Active ingredients: Desmopressin
Minirin / DDAVP 0.1 mg / ml nasal drops, solution
Minirin package inserts are available for pack sizes:- Minirin / DDAVP 0.1 mg / ml nasal drops, solution
- Minirin / DDAVP 50 mcg / ml nasal spray, solution
- Minirin / DDAVP 60 mcg sublingual tablets
Indications Why is Minirin used? What is it for?
Minirin / DDAVP belongs to a group of medicines called vasopressin analogues, which temporarily reduce the amount of urine your body makes.
It is indicated, only when oral administration is not possible, for:
- treatment of pituitary, idiopathic or symptomatic diabetes insipidus (a disease that causes continuous urine production and intense thirst)
- treatment of post-surgical, reversible or permanent polyuria (abundant urine production) and polydipsia (intense and persistent thirst)
- primary nocturnal enuresis (involuntary loss of urine during the night)
- differential diagnosis of diabetes insipidus
- kidney function tests.
Contraindications When Minirin should not be used
There are general restrictions, warnings and precautions that apply to all patients who are prescribed Minirin / DDAVP and other restrictions, warnings and additional precautions that apply under certain conditions and which depend on the use of the medicine.
General restrictions (all patients):
Do not use Minirin / DDAVP
- if you are hypersensitive (allergic) to the active substance or to any of the other ingredients of this medicine
- if you suffer from habitual or psychogenic polydipsia (intense and persistent thirst)
- if you have known or suspected heart failure and other conditions that require treatment with diuretic drugs (drugs that increase urine production)
- if you have moderate or severe kidney failure
- if you suffer from low levels of sodium in the blood (hyponatremia)
- if you suffer from syndrome of inadequate secretion of ADH (antidiuretic hormone, which reduces the production of urine).
Precautions for use What you need to know before taking Minirin
General warnings and precautions (all patients)
Minirin / DDAVP should only be used in patients in whom administration of oral pharmaceutical forms is not possible.
Take special care to avoid low blood sodium levels if any of the following apply to you:
- if you have lower than normal serum sodium levels
- if you suffer from diseases characterized by an imbalance of fluids and electrolytes (for example calcium, magnesium), such as systemic infections, fever, gastroenteritis
- if you suffer from asthma, epilepsy, migraine, heart failure, arterial hypertension (high blood pressure)
- if you have cystic fibrosis
- if you are a patient at risk of increased intracranial pressure (a condition of which you will be informed by your doctor)
- if you are being treated with tricyclic antidepressant medicines or selective serotonin reuptake inhibitors, chlorpromazine (antipsychotic) and carbamazepine (antiepileptic), or with some antidiabetics of the sulphonylurea group, in particular chlorpropamide and non-steroidal anti-inflammatory drugs (NSAIDs) as they may increase "antidiuretic effect (decrease in the amount of urine) and increase the risk of fluid retention (see section" Taking Minirin / DDAVP with other medicines ").
Additional warnings and precautions:
Beyond the restrictions, warnings and general precautions:
Conditions you need to pay particular attention to
All patients should adhere to the restriction of fluid intake during treatment with this medicine.
Ingestion of liquids without limitation can cause fluid retention and low levels of sodium in the blood, symptoms of which are headache, nausea / vomiting, weight gain and, in severe cases, seizures.
If these symptoms occur, contact your doctor urgently
All patients and, if applicable, their guardians should be thoroughly educated about fluid reduction.
In the treatment of primary nocturnal enuresis:
- Fluid consumption should be limited to a minimum from 1 hour before to 8 hours after drug administration
If you are using Minirin / DDAVP for kidney function tests:
- the consumption of liquids should be limited to a minimum and only to satisfy thirst, it should not exceed 0.5 l from 1 hour before until 8 hours after the administration of the drug.
In infants
the intake of liquids with the two meals after administration of Minirin / DDAVP must be reduced by 50% compared to the usual intake, in order to avoid water overload.
If you have changes in the nasal mucosa caused by scarring, fluid accumulation (edema) or other conditions, the use of Minirin / DDAVP is not recommended.
Before starting treatment, your doctor will assess any severe bladder dysfunction and obstruction.
- If you have any of the above conditions or if you are not sure, talk to your doctor or pharmacist before using Minirin / DDAVP.
Use in children
Administration to children should be under close adult supervision in order to control the dose taken
In children under 1 year of age, renal function tests should only be performed in a hospital setting, under medical supervision.
