Ropivacaine 2 Mg/Ml Solution For Injection

Document: leaflet MAH GENERIC_PL 08828-0214 change

01-59-18-XXX

Package leaflet: Information for the user

Ropivacaine 2 mg/ml, 7.5 mg/ml and 10 mg/ml solution for injection

Ropivacaine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor, pharmacist, nurse or any other healthcare professional.

- If you get any side effects, talk to your doctor, pharmacist, nurse or any other healthcare professional. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What Ropivacaine is and what it is used for

2. What you need to know before you use Ropivacaine

3. How to use Ropivacaine

4. Possible side effects

5. How to store Ropivacaine

6. Contents of the pack and other information

1. What Ropivacaine is and what it is used for

Ropivacaine solution for injection contains the active substance ropivacaine hydrochloride which is a type of medicine called local anaesthetic. These are chemical substances that are used to numb an area of the body.

Ropivacaine 2 mg/ml solution for injection is used in adults and children of all ages for acute pain management. It numbs (anaesthetises) parts of the body e.g. after surgery.

Ropivacaine 7.5 mg/ml and 10 mg/ml solution for injection is used in adults and children above 12 years to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to:

- Numb parts of the body during surgery, including having a baby by Caesarean section.

- Relieve pain during childbirth, after surgery, or after an accident.

2. What you need to know before you use Ropivacaine You must not be given Ropivacaine

- if you are allergic to ropivacaine hydrochloride, other so called local

anaesthetics of the amide type or any of the other ingredients of this medicine (listed in section 6).

- if you have a decrease in blood volume (hypovolaemia). This is measured by healthcare personnel.

- for injection into a blood vessel to numb a specific area of your body,

- for injection into the neck of the womb to relieve pain during childbirth.

Warnings and precautions Children

Ropivacaine 2mg/ml solution for injection

- In newborn children as they are more susceptible to Ropivacaine 2 mg/ml solution for injection.

- In children < 12 years as some injections of Ropivacaine 2 mg/ml solution for injection in order to numb parts of the body are not established in younger children.

Ropivacaine 7.5 mg/ml and 10 mg/ml solution for injection

In children up to and including 12 years. Other strengths (2 mg/ml, 5 mg/ml) may be more appropriate).

Special care should be taken to avoid any injection of Ropivacaine directly into a blood vessel to prevent any immediate toxic effects. Injection should not be performed in inflamed areas.

Talk to your doctor, pharmacist, nurse or any other healthcare professional before Ropivacaine is given to you:

- if you are in a poor general conditon due to your age or other factors.

- if you have heart problems (partial or complete heart conduction block)

- if you have advanced liver problems

- if you have severe kidney problems.

Tell your doctor if you have any of these problems because your doctor may need to adjust the dose of Ropivacaine.

Talk to your doctor, pharmacist, nurse or any other healthcare professorial before Ropivacaine is given to you:

- if you suffer from acute porphyria (problems with building up red blood pigment, some times resulting in neurological symptoms).

Tell your doctor if you or somebody in your family have porphyria because your doctor may need to use another anaesthetic.

Other medicines and Ropivacaine

Tell your doctor, pharmacist or healthcare professional if you are taking, have recently taken or might take any other medicines.

Caution should be exercised if you are receiving:

- Other local anaesthetics (e.g. lidocaine) or agents structurally related to amide-type local anaesthetics, e.g. certain medicines used to treat an irregular heart beat (arrhythmia), such as mexiletine or amiodarone

- General anaesthetics or opioids, such as morphine or codeine

- Medicines used to treat depression (e.g. fluvoxamine)

- Certain antibiotics (e.g. enoxacin)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Driving and using machines

Ropivacaine may make you feel sleepy and affect the speed of your reactions. After you have been given Ropivacaine, you should not drive or use any tools or machines until the next day.

Discuss with your doctor or pharmacist if you are unsure about anything.

Important information about some of the ingredients of Ropivacaine

This medicinal product contains a maximum of 0.148 mmol (or 3.4 mg) sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. How to use Ropivacaine Dosage

The dose used will depend on what it is being used for and also on your health, age and weight. The smallest dose that can produce

effective numbing (anaesthesia) of the required area should be used.

The usual dose

- for adults and adolescents older than 12 years of age is between 2 mg and 300 mg

of ropivacaine hydrochloride.

