Linobact IV 600 mg/300 mg Solution

Linezolid is an antibiotic of the oxazolidinones group, that works by stopping the growth of certain bacteria (germs) that cause infections. LINOBACT IV may be prescribed by your doctor to treat certain infections, including pneumonia and some infections in the skin, or under the skin. Your doctor will determine if LINOBACT IV is suitable to be used for the type of infection you have.

LINOBACT IV should not be administered to you:

• if you are hypersensitive (allergic) to linezolid or any of the other ingredients of LINOBACT IV (listed in section 6).
• if you are treated with monoamine oxidase inhibitors (examples of monoamine oxidase inhibitors (MAOIs) are phenelzine, isocarboxacid) or within 2 weeks of taking such a medicine. These medicines may have been prescribed for you for depression or Parkinson’s disease.

LINOBACT IV may not be suitable for you if you have any of the following medical conditions. In this case tell your doctor as he/she will need to check your general health and your blood pressure before and during your treatment or may decide another treatment is better for you. Ask your doctor if you are not sure if you have any of these conditions:

• High blood pressure, and what medicines you are taking for this
• An overactive thyroid
• A tumour of the adrenal glands (phaeochromocytoma) or carcinoid syndrome (caused by tumours of the hormone system with symptoms of diarrhoea, flushing of the skin, wheezing)
• If you are taking any of the following medicines:

• Decongestant, cold or flu remedies containing pseudoephedrine or phenylpropanolamine
• Medicines used to treat Parkinson’s disease (dopamine)
• Medicines used to treat heart failure (dobutamine)
• Antidepressants known as tricyclics or SSRIs (selective serotonin reuptake inhibitors)
• Medicines used to treat anxiety (such as buspirone)
• Medicines used to treat moderate to severe pain, such as pethidine, meperidine.

You will not be expected to give yourself LINOBACT IV. It will be given to you by a person who is qualified to do so. LINOBACT IV is normally administered in hospital. Your doctor will tell you how long your treatment with LINOBACT IV will last. Do not stop treatment early, since a full course of antibiotic treatment is necessary to kill the germs that made you ill (see If you stop using LINOBACT IV).

The usual dose is:

Adults:

• LINOBACT IV will be infused (dripped) into a large vein over a period of 30 to 120 minutes.
• Your doctor will consider your type of infection and medical condition when deciding on a dose. Typical doses are 600 mg every 12 hours. The treatment may last between 10 and 28 days, depending on your infection and response.

Children:

• The dose of LINOBACT IV depends on your child’s body weight and severity of infection. Typical doses are 10 mg/kg every 8 hours, administered via an intravenous drip. The treatment may last from 10 to 28 days, depending on your child’s infection and response.

If you receive haemodialysis, your doctor will administer the LINOBACT IV dose after the dialysis procedure. If you have the impression that the effect of LINOBACT IV is too strong or too weak, tell your doctor or pharmacist.

If you receive more LINOBACT IV than you should

Since a healthcare provider will administer LINOBACT IV, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. Tell your doctor or health care provider at once if you think you may have been given too much LINOBACT IV.

If you missed a dose of LINOBACT IV

Since a healthcare provider will administer LINOBACT IV, it is unlikely that the dose will be missed. If you think that you have missed a dose of treatment, tell a doctor or nurse at once. Do not take a double dose to make up for a forgotten dose.

If you stop using LINOBACT IV

To clear up your infection completely, LINOBACT IV should be used for the full course of treatment as prescribed by your doctor. Your symptoms may improve before the infection is completely treated. Stopping treatment too early may help the germs causing the infection to become resistant to LINOBACT IV.

LINOBACT IV can have side effects. Not all side effects reported for LINOBACT IV are included in this leaflet. Should your general health worsen of if you experience any untoward effects while receiving LINOBACT IV, please consult your healthcare provider for advice. LINOBACT IV is administered in a hospital setting. Your medical condition will be carefully monitored by a healthcare provider.

Tell your healthcare provider immediately if you notice any of the following:

• Serious allergic reactions, including a shock reaction. This may include swelling of the tongue and/or throat, difficulty in swallowing, difficulties in breathing, facial swelling, severe dizziness with a fast heartbeat and heavy sweating.
• Serious skin reactions such as hives (nettle rash), red sore skin and flaking (dermatitis), blisters, widespread skin peeling, rash, itching, or swelling, particularly around the face and neck. These symptoms may be due to a severe allergic reaction. (Toxic Epidermal Necrolysis, Stevens - Johnson syndrome).
• Severe watery diarrhoea, containing blood and/or mucous (antibiotic associated colitis including pseudomembranous colitis, or bacterial infection of the bowels), which may develop into complications that are life-threatening.
• Lactic acidosis (symptoms may include recurrent nausea or vomiting, abdominal pain or over breathing). Lactic acidosis exists when lactic acid builds up in the bloodstream faster than it can be removed and may be life-threatening.
• Fits or seizures (see Tell your doctor or healthcare professional before being given LINOBACT IV injection).
• Serotonin syndrome (you may have symptoms like fast heart rate, confusion, abnormal sweating, hallucinations, involuntary movements, chills and shivering). See Other medicines and LINOBACT IV.

Problems with your vision such as loss of vision, blurred vision, changes in colour vision, difficulty in seeing detail, or if your field of vision becomes restricted.

Transient ischaemic attacks (“mini-stroke”, with signs like temporary disturbance of blood flow to the brain causing short term symptoms such as loss of vision, leg and arm weakness, slurring of speech and loss of consciousness).

Kidney failure, excessive or abnormally large production of urine. If you have these symptoms, your doctor may stop giving you LINOBACT IV and treat you suitably.

Tell your healthcare provider if you notice any of the following:

Frequent side effects

• Fungal infections, especially vaginal or oral “thrush”.
• Difficulty in sleeping.
• Headache, dizziness.
• Metallic taste in the mouth.
• Nausea (feeling sick), vomiting (being sick), abdominal pains, diarrhoea (loose bowels).
• Changes in some blood test results including those measuring your kidney or liver function or blood sugar levels.

Less frequent side effects

• Reversible anaemia (low red blood cells).
• High blood pressure.
• Inflammation of the vagina or genital area in women.
• Changes in numbers of certain cells in the blood which may affect your ability to fight infection.
• Unexplained bleeding or bruising, which may be due to changes in the numbers of certain cells in the blood which may affect blood clotting.
• Skin rash, itching.
• Pain at the injection site, fever.
• Sensations such as tingling or numbness of fingers and toes.
• Convulsions (“fits”).
• Blurred vision, field of vision becomes restricted.
• “Ringing” in the ears (tinnitus).
• Changes in heart rate (quicker heart rate).
• Inflammation of the veins, low blood pressure.
• Indigestion, stomach pain, constipation, distended belly, increased thirst, loose stools.
• Dry or sore mouth, swollen, sore, or discoloured tongue.
• Sweating, red inflamed skin.
• Superficial tooth discolouration.

Side effects occurring at unknown frequency:

• Hair loss
• Changes in colour vision, difficulty in seeing detail, loss of vision, optic neuritis (inflammation in optic nerve causing pain with eye movement).

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 LINOBACT IV.

Store all medicines out of reach of children. Store at room temperature, at or below 25 °C. Do not freeze. Protect from light – the infusion bags must be kept in their foil overpouch, until ready to use. The infusion bags are only intended for single-use. Discard any unused solution. Your healthcare provider will check that the LINOBACT IV is not past its expiry date stated on the label and carton before giving you the injection. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Return all unused medicine to your pharmacist.