Minirin

Patient Information Leaflet

Minirin, 4 micrograms/ml, injection solution
Desmopressini acetas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms appear identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Minirin is and what it is used for
2. Important information before using Minirin
3. How to use Minirin
4. Possible side effects
5. How to store Minirin
6. Contents of the pack and other information

1. What Minirin is and what it is used for

Minirin contains desmopressin, which acts similarly to the natural pituitary hormone –
arginine vasopressin.
Minirin injection solution is used:

• for the treatment of central diabetes insipidus
• for assessing kidney concentrating capacity
• to achieve haemostasis during minor surgical procedures and prior to invasive diagnostic procedures in patients with mild haemophilia A and mild von Willebrand disease. In exceptional cases, the medicine may be used in patients with moderate von Willebrand disease.

2. Important information before using Minirin

When not to use Minirin

• if the patient is allergic to desmopressin or any of the other ingredients of this medicine (listed in section 6),
• if the patient has habitual or psychogenic polydipsia (with urine output exceeding 40 ml/kg/24 hours),
• if the patient has unstable angina pectoris, diagnosed or suspected cardiac failure, or another condition requiring treatment with diuretics,
• if the patient has hyponatremia, i.e. low sodium concentration in blood serum,
• if the patient has syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• if the patient has von Willebrand's disease type II B.

Warnings and precautions
Before starting treatment with Minirin, discuss it with your doctor.
Treatment without simultaneously reducing fluid intake may lead to fluid retention and/or hyponatremia, with or without symptoms.
Additionally, regarding the kidney concentration test:
Fluid intake must be limited to a maximum of 0.5 litres to quench thirst, from 1 hour before administration of the medicine until 8 hours after administration.
The kidney concentration test in children under 1 year of age should be performed exclusively in hospital under strict medical supervision.
Additionally, regarding indications related to achieving hemostasis:
Patients requiring treatment with diuretics should be carefully monitored to prevent fluid overload.
Special attention should be paid to the risk of excessive water retention and hyponatremia.
Fluid intake should be restricted to the absolute minimum and the patient's body weight should be monitored regularly.
If there is a gradual increase in body weight, a decrease in serum sodium concentration below 130 mmol/l, or a decrease in plasma osmolality below 270 mOsm/kg body weight, fluid intake should be drastically reduced and administration of the medicine discontinued.
Minirin does not shorten the prolonged bleeding time in patients with thrombocytopenia.
Precautions:
Before starting treatment of central diabetes insipidus, severe bladder dysfunction and infravesical obstruction should be ruled out.
Caution should be exercised in patients in whom there is a risk of increased intracranial pressure.
In children, elderly patients, and patients with serum sodium concentration at the lower limit of normal, there is an increased risk of hyponatremia.
Particular attention should be paid when desmopressin is administered concomitantly with other medicines affecting water-electrolyte balance. In patients receiving long-term treatment with other medicines affecting water-electrolyte balance, Minirin should be administered only after confirmation of normal sodium concentration.
Caution is advised in patients with moderate and severe renal impairment (creatinine clearance below 50 ml/min).
Due to reported cases of deep vein thrombosis, stroke, cerebrovascular disorders (stroke), cerebral thrombosis, myocardial infarction, angina pectoris, and chest pain following administration of Minirin injection solution, these should be considered before using Minirin injection solution in elderly patients and in patients with risk factors for thrombosis, history of thrombosis, thrombophilia, and cardiovascular disease.
If acute illnesses with water-electrolyte disturbances (such as systemic infection, febrile illnesses, or gastroenteritis) or excessive bleeding occur during treatment, therapy should be discontinued or carefully adjusted, and water-electrolyte balance should be closely monitored.

Minirin and other medicines
Some medicines may affect the action of Minirin.
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

• opioids,
• tricyclic antidepressants,
• selective serotonin reuptake inhibitors (SSRIs),
• chlorpromazine,
• carbamazepine,
• non-steroidal anti-inflammatory drugs (NSAIDs),
• antidiabetic sulfonylurea agents.
  The above-mentioned medicines may lead to excessive water retention or hyponatremia.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
Desmopressin passes into breast milk.

Driving and operating machinery
Minirin has no influence on the ability to drive or operate machinery.

Minirin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning this medicine is considered "sodium-free".

3. How to use Minirin

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor.

Use of Minirin in the treatment of central diabetes insipidus:

Minirin injection solution is administered when oral or intranasal formulations cannot be used. The dose is individually adjusted for each patient based on the effect of the drug on diuresis and urine osmolality.

