Prevymis

Italy
Brand name Prevymis
Form tablets, film-coated
Active substance / Dosage
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
Registration number 045890
Prevymis tablets, film-coated

Table of Contents

  • to the nurse
  • to the nurse

What is
What is

("cytomegalovirus").

  • or or
  • or

to the nurse
or
or
"Other PREVYMIS"
of the other

the list
' "
"

  • used for the treatment of HIV

Breastfeeding the intake
" "
'
until the effect does not
" "

Body weightDaily oral dose of PREVYMISNumber of PREVYMIS tablets once daily
30 kg and above480 mgOne 480 mg tablet or Two 240 mg tablets
15 kg to less than 30 kg240 mgOne 240 mg tablet
Body weightDaily oral dose of PREVYMISNumber of PREVYMIS tablets once daily
30 kg and above240 mgOne 240 mg tablet
15 kg to less than 30 kg120 mgSee the package leaflet of PREVYMIS granules in sachets
  • a little water
  • at the scheduled time
  • the administration the administration

on the use
to the nurse.

  • '

to the nurse
reported in the '
to the latest
'
'
the environment.
"lactose" "PREVYMIS sodium".
of the ASP
("tablet")
"591" on the other.
("tablet")
"595" on the other.

of the marketing authorization to the placing
of the marketing authorization to the placing
България
Merck Sharp & Dohme Bulgaria EOOD
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
A.F.E.E.
Tel
á
Κύπρος
Tel.: 800 00 673 (+357 22866700)
of the Agency

  • to the nurse.
  • to the nurse.

What is
What is

("cytomegalovirus").

  • or or
  • or

to the nurse
or
or
"Other PREVYMIS")
of the other

the list
").
' "
"

  • for the treatment of HIV

Breastfeeding the administration
'
until the
ll'1.15'
'

Body weightDaily intravenous dose without cyclosporineDaily intravenous dose with cyclosporine
30 kg and above480 mg240 mg
Body weightDaily intravenous dose without or with cyclosporine
from 15 kg to less than 30 kg120 mg
from 7.5 kg to less than 15 kg60 mg
from 5 kg to less than 7.5 kg40 mg

If you miss the appointment for administration of

  • the appointment

on use
to the nurse.

  • '

to the nurse.
brought in the '
at the last
'
'
'
'
'
the environment.
" "
"PREVYMIS".
of the appearance
of the marketing authorization
of the marketing authorization
България
Merck Sharp & Dohme Bulgaria Ltd
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
A.F.E.E.
Tel
á
Κύπρος
Tel.: 800 00 673 (+357
of the Agency
the use
of the use

Intravenous doseVolume of 20 mg/mL PREVYMIS concentrate for solution for infusionFinal infusion volumeFinal letermovir concentration
120 mg6 mL of 20 mg/mL75 mL1.6 mg/mL
60 mg3 mL of 20 mg/mL50 mL1.2 mg/mL
Intravenous doseDilution volume of PREVYMIS 2 mg/mL (1:10)*Final infusion volumeFinal letermovir concentration
40 mg20 mL of 2 mg/mL20 mL2 mg/mL
* To prepare the PREVYMIS 2 mg/mL dilution, add 5 mL of PREVYMIS 20 mg/mL concentrate for solution for infusion from the vial to 45 mL of diluent (sodium chloride 9 mg/mL (0.9%) or 5% dextrose) and gently mix.
  • inside

  • the entire

  • to the nurse.

  • to the nurse.

What is
What is

("cytomegalovirus").

  • or or
  • or

to the nurse
or
or
"Other PREVYMIS"
of the other

the list
' "
"

  • for the treatment of HIV

Breastfeeding the intake
4 "Possible side effects" below). Some patients have
'
until the effect does not
"
"

Body weight Daily oral dose of PREVYMIS Number of PREVYMIS sachets once daily
30 kg and above 480 mg Four 120 mg sachets
15 kg to less than 30 kg 240 mg Two 120 mg sachets
7.5 kg to less than 15 kg 120 mg One 120 mg sachet
5 kg to less than 7.5 kg 80 mg Four 20 mg sachets
Body weight Daily oral dose of PREVYMIS Number of PREVYMIS sachets once daily
30 kg and above 240 mg Two 120 mg sachets
Body weight Daily oral dose of PREVYMIS Number of PREVYMIS sachets once daily
15 kg to less than 30 kg 120 mg One 120 mg sachet
7.5 kg to less than 15 kg 60 mg Three 20 mg sachets
5 kg to less than 7.5 kg 40 mg Two 20 mg sachets
  • use '
  • at the time of
  • '
  • taking taking

on use
to the nurse.

