MINIRIN SOLUTION

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
DESMOPRESSIN ACETATE
Available from:
FERRING PHARMACEUTICALS LTD
ATC code:
H01BA02
Pharmaceutical form:
NASAL SOLUTION
Composition:
DESMOPRESSIN ACETATE 0.1 MG/ML
Administration route:
NASAL
Prescription type:
Required
Manufactured by:
FERRING GmbH ,GERMANY
Therapeutic group:
DESMOPRESSIN
Therapeutic area:
DESMOPRESSIN
Therapeutic indications:
Treatment of cranial diabetes insipidus. Treatment of post hypophysectomy polyuria-polydypsia.
Authorization number:
119 68 24562 00
Authorization date:
2020-07-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

23-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

30-08-2017

u}|zq¡fªµ¶ l©¥´¥µ§¶m©¥£³¡´ ¶¡¬³¶¥°¨«§´²¨«¡¨®

›¯ ³¨´³©œµœ¤¤¢ ¡Ÿ¯ ³µ

Šš‹ž ‡^Ÿ” Ÿ “žŽ‡‹š‹—‰˜•‹’˜Š †•‹˜‡^†ž

 ­¥ª¶

«¥´¥¬¥ª

~§´ 

Desmopressin Acetate 0.1 mg/ml

i“’˜š ’‡“ž”‹

Sodiumchloride,chlorbutanolhemihydrate,hydrochloricacid1MtopH4,purified

water.