The usual dose is 1 to 4 micrograms (0.25–1 ml) once daily or divided into two doses.

Use of Minirin in testing renal urine concentrating ability:

For testing renal urine concentrating ability, the following single dose is recommended, administered intramuscularly or subcutaneously: 4 micrograms (1 ml).

Urine voided during the first hour after administration of Minirin should be excluded from the test. During the following 8 hours, two urine samples should be collected and their osmolality measured. Fluid intake should be restricted.

Use of Minirin to achieve hemostasis:

A dose of 0.3 microgram/kg body weight is administered subcutaneously or diluted in 50–100 ml of 0.9% sodium chloride solution as an intravenous infusion over 15–30 minutes.

If a positive effect is achieved, the dose may be repeated 1 or 2 times at intervals of 6–12 hours. Further repeated dosing may result in reduced therapeutic effect.

If intravenous infusion of Minirin does not produce the expected increase in plasma factor VIII C activity, treatment may be supplemented by transfusion of factor VIII concentrate.

Monitoring during treatment:

During treatment with Minirin, factor VIII C activity should be monitored regularly.

Blood pressure should also be monitored during treatment with Minirin.

Use of Minirin in the treatment of central diabetes insipidus:

Children over 1 year: 0.1 to 1 microgram (0.025–0.25 ml) once daily or divided into two doses.

Children under 1 year: Experience with use in children under 1 year of age is limited; case reports suggest that the initial dose should be 0.05 microgram (0.0125 ml), with subsequent doses adjusted according to diuresis and electrolyte levels.

Use of Minirin in testing renal urine concentrating ability:

Children over 1 year: 1 to 2 micrograms (0.25–0.5 ml) as a single dose.

Children under 1 year: 0.4 microgram (0.1 ml) as a single dose.

In children, Minirin nasal formulation is generally recommended for testing renal urine concentrating ability.

Urine voided during the first hour after administration of Minirin should be excluded from the test. During the following 8 hours, two urine samples should be collected and their osmolality measured. Fluid intake should be restricted.

Use of Minirin to achieve hemostasis:

As in adults.

The drug is usually administered intravenously, but if necessary, may also be given intramuscularly or subcutaneously.

Use of a higher than recommended dose of Minirin:

Overdose of Minirin may lead to water retention and hyponatremia.

Treatment of hyponatremia should be individualized. In general, discontinuation of the drug, restriction of fluid intake, and symptomatic treatment if necessary are recommended.

Missed dose of Minirin:

Do not use a double dose to make up for a missed dose.

Discontinuation of Minirin:

If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following common adverse reactions may occur in up to 1 in 10 patients:
headache
tachycardia
flushing with redness
hypotension
abdominal pain
nausea
feeling of fatigue
dizziness
hyponatremia

In addition to the above, the following adverse reactions, for which the frequency is unknown, have been observed after marketing authorization:
hypersensitivity reactions, including anaphylactic reaction and other severe allergic conditions
water intoxication
weight gain
confusion
coma
loss of consciousness
hyponatremic encephalopathy
brain edema
seizures
myocardial infarction
angina pectoris
chest pain
deep vein thrombosis
cerebrovascular incident and cerebrovascular disorder (stroke)
cerebral vessel thrombosis
hypertension
dyspnea
pulmonary embolism
vomiting
maculopapular rash, erythematous rash, macular rash, rash
urticaria
erythema
itching
generalized or local edema (peripheral, facial)
reactions at the injection/infusion site, including itching, pain, pallor, erythema, bruising,
and nodules
chills
malaise

Treatment with desmopressin without concomitant fluid restriction may lead to excessive water retention or hyponatremia, which may manifest as headache, nausea, vomiting, decreased serum sodium concentration, weight gain, or, in severe cases, seizures.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Minirin

Keep this medicine out of sight and reach of children.
Store in a refrigerator (2 °C - 8 °C).
Do not use this medicine after the expiry date stated on the carton and vial label after the word EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Minirin contains

• The active substance is desmopressin acetate
• The other components are: sodium chloride, hydrochloric acid to adjust pH, water for injections

What Minirin looks like and contents of the pack
Minirin is a clear, colourless injection solution in 1 ml ampoules. Each pack contains 10 ampoules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturer:
Ferring GmbH, Wittland 11, P.O. Box 2145, 24109 Kiel, Germany

For further information, please contact the Marketing Authorisation Holder.
Ferring Pharmaceuticals Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81