- in infants and children (0 up to and including 12 years of age) is 1-2 mg for each kilogram of body weight.

Method of administration

Your doctor will administer Ropivacaine to you. It is administered by injection.

Duration of treatment

Administration of ropivacaine hydrochloride usually takes between 2 to 10 hours in case of anaesthesia prior to certain surgeries and can take up to 72 hours in case of pain relief during or after surgery.

If you are given more Ropivacaine than you should be

The first symptoms of being given too much ropivacaine hydrochloride are usually problems with

- hearing and sight,

- numbness around the mouth,

- dizziness or light-headedness,

- tingling,

- speech disorder characterised by poor articulation (dysarthria),

- muscular stiffness, muscular twitching, fits (convulsions),

- low blood pressure,

- slow or irregular heart beat.

These symptoms may precede to cardiac arrest, breathing arrest or severe fits.

If you experience any of these symptoms or think you may have received too much Ropivacaine, tell your doctor or healthcare personnel immediately.

In case of acute toxicity, appropriate corrective actions will be taken immediately by the healthcare personnel.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, nurse or any other healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects to look out for:

Sudden life-threatening allergic reactions (such as anaphylaxis, angioneurotic oedema and urticaria) are rare. Possible symptoms include

- sudden onset of rash,

- itching or lumpy rash (hives),

- swelling of the face, lips, tongue or other parts of the body,

- and shortness of breath, wheezing or difficulty breathing.

If you think that Ropivacaine is causing an allergic reaction, tell your doctor or healthcare personnel immediately.

	Concen tration mg/ml	Volume ml	Dose mg	Onset minutes	Duration hours
Lumbar Epidural Administration
BoIus	2.0	10-20	20-40	10-15	0.5-1.5
intermittent injections (top-up) (e.g, labour pain management)	2.0	10-15 (minimum interval 30 minutes)	20-30
Continuous infusion e.g. labour pain	2.0	6-10 ml/h	12-20 mg/h	n/a	n/a
Postoperative pain management	2.0	6-14 ml/h	12-28 mg/h	n/a	n/a
Thoracic Epidural Administration Continuous infusion (postoperative pain management)	2.0	6-14 ml/h	12-28 mg/h	n/a	n/a
Field Block (e.g. minor nerve blocks and infiltration)	2.0	1-100	2.0-200	1-5	2-6
Peripheral nerve block (Femoral or interscalene block) Continuous infusion or intermittent injections (e.g. postoperative pain management)	2.0	5-10 ml/h	10-20 mg/h	n/a	n/a

n/a = not applicable

Paediatric patients from 0 up to and including 12 years of age

	Concen-tration	Volume	Dose
	mg/ml	ml/kg	mg/kg
Single Caudal Epidural Block Blocks below T12, in children with a body weight up to 25 kg	2.0	1	2
Continuous Epidural Infusion In children with a body weight up to 25 kg
0 up to 6 months
Bolus dose^a	2.0	0.5-1	1-2
Infusion up to 72 hours 6 up to 12 months	2.0	0.1 ml/kg/h	0.2 mg/kg/h
Bolus dose^a	2.0	0.5-1	1-2
Infusion up to 72 hours	2.0	0.2 ml/kg/h	0.4 mg/kg/h
1 to 12 years
Bolus dose^b	2.0	1	2
Infusion up to 72 hours	2.0	0.2 ml/kg/h	0.4 mg/kg/h

The following information is intended for healthcare professionals only:

Handling ^{1 2}

Method of administration

Perineural and epidural administration by injection.

Careful aspiration before and during administration is recommended to prevent intravascular injection. When a large dose is to be injected, a test dose of 3-5 ml lidocaine 2% (lignocaine) with adrenaline (epinephrine) 1:200.000 is recommended. An inadvertent intravascular injection may be recognised by a temporary increase in heart rate and an accidental intrathecal injection by signs of a spinal block.

Aspiration should be performed prior to and during administration of the main dose, which should be injected slowly or in incremental doses, at a rate of 25-50 mg/min, while closely observing the patient’s vital functions and maintaining verbal contact. If toxic symptoms occur, the injection should be stopped immediately.

In epidural block for surgery, single doses of up to 250mg ropivacaine hydrochloride have been used and well tolerated.

In brachial plexus block a single dose of 300mg has been used in a limited number of patients and was well tolerated.

