Consumer medicine information

What is in this leaflet

Please read this leaflet carefully before you are given an injection of PATENT BLUE V. It tells you some of the more important points you need to know about this product.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

What is in the injection

Patent Blue V is a sterile dye solution for injection. It belongs to the group of triphenylmethane dyes used to reveal vessels in order to improve the visualisation of certain vessels of your body.

What Patent Blue V is used for

PATENT BLUE V is used by your doctor to prepare a radiological examination or as a direct aid to diagnosis of some diseases.

Before receiving it

When you must not be given it

Before you receive an injection of PATENT BLUE V, you must tell your doctor if:

• you are allergic (hypersensitive) to the active substance ‘patent blue’, to another triphenylmethane dye or any of the other ingredients of Patent Blue V listed at the end of this leaflet
• you are pregnant.

Before you are given it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, please inform your doctor if you are taking medicines for treating a heart condition or high blood pressure.

Tell your doctor if you are pregnant or you may be pregnant. You must never be given Patent Blue V if you are pregnant.

Tell your doctor if you are breastfeeding or planning to breastfeed.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop. Some medicines may interfere with PATENT BLUE V. These include medicines used to treat high blood pressure, such as beta-blocker or ACE inhibitor agents.

How it is given

PATENT BLUE V will be given to you in hospital or a clinic. The doctor will determine the dose that you will receive and will supervise the injection. PATENT BLUE V will be diluted with suitable fluids and then administered to you under the skin (subcutaneous route).

If you are given too much (overdose)

As you will be administered the injection under the supervision of your doctor, it is extremely unlikely that you will be given too much.

However, if you experience any side effects after being given this medicine, tell your doctor or nurse immediately.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor if you notice any of the following:

• bluish discolouration of the skin after injection, which disappears within the following 24 or 48 hours. If you have a disease affecting your lymph nodes (obstruction of lymph flow) or blood circulation disorders, this discolouration may last longer.
• allergic reactions may also occur, such as:
  - spots on the skin, redness and itching (urticaria), sudden swelling of the face and neck or other parts of the body, breathing difficulties with a cough (bronchospasm)
  - very rarely, sudden fainting and an important drop in blood pressure that can be life-threatening (allergic shock).
  If you experience one of these effects, contact your doctor immediately.

Tell your doctor if you notice anything else that is making you feel unwell, even if you think the problems are not connected with this medicine and are not referred to in this leaflet. Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After being given it

As this is being given to you by a doctor, it is extremely unlikely that you will be expected to look after the injection. However, if you do have to, check the expiry date (EXP) printed on the label and do not use after this date. Also, do not use it if the packaging is torn or shows signs of tampering.

Keep all medicines in a safe place where children cannot reach them. They may be dangerous to children.

Storage

PATENT BLUE V should be stored below 25°C, protected from light.

Product description

PATENT BLUE V is a sterile, concentrated deep blue solution. Available in packs of 5 colourless 2 mL glass ampoules.

Active ingredient:

The active substance is patent blue V sodium salt. One 2 mL ampoule contains 50 mg patent blue V sodium salt.

Inactive ingredients:

Sodium chloride, sodium phosphate-dibasic and water for injections.

Sponsor

Guerbet Australia Pty Ltd
Sydney NSW, Australia.

Telephone: 1800 859 436

Email: [email protected]

Australian Registration Number: AUST R 27539

This leaflet was revised in November 2021.

Published by MIMS January 2022

1 Name of Medicine

Patent Blue V.

2 Qualitative and Quantitative Composition

Patent Blue V injection solution contains 25 mg/mL (2.5% w/v) of Patent Blue V (sodium salt) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Patent Blue V injection solution is a deep blue sterile, isotonic solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Colours the lymph vessels so that they can then be injected with an X-ray contrast medium.

