ft

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tobramycin 40 mg/ml Injection

In this leaflet:

1.    What Tobramycin Injection is and what it is used for

2.    Before you use Tobramycin Injection

3.    How to use Tobramycin Injection

4.    Possible side effects

5.    How to store Tobramycin Injection

6.    Further information

1. WHAT TOBRAMYCIN INJECTION IS AND WHAT IT IS USED FOR

Tobramycin Injection is an antibiotic medicine (used to fight infections caused by bacteria).

Tobramycin can be used to treat:

•    infections of the brain and spinal cord, e.g. meningitis

•    infections of the stomach or intestines

•    infections of the bladder or kidney (urinary tract infection)

•    infections of the lungs, e.g. pneumonia

•    infections of the bone, skin or soft tissue including burns

2. BEFORE YOU USE TOBRAMYCIN INJECTION

Tobramycin Injection must never be injected intrathecally (into the spine).

Do not use Tobramycin Injection

•    if you have shown signs of hypersensitivity (severe allergy) to tobramycin or similar medicines (called aminoglycosides) on previous occasions

Tell your doctor if the above applies to you before this medicine is used.

Take special care with Tobramycin Injection

•    if you have muscle disorders, such as myasthenia gravis (a disease in which the muscles become weak and tire easily) or parkinsonism (a disease of the brain which affects movement)

•    if you have kidney trouble

Tell your doctor or pharmacist if either of the above applies to you before this medicine is used.

Special care is also needed if this medicine is to be given to babies or infants less than 6 weeks of age, or patients with extensive burns.

Taking/using other medicines

Special care is needed if you are taking/using other medicines as some could interact with Tobramycin Injection, for example:

•    some other antibiotics (e.g. cephalothin)

•    amphotericin B (a medicine used to treat fungal infection)

•    some diuretics (water tablets)

•    medicines used as general anaesthetics

•    medicines used as muscle relaxants during general anaesthesia

•    cisplatin (anti-cancer medicine)

•    ciclosporin (a medicine that reduces the activity of the body's immune system)

•    neostigmine and pyridostigmine (medicines used in the treatment of muscle weakness)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine.

There may be a risk of birth defects if this medicine is used during pregnancy. Some children whose mothers took a similar medicine (streptomycin) have been born deaf. It will only be used if the potential benefits clearly outweigh the risks.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or use machines if you experience any side effect (e.g. dizziness or drowsiness) which may lessen your ability to do so.

Important information about some of the ingredients of Tobramycin Injection

This medicine contains sodium metabisulphite, which can cause an allergic type reaction (skin rash, swelling of eyelids, face or lips, or difficulty in breathing). This is rare, but you may be more at risk if you suffer from allergies or asthma.

This medicine contains less than 1 mmol sodium (23 mg) per 700 mg dose of Tobramycin Injection, i.e. essentially sodium free.

3. HOW TO USE TOBRAMYCIN INJECTION

This medicine is given by injection (using a syringe) into a muscle or a vein, or infusion (drip) into a vein.

If it is given as an infusion it will be diluted before use. It will then be infused over a 20 to 60 minute period.

Dose

Your doctor will work out the correct dose of Tobramycin Injection for you and how often it must be given.

The dose will depend on your medical condition, your size, how serious the infection is, your age and how well your kidneys are working. Your doctor will tell how well your kidneys are working using blood or urine samples.

Treatment normally lasts for 7 to 10 days.

^-------------------

Tobramycin 40 mg/ml Injection

The following information is intended for medical or healthcare professionals only

Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.

Incompatibilities

Incompatibility or loss of activity has been reported between tobramycin sulphate and some cephalosporins and penicillins and also heparin sodium. Solutions with clindamycin phosphate in glucose injection are reported to be unstable.

Tobramycin Injection should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

Q7&665

4345SS

If you take tobramycin for more than 10 days or take more than the recommended dose, you may experience more severe side effects. These include dangerous breathing difficulties, which could also occur if you do not drink enough fluid, if you have poor kidney function or if you are taking other drugs that can affect your hearing.