~¶¥¤¥¡°´¶ ²¡³

rª¤¬³¯ ¡ ª ©³ Ÿ§¤£µ«¤¬®¤§¢µ

~¶¥œ¡°´¶¡¨¥®°

µ § žªµ´µ ¤ ©¦ ª ›©¤±¤ž¤q§­ª¤¤¯ ›©Ÿœ±©q¬ ž¤¯¤¬«¤›¬¤£œ›¤žœ§ ¯¤£§

r¨¤§¡ «µ¦¤³±œŸµ¢¯Ÿ©µ ­¯´ ©ª«¤›´

µ³¬Ÿ§¢ µ¤«©Ÿ›± µ¦ª ›©¤± ³µ¤µ«µ´Ÿpµ œ³ªµ´µ ¤ ©¦³ ±¤¤œ§ ¯¤£§

rŸ¡¤¯ ¯¤ŸŸµ£ §œ

ƒ´¥µ§¶µª¶µ ¨«¥œ¥¶ª

rŸ¯ ³µŸ¤œ¤¦³©©ž¢›§µ ´¤³¥§Ÿ­ ž¤¨›´©µ´Ÿ§ª¤›

~¨¡°¥¤ ¶¨£¶ ¥¬°¨œ°¡´±®¡¡¥ ¨¥¨ª °¡´¶µª¶µ ¨«¥œ

rŸ²¤«¤© ›ª ¤³Ÿœ¥«¤Ÿ¨›

plµ ›¤³µ²§žª ¦mŸ©¤´«Ÿµ¦³­©~ž ²¯µœ¤ ²¤§©³œ­œµ§œ¬ ›µs§œ ¬¥«¤Ÿ¨›

rµ§¡«pŸ œ¨ž°¢§p¨ž¤§¦ ›s œ§Ÿ

r¨¤£¤§ ³£²§› ›¨¤§¡ «œª ¡¤›³¬ ¢©µs§œ ¬¥«¤Ÿ¨›

r¤« ¦¤¬¯ ›§¤³³œ ©ª ›©¤±§´¨¤³²©œ´©µ´Ÿ§ª¤›

rŸ¤©³µ« ¯¤Ÿ©³œ­œµ§œ¬ ›µs§œ ¬¥«¤Ÿ¨›

~¶¡´ ¢œ

r¢¯«qªµ´p¨žœ¨¤£¤§ ³£²§›~µ ²¤žœ¥ ³­§´¤ ¡Ÿ¯ ³µœ§ ¯¤£Ÿµ¯ ²µœ

¤«¯§›¯ ³§¥¦§­­¤ž Ÿ§¥¤§­p¤Ÿ´§¦Ÿ¯ ³µ§ › Ÿ´§¦ª ¡©§Ÿs´¤³¥«¤Ÿ¨›

rŸ¯ ³µŸµ§¤£«

µ ©¦²³µ µ´§´¤p¨¤©µ¦¤³±³£´©§­ž¤¯²Ÿ§´¤¨¤´¤´²œ ¨¤³¤­±¨¤ž§¤œ

r›©±Ÿµ´ ¢µµ›µ²¯¬©Ÿ

~¶¡Ÿ£¡¥ª¶¡´ ¢œ

rŸ¬¤©µ•ž–”¤«¯§­µ ¤§œ£•ž–”œ´ ©¤´Ÿµ›ž¤©µ®¤ž­Ÿ§´¤

³² œŸž­ •ž–”µ§¤£«¤«¯§Ÿ­´¦p¨ ©¤«¤©§µ§œ ©µ ¤Ÿ§Ÿ¦¤³±¨¤§¡ «Ÿµ¦¤³±

rlµ ­´|µ ¢¯§mµ³¢©§´

~¶¡¥¶°¡´¶q«¥¶¡¡ž¶

pŸ« ¡µ¤¯¬ µ ¨´³©›§§µ ³¦©«Ÿµ ¯ ³µ§§ ¦pµ¯¬ «Ÿ¯ ³µµs§£ «¥«¤Ÿ¨›

­ «©§¤ž¦§¯£©Ÿ›¯ ³§¢  ž§¥¤§­pµ³¢›Ÿ¯ ³µœ§ ¯¤£Ÿµ­Ÿ¡µ³©¨› ›

µ ± œ²Ÿ©µ ¯ ³µ¤œ§ž¢ ¤©œpµ ¤µ¯ ³µqª¤œµ œ µ©¨¤­œ «Ÿµ §¤­¤q¤› ›¨¤« ¦¤¬

°¢§µž³ Ÿ§µ ¯ ³µpª ›¦¤žž«µ ¯ ³µp¨žµ´¤³²ž«µ ¯ ³µpª¤³¤¯¬›~µ ›œŸ

rž¤©§²«œ¤§ ¨¤£§¤±¤§¬pª¤³¯«¤¯›³ «pª¤±£© ž«¤›pª¤¯¡©œ³²p¨ž

~¥œ¡¡¨¶¡®°¡¶

p¤›  §µ ­¯´Ÿ­¤¯ Ÿ§µ § §­Ÿœ´ ©¤´Ÿª©¡œpŸ¯ ³µŸ§´Ÿ¤ ±³Ÿµ §¤­¯§®¬ «œ

 ›µ²§žp¨¤«¯œ²© ¬p¨žŸ°¢§œµ §²µ ¤§­p´›³œ›¦pª£œœ›¦pŸ§¤¢œ~ª ¦

r§¯£©Ÿ›¯ ³§µ «¯§´¤pŸ«¦´©¤µ §›µ ­¯ µ¨›r®›Ÿ©¨ ©¤ž

Ÿ¤¤§­pµ µ¤  ­p¨ «©«p§ œ§œp¨¤©µ ³œ£±Ÿ¤«©¤¬ «¦µ¤¤¨¤³¤ž«¨¤³²©œ ³µ¤ª «¤©œ

rž¤©›¯ ³§µ «¯§ § ¯¤£Ÿµ›²¤¬¯Ÿ§´¤Ÿ§›¨¤³²©œrŸ«µ´Ÿœµ ¤­œ §²´©œ

¤ «¤´§¢¨› ›pŸ¡ª §­œ «¤ ±›§´¤›  §µ ­¯ µŸs´¤³©¥«¤Ÿ œ´Ÿ³²©§¦œ

rž¤©›¯ ³Ÿ¨­°­¤¤µŸ§¥¤§­µ¤§§¦Ÿ¥µ´³Ÿœ

~¶¡³¡¬¥¶¡©¥Ÿ¨¥¶¡¥¶°¡´¶q«¥¶¡¡ž¶¡¥œ¡¡¨¶¡®°¡¶

µ¯¬ «Ÿ¯ ³µ§¦§­ª¦ ¤›  §µ­¯ µ§¦§­§¯£©Ÿ›¯ ³§¢  ž§¨¤³ ŸŸ§­

eŸsž§¤§µ«µ¤«Ÿ

~«¡¬¥ª

rµ±§© ©ŸŸ«©Ÿ§­³ œ­§ª¤›ržœ§œ›¯ ³Ÿµ ›³ Ÿ¤¯§ª «¤©

r¨¤´ž ¢w§¤§µ¢µ©µ ² «¤µ ¨¤ž§¤§§§¦q¥³žœµž­ ¤©Ÿ«¤› ¡Ÿ¯ ³µ

r§¯£©Ÿ›¯ ³Ÿ¤ž¤q§­­œ²«´¤¯¦¨¤œ ±²¨¤«©¡œ ¡Ÿ¯ ³µœ´©µ´Ÿ§´¤

ª¯ ›¨ ´œ¥›pµ³¦¡«´¦ž¤©Ÿ«©§ £¤§´¤pœ ±²ª©¡œ ¡Ÿ¯ ³µ§ £¤§µ¢¦´¨›

ež¢¤œµ «©¤µ´§ £¤§ª¤›

e¨¥s©¥µ

ržœ§œ¤¯›q¥ µ´ ©¤´§ržœ§œ¤« ±¤¢´ ©¤´§µž­ ¤© ¡Ÿ¯ ³µe­ §œ§›§

~µ¡ª¥µ «°¡œ

i š† ž‹–œ žŒ˜‡Ÿ‹”Ÿ ‹†ž‹Š

³›  ±œ¤œ¬µ›±©«Ÿµ¤£¬§¯Ÿµ­œ£Ÿµ›¤s¥ ´©ru

r¤£¬§¯ŸŸ¬¦©Ÿµ›¤s³¬Ÿrv

¤s´©µ´Ÿrµ¯£¯£Ÿ©ª£²ŸŸ¬¦©Ÿµ›¤sž³ Ÿ ¤sœœ ¬rw

ž¢ ¤©œpŸ§¤¡«­ «©§¤ž¦œŸ¦ ¯ŸŸ µ³ ±œŸ¡Ÿ¬¦©œ

r¥« ›©œ›§´ª¬¢ ›©² œ²œŸ¨›

µ ­œ±›œ µ«© ¬©Ÿµ¤³ «¤±Ÿµ›µ¢›ž¤œ¤s²¡¢Ÿrx

r² œ²œŸ§´® £¯£Ÿµ¤¤¯œ¤s²¡¢ŸŸ¤¤«´Ÿž¤Ÿ

¥ µ§pŸ£©¤¯§¦Ÿ¤¤£Ÿœ® £¯£Ÿµ¤¤¯µ›¤s³ž¢Ÿ

µ¤¤¯§­£­©¤s°¢§ p°¢œª© ¬©Ÿµ¤³ «¤±ŸŸ±²

¨›µŸœ¤ ±³Ÿ¨ ²©§­¤µŸ¬¤©µŸ´ž­p® £¯¤£Ÿ

