국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Desmopressin acetate
Ferring Pharmaceuticals Ltd
H01BA02
Desmopressin acetate
25microgram
Oral lyophilisate
Sublingual
No Controlled Drug Status
Valid as a prescribable product
BNF: 06050200; GTIN: 05015919790015
PACKAGE LEAFLET: INFORMATION FOR THE USER 25 MICROGRAMS ORAL LYOPHILISATE 50 MICROGRAMS ORAL LYOPHILISATE Desmopressin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Noqdirna is and what it is used for 2. What you need to know before you take Noqdirna 3. How to take Noqdirna 4. Possible side effects 5. How to store Noqdirna 6. Contents of the pack and other information 1. WHAT NOQDIRNA IS AND WHAT IT IS USED FOR Noqdirna contains desmopressin, an antidiuretic, which reduces urine production. Noqdirna is used for the treatment of nocturia (frequent need to get up to urinate at night) due to nocturnal polyuria (overproduction of urine during night) in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOQDIRNA DO NOT TAKE NOQDIRNA: - if you are allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6) - if you suffer from polydipsia (excessive thirst and increased fluid intake) or psychogenic polydipsia (psychologically caused increased thirst and increased fluid intake) - if you have known or suspected cardiac insufficiency (heart failure in which the heart is not able to pump enough blood throughout the body) - if you have any disease requiring treatment with diuretics - if you have moderately or severely reduced kidney function - if you have or have had hyponatraemia (low sodium level in the blood) - if you have SIADH (hormone secretion disorder) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Noqdirna. It is especially important tha 전체 문서 읽기
OBJECT 1 NOQDIRNA 25MCG ORAL LYOPHILISATE Summary of Product Characteristics Updated 01-Nov-2016 | Ferring Pharmaceuticals Ltd 1. Name of the medicinal product Noqdirna 25 microgram oral lyophilisate 2. Qualitative and quantitative composition Each oral lyophilisate contains desmopressin acetate equivalent to 25 micrograms desmopressin. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral lyophilisate. White, round, oral lyophilisate of approximately 12 mm marked with 25 on one side. 4. Clinical particulars 4.1 Therapeutic indications Noqdirna is indicated for symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults (see section 5.1). 4.2 Posology and method of administration Posology • Women: 25 microgram daily, one hour before bedtime, administered sublingually without water. • Men: 50 microgram daily, one hour before bedtime, administered sublingually without water. A dose increase with this product is not recommended in elderly patients ≥ 65 years. If higher doses are considered for patients under the age of 65 years in case of an insufficient response to Noqdirna, other desmopressin oral lyophilisate products should be used (see sections 4.4, 4.8 and 5.1) In the event of signs or symptoms of water retention and/or hyponatremia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted and reassessed. When restarting treatment strict fluid restriction should be enforced and serum sodium levels monitored (see section 4.4). Noqdirna should be discontinued if the serum sodium level falls below the lower limit of normal range (i.e.135 mmol/L) Special Populations _Elderly patients (65 years of age and older)_ Elderly patients are at increased risk of developing hyponatraemia with desmopressin treatment and may also have impaired renal function. Caution should therefore be exercised in this age group and daily doses above 25 microgram for females and 50 microgram for males should not be used. In elderly patients 전체 문서 읽기