibitors. See SmPC for full details. Fertility, pregnancy and lactation: There are no adequate data on the use of ropivacaine in human pregnancy. Experimental animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Ropivacaine during pregnancy. There are no data available concerning the excretion of ropivacaine into human milk. Breast-feeding should be temporarily interrupted during treatment with Ropivacaine. The milk should be pumped and discarded for this period. No data on fertility are available. Ability to drive and use machines: Local anaesthetics may have a minor influence on mental function and co-ordination and may temporarily impair locomotion and alertness. Undesirable effects: Very common (≥ 1/10): Hypotension, nausea. Common (≥ 1/100 to < 1/10): Paraesthesia, dizziness, headache, bradycardia, tachycardia, hypertension, vomiting, back pain, urinary retention, temperature elevation, chills. Uncommon (≥ 1/1,000 to < 1/100): Anxiety, symptoms of CNS toxicity (convulsions, Grand mal convulsions, seizures, light-headedness, circumoral paraesthesia, numbness of the tongue, hyperacusis, tinnitus, visual disturbances, dysarthria, muscular twitching, tremor), hypoaesthesia, syncope, dyspnoea, hypothermia. Rare (≥ 1/10,000 to < 1/1,000): Allergic reactions (anaphylactic reactions, angioneurotic oedema and urticaria), cardiac arrest, cardiac arrhythmias. Not known: Dyskinesia. See SmPC for other side effects. Package quantities and basic NHS price: Pack with one Ropivacaine ReadyfusOR infusion pump, carrying pouch: £175. Pack with one Ropivacaine ReadyfusOR infusion pump, carrying pouch, 6.5 cm sterile latex free fenestrated catheter: £200. Pack with one Ropivacaine ReadyfusOR infusion pump, carrying pouch, 15 cm sterile latex free fenestrated catheter: £215.

Marketing authorisation number: PL 45205/0004. Legal category: POM. Marketing authorisation holder: BioQ Pharma Ltd, Garden Cottage, Hascombe Road, Godalming, Surrey GU8 4AE, United Kingdom.

Date of preparation: Aug 2023  MKT-ROP-0017