ROPIVACAINE KABI

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

ROPIVACAINE KABI contains the active ingredient ropivacaine hydrochloride. ROPIVACAINE KABI is used as an anaesthetic to stop the pain of surgery and/or to make childbirth less painful. ROPIVACAINE KABI is also used after surgery to treat post-operative pain.

For more information, see Section 1. Why am I being given ROPIVACAINE KABI? in the full CMI.

Do not use if you have ever had an allergic reaction to ROPIVACAINE KABI or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I am given ROPIVACAINE KABI? in the full CMI.

Some medicines may interfere with ROPIVACAINE KABI and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

Your doctor will have had a lot of experience using ropivacaine hydrochloride or other local anaesthetics and will choose the best dose for you.

Your doctor will inject the medicine into the skin, near a single nerve, or into an area which contains a large number of nerves. It may also be directed into a surgical incision after surgery by a tube.

More instructions can be found in Section 4. How is ROPIVACAINE KABI given? in the full CMI.

For more information, see Section 5. What should I know after being given ROPIVACAINE KABI? in the full CMI.

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary.

The most common side effects are nausea (feeling sick), vomiting, headache, dizziness, irregular or slow heartbeat, fever, a tingling feeling ("pins and needles"), shivering, difficulty passing urine, stiff or twitching muscles, painful joints, difficulty breathing, extreme dizziness, slow heartbeat, pain in the chest and fits.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Not for intravenous administration under any circumstances.

1 Name of Medicine

Ropivacaine hydrochloride.

2 Qualitative and Quantitative Composition

Ropivacaine Kabi solution for injection is a sterile, isotonic, isobaric, aqueous solution of ropivacaine hydrochloride in Water for Injections BP. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0-6.0 during the approved shelf-life. The nominal osmolality of Ropivacaine Kabi 0.2% (2 mg/mL) is 288 mosmol/kg. The solution is preservative free.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

See Section 2 Qualitative and Quantitative Composition.

4 Clinical Particulars

4.9 Overdose

Acute emergencies associated with the use of local anaesthetics are generally related to high plasma levels or to unintended subarachnoid injection of the local anaesthetic solution (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.4 Special Warnings and Precautions for Use).
Accidental intravascular injections of local anaesthetics may cause immediate toxic effects. Toxic effects may also arise from exceptionally rapid absorption from highly vascularised areas. In the event of overdose, peak plasma concentrations may not be reached for one to two hours, depending on the site of the injection and signs of toxicity may thus be delayed. Systemic toxic reactions may involve the central nervous system and the cardiovascular system.
In children, as in adults, early signs of local anaesthetic toxicity may be difficult to detect in cases where the block is given during deep sedation or general anaesthesia.
After intrathecal administration, systemic toxicity is expected to be low, due to the low dose administered. However, an excessive dose administered into the intrathecal space may give rise to total spinal block.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
Symptoms. Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. Initially symptoms such as visual or hearing disturbances, perioral numbness, dizziness, light headedness, tingling and paraesthesia are seen. Dysarthria, muscular rigidity and muscular twitching are more serious and may precede the onset of generalised convulsions.
Unconsciousness and grand mal convulsions may follow, which can last from a few seconds to several minutes. Hypoxia and hypercapnia occur rapidly during convulsions due to the increased muscular activity, together with disruption to respiration and possible loss of functional airways. In severe cases apnoea may occur. Respiratory and metabolic acidosis, hyperkalaemia, hypocalcaemia and hypoxia increase and extend the toxic effects of local anaesthetics.
Recovery follows the redistribution of the local anaesthetic drug from the central nervous system and subsequent metabolism and excretion. Recovery should be rapid unless large amounts of the drug have been injected.
Cardiovascular toxicity indicates a more severe situation. Hypotension, bradycardia, arrhythmia and even cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics. In volunteers the intravenous infusion of ropivacaine hydrochloride resulted in signs of depression of conductivity and contractility.
Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as benzodiazepines or barbiturates. However in rare cases, cardiac arrest has occurred without prodromal CNS effects.
Treatment. If signs of acute systemic toxicity or total spinal block occur, injection of the local anaesthetic should be stopped immediately.
Treatment consists of ensuring adequate ventilation and arresting convulsions. Assisted or controlled ventilation should be maintained with oxygen, if required.
If convulsions occur and do not spontaneously stop within 15-20 seconds, an anticonvulsant should be given intravenously e.g. diazepam 5-10 mg IV or where indicated, sodium thiopentone (5 mg/kg). If convulsions interfere with breathing and/or are not rapidly controlled by specific anticonvulsant medication, suxamethonium (1-2 mg/kg) may be used to paralyse the patient. Artificial ventilation must then be instituted.
If cardiovascular depression is evident (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor and or inotropic agents should be considered. Children aged between 0 and 12 years should be given doses commensurate with their age, weight and clinical status.
If ventricular fibrillation, cardiac arrest or circulatory arrest occur, cardiopulmonary resuscitation must be instituted and maintained. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.
Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the possibility of a successful outcome.
Compatibility and admixtures. Ropivacaine hydrochloride solution for infusion in plastic infusion bags (Polybag) is chemically and physically compatible with fentanyl citrate, morphine sulphate and clonidine hydrochloride. See Table 3.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ROPKAB03.gif Chemical and physical stability of these mixtures have been demonstrated for 30 days at up to 30°C. To reduce microbiological hazard, these admixtures should be used immediately. If not used immediately, store at 2-8°C for not more than 24 hours.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ropivacaine hydrochloride was negative in the Ames Salmonella/ mammalian microsome mutagenicity test, human lymphocyte chromosome aberration test, mouse micronucleus test, E. coli differential DNA repair test, E. coli host mediated DNA repair test in mice, and the somatic mutation and recombination test in Drosophila melanogaster (fruit fly), and weakly mutagenic in the mouse lymphoma test. The clinical use of ropivacaine is unlikely to pose any risk of genotoxicity.
Carcinogenicity. Long-term animal assays of carcinogenic potential have not been performed.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSROPHYD.gif The chemical formula of ropivacaine hydrochloride is C₁₇H₂₆N₂O.HCl.H₂O. The chemical name for ropivacaine hydrochloride is (S)-(-)-propyl- piperidine-2-carboxylic acid (2,6-dimethyl- phenyl)-amide hydrochloride monohydrate.
It is a white crystalline powder and has a water solubility of about 50 mg/mL. Ropivacaine hydrochloride was developed as the pure S-(-)-isomer and has an enantiomeric purity of > 99%. It has a pKa of 8.1 (at 25°C) and a molecular weight of 328.89. The pH of a saturated solution of ropivacaine hydrochloride is 4.5 and that of a 1% (w/v) aqueous solution is 5.0.
CAS number. 84057-95-4.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription.

Summary Table of Changes

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