4.2 Dose and Method of Administration

For subcutaneous use only.
2 mL of Patent Blue V injection solution is diluted with an equal volume of sterile normal saline (an alternative method advocates dilution with 1% lignocaine hydrochloride solution) and 0.5 mL of diluted dye is injected into the subcutaneous tissue of each interdigital web space.
When the lower extremities are being examined, 1 mL is also injected below the tip of each malleolus. The lymphatics should then be visible through the skin and it is important that there should be no accidental spillage of the dye.
Patent Blue V may be used for children at the surgeon's discretion.
After the administration of Patent Blue V, the patient must be monitored for at least 30 minutes.

Note.

4.3 Contraindications

Hypersensitivity to Patent Blue V, triphenylmethane dyes or any of the excipients listed (see Section 6.1).
Pregnancy.

4.4 Special Warnings and Precautions for Use

There is a risk of allergic reactions regardless of the administration route or dose. Patent Blue V may cause minor or major immediate allergic reactions that may be life-threatening or even fatal (anaphylactic shock). They are often unpredictable, but they occur more frequently in patients with a history of hypersensitivity reactions to Patent Blue V or related triphenylmethane dyes contained in medicine, food and cosmetics. The indication should be very carefully assessed in these predisposed patients. In such circumstances it is advisable to administer a corticosteroid or H1-type antihistamine premedication. The preventative effect of premedication with corticosteroids and H1-type antihistamines is not entirely dependable, as only a partial (though significant) inhibition of mediators involved in anaphylactoid reactions can be attained.
The risk of a major reaction implies that emergency measures must be immediately available especially in patients on beta blockers in whom adrenaline and vascular perfusion would be insufficiently effective. Therefore, Patent Blue V must only be administered in hospital or a clinic capable of adequate treatment.
It would also seem prudent to test for hypersensitivity by injecting a very small volume of the solution and waiting a few moments to ascertain if there is a reaction.
Before administration of Patent Blue V:
Identify patients at risk by enquiring if there is a previous history of allergy or intolerance to Patent Blue V or related triphenylmethane dyes.
Insert an indwelling venous catheter.
Throughout the examination, maintain:
Medical monitoring.
An indwelling intravenous catheter.
Medicines and equipment for resuscitation readily available.
After administration of Patent Blue V, the patient must be monitored for at least 30 minutes.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Beta blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists.
These medicinal products reduce the efficacy of cardiovascular compensation mechanisms for haemodynamic disorders. The physician must be aware of this before injecting Patent Blue V and emergency measures must be available.
The value of partial oxygen pressure measured by spectrophotometry may show a transient false decrease of 5 to 10% below baseline values during examinations with Patent Blue. When in doubt, it is advisable to check by arterial blood gas analysis. The value of serum methaemoglobin measured by the same spectrophotometric method may be falsely increased.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Patent Blue V solution can provoke allergic reactions of varying degrees of severity. These reactions are rare and can be rapidly controlled with a corticosteroid. They occur immediately or a few minutes to several hours after injection of the dye.
Immediate hypersensitivity reactions are possible. These reactions may involve one or more effects, occurring concomitantly or successively, and usually including cutaneous, respiratory and/or cardiovascular manifestations, each of which can be a warning sign of incipient shock and, in very rare instances, can even prove fatal. The most frequently reported effects in a context of hypersensitivity reaction include rash, pruritus, erythema, urticaria, angioedema (such as face oedema or laryngeal oedema), bronchospasm, tachycardia, blood pressure decreased, and circulatory collapse.
A bluish colouring of the integuments is observed after the injection, which disappears within 24 to 48 hours. In patients with lymph stasis or circulatory disorders, the colouring may last longer.
Nausea, hypotension and generalised muscle tremors have also been reported; laryngeal spasm, if it occurs, requires the use of a muscle relaxant and intubation. Rare but more serious allergic reactions include circulatory failure with a state of shock, dyspnoea and oedema of the glottis.

Post-marketing experience.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: lymphotropic dye.
The lymphotropic property of Patent Blue V 2.5% w/w results in the staining of local lymph vessels after subcutaneous injection.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Carcinogenicity.

Genotoxicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, dibasic sodium phosphate dodecahydrate, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Patent Blue V is packed in type I clear glass ampoules of 2 mL volume fill.
Available in packs of 5.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes