Kolject 1 Miu Powder For Solution For Infusion
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Colistimethate sodium
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Kolject 1 MIU is and what it is used for
2. What you need to know before you use Kolject 1 MIU
3. How to use Kolject 1 MIU
4. Possible side effects
5. How to store Kolject 1 MIU
6. Contents of the pack and other information
1. What Kolject 1 MIU is and what it is used for
Kolject 1 MIU is an antibiotic. It belongs to a group of antibiotics called polymyxins.
Like all antibiotics, Kolject 1 MIU is only active against some bacteria, so it is only suitable for treating some types of infection.
Kolject 1 MIU is given by infusion to treat some serious infections where other antibiotics are not suitable. These infections include some types of pneumonia, and some bladder or kidney infections.
2. What you need to know before you use Kolject 1 MIU
Kolject 1 MIU is not suitable for everyone. Some people must not have this infusion.
Do not use Kolject 1 MIU
- If you are allergic to colistimethate sodium, colistin sulphate or to other antibiotics with similar structure called polymyxins.
If you are unsure about anything, ask your doctor before you have the infusion.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Kolject 1 MIU
- If you have or have had kidney problems.
- If you suffer from myasthenia gravis (a rare disease where your muscles are extremely weak and get tired very quickly).
- If you suffer from porphyria (a rare metabolic disease that some people are born with).
Children
In premature and newborn infants special care should be employed as renal function is only insufficiently developed in this population.
Other medicines and Kolject 1 MIU
You must tell your doctor if you are taking any of the following medicines:
• Other antibiotics called aminoglycosides (such as gentamicin, tobramycin, amikacin, or netilmicin) as well as cephalosporins. Having Kolject 1 MIU at the same time as one of these antibiotics can increase the risk of damage to the kidneys or cause side effects in the ears and parts of the nervous system.
• Muscle relaxant medicines often used during general anaesthesia. Kolject 1 MIU can increase the effects of these drugs. If you need to have a general anaesthetic, make sure that the anaesthetist knows that you are having Kolject 1 MIU.
Make sure the doctor knows about any other medicines that you are taking, including medicines that
you obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Some people have reported side effects such as dizziness, confusion or problems with vision.
If you are affected do not drive or operate machines and talk to your doctor or pharmacist.
Kolject 1 MIU contains sodium
This medicinal product contains less than 1mmol sodium (23mg) per vial, i.e. essentially ‘sodium-
free’.
3. How to use Kolject 1 MIU
The Kolject 1 MIU powder is made up into a solution and will be given to you either as an injection or infusion (drip) into a vein. Your doctor will decide how Kolject 1 MIU should be given and how long your treatment should last. This will usually be at least 5 days. When treating bacterial infections it is important to complete the full course of treatment.
The doctor will calculate the dose depending on the infection you have and how severe it is. It will also depend on your age, weight and how well your kidneys work.
The recommended dose for adults and children weighing more than 60 kg is between 1 and 2 million units three times a day. The maximum standard dose is 6 million units in 24 hours. In special circumstances doses up to 9 million units per day may be recommended.
The recommended daily dose for adults and children weighing up to 60 kg is 50,000 to 75,000 units/kg in 24 hours. The total daily dose should be divided into three doses given at approximately 8-hour intervals.
People who have moderate or severe kidney problems will probably be given a lower dose.
If you are given too much Kolject 1 MIU than you should
As a doctor or nurse will be giving you Kolject 1 MIU, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medication that you are given.
The symptoms of having too much Kolject 1 MIU can include:
• dizziness and spinning sensation (vertigo)
• slurred speech
• visual disturbance
• confusion
• mental disturbance
• tingling or numbness of the face
• kidney problems
• muscle weakness
• feeling as though you cannot breathe
If you think that you may have missed a dose, please speak to your doctor or nurse.
Stopping Kolject 1 MIU
Your doctor will decide how long you should be given Kolject 1 MIU. 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 medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious.
Tell the doctor or nurse immediately if you notice any of the following symptoms:
• Wheezing or breathing difficulties which can lead to collapse, a rash, itching or hives on the skin, or sudden swelling of the face, throat or lips. These can be signs of a severe allergic reaction.
Kolject 1 MIU 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)
• blood tests may show changes in the way the kidneys are working
• headache
• tingling or numbness around the mouth, lips and face
• itching
• muscle weakness
Rare side effects (affecting less than 1 person in 1 000)
• kidney failure
Other side effects can include:
• dizziness
• difficulty in controlling movements
• soreness at the site of injection
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly to the national reporting system via the internet at www.mhra.gov.uk/yellowcard; or you can report via the Yellow Card Scheme. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Kolject 1 MIU
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and the vials after EXP. The expiry date refers to the last day of that month.
Do not freeze.
Store below 25°C.
Keep the vial(s) in the outer carton, in order to protect from light.
Reconstituted/diluted solution should be used immediately, or within 24 hours when stored in the refrigerator (2 to 8oC).
For single use only. Discard any unused solution.
Do not use this medicine if you notice any discoloration or cloudiness of the solution.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Kolject 1 MIU contains
The active substance is colistimethate sodium. There are no other ingredients.
What Kolject 1 MIU looks like and contents of the pack
Kolject 1 MIU is a creamy white powder for injection or infusion in single dose 10ml vials. Each type I glass vial contains the active ingredient, colistimethate sodium (also called colistin) as an amount of powder equivalent to one million international units,
with red ‘flip-off cap , supplied as pack sizes of:
• 1 vial
• 10 vials
• 30 vials
• 60 vials
• 100 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
YES Pharmaceutical Development Services GmbH Bahnstr. 42 - 46 61381 Friedrichsdorf Germany
Manufacturer
Forest Tosara Ltd.
Unit 146 Baldoyle Industrial Estate Baldoyle, Dublin 13
Ireland
This leaflet was last revised in {MM/YYYY}.
If you find this leaflet difficult to read or understand, please speak to the doctor or nurse or contact the marketing authorisation holder at the above address.