Rocephin 250 mg vials, Rocephin 1 g vials, Rocephin 2 g vials

Rocephin 250 mg vials, Rocephin 1 g vials, Rocephin 2 g vials Powder for solution for injection or infusion

Ceftriaxone (as hydrated disodium ceftriaxone)

What Rocephin is and what it is used for

Rocephin contains a medicine called ceftriaxone. This belongs to a group of medicines called antibiotics.

• Rocephin is used to treat infections caused by bacteria.
• It can be used to treat infections in different parts of the body including the lungs (pneumonia), blood (septicaemia), skin, other soft body parts (tissues), bone, and for infections such as meningitis and gonorrhoea (a sexually transmitted infection).
• It can be used to treat infections in people with low numbers of white blood cells (neutropenia).
• It can also be given before and after operations to stop infections from happening.
• It works by stopping the bacteria from growing properly. This causes the bacteria to die.

Before you are given Rocephin

You must not be given Rocephin if:

• You are allergic (hypersensitive) to ceftriaxone (the only ingredient in Rocephin).
• You are allergic to antibiotics called ‘cephalosporins’. These include cefalexin, cefaclor and cefuroxime.
• You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as amoxicillin or flucloxacillin). The signs include sudden swelling of the throat or face which might make it difficult to breathe 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
• You must not be given Rocephin if any of the above apply to you. If you are not sure, talk to your doctor or nurse before having Rocephin.

Rocephin must not be given to babies if:

• The baby is premature.
• The baby is newborn (up to 28 days) and has certain blood problems or jaundice (yellowing of the skin or the whites of the eyes) or is about to be given another injection that contains calcium.

Take special care with Rocephin

Check with your doctor or nurse before having Rocephin if:

• You have had a mild allergic reaction to penicillin or similar antibiotics (such as a skin rash which may have been itchy).
• You are allergic to anything not already mentioned in this leaflet.
• You have asthma.
• You have recently received or are about to receive calcium.
• You have ever had problems with your gut, in particular colitis (inflammation of the bowel).
• You have liver or kidney problems.
• You have other illnesses, such as blood problems.
• You are on a low sodium diet.

If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you have Rocephin.

Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Rocephin can affect the way some medicines work. Also some medicines can affect the way Rocephin works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

Oral contraceptives (the pill). Rocephin can stop the pill from working, so you should use extra barrier contraception methods (such as condoms) while you are taking Rocephin and for one month afterwards.

• Chloramphenicol (used to treat infections, particularly of the eyes).
• Anticoagulants (medicines used to thin the blood).
• Probenecid (used to treat gout).
• Amsacrine (an anti-cancer medicine).
• Fluconazole (an anti-fungal medicine).
• Vancomycin or other antibiotics (used to treat infections).

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or are breastfeeding.

Driving and using machines

Rocephin can cause dizziness. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

How Rocephin will be given

Rocephin will be given to you by a doctor or nurse. It will be given to you in one of the following ways:

• As an injection into a muscle (such as the muscle in your arm).
• By slow injection into one of your veins. This may take between 2 and 4 minutes.
• Through a small tube into one of your veins. This is called an’intravenous infusion’. It may take at least 30 minutes.

The number of days or weeks that you are given Rocephin for depends on what sort of infection you have. You will usually continue to be given Rocephin for 2 to 3 days after you have started to recover from your illness.

Adults, the elderly and children aged 12 years and over

The usual dose is 1 g (gram) once a day. If you have a severe infection, your doctor may give you a higher dose (between 2 g and 4 g once a day).

If you are going to have an operation you may be given between 1 g and 2 g in one or two injections.

The usual treatment for an infection called ‘gonorrhoea’ is one dose of 250 mg (milligrams), given as an injection into a muscle.

Children up to 12 years

The dose is worked out by the doctor based on the child’s weight. The medicine is usually given to the child once a day through a small tube into a vein (intravenous infusion). This usually takes at least 30 minutes.