When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. Cumulative doses up to 675 mg ropivacaine hydrochloride for surgery and postoperative analgesia administered over 24 hours were well tolerated in adults, as were postoperative continuous epidural infusions at rates up to 28 mg/hour for 72 hours. In a limited number of patients higher doses of up to 800 mg/ day have been administered with relatively few adverse reactions.

The maximum duration of epidural block is 3 days. However, close monitoring of analgesic effect should be performed in order to remove the catheter as soon as the pain condition allows it. With this technique a significant reduction in the need for opioids has been observed.

In clinical studies an epidural infusion of ropivacaine hydrochloride 2 mg/ml alone or mixed with fentanyl 1-4 pg/ml has been given for postoperative pain management for up to 72 hours. The combination of ropivacaine hydrochloride and fentanyl provided improved pain relief but caused opioid side effects. The combination of ropivacaine hydrochloride and fentanyl has been investigated only for ropivacaine hydorchloride 2 mg/ml.

When prolonged peripheral nerve blocks are applied, either through continuous infusion or through repeated injections, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. In clinical studies, femoral nerve block was established with 300 mg ropivacaine hydrochloride 7.5 mg/ml and interscalene block with 225 mg ropivacaine hydrochloride 7.5 mg/ml, respectively, before surgery. Analgesia was then maintained with ropivacaine hydrochloride 2 mg/ml. Infusion rates or intermittent injections of 10-20 mg per hour for 48 hours provided adequate analgesia and were well tolerated.

Concentrations above 7.5 mg/ml ropivacaine hydrochloride have not been documented for Caesarean section.

Renal impairment

Normally there is no need to modify the dose in patients with impaired renal function when used for single dose or short-term treatment.

Hepatic impairment

Ropivacaine hydrochloride is metabolised in the liver and should therefore be used with caution in patients with severe liver disease. Repeated doses may need to be reduced due to delayed elimination.

The dose in the table should be regarded as guidelines for use in paediatrics. Individual variations occur. In children with a high body weight a gradual reduction of the dosage is often necessary and should be based on the ideal body weight. The volume for single caudal epidural block and the volume for epidural bolus doses should not exceed 25 mL in any patient. Standard textbooks should be consulted for factors affecting specific block techniques and for individual patient requirements.

^a Doses in the low end of the dose interval are recommended for thoracic epidural blocks while doses in the high end are recommended for lumbar or caudal epidural blocks.

^b Recommended for lumbar epidural blocks. It is good practice to reduce the bolus dose for thoracic epidural analgesia

Infants and children aged 1-12 years:

The proposed ropivacaine doses for peripheral block in infants and children provide guidelines for use in children without severe disease. More conservative doses and close monitoring are recommended for children with severe disease.

Single injections for peripheral nerve block (e.g. ilioinguinal nerve block, brachial plexus block) should not exceed 2.5-3.0 mg/kg.

Continuous infusion for peripheral nerve block are recommended at 0.2-0.6 mg/kg/h (0.1-0.3 ml/kg/h) up to 72 h.

The use of ropivacaine in premature children has not been documented.

	Concentration	Volume ml	Dose mg	Onset	Duration
	mg/ml			minutes	hours
SURGICAL ANAESTHESIA
Lumbar Epidural Administration
Surgery	7.5	15-25	113-188	10-20	3-5
	10.0	15-20	150-200	10-20	4-6
Caesarean section	7.5	15-20	113-150°	10-20	3-5
Thoracic Epidural Administration
		5-15
To establish block for postoperative pain relief	7.5	(dependent on the level of injec-	38-113	10-20	n/a²⁾
		tion)
Major Nerve Block*
Brachial plexus block	7.5	30-40	225 300²	10-25	6-10
Field Block
(e.g. minor nerve blocks and infiltration)	7.5	1-30	7.5-225	1-15	2-6

This medicinal product is authorised in the Member States of the EEA under the following names:

