PACKAGE LEAFLET: INFORMATION FOR THE USER Ceftriaxone 1g powder for solution for Injection Ceftriaxone 2g powder for solution for injection or infusion Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please ask your doctor or nurse.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What ceftriaxone for injection is and what it is used for

2.    Before you are given ceftriaxone for injection

3.    How ceftriaxone for injection should be given

4.    Possible side effects

5.    How to store ceftriaxone for injection

6.    Further information

1. WHAT CEFTRIAXONE FOR INJECTION IS AND WHAT IT IS USED FOR

Ceftriaxone belongs to a group of medicines called cephalosporins, which are antibiotics. These medicines work by killing bacteria that cause infections. Ceftriaxone for injection is used for the treatment of a range of serious bacterial infections including skin and soft tissue infections, chest infections (pneumonia), gonorrhoea, infection of the membrane covering the brain (meningitis), infections of the blood stream (septicaemia) and to prevent and treat infections following surgical operations.

2. BEFORE YOU ARE GIVEN CEFTRIAXONE FOR INJECTION

Ceftriaxone for injection should not be given if:

•    you are allergic to ceftriaxone or any other cephalosporin.

•    you have previously had a severe allergic reaction to penicillin or any other beta-lactam antibiotic.

•    the patient is a premature baby

•    the patient is a newborn baby with jaundice or a low level of protein in the blood or reduced alkalinity of the blood (acidosis)

•    the patient is a newborn baby requiring calcium treatment or calcium-containing infusions.

If any of the above applies to you, you should not be given Ceftriaxone for Injection.

Take special care with ceftriaxone for injection if:

•    you have previously had an allergic reaction to penicillin or other antibiotics of this type. Not all people who are allergic to penicillins are also allergic to cephalosporins. Before you are given this medicine your doctor should check whether you have previously had an allergic reaction to such drugs.

•    the patient is a baby or small child who needs high doses of ceftriaxone.

•    you have kidney and liver problems, if you have recently been very ill or if you are being fed through a vein.

•    you are on a low sodium diet.

•    you are going to have a blood transfusion, make sure that the doctor who organises your transfusion knows that you are having ceftriaxone for injection.

•    you are diabetic, you may get false positive results with urine glucose tests, such as Clinitest.

•    ceftriaxone can cause bleeding, particularly in patients who are malnourished, have kidney or liver problems or have low vitamin K levels.

•    you have anaemia

•    you have diarrhoea or other bowel related problems

•    you have or have a history of colitis (inflamed colon)

You should be kept under observation in case you develop another infection, particularly colitis (infection of the lower bowel), while you are being treated with ceftriaxone for injection.

Taking other medicines

Taking other medicines when ceftriaxone for injection is being administered can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines while you are being treated with ceftriaxone for injection unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself without a prescription.

Please check with your doctor if you are taking the following (or any other medication):

•    Antibiotics such as vancomycin and chloramphenicol.

•    Anticoagulants (medicines used to stop blood clotting) such as warfarin.

•    Ceftriaxone should not be administered simultaneously with intravenous calcium-containing solutions.

•    Oral contraceptives as ceftriaxone may effect their function. You should use non-hormonal contraceptives during treatment and in the month following treatment.

•    Amsacrine, used in the treatment of leukemia.

•    Fluconazole, an antifungal used in the treatment of thrush.

If you have any doubts about whether you should be given this medicine, then talk to your doctor.

Important information about the sodium content of ceftriaxone for injection

Ceftriaxone for injection contains 3.6mmol (or 82mg) for the 1g vial and 7.2mmol (or 165mg) for the 2g bottle of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Pregnancy and breast-feeding

You should let your doctor or nurse know if you are pregnant or wish to become pregnant or are breast-feeding before this medicine is administered.

Driving and using machines i    i

Ceftriaxone for injection may cause dizziness. If you are affected you should not drive or operate machinery.

3. HOW CEFTRIAXONE FOR INJECTION SHOULD BE GIVEN

Intravenous infusion: 2g of ceftriaxone should be dissolved in 40ml of one of the following calcium-free solutions; Glucose Intravenous Infusion BP 5% or 10%, Sodium Chloride Intravenous Infusion BP, Sodium Chloride and Glucose Intravenous Infusion BP (0.45% sodium chloride and 2.5% Glucose), Dextran 6% in Glucose Injection BP 5%, isotonic hydroxyethylstarch 6-10% infusions. The infusion should be administered over at least 30 minutes.

Adults and children 12 years and over:

Standard therapeutic dosage: 1g once daily.

Severe infections: 2-4 g daily, normally as a once daily dose.

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 a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

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

Peri-operative prophylaxis: Usually one dose of 1g given by intramuscular or slow intravenous injection. In colorectal surgery, 2g should be given intramuscularly (in divided doses at different injection sites), by slow intravenous injection 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 (see below).

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 (refer to the Summary of Product Characteristics).

Children under 12 years

Standard therapeutic dosage: 20-50mg/kg body-weight once daily.

Up to 80mg/kg body-weight daily may be given in severe infections, except in premature neonates where a daily dosage of 50mg/kg should not be exceeded. For children with

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Adults and the Elderly

The usual dose for adults (including the elderly) by intramuscular or intravenous ii infection appears to have cleared.

Children

The usual dose for newborn babies and children aged up to twelve years is 20-50mg per kg body weight once daily.

Higher doses may be given, particularly in severe infections.

Your doctor will decide the dose that is best for you. If you do not understand, or are in any doubt, ask your doctor or nurse.

