PACKAGE LEAFLET: INFORMATION FOR THE USER

Cefotaxime Sodium for Injection 500mg, 1g

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

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

2.    Before you are given Cefotaxime Injection.

3.    How Cefotaxime Injection is given.

4.    Possible side effects.

5.    How to store Cefotaxime Injection

6.    Further information.

The name of your medicine is "Cefotaxime sodium for injection" (referred to as Cefotaxime Injection throughout this leaflet).

| 1. WHAT CEFOTAXIME INJECTION IS AND WHAT IT IS USED FOR |

Cefotaxime is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotic are similar to penicillin.

Cefotaxime kills bacteria and it can be used to treat infections of the:

•    Kidneys and bladder

•    Blood (septicaemia)

•    Skin and flesh immediately under the skin

•    Bones

•    Heart valves

•    Brain (meningitis)

•    Abdomen (peritonitis)

•    Some sexually transmitted infections (gonorrhoea)

It can also be used to prevent and treat infections following surgical operations.

Taking other medicines

Tell the doctor or nurse if you are taking any of the following medicines:

•    the contraceptive pill (in which case you will need to take extra contraceptive precautions such as using a condom)

•    any diuretic medicine ("water tablets") e.g. furosemide

•    another antibiotic e.g. chloramphenicol or aminoglycoside antibiotics

•    probenecid (for gout)

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

Pregnancy and breast-feeding

If you are pregnant, think you might be pregnant or are breastfeeding, you must tell your doctor before you are given this medicine.

Driving and using machines

If you are given high doses of cefotaxime, you may feel dizzy/drowsy or fall asleep or experience convulsions (fits) or unusual body movements. If this happens, you should not drive or operate machinery.

Important information about some of the ingredients of Cefotaxime injection

Cefotaxime Injection contains approximately 50mg (2.2 mmol) of sodium per 1g dose. This should be taken into consideration by patients on a controlled sodium diet. Tell your doctor or nurse if you are on a low sodium diet.

| 2. BEFORE YOU ARE GIVEN CEFOTAXIME INJECTION |

You should not be given Cefotaxime injection if:

•    you are allergic (hypersensitive) to cefotaxime

•    you are allergic to any similar antibiotics (known as "cephalosporins")

•    you have ever had a serious allergic reaction when given penicillin or similar antibiotics

•    you are allergic to lidocaine

Tell your doctor or nurse if any of the above apply to you.

Before you are given Cefotaxime injection

You must tell the doctor or nurse if any of the following apply to you:

•    you have a history of allergies or asthma

•    you are on a low sodium diet

•    you have a heart or kidney disorder

•    you are having any blood or urine tests

•    you have a history of gastro-intestinal problems e.g. colitis, which causes diarrhoea containing blood.

| 3. HOW CEFOTAXIME INJECTION IS GIVEN |

Cefotaxime Injection is supplied as a powder so before it can be given it must be diluted and made into a solution. Your doctor or nurse normally does this. They will inject this directly into a vein (intravenous) or muscle (intramuscular). It may also be given by an intravenous infusion ("drip").

Your doctor will decide how much you need and how often the injections should be given.

The usual doses are given below but doctors may prescribe different doses depending on the severity and type of your infection, your weight, your age and how well your kidneys are working.

Treatment with Cefotaxime injection is usually continued for 2-3 days after you start to recover from your illness or after your operation.

Adults and children over 12 years old:

The usual dose is 1 g every twelve hours. In some patients where infections are severe, the doctor may give a higher dose up to 12g every day.

For the treatment of gonorrhoea, a single 500mg dose is usually given.

To prevent an infection after surgery, 1 -2 g is given before the operation. A second dose may be needed after the operation.

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Cefotaxime Sodium for Injection 500mg, 1g

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SEPARATIONS:

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PRODUCT NAME:

I - Cefotaxime Villerton UK

PRODUCT CODE:

L08GBCTX03

PHARMACODE: I I X X I I X I X MEAS. (mm): 420 x 420 (105x52,5) CUTTING PROFILE: ACSI079F01 TECHNICAL SPECIF.: ACSI079F01 g/sq.mt: 40 gr/m² Thikness: 0,049mm FONT TYPE: Century Gothic 8pt

GRAFIFARMA GRAFIFLEX QUALITY SYSTEM - ISO 9001:2008

ISSUE DATE

11/03/15

OPERATOR

RI006M

DRAFT

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The following table may serve as a guide to dosages:

Adults and children over 12 years in general receive 1 g Cefotaxime every 12 hours. In severe cases, the daily dose can be increased up to 12 g. Daily doses up to 6 g can be divided into at least two individual administrations at 12 hourly intervals. Higher daily doses must be divided into at least 3 to 4 individual administrations at 8 or 6 hour intervals respectively.

In case of life-threatening situations it may be necessary to increase the daily dose.

In those situations the following table is recommended.

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Package leaflet: Information for the Patient    that contains calcium into their vein.