Interactions Which drugs or foods may change the effect of Minirin
Tell your doctor if you are taking, have recently taken or might take any other medicines, even those obtained without a prescription.
There are medicines which may alter the effect of Minirin / DDAVP or whose effect may be altered by Minirin / DDAVP:
- Indomethacin an anti-inflammatory which may increase the extent but not the duration of the response to desmopressin.
- Tricyclic antidepressants or selective serotonin reuptake inhibitors (antidepressants), chlorpromazine (antipsychotic) and carbamazepine (antiepileptic), chlorfibrate (lipid-lowering) and as well as some antidiabetic drugs of the sulfonylurea group, particularly chlorpromazine (anti-inflammatory drugs), and anti-inflammatory drugs (NSAIDs) as these medicines may increase the antidiuretic effect of desmopressin (decrease in the amount of urine) and thus increase the risk of water retention and decreased sodium in the blood (hyponatremia)
- Glibenclamide (antidiabetic) which instead reduces the antidiuretic effect of desmopressin.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Normally this medicine has no or negligible influence on the ability to drive or use machines.
For those who carry out sporting activities
The use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dosage and method of use How to use Minirin: Dosage
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The plastic graduated tube included in the package (rhinyl) has a graduated scale corresponding to 2.5 mcg, 5 mcg, 10 mcg, 15 mcg and 20 mcg of desmopressin acetate. Treatment should always be started at the lowest dose. Your doctor will decide on the appropriate dosage and duration of treatment.
Fluid intake should be limited (see section "Warnings and precautions"). It is recommended that you empty your bladder just before administering the drug.
The recommended doses are:
Therapeutic use:
- Diabetes insipidus, post-surgical polyuria and polydipsia
Adults: 0.1 - 0.2 ml (10 - 20 mcg) once - twice a day
Children: 0.05 - 0.1 ml (5 - 10 mcg) once - twice a day
- Primary nocturnal enuresis
The recommended starting intranasal dose is 0.1 ml (10 mcg) in the evening, before bedtime. If this is not effective, the dose can be increased to a maximum of 0.2 ml (20 mcg) for a minimum duration of one week.
Minirin / DDAVP is indicated for treatment periods of up to 3 months. The need for following a period of at least one week without Minirin / DDAVP. The clinically effective intranasal dose should be individualized and can range from 0.1 ml (10 mcg) to 0.2 ml (20 mcg) in the evening, before bedtime.
Diagnostic use:
Differential Diagnosis of Diabetes Insipidus
- Children and adults: 0.2 ml (20 mcg)
Kidney function tests
Infants (up to 1 year of age): 0.1ml (10mcg)
Children (1 - 15 years): 0.2 ml (20 mcg)
Adults: 0.4 ml (40 mcg).
Urine collected within one hour of administering Minirin / DDAVP should be discarded. Over the next 8 hours, two portions of urine should be collected for osmolality testing.
Instructions for Use
Before using Minirin / DDAVP please read the following instructions carefully. The administration of Minirin / DDAVP is carried out through a special graduated plastic tube (rhinyl).
- Tear off the guarantee seal.
- Remove the brown plastic cap.
- Remove the small knurled cap from the dropper by rotating it. To close the dropper, use the same cap and reapply it so as to prevent loss of solution, especially if the bottle is not stored in an upright position.
- Hold the rhino with one hand, placing the fingers of the other hand around the dropper neck. Insert the tip of the dropper, angled down, into the end of the rhino marked with an arrow and press the dropper until the solution reaches If you have difficulty filling the rhinyl, you can use an insulin or tuberculin type syringe to withdraw the desired dose and then transfer the contents into the rhinyl.
- Hold with your fingers, about 2 cm from the end, the part of the rhinyl containing the solution, inserting this end into one nostril until the tip of the fingers reaches the nostril.
- Insert the other end of the rhinyl between the lips. Tilt the head back and then blow briefly and intensely into the rhinyl so that the solution penetrates the nasal cavity. If this procedure is followed, the solution stops in the nasal cavity and does not penetrate the back of the throat.
- After use, close the dropper with the knurled cap and then the brown plastic cap. Wash the rhinyl with tap water and then shake it carefully to avoid traces of it remaining inside. The rhinile is thus ready for subsequent applications. Always store the bottle upright.
If you are unsure whether you are taking the correct dose of the product, do not administer the drug until your next scheduled dose.
