Triaphin 1 g Injection

TRIAPHIN contains ceftriaxone sodium which is an antibiotic belonging to a group of antibiotic medicines called cephalosporins. TRIAPHIN is used for the treatment of infections caused by bacteria. It is also used prior to some surgical operations to reduce the risk of bacterial infections.

TRIAPHIN should not be administered to you:

• if you are hypersensitive (allergic) to ceftriaxone or to other medicines containing related antibiotics such as cephalosporins or penicillins
• if you have had a bad reaction to a lidocaine/lignocaine injection in the past.

TRIAPHIN should not be administered 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.

Warnings and precautions

Tell your doctor or health care provider before being given TRIAPHIN or while being given TRIAPHIN if:

• you have recently received or are about to receive calcium: if TRIAPHIN is mixed together with calcium-containing solutions or products, or if TRIAPHIN is going to be administered to you through an intravenous infusion line which contains calcium-containing fluid, it could cause precipitation of ceftriaxone-calcium salt
• you develop a severe diarrhoea or if you have ever had problems with your gut, in particular colitis (inflammation of the bowel)
• you have liver and 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
• you experience a change in mental state, fits, or sudden jerks
• 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”).

Children

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

• your child has recently been given or is to be given a product that contains calcium into their vein.

Other medicines and TRIAPHIN

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

• TRIAPHIN should not be added to solutions containing calcium
• if you are taking medicine to reduce the clotting of your blood, tell your doctor before you receive TRIAPHIN
• if you are taking a medicine containing chloramphenicol (an antibiotic used to treat infections, particularly of the eyes), tell your doctor before you receive TRIAPHIN.

If you need a blood or urine test

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

Pregnancy and breastfeeding

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 TRIAPHIN. Safety and efficacy have not been established. You should not receive TRIAPHIN when you are pregnant or breastfeeding your baby.

Driving and using machines

TRIAPHIN can cause drowsiness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience these symptoms.

TRIAPHIN contains sodium

Each TRIAPHIN 250 mg vial contains less than 1 mmol sodium (23 mg) per 250 mg vial, i.e. is essentially “sodium free”. Each TRIAPHIN 1 g vial contains approximately 83 mg of sodium per 1 g vial, equivalent to 4,15 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

The usual dosage for adults and children over 12 years is 1 — 2 g of TRIAPHIN once daily. The dosage could be raised by your doctor depending on the severity of the disease. The dosage may also be changed by your doctor depending on how your liver and kidneys are functioning. The dose for newborn babies (up to 14 days) is calculated by your doctor according to the body weight of the baby. A similar calculation is done for infants (15 days and older) and children up to 12 years. Carefully follow all instructions given to you by your doctor, nurse or pharmacist.

Duration of administration

Your doctor will tell you how long your treatment with TRIAPHIN will last. If you have the impression that the effect of TRIAPHIN is too strong or too weak, tell your doctor or pharmacist.

Method of administration

TRIAPHIN will be injected in a muscle or directly into a vein. You will not be expected to give yourself TRIAPHIN. It will be given to you by a person who is qualified to do so.

If you are given more TRIAPHIN than you should

Since a health care provider will administer TRIAPHIN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you did not get your dose of TRIAPHIN

Since a health care provider will administer TRIAPHIN, it is unlikely that the dose will be missed.

Effects when treatment with TRIAPHIN is stopped

The duration of TRIAPHIN therapy varies, depending on the nature of your illness and your individual response to the treatment. You will receive TRIAPHIN for at least 2 - 3 days after starting to recover from your illness or after a surgical operation to prevent infections from occurring.

TRIAPHIN can have side effects. Not all side effects reported for TRIAPHIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving TRIAPHIN, please consult your health care provider for advice.

If any of the following happens, while or after receiving TRIAPHIN, tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• fainting
• 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, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (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 TRIAPHIN treatment for infections caused by spirochetes such as Lyme disease.

These are very serious side effects. If you have them, you may have had a serious reaction to TRIAPHIN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• diarrhoea, usually with blood and mucus, stomach pain and fever, these may be signs of inflammation of the large intestine (colitis)
• signs of recurrent infections such as fever or sore throat
• feeling tired all the time, noticing that your skin looks pale, could be due to anaemia (reduction in number of red blood cells)
• problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay-coloured stools
• progressive loss of memory and ability to think, subtle personality changes, inability to concentrate, feeling extremely tired, and progressive loss of consciousness, these may be signs of encephalopathy
• convulsions (fits)
• kidney problems caused by deposits of calcium ceftriaxone. There may be pain when passing water (urine) or low output of urine
• inflammation of the pancreas (pancreatitis). The signs include severe pain in the stomach which spreads to your back.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes)
• loose stools or diarrhoea
• changes in the results of blood tests for liver function
• rash.

Less frequent side effects:

• fungal infections affecting the genital regions (e.g. thrush)
• a decrease in the number of white blood cells (granulocytopenia)
• 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
• difficulty in breathing (bronchospasm)
• pruritis (itching) or urticaria (hives)
• fever, shivering, pain or a burning feeling along the vein where the injection has been given, pain where the injection was given, oedema (fluid build-up)
• abnormal kidney function test (blood creatinine increased)
• sugar in your urine (seen on a urine test).

Side effects with frequency unknown:

• secondary infection
• vertigo (spinning sensation).
• inflammation of the mucus lining of the mouth (stomatitis).
• inflammation of the tongue (glossitis). The signs include swelling, redness and soreness of the tongue.
• problems with your gallbladder, which may cause pain, feeling sick and being sick.
• a neurological condition that may occur in neonates with severe jaundice (kernicterus)
• a false positive result in a Coombs’ test (a test for some blood problems)
• a false positive result for galactosaemia (an abnormal build up of the sugar galactose). TRIAPHIN may interfere with some types of blood glucose tests - please check with your doctor.

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, 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 TRIAPHIN. Suspected side effects can also be reported directly to the Holder of the Certificate of Registration via [email protected]

Store all medicines out of reach of children.

Store at or below 25 °C. Protect from light and moisture.

Storage directions for reconstituted product: Store for up to 6 hours at 25 °C or 24 hours at 2 - 8 °C in a refrigerator. Do not freeze.

The doctor or nurse who is administering TRIAPHIN to you, will make sure that the medicine is not used after the expiry date printed on the vial.