Minirin

Package Leaflet: Information for the Patient

Minirin, 4 micrograms/ml, Solution for Injection

Desmopressin Acetate

Read All of This Leaflet Carefully Before Using 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. Do Not Pass It on to Others. It May Harm Them, Even if Their Symptoms Are the Same as Yours.
• If You Experience Any Side Effects, Tell Your Doctor or Pharmacist. See Section 4.

Contents of the Pack:

• 1. What Minirin Is and What It Is Used For
• 2. Important Information Before You Use 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 Hormone Produced by the Pituitary Gland - Arginine Vasopressin.
Minirin Solution for Injection Is Used:

• to Treat Central Diabetes Insipidus
• to Test the Ability of the Kidneys to Concentrate Urine
• to Ensure Haemostasis in Minor Surgical Procedures and Before Invasive Diagnostic Procedures in Patients with Mild Haemophilia A and Mild von Willebrand's Disease. In Exceptional Cases, the Medicine May Be Used in Patients with Moderate von Willebrand's Disease.

2. Important Information Before You Use Minirin

When Not to Use Minirin

• if You Are Allergic to Desmopressin or Any of the Other Ingredients of This Medicine (Listed in Section 6),
• if You Have Habitual or Psychogenic Polydipsia (with a Urine Output Exceeding 40 ml/kg/24 Hours),
• if You Have Unstable Angina, Recognised or Suspected Heart Failure, or Other Conditions Requiring Treatment with Diuretics,
• if You Have Hyponatraemia, i.e. Low Sodium Levels in the Blood,
• if You Have the Syndrome of Inappropriate Antidiuretic Hormone Secretion
• if You Have von Willebrand's Disease Type II B.

Warnings and Precautions

Before Starting Treatment with Minirin, Discuss It with Your Doctor.
Treatment Without Concurrent Reduction of Fluid Intake May Lead to Fluid Retention and (or) Hyponatraemia with or Without Symptoms.
Additionally, Regarding the Test of the Ability of the Kidneys to Concentrate Urine:
Fluid Intake Must Be Limited to a Maximum of 0.5 Litres to Quench Thirst, from 1 Hour Before Administration to 8 Hours After Administration.
The Test of the Ability of the Kidneys to Concentrate Urine in Children Under 1 Year of Age Should Only Be Performed in a Hospital Under Close Medical Supervision.
Additionally, Regarding the Indications Related to Ensuring Haemostasis:
Patients Requiring Treatment with Diuretics Should Be Subjected to Close Monitoring to Prevent Fluid Overload.
Particular Attention Should Be Paid to the Risk of Excessive Water Retention and Hyponatraemia.
Fluid Intake Should Be Limited to the Minimum Necessary and the Patient's Body Weight Should Be Monitored Regularly.
In Case of a Gradual Increase in the Patient's Body Weight, Decrease in Sodium Levels in the Blood to Below 130 mmol/l or Decrease in Osmolality of the Serum to Below 270 mOsm/kg Body Weight, Fluid Intake Should Be Drastically Limited and Administration of the Medicine Should Be Stopped.
Minirin Does Not Shorten the Prolonged Bleeding Time in Patients with Thrombocytopenia.
Precautions:
Before Starting Treatment for Central Diabetes Insipidus, Severe Disorders of Bladder Function and Obstruction of the Urinary Tract Should Be Ruled Out.
Caution Should Be Exercised in Patients with a Risk of Increased Intracranial Pressure.
In Children, the Elderly, and Patients with Sodium Levels in the Blood at the Lower Limit of Normal, There Is a Greater Risk of Hyponatraemia.
Particular Attention Should Be Paid When Desmopressin Is Administered in Combination with Other Medicines That Affect Water and Electrolyte Balance. In Patients Treated Long-Term with Other Medicines That Affect Water and Electrolyte Balance, Minirin Should Only Be Administered After Confirmation of Normal Sodium Levels.
Caution Should Be Exercised in Patients with Moderate and Severe Renal Impairment (Creatinine Clearance Below 50 ml/min.).
Due to Reports of Deep Vein Thrombosis, Stroke, Cerebrovascular Disorders (Stroke), Cerebral Thrombosis, Myocardial Infarction, Angina Pectoris, and Chest Pain After the Marketing Authorisation of Minirin Solution for Injection, These Should Be Considered Before Administering Minirin Solution for Injection to Elderly Patients and Patients with Risk Factors for Thrombosis, a History of Thrombosis, Thrombophilia, and Cardiovascular Disease.
If Acute Illnesses with Water and Electrolyte Imbalance (Such as Generalised Infections, Febrile Diseases, Gastroenteritis) or Excessive Bleeding Occur During Treatment, Treatment Should Be Discontinued or Carefully Adjusted and Water and Electrolyte Balance Should Be Closely Monitored.