Overdose What to do if you have taken too much Minirin
If you take more Minirin / DDAVP than you should
In case of ingestion / intake of an excessive dose of Minirin / DDAVP notify your doctor immediately or go to the nearest hospital.
If you forget to take Minirin / DDAVP
Do not take a double dose to make up for a forgotten dose.
If you stop taking Minirin / DDAVP
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Minirin
Like all medicines, Minirin / DDAVP can cause side effects, although not everybody gets them.
The following are the side effects that may occur with the use of this medicine:
Very common (occurs in more than 1 in 10 people)
- Nasal congestion, rhinitis
- Increased body temperature
Common (occurs in less than 1 in 10 people)
- Insomnia, emotional lability, nightmares, nervousness, aggression
- Headache
- Nosebleed (epistaxis), upper respiratory tract infection
- Gastroenteritis, nausea, abdominal pain
Uncommon (occurs in less than 1 in 100 people)
- Low levels of sodium in the blood (hyponatremia)
- Menstrual-type uterine spasms
- Cardiac ischaemia (lack of or decreased blood supply to the heart)
- He retched
- Redness of the face
Not known (frequency cannot be estimated from the available data)
- Allergic reactions
- Dehydration
- Confusional state
- Convulsions, coma, dizziness, sleepiness
- Hypertension (high blood pressure)
- Dyspnea (difficulty breathing)
- Diarrhea
- Itching, rash, hives
- Muscle spasms
- Fatigue, peripheral edema (fluid accumulation), chest pain, chills
- Weight gain.
Description of selected adverse reactions:
The most serious adverse reaction with desmopressin is hyponatremia, and in severe cases its complications, eg. convulsions and coma. The cause of the potential hyponatremia is the anticipated antidiuretic effect (see section "Warnings and precautions").
Pediatric population:
Hyponatremia is reversible and has often occurred in children in connection with changes in habitual daily behavior involving fluid intake and / or sweating. In children, particular attention should be paid to the precautions indicated in paragraph 2 "Warnings and precautions".
Other special populations:
Children, the elderly and patients with serum sodium levels below normal may have an increased risk of developing hyponatremia (see section "Warnings and precautions").
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, including any possible side effects not listed in this leaflet, contact your doctor or pharmacist.
Undesirable effects can also be reported directly through the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Store in the refrigerator (between + 2 ° and + 8 ° C).
The product can be stored for 4 weeks at a temperature below 25 ° C in unopened packaging, after which it must be immediately discarded.
After opening, the product can be stored for 2 months in the refrigerator.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Keep this medicine out of the sight and reach of children.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Minirin / DDAVP nasal drops, solution contains
- The active ingredient is desmopressin. 1 ml contains 0.1 mg of desmopressin acetate equivalent to 89 mcg of desmopressin.
- The other ingredients are sodium chloride, chlorobutanol, 1M hydrochloric acid, purified water.
What Minirin / DDAVP nasal drops, solution and contents of the pack look like
0.1 mg / ml nasal drops solution - 2.5 ml nebulizer bottle with rhinyl for intranasal administration.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MINIRIN / DDAVP.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.1 mg of desmopressin acetate equivalent to 89 mcg of desmopressin.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Nasal drops, solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Therapeutic use
Pituitary, idiopathic or symptomatic diabetes insipidus.
Post-surgical, reversible or permanent polyuria and polydipsia.
Primary nocturnal enuresis.
N.B. Renal diabetes insipidus is not sensitive to treatment with Minirin / DDAVP.
Diagnostic use
For the differential diagnosis of diabetes insipidus.
For kidney function tests.
04.2 Posology and method of administration
Dosage
The rhinyl has a graduated scale corresponding to 2.5 mcg, 5 mcg, 10 mcg, 15 mcg and 20 mcg of desmopressin acetate.
Dosage in both diabetes insipidus and enuresis must be individualized on a case-by-case basis.
In post-surgical polyuria and polydipsia, the dose must be adjusted in relation to changes in urinary osmolality.
Method of administration
Fluid intake should be limited (see section 4.4).
In case of signs and symptoms of water retention and / or hyponatremia (headache, nausea / vomiting, weight gain and, in severe cases, seizures) treatment should be stopped until the patient is completely recovered. When restarting treatment, fluid intake should be limited as much as possible (see section 4.4).
Specific indications
Therapeutic use.