The Netherlands	Ropivacaine HCl Fresenius Kabi 2 mg/ml oplossing voor injectie Ropivacaine HCl Fresenius Kabi 7,5 mg/ml oplossing voor injectie Ropivacaine HCl Fresenius Kabi 10 mg/ml oplossing voor injectie
Belgium	Ropivacaine Fresenius Kabi 2 mg/ml oplossing voor injectie / solution injectable / Injektionslosung Ropivacaine Fresenius Kabi 7,5 mg/ml oplossing voor injectie / solution injectable / Injektionslosung Ropivacaine Fresenius Kabi 10 mg/ml oplossing voor injectie / solution injectable / Injektionslosung
Bulgaria	Ropivacain Kabi 2 mg/ml, MHwex^uoHeH pa3TBop Ropivacain Kabi 7,5 mg/ml, MHwex^uoHeH pa3TBop Ropivacain Kabi 10 mg/ml, MHwex^uoHeH pa3TBop
Cyprus	Ropivacaine Kabi 2 mg/ml, evssipo diaAupa Ropivacaine Kabi 7,5 mg/ml, evssipo diaAupa Ropivacaine Kabi 10 mg/ml, evssipo diaAupa
Germany	Ropivacainhydrochlorid Kabi 2 mg/ml Injektionslosung Ropivacainhydrochlorid Kabi 7,5 mg/ml Injektionslosung Ropivacainhydrochlorid Kabi 10 mg/ml Injektionslosung
Denmark	Ropivacain Fresenius Kabi injektionsv^ske, oplosning, 2 mg/ml Ropivacaine Fresenius Kabi, injektionsv^ske, oplosning,7.5 mg/ml Ropivacaine Fresenius Kabi, injektionsv^ske, oplosning,10 mg/ml
Greece	Ropivacaine Kabi 2 mg/ml, evssipo diaAupa Ropivacaine Kabi 7,5 mg/ml, evssipo diaAupa Ropivacaine Kabi 10 mg/ml, evssipo diaAupa
Spain	Ropivacaina Kabi 2 mg/ml solucion inyectable Ropivacaina Kabi 7,5 mg/ml solucion inyectable Ropivacaina Kabi 10 mg/ml solucion inyectable
Finland	Ropivacain Fresenius Kabi 2 mg/ml injektioneste, liuos Ropivacain Fresenius Kabi 7,5 mg/ml injektioneste, liuos Ropivacain Fresenius Kabi 10 mg/ml injektioneste, liuos
France	Ropivacaine Kabi 2 mg/ml, solution injectable Ropivacaine Kabi 7,5 mg/ml, solution injectable Ropivacaine Kabi 10 mg/ml, solution injectable
Ireland	Ropivacaine 2 mg/ml solution for injection Ropivacaine 7.5 mg/ml solution for injection
Italy	Ropivacaina Kabi 2mg/ml Soluzione iniettabile Ropivacaina Kabi 7,5mg/ml soluzione iniettabile Ropivacaina Kabi 10 mg/ml soluzione iniettabile
Luxemburg	Ropivacainhydrochlorid Kabi 2 mg/ml Injektionslosung Ropivacainhydrochlorid Kabi 7,5 mg/ml Injektionslosung Ropivacainhydrochlorid Kabi 10 mg/ml Injektionslosung
Norway	Ropivacain Fresenius Kabi 2 mg/ml injeksjonsvaske, opplosning Ropivacain Fresenius Kabi 7,5 mg/ml injeksjonsvaske, opplosning Ropivacain Fresenius Kabi 10 mg/ml injeksjonsvaske, opplosning
Portugal	Ropivacaina Kabi 2 mg/mL solugao injectavel Ropivacaina Kabi 7,5 mg/mL solugao injectavel Ropivacaina Kabi 10 mg/mL solugao injectavel
Romania	Ropivacaina Kabi 2 mg/ml solutie injectabila Ropivacaina Kabi 7,5 mg/ml solutie injectabila Ropivacaina Kabi 10 mg/ml solutie injectabila
Sweden	Ropivacain Fresenius Kabi 2 mg/ml, injektionsvatska, losning Ropivacain Fresenius Kabi 7,5 mg/ml, injektionsvatska, losning Ropivacain Fresenius Kabi 10 mg/ml, injektionsvatska, losning
Slovenia	Ropivakainijev klorid Kabi 7,5 mg/ml raztopina za injiciranje Ropivakainijev klorid Kabi 10 mg/ml raztopina za injiciranje
UK	Ropivacaine 2 mg/ml solution for injection Ropivacaine 7.5 mg/ml solution for injection Ropivacaine 10 mg/ml solution for injection
The leaflet was last revised in September 2013

Other possible side effects:

Very common (may affect more than 1 in 10 people)

• Low blood pressure (hypotension). This might make you feel dizzy or light-headed.

