Document: leaflet MAH GENERIC_PL 26928-0004 change

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• leaflet MAH GENERIC_PL 42671-0001

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ceftriaxone 1 g

powder for solution for injection / infusion

Ceftriaxone 2 g

powder for solution for infusion

Ceftriaxone (as ceftriaxone sodium)

What is in this leaflet:

1.    What Ceftriaxone is and what it is used for

2.    What you need to know before you use Ceftriaxone

3.    How to use Ceftriaxone

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 use Ceftriaxone

You must not be given Ceftriaxone if:

•    You are allergic to ceftriaxone.

•    You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbape-nems 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 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 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 Coomb's 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 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.

3. How to use Ceftriaxone

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 accidentally 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.

6. Contents of the pack and other information

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)

•    I nflammation 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).

•    I nflammation 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).

•    I nflammation 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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.mhra.gov.uk/yel-lowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ceftriaxone

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 outer carton and the label after 'EXP'. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Ceftriaxone contains

•    The active substance is ceftriaxone. Each vial contains ceftriaxone sodium corresponding to 1 g or 2 g ceftriaxone, respectively.

•    There are no other ingredients.

What Ceftriaxone looks like and contents of the pack

Fine, almost white or yellowish powder.

Ceftriaxone is available in packages with 1, 5 or 10 glass vials with a rubber stopper and a flip-off cap.

Marketing authorisation holder

MIP Pharma GmbH Kirkeler Str. 41 66440 Blieskastel Germany

Phone 0049 (0) 6842 9609 0 Fax 0049 (0) 6842 9609 355

Manufacturer

MIP Pharma GmbH Kirkeler Str. 41 66440 Blieskastel Germany

This leaflet was last revised in May 2014

The following information is intended for healthcare professionals only:

Mode of application and therapy duration

Solutions to be administered intravenously must not be administered using tubing that contains, or has contained, calcium-containing fluids.

Important incompatibilities

Ceftriaxone must not be mixed with calcium-containing solutions. 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 IV administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions. Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole, aminoglycosides and labetalol.

Intramuscular injection

Ceftriaxone 1 g should be dissolved in 3.5 ml of 1% lidocaine hydrochloride solution. The solution should be administered by deep intramuscular injection into the gluteus maximus muscle. Solutions in lidocaine must not be administered intravenously.

Preparation of the solution for injection

Ceftriaxone 1 g is dissolved in 10 ml water for injections. The injection should be administered over at least 2-4 minutes, directly into the vein.

Preparation of the solution for infusion

The content of one vial Ceftriaxone 1 g/2 g is dissolved in 40 ml of the compatible solutions listed below. The infusion should be administered over at least 30 minutes.

For preterm and full-term newborns and babies, the required dose can be administered as short-term infusion. For this, the low dosed solution for injection is prepared in 5 ml water for injections and further diluted with physiological sodium chloride solution (9 mg/ml).

Compatibility with intravenous liquids

The following solvents are suitable for preparation of the solution: water for injections, 5% glucose solution and physiological sodium chloride solution.

The reconstitution/dilution is to be made under aseptic conditions. Add the recommended volume of reconstitution solution and shake gently until the contents of the vial have dissolved completely.

When reconstituted, the white to yellowish crystalline powder gives a pale yellow to amber solution.

As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discolouration prior to administration. The solution should only be used if the solution is clear and practically free from particles.

For single use only. Any remaining solution should be discarded. Any unused product or waste material should be disposed of in accordance with local requirements.

Storage after reconstitution

Shelf-life of the prepared solution

The chemical and physical in-use stability of the prepared solution has been demonstrated for 24 hours at 25°C and for 48 hours at 2-8°C. 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 reconstitution has taken place in controlled and validated aseptic conditions.

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Ceftriaxon MIP 1g,2g - 210 x 400 mm - Pantone 288C / Pantone 288 C - 30%