Ropivacaine-AFT

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ropivacaine hydrochloride 2 mg/mL

Available from:

AFT Pharmaceuticals Ltd

Dosage:

2 mg/mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Ropivacaine hydrochloride 2 mg/mL Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium hydroxide Water for injection

Prescription type:

Prescription

Therapeutic indications:

Surgical analgesia - Epidural block for surgery, including caesarean section - Intrathecal block - Major nerve block - Field block (minor nerve block and infiltration)

Product summary:

Package - Contents - Shelf Life: Bag, plastic, Latex free plastic (polyolefin) with two tubes (one injection and one infusion ports) 10 x 200 mL - 10 dose units - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate. Do not freeze. - Bag, plastic, Latex free plastic (polyolefin) with two tubes (one injection and one infusion ports) 10 x 100 mL - 10 dose units - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate. Do not freeze.

Authorization date:

2020-11-19

Patient Information leaflet

New Zealand Consumer Medicine Information
ROPIVACAINE-AFT
ROPIVACAINE HYDROCHLORIDE
2 mg/mL (0.2%) Solution for infusion
WHAT IS IN THIS LEAFLET
Please use this leaflet carefully before you are given
Ropivacaine-AFT.
This leaflet answers some common
questions about Ropivacaine-AFT. It does not contain
all the available information. It
does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given Ropivacaine-AFT against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with you. You may need to read it again.
WHAT ROPIVACAINE-AFT IS USED FOR
Ropivacaine-AFT is a local anaesthetic (an-es-thet-ic). It is injected
into the body where it makes the nerves unable to
pass messages to the brain. Depending on the amount used,
Ropivacaine-AFT will either totally stop pain or will cause a
partial loss of feeling.
Ropivacaine-AFT is used as an anaesthetic to stop the pain of surgery
and/or to make childbirth less painful. Ropivacaine-
AFT is also used after surgery to treat post-operative pain.
Your doctor may have prescribed Ropivacaine-AFT for another reason.
Your doctor will have explained why you are being
treated with Ropivacaine-AFT and told you what dose you will be given.
Ask your doctor if you have any
questions about why Ropivacaine-AFT have been
prescribed for you.
This medicine is available only with a doctor’s prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN ROPIVACAINE-AFT
_WHEN YOU MUST NOT BE GIVEN IT _
Ropivacaine-AFT must not be used if:
•
you have any allergies to:
−
any ingredient listed at the end of this leaflet
−
any other local anaesthetics.
•
you have problems controlling your low blood pressure
•
you have inflammation and/or an infection at the site of injection.
_BEFORE YOU START TO USE IT _
Tell your doctor if:
•
YOU HAVE ANY ALLERGIES TO OTHER SUBSTANCES
•
YOU HAVE OR HAVE H

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1.
ROPIVACAINE-AFT 2 MG/ML SOLUTION FOR INFUSION
Ropivacaine hydrochloride 2 mg/mL (0.2%) solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Ropivacaine-AFT solution for infusion contains 2 mg
ropivacaine
hydrochloride.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Ropivacaine-AFT solution for infusion is a clear, colourless, sterile,
isotonic, isobaric,
aqueous solution and is practically free from visible particles.
The
solution
has
a
pH of
4.0
–
6.0
and
an
osmolality of
270
– 340
mOsmol/kg.
4.
CLINICAL PARTICULARS
_4.1. _
_THERAPEUTIC INDICATIONS _
Ropivacaine-AFT is indicated for:
Surgical analgesia
−
Epidural block for surgery, including caesarean section
−
Intrathecal block
−
Major nerve block
−
Field block (minor nerve block and infiltration)
Acute pain management
−
Continuous epidural infusion (Ropivacaine-AFT alone or in combination
with
fentanyl) or intermittent bolus epidural administration for analgesia
in post-
operative pain or labour pain
−
Field block (minor nerve block and infiltration)
−
Intra-articular injection
−
Continuous peripheral nerve block infusion or intermittent injections
e.g. for
post-operative pain management
−
Continuous wound infusion for post-operative pain management (adults
only)
Acute pain management in paediatrics (Children aged 0 – 12 years)
−
Caudal epidural block in neonates, infants and children up to and
including
12 years
−
Peripheral nerve block in children aged 1 up to and including 12 years
−
Continuous epidural infusion in neonates, infants and children up to
and
including 12 years
For peri- and post-operative pain management.
There are no safety or efficacy data to support the use of
Ropivacaine-AFT for
analgesia for longer than 72 hours. (Data for peripheral nerve block
administered as a
continuous peripheral infusion or intermittent injections and for
continuous wound
infusion support the use for up to 48 hours only)