Your doctor may take regular blood samples to ensure you are receiving the correct dose.

If you are given too much or too little Tobramycin Injection

This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tobramycin Injection can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

•    severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

•    loss of hearing

•    ringing, buzzing or roaring noise in your ears

•    dizziness

•    vertigo (a feeling that you or your surroundings are spinning)

•    numbness or pins and needles

•    muscle twitching

•    convulsions

These are serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor as soon as possible:

•    fever (high temperature)

•    rash or development of raised coloured blotches

•    scaly skin

•    itching

•    feeling or being sick

•    headache

•    feeling tired or drowsy

•    pain at the injection site

•    confusion and disorientation

•    diarrhoea

Tobramycin Injection may lead to changes in your blood cells and liver and kidney function. Your doctor may take blood samples to monitor for these. Your doctor may also check for hearing problems.

Some patients who have received an injection of tobramycin into the eye have experienced serious vision problems. This is not a recommended use of this medicine.

Reporting of side effects

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TOBRAMYCIN INJECTION

Keep out of the reach and sight of children

Expiry

This medicine must not be used after the expiry date which is stated on the vial label and carton after 'EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage

The vials should be kept in the outer carton to protect from light and stored at or below 25°C.

Unused portions of opened vials must not be stored for later use.

Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 24 hours provided they have been prepared in a way to exclude microbial contamination.

6. FURTHER INFORMATION

What Tobramycin Injection contains

The active substance is tobramycin. Each millilitre (ml) of solution contains 40 milligrams (mg) of tobramycin.

The other ingredients are sodium metabisulphite (E223), disodium edetate, sulphuric acid and Water for Injections.

What Tobramycin Injection looks like and contents of the pack

Tobramycin Injection is a clear colourless solution for injection presented in glass containers called vials.

It may be supplied in packs containing:

•    5 x 40 mg/1 ml vials

•    5 x 80 mg/2 ml vials

•    1 or 5 x 240 mg/6 ml vials Not all packs may be marketed.

Marketing authorisation holder and manufacturer responsible for batch release in Europe

Hospira UK Limited

Horizon

Honey Lane

Hurley

Maidenhead

SL6 6RJ, UK

Manufacturer

Hospira Australia Pty Ltd 1-5, 7-23 and 25-39 Lexia Place MULGRAVE VIC 3170 Australia

This leaflet was last revised in 09/2015

^-------------------

Instructions for use and handling

Single use only

Discard any unused contents

When given by infusion, Tobramycin Injection may be diluted (with 0.9% Sodium Chloride Intravenous Infusion BP or 5% Dextrose Intravenous Infusion BP) to volumes of 50-100 ml for adult doses. For children, the volume of diluent should be proportionately less than for adults.

After dilution, chemical and physical in-use stability has been demonstrated in dextrose 5% and sodium chloride 0.9% infusion solutions for 24 hours at 24°C in the presence of light.

From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions. Q7&665

Component Specification

Item number:		Q78665
Request number:		AS4991
Country:		United Kingdom
OI template:	88S119
Amalia version:	6
Mulgrave version:	5
Dimensions:	118 x 513 mm (18 panels)
Container(s):	vial
Supplier:	Howden Printing
Stock:	Primapharm 40gsm /
	Teropaque Thin Medical 40gsm
Folded dimensions: 28.5 x 118 mm
Printed both sides:	Yes
Perforated:	No	_
Pharma code:	115 (221211)
Pharma code length: 11 mm
Mulgrave 4 series no	.: 434522
Colours
Black:		■

ft

Hospira

Requester

I have checked this artwork against the registered text including spelling, layout, size, colours, registration numbers and scientific equations, the name and address and trademarks. Also for any possible changes to related items.

This artwork is in conformance with the Marketing Authorisation and can now proceed to the printing stage.

