Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about POR-8 FERRING.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

Please read this leaflet before treatment with POR-8 FERRING is commenced.

All medicines have risks and benefits. Your doctor has weighed the risks of you using POR-8 FERRING against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine. You may need to read it again.

What POR-8 FERRING is used for

This medicine is used to help control bleeding. It narrows blood vessels at the site of an operation.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

There is no evidence that POR-8 FERRING medicine is addictive.

It is available only with a doctor's prescription.

Before you use POR-8 FERRING

When you must not use it

Do not use POR-8 FERRING if you have/are:

• coronary heart disease
• very high blood pressure
• epilepsy
• advanced hardening of the arteries
• infection relating to pregnancy
• pregnant
• allergies to the contents of the product

There are some anaesthetic procedures where POR-8 FERRING should not be used.

Your doctor has more information about these.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to use it

Tell your doctor if you have or have had any of the medical conditions listed above or if you have a condition in which a rise in blood pressure may cause you to become unwell.

Tell your doctor if you plan to become pregnant

Using other medicines

Tell your doctor or pharmacist if you are using any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being treated with this medicine.

How to use POR-8 FERRING

POR-8 FERRING is not intended for self administration.

POR-8 FERRING is given by regional infiltration.

Your doctor will administer this medication to you during surgery.

How much POR-8 FERRING will be used?

Your doctor will determine the dose according to your needs.

Overdose

Overdose is highly unlikely. However, high doses may cause gastrointestinal disturbances, high blood pressure, convulsion and sweating in some people.

Side effects

This medicine helps most people but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

• facial paleness
• rise in blood pressure
• fall in blood pressure
• irregular heartbeat
• angina pain
• perspiration
• increased bowel motility
• allergic skin reactions

Isolated reports have been received of cardiac arrest when POR-8 FERRING has been used in conjunction with other medication.

Ask your doctor or pharmacist to answer any questions you may have.

After using POR-8 FERRING

Storage

POR-8 FERRING is usually stored in the hospital pharmacy or in the ward. It should be protected from light and stored in a refrigerator at a temperature between 2°C and 8°C.

Disposal

Any POR-8 FERRING which is left over, not used or has passed its expiry date will be disposed of by hospital staff.

Product description

What it looks like

POR-8 FERRING is supplied in 1mL glass ampoules. It is a clear, colourless solution.

Ingredients

POR-8 FERRING contains the active ingredient ornipressin as well as the following inactive ingredients:

• sodium acetate
• sodium chloride
• acetic acid
• Water for injections.

Sponsor

Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble NSW 2073
Australia

This leaflet was prepared in
April 2012.

AUST R 13369

Name of the medicine

Ornipressin.

Excipients

Description

Chemical name: 8-ornithine-vasopressin. Molecular formula: C₄₅H₆₃N₁₃O₁₂S₂. MW: 1042.2. CAS: 3397-23-7. Por-8 Ferring is ornipressin, a synthetic polypeptide. It is closely related to synthetic vasopressin, and differs from that substance only by the substitution of ornithine for lysine in the side chain. The sterile solution is clear and pH is adjusted to 3.7.

Pharmacology

Por-8 Ferring has a potent and specific constrictor effect on the microcirculation and veins which is equal to, if not greater than, that of vasopressin. It has antidiuretic activity but this is weak by comparison with vasopressin.
Topical administration or infiltration leads within 10 minutes to local ischaemia which usually lasts for 1 to 2 hours, and is not followed by reactive hyperaemia.
Por-8 Ferring may be used with general anaesthetics which are usually not compatible with adrenaline, e.g. halothane, without fear of precipitating cardiac arrhythmias.

Indications

Local administration.

Plastic surgery.

Obstetrics/ gynaecology.

ENT surgery.

Other types of surgery.

Contraindications

Coronary heart disease, severe hypertension, toxaemia of pregnancy; advanced arteriosclerosis; epilepsy; as an adjunct to local anaesthetics intended to be used in regions of terminal arteries, e.g. fingers, and for spinal anaesthesia; hypersensitivity to the drug.

Use in pregnancy.

Warnings

In isolated cases, severe cardiovascular incidents associated with unmeasurable peripheral blood pressure have been reported. Since in such conditions peripheral resistance may be increased by Por-8 Ferring, caution is required when using additional vasoconstrictor agents.

Precautions

As is the case with adrenaline, some absorption may occur from local application leading to systemic vasoconstriction. A rise in blood pressure may occur in some patients. Caution is therefore indicated in conditions in which a rise in blood pressure would be medically undesirable. Anginal symptoms may be precipitated in patients with ischaemic heart disease.

Adverse Effects

Por-8 Ferring is generally well tolerated. Some patients may display facial or general pallor, but this is due to capillary constriction which in itself is harmless. Less common adverse reactions include a rise (or occasionally fall) in blood pressure, cardiac arrhythmias, anginal pain, increased perspiration and increased bowel motility. Absorption from local application may lead to alterations in heart rate, and isolated reports have been received of fibrillation and cardiac arrest in conjunction with other medication. See also Warnings. Generalised cyanosis, circulatory collapse and proptosis have been observed but their relationship to Por-8 Ferring is uncertain. Allergic skin reactions are rare.

Dosage and Administration

Por-8 Ferring should be diluted before use. Usually 5 IU (1 ampoule) is diluted in 30 mL of physiological saline. No data are available on the compatibility or stability of Por-8 Ferring when mixed with local anaesthetic solution. The diluted solution is administered by regional infiltration at the operation site.
The maximum permitted total dose for tissue infiltration is 5 IU, due to the possibility of systemic absorption.
For gynaecological surgery and laparotomies, more dilute solutions, e.g. 5 IU in 50 or 60 mL physiological saline are used.
For ENT surgery, somewhat more concentrated solutions, 5 IU in 20 mL physiological saline may be required.
Extemporaneous dilutions of Por-8 Ferring should be used on the day on which they are prepared.

Overdosage

The indications suggest that overdosage is highly improbable. However, toxic doses may cause gastrointestinal disturbances, increased bowel motility, hypertension, circulatory collapse, convulsions in predisposed patients and sweating. Treatment is symptomatic. Circulation, electrolytes and fluids should be closely monitored.

Presentation

Injection (clear, sterile solution), 5 IU/1 mL: 5's (ampoule).

Storage

Por-8 Ferring should be stored in a refrigerator between 2 and 8°C. Do not freeze.

Poison Schedule

S4.