NABOTA POWDER FOR SOLUTION FOR INJECTION 100 UNITSVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Clostridium Botulinum Toxin Type A

Available from:

HYPHENS PHARMA PTE. LTD.

ATC code:

M03AX01

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Clostridium Botulinum Toxin Type A 100 Units/vial

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Daewoong Pharmaceutical Co., Ltd.

Authorization status:

ACTIVE

Authorization date:

2023-01-20

Summary of Product characteristics

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PACKAGE INSERT
1. NAME OF THE MEDICINAL PRODUCT
NABOTA Powder for Solution for Injection 100units/vial
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains:
-
Active ingredient: Clostridium botulinum toxin type A – 100 Units
-
Stabilizing agent: Human serum albumin – 0.5mg
-
Isotonic agent: Sodium chloride – 0.9mg
3. PHARMACEUTICAL FORM
It appears as a white to yellowish, vacuum-dried powder for injection
in a colourless and transparent
vial. It should become clear transparent liquid when dissolved in the
diluent (physiological saline
solution).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temporary improvement in the appearance of moderate to severe
glabellar lines (vertical lines
between the eyebrows) associated with corrugator muscle and/or
procerus muscle activities, in adults
below 65 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intramuscular use only.
Reconstitute
by
diluting
with
preservative-free,
sterile
saline
solution
to
make
100U/2.5mL
(4U/0.1mL). Using a sterile 30-gauge needle, inject a dose of 0.1mL
into each of the 5 injection sites:
2 injections in each corrugator muscle and 1 injection in the procerus
muscle for a total dose of 20
Units.
Physical manipulation (such as rubbing) of the injection site in the
immediate post-administration
period should be avoided.
_ _
In order to reduce the complication of ptosis, injections near the
levator palpebrae superioris muscle
must be avoided, particularly in patients with larger brow-depressor
complexes (depressor supercilii).
Injections into inner corrugators muscle and central eyebrow should be
placed at least 1 cm above the
bony supraorbital ridge.
Careful attention should be paid to avoid injection of this product
into the blood vessel. The thumb or
index finger should be placed firmly below the orbital rim in order to
prevent extravasation below the
orbital rim. The needle should be oriented superiorly and medially
during the injection and careful
attention should be paid to inject accurate volume.
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Gla