Ceftriaxone 250 mg, 1g, 2g Powder for Solution for Injection or Infusion

Ceftriaxone (as Ceftriaxone Sodium)

Read all of this leaflet carefully before you are given 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.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    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 Ceftriaxone injection is and what it is used for

2.    What you need to know before you are given Ceftriaxone injection

3.    How Ceftriaxone injection is given

4.    Possible side effects

5.    How to store Ceftriaxone injection

6.    Contents of the pack and other information

Other medicines and Ceftriaxone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    A type of antibiotic called an aminoglycoside.

•    An antibiotic called chloramphenicol (used to treat infections, particularly of the eyes).

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The doctor will consider the benefit of treating you with Ceftriaxone against the risk to your baby.

Driving and using machines

Ceftriaxone can cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience these symptoms.

Ceftriaxone injection contains sodium

This medicine contains 0.9 mmol (250mg vial), 3.6 mmol (1g vial) or 7.2 mmol (2g vial) of sodium. This should be taken into consideration by patients on a controlled sodium diet. Tell your doctor or nurse if you are on a low sodium diet.

If you get a severe skin rash, tell a doctor straight away.

The signs may include a severe rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth.

Other possible side effects:

Common (may affect up to 1 in 10 people)

•    Abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes).

•    Loose stools or diarrhoea.

•    Changes in the results of blood tests for liver functions.

•    Rash.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only.

For further information, refer to the Summary of Product Characteristics.

Instructions for use and handling:

This medicinal product is for single use only. Reconstitute immediately before use.

Discard any unused contents.

The name of your medicine is “Ceftriaxone Powder for Solution for Injection or Infusion" (referred to as Ceftriaxone injection throughout this leaflet).

3. How Ceftriaxone injection is given

1. What Ceftriaxone injection is and what it is used for

Ceftriaxone is an antibiotic given to adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceftriaxone injection is used to treat infections of:

•    the brain (meningitis).

•    the lungs.

•    the middle ear.

•    the abdomen and abdominal wall (peritonitis).

•    the urinary tract and kidneys.

•    bones and joints.

•    the skin or soft tissues.

•    the blood.

•    the heart.

It can be given:

•    to treat specific sexually transmitted infections (gonorrhoea and syphilis).

•    to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection.

•    to treat infections of the chest in adults with chronic bronchitis.

•    to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age.

•    to prevent infections during surgery.

2. What you need to know before you are given Ceftriaxone injection

You must not be given Ceftriaxone injection if:

•    You are allergic to ceftriaxone

•    You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). The signs include sudden swelling of the throat or face which might make it difficult to breath or swallow, sudden swelling of the hands, feet and ankles, and a severe rash that develops quickly.

•    You are allergic to lidocaine and you are to be given Ceftriaxone injection as an injection into a muscle.

Ceftriaxone injection must not be given to babies if:

•    The baby is premature.

•    The baby is newborn (up to 28 days of age) and has certain blood problems or jaundice (yellowing of the skin or the whites of the eyes) or is to be given a product that contains calcium into their vein.

Ceftriaxone injection is usually given by a doctor or nurse. It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle. Ceftriaxone injection is made up by the doctor, pharmacist or nurse and will not be mixed with or given to you at the same time as calcium-containing injections.

The usual dose

Your doctor will decide the correct dose of Ceftriaxone for you. The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working. The number of days or weeks that you are given Ceftriaxone depends on what sort of infection you have.

Adults, older people and children aged 12 years and over with a body weight greater than or equal to 50 kilograms (kg):

1    to 2 g once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose (up to 4 g once a day). If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.

Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg:

50-80 mg Ceftriaxone for each kg of the child's body weight once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose up to 100 mg for each kg of body weight to a maximum of 4 g once a day. If your daily dose is higher than

2    g, you may receive it as a single dose once a day or as two separate doses.

Children with a body weight of 50 kg or more should be given the usual adult dose.

Newborn babies (0-14 days)

20 - 50 mg Ceftriaxone for each kg of the child's body weight once a day depending on the severity and type of infection. The maximum daily dose is not to be more than 50 mg for each kg of the baby's weight.

People with liver and kidney problems

You may be given a different dose to the usual dose. Your doctor will decide how much Ceftriaxone you will need and will check you closely depending on the severity of the liver and kidney disease.

If you are given more Ceftriaxone than you should

If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.

Uncommon (may affect up to 1 in 100 people)

•    Fungal infections (for example, thrush).

•    A decrease in the number of white blood cells (granulocytopenia).

•    Reduction in number of red blood cells (anaemia).

•    Problems with the way your blood clots. The signs may include bruising easily and pain and swelling of your joints.

•    Headache.

•    Dizziness.

•    Feeling sick or being sick.

•    Pruritis (itching).

•    Pain or a burning feeling along the vein where Ceftriaxone has been given.

•    Pain where the injection was given.

