Colistimethate Accord

Package leaflet: Information for the user

Colistimethate Accord 1 million International Units (IU) powder for injectable solution and for
infusion
Equivalent medicine
Please 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 questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Colistimethate Accord is and what it is used for
2. What you need to know before using Colistimethate Accord
3. How to use Colistimethate Accord
4. Possible side effects
5. How to store Colistimethate Accord
6. Contents of the pack and other information

1. What Colistimethate Accord is and what it is used for

This medicine is an antibiotic belonging to the polymyxin group.
Colistimethate Accord is administered by injection for the treatment of certain serious infections caused by specific bacteria. Colistimethate Accord is used when other antibiotics are not suitable.
Colistimethate Accord is administered by inhalation for the treatment of chronic lung infections in patients with cystic fibrosis. Colistimethate Accord is used when these infections are caused by a specific bacterium called Pseudomonas aeruginosa.

2. What you need to know before using Colistimetate Accord

Do not use Colistimetate Accord

• if you are allergic (hypersensitive) to colistimethate sodium, colistin, or other polymyxins.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using colistimethate sodium

• if you have or have had kidney problems.
• if you suffer from myasthenia gravis.
• if you suffer from porphyria.
• if you suffer from asthma (for the inhaled route).

Special care must be taken when using colistimethate sodium in premature infants and newborns, as their kidneys are not yet fully developed.
Other medicines and Colistimetate Accord

• Medicines that may affect kidney function. If you take such medicines together with colistimethate sodium, the risk of kidney damage may increase.
• Medicines that may affect the nervous system. If you take such medicines together with colistimethate sodium, the risk of nervous system side effects may increase.
• Medicines called muscle relaxants, often used during general anaesthesia. Colistimethate sodium may enhance the effects of these medicines. If you are given a general anaesthetic, inform the anaesthetist that you are receiving colistimethate sodium.

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 colistimethate sodium further increases the risk of muscle weakness and breathing difficulties.
If you receive colistimethate sodium simultaneously by infusion and inhalation, the risk of side effects may increase.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using Colistimetate Accord.
Colistimetate Accord may be administered during pregnancy or when trying to become pregnant if your doctor considers the benefits to outweigh the possible risks.
Do not breastfeed during treatment with this medicine.
Driving and using machines
Colistimetate Accord may cause dizziness, confusion, or vision problems such as blurred vision. If this occurs, do not drive and do not operate tools or machinery.

3. How to use Colistimetate Accord

Follow these instructions unless your doctor has given you different advice.
Remember to take your medicine. Your doctor will inform you about how long your treatment with Colistimetate Accord should last; do not stop the treatment early, as there is a risk that the infection may return.
Colistimetate Accord can be administered either intravenously or by inhalation using a nebulizer.

Intravenous use:
Colistimethate sodium is administered to you by your doctor as an intravenous infusion lasting 30–60 minutes.
The usual daily dose for adults is 9 million units, divided into two or three doses. If you are severely ill, you may receive an initial higher dose of 9 million units once at the beginning of treatment.
In some cases, your doctor may decide to administer a higher daily dose, up to a maximum of 12 million units.
The usual daily dose for children weighing up to 40 kg is 75,000–150,000 units per kilogram of body weight, divided into three doses.
Higher doses have occasionally been used in cystic fibrosis.
Children and adults with kidney problems, including those undergoing dialysis, normally receive lower doses.
Your doctor will regularly monitor your kidney function while you are receiving Colistimetate Accord.

Inhalation use:
The usual dose for adults, adolescents, and children from 2 years of age is 1–2 million units two to three times daily (maximum 6 million units per day).
The usual dose for children under 2 years of age is 0.5–1 million units twice daily (maximum 2 million units per day).
Your doctor may decide to adjust the dose depending on individual circumstances. If you are also using other inhaled medicines, your doctor will advise you on the order in which to take them.

If you take more Colistimetate Accord than you should
If you have used more Colistimetate Accord than you should, you may experience breathing difficulties, muscle weakness, and kidney function problems.

If you forget to take Colistimetate Accord
Do not take a double dose to make up for a forgotten dose.
If you are receiving this medicine intravenously and less than 3 hours have passed since the missed dose was due, ask for the missed dose to be administered. If more than 3 hours have passed, wait for your next scheduled dose.
If you are using the inhaled form, take the missed dose as soon as you remember, then continue taking your medicine at the usual times.

