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ROPIVACAINE 2MG/ML SOLUTION FOR INFUSION

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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:
1 What Ropivacaine solution is and
what it is used for
2 Before Ropivacaine solution is given
to you
3 How Ropivacaine solution is given to
you
4 Possible side effects
5 How to store
6 Further information

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1 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.

2 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.

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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.
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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.

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
item no: AAAD9332

dimensions: 220x190

print proof no: 4

pharmacode:

origination date: 19/06/12

min pt size:

1. Black
2.
3.
4.
5.
6.

originated by: C.Paull
approved for print/date

colours/plates:

revision date: 05-07-12

Technical Approval

revised by: BW

date sent: 19/06/12 (resent 05-07-12 BW)

supplier: Holopack

technically app. date: 05-07-12 BW

Non Printing Colours
1.
2.
3.

Important information about some of the
ingredients of Ropivacaine solution:

1ml 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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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).

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.

5 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, Barnstaple, EX32 8NS, UK

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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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• 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, stiff muscles 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.

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.

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.

Incompatibilities

In alkaline solution precipitation may occur as
ropivacaine shows poor solubility at pH>6.
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Actavis, Barnstaple, EX32 8NS, UK

Ropivacaine 2mg/ml Solution for Infusion PIL - UK
item no: AAAD9332

dimensions: 220x190

print proof no: 4

pharmacode:

origination date: 19/06/12

min pt size:

1. Black
2.
3.
4.
5.
6.

originated by: C.Paull
approved for print/date

colours/plates:

revision date: 05-07-12

Technical Approval

revised by: BW

date sent: 19/06/12 (resent 05-07-12 BW)

supplier: Holopack

technically app. date: 05-07-12 BW

Non Printing Colours
1.
2.
3.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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