If you think you have been given too much or too little ceftriaxone for injection

Your doctor will decide which dose is best for you. If you think too much or too little medicine has been given to you contact your doctor, nurse, pharmacist or nearest hospital.

4. POSSIBLE SIDE EFFECTS

Like many medicines, ceftriaxone for injection may cause side effects in some patients, particularly when treatment is first started. You should inform your doctor or nurse immediately if you feel unwell.

These include:

•    Allergic reactions, with skin rash, itching and swelling of the eyes and face. More severe allergic reactions may be associated with headache, fever, shivering, wheezing, aching joints, sore eyes, or red, blistering and peeling skin.

Tell your doctor immediately if you think you are having an allergic reaction to ceftriaxone.

•    The most common side effects are loose stools and diarrhoea or, occasionally nausea and vomiting or a sore mouth and tongue.

•    Some other side effects patients have had with ceftriaxone include headache and anaemia or other changes in the blood (causing sore throat and mouth ulcers or a tendency to bleed or bruise easily).

•    Rarely, dizziness, vertigo, stomach pain, disturbances of liver or kidney function, hepatitis, jaundice, blood or glucose in the urine or a fungal infection of the genital tract (thrush) can occur. Deposits in the urinary passages or gall bladder may cause problems with passing water, passing little or no water, or stomach pains, especially in very young, dehydrated or bedridden patients. These deposits usually disappear when ceftriaxone treatment is stopped.

•    Antibiotic treatment can affect the normal bacteria in the gut, causing new infection (colitis). You should tell your doctor immediately if you develop diarrhoea after starting treatment with ceftriaxone.

•    Occasionally, if you have had an intravenous injection there may be soreness t 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 national reporting systems listed below.

United Kingdom Yellow Card Scheme www.mhra.gov.uk/yellowcard Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CEFTRIAXONE FOR INJECTION

Keep this medicine out of the sight and reach of children.

•    This medicine should not be used after the expiry date shown on the label. The expiry date refers to the last day of that month.

•    The vials and bottles should not be stored above 25°C.

•    Keep the vial or bottle in the outer carton in order to protect from light.

•    From a microbiological point of view, the product should be used immediately. In use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. Once reconstituted, any unused portion of solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

6. FURTHER INFORMATION

What ceftriaxone for injection contains

Ceftriaxone for injection contains the active ingredient ceftriaxone as ceftriaxone sodium. Each container contains the equivalent of 1g or 2g of ceftriaxone. The sodium content is approximately 82mg (3.6mmol) for the 1g vial and 165mg (7.2mmol) for the 2g bottle.

What ceftriaxone for injection looks like and contents of the pack

Ceftriaxone for injection is a white to pale yellow powder, which must be made into a solution before injection or infusion.

Ceftriaxone for injection 1g is available in packs of 1,5, 10, 25 or 50 vials. Not all pack sizes are marketed.

Ceftriaxone for injection 2g is available in packs of 1 or 10 bottles. Not all pack sizes are marketed.

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Product Name		Referer	ce Number
Ceftriaxone 1g powder for solution for injection		29831/0034
Ceftriaxone 2g powder for solution for injection or infusion		29831/0033

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This leaflet was last revised in 08/2015

body weights of 50kg or more, the usual 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 ceftriaxone provided liver function is intact. Only in cases of preterminal 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 ceftriaxone should be determined at regular intervals and dosage adjusted.

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

•    Incompatibilities

Solutions containing ceftriaxone should not be mixed with or added to solutions containing other agents except 1% Lidocaine Injection BP (for intramuscular injection only). In particular, diluents containing calcium, (e.g. Ringer’s solution, Hartmann’s solution) should not be used to reconstitute ceftriaxone or to further dilute a reconstituted container for IV administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions (refer to the Summary of Product Characteristics). Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole, aminoglycosides, pentamidine, clindamycin phosphate and labetalol.

•    Shelf life and special precautions for storage

Unopened - Three years. Do not store above 25°C. Keep the vials or bottles in the outer carton.

For reconstituted solution, chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and for four days at 2-8°C. From a microbiological point of view,

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once opened, 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 normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

• Instructions for use/handling

Container size	Diluent to be added	Approx available volume		Approx displacement volume
Reconstitution table Water for Injection (Intravenous Injection):
1g	10ml	10.5ml	0.5ml
Reconstitution table 1% Lidocaine Injection BP (Intramuscular Injection):
1g	3.5ml	4.05ml	0.55ml
Reconstitution table (Intravenous Infusion):
2g	40ml	41.03ml	1.03ml

Ceftriaxone is compatible with several commonly used intravenous infusion fluids

e.g. Sodium Chloride Intravenous Infusion BP, 5% j or 10% Glucose Intravenous Infusion BP, Sodium Chloride and Glucose Intravenous Infusion BP (0.45% sodium chloride and 2.5% glucose), Dextran 6% in Glucose Intravenous Infusion BP 5% and isotonic hydroxyethylstarch 6-10% infusions.

Ceftriaxone should not be mixed in the same syringe with any drug other than 1% Lidocaine Injection BP (for intramuscular injection only).

The reconstituted solution should be clear. Do not use if particles are present.

Ceftriaxone sodium when dissolved in Water for Injections Ph Eur forms a pale yellow to amber solution. Variations in the intensity of colour of the freshly prepared solutions do not indicate a change in potency or safety.

For single use only. Discard any unused contents.

Date leaflet last revised: 08/2015

The information in this leaflet applies only to Ceftriaxone 1g Powder for solution for injection and Ceftriaxone 2g Powder for solution for injection/infusion

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