Ÿ±²Ÿª¤œžž©«´³ž«Ÿª «¤©Ÿrµ¤³ «¤±Ÿ§­ª ©¤¬§

³¯¬ ©©›§Ÿª ©¤¬Ÿr¤ ±³Ÿª ©¤¬Ÿž­ °¢œª© ¬©Ÿ

¥³­œ «¤Ÿptrtyª©¤¬Ÿª¤œ§µ¤³ «¤±ŸŸ±²ª¤œ›±©«Ÿ

r² œ²œŸ©µ¤³ «¤±Ÿµ›¤s²µ«r§f©trtvyœ±©œ

³› µ©Ÿ¤¯§µ¤³ «¤±Ÿ¤ §¤©œ¤´ ²¨¤¤²¨›~Ÿ³­Ÿ 

²³¡©¤f­² œ²œŸ©Ÿ¬¤©µŸµ›œ ›´§ªµ¤«p§¤­§

 µ³¡­œ pª¤§ ²³œ £²³¡© ›ª¤§ ¬«¤›²³¡©~ª ¦p²¤²ž

r´³ž«Ÿª «¤©œµ¤³ «¤±Ÿµ››§©§

©f¬uryqv§´²¢³©œ¥¤µ ­œ±›œµ¤³ «¤±Ÿµ›¤s²¡¢Ÿry

¨¤¤³¤¢«Ÿž¢›¥ µ§Ÿµ ›¤s¬«¦Ÿ pµ›§¤©´Ÿ±²Ÿ©

r³¤¢«œŸ«­¤µµ ­œ±›Ÿµ ±²´ž­

¤s³ ±­p¥¤¯¥ µ§µ¤³ «¤±Ÿ§´¤«´ŸŸ±²Ÿµ›¤s¬«¦Ÿrz

¤s® ´«¡› ³ ¢›§¥´›³µ›¤sŸ£Ÿp¥µ©¤´«µ›

¥¦µ¤³ «¤±Ÿ¥³ž§¡ «Ÿµ›Ÿ³±² Ÿ²¡¢Ÿ¯¤´«œ

¥³žœr®›Ÿ§§¢¥ µ§›~ª ¦«Ÿ¨ ²©§­¤µŸ¬¤©µŸ´

­ §§µ³ž ¢Ÿ«¤› žœ§œ®›Ÿ§§¢œµ³›´«Ÿ¯ ³µŸ ¡

rlzŸ« ©µ¤sŸ›³m

r¤£¬§¯ŸŸ¬¦©Ÿ¨­² œ²œŸµ›¤s³ ¬p´ ©¤´Ÿ³¢›§r{

µ›±ž­œ£¤ŸŸµ ›¤s³­« ¨¤©œµ¤³ «¤±Ÿµ›¤s® £´

r›œŸ´ ©¤´§Ÿ«¦ ©¡›µ¤³ «¤±ŸrŸ¯¤£´Ÿ¤©§¦

ƒ¨¡°¥¤ ¶£¨² ¨®¥¥­¨¥s¨§¡¶Ÿ²¥§

r›¯ ³Ÿ¤ž¤q§­°§© Ÿ´§ ¯¤£Ÿµ›¨¤§´Ÿ§¥¤§­

§ ¯¤£Ÿµ›²¤¬¯Ÿ§ª¤›¥µ ›¤³œœ±©œ³ ¯¤´§¢¨›¨

r›¯ ³¨­µ ±­¤¤µŸ›§§Ÿ¯ ³µœ

e ¨®´ ¥s®¬ª

 ›s ¨¤ž§¤§´¨ž¤´¤Ÿ§° ¢©³ ¬¨ ²©œ³ ©´§´¤µ³¢›Ÿ¯ ³µ§¦  ¡Ÿ¯ ³µ

ª©ž§¤­§œµ ­£œ¨› ›³µ¤µ«©µ§£«¨›rŸ§­³Ÿ¤s­«©µ¥¦¤ž¤q§­ µ ² «¤µ

r¥µ¤›Ÿ¯ ³µŸµ¡¤³›¤s›œŸ ¨¤§ ¢qµ¤œ§´ª ¤©³ž¢§ž¤©¤sŸ«¯pŸ¯ ³µŸ

p¥µ§¢©œ§ ¯¤£§Ÿ©´³« ¡Ÿ¯ ³µe›¯ ³©µ´³ ¯©Ÿ›³ Ÿ›§§Ÿ›²Ÿ§¨ ³§ª¤›

]ž‘”‹†–‘Ÿ[‡‹ž’‹ŒŠš‹ž ^•  ’†r²¤¡Ÿ§Ÿ§ §­›¤Ÿµs³¢›Ÿ§ ¢œ

rŸ¯ ³µµs§£ «¥«¤Ÿ´¨­¯§¦œŸ«©Ÿ µ¤  µŸ² žœ§´¤e¥´ ¢œµ ¯ ³µ§ £¤§ª¤›

r¨Ÿ§Ÿs² ²¡¥«¤Ÿ¨›¨¤¤¯²´©œ¤¦³Ÿ§´¤

~ ¬­£œ

r¨¤¤´ž ¢¥ µœ´©µ´Ÿ§´¤Ÿ« ´›³Ÿ¢¤µ¯³¢›§rlv t C q| t C m³³²©œ

ržœ§œµ§œ ©Ÿ¯ ²µ§µ ³©´«µ ¯ ³µp¨¤±§© ©ŸŸ«¬¢›ŸsŸ¡¤³›Ÿ¤›«µ¤¯§¨

¢² ³œ°­  ¤Ÿ§¥¤§­p²¯¬§´Ÿ³²©§¦œe³¤´¦µŸ§´Ÿ ¯µŸ¥¤³›µ§œ§¨¤´§›«

rŸ¡¤³›Ÿµ ›œµ « ´µ ¯ ³µª¬¢›§ª¤›rŸ¯ ³µŸµ›¥§²¯¤¬´

uu}z|vxyzv~ °¡´¶ ©¡µ¥´k­ª

rŸ¤«©³p«¤³¯~«´²¥

p©f­œ¬§²¤£¤ ±©³¯«¤³¯~©¡µ¥´ ¨®

rw|}ttŸ¤³¬¤²Ÿ¤´­µŸ²³›¯p|Ÿ£¤´Ÿk¢³

p©f­œ¬§²¤£¤ ±©³¯µ ž¤¯§r­~«œ¡¥

rw|}ttŸ¤³¬¤²Ÿ¤´­µŸ²³›¯p|Ÿ£¤´Ÿk¢³

‹‰\’˜žŸ‹†‹‰‡–‹–‘‹ ‹ ‹†ž‡Š‰žŸ”‰\’˜˜‡–ŠŒ•‹’˜Ž”ž‹š

]a_`_–‹‡

MINI SOL PL SH 120910

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986

The dispensing of this medicine requires a doctor's prescription

Read this package insert carefully in its entirety before using this medicine

MINIRINSOLUTION

Composition:

Desmopressin acetate 0.1 mg/ml

Inactive ingredients:

Sodiumchloride,chlorbutanolhemihydrate,hydrochloricacid1MtopH4,purified

water.

Therapeutic group:

Synthetic substitute for the hormone vasopressin.

Therapeutic activity:

Forthetreatmentofdiabetesinsipidus-aconditionthatischaracterizedbythirst

and large quantities of urine which are not affected by decreasing fluid intake.

Fortreatingtheproductionoflargeamountsofurine,excessiveurinationandthirst

following surgical removal of the pituitary gland.