Minirin and Other Medicines

Some Medicines May Affect the Action of Minirin.
Tell Your Doctor About All Medicines You Are Currently Taking or Have Recently Taken, as Well as Any Medicines You Plan to Take.
In Particular, Inform Your Doctor If You Are Taking:

• Opioids,
• Tricyclic Antidepressants,
• Selective Serotonin Reuptake Inhibitors,
• Chlorpromazine,
• Carbamazepine,
• Non-Steroidal Anti-Inflammatory Drugs,
• Antidiabetic Medicines from the Sulphonylurea Group. The Above Medicines May Lead to Excessive Water Retention or Hyponatraemia.

Pregnancy and Breast-Feeding

If You Are Pregnant or Breast-Feeding, Think You May Be Pregnant or Are Planning to Have a Baby, Ask Your Doctor for Advice Before Taking This Medicine.
Desmopressin Passes into Breast Milk.

Driving and Using Machines

Minirin Does Not Affect the Ability to Drive and Use Machines.

Minirin Contains Sodium

This Medicine Contains Less Than 1 mmol (23 mg) of Sodium per Dose, i.e. the Medicine Is Considered to Be "Sodium-Free".

3. How to Use Minirin

This Medicine Should Always Be Used Exactly as Prescribed by Your Doctor. If You Are Not Sure, Ask Your Doctor.
Using Minirin for the Treatment of Central Diabetes Insipidus:
Minirin Solution for Injection Is Administered When the Oral or Intranasal Form of the Medicine Cannot Be Used. The Dose Is Determined Individually for Each Patient After Assessing the Effect of the Medicine on Diuresis and Urine Osmolality.
Usually, the Dose Is 1 to 4 Micrograms (0.25-1 ml) Once a Day or in Two Divided Doses.
Using Minirin for the Test of the Ability of the Kidneys to Concentrate Urine
A Single Dose of 4 Micrograms (1 ml) Is Recommended for the Test of the Ability of the Kidneys to Concentrate Urine, Administered Intramuscularly or Subcutaneously. Urine Excreted in the First Hour After Administration of Minirin Is Excluded from the Test. Over the Next 8 Hours, Two Urine Samples Should Be Collected and Their Osmolality Measured. Fluid Intake Should Be Limited.
Using Minirin to Ensure Haemostasis
A Dose of 0.3 Micrograms/kg Body Weight Is Administered Subcutaneously or Diluted in 50-100 ml of 0.9% Sodium Chloride Solution by 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 Administration of the Dose May Result in a Weaker Therapeutic Effect.
If Intravenous Infusion of Minirin Does Not Lead to the Expected Increase in Factor VIII C Activity in the Serum, Treatment May Be Supplemented with Factor VIII Concentrate Infusion.
Monitoring During Treatment
During Treatment with Minirin, Factor VIII C Activity Should Be Regularly Monitored.
During Treatment with Minirin, Blood Pressure Should Be Monitored.
Using Minirin for the Treatment of Central Diabetes Insipidus:
Children Over 1 Year:0.1 to 1 Microgram (0.025-0.25 ml) Once a Day or in Two Divided Doses.
Children Under 1 Year:Experience with the Use of Minirin in Children Under 1 Year of Age Is Limited; Case Reports Suggest That the Initial Dose Should Be 0.05 Micrograms (0.0125 ml), and Subsequent Doses Should Be Determined Based on the Size of Diuresis and Electrolyte Levels.
Using Minirin for the Test of the Ability of the Kidneys to Concentrate Urine
Children Over 1 Year:1 to 2 Micrograms (0.25-0.5 ml) as a Single Dose
Children Under 1 Year:0.4 Micrograms (0.1 ml) as a Single Dose
In Children, Minirin Is Mainly Recommended for the Test of the Ability of the Kidneys to Concentrate Urine in the Form of Intranasal Administration. Urine Excreted in the First Hour After Administration of Minirin Is Excluded from the Test. Over the Next 8 Hours, Two Urine Samples Should Be Collected and Their Osmolality Measured. Fluid Intake Should Be Limited.
Using Minirin to Ensure Haemostasis
As in Adults
Minirin Is Usually Administered Intravenously, but If Necessary, It Can Also Be Administered Intramuscularly or Subcutaneously.

