Ventolin Solution

Salbutamol is one of a group of medicines called beta - 2 - agonists which act on special receptor sites in the body. VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION can be used for two purposes.

1. To relieve severe bronchospasm (wheeze as in asthma and chronic bronchitis).
2. To stop premature labour.

VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION should not be administered to you:

• if you are hypersensitive (allergic) to salbutamol sulphate or the other ingredients of VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION which are listed in section 6 of this leaflet
• if you are less than 22 weeks pregnant
• if you suffer from or have a known risk of developing ischaemic heart disease (disease characterised by reduced blood supply to your heart muscle, causing symptoms such as chest pain (angina)
• if you are pregnant and you or your baby have certain conditions when prolongation of your pregnancy would be dangerous (such as severe high blood pressure, infection of the womb, bleeding from vagina during pregnancy (postpartum haemorrhage), placenta is covering the birth canal or is detaching (placenta praevia), abnormal condition of pregnancy which is characterised by high blood pressure, swelling and protein in the urine (toxaemia in pregnancy). or your baby has died inside the womb).

If you are not sure whether you should receive VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION, please discuss with your doctor before receiving this medicine.

Warnings and precautions:

Take special care with VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION: Tell your doctor or healthcare professional before being given the injection:

• if you have an overactive thyroid gland
• if you have high blood pressure
• if you have low blood potassium levels, as treatment with VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION can make this condition worse
• if you suffer from heart disease with palpitations (e.g. heart valve disorder) or long - standing lung disease (e.g. chronic bronchitis, emphysema) causing an increase of blood pressure to your lungs (pulmonary hypertension)
• if you are taking beta - blocking medicines
• if you have diabetes
• if during pregnancy, your waters have broken
• you have too much fluid in the lungs causing breathlessness (pulmonary oedema).

If any of these points apply to you, consult your doctor first before you are given VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION.

Other medicines and VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION

Always tell your healthcare professional if you are taking any other medicine (this includes complimentary or traditional medicines). Tell your doctor or nurse if you are taking:

• medicines for an irregular or fast heartbeat (such as digoxin)
• beta - blocking agents (such as atenolol or propranolol)
• xanthine medicines (such as theophylline or aminophylline)
• cortisone medicines (such as prednisolone)
• water tablets, also known as diuretics (such as furosemide)
• medicines for diabetes to reduce your blood sugar (such as insulin, metformin or glibenclamide)
• other medicines for asthma.

VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION should not be administered in the same syringe as any other medication.

Do not share medicines prescribed for you with any other person. You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.

VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION is diluted to prepare a suitable infusion solution. This is then given to you by a doctor or nurse. The usual dose is:

• To treat severe breathing problems: 3 to 20 micrograms per minute for as long as required
• To temporarily delay premature labour: 10 to 45 micrograms per minute until contractions stop. If your labour continues despite this treatment then the infusion should be stopped.

You will be given VENTOLIN Infusion by a doctor where facilities are available to continually monitor your health and that of your baby throughout administration.

If you receive more VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION than you should: VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION will always be given under carefully controlled conditions. However, if you think that you have been given more than you should, tell your doctor or nurse as soon as possible.

VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION can cause side effects. Not all side effects reported for VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION are included in this leaflet. Should your general health worsen, or if you experience any untoward effects, while using VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION, please consult your doctor, pharmacist or other healthcare professional for advice.

The following side effects are very serious. You may need urgent medical attention: Some people can be allergic to VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION. If you have any of the following symptoms soon after receiving VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION, talk to your doctor immediately:

• swelling of eyelids, face or lips
• lumpy skin rash or ‘hives’ anywhere on the body
• sudden wheeziness or chest tightness
• feeling faint and lightheaded, or collapse.

Patients receiving VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION for the treatment of premature labour: cough, wheezing, chest pain, shortness of breath, which may be signs of pulmonary oedema (fluid in the lungs). These side effects are less frequent. Tell your doctor immediately if you have any of these side effects.

Talk to your doctor as soon as possible if you experience any of the following:

• Frequent side effects:
• your heart is beating faster or stronger than usual (palpitations)
• your heartbeat is uneven or gives extra beats
• feeling shaky
• headache
• muscle cramps.

The following side effects can also occur less frequently:

• chest pain due to heart problems (angina). Tell your doctor, nurse or pharmacist if this occurs. Do not stop using VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION unless told to do so
• a condition known as lactic acidosis which may cause stomach pain, rapid breathing or shortness of breath, cold feet and hands, irregular heartbeat or thirst
• changes in behaviour such as restlessness and excitability
• being sick (vomiting) or feeling sick (nausea) can occur when VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION is used to treat premature labour.

The following could be seen in your blood test results:

• low potassium levels
• high glucose levels
• high lactic acid levels.

If any of these side effects get serious, please tell your doctor or pharmacist. 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 VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION.

Do not use after the date shown as ‘Exp’ on the carton and label. Store at or below 30 °C. Protect from light. Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).