When should the preparation not be used?

Do not use this medicine if you are sensitive to any of its ingredients.

Donottakethismedicinewithoutconsultingadoctorbeforestarting

treatment:

If you are pregnant or breastfeeding.

Ifyouaresuffering,orhavesufferedinthepastfromimpairedfunctionof:the

respiratorysystem(e.g.pneumonia),theheartand/orvascularsystem,hypertension,

runny nose.

If you suffer from imbalance of fluids or electrolytes.

Do not use in cases of habitual or psychogenic increased thirst.

If you suffer or have suffered in the past from hyponatraemia.

Warnings:

Duringtreatmentwiththismedicine,thefollowingtestsshouldbeperformed:blood

electrolyte levels, urine - volume.

Ifyouaresensitivetoanytypeoffoodormedicine,informyourdoctorbefore

commencing treatment with this medicine.

Inyoungchildrenandelderlypatients,takecaretorestrictfluidintake.Drinkthe

minimum amount of fluid necessary to quench your thirst.

Special Warnings:

TheuseofMinirinTabletsshouldalwaysbepreferredoverMinirinSolution.

Liquidintakeshouldbelimitedtoaminimum,fromaboutanhourbeforeMinirin

administration until the following morning (at least 8 hours).

Drug interactions:

Ifyouaretakinganotherdrug,includingnon-prescriptionmedicinesandfood

supplements,orifyouhavejustfinishedtreatmentwithanothermedicine,inform

theattendingdoctor,inordertopreventhazardsorlackofefficacyarisingfromdrug

interactions.Thisisespeciallyimportantformedicinesbelongingtothefollowing

groups:aspirin,anticoagulants,antidepressants,antihypertensives,carbamazepine,

indomethacin, norepinephrine, salicylates and glibenclamide.

Side effects:

Inadditiontothedesiredeffectofthemedicine,adversereactionsmayoccurduring

thecourseoftakingthismedicine,forexample:nausea,stomachpain,headache,

slightriseinbloodpressure,flushedface,nasalbleedingorinflammation.Ifthese

effects continue, consult the attending doctor.

Symptomsoffluidretention,confusion,drowsiness,convulsions,weightgainand

problemsinurinationmightoccurincasesofoverdosageandinrarecases.Inthese

events, discontinue treatment and contact the doctor immediately.

Intheeventthatyouexperiencesideeffectsnotmentionedinthisleaflet,orifthere

is a change in your general health, consult your doctor immediately.

Adverse reactions and drug interactions in children and infants:

Parentsmustinformtheattendingdoctoraboutanysideaffects,aswellasany

additional medicine being taken by the child!

Dosage:

Dosage is according to doctor's instructions only.

Do not exceed the recommended dosage.