Using a Higher Dose of Minirin Than Recommended

Overdose of Minirin May Lead to Water Retention and Hyponatraemia.
Treatment of Hyponatraemia Should Be Individual. In General, It Is Recommended to Discontinue the Medicine, Limit Fluid Intake, and Treat Symptoms If Necessary.

Missing a Dose of Minirin

Do Not Take a Double Dose to Make Up for a Forgotten Dose.

Stopping Treatment with Minirin

If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.
The Following Common Side EffectsMay Occur in Less Than 1 in 10 Patients:
Headache
Tachycardia
Flushing
Hypotension
Abdominal Pain
Nausea
Fatigue
Dizziness
Hyponatraemia
In Addition to the Above, the Following Side EffectsHave Been Observed After the Marketing Authorisation of Minirin, Whose Frequency Is Unknown:
Hypersensitivity Reactions, Including Anaphylactic Reaction and Other Severe Allergic Conditions
Water Intoxication
Weight Gain
Confusional State
Coma
Loss of Consciousness
Hyponatraemic Encephalopathy
Cerebral Oedema
Seizures
Myocardial Infarction
Angina Pectoris
Chest Pain
Deep Vein Thrombosis
Cerebrovascular Incident (Stroke)
Cerebral Thrombosis
Hypertension
Dyspnoea
Pulmonary Embolism
Vomiting
Maculopapular Rash, Erythematous Rash, Papular Rash, Rash
Urticaria
Flushing
Pruritus
Generalised or Localised Oedema (Peripheral, Facial)
Reactions at the Injection/Infusion Site, Including Pruritus, Pain, Erythema, Flushing, and Induration
Chills
Malaise
Treatment with Desmopressin Without Concurrent Reduction of Fluid Intake May Lead to Excessive Water Retention or Hyponatraemia, Which May Manifest as Headache, Nausea, Vomiting, Decreased Sodium Levels in the Blood, Weight Gain, or, in Severe Cases, Seizures.

Reporting Side Effects

If You Experience Any Side Effects, Including Any Not Listed in This Leaflet, Tell Your Doctor. Side Effects Can Be Reported Directly to the Department of Drug Safety Monitoring 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: ndl@urpl.gov.pl.
Side Effects Can Also Be Reported to the Marketing Authorisation Holder.
Reporting Side Effects Will Help to Obtain More Information on the Safety of This Medicine.

5. How to Store Minirin

Keep This Medicine Out of the 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 on the Label of the Ampoule After the Word EXP. The Expiry Date Refers to the Last Day of the Month
Medicines Should Not Be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medicines No Longer Required. This Will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Minirin Contains

• The Active Substance Is Desmopressin Acetate
• The Other Ingredients 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 Solution for Injection 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 More Detailed Information, Please Contact the Representative of the Marketing Authorisation Holder.
Ferring Pharmaceuticals Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw
Tel.: +48 22 246 06 80, Fax: +48 22 246 06 81

Date of Last Revision of the Leaflet: