Fentanyl 500micrograms/10ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl citrate

Available from:

hameln pharma Ltd

ATC code:

N01AH01

INN (International Name):

Fentanyl citrate

Dosage:

50microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous; Intramuscular

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010403; GTIN: 5016386000621

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FENTANYL 50 MICROGRAMS/ML INJECTION
fentanyl citrate
1. What Fentanyl 50 micrograms/ml Injection
is and what it is used for
Fentanyl
50 micrograms/ml
Injection
is
an
analgesic drug. It is used:
• in anaesthesia
• as a pain relief agent
• to induce calmness
• as a premedication to sedate and prepare a
patient for general anaesthesia
2. What you need to know before you use
Fentanyl 50 micrograms/ml Injection
DO NOT USE FENTANYL 50 MICROGRAMS/ML
INJECTION:
• if you are allergic to Fentanyl 50 micrograms/ml
Injection, drugs similar to morphine or muscle
relaxants, or any of the other ingredients in this
injection (listed in section 6).
• if you have any breathing problems or a lung
disorder, such as asthma, chronic bronchitis or
emphysema.
• if you are taking, or have taken, monoamine
oxidase inhibitor (MAOI) drugs for depression,
in the last 2 weeks.
• if you are in labour or before the cord is clamped
during a Caesarean section. Fentanyl injection
may affect the baby’s breathing.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE USING
FENTANYL 50 MICROGRAMS/ML INJECTION:
• if you have myasthenia
gravis
• if you have reduced blood
volume or low blood
pressure
• if you have an under active thyroid gland
• if you have liver or kidney disease
• if you have problems with your lungs
• if you have a recent head injury
• if you have a history of alcohol or opioid abuse
• if you are elderly or weak due to ill health
SPECIAL MONITORING
• Fentanyl 50 micrograms/ml Injection may make
you breathe more slowly. Your breathing will be
carefully monitored until it returns to normal.
• Your blood pressure and heart rate may also be
monitored
OTHER
MEDICINES
AND
FENTANYL
50
MICROGRAMS/ML INJECTION:
Tell
your
doctor
or
nurse
if
you
are
using
or
have
recently
used
or
might
use
any
other
medicines,
including
medicines obtained without a prescription.
In particular, do not have this medicine and tell
your doctor or nurse if you have taken:
• m

Summary of Product characteristics

OBJECT 1
FENTANYL 50 MICROGRAM/ML INJECTION
Summary of Product Characteristics Updated 04-Jan-2018 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Fentanyl 50 microgram/ml Injection
2. Qualitative and quantitative composition
Fentanyl citrate 78.5 micrograms equivalent to 50 micrograms per ml
fentanyl.
Each 2ml ampoule contains 100 micrograms of fentanyl as fentanyl
citrate.
Each 10ml ampoule contains 500 micrograms of fentanyl as fentanyl
citrate.
Each 50ml vial contains 2500 micrograms of fentanyl as fentanyl
citrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
Clear, colourless solution
4. Clinical particulars
4.1 Therapeutic indications
Fentanyl is an opioid analgesic used:
- in low doses to provide analgesia during short surgical procedures
- in high doses as an analgesic/respiratory depressant in patients
requiring assisted ventilation
- in combination with a neuroleptic drug as part of the technique of
neuroleptanalgesia
- in the treatment of severe pain, such as the pain of myocardial
infarction
4.2 Posology and method of administration
_Route of administration _
Intravenous administration either as a bolus or by infusion.
Intramuscular administration.
Fentanyl should be given only in an environment where the airway can
be controlled and by personnel
who can control the airway (see section 4.4 Special warnings and
precautions for use).
To avoid bradycardia, it is recommended to administer a small
intravenous dose of an anti-cholinergic
just before anaesthetic induction.
It is recommended to wear gloves while opening the ampoule (see
section 6.6).
Posology
Fentanyl, by the intravenous route, can be administered to both adults
and children. The dose of fentanyl
should be individualised according to age, body weight, physical
status, underlying pathological
condition, use of other drugs and type of surgery and anaesthesia.
_Adults _
The usual dosage regimen in adults is as follows:
Initial
Supplemental
Spontaneous
Respiration
50-200 micrograms