Thismedicineisnotusuallyintendedforuseinchildrenandinfantsunderthree

months of age.

Thismedicineistobetakenatspecifictimeintervalsasdeterminedbytheattending

doctor.Ifyouforgettotakethismedicineatthespecifiedtime,takethedose

assoonasyouremember,butnevertakeadoubledosetocompensatefora

missed one!

Attention!

Do not swallow! This medicine is intended for external use only.

Intranasal use only.

Directions for use:

Intranasal application of Minirin with the nasal tube:

1.Pulltheplasticringthatsurroundstheneckofthe

2.Remove the plastic cover.

3.Twistoffthesmallcoverfromthedropper.Usethe

samecoverreversedinordertopreventleakage,

especially if the bottle is not stored upright.

4.Inonehandholdthecalibratedtubeandwiththe

fingersoftheotherhandholdthetopofthedropper.

Insertitinadownwardslantedpositionintothetipof

thecalibratedtubemarkedwithanarrow,andsqueeze

thedroppergentlyuntilthesolutionreachesthe

desiredareainaccordancewiththecalibrationonthe

tube.Thenecessarydoseismeasuredfromtheline

marked by the arrow until the desired calibration.

Theun-numberedcalibrationbetweentheendofthe

tubeandthe0.05markisapproximatelythe0.025

ml position. Detach the tube from the bottle.

Note:Ifthereisdifficultyinfillingthetubeaccordingto

theabovedirections,youmaywithdrawthesolution

fromthebottlewithathinsyringe,suchas:insulin

ortuberculinsyringe,andthisaidmaybeusedtofill

the tube with the require dosage.

5.Holdthetubewithyourfingersapproximately

1.5-2cmfromtheendthatyoufilledandplaceitin

oneofthenostrilsuntilthetipsofthefingerstouch

the nostril.

6.Placethesecondendofthetubeintoyourmouth

andholdyourbreath,tiltyourheadbackwardand

thenblowwithashortstrongpuffthroughthetubeso

thatthesolutionreachestherightplaceinthenasal

cavityandthepreparationdoesnotpassdowninto

the back of the throat (see picture 6).

7.Afteruse,closethebottlewiththeplasticcover,

washthetubeinwaterandshakethoroughlyuntil

nomorewaterisleft.Thetubeisnowreadyforthe

next application.

Howcanyoucontributetothesuccessofthe

treatment?

Completethefullcourseoftreatmentasinstructed

bythedoctor.Evenifthereisanimprovementinyour

health,donotdiscontinueuseofthismedicinewithout

consulting your doctor.

Avoid poisoning!

Thismedicine,andallothermedicines,mustbestoredinasafeplaceoutofthe

reachofchildrenand/orinfants,toavoidpoisoning.Ifyouhavetakenanoverdose,

orifachildhasaccidentallyswallowedthemedicine,proceedimmediatelytoa

hospital emergency room and bring the package of the medicine with you.

Do not induce vomitingunless explicitly instructed to do so by a doctor!

Thismedicinehasbeenprescribedforthetreatmentofyourailment;inanother

patientitmaycauseharm.Donotgivethismedicinetoyourrelatives,neighbors

or acquaintances.

Donottakemedicinesinthedark!Checkthelabelandthedoseeachtimeyou

take your medicine. Wear glasses if you need them.

Storage:In the refrigerator (2 0 C-8 0 C). After first opening use within two months.

Evenifkeptintheiroriginalcontainerandstoredasrecommended,medicinesmay

bekeptforalimitedperiodonly.Pleasenotetheexpirydateofthemedicine!Incase

of doubt, consult the pharmacist who dispensed the medicine to you.

Do not store different medications in the same package.

Drug registration number:119 68 24562

Manufacturer:Ferring, Germany.

License holder:Ferring Pharmaceuticals Ltd.,

8 Hashita Street, Industrial Park Caesarea 38900.

Importer:A. Lapidot Pharmaceuticals Ltd.,

8 Hashita Street, Industrial Park Caesarea 38900.

TheformatofthisleafletwasdeterminedbytheMinistryofHealthandits

content was checked and approved in June 2010.

1.

NAME OF MEDICINAL PRODUCT

MINIRIN Melt 60 micrograms

MINIRIN Melt

120 micrograms

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Minirin Melt 60 mcg

: each unit contains 60 micrograms desmopressin (free base), present as

desmopressin acetate.

Minirin Melt 120 mcg

: each unit contains 120 micrograms desmopressin (free base) present as

desmopressin acetate.

3.

PHARMACEUTICAL FORM

Oral lyophilizate

White, round, oral lyophilisate marked with one (60mcg) or two drop (120mcg) shaped figures on one side.

4.

CLINICAL PARTICULARS

4.1 THERAPEUTIC INDICATIONS

Minirin Melt is indicated Nocturnal Enuresis.

4.2 POSOLOGY AND METHOD OF ADMINISTRATION

Nocturnal Enuresis:

Oral lyophilisate administration

Children over 5 years:

The recommended initial dose is 120 microg at bedtime, administered sublingually. If this dose is not

sufficient effective, the dose may be increased up to 240 microg sublingually.

If treatment continues over the long-term, a treatment-free week should be introduced every three

months, in order to ascertain whether the condition has resolved spontaneously.

If the desired clinical effect has not been achieved after 4 weeks of dose titration, treatment should be

discontinued.

