Bufyl 1mg/ml and 2micrograms/ml 500ml infusion bags

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bupivacaine hydrochloride; Fentanyl

Available from:

Sintetica Ltd

ATC code:

N01AH51

INN (International Name):

Bupivacaine hydrochloride; Fentanyl

Dosage:

1mg/1ml ; 2microgram/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Epidural

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15020100; GTIN: 5099602001749 05021691001515

Patient Information leaflet

• constipation
• chills, cold (hypothermia), sweating, micturition difficulties
• airway complication of anaesthesia.
RARE: MAY AFFECT UP TO 1 In 1,000 PEOPLE
• weakness, loss of sensation (persistent anasthesia), bowel
incontinence (loss of sphincter control),
weakness or numbness in peripheral nerves (neuropathy), peripheral
nerve injury, a pain disorder
caused by inflammation of one of the membranes that surrounds and
protects the nerves of the
spinal
cord.
It
is
characterized
by
severe
stinging,
burning
pain
and
neurological
problems
(arachnoiditis), muscular weakness caused by nerve damage (paresis),
paralysis of legs and lower
body (paraplegia)
• double vision (diplopia).
NOT KNOWN: FREQUENCY CANNOT BE ESTIMATED FROM THE AVAILABLE DATA
• loss of consciousness, involuntary twitching of a muscle
(myoclonus), impairment of voluntary
movement (Dyskinesia), rise in the pressure inside the skull that can
result from or cause brain injury
(raised intracranial pressure)
• cough.
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 nurse.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. You can also
report
side
effects
directly via
the Yellow
Card
Scheme
at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5.
HOW TO STORE BUFYL
Keep this medicine out of the sight and reach of children.
You should not be given Bufyl after the expiry date which is stated on
the container label after EXP.
The doctor or nurse will check that the expiry date on the label has
not been passed before
administering the infusion to you. The expiry date refers to the last
day of that month.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how
to throw away medicines you no longer use. These measures will help
protect the environment.
6. CONTENT

Summary of Product characteristics

OBJECT 1
BUFYL 1MG/ML AND 2MICROGRAM/ML SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 07-Apr-2017 | Concordia
International - formerly AMCo
1. Name of the medicinal product
BUFYL 1mg/ml and 2microgram/ml Solution for Infusion
Bupivacaine Hydrochloride 1mg/ml and Fentanyl Citrate 2 micrograms/ml
Solution for infusion
2. Qualitative and quantitative composition
Each 1ml of solution contains 1mg bupivacaine hydrochloride and 2
micrograms fentanyl (as fentanyl
citrate)
Excipient with known effect
Contains up to 3.5mg sodium per ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for epidural infusion.
Clear, colourless aqueous sterile solution.
4. Clinical particulars
4.1 Therapeutic indications
Bufyl/ Bupivacaine and Fentanyl solution for infusion is indicated
for:
(i) maintaining analgesia post-operatively and
(ii) for maintaining epidural analgesia during labour.
4.2 Posology and method of administration
Posology
ADULTS
The length of continuous epidural infusions given post-operatively
should be minimized, due to the
increased risks of reaching a toxic plasma concentration, inducing
local neural injury or local infection.
Administration of bupivacaine with fentanyl epidural infusion has not
been adequately studied for more
than 72 hours. The dosages in the following table are recommended as a
guide for use in healthy adults
during labour and in the post operative period. It should not be
necessary to exceed an infusion dosage of
20mg/hour for bupivacaine. Standard textbooks should be consulted for
factors affecting specific block
techniques; dosing should be titrated to meet the individual patient
requirements and the lowest dose
required to provide adequate analgesia should be used.
Bufyl/ Bupivacaine 1mg/mL + Fentanyl 2 microgram/mL solution for
infusion
Indication
Administration by
continuous epidural
infusion
Volume mL/hour Dosage / hour
Bupivacaine (mg)
Dosage / hour
Fentanyl
(microgram)
Analgesia in labour
Lumbar epidural
10 - 15
10 - 15
20 - 30
Control of