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ROPIVACAINE 5 MG/ML SOLUTION FOR INJECTION

Active substance(s): ROPIVACAINE HYDROCHLORIDE MONOHYDRATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Ropivacaine 5 mg/ml solution for injection
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.

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.

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

An injection into the lower part of your spine may induce low
blood pressure or slow heart beat. If this occurs your doctor will
initiate the appropriate measures.

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 0.138 mmol (or 3.17 mg) sodium per
ml. To be taken into consideration by patients on a controlled
sodium diet.
3. HOW TO USE 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.

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. These are chemical substances that are used to numb an area of the body.
Ropivacaine is used to numb (anaesthetise) specific parts of the
body and to stop pain during surgery.
2. BEFORE YOU USE ROPIVACAINE
You must not be given Ropivacaine
- if you are allergic (hypersensitive) to ropivacaine 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 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.
Take special care with Ropivacaine
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.

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

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.

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 15 mg and 25 mg of ropivacaine hydrochloride.

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)

Duration of treatment
Administration of ropivacaine hydrochloride usually takes between
2 to 6 hours in case of anaesthesia prior to certain surgeries.
It is administered by injection into the lower part of your spine
(intrathecal administration).

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.
Paediatric patients
There is no experience with injection into the lower part of the
spine (intrathecal administration), neither in infants nor in children of
12 years of age or younger.

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.


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).

Concentration
mg/ml

Volume
ml

Dose
mg

Onset
minutes

Duration
hours

5.0

3-5

15-25

1-5

2-6

SURGICAL
ANAESTHESIA
1. Hold ampoule upright and flick the neck to remove any solution.
Open by sharply twisting the top of the ampoule.
2. The ampoule can then be attached directly to the syringe as
shown.
The ampoule fits both Luerfit and LuerLock syringes.
3. Hold the syringe with ampoule uppermost. Without squeezing the
ampoule, withdraw the solution. Maintain downward pressure on
the syringe piston after the solution has been withdrawn until the
empty ampoule has been removed.
Shelf life
Shelf-life before opening
2 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.

Intrathecal
Administration
Surgery

The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use
in adults. Individual variations in onset and duration occur. The figures
in the column 'Dose' reflect the expected average dose range needed. Standard textbooks should be consulted for both factors affecting specific block techniques and individual patient requirements.
Method of administration
For intrathecal administration by injection only.
Careful aspiration before and during injection is recommended to prevent intravascular injection. An inadvertent intravascular injection may
be recognised by a temporary increase in heart rate.
Aspiration should be performed prior to and during administration
of the main dose, which should be injected slowly, 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.
The intrathecal injection should be made after the subarachnoid
space has been identified and clear cerebrospinal fluid (CFS) is seen
to escape from the spinal needle, or is detected by aspiration.

The intact container must not be re-autoclaved.
Posology
Adults and adolescents (>12 years of age)
The following table is a guide to dosage for intrathecal block in adults.
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.

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

Medicines should not be disposed of via wastewater or household
waste. Your doctor or pharmacist will dispose of medicines no longer
required. These measures will help to protect the environment.

4. POSSIBLE SIDE EFFECTS

Uncommon
• 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 “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

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

Rare
• Cardiac arrest, irregular heart beat (cardiac arrhythmias)

The evaluation of side effects is based on the following frequencies:

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).

What Ropivacaine looks like and contents of the pack
Ropivacaine solution for injection is a clear, colourless, sterile, isotonic, isobaric aqueous solution for injection.
Ropivacaine 5 mg/ml solution for injection is available in 10 ml transparent polypropylene ampoules.

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.
Due to the low dose administered during injection into the lower part
of the spine (intrathecal administration), side effects affecting your
whole body in general are not expected to occur.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

very common:
common:
uncommon:
rare:
very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

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.

Adolescents
In adolescents, the side effects are the same as in adults except for
low blood pressure which happens less often in adolescents (affecting
less than 1 in 10) and being sick which happens more often in adolescents (affecting more than 1 in 10). Ropivacaine should not to be
used for injection into the lower part of the spine in infants and children younger than 12 years of age.

6. FURTHER INFORMATION
What Ropivacaine contains
- The active substance is ropivacaine hydrochloride 5 mg/ml. Each 10
ml polypropylene ampoule contains 50 mg ropivacaine (as hydrochloride).
- The other ingredients are sodium chloride, sodium hydroxide (for pH
adjustment) and water for injections.

Pack sizes:
10 ampoule(s) in plastic overwrap
Marketing Authorisation Holder and Manufacturer
Goldshield Pharmaceuticals Ltd
NLA Tower
12-16 Addiscombe Rd
Croydon
CR0 0XT, UK
101947/LF/A
This leaflet was last approved in 11/05/2011.

If any of the side effects get serious, or if you notice any side effects
not listed in this leafl et, please tell your doctor or pharmacist.
5. HOW TO STORE ROPIVACAINE

Other possible side effects:
Keep out of the reach and sight of children.
Very common
• Low blood pressure (hypotension). This might make you feel dizzy
or light-headed.
• Feeling sick (nausea)
Common
• 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 retension)
• Back pain, increased temperature, muscular stiffness (rigor)

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



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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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