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Package leaflet: Information for the Patient
Rocephin 2 g Powder for solution for injection or 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
- What Rocephin is and what it is used for
- What you need to know before you are given Rocephin
- How Rocephin is given
- Possible side effects
- How to store Rocephin
- 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.
- 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 Rocephin
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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 (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 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.
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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
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Treatment with ceftriaxone, particularly in elderly patients with serious kidney or nervous system problems may rarely cause decreased consciousness, abnormal movements, agitation and convulsions.
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 reactions (not known, frequency cannot be estimated from the available data) If you get a severe skin reaction, 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 (Stevens-Johnson syndrome and toxic epidermal necrolysis which are also known as SJS and TEN).
- A combination of any of the following symptoms: widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
- Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting. This occurs shortly after starting Rocephin treatment for infections with spirochete such as Lyme disease.
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.
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Uncommon (may affect up to 1 in 100 people)
- Fungal infections (for example, thrush or genital fungal infections).
- 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. Blisters, deep redness or rash, burned areas, pain, irritation, itching at the injection site.
- 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 and/or liver which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay coloured stools.
- 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.
United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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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.
Marketing Authorisation Holder
Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom
Manufacturer (Great Britain) Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom
Manufacturer (Northern Ireland) Roche Pharma AG Emil-Barell-Strasse- 79639 Grenzach-Wyhlen Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
Rocephin 2 g Powder for Solution for Injection or Infusion United Kingdom: Rocephin
Rocephin 1 g Powder for Solution for Injection or Infusion Ireland, United Kingdom: Rocephin
Rocephin 250 mg Powder for Solution for Injection United Kingdom: Rocephin
This leaflet was last revised in December 2021
The following information is intended for healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Rocephin 2 g Powder for solution for injection or infusion Rocephin 1 g Powder for solution for Injection or Infusion
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Rocephin 250 mg Powder for solution for injection
Ceftriaxone (as Ceftriaxone Sodium)
Please refer to the Summary of Product Characteristics for full prescribing information.
Posology The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato- renal function of the patient.
The doses recommended in the tables below are the generally recommended doses in these indications. In particularly severe cases, doses at the higher end of the recommended range should be considered.
Adults and children over 12 years of age (≥ 50 kg)
Ceftriaxone Dosage*
**Treatment frequency****
Indications
1-2 g Once daily Community acquired pneumonia Acute exacerbations of chronic obstructive pulmonary disease Intra-abdominal infections Complicated urinary tract infections (including pyelonephritis) 2 g Once daily Hospital acquired pneumonia Complicated skin and soft tissue infections Infections of bones and joints 2-4 g Once daily Management of neutropenic patients with fever that is suspected to be due to a bacterial infection Bacterial endocarditis Bacterial meningitis
- 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.
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Complicated skin and soft tissue infections Complicated urinary tract infections (including pyelonephritis) Community acquired pneumonia Hospital acquired pneumonia Infections of bones and joints Management of neutropenic patients with fever that is suspected to be due to a bacterial infection 50 mg/kg Once daily Bacterial meningitis Bacterial endocarditis
- In documented bacteraemia, the higher end of the recommended dose range should be considered. A maximum daily dose of 50 mg/kg should not be exceeded.
Indications for neonates 0-14 days 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.
Pre-operative prophylaxis of surgical site infections 20-50 mg/kg as a single pre-operative dose.
Syphilis The generally recommended dose is 50 mg/kg 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.
Duration of therapy The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 - 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.
Older people The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory.
Patients with hepatic impairment Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired.
There are no study data in patients with severe hepatic impairment.
Patients with renal impairment In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily. In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. Ceftriaxone is not removed by peritoneal- or haemodialysis. Close clinical monitoring for safety and efficacy is advised.
Patients with severe hepatic and renal impairment In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.
Method of administration Intramuscular administration
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Rocephin can be administered by deep intramuscular injection. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site.
As the solvent used is lidocaine, the resulting solution should never be administered intravenously. Accidental intravenous injection should be checked for by aspiration of the syringe before injection. The information in the Summary of Product Characteristics of lidocaine should be considered.
Intravenous administration Rocephin can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes. Intravenous intermittent injection should be given over 5 minutes preferably in larger veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy. Intramuscular administration should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2 g intravenous administration should be used.
Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium.
For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30- minutes prior to surgery.
Instructions for use The use of freshly prepared solutions is recommended. For storage conditions of the reconstituted medicinal product, see “How to store Rocephin name” section.
Rocephin should not be mixed in the same syringe with any drug other than 1% Lidocaine Hydrochloride solution (for intramuscular injection only). The infusion line should be flushed after each administration.
Intramuscular injection: 250 mg Rocephin is dissolved in 2 ml of 1% Lidocaine Hydrochloride solution, or 1 g in 3.5ml of 1% Lidocaine Hydrochloride solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site.
Solutions in Lidocaine should not be administered intravenously.
Intravenous injection: 250 mg Rocephin is dissolved in 2.5 ml of Water for Injections or 1 g in 10 ml of Water for Injections. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.
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.
Intramuscular injection: 1g Rocephin is dissolved in 3.5 ml of 1% Lidocaine Hydrochloride solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1g should be divided and injected at more than one site.
Solutions in Lidocaine should not be administered intravenously.
Intravenous injection: 1 g Rocephin is dissolved in 10 ml of Water for Injections. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.
