Enoxirt 1 gm IM Vial

1. What this product is and what it is used for

Enoxirt 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.

Enoxirt 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.

2. What you need to know before you use this product

You must not be given Enoxirt if:

· You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6: “Further Information”).

· 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 Enoxirt as an injection into a muscle.

Enoxirt 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 Enoxirt 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.

· 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.

If you need a blood or urine test

If you are given Enoxirt for a long time, you may need to have regular blood tests. Enoxirt 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 Enoxirt.

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 Enoxirt. 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 Enoxirt if:

· He / She has recently been given or is to be given a product that contains calcium into their vein.

Other medicines and Enoxirt

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 using this medicine.

The doctor will consider the benefit of treating you with Enoxirt against the risk to your baby.

Driving and using machines

Enoxirt 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.

3. How to use this product.

Enoxirt 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.

Enoxirt 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 Enoxirt 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 Enoxirt depends on what sort of infection you have.

Adults, older people and children aged 12 years and