Rocephin 2g Powder for Solution for Injection or Infusion

• 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.

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

• 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, chest pain 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.

• 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.

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 (see section 4).
• 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.
• You experience or have previously experienced a combination of any of the following symptoms: rash, red skin, blistering of the lips eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

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.

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.

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).

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.

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.

Rocephin 2 g powder for solution for injection or infusion contains 169.1 mg sodium (main component of cooking/table salt) in each 2 g bottle. This is equivalent to 8.5% of the recommended maximum daily dietary intake of sodium for an adult.

Rocephin 1 g powder for solution for injection or infusion contains 85.4 mg sodium (main component of cooking/table salt) per 1g vial, equivalent to 4.3% of the recommended maximum daily dietary intake of sodium for an adult.

Rocephin 250 mg powder for solution for injection contains less than 1 mmol sodium (23 mg) per 250 mg vial, i.e. is essentially “sodium free”.

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.

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.

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

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.

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.

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 Website:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Rocephin 2 g powder for solution for injection or infusion

The active substance is ceftriaxone.

Each bottle contains 2 g (grams) ceftriaxone as ceftriaxone sodium. There are no other ingredients.

The displacement volume of 2 g of Rocephin is 1.37 ml in water for injections. This requires the offset of solvent volume, if only part of the total solution is measured and administered (i.e. in Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg). To prepare a final solution concentration of 50 mg/ml, reconstitute 2 g of Rocephin in 39 ml calcium-free infusion fluid.

Rocephin 1 g powder for solution for injection or infusion

The active substance is ceftriaxone.

Each vial contains 1 g (grams) ceftriaxone as ceftriaxone sodium. There are no other ingredients.

The displacement volume of 1 g of Rocephin is 0.71 ml in water for injections and 1% lidocaine hydrochloride solution. This requires the offset of solvent volume, if only part of the total solution is measured and administered (i.e. in Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg).

• To prepare a final intravenous solution concentration of 100 mg/ml, reconstitute 1 g of Rocephin in 9.4 ml of water for injections.
• To prepare a final intramuscular solution concentration of 285 mg/ml, reconstitute 1 g of Rocephin in 2.9 ml of 1% lidocaine hydrochloride solution.

Rocephin 250 mg powder for solution for injection

The active substance is ceftriaxone.

Each vial contains 250 mg (milligrams) ceftriaxone as ceftriaxone sodium.

Rocephin should not be mixed in the same syringe with any drug.

The displacement volume of 250 mg of Rocephin is 0.18 ml in water for injections and 1% lidocaine hydrochloride solution. When adding 2.5 ml of water for injections, the final concentration of the reconstituted solution is 93.28 mg/ml. When adding 2 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 114.68 mg/ml.

Rocephin 2 g powder for solution for injection or infusion

Rocephin consists of a powder for solution for infusion

Rocephin 1 g powder for solution for injection or infusion

Rocephin consists of a powder for solution for injection or infusion

Rocephin 250 mg powder for solution for injection

Rocephin consists of a powder for solution for injection.

The powder is white to yellowish-orange.

Rocephin is available in packs of 1 vial or bottle.

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

• dosage
• schedules
• duration of treatment.

1. Use antibiotics only when prescribed.
2. Strictly follow the prescription.
3. Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
5. After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly.