Kolject 2 Miu Powder For Solution For Infusion
Package leaflet: Information for the user Kolject 2 MIU, Powder for solution for infusion
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 2 MIU is and what it is used for
2. What you need to know before you use Kolject 2 MIU
3. How to use Kolject 2 MIU
4. Possible side effects
5. How to store Kolject 2 MIU
6. Contents of the pack and other information
1. What Kolject 2 MIU is and what it is used for
Kolject 2 MIU contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic. It belongs to a group of antibiotics called polymixins.
Kolject 2 MIU is given by injection to treat some types of serious infections caused by certain bacteria. Kolject 2 MIU is used when other antibiotics are not suitable.
2. What you need to know before you use Kolject 2 MIU Do not use Kolject 2MIU
- If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Kolject 2MIU
- If you have or have had kidney problems.
- If you suffer from myasthenia gravis
- If you suffer from porphyria
In premature and new-born babies, special care should be taken when using Kolject 2MIU as the kidneys are not yet fully developed.
Other medicines and Kolject 2 MIU
You must tell your doctor if you are taking any of the following medicines:
- medicines like antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins which can affect how your kidneys function. Taking such medicines at the same time as Kolject 2MIU can increase the risk of damage to the kidneys
- medicines like antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin, and netilmicin) and cephalosporins which can affect your nervous system. Taking such medicines at the same time as Kolject 2 MIU can increase the risk of side effects in the ears and other parts of your nervous system
- medicines called muscle relaxants, often used during general anaesthesia. Kolject 2MIU can increase the effects of these medicines. If you have a general anaesthetic, let your anaesthetist know that you are having Kolject 2MIU
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 Kolject 2 MIU further increases the risk of muscle weakness and breathing difficulties.
Having Kolject 2MIU as an infusion at the same time as receiving Kolject 2MIU as an inhalation can increase your risk of side effects.
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 2 MIU contains sodium
This medicinal product contains less than 1mmol sodium (23mg) per vial, i.e. essentially ‘sodium-free’.
3. How to use Kolject 2 MIU
Kolject 2MIU is given to you by your doctor as a slow injection (infusion into a vein over 30 - 60 minutes) or as a fast injection (over 5 minutes into a special kind of tube in a vein). Kolject 2 MIU may occasionally be given by injection into the heart or the spine.
The usual daily dose in adults is 9 million units, divided into two or three doses. If you are quite unwell, you will be given a higher dose of 9 million 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 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 Kolject 2MIU.
Your doctor will decide how long your treatment should last depending of the severity of the infection. When treating bacterial infections it is important to complete the full course of treatment.
As a doctor or nurse will be giving you Kolject 2 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 2 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 2 MIU
Your doctor will decide how long you should be given Kolject 2 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 2 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 2 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 after preparation. If this is not possible, talk first to your doctor or pharmacist as the solutions may bestored in the refrigerator (2 to 8oC)for no longer than 24 hours.
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 2 MIU contains
The active substance is colistimethate sodium. There are no other ingredients.
What Kolject 2 MIU looks like and contents of the pack
Kolject 2 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 two million international units,
with lilac ‘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
Forest Pharma B.V.
Newtonlaan 115 3584 BH, Utrecht Netherlands
Manufacturer
Forest Tosara Ltd.
Unit 146 Baldoyle Industrial Estate
Baldoyle, Dublin 13
Ireland
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Austria |
Colintens 2 Mio. I.E. Pulver zur Herstellung einer Infusionslosung |
|
Belgium |
Colistiject 2 Millionen I.E./Colistiject 2 million UI/Colistiject 2 miljoen Internationale Eenheden (I.E.), Pulver zur Herstellung einer Infusionslosung/Poudre pour solution pour perfusion/Poeder voor oplossing voor infusie |
|
Germany |
Colist-Infusion 2 Millionen I.E. Pulver zur Herstellung einer Infusionslosung |
|
The Netherlands |
Kolject, 2 miljoen Internationale Eenheden (IE) poeder voor oplossing voor infusie |
This leaflet was last revised in 09/2015.
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.