Fentanyl 100micrograms/2ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fentanyl citrate

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

N01AH01

INN (International Name):

Fentanyl citrate

Dosage:

50microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Intravenous

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 15010403; GTIN: 5014124170674

Patient Information leaflet

WHAT IS IN THIS LEAFLET:
1.
What Fentanyl Injection is and what it is used for
2.
What you need to know before having Fentanyl Injection
3.
How Fentanyl Injection is given
4.
Possible side effects
5.
How to store Fentanyl Injection
6.
Contents of the pack and other information
1. WHAT FENTANYL INJECTION IS AND WHAT IT IS USED
FOR
Fentanyl belongs to a group of medicines called opioid
analgesics, often used in anaesthesia or as a painkiller.
Fentanyl Injection can be used in the following situations:
• In low doses it is used to provide pain relief during short
surgical procedures.
• Where breathing is assisted, it is used in higher doses as an
anaesthetic and analgesic.
• It may also be given in combination with a tranquilliser to
induce both calmness and pain relief.
• For the treatment of severe pain.
2. WHAT YOU NEED TO KNOW BEFORE HAVING
FENTANYL INJECTION
YOU SHOULD NOT BE GIVEN FENTANYL INJECTION IF YOU:
• are allergic (hypersensitive) to fentanyl citrate or other opioid
medicines or any of the other ingredients (listed in section 6).
• suffer from asthma, shallow breathing or other breathing
difficulties.
• are taking or have recently (within the last two weeks) taken
any drugs used to treat depression known as Monoamine
Oxidase Inhibitors (MAOI’s) (see ‘Taking other medicines).
• you are in labour or before the cord is clamped during a
Caesarean section. Fentanyl injection may affect the baby’s
breathing.
TAKE SPECIAL CARE WITH FENTANYL INJECTION
Tell your doctor if you:
• are pregnant, planning to become pregnant or are
breast-feeding.
• have an under active thyroid gland.
• are suffering from lung disease.
• suffer from a muscle disorder known as myasthenia gravis.
• are suffering from liver or kidney disease.
• are receiving opioid therapy or have a history of opioid
abuse.
• suffer from alcoholism.
• are suffering from severe undiagnosed headaches or if you
have recently suffered a head injury.
• have been told you are suffering from low blood volume.
• have p

Summary of Product characteristics

OBJECT 1
FENTANYL 50 MICROGRAMS/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 17-Apr-2018 | Martindale
Pharma
1. Name of the medicinal product
Fentanyl 50 micrograms/ml Solution for Injection
2. Qualitative and quantitative composition
Fentanyl citrate 78.5 micrograms equivalent to 50 micrograms per ml
fentanyl base.
Excipient(s) with known effect:
Sodium 3.5 mg/ml.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Clear, colourless, sterile solution for Injection
4. Clinical particulars
4.1 Therapeutic indications
Fentanyl citrate 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 in the technique of
neuroleptanalgesia.
In the treatment of severe pain, such as the pain of myocardial
infarction.
4.2 Posology and method of administration
Routes of 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)
Intravenous administration, either as a bolus or by infusion.
Intramuscular administration.
To avoid bradycardia, it is recommended to administer a small
intravenous dose of an anti-cholinergic
just before anaesthetic induction.
Posology
Fentanyl Injection 50 micrograms/ml, by the intravenous route, can be
administered to both adults and
children. The dose of Fentanyl Injection 50 micrograms/ml 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 regime is as follows:
Initial
Supplemental
Spontaneous respiration
50-200 micrograms
50 micrograms
Assisted ventilation
300-3500 micrograms
100-200 micrograms
Doses in excess of 200 micrograms are for use in anaesthesia only.
As a premedicant, 1-2 ml Fentanyl Injection 50 micrograms/ml may be
administered intramuscularly 45