•    A high temperature (fever).

•    Abnormal kidney function test (blood creatinine increased).

Rare (may affect up to 1 in 1,000 people)

•    Inflammation of the large bowel (colon). The signs include diarrhoea, usually with blood and mucus, stomach pain and fever.

•    Difficulty in breathing (bronchospasm).

•    A lumpy rash (hives) that may cover a lot of your body, feeling itchy and swelling.

•    Blood or sugar in your urine.

•    Oedema (fluid build-up).

•    Shivering.

Not known (Frequency cannot be estimated from the available

data)

•    A secondary infection that may not respond to the antibiotic previously prescribed.

•    Form of anaemia where red blood cells are destroyed (haemolytic anaemia).

•    Severe decrease in white blood cells (agranulocytosis).

•    Convulsions.

•    Vertigo (spinning sensation).

•    Inflammation of the pancreas (pancreatitis). The signs include severe pain in the stomach which spreads to your back.

•    Inflammation of the mucus lining of the mouth (stomatitis).

•    Inflammation of the tongue (glossitis). The signs include swelling, redness and soreness of the tongue.

•    Problems with your gallbladder, which may cause pain, feeling sick and being sick.

•    A neurological condition that may occur in neonates with severe jaundice (kernicterus).

•    Kidney problems caused by deposits of calcium ceftriaxone. There may be pain when passing water (urine) or low output of urine.

•    A false positive result in a Coombs' test (a test for some blood problems).

•    A false positive result for galactosaemia (an abnormal build up of the sugar galactose).

•    Ceftriaxone may interfere with some types of blood glucose tests - please check with your doctor.

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 via the Yellow Card Scheme at 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 Ceftriaxone injection

Preparation of solutions:

^THIS ARTWORK IS PROPERTY OF:

FACTA TERAMO

PRODUCT NAME:

I - Ceftriaxone Villerton UK MK08

PRODUCT CODE:

L08GBCTRX02

Solutions reconstituted with Lidocaine Hydrochloride BP solution should not be administered intravenously.

Dosages greater than 1 g should be divided and injected at more than one site.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before you are given Ceftriaxone injection if:

•    You have recently received or are about to receive products that contain calcium.

•    You have recently had diarrhoea after having an antibiotic medicine.

•    You have ever had problems with your gut, in particular colitis (inflammation of the bowel).

•    You have liver or kidney problems.

•    You have gall stones or kidney stones

•    You have other illnesses, such as haemolytic anaemia (a reduction in your red blood cells that may make your skin pale yellow and cause weakness or breathlessness).

•    You are on a low sodium diet.

If you need a blood or urine test

If you are given Ceftriaxone for a long time, you may need to have regular blood tests. Ceftriaxone can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:

•    Tell the person taking the sample that you have been given Ceftriaxone.

Children

Talk to your doctor or pharmacist or nurse before your child is administered Ceftriaxone if:

•    He/she has recently been given or is to be given a product

If you forget to use Ceftriaxone injection

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Ceftriaxone injection

Do not stop taking Ceftriaxone unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Keep out of the sight and reach of children.

Do not use Ceftriaxone injection after the expiry date which is printed on the label and carton.

Do not store above 25°C. Your doctor, pharmacist or nurse will know how to store Ceftriaxone Injection properly.

6. Contents of the pack and other information

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)

If you have a severe allergic reaction, tell a doctor straight away.

The signs may include:

•    Sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or swallow.

•    Sudden swelling of the hands, feet and ankles.

Severe skin rashes (not known, frequency cannot be estimated from the available data)

What Ceftriaxone injection contains

Each vial contains 250mg, 1g, or 2g ceftriaxone (as ceftriaxone sodium).

The vials contain no other ingredients.

What Ceftriaxone injection looks like and contents of the pack

Ceftriaxone injection is a white or almost white powder in a glass vial.

Each carton contains 1,5, 10, 20, 50 or 100 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Villerton Invest SA, 40 Avenue Monterey, L-2163 Luxembourg. Manufacturer

Anfarm Hellas, Schimatari Viotias, 32009 Schimatari, Greece; or

Facta Farmaceutici S.p.A., Nucleo Industriale S. Atto, S. Nicolo a Tordino, 64100 Teramo, Italy

This leaflet was last revised in September 2016.

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FRONT

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SEPARATIONS:

(black)

PHARMACODE: I X I X I I X X X MEAS. (mm): 420 x 420 (105 x 52,5) TECHNICAL SPECIF.: ACSI089F00 g/sq.mt: 40 gr/m² Thikness: 0,049 FONT TYPE: Century Gothic 9 pt

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GRAFIFARMA GRAFIFLEX QUALITY SYSTEM - ISO 9001:2008

EURPACK Grafrfarma Grafiflex - Aprilia (IT) tel. +39 06 92732420 produzione@grafrfarma.it - Robecco s/N (Ml) tel. +39 02 94974002 milano@grafiffamia.it J