Ropivacaine 2mg/ml Solution for Infusion

Ropivacaine Hydrochloride

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.

•    The full name of this medicine is Ropivacaine 2mg/ml Solution for Infusion but within the leaflet it will be referred to as Ropivacaine solution.

In this leaflet:

T| What Ropivacaine solution is and what it is used for

"21 Before Ropivacaine solution is given to you

3) How Ropivacaine solution is given to you

"4 Possible side effects

3| How to store

"6 Further information

T| What Ropivacaine solution is and what it is used for

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

3) Before Ropivacaine solution is given to you

You must not be given Ropivacaine solution:

•    If there is hypersensitivity to ropivacaine, to other amide-type local anesthetic or any of the other ingredients of Ropivacaine solution.

•    General contraindications connected with anesthesia in the vicinity of the nerves in the sacral region (epidural anesthesia) should be observed irrespective of the local anesthetic used.

•    For intravenous regional anesthesia.

•    For anesthesia in obstetrics (paracervical anesthesia).

•    In persons with hypovolemia (decrease in the amount of blood in the bloodstream).

Take special care with Ropivacaine solution:

•    If you suffer from problems with your heart, liver or kidney. If so, tell your doctor, because he might need to adjust the doses of Ropivacaine solution.

•    If you or anyone in your family has ever been told that you have a rare disease of the blood pigment (porphyria). If so, tell your doctor because he may need to give you an other anesthetic medicine.

•    Before treatment with Ropivacaine solution, tell your doctor about any diseases or medical conditions that you have.

•    If you are not sure if any of the above applies to you, talk to your doctor before you are given Ropivacaine solution.

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

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

Taking/ Using other medicines

Please tell your doctor if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.

Ropivacaine solution should only be used with caution if you are taking/ receiving:

•    other anesthetics

•    medicines used for the treatment of heart-rhythm disturbances (antiarrhythmics)

•    strong pain relievers (opioids)

The simultaneous use of Ropivacaine solution and one of the above mentioned medicines can strengthen their respective effects and side effects.

Prolonged use of ropivacaine should be avoided if you are receiving/ taking:

•    medicines for depression (e.g. fluvoxamine)

•    antibiotics for treatment of bacterial infections (e.g. enoxacin)

Your body takes longer to get rid of Ropivacaine solution if you are taking one of these medicines.

Pregnancy and breast-feeding

Before you are given Ropivacaine solution, tell your doctor if you are pregnant, if you intend to become pregnant or if you are breast-feeding. It is unknown if ropivacaine influences pregnancy or passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, a slight effect on mental functions and coordination can be expected, depending on the dose. Motoricity and reaction speed may be temporarily impaired, even if there are no other clear signs of poisoning of the central nervous system (central nervous system toxicity).

You should not drive or use tools or machines after you have been given Ropivacaine solution until the next day.

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

Ropivacaine 2mg/ml Solution for Infusion

Ropivacaine Hydrochloride

Handling

The medicinal product should be visually examined before use. The solution should only be used if it is clear and practically free from particulate matter and if the container is undamaged.

The intact container must not be re-autoclaved. Container in sterile pouch should be chosen when a sterile outside is required.

Posology

See the Summary of Product Characteristics for information on posology.

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Method of administration

Perineural and epidural administration via injection or infusion.

Ropivacaine solution should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia.

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Ropivacaine 2mg/ml Solution for Infusion PIL - UK			colours/plates:
			1. Black
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	print proof no: 4	pharmacode:	3.
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	origination date: 19/06/12	min pt size:	5.
@ artworkstudio@actavis.co.uk	originated by: C.Paull		6.
approved for print/date	revision date: 05-07-12	Technical Approval	Non Printing Colours
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	revised by: BW	date sent: 19/06/12 (resent 05-07-12 BW)
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Important information about some of the ingredients of Ropivacaine solution:

1 ml contains 3.6mg sodium. You have to take this into consideration if you are on a controlled sodium diet.

3) How Ropivacaine solution is given to you

Ropivacaine solution is given to you by a doctor. The dose that you receive depends on your body size, age, physical condition and on which kind of pain relief you need.

You will receive Ropivacaine 2mg/ml Solution for Infusion as an infusion in one of the following places:

•    the body part that has to be numbed

•    near the body part that has to be numbed, or

•    in an area away from the part of the body that has to be numbed, for example if you are given an epidural infusion (into the area around the spinal cord).

After the administration of Ropivacaine solution, you won't feel pain, heat or cold, but you are able to feel pressure and touch.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you you have been given too much Ropivacaine solution

Serious side effects caused by an administration of too much Ropivacaine solution needs special treatment and the doctor treating you is trained to handle such situations (see section 4 for possible side effects related to overdose).

"4 Possible side effects

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

Important side effects to pay attention to:

Allergic reactions in a life threatening occurrence, such as anaphylaxis are rare (affecting less than 1 in 1000 people). Possible symptoms to look out for, are swelling of the face, lips, tongue or other parts of the body, breathlessness, wheezing or difficult breathing. Tell your doctor immediately, if you think that Ropivacaine solution is causing an allergic reaction.

