Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
Clostridium Botulinum neurotoxin type A (150 kDa), free from complexing proteins
MERZ ASIA PACIFIC PTE. LTD.
M03AX01
50 LD50 units
INJECTION, POWDER, FOR SOLUTION
Clostridium Botulinum neurotoxin type A (150 kDa), free from complexing proteins 50 LD50 units
INTRAMUSCULAR
Prescription Only
Merz Pharma GmbH & Co. KGaA
ACTIVE
2014-08-12
1 1. NAME OF THE MEDICINAL PRODUCT XEOMIN powder for solution for injection 50 LD 50 units XEOMIN powder for solution for injection 100 LD 50 units 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 50 or 100 LD 50 units* of Clostridium Botulinum neurotoxin type A (150kD), free from complexing proteins, human albumin, sucrose. * One unit corresponds to the median lethal dose (LD 50 ) when the reconstituted product is injected intraperitoneally into mice under defined conditions. 3. PHARMACEUTICAL FORM Powder for solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XEOMIN is indicated for the symptomatic treatment of blepharospasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis) and of post-stroke spasticity of the upper limb in adults. XEOMIN is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown (glabellar frown lines) in adults below 65 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Due to unit differences in the potency assay, unit doses recommended for XEOMIN are not interchangeable with those for other preparations of Botulinum toxin. Comparative clinical study results suggest that XEOMIN and the comparator product containing conventional Botulinum toxin type A complex (900 kD) are of equal potency when used in a dose conversion ratio of 1:1. XEOMIN may only be administered by health care professionals. XEOMIN is reconstituted prior to use with sodium chloride 9 mg/ml (0.9%) solution for injection. It is good practice to perform vial reconstitution and syringe preparation over plastic-lined paper towels to catch any spillage. An appropriate amoun Baca dokumen lengkap
1. NAME OF THE MEDICINAL PRODUCT XEOMIN powder for solution for injection 50 units XEOMIN powder for solution for injection 100 units 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 50 or 100 units of Clostridium Botulinum neurotoxin type A (150kD), free from complexing proteins* * Botulinum neurotoxin type A, purified from cultures of Clostridium Botulinum (Hall strain) 3. PHARMACEUTICAL FORM Powder for solution for injection 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XEOMIN is indicated in adults for the treatment of: Cervical dystonia (spasmodic torticollis) Blepharospasm Spasticity of the upper limb XEOMIN is indicated for the temporary improvement in the appearance of moderate to severe Upper facial lines o Glabellar frown lines o Lateral periorbital lines (crow’s feet lines) o Horizontal forehead lines in adults below 65 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 METHOD OF ADMINISTRATION Due to unit differences in the potency assay, unit doses recommended for XEOMIN are not interchangeable with those for other preparations of Botulinum toxin. XEOMIN may only be administered by health care professionals with suitable qualifications and proven experience in the application of Botulinum neurotoxin type A. XEOMIN is reconstituted prior to use with sodium chloride 9 mg/ml (0.9%) solution for injection. It is good practice to perform vial reconstitution and syringe preparation over plastic-lined paper towels to catch any spillage. An appropriate amount of solvent is drawn up into a syringe. A 20-27 G short bevel needle is recommended for reconstitution. After vertical insertion of the needle through the rubber stopper the solvent is injected gently into the vial in order to avoid foam formation. The vial must be discarded if the vacuum does not pull the solvent into the vial. Remove the syringe from the vial and mix XEOMIN with the solvent by carefully swirling and inverting/flipping the vial – do not shake vigorously. If needed, the needle used for re Baca dokumen lengkap