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Dysport 300 IU 1 Vial
€85
Each 300 Unit vial of DYSPORT® is to be reconstituted with 2.5 mL of preservative-free 0.9% Sodium Chloride Injection USP prior to injection. The concentration of the resulting solution will be 10 Units per 0.08 mL (12 Units per 0.1 mL) to be delivered in five equally divided aliquots of 0.08 mL each.
Description
ATC classification
Substance; botulinum toxin type A
Excipients
Presentation
Cip: 3400957764906
Storage conditions: Before opening: 2° < t < 8° for 24 months (Keep in the refrigerator, do not freeze)
After opening: 2° < t < 8° for 24 hours (Keep in the refrigerator)
PRESCRIPTION/DISPENSING/COVERAGE |
LIST I
| Reserved for hospital use. | |
| AMM | 3400957764906 (2010, RCP rev 22.06.2022) 300 U Speywood. |
| 3400955810599 (1993, RCP rev 22.06.2022) 500 U Speywood. | |
| Collected and supported under the list in addition to SMR establishments in the indications: | |
| Adult: | |
|
|
| Children from 2 years old: | |
|
| Price and liability rate (excluding VAT) per UCD: | |
| UCD 3400893602089 (300 U Speywood): 159,900 euros. | |
| UCD 3400891669664 (500 U Speywood): 266,500 euros. | |
FORMS and PRESENTATIONS |
Powder for solution for injection (SC, IM): Vials, unit boxes.
COMPOSITION |
| per bottle | ||
| Botulinum toxin type A (toxin-hemagglutinin complex BoTX-A) | 300 or 500 U Speywood | |
Excipients (common): 20% human albumin solution, lactose monohydrate.
Dysport Speywood units are preparation specific and are not interchangeable with other botulinum toxin preparations.
INDICATIONS |
- Adult:
-
- Blepharospasm.
- Hemifacial spasm.
- Spasmodic torticollis.
- Local symptomatic treatment of spasticity (muscle hyperactivity) of the upper and/or lower limbs.
- Treatment of urinary incontinence in adults with neurological detrusor overactivity due to spinal cord injury (traumatic or non-traumatic) or multiple sclerosis, who regularly perform clean intermittent catheterization.
- Children from 2 years old:
-
- Local symptomatic treatment of spasticity of the upper and/or lower limbs.
- Local symptomatic treatment of spasticity of the upper and/or lower limbs.
WARNINGS AND PRECAUTIONS FOR USE |
The concentration of the reconstituted Dysport solution is expressed in Speywood Units.
Given the lack of harmonization of unit systems for the various commercially available botulinum toxins, extreme caution should be exercised if it becomes necessary to switch from one pharmaceutical company’s botulinum toxin to another pharmaceutical company’s botulinum toxin.
Adverse reactions related to the spread of the toxin away from the administration site have been reported ( see Adverse reactions ). Patients treated at therapeutic doses may experience excessive muscle weakness. The risk of such adverse reactions can be reduced by using the lowest effective dose and not exceeding the maximum recommended dose.
Very rare cases of death sometimes following dysphagia, pneumonia (including but not limited to: dyspnea, respiratory failure, respiratory arrest) and/or in patients with significant asthenia have been reported after treatment with botulinum toxin type A or B.
Dysport should be administered with caution to patients with a history of swallowing or respiratory disorders because diffusion of the toxin into the involved muscles may aggravate these disorders. Aspiration pneumonitis has been observed in rare cases and represents a risk in patients with chronic respiratory disorders.
Dysport should only be used with caution and under close medical supervision in patients with clinical or subclinical marked impairment of neuromuscular transmission (e.g., myasthenia gravis). These patients may have an increased sensitivity to products such as Dysport, which may lead to excessive muscle weakness.
The existence of a history of neurogenic facial damage (facial paralysis, polyradiculoneuritis) requires, during the first injection, the use of doses equal to a quarter of the recommended dose ( see Dosage and Method of Administration ).
Patients with blepharospasm may have been sedentary for a very long time. Therefore, during treatment with botulinum toxin, it is necessary to advise them to resume activity gradually.
Decreased blinking due to injection of botulinum toxin into the orbicularis oculi muscle can lead to prolonged corneal exposure, persistent epithelial damage, and corneal ulceration, especially in patients with facial paralysis. In this case, preventive and curative measures should be taken.
Cases of dry eye have been reported with the use of Dysport in the periocular areas ( see Adverse Reactions ). It is important to pay particular attention to this adverse effect because dry eye may predispose to corneal disorders. Protective drops, ointments, occlusion of the eye with a bandage, or other means may be necessary to prevent corneal disorders.
As with any intramuscular injection, Dysport should only be injected if strictly necessary, in patients with prolonged bleeding times or infection/inflammation at the injection site.
In case of atrophy of the targeted muscle, special precautions should be taken. Cases of muscle atrophy have been reported after the use of botulinum toxin ( see Adverse reactions ).