4.3 CONTRA-INDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

A history of known or suspected cardiac insufficiency and other conditions requiring treatment with

diuretic agents. Habitual or psychogenic polydipsia (resulting in a urine production exceeding 40

ml/kg/24 hours)

Patients over the age of 65

Moderate and severe renal insufficiency (creatinine clearance below 50ml/min)

Known hyponatremia

Syndrome of inappropriate ADH secretion (SIADH)

Before prescribing Minirin Melt the diagnosis of psychogenic polydipsia and alcohol abuse

should be excluded.

4.4

SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Special warnings:

When Minirin Melt is used for the treatment of enuresis, the fluid intake must be limited to a minimum from

1 hour before until the next morning (at least 8 hours) after administration.

Treatment without concomitant reduction in fluid intake can lead to water retention and/or hyponatraemia

with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain and in

serious cases convulsions).

All patients and, when applicable, their guardians should be carefully instructed to adhere to the fluid

restrictions.

Use of the product should be under specialist supervision with appropriate facilities available for monitoring

and interpretation of response.

All patients on desmopressin therapy should be observed for the signs of symptoms associated with

hyponatraemia (headache, nausea/vomiting, weight increased and, in severe cases, convulsions).

Care should be taken with patients who have reduced renal function and/or cardiovascular disease or cystic

fibrosis.

Patients being treated for primary nocturnal enuresis or nocturia should discontinue Minirin Melt during an

episode of vomiting and/or diarrhoea until their fluid balance is once again normal.

Precautions:

Severe bladder dysfunction and outlet obstruction should be considered before starting treatment.

Elderly patients and patients with serum sodium levels in the lower range of normal may have an

increased risk of hyponatraemia, therefore Minirin Melt is contraindicated in patients being treated for

primary nocturnal enuresis.

Treatment with desmopressin should be interrupted during acute intercurrent illnesses characterised by

fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis).

Desmopressin should be used with caution in patients with conditions characterised by fluid and/or

electrolyte imbalance.

Precautions must be taken in patients at risk for increased intracranial pressure.

Precautions to avoid hyponatraemia including careful attention to fluid restriction and more frequent

monitoring of serum sodium must be taken in case of concomitant treatment with drugs, which are

known to induce Syndrome of Inappropriate Antidiuretic Hormone (SIADH), e.g. tricyclic

antidepressants, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine, case of

concomitant treatment with Non steroidal Anti-Inflammatory Drugs NSAIDs.

4.5 ITERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF

INTERACTION

Substances, which are suspected to induce SIADH, eg. tricyclic antidepressants, selective serotonine

reuptake inhibitors, chlorpromazine and carbamazepine, as well as some antidiabetics of the

sulfonylurea group particularly chlorpropamide, may cause an additive antidiuretic effect leading to an

increased risk of water retention/hyponatraemia (see section 4.4).

NSAIDs may induce fluid retention and/or hyponatraemia.

Concomitant treatment with loperamide may result in a three-fold increase in desmopressin plasma

concentration, which may lead to an increased risk of water retention/ hyponatraemia. Although not

investigated, other drugs slowing intestinal transport might have the same effect.

It is unlikely that desmopressin will interact with drugs affecting hepatic metabolism, since

desmopressin has been shown not to undergo significant liver metabolism in in vitro studies with human

microsomes. However, formal in vivo interaction studies have not been performed.

A standardized 27% fat meal significantly decreased the absorption (rate and extent) of desmopressin

tablets. No significant effect was observed with respect to pharmacodynamics (urine production or

osmolality).

Food intake may reduce the intensity and duration of the antidiuretic effect at low oral doses of

desmopressin tablets.

4.6

FERTILITY, PREGNANCY AND LACTATION

Pregnancy

Data on a limited number (n = 53) of exposed pregnancies in women with diabetes insipidus as well as

data on a limited number of exposed pregnancies in women with von Willebrand disease indicate no

adverse effects of desmopressin on pregnancy or on the health of the foetus/ newborn child.. To date, no

other relevant epidemiological data are available.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,

embryonal/foetal development, parturition or postnatal development.

Caution should be exercised when prescribing to pregnant women. Fertility studies have not been done.

In vitro analysis of human cotyledon models have shown that there is no transplacental transport of

desmopressin when administered at therapeutic concentrations corresponding to recommended dose.

Breastfeeding

Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 μg

intranasally), indicate that the amounts of desmopressin that may be transferred to the child are

considerably less than the amounts required to influence diuresis.

4.7

EFFECTS ON ABILITY TO

DRIVE AND USE MACHINES

Minirin Melt has no or negligible influence on the ability to drive and use machines.

4.8

UNDESIRABLE EFFECTS

Summary of the safety profile

The most serious adverse reaction with desmopressin is hyponatraemia, which may cause headache,

nausea, vomiting, , weight increase, malaise, memory impairment, vertigo, falls, dizziness, confusion,

and in severe cases convulsions and coma.

The majority of adults treated for nocturia who develop hyponatraemia have developed low serum

sodium after three days of dosing. In adults the risk of hyponatraemia increases with increasing dose of

desmopressin and the risk has been found to be more prominent in women.

