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PROMIXIN 1 MILLION INTERNATIONAL UNITS (IU) POWDER FOR SOLUTION FOR INFUSION

Active substance(s): COLISTIMETHATE SODIUM / COLISTIMETHATE SODIUM / COLISTIMETHATE SODIUM

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1 million International Units (IU)
Powder for Solution for Infusion
colistimethate sodium

Promixin

PACKAGE LEAFLET: INFORMATION FOR THE USER

PL393 Issue 7 UK

1. WHAT PROMIXIN IS AND WHAT IT IS USED FOR
Promixin contains colistimethate sodium. It is an antibiotic that
is given by injection to treat some types of serious infections caused
by certain bacteria.
Promixin is used when other antibiotics are not suitable.

2. BEFORE YOU ARE GIVEN PROMIXIN
In certain circumstances your doctor may decide not to prescribe
Promixin.

Do not have Promixin and tell your doctor if:
you are allergic (hypersensitive) to colistimethate sodium,
colistin or to other polymyxins;
If this applies to you, tell your doctor before you are given
Promixin.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Promixin
1 million International Units (IU)
Powder for Solution for Infusion
colistimethate sodium

Take special care with Promixin and tell your doctor,
pharmacist or nurse if:
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Read all of this leaflet carefully before you are given
this medicine

you suffer from myasthenia gravis (a rare disease where your
muscles are extremely weak and get tired very quickly);
you suffer from porphyria (a rare metabolic disease that some
people are born with).

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Keep this leaflet. You may need to read it again.

Taking other medicines

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If you have further questions, please ask your doctor, nurse or
pharmacist.

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If any of the side effects gets serious, or you notice any side
effects not listed in this leaflet, please tell your doctor, nurse or
pharmacist.

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including non-prescription
medicines. These medicines may interfere with the effects of
Promixin.

In this leaflet
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1. What Promixin is and what it is used for
2. Before you are given Promixin
3. How you will be given Promixin
4. Possible side effects
5. How to store Promixin
6. Further information

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If you were not given Promixin when expected

You may be given Promixin if you are pregnant or trying to get
pregnant if your doctor considers the benefits are greater than
the possible risks. It is unknown if having Promixin may harm
your unborn baby.

If you think that you have missed a dose of Promixin and it is less
than 3 hours since you should have been given the dose, tell your
doctor or nurse.

It is not recommended that you breast-feed while you are taking
this medicine as Promixin can pass into breast milk.

Driving and using machines
Promixin may make you feel dizzy, confused or have problems
with your sight, such as blurred vision. If this happens to you,
do not drive or use any tools or machines.

you have or have had kidney problems;

In premature and new-born babies, special care should be taken
when using Promixin as the kidneys are not yet fully developed.

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Pregnancy and breast-feeding

Medicines which can affect how your kidneys function. Taking
such medicines at the same time as Promixin can increase the
risk of damage to the kidneys.
Medicines which can affect your nervous system. Taking such
medicines at the same time as Promixin can increase the risk of
side effects in your nervous system.
Medicines called muscle relaxants, often used during general
anaesthetia. Promixin can increase the effects of these medicines.
If you have a general anaesthetic, let your anaesthetist know that
you are having Promixin.

If you suffer from myasthenia gravis and are also taking other
antibiotics called macrolides (such as azithromycin, clarithromycin
or erythromycin) or antibiotics called fluoroquinolones (such as
ofloxacin, norfloxacin and ciprofloxacin), taking Promixin further
increases the risk of muscle weakness and breathing difficulties.
Having Promixin as an infusion at the same time as receiving
colistimethate sodium as an inhalation can increase your risk of
side effects.

If it is more than 3 hours after the missed dose the doctor or nurse
will wait for your next dose.

Stopping Promixin
Your doctor will decide how long you should be given Promixin.
It is important that your treatment is completed as advised by your
doctor or your symptoms may get worse.
If you have any further questions on the use of this product, ask
your doctor.

3. HOW YOU WILL BE GIVEN PROMIXIN
Your treatment with Promixin will be given to you by your doctor as
an infusion into a vein over 30 - 60 minutes.
The usual daily dose in adults is 9 million international units,
divided into two or three doses. If you are quite unwell, you will
be given a higher dose of 9 million international units once at the
start of treatment.
In some cases, your doctor may decide to give a higher daily dose
of up to 12 million international units.
The usual daily dose in children weighing up to 40 Kg is 75,000 to
150,000 units per kilogram body weight, divided into three doses.
Higher doses have occasionally been given in cystic fibrosis.
Children and adults with kidney problems, including those on
dialysis, are usually given lower doses. Your doctor will monitor
your kidney function regularly while you receive Promixin.

If you are given too much Promixin
As a doctor or nurse will be giving you Promixin, it is unlikely that
you will receive an incorrect dose. Tell your doctor or nurse if you
have any concerns about the amount of medicine that you are
given.
The symptoms of having too much Promixin can include:
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dizziness and spinning sensation (vertigo)

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slurred speech

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visual disturbance

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confusion

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mental disturbance

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flushing (reddening of the face)

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kidney problems

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muscle weakness

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feeling as though you cannot breathe

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Promixin can cause side effects, although not
everybody gets them.
Promixin can sometimes cause allergic reactions like skin rash
or red and lumpy skin rash, swollen eyelids, face, lips, mouth or
tongue, itching, difficulty breathing or swallowing. If this happens,
your Promixin treatment will be stopped immediately.
Promixin can also affect your kidneys, especially if the dose is high
or you are taking other medicines that may affect your kidneys.

Very common side effects (affecting more than
1 person in 10)
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blood tests may show changes in the way the kidneys are
working

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headache

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tingling or numbness around the mouth, lips and face

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itching

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muscle weakness

Rare side effects (affecting less than 1 person
in 1,000)
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kidney failure

Other side effects can include:
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dizziness

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difficulty in controlling movements

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soreness at the site of injection

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE PROMIXIN

6. FURTHER INFORMATION

Keep Promixin out of the sight and reach of children.

What Promixin contains

Do not use Promixin after the expiry date which is stated on the
vial or carton. The expiry date refers to the last day of that month.

The active substance is colistimethate sodium.

Do not store above 25ÂșC
Promixin contains no preservatives. Once prepared, Promixin
should be used immediately.
Your doctor or nurse will dispose of any unused medicine safely.
These measures will help to protect the environment.

Each vial contains 1 million International Units (IU) of
colistimethate sodium, which weighs about 80 milligrams (mg).
There are no other ingredients.

What Promixin looks like and contents of the pack
Promixin is supplied as a powder in a glass vial. The powder must
be made into a solution for infusion.
Promixin is supplied in packs containing 10 vials.

Marketing Authorisation Holder
Profile Pharma Limited
Bicentennial Building
Southern Gate
Chichester
West Sussex
PO19 8EZ
UK
Tel: +44 (0) 800 0288 942
Email: info.profilepharma@zambongroup.com

Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300
Copenhagen S
Denmark

This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, The Netherlands, Sweden: Tadim
Germany, Denmark, Norway, United Kingdom: Promixin
This leaflet was last approved in March 2017.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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