  • '

to the nurse
in the '
in the last
in water
the environment.
"PREVYMIS lactose" "PREVYMIS sodium".
of the appearance

  • of the authorization to placing on the market

of the authorization to placing on the market
България
Merck Sharp & Dohme Bulgaria EOOD
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
A.F.E.E.
Tel
á
Κύπρος
Tel.: 800 00 673 (+357 22866700)
of the Agency

Instructions for use

on use
These "Instructions for use" contain information on how to take PREVYMIS

  • or
  • or
  • or

or
or
'.

  • Refer to the section "Mixing with food ".
  • Refer to the section "Administering ".
A tall yogurt container with a dark label next to a small bowl containing apple puree on a diagonally striped surface
  • or
A stopwatch icon with a blue section indicating elapsed time and the text '10 minutes' above it
  • or
Black and white drawing of soapy hands under a running tap with water flowing toward the sink drain Profile of a face looking to the side A yogurt container, a glass bowl, a spoon, an open sachet, and a pair of scissors on a striped surface A hand holding a spoon with product over an open yogurt container and a closed jar on a table A hand holding a bag of powder and with
  • towards the
A hand holds a sachet containing small pills while scissors cut the upper edge of the container indicated by a red arrow A hand holds a vial and gently taps it with a finger above a small bowl containing liquid and bubbles A hand uses a spoon to stir a granular substance in a circular motion Black and white drawing of a child with an open mouth while a hand holds a spoon to administer liquid medication

'

A hand holds a bowl under an open tap while water flows into it

For further information, refer to the sections "Co
" and "
PREVYMIS".

Technical drawing of a syringe connected via tubing to a catheter inserted into the nostril of a stylized face with lips and nose Technical drawing of a syringe connected via tubing to a medical device inserted into a person's body between the chest and A vial with label LA next to a carton of apple juice and a carton of milk on a diagonally striped surface

or
or

Stopwatch with dial and red hand indicating a blue sector labeled '10 minutes waiting time' above
  • or

or

Black and white drawing showing hands washing under a tap and a person examining the packaging of the medication Prevymis Technical drawing of a syringe, a stopwatch, two cylindrical containers, scissors, and small objects on a diagonally striped surface Black and white drawing showing a vial labeled LA, a carton of apple juice, and a carton of milk above a glass
  • '
Two hands hold a syringe with needle and plunger to draw up liquid contained in

'

Two hands hold a syringe with a needle to aspirate liquid from a small transparent container placed on a flat surface A hand holds a powder sachet and with
  • towards the
A hand holds a powdered medication sachet while a pair of scissors cuts the top edge indicated by a red arrow A hand gently taps the top of a glass vial containing liquid to dislodge air bubbles Black text on white background reading '10 minutes: waiting time' above a stylized stopwatch with a blue segment on the dial

'

A glass
  • minutes, the mixture will be ready for use.
Two drawings show hands shaking a syringe

'

A hand rotates a syringe filled with gray liquid from a vertical position to an inverted position following a curved red arrow
  • or shake the syringe to avoid formation of air bubbles.
Line drawing of a syringe connected via tubing to an infusion device placed on a person's torso Technical drawing of a syringe connected via tubing to a nasal tube inserted into the nostrils of a stylized face with closed lips Two hands hold a syringe to immerse the

'

Two hands hold a syringe with a needle to aspirate liquid contained in a small transparent container on a flat surface Technical drawing showing a hand shaking a syringe inside a glass with liquid and a second hand removing the syringe upward

and pull up the plunger of the

Diagram showing the rotational movement of a syringe with a curved red arrow indicating rotation between two vertical positions
  • or shake the syringe to avoid formation of air bubbles.
Technical drawing of a syringe connected via tubing to a catheter inserted into a patient's abdominal area Line drawing of a syringe connected via tubing to a catheter inserted into one nostril and running down toward the mouth A hand holds a glass under an open tap to collect water
  • or or
  • For further information, refer to the sections "Co " and " PREVYMIS".

'