BOCOUTURE BTX

Due to unit differences in the potency assay, unit doses for BOCOUTURE are not interchangeable with those for other preparations of Botulinum toxin type A.

4.1 Therapeutic indications

BOCOUTURE is indicated for the temporary improvement in the appearance of upper facial lines in adults below 65 years when the severity of these lines has an important psychological impact for the patient:

• moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar frown lines) and/or

• moderate to severe lateral periorbital lines seen at maximum smile (crow's feet lines) and/or

• moderate to severe horizontal forehead lines seen at maximum contraction

4.2 Posology and method of administration

Due to unit differences in the potency assay, unit doses for BOCOUTURE are not interchangeable with those for other preparations of Botulinum toxin type A.

For detailed information regarding clinical studies with BOCOUTURE in comparison to conventional Botulinum toxin type A complex (900 kD), see section 5.1.

General

BOCOUTURE should only be administered by an appropriately qualified healthcare practitioner with expertise in the treatment of the relevant indication and the use of the required equipment, in accordance with national guidelines

Posology

Vertical Lines between the Eyebrows seen at maximum frown (Glabellar Frown Lines)

After reconstitution of BOCOUTURE a dose of 4 units is injected into each of the 5 injection sites: two injections in each corrugator muscle and one injection in the procerus muscle, which corresponds to a standard dose of 20 units. The dose may be increased by the physician to up to 30 units if required by the individual needs of the patients, with at least '3-months' interval between treatments.

An improvement in the vertical lines between the eyebrows seen at maximum frown (glabellar frown lines) generally takes place within 2 to 3 days with the maximum effect observed on day 30. The effect lasts up to 4 months after the injection.

Lateral Periorbital Lines seen at maximum smile (Crow's Feet Lines)

After reconstitution of BOCOUTURE 4 units are injected bilaterally into each of the 3 injection sites. One injection is placed approximately 1 cm lateral from the bony orbital rim. The other two injections each should be placed approximately 1 cm above and below the area of the first injection.

The total recommended standard dose per treatment is 12 units per side (overall total dose: 24 units).

An improvement in lateral periorbital lines seen at maximum smile (crow's feet lines) mostly takes place within the first 6 days with the maximum effect observed on day 30. The effect lasts up to 4 months after the injection.

Horizontal Forehead Lines seen at maximum contraction

The recommended total dose range is 10 to 20 units according to the individual needs of the patients, with at least '3-months' interval between treatments. After reconstitution of BOCOUTURE a total dose of 10 to 20 units is injected into the frontalis muscle in five horizontally aligned injection sites at least 2 cm above the orbital rim. Per injection point, 2 units, 3 units or 4 units are applied, respectively.

An improvement in the horizontal forehead lines seen at maximum contraction usually occurs within 7 days with the maximum effect observed on day 30. The effect lasts up to 4 months after the injection.

All indications

If no treatment effect occurs within one month after the initial injection, the following measures should be taken:

• Analysis of the reasons for non-response, e.g. too low dose, poor injection technique, possible development of neurotoxin-neutralising antibodies

• Dose adjustment with regard to the analysis of the most recent therapy failure

• Review of Botulinum neurotoxin type A treatment as an adequate therapy

• If no adverse reactions have occurred during the initial treatment, an additional course of treatment can be performed in compliance with the minimum interval of 3 months between the initial and repeat treatment.

Special populations

There are limited clinical data from phase 3 studies of BOCOUTURE in patients over 65 years of age. Until further data are available in this age group, BOCOUTURE is not recommended for use in patients over 65 years of age.

Paediatric population

The safety and efficacy of BOCOUTURE for the treatment of vertical lines between the eyebrows seen at maximum frown, lateral periorbital lines seen at maximum smile and horizontal forehead lines seen at maximum contraction has not been studied in children and adolescents younger than 18 years. BOCOUTURE is thus not recommended in the paediatric population.

Method of administration

All indications

Reconstituted BOCOUTURE is intended for intramuscular injection.

After reconstitution, BOCOUTURE should be used immediately and may only be used for one treatment per patient.

Reconstituted BOCOUTURE is injected using a thin sterile needle (e.g. 30-33 gauge/0.20-0.30 mm diameter/13 mm length needle). An injection volume of approximately 0.04 to 0.1 ml per injection site is recommended.

For instructions on reconstitution of the medicinal product before administration and for instructions on disposal of the vials, see section 6.6.

The intervals between treatments should not be shorter than 3 months. If the treatment fails, or the effect lessens with repeated injections, alternative treatment methods should be used.

Vertical Lines between the Eyebrows seen at maximum frown (Glabellar Frown Lines)

Before and during the injection, the thumb or index finger should be used to apply firm pressure below the edge of the eye socket in order to prevent diffusion of the solution in this region.

Superior and medial alignment of the needle should be maintained during the injection. To reduce the risk of blepharoptosis, injections near the levator palpebrae superioris and into the cranial portion of the orbicularis oculi should be avoided. Injections into the corrugator muscle should be done in the medial portion of the muscle, and in the central portion of the muscle belly at least 1 cm above the bony edge of the eye socket.