Autonomic dysreflexia associated with the treatment procedure for neurological detrusor overactivity may occur.This product contains a small amount of human albumin. The risk of transmission of viral infection cannot be completely excluded after use of human blood or blood derivatives.
Antibodies to botulinum toxin have been rarely observed in patients treated with Dysport. Clinically, neutralizing antibodies are suspected if there is a decreased response to treatment and/or a need for continued dose increases.
Pediatric population:
In dynamic equinus foot deformity in children with cerebral palsy, an initial precise functional assessment must be carried out in a specialized environment. It allows:
- to assess the relevance of the indication:
- predominant spasticity;
- absence of muscle weakness sometimes masked by hypertonia. This weakness could be aggravated by an injection of botulinum toxin;
- absence of significant fixed retraction or post-surgical scar making botulinum toxin injection unnecessary;
- to determine the different components of the treatment (physiotherapy, wearing splints, etc.);
- to adapt the treatment according to clinical development.
. In general, the dose used in these cases was higher than that recommended ( see Adverse Reactions ).
Treatment of pediatric patients with severe neurological impairment, dysphagia, or a history of aspiration pneumonia or lung disease requires extreme caution.\
FERTILITY/PREGNANCY/BREASTFEEDING |
Pregnancy:
Animal studies have not shown direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development, except at very high doses that are toxic to the mother ( see Preclinical safety ). Dysport 300 IU 1 Vial
DRIVING AND USING MACHINES |
The risks of muscle weakness and vision disturbances may, if they occur, temporarily impair the ability to drive vehicles and operate machinery.
OVERDOSE |
Excessive doses can cause profound neuromuscular paralysis at a later stage.
Overdose may increase the risk of the neurotoxin entering the bloodstream and may lead to complications associated with botulinum syndrome (e.g., dysphagia and dysphonia). Respiratory resuscitation may be necessary if excessive doses cause paralysis of the respiratory muscles.
Symptoms of overdose may not necessarily occur immediately after injection.
PRECLINICAL SAFETY |
Intramuscular administration (striated muscles)
In a chronic toxicity study in rats (up to 12 U/animal), no systemic toxicity was observed. Reproductive toxicity studies in pregnant rats and rabbits administered daily intramuscular injections of Clostridium botulinum hemagglutinin-toxin A complex at doses of 79 U/kg and 42 U/kg, respectively, did not result in embryo-fetal toxicity. In rats, the observed decrease in male and female fertility was due to the decrease in the number of matings due to muscle paralysis secondary to the administration of high doses. Dysport 300 IU 1 Vial
In a juvenile toxicity study, rats treated weekly from weaning to postnatal day 21 and up to week 13 , used as an animal model of children from 2 years of age to young adults (11 administrations over 10 weeks, up to a total dose of approximately 33 U/kg) did not show adverse effects on postnatal growth (including skeletal) and development of reproductive, neurological and neurobehavioral functions.
STORAGE CONDITIONS |
- Retention period:
- 2 years.. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Store in the refrigerator (between +2°C and +8°C).
Do not freeze.
HANDLING/DISPOSAL TERMS |
- Product preparation:
-
- To reconstitute Dysport, use 0.9% sodium chloride injection.
- Draw up an amount of solvent suitable for the desired dilution into a syringe of suitable size.
- After cleaning the central part of the rubber stopper with alcohol, slowly introduce this solvent into the bottle at room temperature and mix gently to dissolve the contents, avoiding the formation of bubbles that could denature the product.
- This gives a clear reconstituted solution at the desired concentration, expressed in Speywood units.
- Speywood units are specific to Dysport and are not interchangeable with other medicines containing botulinum toxin.
- Instructions for reconstitution are specific to each strength of Dysport. Dilution volumes correspond to concentrations that are specific to each indication, except in the case of urinary incontinence in adults with neurological detrusor overactivity for which specific instructions apply (see below).
Concentration in Speywood units per ml (after reconstitution) Volume of injectable solution NaCl 0.9% * to be added per vial Dysport 300 Units Dysport 500 Units 500 Units/ml 0.6 ml 1 ml 200 Units/ml 1.5 ml 2.5 ml 100 Units/ml 3 ml 5 ml * Sterile, preservative-free at 9 mg/mL sodium chloride.
- Dilution instructions for urinary incontinence due to neurological detrusor overactivity:
The preparation provides the required volume of 15 mL of reconstituted Dysport injection divided equally into two 10 mL syringes. Each syringe contains 7.5 mL of reconstituted Dysport at the same concentration.- Dilution instructions for 300 U vials
- For a 600 U dose : Reconstitute two vials of 300 U each with 1.5 mL of 0.9% (9 mg/mL) preservative-free sodium chloride injection. Withdraw the entire 1.5 mL from the first vial into the first 10 mL syringe and withdraw the entire 1.5 mL from the second vial into the second 10 mL syringe. Complete the reconstitution by adding 6.0 mL of 0.9% (9 mg/mL) preservative-free sodium chloride injection to both syringes and mix gently.
