Document: leaflet MAH GENERIC_PL 12762-0466 change

• leaflet MAH GENERIC_PL 08828-0215
• leaflet MAH GENERIC_PL 12762-0466

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Read all of this leaflet carefully before you start using this medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Ropivacaine is and what it is used for

2. Before you use Ropivacaine

3. How to use Ropivacaine

4. Possible side effects

5. How to store Ropivacaine

6. Further information

This product will be referred to as Ropivacaine from here on.

1.    WHAT ROPIVACAINE IS AND WHAT IT IS USED FOR

Ropivacaine contains the active substance ropivacaine hydrochloride which is a type of medicine called local anaesthetic. Ropivacaine 2 mg/ml solution for infusion is used in adults and children of all ages for acute pain management. It numbs (anaesthetises) parts of the body e.g. after surgery.

2.    BEFORE YOU USE ROPIVACAINE You must not be given Ropivacaine

•    if you are allergic (hypersensitive) to rop-ivacaine hydrochloride, other so called local anaesthetics of the amide type or any of the other ingredients of Ropivacaine,

•    if you have a decrease in blood volume

(hypovolaemia). This is measured by healthcare personnel.

•    for infusion into a blood vessel to numb a specific area of your body,

•    for infusion into the neck of the womb

to relieve pain during childbirth.

Take special care with Ropivacaine

•    In newborn children as they are more susceptible to Ropivacaine.

•    In children < 12 years as some injections of Ropivacaine in order to numb parts of the body are not established in younger children.

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

Please tell your doctor:

•    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.

Please tell your doctor:

•    if you suffer from acute porphyria (problems with building up red blood pigment, sometimes 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. Taking other medicines Please tell your doctor or healthcare personnel if you are taking or have recently

taken any other medicines, including medicines obtained without a prescription.

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 ami-odarone

•    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

Before you are given Ropivacaine please tell your doctor if you are pregnant, planning to get pregnant, or if you are breastfeeding. It is not known if ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

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 0.147 mmol (or 3.39 mg) sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO USE ROPIVACAINE Method of administration Your doctor will administer Ropivacaine to you. It is administered by infusion.

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 200 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.

Duration of treatment

Administration of ropivacaine hydrochloride usually takes between 0.5 to 6 hours but 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 proceed 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 product, ask your doctor or pharmacist.

The following information is intended for medical or healthcare professionals only:

Handling

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 30 months

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 reautoclaved.

Posology

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. Method of administration Perineural and epidural administration by infusion.

Careful aspiration before and during administration is recommended to prevent intravascular administration. When a large dose is to be injected, a test dose of 3-5 ml lidocaine 2% (lig-nocaine) with adrenaline (epinephrine) 1:200.000 is recommended. An inadvertent intravascular infusion 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 2550 mg/min, while closely observing the patient’s vital functions and maintaining verbal contact. If toxic symptoms occur, the infusion should be stopped immediately.

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.

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 hy-dorchloride 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. Paediatric patients 0 up to and including 12 years of age

Bolus dose^a Infusion up to 72 hours 6 up to 12 months Bolus dose^a Infusion up to 72 hours 1 to 12 years Bolus dose^b

Infants and children aged 1-12years:

The proposed ropivacaine hydrochloride 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 hydrochloride in premature children has not been documented.

2.0	0.5-1	1-2
2.0	0.1 ml/kg/h	0.2 mg/kg/h
2.0	0.5-1	1-2
2.0	0.2 ml/kg/h	0.4 mg/kg/h

Method of administration Epidural administration by infusion. Careful aspiration before and during application is recommended to prevent intravascular application. The patient’s vital functions should be observed closely during the infusion. If toxic symptoms occur, the infusion 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 injection of ropivacaine hydrochloride is recommended, Ropivacaine solution for injection can be used. Incompatibilities

Compatibilities with other solutions than those mentioned below have not been investigated. In alkaline solutions precipitation may occur as ropivacaine hydrochloride shows poor solubility at pH > 6.0.

Ropivacaine solution for infusion in plastic infusion bags is chemically and physically compatible with the following drugs:

Concentration of Ropivacaine: 1-2 mg/ml

Additive

Fentanyl citrate Sufentanil citrate Morphine sulphate Clonidine hydrochloride

* The concentration ranges stated in the table are wider than those used in clinical practice. Epidural infusions of Ropivacaine /sufentanil citrate, Ropivacaine /morphine sulphate and Ropivacaine/clonidine hydrochloride have not been evaluated in clinical studies.

The mixtures are chemically and physically stable for 30 days at 20 to 30°C. From a microbiological point of view, the mixtures 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 2-8°C.

Disposal

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