If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In the case of colistimethate sodium, these side effects mainly affect the nervous system and kidney function. The most common side effects after nebulization are cough and breathing difficulties.

Nervous system disorders
Tingling or numbness around the lips and face, dizziness, difficulty speaking, visual disturbances, confusion, mental disorders, or flushing (reddening of the face).

Respiratory, thoracic and mediastinal disorders
Nebulization of Colistimethate Accord via a nebulizer may cause cough and, in some individuals, chest tightness, breathlessness, or shortness of breath.

Renal and urinary disorders
Colistimethate Accord may affect the kidneys, particularly if the dose is high or if you are taking other medicines that have effects on the kidneys.

General disorders and administration site conditions
Colistimethate Accord may cause allergic reactions such as skin rashes. If these occur, inform your doctor immediately, as treatment may need to be discontinued.
Colistimethate Accord administered via a nebulizer may cause mouth or throat pain, which could be due to an allergy to the medicine or to an additional fungal infection.
After intravenous injection, you may experience mild pain at the injection site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colistimetate Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or carton. The expiry date refers to the last
day of that month.
This medicine does not require any special storage conditions.
Colistimetate Accord does not contain preservatives. Once prepared, Colistimetate Accord must be used
immediately.
Your doctor or nurse will safely dispose of any unused medicines. This will help protect the environment.

6. Package contents and other information

What Colistimetate Accord contains

• The active substance is colistimethate sodium. Each vial contains 1 million international units (IU) of colistimethate sodium, with a weight of approximately 80 milligrams (mg).
• There are no other components.

This medicine contains less than 23 mg (1 mmol) of sodium per vial and is therefore essentially sodium-free.
Description of the appearance of Colistimetate Accord and contents of the pack
Colistimetate Accord is a powder in a glass vial. The powder must be reconstituted to form a solution for injection or infusion. Colistimetate Accord is supplied in packs containing 10 vials.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
2300 Copenhagen S
Denmark

Package leaflet: Information for the user

Colistimethate Accord 2 million International Units (IU) powder for injectable solution and for infusion
Equivalent medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Colistimethate Accord is and what it is used for
2. What you need to know before you use Colistimethate Accord
3. How to use Colistimethate Accord
4. Possible side effects
5. How to store Colistimethate Accord
6. Contents of the pack and other information

1. What Colistimetate Accord is and what it is used for

This medicine is an antibiotic belonging to the polymyxin group.
Colistimetate Accord is administered by injection for the treatment of certain types of serious infections
caused by specific bacteria. Colistimetate Accord is used when other antibiotics are not suitable.
Colistimetate Accord is administered by inhalation for the treatment of chronic lung infections
in patients with cystic fibrosis. Colistimetate Accord is used when these infections are
caused by a specific bacterium called Pseudomonas aeruginosa.

2. What you need to know before using Colistimetate Accord

Do not use Colistimetate Accord

• if you are allergic (hypersensitive) to colistimethate sodium, colistin, or other polymyxins.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using colistimethate sodium

• if you have or have had kidney problems.
• if you suffer from severe myasthenia gravis.
• if you suffer from porphyria.
• if you suffer from asthma (in case of inhaled administration).

Special care must be taken when using colistimethate sodium in premature infants and newborns, as their kidneys are not yet fully developed.
Other medicines and Colistimetate Accord

• Medicines that may affect kidney function. If you take such medicines at the same time as colistimethate sodium, the risk of kidney damage may increase.
• Medicines that may affect the nervous system. If you take such medicines at the same time as colistimethate sodium, the risk of nervous system-related side effects may increase.
• Medicines called muscle relaxants, often used during general anesthesia. Colistimethate sodium may enhance the effects of these medicines. If you are given a general anesthetic, inform the anesthetist that you are receiving colistimethate sodium.

