Inoxiphin 250 mg Solution

INOXIPHIN is contains an antibiotic called ceftriaxone, 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.

Do not receive INOXIPHIN if :

• You are allergic to ceftriaxone or any of the other ingredients of INOXIPHIN 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 (lignocaine) and you are to be given INOXIPHIN injection into a muscle

INOXIPHIN Injection 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 whites of the eyes) or is about to be given a product that contains calcium into their vein

Warnings and precautions

Take special care with INOXIPHIN if :

• You have recently received or are about to receive products that contain calcium
• If your child has recently been given or is to be given a product that contains calcium into their vein
• 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
• If 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)
• If you are on a low sodium diet.
• If you need a blood or urine test. INOXIPHIN injection can affect the results of urine tests for sugar and a blood test known as the Coombs test (A test checks your blood for antibodies that attack red blood cells)
• Tell the person taking the sample that you have been given INOXIPHIN
• If you are given INOXIPHIN for a long time, you may need to have regular blood tests.
• 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 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 INOXIPHIN. If you use such systems check the instructions for use and tell your healthcare professional. Alternative testing methods should be used if necessary.

Children

Talk to your doctor or pharmacist or nurse before your child is administered INOXIPHIN if:

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

Other medicines and INOXIPHIN

Always tell your health care professional if you are taking any other medicine. (This includes complementary or traditional medicines).

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

• A type of antibiotic called an aminoglycoside like amikacin, gentamycin and neomycin which is used to treat certain infections. INOXIPHIN may intensify the effects of the aminoglycosides.
• An antibiotic called chloramphenicol (used to treat infections, particularly of the eyes). INOXIPHIN can weaken the effectiveness of chloramphenicol.
• Anticoagulants like warfarin used to thin the blood as INOXIPHIN can intensify the effect of anticoagulants and cause increased bleeding.
• Alcohol. When [PRODUCT NAME] is used with alcohol it can increase the effects of alcohol, and cause side effects like vomiting, nausea and abdominal pain.

INOXIPHIN with food and drink and alcohol

INOXIPHIN should not be taken with alcohol.

Pregnancy and breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. Breastfeeding mothers should take care as ceftriaxone as contained in INOXIPHIN is excreted in breastmilk.

Do not share medicines prescribed for you with any other person. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will decide how much INOXIPHIN to give you. He or she will also decide how often you need it and for how long. INOXIPHIN 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. INOXIPHIN 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. Your doctor will decide the correct dose of INOXIPHIN 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 INOXIPHIN 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): The usual dose is 1 to 2 g once a day.

Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg: The usual dose is 20 - 80 mg of INOXIPHIN for each kg of the child’s body weight once a day.

Newborn babies (0 - 14 days) The usual dose is 20 – 50 mg of INOXIPHIN for each kg of the child’s body weight once a day.

People with liver and kidney problems You may be given a different dose to the usual dose. Your doctor will decide how much of INOXIPHIN injection you will need and will check you closely depending on the severity of the liver and kidney disease.

If you take more INOXIPHIN than you should Since a health care provider will administer INOXIPHIN, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take INOXIPHIN Since a health care provider will administer [PRODUCT NAME], it is unlikely that the dose will be missed.

If you stop taking INOXIPHIN Your doctor will determine when you will be stop taking INOXIPHIN.

INOXIPHIN can have side - effects. Not all side effects reported for INOXIPHIN are included in this leaflet. Should your health worsen or if you experience any untoward effects while taking INOXIPHIN, please consult your doctor, pharmacist or other health care professional for advice. If any of the following happens, stop taking INOXIPHIN and tell your doctor immediately or go to the casualty department at your nearest hospital: 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.
• 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 (yellowing of skin and the whites of the eyes, swollen abdomen, fatigue), enlarged lymph nodes and other body organs involvement (fever, night sweats, weight loss) [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 INOXIPHIN treatment for infections with spirochete such as Lyme disease.

These are very serious side effects. If you have them, you may have had a serious allergic reaction to INOXIPHIN. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following:

• Frequent: Loose stools or diarrhoea
• Rash

Less frequent:

• Fungal infections (for example, thrush)
• 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 INOXIPHIN has been given. Pain where the injection was given
• A high temperature (fever)
• 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 (swelling)

Not known (Frequency cannot be estimated from the available data):

• Liver Damage

Laboratory results:

• Abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes)
• Changes in the results of blood tests for liver functions
• Abnormal kidney function test (blood creatinine increased)
• A decrease in the number of white blood cells (granulocytopenia)
• Reduction in number of red blood cells (anaemia)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse drug Reaction reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of INOXIPHIN.

KEEP OUT OF REACH OF CHILDREN

Store at or below 25 °C. Keep product in outer container until required for use.

Storage Directions for Reconstituted Product

Store for up to 6 hours at or below 25 °C or 24 hours in the refrigerator at or below 2 - 8 °C. This medicine should not be used after the expiry date (EXP) shown on the pack.