Newborn babies

The dose is worked out by the doctor based on the baby’s weight. The medicine is usually given to the baby once a day through a small tube into a vein (intravenous infusion). This usually takes 1 hour.

People with liver and kidney problems

If you have problems with your liver and kidneys, you may be given a lower dose. You may need to have blood tests to check that you are getting the dose you need.

If you are given too much Rocephin

If you think you have been given too much Rocephin, tell your doctor or nurse.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

Possible side effects

Like all medicines, Rocephin can cause side effects, although not everyone will get them. The following side effects may happen with this medicine.

Severe allergic reactions (uncommon, affect less than 1 in 100 people) 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 rashes (very rare, affect less than 1 in 10,000 people) If you get a severe skin rash, 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.

Other possible side effects:

Common (affect less than 1 in 10 people)

• Loose stools or diarrhoea.
• Feeling sick or being sick.

Uncommon (affect less than 1 in 100 people)

• Other skin reactions. These include a rash which may cover a lot of your body, a lumpy rash (hives), feeling itchy and swelling.

Rare (affect less than 1 in 1,000 people)

Other types of infection, such as those caused by fungi and yeasts (for example, thrush).

• Blood problems. The signs include feeling tired, bruising easily, being short of breath and nosebleeds.
• Headache.
• Feeling dizzy.
• A sore mouth.
• Inflammation of the tongue (glossitis). The signs include swelling, redness and soreness of the tongue.
• Liver problems (shown in a blood test).
• Problems with your gallbladder which may cause pain, feeling sick and being sick.
• Kidney problems. These may affect the amount of water (urine) that you pass. Some people pass less water than usual. Very rarely, people stop passing water altogether.
• Blood or sugar in your urine.
• Pain or a burning feeling along the vein where Rocephin has been given.
• Pain where the injection was given.
• A high temperature (fever) or shivering.

Very rare (affect less than 1 in 10,000 people)

• Positive results in a Coombs’ test (a test for some blood problems).
• Problems with the way your blood clots. The signs include bruising easily and pain and swelling of your joints.
• Changes in the numbers of white cells in your blood. The signs include a sudden high temperature (fever), shivering and a sore throat.
• Inflammation of the pancreas (pancreatitis). The signs include severe pain in the stomach which spreads to your back.
• Inflammation of the large bowel (colon). The signs include diarrhoea, usually with blood and mucus, stomach pain and fever.

If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

How Rocephin is stored

Your doctor or pharmacist is responsible for storing Rocephin. They are also responsible for disposing of any unused Rocephin correctly.

Keep out of the reach and sight of children.

Do not store Rocephin above 25°C.

Do not use Rocephin after the expiry date printed on the pack.

Further information

What Rocephin contains

The active substance in Rocephin powder for solution for injection or infusion is ceftriaxone. Rocephin is supplied in glass vials containing either 250 mg (milligrams), 1 g (gram) or 2 g of ceftriaxone.

There are no other ingredients in Rocephin.

What Rocephin looks like and contents of the pack

Rocephin is a powder. It is white to yellowish-orange in colour. It is supplied in a glass vial.

Before it is given to the patient, Rocephin is made into a solution by adding sterile liquid to the vial. The correct dose is then taken out of the vial. It can be given to the patient either as an injection or added to a bag of infusion solution which is given through a small tube into one of your veins.

Rocephin is supplied in packs of 1 vial.

Information for healthcare professionals

Rocephin   250 mg vials Rocephin   1 g vials Rocephin   2 g vials

Ceftriaxone (as hydrated disodium ceftriaxone) Powder for solution for injection or infusion

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

Presentation

250mg and lg vial: Clear glass 15ml vial with rubber stopper and aluminium cap.

2g vial: Clear glass 50ml vial with rubber stopper and aluminium cap.

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.

Posology and method of administration

Rocephin may be administered by deep intramuscular injection, slow intravenous injection, or as a slow intravenous infusion, after reconstitution of the solution according to the Instructions for use section. 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 IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously.

