What it is and what it is used for

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.

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2.

What you need to know before you take it

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, 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. 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. 2 uk-pil-Rocephin-clean-251111-1g-2g-250mg

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. Rocephin contains sodium 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".

3.

How to take it

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. 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.

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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

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. • Chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome). 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. 4 uk-pil-Rocephin-clean-251111-1g-2g-250mg

•

Rash.

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 where Rocephin has been given. Blisters, bruising, deep redness or rash, irritation, itching, hardening of the skin or swelling 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. • Infection at the site of injection. 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 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.

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5.

How to store it

Rocephin

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 and on the vial or bottle label after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Keep the vial or bottle in the outer carton in order to protect from light. Chemical and physical in-use stability of the reconstituted product has been demonstrated for at least 6 hours at or below 25°C or 24 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 not be longer than the times stated above for the chemical and physical in-use stability. For single use only. Do not throw away any medicines via wastewater. Ask your pharmacist to throw away medicines you no longer use. These measures will help protect the environment. 6.

Contents of the pack and other information

What Rocephin contains 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 calciumfree 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.

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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. What Rocephin looks like and contents of the pack 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. Marketing Authorisation Holder and Manufacturer Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom

This leaflet was last revised in October 2025

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Advice/medical education 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. Consequently, to preserve the efficacy of this drug: 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.

———————————————————————————————————————–The following information is intended for healthcare professionals only: Please refer to the Summary of Product Characteristics for full prescribing information. Solutions containing Rocephin should not be mixed with or added to solutions containing other agents. In particular, Rocephin is not compatible with calcium-containing solutions. Diluents containing calcium, (e.g. Ringer's solution or 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. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calciumcontaining solutions in the same intravenous administration line. Therefore, ceftriaxone and calciumcontaining solutions must not be mixed or administered simultaneously. Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides. Posology The dose depends on the severity, susceptibility, site and type of infection and on the age and hepatorenal 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. 8 uk-pil-Rocephin-clean-251111-1g-2g-250mg

Adults and children over 12 years of age (≥ 50 kg) Ceftriaxone Dosage* 1-2 g

Treatment frequency** Once daily

2g

Once daily

2-4 g

Once daily

Indications Community acquired pneumonia Acute exacerbations of chronic obstructive pulmonary disease Intra-abdominal infections Complicated urinary tract infections (including pyelonephritis) Hospital acquired pneumonia Complicated skin and soft tissue infections Infections of bones and joints 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. Disseminated Lyme borreliosis (early [Stage II] and late [Stage III]) 2 g once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration. Paediatric population Infants and children 15 days to 12 years of age (< 50 kg) For children with bodyweight of 50 kg or more, the usual adult dosage should be given. Ceftriaxone dosage* 50-80 mg/kg

Treatment frequency** Once daily

Indications Intra-abdominal infections 9 uk-pil-Rocephin-clean-251111-1g-2g-250mg

50-100 mg/kg (Max 4 g)

Once daily

Complicated urinary tract infections (including pyelonephritis) Community acquired pneumonia Hospital acquired pneumonia Complicated skin and soft tissue infections Infections of bones and joints Management of neutropenic patients with fever that is suspected to be due to a bacterial infection Bacterial meningitis

80-100 mg/kg Once daily (max 4 g) 100 mg/kg (max Once daily Bacterial endocarditis 4 g)

• 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, 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). Ceftriaxone dosage* 20-50 mg/kg

Treatment frequency Once daily

Indications

Intra-abdominal infections 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. 10 uk-pil-Rocephin-clean-251111-1g-2g-250mg

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. Instructions for use For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The use of freshly prepared solutions is recommended. For storage conditions of the reconstituted medicinal product, see "How to store Rocephin" section. Rocephin is completely reconstituted in its respective solvent within 150 seconds. The reconstituted solution is a clear solution with a yellow to brownish-yellow colour.

