Nuceiva · 4.6 Fertility, pregnancy and lactation · 1

HOS-098467 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Serious adverse reactions that may occur following treatment with this medicine include eyelid ptosis, an immune response, distant spread of toxin, development or exacerbation of a neuromuscular disorder, and hypersensitivity reactions. The most commonly reported adverse reactions during treatment are headache, occurring in 9% of patients, followed by eyelid ptosis, occurring in 1% of patients. Tabulated list of adverse reactions Table 1 The NUCEIVA related adverse reactions are classified by System Organ Class and frequency defined as follows: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000). 5 System organ class Preferred term Frequency Infections and infestations Upper respiratory tract infection Rare Psychiatric disorders Depression Rare Nervous system disorders Headache Common Dizziness, migraine, muscle tone Uncommon disorder, speech disorder Dysaesthesia, head discomfort, Rare hypoaesthesia, paraesthesia, sensory disturbance Eye disorders Eyelid ptosis Common Asthopenia, blepharospasm, Uncommon brow ptosis, eyelid oedema, eye swelling, vision blurred Diplopia, dry eye, eyelid Rare sensory disorder Ear and labyrinth Vertigo Rare disorders Vascular disorders Flushing Rare Respiratory, thoracic and Epistaxis Rare mediastinal disorders Gastrointestinal disorders Diarrhea Rare Skin and subcutaneous Pruritis Uncommon tissue disorders Dermal cyst, erythema, Rare photosensitivity reaction, skin mass, skin tightness Musculoskeletal and

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HOS-098463 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3 Generalised disorders of muscle activity (e.g. myasthenia gravis or Eaton Lambert Syndrome) Infection or inflammation at the proposed injection sites.

HOS-098462 · has-indication-information · PDF-Seite 2

NUCEIVA is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.

HOS-098465 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. Theoretically, the effect of botulinum toxin may be potentiated by aminoglycoside antibiotics, spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. neuromuscular blocking medicinal products). The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

HOS-098466 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no adequate data from the use of botulinum toxin type A in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). This medicine is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast-feeding There is no information on whether botulinum toxin type A is excreted in human breast milk. This medicine should not be used during breast-feeding. Fertility The effect of this medicine on human fertility is unknown. However, another botulinum toxin type A has been shown to impair the fertility of male and female animals.

HOS-098464 · has-warning-information · PDF-Seite 4

General The anatomy and anatomical land marks of procerus corrugator supercilli muscles and the surrounding vasucular and nervous structures in the glabellar region must be understood prior to administration of this medicine. Injection into vulnerable anatomical structures, such as nerves and blood vessels, must be avoided. Localised pain, inflammation, paraesthesia, hypoaesthesia, tenderness, swelling/oedema, erythema, localised infection, bleeding and/or bruising have been associated with the injection. Needle-related pain and/or anxiety have resulted in vasovagal responses, including transient symptomatic hypotension and syncope. Caution should be taken when the targeted muscle shows pronouced weakness or atrophy. Care should be taken to ensure that this medicine is not injected into a blood vessel when it is injected in the glabellar lines seen at maximum frown (see section 4.2). There is a risk of eyelid ptosis following treatment (see section 4.2). Caution should be taken if complications have resulted with previous botulinum toxin injections. Bleeding disorders Caution should be exercised when this medicine is used in patients with bleeding disorders as injection may lead to bruising. Local and distant spread of toxin effect Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin (see section 4.8). Swallowing and breathing difficulties are serious and can result in death. Injection of this medicine is not recommended in patients with a history of dysphagia and aspiration. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise. Pre-existing neuromuscular disorders Patients with unrecognised neuromuscular disorders may be at increased risk of clinically significant systemic effects, including severe dysphagia and respiratory compromise from typical doses of botulinum toxin type A. In some of these cases, dysphagia has lasted several months and required placement of a gastric feeding tube (see section 4.3). Caution should also be exercised when botulinum toxin type A is used for treatment of patients with amyotrophic lateral sclerosis or with peripheral neuromuscular disorders. Hypersensitivity reactions An anaphylactic reaction may occur very rarely after injection of botulinum toxin. Epinephrine (adrenaline) or any other anti-anaphylactic measures should therefore be availa

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