• Feeling sick (nausea)

Common (may affect up to 1 in 10 people)

• Headache, pins and needles (paraesthesia), feeling dizzy

• Slow or fast heart beat (bradycardia, tachycardia)

• High blood pressure (hypertension)

• Being sick (vomiting)

• Difficulty in passing urine (urinary retention)

• Back pain, increased temperature, muscular stiffness (rigor)

Uncommon (may affect up to 1 in 100 people)

• Anxiety

• Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much Ropivacaine (see also section 3 "If you are given more Ropivacaine than you should be" above).

These include fits (convulsions, seizures), feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with your sight (vision), problems with your speech (dysarthria), muscular twitching and trembling, reduced sense of touch (hypoaesthesia)

• Fainting (syncope)

• Difficulty breathing (dyspnoea)

• Low body temperature

Rare (may affect up to 1 in 1000 people)

• Cardiac arrest, irregular heart beat (cardiac arrhythmias)

Possible side effects seen with other local anaesthetics which might also be caused by Ropivacaine include:

• Numbness, due to nerve irritation caused by the needle or the injection. This does not usually last for long.

• Damaged nerves. Rarely, this may cause permanent problems.

• If too much Ropivacaine is given into the spinal fluid, the whole body may become numbed (anaesthetised).

Children

In children, the side effects are the same as in adults except for low blood pressure which happens less often in children (affecting less than 1 in 10 children) and being sick which happens more often in children (affecting more than 1 in 10 children).

If you get any side effects, talk to your doctor, pharmacist, nurse or any other healthcare professional. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

For UK - You can also report side effects directly via the Yellow Card Scheme at: HYPERLINK http://www.mhra.gov.uk/yellowcard www.mhra.gov.uk/yellowcard

Method of administration

Epidural administration by injection.

Careful aspiration before and during injection is recommended to prevent intravascular injection. The patient’s vital functions should be observed closely during the injection. If toxic symptoms occur, the injection should be stopped immediately.

A single caudal epidural injection of ropivacaine hydrochloride 2 mg/ml produces adequate postoperative analgesia below T12 in the majority of patients when a dose of 2 mg/kg is used in a volume of 1 ml/kg. The volume of the caudal epidural injection may be adjusted to achieve a different distribution of sensory block, as recommended in standard textbooks. In children above 4 years of age, doses up to 3 mg/kg of a concentration of ropivacaine hydrochloride 3 mg/ml have been studied. However, this concentration is associated with a higher incidence of motor block.

Fractionation of the calculated local anaesthetic dose is recommended, whatever route of administration.

In case infusion of ropivacaine hydrochloride is recommended, Ropivacaine solution for infusion can be used.

Ropivacaine Kabi 7.5 mg/ml and Ropivacaine 10 mg/ml solution for injection Adults and children above 12 years of age

The following table is a guide to dosage for the more commonly used blocks. The smallest dose required to produce an effective block should be used. The clinician's experience and knowledge of the patient's physical status are of importance when deciding the dose.

5. How to store Ropivacaine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister, ampoule or carton box. The expiry date refers to the last day of that month.

Do not refrigerate or freeze.

Do not use this medicine if you notice any precipitation in the solution for injection.

Your doctor or the hospital will normally store Ropivacaine and they are responsible for the quality of the product when it has been opened if it is not used immediately. They are also responsible for disposing of any unused Ropivacaine correctly.

Do not throw away any medicines via waste water or household waster. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Ropivacaine solution for injection contains

- The active substance is ropivacaine hydrochloride.

- For Ropivacaine 2 mg/ml solution for injection:

Each 10 ml polypropylene ampoule contains 20 mg ropivacaine hydrochloride.

Each 20 ml polypropylene ampoule contains 40 mg ropivacaine hydrochloride.

- For Ropivacaine 7.5 mg/ml solution for injection:

Each 10 ml polypropylene ampoule contains 75 mg ropivacaine hydrochloride.

Each 20 ml polypropylene ampoule contains 150 mg ropivacaine hydrochloride.

- For Ropivacaine 10 mg/ml solution for injection:

Each 10 ml polypropylene ampoule contains 100 mg ropivacaine hydrochloride.

