Document: leaflet MAH GENERIC_PL 04515-0399 change

• leaflet MAH GENERIC_PL 04515-0399
• leaflet MAH GENERIC_PL 26928-0005

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Hospira

Package leaflet: Information for the patient

Ceftriaxone 500 mg Powder for Solution for Injection (IM, IV)

Ceftriaxone 1 g Powder for Solution for Injection (IM, IV)

Ceftriaxone 2 g Powder for Solution for Infusion (IV)

Ceftriaxone

What is in this leaflet

1.    What Ceftriaxone is and what it is used for

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

3.    How Ceftriaxone will be given

4.    Possible side effects

5.    How to store Ceftriaxone

6.    Contents of the pack and other information

1. What Ceftriaxone 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 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

You must not be given Ceftriaxone if:

•    You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).

•    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 breathe 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 as an injection into a muscle.

Ceftriaxone 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 about

to be given a product that contains calcium into their vein.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before you are given Ceftriaxone 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 that contains calcium into their vein.

Other medicines and Ceftriaxone

Tell your doctor or pharmacist or nurse 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 advise 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 contains sodium

Each gram of Ceftriaxone contains approximately 3.6 mmol (82.8 mg) sodium. To be taken into consideration by patients on a controlled sodium diet.

3. How Ceftriaxone will be given

Ceftriaxone 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 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 accidently receive more than your prescribed dose contact your doctor or nearest hospital straight away.

If you forget to use Ceftriaxone

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

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.

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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)

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

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 national reporting system for:

United Kingdom

Yellow Card Scheme Website:

http://www.mhra.gov.uk/yellowcard

or

Malta

ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira Website:

http://www.medicinesauthority.gov.mt

e-mail:

postlicensing.medicinesauthority@gov.mt

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

5. How to store Ceftriaxone

•    Your doctor or pharmacist is responsible for storing this medicine.

•    This medicine does not require any special temperature storage conditions. Keep the vial in the outer carton in order to protect from light.

•    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 carton after EXP.

6. Contents of the pack and other information

What Ceftriaxone contains

The active substance in Ceftriaxone is ceftriaxone sodium.

Each vial contains 500 mg ceftriaxone as 596 mg ceftriaxone sodium.

Each vial contains 1 g ceftriaxone as 1.193 g ceftriaxone sodium.

Each vial contains 2 g ceftriaxone as 2.386 g ceftriaxone sodium.

There are no other ingredients in Ceftriaxone.

What Ceftriaxone looks like and contents of the pack

•    Ceftriaxone is a powder. It is almost white to yellowish in colour. It is supplied in a glass vial.

•    Ceftriaxone is supplied in packs of

1,5, 10 or 25 vials per carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

Alternate Batch release site:

Hospira Enterprises B.V.

Randstad 22-11,

1316 BNALMERE The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

Ceftriaxone Hospira 250 mg Powder for Solution for Injection

Ceftriaxone Hospira 500 mg Powder for Solution for Injection

Ceftriaxone Hospira 1 g Powder for Solution for Injection

Ceftriaxone Hospira 2 g Powder for Solution for Infusion

Ceftriaxone Hospira 0.25 g Powder for Solution for Injection

Ceftriaxone Hospira 0.50 g Powder for Solution for Injection

Ceftriaxone 500 mg Powder for Solution for Injection

Ceftriaxone 1 g Powder for Solution for Injection

Ceftriaxone 2 g Powder for Solution for Infusion

This leaflet was last revised in

02/2014.

For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes prior to surgery. For instructions on reconstitution of the medicinal product before administration, see section 6.6 of the SmPC.

Instructions for use

The use of freshly prepared solutions is recommended. These maintain potency for at least 6 hours at or below 25°C in daylight, or 24 hours at 2-8°C.

When reconstituted in water for injections, ceftriaxone powder gives a light yellow to amber coloured clear solution.

Ceftriaxone Powder for Solution for Injection or Infusion should not be mixed in the same syringe with any drug other than 1.0 % Lidocaine Hydrochloride BP solution (for intramuscular injection only).

Intramuscular injection:

Solution for Reconstitution	Powder	Concentration of Solution	Volume of Diluent	Displacement Volume/Rise in volume upon reconstitution	Total volume in vial after reconstitution	Approx. concentration of solution based on displacement volume
1.0% Lidocaine Hydrochloride solution	250 mg	250 mg/ml	1 ml	0.193 ml	1.193 ml	210 mg/ml
	500 mg	250 mg/ml	2 ml	0.447 ml	2.447 ml	204 mg/ml
	1 g	250 mg/ml	3.5 ml	0.726 ml	4.226 ml	237 mg/ml

The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site. Not more than 1 g of ceftriaxone should be injected on either side of the body (see section 4.2).

Solutions in Lidocaine should not be administered intravenously.

Intravenous injection:

Solution for Reconstitution	Powder	Concentration of Solution	Volume of Diluent	Displacement Volume/Rise in volume upon reconstitution	Total volume in vial after reconstitution	Approx. concentration of solution based on displacement volume
Water for Injections	250 mg	50 mg/ml	5 ml	0.218 ml	5.218 ml	48 mg/ml
	500 mg	100 mg/ml	5 ml	0.327 ml	5.327 ml	94 mg/ml
	1 g	100 mg/ml	10 ml	0.807 ml	10.807 ml	93 mg/ml

The injection should be administered over at least 2-4 minutes, directly into the vein or via the tubing of an intravenous infusion. Intravenous infusion:

Solution for Reconstitution	Powder	Concentration of Solution	Volume of Diluent	Displacement Volume/Rise in volume upon reconstitution	Total volume in vial after reconstitution	Approx. concentration of solution based on displacement volume
Glucose Injection 5% or 10%	2 g	50 mg/ml	40 ml	1.170 ml	41.170 ml	49 mg/ml
Sodium Chloride Injection
Sodium Chloride and Glucose Injection (0.45% sodium chloride and 2.5% glucose)
Dextran 6% in Glucose Injection 5%

The infusion should be administered over at least 30 minutes.

Add the recommended volume of reconstitution solution and shake well until the contents of the vial have dissolved completely. The solution should be visually inspected prior to use. Only clear solutions practically free from particles should be used.

For single use only. Discard any unused solution.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

It is necessary to rinse the tubing between each administration.

Incompatibilities

Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.

Solutions containing ceftriaxone should not be mixed with or added to other agents except those mentioned in section 6.6 of the SmPC. In particular, diluents containing calcium, (e.g. Ringer's solution, Hartmann's solution) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions including total parenteral nutrition (see section 4.2, 4.3, 4.4 and 4.8 of the SmPC).

Shelf life

Unopened: 2 years

Opened & After reconstitution: Chemical and physical in-use stability has been demonstrated for 6 hours at or below 25°C or 24 hours at 2°C to 8°C.

From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, 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 the times stated above for the chemical and physical in-use stability.

Unused solution should be discarded.

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep the vial in the outer carton in order to protect from light.