BOCOUTURE POWDER FOR INJECTION SOLUTION PREPARATION 100 U

Active ingredient: Each vial contains 100 units of Botulinum toxin type A obtained from Clostridium botulinum (Hall strain).

Excipients: Human serum albumin and sucrose

▼This drug is subject to additional monitoring. This triangle will enable rapid identification of new safety information. You can help by reporting any side effects that occur. To learn how to report side effects, see the end of Chapter 4.

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

Detailed information for this product is available in the patient information leaflet.

Instructions for proper use and dosage/frequency of administration

BOCOUTURE can only be administered by doctors with appropriate specialist knowledge of treatment with Botulinum neurotoxin type A.

Vertical lines between the eyebrows seen when the eyebrows are maximally frowned

When treating vertical lines between the eyebrows (glabellar lines) seen when the eyebrows are maximally frowned, the usual total dose is 20 units. Your doctor will inject 4 units into each of 5 injection sites. The total dose may be increased by the physician up to 30 units according to the individual needs of the patient, with an interval of at least “3 months” between treatments.

The reduction in the vertical lines between the eyebrows, which are seen when the eyebrows are maximum frowned, usually occurs within 2 to 3 days, and the maximum effect is seen on the 30th day. The effect lasts up to 4 months after injection.

Like all medicines, there may be side effects in people who are sensitive to the ingredients contained in BOCOUTURE.

An allergic reaction may occur with BOCOUTURE. Serious and/or sudden allergic reactions (anaphylaxis) or allergic reactions (serum sickness) to the serum in the product, causing, for example, difficulty breathing (dyspnea), hives (urticaria) or swelling of soft tissue (edema), have been reported rarely. Some of these reactions have been observed following the use of conventional Botulinum toxin type A complex. They have occurred when the toxin was administered alone or in combination with other products known to cause similar reactions. The possibility of these effects cannot be excluded when using BOCOUTURE.

If any of the following occur, stop using BOCOUTURE and IMMEDIATELY inform your doctor or go to the emergency department of your nearest hospital.

An allergic reaction can cause any of the following symptoms:

These are all very serious side effects.

⚠️ Disclaimer: The information provided on this website is for informational purposes only and does not substitute professional medical advice. Always consult a healthcare provider before using any medication.