Diabetes insipidus, post-surgical polyuria and polydipsia
Adults
0.1 - 0.2 ml (10 - 20 mcg) once - twice a day.
Children
0.05 - 0.1 ml (5 - 10 mcg) once - twice a day.
Primary nocturnal enuresis
The recommended initial intranasal dose is 10 mcg in the evening, before bedtime. If this is not effective, the dose can be increased to a maximum of 20 micrograms for a minimum duration of one week. Minirin / DDAVP is indicated for treatment periods of up to 3 months. The need for continued treatment should be reassessed following a period of at least one week without Minirin / DDAVP.
The clinically effective intranasal dose should be individualized and may range from 10 to 20 micrograms in the evening, before bedtime.
Diagnostic use.
Differential Diagnosis of Diabetes Insipidus
The diagnostic dose in children and adults is 0.2 ml (20 mcg).
The inability to process concentrated urine after water deprivation, followed by the ability to process concentrated urine after administration of Minirin / DDAVP, confirms a diagnosis of pituitary diabetes insipidus.
The inability to process concentrated urine after administration of Minirin / DDAVP suggests nephrogenic diabetes insipidus.
Kidney function tests
The following doses are recommended:
Infants (up to 1 year of age)
0.1 ml (10 mcg);
children (1 - 15 years)
0.2 ml (20 mcg);
adults
0.4 ml (40 mcg).
Urine collected within one hour of administering Minirin / DDAVP should be discarded. Over the next 8 hours, two portions of urine should be collected for osmolality testing.
In the infants a urine concentration of 600 mOsm / kg should be achieved within 5 hours of administration of Minirin / DDAVP.
In the children and adults with normal renal function, urinary concentrations above 700 mOsm / kg can be expected within 5 - 9 hours following administration of Minirin / DDAVP.
It is recommended to empty the bladder immediately before administering the drug.
Special populations
Elderly: see section 4.4
Renal insufficiency: see section 4.3
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Habitual or psychogenic polydipsia (resulting in urine production greater than 40 ml / kg / 24 hours).
Known or suspected heart failure and other conditions requiring treatment with diuretic drugs.
Moderate or severe renal insufficiency (creatinine clearance less than 50 ml / min).
Known hyponatremia.
Inadequate ADH secretion syndrome (SIADH).
04.4 Special warnings and appropriate precautions for use
Special warnings
Minirin / DDVAP nasal drops, solution should only be used in patients in whom administration of oral pharmaceutical forms is not possible.
When Minirin / DDVAP nasal drops solution is prescribed, it is recommended to
• Start treatment at the lowest dose.
• Make sure you comply with the restriction on fluid intake.
• Increase the dose gradually, with caution.
• Ensure that administration to children is under adult supervision in order to control the dose taken.
For primary nocturnal enuresis:
when Minirin / DDAVP is used for primary nocturnal enuresis, fluid intake should be limited from 1 hour before administration of the product to 8 hours after administration.
Treatment without concomitant limitation of fluid ingestion may lead to fluid retention and / or hyponatremia accompanied or not by warning signs and symptoms (headache, nausea / vomiting, weight gain and, in severe cases, convulsions).
All patients and, if applicable, their guardians should be thoroughly educated about fluid reduction.
For kidney function tests:
when Minirin / DDAVP is used for diagnostic purposes, fluid intake should be limited and should not exceed 0.5 l to satisfy thirst from 1 hour before to 8 hours after drug administration.
In infants, the fluid intake with the two meals after administration of Minirin / DDAVP should be reduced by 50% compared to the usual intake, in order to avoid water overload.
The renal concentration capacity test in children under 1 year of age should only be performed in a hospital setting, under strict medical supervision.
Precautions
Severe bladder dysfunction and obstruction should be evaluated before starting treatment.
Children, the elderly and patients with lower than normal serum sodium levels may have an increased risk of hyponatremia. Desmopressin treatment should be discontinued or carefully adapted during acute intercurrent illnesses characterized by fluid and electrolyte imbalance (such as systemic infections, fever, gastroenteritis).
Any alterations of the nasal mucosa caused by scars, edema and other diseases, could give rise to an irregular, unstable absorption of the drug; in this case the use of the product is not recommended.
The product should be administered with caution to patients suffering from asthma, epilepsy, migraine, heart failure, arterial hypertension, conditions that could worsen due to water retention.
Equal caution should be adopted in patients with cystic fibrosis and in patients at risk for increased intracranial pressure.