In adults the most commonly reported adverse reaction during treatment was headache (12%). Other

common adverse reactions were hyponatraemia (6%), dizziness (3%), hypertension (2%), and

gastrointestinal disorders (nausea (4%), vomiting (1%), abdominal pain (3%), diarrhoea (2%) and

constipation (1%)). Less common is an influence of the sleep pattern/consciousness level presenting

itself as e.g. insomnia (0.96%), somnolence (0.4%) or asthenia (0.06%). Anaphylactic reactions have

not been seen in clinical trials but spontaneous reports have been received.

In children the most commonly reported adverse reaction during treatment was headache (1%), less

common were psychiatric disorders (affect lability (0.1%), aggression (0.1%), anxiety (0.05%), mood

swings (0.05%), nightmare (0.05%)) which generally abated after treatment discontinuation and

gastrointestinal disorders (abdominal pain (0.65%), nausea (0.35%), vomiting (0.2%) and diarrhoea

(0.15%)). Anaphylactic reactions have not been seen in clinical trials but spontaneous reports have been

received.

Tabulated summary of adverse reactions

Adults

Based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin

conducted in adults for treatment of Nocturia (N=1557) combined with the post marketing experience

for all adult indications (incl Central Diabetes Insipidus). Reactions only seen in post marketing have

been added in the ‘Not known’-frequency column.

MedDRA

Organ Class

Very

common

(>10%)

Common

1-10%)

Uncommon

0.1-1%)

Rare

0.1-0.01%)

Not known

Immune system

disorders

Anaphylactic

reaction

Metabolism and

nutrition

disorders

Hyponatraemia*

Dehydration**,

Hypernatraemia**

Psychiatric

disorders

Insomnia

Confusional

state*

Nervous system

disorders

Headache*

Dizziness*

Somnolence,

paraesthesia

Convulsions*,

Asthenia**,

Coma*

Eye disorders

Visual

impairment

Ear and

labyrinth

disorders

Vertigo*

Cardiac

disorders

Palpitations

Vascular

disorders

Hypertension

Orthostatic

hypotension

Respiratory,

thoracic and

mediastinal

disorders

Dyspnoea

Gastrointestinal

disorders

Nausea*

Abdominal

pain*

Diarrhoea

Constipation,

Vomiting*,

Dyspepsia,

Flatulence,

bloating and

distension

Skin and

subcutaneous

tissue disorders

Sweating,

Pruritus,

Rash,

Urticaria

Dermatitis

allergic

Renal and

urinary disorders

Bladder and

urethral

symptoms

General

disorders and

administration

site conditions

Oedema

Fatigue

Malaise*,

Chest pain,

Influeza like

illness

Investigations

Weight

increased*,

Hepatic

enzyme

increased,

Hypokalaemia

* Hyponatraemia may cause headache, abdominal pain, nausea, vomiting, weight increase, dizziness,

confusion, malaise, memory impairment, vertigo, falls and in severe cases convulsions and coma

** Only seen in the CDI indication

Children and Adolescents:

Based on the frequency of adverse drug reactions reported in clinical trials conducted in children and

adolescents with oral desmopressin for treatment of Primary Nocturnal Enuresis (N = 1923). Reactions

only seen in post marketing have been added in the ‘Not known’-frequency column.

MedDRA

Organ Class

Very

common

(>10%)

Common

1-10%)

Uncommon

0.1-1%)

Rare

0.1-0.01%)

Not known

Immune system

disorders

Anaphylactic

reaction

Metabolism and

nutrition disorders

Hyponatraemia*

Psychiatric

disorders

Affect

lability**,

Aggression***

Anxiety

symptoms,

Nightmare****,

Mood

swings****

Abnormal

behaviour,

Emotional

disorder,

Depression,

Hallucination,

Insomnia

Nervous system

disorders

Headache*

Somnolence,

Disturbance in

attention,

Psychomotor

hyperactivity,

Convulsions*

Vascular disorders

Hypertension

Respiratory,

thoracic and

mediastinal

disorders

Epistaxis

Gastrointestinal

disorders

Abdominal

pain*

Nausea*

Diarrhoea

Vomiting*,

Skin and

subcutaneous tissue

disorders

Dermatitis

allergic, Rash,

Sweating,

Urticaria

Renal and urinary

disorders

Bladder and

urethral

symptoms

General disorders

and administration

site conditions

Oedema

peripheral

Fatigue

Irritability

* Hyponatraemia may cause headache, abdominal pain, nausea, vomiting, weight increase, dizziness,

confusion, malaise, memory impairment, vertigo, falls and in severe cases convulsions and coma

** Post marketing reported equally in children and adolescents (<18 years)

*** Post marketing almost exclusively reported in children and adolescents (<18 years)

****Post marketing reported primarily in children (<12 years)

Other special populations:

Elderly patients and patients with serum sodium levels in the lower range of normal may have an increased risk

of developing hyponatraemia (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to

report any suspected adverse reactions.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation

by using an online form

https://sideeffects.health.gov.il/

4.9 OVERDOSE

Overdose of Minirn Melt leads to a prolonged duration of action with an increased risk of water

retention and hyponatraemia.

Treatment:

Although the treatment of hyponatraemia should be individualized, the following general recommendations can

be given: discontinue the desmopressin treatment, fluid restriction and symptomatic treatment is needed.

5. PHARMACOLOGICAL PROPERTIES

5.1 PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: vasopressin and analogues.

ATC code: HO1B A02

Minirin Melt contains desmopressin, a structural analogue of the natural pituitary hormone arginine vasopressin.

The difference lies in the desamination of cysteine and substitution of L-arginine by D-arginine. This results in a

considerably longer duration of action and a complete lack of pressor effect in the dosages clinically used.