This produces two 10 mL syringes, each containing 7.5 mL, corresponding to a total of 600 U of reconstituted Dysport. - For a dose of 800 U : Reconstitute three vials of 300 U each with 1.5 mL of preservative-free 0.9% (9 mg/mL) sodium chloride injection. In the first 10 mL syringe, withdraw the entire 1.5 mL from the first vial and 0.5 mL from the second vial. In the second 10 mL syringe, withdraw 0.5 mL from the second vial and the entire 1.5 mL from the third vial. Complete the reconstitution by adding 5.5 mL of preservative-free 0.9% (9 mg/mL) sodium chloride injection to both syringes and mix gently.
This produces two 10 mL syringes, each containing 7.5 mL, corresponding to a total of 800 U of reconstituted Dysport.
- For a 600 U dose : Reconstitute two vials of 300 U each with 1.5 mL of 0.9% (9 mg/mL) preservative-free sodium chloride injection. Withdraw the entire 1.5 mL from the first vial into the first 10 mL syringe and withdraw the entire 1.5 mL from the second vial into the second 10 mL syringe. Complete the reconstitution by adding 6.0 mL of 0.9% (9 mg/mL) preservative-free sodium chloride injection to both syringes and mix gently.
- Dilution instructions for 500 U vials
- For a 600 U dose : Reconstitute two vials of 500 U each with 2.5 mL of 0.9% (9 mg/mL) preservative-free sodium chloride injection. In the first 10 mL syringe, withdraw 1.5 mL from the first vial and in the second 10 mL syringe, withdraw 1.5 mL from the second vial. Complete the reconstitution by adding 6 mL of 0.9% (9 mg/mL) preservative-free sodium chloride injection to both syringes and mix gently. This produces two 10 mL syringes, each containing 7.5 mL, corresponding to a total of 600 U of reconstituted Dysport.
- For a dose of 800 U : Reconstitute two vials of 500 U each with 2.5 mL of preservative-free 0.9% (9 mg/mL) sodium chloride injection. In the first 10 mL syringe, withdraw 2 mL from the first vial and in the second 10 mL syringe, withdraw 2 mL from the second vial. Complete the reconstitution by adding 5.5 mL of preservative-free 0.9% (9 mg/mL) sodium chloride injection to both syringes and mix gently.
This produces two 10 mL syringes, each containing 7.5 mL, corresponding to a total of 800 U of reconstituted Dysport.
- Dilution instructions using a combination of 500 U and 300 U vials (only applicable for the 800 U dose)
- For an 800 U dose : Reconstitute the 500 U vial with 2.5 mL of preservative-free 0.9% (9 mg/mL) sodium chloride injection and the 300 U vial with 1.5 mL of preservative-free 0.9% (9 mg/mL) sodium chloride injection. In the first 10 mL syringe, withdraw 2 mL from the 500 U vial. In the second 10 mL syringe, withdraw the remaining 0.5 mL from the 500 U vial and the entire 1.5 mL from the 300 U vial. Complete the reconstitution by adding 5.5 mL of preservative-free 0.9% (9 mg/mL) sodium chloride injection to both syringes and mix gently. This produces two 10 mL syringes, each containing 7.5 mL, corresponding to a total of 800 U of reconstituted Dysport. Dysport 300 IU 1 Vial
- Dilution instructions for 300 U vials
- Recommendations in the event of an incident when handling botulinum toxin:
- Each vial corresponds to a dose less than 1/200th of the lethal parenteral dose in humans.
- Botulinum toxin is very sensitive to heat and certain chemical agents.
- either with absorbent material soaked in a sodium hypochlorite solution (bleach) in the case of a freeze-dried product;
- either with dry absorbent material in the case of a reconstituted product.
- In case of bottle breakage, proceed as indicated above and carefully collect the glass particles and wipe off the product, avoiding skin cuts.
- In case of skin splash, wash with a sodium hypochlorite solution (bleach) then rinse thoroughly with water.
- In case of eye splash, rinse thoroughly with water or eye wash solution.
- In the event of injury to the operator (cut, self-prick), proceed as above and take appropriate medical measures depending on the dose injected. Dysport 300 IU 1 Vial
- Botulinum toxin is very sensitive to heat and certain chemical agents.
PRESCRIPTION/DISPENSING/COVERAGE |
LIST I
| Reserved for hospital use. | |
| AMM | 3400957764906 (2010, RCP rev 22.06.2022) 300 U Speywood. |
| 3400955810599 (1993, RCP rev 22.06.2022) 500 U Speywood. | |
| Collected and supported under the list in addition to SMR establishments in the indications: | |
| Adult: | |
|
|
| Children from 2 years old: | |
|
| Price and liability rate (excluding VAT) per UCD: | |
| UCD 3400893602089 (300 U Speywood): 159,900 euros. | |
| UCD 3400891669664 (500 U Speywood): 266,500 euros. | |