Previous Item Number: Q62989 / 431470 Signed:

Date:

Version 1 Technician: Date:	LB 18/Feb/15	Version 2 Technician: Date:	JH 10/Mar/15
Version 3 Technician: Date:	NR 18/Sep/15	Version 4 Technician: Date:	NR 18/Sep/15
Version 5 Technician: Date:	JW 15/Oct/15	Version 6 Technician: Date:	XX dd/mmm/yy
Version 7 Technician: Date:	XX dd/mmm/yy	Version 8 Technician: Date:	XX dd/mmm/yy
Version 9 Technician: Date:	XX dd/mmm/yy	Version 10 Technician: Date:	XX dd/mmm/yy

ft

Hospira

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tobramycin 40 mg/ml Injection

In this leaflet:

1.    What Tobramycin Injection is and what it is used for

2.    Before you use Tobramycin Injection

3.    Howto use Tobramycin Injection

4.    Possible side effects

5.    Howto store Tobramycin Injection

6.    Further information

1. WHAT TOBRAMYCIN INJECTION IS AND WHAT IT IS USED FOR

Tobramycin Injection is an antibiotic medicine (used to fight infections caused by bacteria).

Tobramycin can be used to

treat:

•    infections of the brain and spinal cord, e.g. meningitis

•    infections of the stomach or intestines

•    infections of the bladder or kidney (urinary tract infection)

•    infections of the lungs, e.g. pneumonia

•    infections of the bone, skin or soft tissue including burns

2. BEFORE YOU USE TOBRAMYCIN INJECTION

Tobramycin Injection must never be injected intrathecally (into the spine).

Do not use Tobramycin Injection

•    if you have shown signs of hypersensitivity (severe allergy) to tobramycin or similar medicines (called aminoglycosides) on previous occasions

Tell your doctor if the above applies to you before this medicine is used.

Take special care with Tobramycin Injection

•    if you have muscle disorders, such as myasthenia gravis (a disease in which

the muscles become weak and tire easily) or parkinsonism (a disease of the brain which affects movement)

•    if you have kidney trouble

Tell your doctor or pharmacist if either of the above applies to you before this medicine is used.

Special care is also needed if this medicine is to be given

to babies or infants less than 6 weeks of age, or patients with extensive burns.

Taking/using other medicines

Special care is needed if you are taking/using other medicines as some could interact with Tobramycin Injection, for example:

•    some other antibiotics (e.g. cephalothin)

•    amphotericin B (a medicine used to treat fungal infection)

•    some diuretics (water tablets)

•    medicines used as general anaesthetics

•    medicines used as muscle relaxants during general anaesthesia

•    cisplatin (anti-cancer medicine)

•    ciclosporin (a medicine that reduces the activity of the body’s immune system)

•    neostigmine and pyridostigmine (medicines used in the treatment of muscle weakness)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine.

There may be a risk of birth defects if this medicine is used during pregnancy.

Some children whose

mothers took a similar medicine (streptomycin) have been born deaf. It will only be used if the potential benefits clearly outweigh the risks.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or use machines if you experience any side effect (e.g. dizziness or drowsiness) which may lessen your ability to do so.

Important information about some of the ingredients of Tobramycin Injection

This medicine contains sodium metabisulphite, which can cause an allergic type reaction (skin rash, swelling of eyelids, face or lips, or difficulty in breathing). This is rare, but you may be more at risk if you suffer from allergies or asthma.

This medicine contains less than 1 mmol sodium (23 mg) per 700 mg dose of Tobramycin Injection, i.e. essentially sodium free.

$. HOW TO USE TOBRAMYCIN INJECTION

This medicine is given by injection (using a syringe) into a muscle or a vein, or infusion (drip) into a vein.

If it is given as an infusion it will be diluted before use. It will then be infused over a 20 to 60 minute period.

Dose

Your doctor will work out the correct dose of Tobramycin Injection for you and how often it must be given.