In order to avoid hyponatremia, precautions should be taken including restriction of fluid intake and more frequent monitoring of serum sodium in case of concomitant treatment with drugs that can induce SIADH, eg tricyclic antidepressants, selective reuptake inhibitors serotonin, chlorpromazine and carbamazepine, and some antidiabetics of the sulfonylurea group, in particular chlorpropamide, and in case of concomitant treatment with NSAIDs.
Post-marketing data show some cases of severe hyponatremia associated with the nasal spray formulation of desmopressin when used in the treatment of central diabetes insipidus.
04.5 Interactions with other medicinal products and other forms of interaction
Indomethacin may increase the extent but not the duration of the response to desmopressin.
Substances known to induce SIADH, such as tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine, clofibrate, as well as some antidiabetic agents of the sulfonylurea group, in particular chlorpropamide, can cause an additive antidiuretic effect and increase the risk of fluid retention / hyponatremia (see section 4.4).
NSAIDs can cause fluid retention / hyponatremia (see section 4.4). Glibenclamide, on the other hand, reduces the antidiuretic effect of desmopressin.
Desmopressin is unlikely to interact with drugs affecting hepatic metabolism, as desmopressin has not been shown to have significant influence on hepatic metabolism in in vitro studies in human microsomes. However, in vivo interaction studies have not been performed.
04.6 Pregnancy and lactation
Pregnancy
Published data on a limited number of pregnant women with diabetes insipidus (n = 53) as well as data on pregnant women with bleeding complications (n = 216) did not indicate adverse effects of desmopressin on pregnancy or fetal / newborn health. So far, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryo-fetal development, parturition or postnatal development.
Use caution when prescribing to pregnant women.
There is a lack of female data regarding the transplacental transfer of desmopressin. In vitro analyzes of human cotyledon models showed that there is no transplacental transport of desmopressin when administered at therapeutic concentrations corresponding to the recommended dose.
Feeding time
The results of the analysis of the milk of nursing mothers treated with a high dose of desmopressin (300 mcg intranasally) indicate that the quantities of desmopressin that can be supplied with breast milk are considerably lower than those necessary to exert an effect on diuresis.
Fertility
Fertility studies in animals have not shown clinically relevant effects on the parents and offspring.
04.7 Effects on ability to drive and use machines
Minirin / DDAVP nasal drops, solution has no or negligible influence on the ability to drive or use machines.
04.8 Undesirable effects
The most serious adverse reaction with desmopressin is hyponatremia, which can cause headache, nausea, vomiting, decreased serum sodium, weight gain, malaise, abdominal pain, muscle cramps, dizziness, confusion, decreased consciousness and, in severe cases, convulsions and coma.
Most other events are reported as non-serious.
The most commonly reported adverse reactions during treatment are nasal congestion (27%), increased body temperature (15%) and rhinitis (12%). Other common adverse reactions are headache (9%), upper respiratory tract infections (9%), gastroenteritis (7%), abdominal pain (5%). No anaphylactic reactions were reported in clinical studies but spontaneous reports have been received.
The following table is based on the frequency of adverse drug reactions reported in clinical studies with the nasal formulations of Minirin / DDAVP conducted in children and adults for the treatment of central diabetes insipidus, primary nocturnal enuresis, and tests of renal function (N = 745 ), combined with post-marketing experience for all indications. Reactions noted only in post-marketing experience or with other formulations of desmopressin have been added to the "not known" frequency column.
* reported in association with hyponatremia
** mainly reported in children and adolescents
*** reported for the indication central diabetes insipidus.
Description of selected adverse reactions:
The most serious adverse reaction with desmopressin is hyponatremia, and in severe cases its complications, eg. convulsions and coma. The cause of the potential hyponatremia is the anticipated antidiuretic effect.
Pediatric population:
Hyponatremia is reversible and has often occurred in children in connection with changes in habitual daily behavior involving fluid intake and / or sweating. In children, particular attention should be paid to the precautions indicated in section 4.4.
Other special populations:
children, the elderly and patients with serum sodium levels below normal may have an increased risk of developing hyponatremia (see section 4.4).
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
04.9 Overdose
Overdose of desmopressin results in a prolonged duration of action with an increased risk of fluid retention and hyponatremia.
