Patient Leaflet Updated 25-Jan-2021 | Roche Products Limited
Rocephin 250mg Powder for Solution for Injection, 1g Powder for Solution for Injection or Infusion, 2g Powder for Solution for Injection/Infusion
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.
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
It can be given:
2. What you need to know before you are given Rocephin
You must not be given Rocephin if:
Rocephin must not be given to babies if:
Warnings and precautions
Talk to your doctor or pharmacist or nurse before you are given Rocephin if:
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:
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:
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:
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.
Sodium content
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 Rocephin is given
Rocephin is usually given by a doctor or nurse. It can be given as
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):
Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg:
Newborn babies (0-14 days)
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:
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:
Other possible side effects:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (Frequency cannot be estimated from the available data)
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
or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 and Manufacturer
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 January 2021
uk-pil-rocephin-clean-210121-2g-1g-250mg-vial
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