Tobramycin 40 mg/ml Injection

The following information is intended for medical or healthcare professionals only

Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.

Incompatibilities

Incompatibility or loss of activity has been reported between tobramycin sulphate and some cephalosporins and penicillins and also heparin sodium. Solutions with clindamycin phosphate in glucose injection are reported to be unstable. Tobramycin Injection should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

Instructions for use and handling

Single use only Discard any unused contents When given by infusion, Tobramycin Injection may be diluted (with 0.9% Sodium Chloride Intravenous Infusion BP or 5% Dextrose Intravenous Infusion BP) to volumes of 50-100 ml for adult doses. For children, the volume of diluent should be proportionately less than for adults.

After dilution, chemical and physical in-use stability has been demonstrated in dextrose 5% and sodium chloride 0.9% infusion solutions for 24 hours at 24°C in the presence of light.

a?asst M3M5E3

The dose will depend on your medical condition, your size, how serious the infection is, your age and how well your kidneys are working. Your doctor will tell how well your kidneys are working using blood or urine samples.

Treatment normally lasts for 7 to 10 days.

If you take tobramycin for more than 10 days or take more than the recommended dose, you may experience more severe side effects. These include dangerous breathing difficulties, which could also occur if you do not drink enough fluid, if you have poor kidney function or if you are taking other drugs that can affect your hearing.

Your doctor may take regular blood samples to ensure you are receiving the correct dose.

If you are given too much or too little Tobramycin Injection

This medicine will be given to you in a hospital, under the supervision of a doctor.

It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tobramycin Injection can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

• severe allergic reaction - you may experience a sudden itchy rash (hives),

swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

•    loss of hearing

•    ringing, buzzing or roaring noise in your ears

•    dizziness

•    vertigo (a feeling that you or your surroundings are spinning)

•    numbness or pins and needles

•    muscle twitching

•    convulsions

These are serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor as soon as possible:

•    fever (high temperature)

•    rash or development of raised coloured blotches

•    scaly skin

•    itching

•    feeling or being sick

•    headache

•    feeling tired or drowsy

•    pain at the injection site

•    confusion and disorientation

•    diarrhoea

Tobramycin Injection may lead to changes in your blood cells and liver and kidney function. Your doctor may take blood samples to monitor for these. Your doctor may also check for hearing problems.

Some patients who have received an injection of tobramycin into the eye have experienced serious vision problems. This is not a recommended use of this medicine.

Reporting of side effects

If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom

Yellow Card Scheme Website:

www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TOBRAMYCIN INJECTION

Keep out of the reach and sight of children

Expiry

This medicine must not be used after the expiry date which is stated on the vial label and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage

The vials should be kept in the outer carton to protect from light and stored at or below 25°C.

Unused portions of opened vials must not be stored for later use.

Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 24 hours provided they have been prepared in a way to exclude microbial contamination.

6. FURTHER INFORMATION

What Tobramycin Injection contains

The active substance is tobramycin. Each millilitre (ml) of solution contains 40 milligrams (mg) of tobramycin.

The other ingredients are sodium metabisulphite (E223), disodium edetate, sulphuric acid and Water for Injections.

What Tobramycin Injection looks like and contents of the pack

Tobramycin Injection is a clear colourless solution for injection presented in glass containers called vials.

It may be supplied in packs containing:

•    5 x 40 mg/1 ml vials

•    5 x 80 mg/2 ml vials

•    1 or 5 x 240 mg/6 ml vials

Not all packs may be marketed.

Marketing authorisation holder and manufacturer responsible for batch release in Europe

Hospira UK Limited

Horizon

Honey Lane

Hurley

Maidenhead

SL6 6RJ, UK

Manufacturer

Hospira Australia Pty Ltd 1-5, 7-23 and 25-39 Lexia Place MULGRAVE VIC 3170 Australia

This leaflet was last revised in 09/2015

a?asst M3M5E3