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ROPIVACAINE 2MG/ML SOLUTION FOR INJECTION

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Ropivacaine 2mg/ml, 7.5mg/ml and
10mg/ml Solution for Injection
Ropivacaine Hydrochloride
Take special care with Ropivacaine solution:
Read all of this leaflet carefully before
• If you suffer from problems with your heart, liver
you start using this medicine.
or kidney. If so, tell your doctor, because he might
• Keep this leaflet. You may need to read it
need to adjust the does of Ropivacaine solution.
again
• If you or anyone in your family has ever been told
• If you any further questions, ask your doctor
that you have a rare disease of the blood pigment
or pharmacist.
(porphyria). If so, tell your doctor because he may
• This medicine has been prescribed for you.
need to give you another anesthetic medicine.
• Before treatment with Ropivacaine solution,
Do not pass it on to others. It may harm
tell your doctor about any diseases or medical
them, even if their symptoms are the same
conditions that you have.
as yours.
• Ropivacaine Solution 7.5mg/ml & 10mg/ml in
• If any of the side effects get serious, or
children up to and including 12 years. Other
if you notice any side effects not listed
strengths (2 mg/ml, 5 mg/ml) may be more
in this leaflet, please tell your doctor or
appropriate.
pharmacist.
• The full name of this medicine is
Take special care with Ropivacaine Solution
Ropivacaine 2mg/ml, 7.5mg/ml and 10mg/
2 mg/ml solution for injection:
ml Solution for Injection but within the
• In newborn children as they are more susceptible
to Ropivacaine Solution.
leaflet it will be referred to as Ropivacaine
• In children < 12 years as some injections of
solution.

Ropivacaine Solution in order to numb parts of the
body are not established in younger children.

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
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 solution 7.5 mg/ml & 10 mg/ml solution
for injection is used in:
Ropivacaine solution 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.
Ropivacaine solution 2 mg/ml solution for
injection 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 you are allergic (hypersensitive) to ropivacaine
hydrochloride or to any of the other ingredients of
Ropivacaine solution.
• If you have an existing allergy to any other local
anesthetic of the amide-type, such as bupivacaine
or lidocaine.
• If you have a decreased volume of blood in your
bloodstream (hypovolemia).
• Ropivacaine solution must not be injected into
a blood vessel, or into the neck of the womb to
relieve pain during childbirth.
If you are not sure if any of the above applies to
you, talk to your doctor before you are given
Ropivacaine solution.

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
and herbal medicines.
Ropivacaine solution should only be used with
caution if you are taking / receiving:
• other anesthetics
• medicines that are used for 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) or
• antibiotics for the 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.

Important information about some of the
ingredients of Ropivacaine solution:

Ropivacaine 2mg/ml Solution for Injection:1ml
contains 3.6mg sodium.
Ropivacaine 7.5mg/ml Solution for Injection:1ml
contains 3.0mg sodium.
Ropivacaine 10mg/ml Solution for Injection:1ml
contains 2.9mg sodium.
You have to take this into consideration if you are on
a controlled sodium diet.

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

Ropivacaine 2mg/ml, 7.5mg/ml and 10mg/ml Solution for Injection
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.

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.
May not be administered in intravenous
regional anaesthesia or in obstertric paracervical
anaesthesia.

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Ropivacaine 2mg/ml, 7.5mg/ml and 10mg/ml Solution for Injection PIL - UK
item no: AAAD9333

dimensions: 160x460

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: 16/06/12 (resent 05-07-12 BW)

supplier: Holopack

technically app. date: 05-07-12 BW

Non Printing Colours
1.
2.
3.

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 solution as an
injection. It will be injected by your doctor in one of
the following places:
• the body part that needs to be numbed
• near the body part that has to be numbed or
• in an area away from the part of the body that
needs to be numbed, for example if you are given
an epidural injection (into the area around the
spinal cord).
After the administration you won’t feel pain, heat
or cold in the numbed area, but you are still 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 pressure (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
• 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 temperature (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 tonge,
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 ny 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 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.
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 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
2-8 °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.
Ropivacaine 2mg/ml Solution for Injection:1ml
contains 2.12mg ropivacaine hydrochloride
monohydrate, equivalent to 2mg of ropivacaine
hydrochloride.
Ropivacaine 7.5mg/ml Solution for Injection:1ml
contains 7.94mg ropivacaine hydrochloride
monohydrate, equivalent to 7.5mg of ropivacaine
hydrochloride.
Ropivacaine 10mg/ml Solution for Injection:1ml
contains 10.58mg ropivacaine hydrochloride
monohydrate, equivalent to 10mg 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
injection.
Ropivacaine solution is in plastic ampoules (PP)
which are packed in sterile blister pouches or see
through pouches.
Pack-size:
5 x 10ml plastic ampoules

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

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Actavis, Barnstaple, EX32 8NS, UK

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

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 on treatment.

Incompatibilities

This medicinal product must not be mixed with
other medical products. In alkaline solution
precipitation may occur as ropivacaine shows poor
solubility at pH>6.

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.

Continued on top of next column
AAAD9333

Actavis, Barnstaple, EX32 8NS, UK

Ropivacaine 2mg/ml, 7.5mg/ml and 10mg/ml Solution for Injection PIL - UK
item no: AAAD9333

dimensions: 160x460

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: 16/06/12 (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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