Package leaflet: Information for the Patient 10163974 GB

Rocephin® 2 g    <S§>

Powder for solution for injection/infusion

Rocephin® 1 g

Powder for solution for injection or infusion

Rocephin® 250 mg

Powder for solution for injection

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 Rocephin is and what it is used for

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

3.    How Rocephin is given

4.    Possible side effects

5.    How to store Rocephin

6.    Contents of the pack and other information

1. What Rocephin is and what it is used for

Rocephin 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.

Rocephin is used to treat infections of

•    the brain (meningitis).

•    the lungs.

•    the middle ear.

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 Rocephin

You must not be given Rocephin 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 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 Rocephin as an injection into a muscle.

Rocephin 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 Rocephin 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 Rocephin for a long time, you may need to have regular blood tests.

Rocephin 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 Rocephin.

If you are diabetic or need to have your blood glucose level monitored you should not use certain blood glucose monitoring systems which may estimate blood glucose incorrectly while you are receiving ceftriaxone. If you use such systems check the instructions for use and tell your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children

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

•    He/She has recently been given or is to be given a product that contains calcium into their vein.

Other medicines and Rocephin

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 Rocephin against the risk to your baby.

Driving and using machines

Rocephin 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 Rocephin is given

Rocephin 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.

Rocephin 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 Rocephin 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 Rocephin 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.

1    Please turn over ^

------------------------------------------------__x

The following information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS

Rocephin® 2 g Powder for solution for injection/infusion Rocephin® 1 g Powder for solution for injection or infusion Rocephin^® 250 mg Powder for solution for injection

Ceftriaxone (as Ceftriaxone Sodium)

Please refer to the Summary of Product Characteristics for full prescribing information.

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.

Indications for adults and children over 12 years of age (> 50 kg) that require specific dosage schedules:

Acute otitis media

A single intramuscular dose of Rocephin 1-2 g can be given.

Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Rocephin may be effective when given as an intramuscular dose of 1-2 g daily for 3 days.

Pre-operative prophylaxis of surgical site infections

2 g as a single pre-operative dose.

Gonorrhoea

500 mg as a single intramuscular dose.

Syphilis

The generally recommended doses are 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data.

National or local guidance should be taken into consideration.    1

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.

Indications for neonates, infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Rocephin 50 mg/kg can be given. Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Rocephin may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.

Pre-operative prophylaxis of surgical site infections

50-80 mg/kg as a single pre-operative dose. Syphilis

The generally recommended doses are 75-100 mg/kg (max 4 g) once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

50-80 mg/kg once daily for 14-21 days.

The recommended treatment durations vary and national or local guidelines should be taken into consideration.

Neonates 0-14 days

Rocephin is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

Please turn over ^

06.02.2015 13:17:39

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

•    50-80 mg Rocephin 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 Rocephin 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 Rocephin you will need and will check you closely depending on the severity of the liver and kidney disease.

If you are given more Rocephin 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 Rocephin

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 Rocephin

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

4. Possible side effects

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).

•    Rocephin 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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

Malta

ADR Reporting Website:

http://www.medicinesauthority.gov.mt/adrportal

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

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 Rocephin 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.

2

5. How to store Rocephin

•    Your doctor or pharmacist is responsible for storing Rocephin. They are also responsible for disposing of any unused Rocephin correctly.

•    Keep out of the reach and sight of children.

•    Do not store Rocephin above 25°C.

•    Do not use Rocephin after the expiry date printed on the pack.

6. Contents of the pack and other information

What Rocephin contains

The active substance in Rocephin powder for solution for injection or infusion is ceftriaxone. Rocephin is supplied in glass vials containing either 250 mg (milligrams),

1    g (gram) or 2 g of ceftriaxone.

There are no other ingredients in Rocephin.

What Rocephin looks like and contents of the pack

•    Rocephin is a powder. It is white to yellowish-orange in colour. It is supplied in a glass vial.

•    Before it is given to the patient, Rocephin is made into a solution by adding sterile liquid to the vial. The correct dose is then taken out of the vial. It can be given to the patient either as an injection or added to a bag of infusion solution which is given through a small tube into one of your veins.

•    Rocephin is supplied in packs of 1 vial.

Marketing Authorisation Holder and Manufacturer

Roche Products Limited 6 Falcon Way Shire Park

Welwyn Garden City, AL7 1TW United Kingdom.

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

2    g Powder for Solution for Injection/Infusion Malta, United Kingdom: Rocephin

1 g Powder for Solution for Injection or Infusion Ireland, Latvia, Malta, United Kingdom: Rocephin

Rocephin 250 mg Powder for Solution for Injection

Malta, United Kingdom: Rocephin

This leaflet was last revised in February 2015

X

10163974.indd 2 06.02.2015 1 3:17:39