Bupafen epidural infusion

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Bupivacaine hydrochloride monohydrate 1.319 mg/mL equivalent to 1.25 mg/mL bupivacaine hydrochloride;  ; Fentanyl citrate 3.144 µg/mL equivalent to 2 µg/mL fentanyl;  

Inapatikana kutoka:

Biomed Limited

INN (Jina la Kimataifa):

Bupivacaine hydrochloride monohydrate 1.319 mg/mL (equiv. 1.25 mg/mL bupivacaine hydrochloride)

Kipimo:

0.125% / 2µg/mL

Dawa fomu:

Solution for infusion

Tungo:

Active: Bupivacaine hydrochloride monohydrate 1.319 mg/mL equivalent to 1.25 mg/mL bupivacaine hydrochloride   Fentanyl citrate 3.144 µg/mL equivalent to 2 µg/mL fentanyl   Excipient: Sodium chloride Water for injection

Vitengo katika mfuko:

Bag, plastic, plastic copolymer 200mL, 20 dose units

Darasa:

Class B3 Controlled Drug

Dawa ya aina:

Class B1 Controlled Drug

Viwandani na:

Cambrex Karlskoga AB

Matibabu dalili:

Bupafen for epidural infusion is intended for post-operative or obstetric analgesia, except where specifically contraindicated.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Bag, plastic, flexible non-PVC polypropylene IV bag with foil overwrap - 100 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze. 24 hours opened stored at or below 25°C - Bag, plastic, flexible non-PVC polypropylene IV bag with foil overwrap - 200 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze. 24 hours opened stored at or below 25°C

Idhini ya tarehe:

1997-01-06

Tabia za bidhaa

NEW ZEALAND DATA SHEET
BUPAFEN EPIDURAL INFUSION SOLUTION FOR INFUSION
Page 1 of 14
1
PRODUCT NAME
Bupafen epidural infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bupafen consists of 1.25 mg/mL bupivacaine HCI and 2 μg/mL fentanyl
citrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Infusion solution: a clear, colourless, particle-free solution
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bupafen for epidural infusion is intended for post-operative or
obstetric analgesia, except
where specifically contraindicated.
4.2
DOSE AND METHOD OF ADMINISTRATION
The lowest dosage that results in effective analgesia should be used
and should be based on
the status of the patient and the analgesia required.
ADULTS
Recommended dosages for infusion for analgesia in the average, healthy
70 kg adult patient.
BUPAFEN
POSTOPERATIVE ANALGESIA: EPIDURAL
VOLUME
BUPIVACAINE
FENTANYL
Epidural infusion (for
up to 48 hours)
6 – 15 mL/hr
7.5 – 18.75 mg/hr
12 – 30 µg/hr
NOTE: RECOMMENDED DOSES
Toxic doses vary widely between patients. Careful observation of the
patient must therefore
be maintained. It is recommended that a single dose of bupivacaine at
any time should not
exceed 2 mg/kg. However the dose administered must be tailored to the
individual patient and
procedure, and the maximum dose quoted here should be used as a guide
only.
When
calculating
the
dosage
for
post-operative
analgesia,
the
use
of
intra-operative
bupivacaine and/or fentanyl (or other opioid agonist analgesic) should
be taken into account.
When given by bolus injection, doses should not be repeated more
frequently than every 3
hours. The maximum daily dosage should not exceed 400 mg bupivacaine
in a 70 kg adult,
whether administered by bolus injection and/or by infusion.
The rapid injection of a large volume of Bupafen solution should be
avoided and fractional
doses should be used when feasible.
TEST DOSE
For epidural analgesia, a 3 – 5 mL test dose of a local anaesthetic,
preferably containing up
to 15 μg of adrenalin