Each 20ml polypropylene ampoule contains 200 mg ropivacaine hydrochloride.

- The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Ropivacaine looks like and contents of the pack

Ropivacaine solution for injection is a clear, colourless solution.

Ropivacaine 2 mg/ml, 7.5 mg/ml and 10 mg/ml solution for injection are available in 10 ml and 20 ml transparent polypropylene ampoules.

Pack sizes:

1, 5, 10 ampoule(s) in blister pack Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Limited

Cestrian Court, Eastgate Way, Manor Park,

Runcorn, Cheshire WA7 1NT United Kingdom Manufacturer Fresenius Kabi Norge AS NO-1753 Halden,

Norway * With regard to major nerve block, only for brachial plexus block a dose

recommendation can be given. For other major nerve blocks lower doses may be required. However, there is presently no experience of specific dose recommendations for other blocks.

1) Incremental dosing should be applied, the starting dose about 100 mg (97.5 mg = 13 ml; 105 mg = 14 ml) to be given over 3-5 minutes. Two extra doses, in total an additional 50mg, may be administered as needed.

2) n/a = not applicable

3) The dose for a major nerve block must be adjusted according to site of administration and patient status. Interscalene and supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used.

Method of administration

Perineural and epidural administration by injection.

Careful aspiration before and during injection is recommended to prevent intravascular injection. When a large dose is to be injected, a test dose of 3-5 ml lidocaine 2% (lignocaine) with adrenaline (epinephrine) 1:200.000 is recommended. An inadvertent intravascular injection may be recognised by a temporary increase in heart rate and an accidental intrathecal injection by signs of a spinal block.

In epidural block for surgery, single doses of up to 250 mg ropivacaine hydrochloride have been used and well tolerated.

In brachial plexus block a single dose of 300 mg has been used in a limited number of patients and was well tolerated.

When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. Cumulative doses up to 675 mg ropivacaine hydrochloride for surgery and postoperative analgesia administered over 24 hours were well tolerated in adults, as were postoperative continuous epidural infusions at rates up to 28 mg/hour for 72 hours. In a limited number of patients higher doses of up to 800 mg/day have been administered with relatively few adverse reactions.

For treatment of postoperative pain, the following technique can be recommended: Unless preoperatively instituted, an epidural block with Ropivacaine 7.5 mg/ml is induced via an epidural catheter. Analgesia is maintained with Ropivacaine 2 mg/ml infusion. Infusion rates of 6-14 ml (12-28 mg), per hour provide adequate analgesia with only slight and non-progressive motor block in most cases of moderate to severe postoperative pain. The maximum duration of epidural block is 3 days. However, close monitoring of analgesic effect should be performed in order to remove the catheter as soon as the pain condition allows it. With this technique a significant reduction in the need for opioids has been observed.

Concentrations above 7.5 mg/ml ropivacaine hydrochloride have not been documented for Caesarean section.

Renal impairment

Normally there is no need to modify the dose in patients with impaired renal function when used for single dose or short-term treatment.

Hepatic impairment

Paediatric population up to and including 12 years

The use of Ropivacaine 7,5 mg/ml may be associated with systemic and central toxic events in children. Lower strengths (2 mg/ml, 5 mg/ml) are more appropriate for administration to this population.

In general, surgical anaesthesia (e.g. epidural administration) requires the use of the higher concentrations and doses. The Ropivacaine 10 mg/ml formulation is recommended for epidural anaesthesia in which a complete motor block is essential for the surgery.

For analgesia (e.g. epidural administration for acute pain management) the lower concentrations and doses are recommended.

Incompatibilities

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

In alkaline solutions precipitation may occur as ropivacaine hydrochloride shows poor solubility at pH > 6.0.

Disposal

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

FRESENIUS KABI

V004/UK

01-59-18-xxx

15918XXX_UK.indd 2 2013-10-02 14:29:02

Ropivacaine should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia (see section 3).

Shelf life

Shelf-life before opening

years

Shelf-life after opening

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C.

Ropivacaine products are preservative free and are intended for single use only. Discard any unused solution.

The medicinal product should be visually inspected prior to use. The solution should only be used if it is clear, practically free from particles and if the container is undamaged.

The intact container must not be re-autoclaved.

Posology

Ropivacaine 2 mg/ml solution for injection Adults and children above 12 years of age