Consumer medicine information

1. Why am I using B. BRAUN FENTANYL Injection?

B. BRAUN FENTANYL Injection contains the active ingredient fentanyl citrate. B. BRAUN FENTANYL Injection is used to provide short-term pain relief and to help anaesthesia when you have an operation. It is a strong painkiller for use in hospitals.
For more information, see Section 1. Why am I using B. BRAUN FENTANYL Injection? in the full CMI.

2. What should I know before I use B. BRAUN FENTANYL Injection?

Do not use if you have ever had an allergic reaction to fentanyl or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use B. BRAUN FENTANYL Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with B. BRAUN FENTANYL Injection and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use B BRAUN FENTANYL Injection?

• B. BRAUN FENTANYL is given by your doctor as an injection into a muscle or a vein.

• Your doctor will decide how much B. BRAUN FENTANYL you need. This will depend on your age, body weight, medical conditions and history.

5. What should I know while using B. BRAUN FENTANYL Injection?

6. Are there any side effects?

Common side effects include: dizziness, low or high or variable blood pressure, hiccups, blurred vision, nausea, vomiting, excessive sweating, itching, sedation, headaches, post-operative confusion or agitation, vein pain or inflammation, chills or lower body temperature, visual disturbance. Serious side effects include: difficulty breathing, muscle stiffness or involuntary movements, irregular heartbeat or cardiac arrest, allergic reactions, severe drowsiness, convulsions, loss of consciousness.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Limitations of use. Because of the risks associated with the use of opioids, B. Braun Fentanyl should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special Warnings and Precautions for Use).
Hazardous and harmful use. B. Braun Fentanyl poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4 Special Warnings and Precautions for Use).
Life threatening respiratory depression. Serious, life-threatening or fatal respiratory depression may occur with the use of B. Braun Fentanyl. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking B. Braun Fentanyl.

1 Name of Medicine

Fentanyl citrate.

2 Qualitative and Quantitative Composition

B. Braun Fentanyl for injection contains fentanyl 50 microgram per mL (as fentanyl citrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

It is a sterile, clear, colourless solution practically free from visible particles with a pH 4.0-6.5.

4 Clinical Particulars

4.9 Overdose

The oral LD₅₀ for fentanyl in rats is 18.0 mg/kg. The intravenous LD₅₀ is 2.3 mg/kg, and the intramuscular LD₅₀ is 1.0 mg/kg in rats. The toxic dose in man is unknown.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Signs and symptoms. The manifestations of fentanyl overdosage are an extension of its pharmacological actions. In sufficient overdosage, fentanyl would produce narcosis, which may be preceded by marked skeletal muscle rigidity. Cardiorespiratory depression which can vary in severity from bradyapnoea to apnoea, may occur. This may be accompanied by cyanosis, followed by a fall in body temperature, circulatory collapse, coma and death. Toxic leukoencephalopathy has been observed with fentanyl overdose.
Treatment. In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted or controlled as indicated. A patent airway must be maintained. An oropharyngeal airway or endotracheal tube might be indicated. If depressed respiration is associated with muscular rigidity, an intravenous neuromuscular blocking agent might be required to facilitate assisted or controlled respiration.
A specific opioid antagonist, such as naloxone, should be available for use as indicated to manage respiratory depression. This does not preclude the use of more immediate countermeasures. The duration of respiratory depression following overdosage of fentanyl may be longer than the duration of opioid antagonist action. Consult the package insert of the individual opioid antagonists for details about use. The patient should be carefully observed for 24 hours. Body warmth and adequate fluid intake should be maintained. If hypotension occurs, and is severe or persists, the possibility of hypovolaemia should be considered and managed with appropriate parenteral fluid therapy. The use of an opioid antagonist will also reverse analgesia.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Fentanyl showed no evidence of genotoxic potential in assays for gene mutations (Ames reverse mutation test, mouse lymphoma thymidine kinase assay), chromosomal damage (Chinese hamster ovary cells, mouse micronucleus test) and other genotoxic effects (unscheduled DNA synthesis in rat hepatocytes, mammalian cell transformation assay). The genotoxic potential of fentanyl is considered to be low.
Carcinogenicity. In a two year carcinogenicity study in rats, fentanyl was not associated with an increased incidence of tumours at subcutaneous doses up to 33 microgram/kg/day in males or 100 microgram/kg/day in females, which were the respective maximum tolerated doses.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Fentanyl citrate is a 4-anilinopiperidine derivative. It is a white to almost white powder with a pKa of 8.4.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFENCIT.gif N-phenyl-N-[1-(2-phenylethyl) piperidin-4-yl]propanamide dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate.
Fentanyl citrate MW: 528.6; C₂₂H₂₈N₂O.C₆H₈O₇.
Fentanyl MW: 336.5.
CAS number. CAS (fentanyl citrate) 990-73-8;
CAS (fentanyl) 438-38-7.

7 Medicine Schedule (Poisons Standard)

Controlled Drug (Schedule 8).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BBRFENST.gif