SUPRECUR Nasal spray solution (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Suprecur 150 micrograms Nasal Spray Solution.
2. Qualitative and quantitative composition
Suprecur nasal spray contains 150 micrograms buserelin, as buserelin acetate, in one spray dose. 150 micrograms buserelin is equivalent to 157.5 micrograms buserelin acetate. For full list of excipients, ...
3. Pharmaceutical form
Nasal Spray Solution. The preparation is a clear solution.
4.1. Therapeutic indications
The treatment of endometriosis in cases that do not require surgery as primary therapy. Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins.
4.2. Posology and method of administration
Endometriosis The total daily dose is 900 micrograms buserelin, administered as one spray dose in each nostril in the morning, at mid-day and in the evening. The product may be used before or after meals ...
4.3. Contraindications
Buserelin should not be used if the tumour is found to be insensitive to hormone manipulation, after surgical removal of the testes or in cases of undiagnosed vaginal bleeding. It is contraindicated in ...
4.4. Special warnings and precautions for use
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as Buserelin. Patients should be informed accordingly and treated as appropriate ...
4.5. Interaction with other medicinal products and other forms of interaction
During treatment with buserelin, the effect of antidiabetic agents may be attenuated. In concomitant treatment with sexual hormones (add back), the dosage is to be selected so as to ensure that the overall ...
4.6. Pregnancy and lactation
Suprecur is contraindicated in pregnancy and lactation. In rats, fetal malformations have been seen after very high doses. Buserelin passes into breast milk in small amounts. Although negative effects ...
4.7. Effects on ability to drive and use machines
Certain adverse effects (e.g. dizziness) may impair the patients ability to concentrate and react, and therefore, constitute a risk in those situations where these abilities are of special importance (e.g. ...
4.8. Undesirable effects
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated ...
4.9. Overdose
Overdose may lead to signs and symptoms such as asthenia, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, oedema of the lower extremities and mastodynia. Treatment should be symptomatic. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Hormones and Related Agents <b>ATC Code:</b> L02AE01 Buserelin is a synthetic peptide. It is a superactive analogue of natural gonadotrophin releasing hormone (gonadorelin, ...
5.2. Pharmacokinetic properties
The intra-nasal absorption rate of buserelin is about 3%. Metabolic inactivation by peptides occurs in the liver and kidney. The drug is also inactivated by pituitary membrane enzymes. After intra-nasal ...
5.3. Preclinical safety data
None of clinical relevance.
6.1. List of excipients
The nasal spray also contains citric acid, sodium citrate, sodium chloride and benzalkonium chloride in aqueous solution.
6.2. Incompatibilities
None.
6.3. Shelf life
3 years. 5 weeks after first opening.
6.4. Special precautions for storage
Store between 2 and 25°C. Do not freeze
6.5. Nature and contents of container
Cartons containing two bottles and two metered-dose pumps (nebulisers). Each bottle contains l0g solution.
6.6. Special precautions for disposal and other handling
How to use the spray bottle: Remove screw cap from bottle. Remove metered-dose nebulizer from transparent plastic container and take off both protective caps. Screw nebulizer on to bottle. Before first ...
7. Marketing authorization holder
Neon Healthcare Limited, Mill Studio Business Centre, Crane Mead, Ware, Hertfordshire, SG12 9PY, United Kingdom
8. Marketing authorization number(s)
PL 45043/0049
9. Date of first authorization / renewal of the authorization
Date of first Authorisation: 23 April 2002 Date of latest Renewal: 20 January 2005
10. Date of revision of the text
01/12/2020
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