ROCEPHIN 250 MG POWDER FOR SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Rocephin

Rocephin

Rocephin

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.

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.

3. How Rocephin is given

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 (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.

1

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.

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.

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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

Rocephin® 250 mg Powder for solution for injection

Ceftriaxone (as Ceftriaxone Sodium)

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

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 January 2022

Presentation

250 mg and 1g vial: Type 1 Ph. Eur 15 ml glass vial with fluorobutyl rubber stopper and aluminium cap, containing a sterile powder, equivalent to 250 mg or 1g ceftriaxone.

2g vial: Type II Ph. Eur 50 ml glass bottle with fluorobutyl rubber stopper and aluminium cap, containing a sterile powder, equivalent to 2 g ceftriaxone.

Vials contain a sterile, white to yellowish-orange crystalline powder. There are no excipients.

Each gram of Rocephin contains approximately 3.6 mmol sodium.

Supplied in packs of 1 vial or bottle.

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.

Adults and children over 12 years of age (> 50 kg)

* 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

Neonates, 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.

* 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).

* 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.

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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.

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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.

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.

Instructions for use

The use of freshly prepared solutions is recommended. These maintain potency for at least 6 hours at or below 25°C or 24 hours at 2–8°C. Protect from light.

5. how to store 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 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.

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.

The displacement volume of 2 g of Rocephin is 1.37 ml in water for injections. When adding 40 ml of water for injections, the final concentration of the reconstituted solution is 48.34 mg/ml.

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.

The displacement volume of 1 g of Rocephin is 0.71 ml in water for injections and 1% lidocaine hydrochloride solution. When adding 10 ml of water for injections, the final concentration of the reconstituted solution is 93.37 mg/ml. When adding 3.5 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 237.53 mg/ml.

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.

The infusion line should be flushed after each administration.

What Rocephin looks like and contents of the pack

Rocephin 2 g powder for solution for injection or 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

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-1

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

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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).

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.

The displacement volume of 1 g of Rocephin is 0.71 ml in water for injections and 1% lidocaine hydrochloride solution. When adding 10 ml of water for injections, the final concentration of the reconstituted solution is 93.37 mg/ml. When adding 3.5 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 237.53 mg/ml.

Intravenous infusion: 2 g of Rocephin is 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%, hydroxyethly-starch 6 – 10%, water for injections. The infusion should be administered over at least 30 minutes.

The displacement volume of 2 g of Rocephin is 1.37 ml in water for injections. When adding 40 ml of water for injections, the final concentration of the reconstituted solution is 48.34 mg/ml.

Refer to ‘Posology’ and ‘Method of administration’ for further information.

Incompatibilities

Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.

Solutions containing ceftriaxone should not be mixed with or added to other agents except those mentioned in ‘Instructions for use’. 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 or bottle for intravenous administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition.

Shelf life

3 years.

For shelf life of diluted product see ‘Instructions for use’.

Special precautions for storage

Do not store above 30°C, keep vial or bottle in the outer carton in order to protect from light.

This leaflet was last revised in January 2022

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