Synacthen contains tetracosactide, which is similar to ACTH, a hormone that stimulates the adrenal gland (a gland located above the kidney) to produce certain hormones.
Diagnostic use:
Synacthen is used by intravenous and intramuscular administration in diagnostics for the evaluation of adrenal function.
Therapeutic use:
Synacthen is indicated as a substitute for Synacthen 1 mg/ml when intravenous administration is preferred over intramuscular administration.

Do not use Synacthen:
• if you are allergic to tetracosactide, other ACTH hormones or any of the other ingredients of this medicine.

Talk to your doctor or pharmacist before using Synacthen.

Fertility, pregnancy and breastfeeding:
If you are pregnant, think you may be pregnant or are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy and breastfeeding:
No clinical data are available on the risk during pregnancy and lactation.

Your doctor will only prescribe Synacthen if it is really necessary.
Fertility:
There is no data available.

Driving and using machines:
Special care should be taken when driving or using machinery.

Synacthen contains sodium:
This medicine contains less than 1 mmol (23 mg) sodium per vial, that is to say essentially “sodium-free”.
For those involved in sports activities:
Use of the drug without therapeutic need constitutes doping and may result in a positive doping test.

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Synacthen should only be administered under medical supervision.

THERAPEUTIC USE:
Treatment begins with a daily infusion and after approximately 3 days intermittent therapy is initiated. The infusion lasts a maximum of 4 hours.

Adults and adolescents over 12 years of age:
The recommended starting dose is 1 mg per day.
In acute cases, 1 mg every 12 hours.
Once acute manifestations are under control, the recommended maintenance dose is 1 mg every 2-3 days.
If you respond well to treatment, the dose is reduced to 0.5 mg every 2-3 days or to 1 mg every week.

Children:
The doctor will assess the appropriate dose depending on the effects on each individual patient.

Infants (28 days-23 months):
The recommended starting dose is 0.25 mg per day.
The recommended maintenance dose is 0.25 mg every 2-8 days.

Children aged 2 to 5 years:
The recommended initial dose is 0.25-0.5 mg per day.
The recommended maintenance dose is 0.25-0.5 mg every 2-8 days.

Children aged 6 to 12 years:
The recommended initial dose is 0.25-1 mg per day.
The recommended maintenance dose is 0.25-1 mg every 2-8 days.

USE FOR DIAGNOSTICS:
The doctor will assess plasma cortisol levels immediately before and 30 minutes after the intramuscular or intravenous injection of 0.25 mg Synacthen.
If the rapid test is inconclusive or if the aim is to determine the functional reserve of the adrenal gland, the 5-hour test with Synacthen 1 mg/mL extended-release injectable suspension is performed.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

- The active ingredient is tetracosactide hexaacetate. Each vial contains 0.27 mg tetracosactide hexaacetate equal to 0.25 mg tetracoside.
- The other ingredients are acetic acid, sodium acetate, sodium chloride, water for injections.

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

1 bottle