Lateral Periorbital Lines seen at maximum smile (Crow's FeetLines)

The injection should be done intramuscularly into the orbicularis oculi muscle, directly under the dermis to avoid diffusion of BOCOUTURE. Injections too close to the zygomaticus major muscle should be avoided to prevent lip ptosis.

Horizontal Forehead Lines seen at maximum contraction

Paralyzing of lower muscle fibers by injecting BOCOUTURE near the orbital rim should be avoided to reduce the risk of brow ptosis.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert- Eaton syndrome).

• Infection or inflammation at the proposed injection site.

4.4 Special warnings and precautions for use

General

Prior to administering BOCOUTURE, the physician must familiarise himself/herself with the patient's anatomy and any alterations to the anatomy due to prior surgical procedures.

Care should be taken to ensure that BOCOUTURE is not injected into a blood vessel.

It should be taken into consideration that horizontal forehead lines may not only be dynamic, but may also result from the loss of dermal elasticity (e.g. associated with aging or photodamage). In this case, patients may not respond to Botulinum toxin products.

BOCOUTURE should be used with caution:

• if bleeding disorders of any type exist

• in patients receiving anticoagulant therapy or other substances that could have an anticoagulant effect.

Local and distant spread of toxin effect

Undesirable effects may occur from misplaced injections of Botulinum neurotoxin type A that temporarily paralyse nearby muscle groups.

There have been reports of undesirable effects that might be related to the spread of Botulinum toxin type A to sites distant from the injection site (see section 4.8).

Patients treated with therapeutic doses may experience excessive muscle weakness.

Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders occur.

Pre-existing Neuromuscular Disorders

The injection of BOCOUTURE is not recommended for patients with a history of aspiration or dysphagia.

BOCOUTURE should be used with caution:

• in patients suffering from amyotrophic lateral sclerosis

• in patients with other diseases which result in peripheral neuromuscular dysfunction

• in targeted muscles which display pronounced weakness or atrophy

Hypersensitivity reactions

Hypersensitivity reactions have been reported with Botulinum neurotoxin type A products. If serious (e.g. anaphylactic reactions) and/or immediate hypersensitivity reactions occur, appropriate medical therapy should be instituted.

Antibody formation

Too frequent doses may increase the risk of antibody formation, which can result in treatment failure (see section 4.2).

The potential for antibody formation may be minimised by injecting with the lowest effective dose given at the indicated minimum intervals between injections.

4.5 Interaction with other medicinal products and other forms of interaction

No drug interaction studies have been performed.

Theoretically, the effect of Botulinum neurotoxin may be potentiated by aminoglycoside antibiotics or other medicinal products that interfere with neuromuscular transmission e.g. tubocurarine-type muscle relaxants.

Therefore, the concomitant use Buy bocouture with aminoglycosides or spectinomycin requires special care. Peripheral muscle relaxants should be used with caution, if necessary reducing the starting dose of relaxant, or using an intermediate- acting substance such as vecuronium or atracurium rather than substances with longer lasting effects.

4-Aminoquinolines may reduce the effect of BOCOUTURE.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of Botulinum neurotoxin type A in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Therefore, BOCOUTURE should not be used during pregnancy unless clearly necessary and unless the potential benefit justifies the risk.

Breast-feeding

It is unknown whether Botulinum neurotoxin type A is excreted into breast milk. Therefore, BOCOUTURE should not be used during breast-feeding.

Fertility

There are no clinical data from the use of Botulinum neurotoxin type A. No adverse effects on male or female fertility were detected in rabbits (see section 5.3).

4.7 Effects on ability to drive and use machines

BOCOUTURE has a minor or moderate influence on the ability to drive and use machines. Patients should be counselled that if asthenia, muscle weakness, dizziness, vision disorders or drooping eyelids occur, they should avoid driving or engaging in other potentially hazardous activities.

4.8 Undesirable effects

Usually, undesirable effects are observed within the first week after treatment and are temporary in nature. Undesirable effects may be related to the active substance, the injection procedure, or both.

Undesirable effects independent from indication

Application related undesirable effects

Localised pain, inflammation, paraesthesia, hypoaesthesia, tenderness, swelling, oedema, erythema, itching, localised infection, haematoma, bleeding and/or bruising may be associated with the injection.

Needle related pain and/or anxiety may result in vasovagal responses, including transient symptomatic hypotension, nausea, tinnitus and syncope.

Undesirable effects of the substance class Botulinum toxin type A

Localised muscle weakness is one expected pharmacological effect of Botulinum toxin type A. Blepharoptosis, which can be caused by injection technique, is associated with the pharmacological effect of if you Buy bocouture online.

Toxin spread

When treating other indications with Botulinum toxins, undesirable effects related to spread of toxin distant from the site of administration have been reported very rarely to produce symptoms consistent with Botulinum toxin type A effects (excessive muscle weakness, dysphagia, and aspiration pneumonia with a fatal outcome in some cases) (see section 4.4). Undesirable effects such as these cannot be completely ruled out with the use of BOCOUTURE.

Hypersensitivity reactions

Serious and/or immediate hypersensitivity reactions including anaphylaxis, serum sickness, urticaria, soft tissue oedema, and dyspnoea have been rarely reported. Some of these reactions have been reported following the use of conventional Botulinum toxin type A complex either alone or in combination with other agents known to cause similar reactions.


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