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1. NAME OF THE MEDICINAL PRODUCT
Synacthen® Ampoules 250mcg
2. Qualitative and Quantitative Composition
Tetracosactide acetate PhEur 250micrograms per ampoule.
For a full list of excipients, see section 6.1.
4.3 Contraindications
History of hypersensitivity to Adrenocorticotropic hormone (ACTH), Synacthen or Synacthen Depot. Synacthen is contra-indicated in patients with allergic disorders (e.g. asthma) (see Section 4.4 Special warnings and special precautions for use), acute psychosis, infectious diseases, peptic ulcer, refractory heart failure, Cushing’s syndrome, and primary adrenocortical insufficiency.
Synacthen Ampoules should not be used during pregnancy or lactation unless there are compelling reasons to do so.
4.4 Special warnings and special precautions for use
Synacthen Ampoules should not be used in the presence of active infectious or systemic diseases, when the use of live vaccine is contemplated or in the presence of a reduced immune response, unless adequate disease specific therapy is being given.
Use with care in patients with hypertension and thromboembolic tendencies.
The increased production of adrenal steroids may result in corticosteroid type effects:
· Psychological disturbances may be triggered or aggravated.
· Latent infections (e.g. amoebiasis, tuberculosis) may become activated.
· Ocular effects may be produced (e.g. glaucoma, cataracts).
· Dosage adjustments may be necessary in patients being treated for diabetes or hypertension.
4.5 Interaction with other medicinal products and other forms of Interaction
Since Synacthen increases the adrenocortical production of glucocorticoids and mineralocorticoids, drug interactions of the type seen with these corticosteroids may occur (see Section 4.4 Special warnings and special precautions for use). Patients already receiving medication for diabetes mellitus or for moderate to severe hypertension must have their dosage adjusted if treatment with Synacthen is started.
Synacthen contains an active substance that may interfere with routine drug testing in athletes.
4.6 Fertility, pregnancy and lactation
Usage in pregnancy: There is limited amount of data in the use of tetracosactide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see Section 5.3 Preclinical safety data). Usage in pregnancy is contraindicated (see Section 4.3 Contraindications).Therefore the Synacthen test should not be utilised during pregnancy and lactation unless there are compelling reasons for doing so.
Usage in lactation: It is not known whether tetracosactide enters breast milk or not. Usage in lactation is contraindicated (see Section 4.3 Contraindications).
Fertility: Animal studies are insufficient with respect to reproductive toxicity (see Section 5.3 Preclinical safety data).
4.8 Undesirable effects
Synacthen may provoke hypersensitivity reactions. In patients suffering from, or susceptible to, allergic disorders (especially asthma) this may take the form of anaphylactic shock (see Section 4.3 “Contra-indications”).
Hypersensitivity may be manifested as skin reactions at the injection site, dizziness, nausea, vomiting, urticaria, pruritus, flushing, malaise, dyspnoea, angioneurotic oedema and Quinke's oedema.
The undesirable effects related to glucocorticoid and mineralocorticoid effects are unlikely to be observed with short-term use of Synacthen as a diagnostic tool, but may be reported when Synacthen is used in therapeutic indications. Should information be required on the side effects reported with therapeutic use of tetracosactide acetate, see Synacthen Depot Summary of Product Characteristics.
Adverse reactions in Table 1 are ranked under heading of frequency where known, the most frequent first, using the following convention: very common (greater than or equal to 1 in 10); common (less than or equal to 1 in 100, less than 1 in 10); uncommon (greater than or equal to 1 in 1,000, less than 1 in 100); rare (greater than or less than 1 in 10,000, less than 1 in 1,000) very rare (less than 1 in 10,000), not known (where no valid estimate of the incidence has been derived).
Table 1. Adverse events
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Infections and infestations
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Not known
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Increased susceptibility to infection, abscess
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Blood and the lymphatic system disorders
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Not known
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Leukocytosis
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Immune system disorders
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Not Known
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Anaphylactic shock, skin reactions at the injection site, urticaria, angioneurotic oedema, Quinke's oedema
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Endocrine disorders
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Not known
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Menstruation irregular, Cushings’s syndrome, secondary adrenocortical and pituitary unresponsiveness. Decreased carbohydrate tolerance, hyperglycaemia, manifestations of latent diabetes mellitus, hirsutism1)
Adrenal haemorrhage.
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Metabolism and nutrition disorders
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Not known
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Increased appetite, hypokalaemia, calcium deficiency, sodium retention, fluid retention
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Psychiatric disorders
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Not known
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Mental disorder2)
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Nervous system disorders
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Not known
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Headache, vertigo, convulsions, dizziness
Benign intracranial pressure with papilloedema, usually after treatment
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Eye disorders
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Not known
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Posterior sub capsular cataracts, increased intraocular pressure, glaucoma, exophthalmoses
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Cardiac disorders
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Not known
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Cardiac failure congestive, blood pressure increase
Dyspnoea
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Vascular disorders
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Not known
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Thromboembolism, necrotising vasculitis
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Gastrointestinal disorders
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Not known
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Peptic ulcer with possible perforation and haemorrhage, pancreatitis, abdominal distension, oesophagitis ulcerative
Nausea, vomiting
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Skin and subcutaneous tissue disorders
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Not known
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Skin atrophy, petechiae and ecchymosis, erythema, hyperhidrosis, acne and skin hyper pigmentation, pruritus, urticaria
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Musculoskeletal, connective tissue and bone disorders
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Not known
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Osteoporosis, muscular weakness, myopathy steroid, loss of muscle mass, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathological fracture of long bones, tendon rupture
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General disorders and administration site conditions
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Not known
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Hypersensitivity reactions2) , weight increased, impaired healing, growth retardation in children, flushing, malaise
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Investigations
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Not known
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Negative nitrogen balance due to protein catabolism, suppression of skin test reactions
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1) Particularly in times of stress, e.g. after trauma, surgery, or illness
2) Also see section 4.4
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anterior pituitary lobe hormones and analogues – ACTH.
ATC code: H01AA02.
6.6 Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
10. DATE OF REVISION OF THE TEXT
04 January 2011
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