Adults and children 12years and over

Standard therapeutic dosage:  lg once daily.

Severe infections: 2 – 4g daily, normally as a single dose every 24 hours.

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of Rocephin should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

Acute, uncomplicated gonorrhoea: A single dose of 250mg intramuscularly should be administered. Simultaneous administration of probenecid is not indicated.

Peri-operative prophylaxis: Usually lg as a single intramuscular or slow intravenous dose. In colorectal surgery, 2g should be given intramuscularly (dosages greater than lg should be divided and injected at more than one site), or by slow intravenous infusion, in conjunction with a suitable agent against anaerobic bacteria.

Elderly

These dosages do not require modification in elderly patients provided that renal and hepatic function are satisfactory (‘Renal and hepatic impairment’ below).

Neonates

Recommended for once daily administration of 20 – 50mg/kg body weight, not to exceed 50mg/kg.

In the neonate, the intravenous dose should be given over 60 minutes to reduce the displacement of bilirubin from albumin, thereby reducing the potential risk of bilirubin encephalopathy (see Section 4.4 of the Summary of Product Characteristics).

Infants and children of up to 12 years

The following dosage schedules are recommended for once daily administration:

Standard therapeutic dosage: 20 – 50mg/kg body weight.

In severe infections up to 80mg/kg body weight may be given. For children with body weights of 50kg or more, the usual adult dosage should be used. Doses of 50mg/kg or over should be given by slow intravenous infusion over at least 30 minutes. Doses greater than 80mg/kg body weight should be avoided because of the increased risk of biliary precipitates.

Renal and hepatic impairment

In patients with impaired renal function, there is no need to reduce the dosage of Rocephin provided liver function is intact. Only in cases of pre-terminal renal failure (creatinine clearance < 10ml per minute) should the daily dosage be limited to 2g or less.

In patients with liver damage there is no need for the dosage to be reduced provided renal function is intact.

In severe renal impairment accompanied by hepatic insufficiency, the plasma concentration of Rocephin should be determined at regular intervals and dosage adjusted.

In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored, however, to determine whether dosage adjustments are necessary, since the elimination rate in these patients may be reduced.

Instructions for use

The use of freshly prepared solutions is recommended. These maintain potency for at least 6 hours at or below 25°C in daylight, or 24 hours at 2-8°C.

Rocephin should not be mixed in the same syringe with any drug other than 1.06% Lidocaine Hydrochloride BP solution (for intramuscular injection only).

Intramuscular injection: 250mg Rocephin should be dissolved in 1ml of 1.06% Lidocaine Hydrochloride BP solution, or lg in 3.5ml of 1.06% Lidocaine Hydrochloride BP solution. The solution should be administered by deep intramuscular injection. Dosages greater than lg should be divided and injected at more than one site.

Solutions in Lidocaine should not be administered intravenously.

Intravenous injection: 250mg Rocephin should be dissolved in 5ml of Water for Injections BP or lg in 10ml of Water for Injections BP. The injection should be administered over at least 2-4 minutes, directly into the vein or via the tubing of an intravenous infusion.

Intravenous infusion: 2g of Rocephin should be dissolved in 40ml of one of the following calcium-free solutions: Dextrose Injection BP 5% or 10%, Sodium Chloride Injection BP, Sodium Chloride and Dextrose Injection BP (0.45% Sodium Chloride and 2.5% Dextrose), Dextran 6% in Dextrose Injection BP 5%, Hydroxyethyl Starch 6 – 10% infusions. The infusion should be administered over at least 30 minutes.

The displacement value of 250mg of Rocephin is 0.194ml.

Incompatibilities

Solutions containing Rocephin should not be mixed with or added to other agents. 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 for IV administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions. Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole, aminoglycosides and labetalol.

Shelf life 3 years.

For shelf life of diluted product see Instructions for use.

Special precautions for storage

Do not store above 25°C.