5.2 PHARMACOKINETIC PROPERTIES

Absorption

The overall mean absolute bioavailability of desmopressin administered sublingually as Melts at doses of 200,

400 and 800 micrograms is 0.25% with a 95% confidence interval of 0.21% - 0.31%. The Cmax was 14, 30 and

65pg/ml after administration of 200, 400 and 800 micrograms respectively. Tmax was observed at 0.5 – 2.0

hours after dosing. The geometric mean terminal half-life is 2.8 (CV = 24%) hours.

Correlation table between desmopressin in Tablet and Melt forms:

Tablet

Tablet

Melt

Melt

Desmopressin

acetate

Desmopressin

free base

Desmopressin

free base

Desmopressin acetate

0.1mg

89 micrograms

60 micrograms

Approx. 67 micrograms*

0.2mg

178 micrograms

120 micrograms

Approx. 135 micrograms*

0.4mg

356 micrograms

240 micrograms

Approx. 270 micrograms*

calculated for comparative purposes

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

human liver microsome metabolism

studies of desmopressin have shown that no significant amount is metabolised in the liver by the cytochrome

P450 system. Thus human liver metabolism

in vivo

by the cytochrome P450 system is unlikely to occur. The

effect of desmopressin on the pharmacokinetics of other drugs is likely to be minimal due to its lack of

inhibition of the cytochrome P450 drug metabolizing system.

Elimination

The total clearance of desmopressin has been calculated to 7.6 L/hr. The terminal half-live of desmopressin is

estimated to 2.8 hours. In healthy subjects the fraction excreted unchanged was 52 % (44 % - 60 %).

Linearity/non-linearity

There are no indications of non-linearities in any of the pharmacokinetic parameters of desmopressin.

Characteristics in sp

ecific groups of patients

Renal impairment:

Depending on the degree of renal impairment the AUC and half-live increased with the severity of the renal

impairment. Desmopressin is contraindicated in patients with moderate and severe renal impairment

(creatinine clearance below 50 ml/min).

Hepatic impairment:

No studies have been performed.

Children:

The population pharmacokinetics of desmopressin tablets has been studied in children with PNE and no

significant difference from adults were detected.

5.3 PRECLINICAL SAFETY DATA

Non-clinical data revealed no special hazard for humans based on conventional studies of safety

pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

Carcinogenicity studies have not been performed with desmopressin, because it is closely related to the

naturally-occurring peptide hormone.

6.

PHARMACEUTICAL PARTICULARS

6.1 LIST OF EXCIPIENTS

Minirin Melt: Gelatin, Mannitol, Citric acid (anhydrous).

6.2

INCOMPATABILITIES

Not applicable

6.3 SHELF LIFE

The expiry date of each product is indicated on the packaging materials.

6.4 STORAGE CONDITIONS

Store at room temperature not above 25°C and in dry place.

6.5 NATURE AND CONTENTS OF CONTAINER

PVC/Polyamide/Aluminium/Polyamide/PVC blisters. Top foil consists of Paper/Polyester

terephthalate/Aluminium/heat seal lacquer. Strips of 10 oral lyophilisates in packs of 30 oral lyophilisates.

MANUFACTURER

Ferring GmbH, Germany

LICENSE HOLDER

Ferring Pharmaceuticals Ltd

8, Hashita Street, Industrial Park, Caesarea 3088900, Israel

Revised in August 2020

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ( ןכדועמ(

05.2013

05.2013

)

)

________ ךיראת

11.06.2015

____

םושירה רפסמו תילגנאב רישכת םש

:

MINIRIN MELT 120 MCG , 137 23 31463 00

.

MINIRIN MELT 60 MCG , 137 22 31462 00

.

MINIRIN NASAL SPRAY , 023 27 24986 00

.

MINIRIN SOLUTION , 119 68 24562 00

.

MINIRIN TABLETS 0.1 MG , 141 99 25705 01

.

MINIRIN TABLETS 0.2 MG , 141 98 25704 01

.

םושירה לעב םש

FERRING PHARMACEUTICALS LTD

_

! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט

Adverse events

Post Marketing: There have been rare reports

of thrombotic events (acute cerebrovascular

thrombosis, acute myocardial infarction)

following the treatment with Desmopressin,

causality hasn't been proven yet, but caution

should be taken when treating patients with

risk factors.

ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה ןכדועמ( ןכדועמ(

05.2013

05.2013

)

)

________ ךיראת

11.06.2015

____

םושירה רפסמו תילגנאב רישכת םש

:

MINIRIN MELT 120 MCG , 137 23 31463 00

.

MINIRIN MELT 60 MCG , 137 22 31462 00

.

MINIRIN NASAL SPRAY , 023 27 24986 00

.

MINIRIN SOLUTION , 119 68 24562 00

.

MINIRIN TABLETS 0.1 MG , 141 99 25705 01

.

MINIRIN TABLETS 0.2 MG , 141 98 25704 01

.

! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט :יאוול תועפות

וחווד

םיעוריא

םילובמאובמורט

רחאל

לופיט ירישכתב

Desmopressin

ןיידע ,

אל

חכוה רשק

ךא ,יתביסנ

שי

רהזיהל

לופיטב

םילוחב םע

ימרוג

.ןוכיס

Similar products

Search alerts related to this product

View documents history

Share this information