If you suffer from severe 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 colistimethate sodium further increases the risk of muscle weakness and breathing difficulties.
If you receive colistimethate sodium simultaneously by infusion and inhalation, the risk of side effects may increase.
Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using Colistimetate Accord.
Colistimetate Accord may be administered during pregnancy or when trying to become pregnant if your doctor considers the benefits to outweigh the possible risks.
Do not breastfeed during treatment with this medicine.
Driving and using machines

Colistimetate Accord may cause dizziness, confusion, or vision problems such as blurred vision. If this occurs, do not drive and do not operate tools or machinery.

3. How to use Colistimethate Accord

Follow these instructions unless your doctor has given you different advice.
Remember to take the medicine. Your doctor will inform you of the duration of treatment with Colistimethate Accord. Do not stop treatment early, as there is a risk that the infection may return.
Colistimethate Accord can be administered intravenously or by inhalation using a nebulizer.

Intravenous use:
Your doctor will administer colistimethate sodium to you as an infusion into a vein over a period of 30–60 minutes.
The usual daily dose for adults is 9 million units, divided into two or three doses. If you are quite ill, you may receive an initial higher dose of 9 million units once at the beginning of treatment.
In some cases, your doctor may decide to administer a higher daily dose, up to a maximum of 12 million units.
The usual daily dose for children weighing up to 40 kg is 75,000–150,000 units per kilogram of body weight, divided into three doses.
Higher doses have occasionally been administered in cystic fibrosis.
Children and adults with kidney problems, including those undergoing dialysis, usually receive lower doses.
Your doctor will regularly monitor your kidney function while you are receiving Colistimethate Accord.

Inhalation use:
The usual dose for adults, adolescents, and children from 2 years of age is 1–2 million units two to three times daily (maximum 6 million units per day).
The usual dose for children under 2 years of age is 0.5–1 million units twice daily (maximum 2 million units per day).
Your doctor may decide to adjust the dose depending on individual circumstances. If you are also using other inhaled medicines, your doctor will advise you on the order in which to take them.

If you take more Colistimethate Accord than you should
If you have used more Colistimethate Accord than you should, you may experience breathing problems, muscle weakness, and kidney function impairment.

If you forget to take Colistimethate Accord
Do not take a double dose to make up for a forgotten dose.
If you are receiving this medicine by intravenous infusion and less than 3 hours have passed since the missed dose was due, ask for the missed dose to be administered. If more than 3 hours have passed since the missed dose, wait and take the next dose at the usual time.
If you are using the inhaled form, take the missed dose as soon as you remember, then continue taking the medicine at your usual times.

If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In the case of colistimethate sodium, these side effects mainly affect the nervous system and kidney function. The most common side effects after nebulisation are cough and breathing difficulties.

Nervous system disorders
Tingling or numbness around the lips and face, dizziness, difficulty speaking, visual disturbances, confusion, psychiatric disorders, or flushing (reddening of the face).

Respiratory, thoracic and mediastinal disorders
Nebulisation of Colistimetate Accord via a nebuliser may cause cough and, in some people, a feeling of chest tightness, breathlessness, or shortness of breath.

Renal and urinary disorders
Colistimetate Accord may affect the kidneys, particularly if the dose is high or if you are taking other medicines that have effects on the kidneys.

Systemic disorders and administration site conditions
Colistimetate Accord may cause allergic reactions such as skin rashes. If these occur, inform your doctor immediately, as treatment may need to be discontinued.
Colistimetate Accord administered via a nebuliser may cause mouth or throat pain, which could be due to an allergy to the medicine or an additional fungal infection.
After intravenous injection, you may experience mild pain at the injection site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or nurse. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Colistimetato Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Colistimetato Accord does not contain preservatives. Once prepared, Colistimetato Accord must be used immediately.
The doctor or nurse will safely dispose of any unused medicines. This will help protect the environment.

6. Package contents and other information

What Colistimetato Accord contains

• The active substance is colistimethate sodium. Each vial contains 2 million international units (IU) of colistimethate sodium, weighing approximately 160 milligrams (mg).
• There are no other components.

This medicine contains less than 23 mg (1 mmol) of sodium per vial, therefore it is essentially sodium-free.
Description of the appearance of Colistimetato Accord and contents of the pack
Colistimetato Accord is a powder in a glass vial. The powder must be converted into an injectable or infusion solution. Colistimetato Accord is supplied in packs containing 10 vials.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
2300 Copenhagen S
Denmark