Other possible side effects

Very common (affects more than 1 user in 10):

•    Low blood preasure (hypotension)

•    Feeling sick (nausea)

Common (affects less than 1 in 10 people):

•    Pins and needles

•    Dizziness

•    Headache

•    Slow or fast heart beat (bradycardia, tachycardia)

•    High blood pressure (hypertension)

•    Being sick (vomiting)

•    Difficulty in passing urine

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•    High temperature (fever) or stiffness (rigor)

•    Back pain

Uncommon (affects less than 1 in 100 people):

•    Anxiety

•    Decreased sensitivity or feeling in the skin

•    Fainting

•    Difficulty with breathing

•    Low body temperatrue (hypothermia)

•    Some symptoms can happen if the injection was given into a blood vessel by a mistake, or if you have been given too much Ropivacaine solution (see also "If you have been given too much Ropivacaine solution"). These include fits (seizures), numbness, tingling or pins and needles, feeling dizzy or light-headed, numbness of lips and around the mouth, numbness of the tongue, visual and auditory disturbances, problems with your speech, stiffmuscles and trembling.

Rare (affects less than 1 in 1000 people):

•    Heart attack (cardiac arrest)

•    Uneven heart beat (arrhythmias)

•    Itchy skin rash

Other possible side effects

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

The first signs of an overdose of Ropivcaine solution are:

•    dizziness or light headedness,

•    visual or auditory disturbances,

•    numbness of the lips and around the mouth,

•    numbness of the tongue.

Tell your doctor immediately, if any of these symptoms happen to you or when you think that you received too much of Ropivcaine solution. He will stop giving you Ropivcaine solution to reduce the risk of serious side effects.

Further serious side effects caused by too high doses of Ropivcaine solution are problems with speech, tingling, tremor, twitching of your muscles, fits (seizures) and loss of consciousness.

Possible side effects of other local anaesthetics which might also be caused by Ropivacaine solution

•    Rare (affecting less than 1 in 1000 people): damaged nerves. This may cause permanent problems.

•    The whole body may get numbed (anesthesised), if too much Ropivacaine solution is injected into the spinal fluid.

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).

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

3| How to store

Keep out of the reach and sight of children.

Do not use Ropivacaine solution after the expiry date which is stated on the pack.

Do not freeze.

Do not store above 30°C.

In-use shelf-life:

From 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 2-8 °C.

Usually Ropivacaine solution is stored in pharmacies and hospitals. If this medicinal product is not used immediately, the responsibility for its storage lies with the doctors. They are also responsible for the correct disposal. Residues of this medicinal product and all equipment used in its reconstitution, dilution, and administration must be destroyed in accordance with the hospital's standard procedures, with due observation of legal regulations for disposal of hazardous waste.

"6 Further information

What Ropivacaine solution contains

The active substance is ropivacaine hydrochloride.

1ml contains 2.12mg ropivacaine hydrochloride monohydrate, equivalent to 2mg of ropivacaine hydrochloride.

The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (3.6%)

(for pH adjustment) and water for injection.

What Ropivacaine solution looks like and contents of the pack

Ropivacaine solution is a clear, colourless solution for infusion.

Ropivacaine solution is in plastic bags (PP) which are packed sterile in blister pouches or see through pouches. Pack size:

5 x 200ml bags

Marketing Authorisation Holder

Actavis Group PTC ehf, Reykjavikurvegi 76-78,

Hafnarfjordur, Iceland

Manufacturers:

Actavis Nordic A/S, Ornesgardsvej 16, 2820 Gentofte, Denmark

Actavis Deutschland GmbH & Co.KG, Willy-Brandt-Allee 2,

81829 Munchen, Germany

This leaflet was last revised in June 2012

Actavis

Actavis, Barnstaple, EX32 8NS, UK

May not be administered in intravenous regional anaesthesia or in obstetric paracerivical anaesthesia. Careful aspiration before and during infusion is recommended to prevent intravascular injection. The patient's vital functions should be observed closely during the infusion. If toxic symptoms occur, the infusion should be stopped immediately. Fractionation of the calculated local anaesthetic dose is recommended, whatever rout of administration.

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Treatment of acute toxicity

Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available. If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately. See the Summary of Product Characteristics for further information.

Incompatibilities

In alkaline solution precipitation may occur as ropivacaine shows poor solubility at pH>6.

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Shelf-life and storage

Ropivacaine solution contains no preservatives. For single use only. Discard any unused solutions in line with standard procedure for disposal of hazardous waste.

actavis

Actavis, Barnstaple, EX32 8NS, UK

Ropivacaine 2mg/ml Solution for Infusion PIL - UK			colours/plates:
			1. Black
^actavis creating value In pharmaceuticals t 00441271 311400 f 00441271 311449	item no: AAAD9332	dimensions: 220x190	2.
	print proof no: 4	pharmacode:	3.
			4.
	origination date: 19/06/12	min pt size:	5.
@ artworkstudio@actavis.co.uk	originated by: C.Paull		6.
approved for print/date	revision date: 05-07-12	Technical Approval	Non Printing Colours
			1.
	revised by: BW	date sent: 19/06/12 (resent 05-07-12 BW)
			2.
	supplier: Holopack	technically app. date: 05-07-12 BW	3.