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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. Intravenous 2g infusion: Use in adults and children over 12 years of age (≥ 50 kg) 2g of Rocephin is be dissolved in 40 ml of one of the following calcium-free solutions: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, water for injections. The bottle should be gently rolled between the palms, and visually inspected to ensure that reconstitution is complete and no particulate material is present. The infusion should be administered over at least 30 minutes. Use in the paediatric population Neonates, infants and children 15 days to 12 years of age (< 50 kg) The displacement volume of 2 g of Rocephin is 1.37 ml in water for injections. This requires the offset of solvent volume to facilitate weight-dependent dosing (primarily in children up to 12 years), if only part of the total solution is measured and administered. To prepare a final solution concentration of 50 mg/ml, reconstitute 2 g of Rocephin in 39 ml calcium-free infusion fluid. Intravenous 1g administration (injection or infusion): Use in adults and children over 12 years of age (≥ 50 kg) 1 g Rocephin is dissolved in 10 ml of Water for Injections. The vial should be gently rolled between the palms, and visually inspected to ensure that reconstitution is complete and no particulate material is present. For intravenous injection administer over 5 minutes, directly into the vein or via the tubing of an intravenous infusion. Alternatively, for intravenous infusion, the reconstituted solution should be transferred to 10 ml of one of the following calcium-free infusion fluids: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, water for injections. The infusion should be administered over at least 30 minutes. Use in the paediatric population Neonates, infants and children 15 days to 12 years of age (< 50 kg) The displacement volume of 1 g of Rocephin is 0.71 ml in water for injections. This requires the offset of solvent volume to facilitate weight-dependent dosing (primarily in children up to 12 years), if only part of the total solution is measured and administered. To prepare a final solution concentration of 100 mg/ml, reconstitute 1 g of Rocephin in 9.4 ml of water for injections. Intramuscular 1g injection: Use in adults and children over 12 years of age (≥ 50 kg) 1g Rocephin is dissolved in 3.5 ml of 1% Lidocaine Hydrochloride solution. The vial should be gently rolled between the palms, and visually inspected to ensure that reconstitution is complete and no particulate material is present. The solution should be administered by deep intramuscular injection. Dosages greater than 1g should be divided and injected at more than one site. Use in the paediatric population Use in neonates, infants and children 15 days to 12 years of age (< 50 kg) The displacement volume of 1 g of Rocephin is 0.71 ml in 1% lidocaine hydrochloride solution. This requires the offset of solvent volume to facilitate weight-dependent dosing (primarily in children up to 12 uk-pil-Rocephin-clean-251111-1g-2g-250mg

12 years), if only part of the total solution is measured and administered. To prepare a final solution concentration of 285 mg/ml, reconstitute 1 g of Rocephin in 2.9 ml of 1% lidocaine hydrochloride solution. Solutions in Lidocaine should never be administered intravenously. Intravenous 250mg injection: Use in adults and children over 12 years of age (≥ 50 kg) 250 mg Rocephin is dissolved in 2.5 ml of Water for Injections or 1 g in 10 ml of Water for Injections. The vial should be gently rolled between the palms, and visually inspected to ensure that reconstitution is complete and no particulate material is present. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion. Use in the paediatric population Use in neonates, infants and children 15 days to 12 years of age (< 50 kg) The displacement volume of 250 mg of Rocephin is 0.18 ml in water for injections. 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 250mg injection: Use in adults and children over 12 years of age (≥ 50 kg) 250 mg Rocephin is dissolved in 2 ml of 1% Lidocaine Hydrochloride solution or 1 g in 3.5 ml of 1% Lidocaine Hydrochloride solution. The vial should be gently rolled between the palms, and visually inspected to ensure that reconstitution is complete and no particulate material is present. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site. Use in neonates, infants and children 15 days to 12 years of age (< 50 kg) The displacement volume of 250 mg of Rocephin is 0.18 ml in 1% lidocaine hydrochloride solution. This requires the offset of solvent volume to facilitate weight-dependent dosing (primarily in children up to 12 years), if only part of the total solution is measured and administered. To prepare a final solution concentration of 125 mg/ml, reconstitute 250 mg of Rocephin in 1.9 ml of 1% lidocaine hydrochloride solution. Solutions in Lidocaine should never be administered intravenously.

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