Treatment:
Although treatment must be individualized, these general recommendations can be made:
- Unaccompanied hyponatremia can be treated by stopping treatment with desmopressin and reducing fluid intake;
- in the presence of symptomatic hyponatremia these measures may be accompanied by infusion of an isotonic or hypertonic sodium chloride solution;
- when fluid retention is severe (convulsions and unconsciousness) treatment with furosemide can be added.
There are no known specific antidotes for Minirin / DDAVP.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: vasopressin and analogues, ATC code: H01BA02
Minirin / DDAVP nasal drops, solution contains desmopressin, a synthetic analogue of the natural antidiuretic hormone with respect to which it has two structural modifications: desamination of cysteine1 and replacement of L-arginine8 with D-arginine8.
These changes resulted in a considerably longer duration of action and a complete lack of blood pressure activity at the dosages used clinically.
05.2 "Pharmacokinetic properties
Absorption
Bioavailability is approximately 3-5%. The maximum plasma concentration is reached after approximately one "hour.
Distribution
The distribution of desmopressin is best described by a two-compartment distribution model with a volume of distribution during the elimination phase of 0.3-0.5 L / kg.
Biotransformation
The in vivo metabolism of desmopressin has not been studied. In-vitro metabolic studies on human liver microsomes have shown that an insignificant amount is metabolised in the liver by the cytochrome P450 system, and, therefore, human liver metabolism in vivo does not appear to be involved. The effect of desmopressin on the pharmacokinetics of other drugs is likely to be minimal due to the lack of inhibition of cytochrome P450.
Elimination
The total clearance of desmopressin was calculated to be 7.6 l / h. The mean terminal half-life of desmopressin is 2.8 hours. In healthy subjects, the unchanged fraction excreted was 52% (44-60%).
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, reproductive and developmental toxicity.
No studies on carcinogenic potential have been performed.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium chloride, chlorobutanol, 1M hydrochloric acid, purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
After opening: 2 months.
06.4 Special precautions for storage
Minirin / DDAVP nasal drops, solution must be stored in the refrigerator (between + 2 ° C and + 8 ° C).
The product can be stored for 4 weeks below 25 ° C, after which it must be immediately discarded.
06.5 Nature of the immediate packaging and contents of the package
Minirin / DDAVP 0.1 mg / ml nasal drops, solution is packaged in dark glass bottles, tightly closed by a dropper and containing 2.5 ml of solution. The dropper is also hermetically protected by a cap. The package also includes two cannulas for intranasal administration (rhinyl) packed together in a plastic sachet.
06.6 Instructions for use and handling
Before using Minirin / DDAVP nasal drops solution please read these instructions carefully.
N.B. The administration of Minirin / DDAVP nasal drops, solution is carried out through a special graduated plastic tube (rhinyl).
Before using Minirin / DDAVP nasal drops solution please read these instructions carefully.
1. Tear off the guarantee seal.
2. Remove the brown plastic cap.
3. Remove the small knurled cap from the dropper by twisting it.
To close the dropper, use the same cap and reapply it so as to prevent loss of solution, especially if the bottle is not stored in an upright position.
4. Hold the rhino with one hand by placing the fingers of the other hand around the dropper neck. Insert the tip of the dropper, angled down, into the end of the rhino marked with an arrow and press the dropper until the solution reaches the desired mark. The part of the mark not marked with a number, between that end and the mark marked 0.05 ml, corresponds to approximately 0.025 ml. If you experience difficulty in filling the rhinyl, a syringe type insulin or tuberculin to take the desired dose and then transfer its contents into the rhinyl.
5. Hold the part of the rhinyl containing the solution with your fingers about 2 cm from the tip, inserting this tip into one nostril until the fingertips reach the nostril.
6. Insert the other end of the rhinyl between the lips. Tilt the head back and then blow briefly and intensely into the rhinyl so that the solution penetrates the nasal cavity. If this procedure is followed, the solution stops in the nasal cavity and does not penetrate the back of the throat.
7. After use, reapply the knurled cap and then the brown plastic cap, wash the rhinyl with tap water and then shake it thoroughly to avoid traces of it remaining inside. The rhinile is thus ready for subsequent applications.
07.0 MARKETING AUTHORIZATION HOLDER
Ferring S.p.A. - Via Senigallia 18/2 - 20161 Milan.
08.0 MARKETING AUTHORIZATION NUMBER
A.I.C. n. 023892019.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 2010.
10.0 DATE OF REVISION OF THE TEXT
AIFA Resolution of 18 July 2013.
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