Winrevair

Italy
Brand name Winrevair
Form solution for injection, powder and solvent
Active substance / Dosage
SOTATERCEPT
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
C02KX06
Registration number 051390
Manufacturer MERCK SHARP & DOHME B.V.

Table of Contents

reported during treatment with this medicine. See the end of this section.
If you have any doubts, consult your doctor, pharmacist, or nurse.
consult your doctor, pharmacist, or nurse
What is
What is
’
use of
’
during use
each dose and regularly during treatment
months after the last dose of Winrevair. You should contact your
’
’
essentially “
sodium”.
of the nurse. If you have any doubts, contact your doctor, pharmacist, or nurse.
’
’

  • cm away from the navel,
  • ’ ’

’Pamphlet “Instructions for Use”
If you have any questions about the use of this medicine,
to the nurse.

  • A urinary tract infection (kidneys, bladder, or urethra) ’

to your doctor, pharmacist, or nurse. You may also report side effects directly
on the ’
“S ”. The expiry date refers to the last day of that month.
’
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how
This will help protect the environment.

  • “ contains sodium” 2 “Winrevair ”
  • Description of the appearance of

Marketing Authorisation Holder and Manufacturer
of the marketing authorisation:
България
Merck Sharp & Dohme Bulgaria EOOD
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
MSD A.E.E.
Tel: +30 210 98 97 300
Κύπρος
Tel.: 800 00 673 (+357 22866700)
More detailed information on this medicine is available on the website of the European Medicines
solution for injection must be reconstituted before use and
See the “Instructions for Use” leaflet provided
’
’
’
’ ’
’
’

’
’
’
’

  • ’ ’

accuracy of the dose

  • ’ ’ ’

’ ’

  • ’ ’ ’ “Instructions for Use” ’

Instructions for Use

before use
Instructions for Use
The package leaflet, also supplied in the package, contains all
’
’
your doctor or nurse
the
the
’
!
“ ’ ”

Medical diagram showing a syringe with plunger, a glass vial with white powder, and a connector with a blue valve on a white background Black and white technical drawing of a syringe with liquid inside Transparent glass vial with black cap and white label containing gray powder at the bottom with black indicator lines
Black medical device composed of an upper cylindrical container and a wide base with three separate vertical supports Diagram with instructions to lift the packaging containing a syringe with needle and a syringe body separated by a central element Black and white technical drawing of a medical device shaped like a clamp or applicator with a toothed upper part and a cylindrical body Technical drawing of a horizontal syringe with graduated barrel, gray plunger, and threaded tip for attachment
  • the
Stylized drawing of two overlapping rectangular packages with black borders and gray inner panels on a white background

’

  • ’ ’

  • “ ”

  • ’

  • ’

’

Icon of an analog clock with a white dial and black borders, with a mauve-colored sector covering the upper right quarter Yellow biological waste container with biohazard symbol next to a bandage and a white sterile gauze Hands washing with soap under a stream of water White panel with dark blue border and a horizontal gray band at the bottom containing a yellow triangle with a black exclamation mark Medical diagram showing a syringe with plunger, a glass vial with white powder, and a connector with a blue valve on a white background L

’

Glass vial with black cap, syringe with gray liquid, and pre-filled syringe packaging on a flat gray surface Glass vial with black cap and white label containing white powder inside

’
’

Two illustrations show hands removing the cap from a glass vial and then peeling off the protective film from the top edge Two identical warning symbols consisting of a yellow triangle with black border and a black exclamation mark in the center, vertically superimposed

’

Two hands opening a transparent plastic package to extract a medical device with a blue cap and white base

’

A hand holds a small glass vial while the

of the adapter
To connect the adapter for

Diagram showing correct insertion of a medical device with a green checkmark and the

blue part of the adapter for
of the adapter
the adapter for

’ ’
’

Two hands pressing a white transparent container downward on a flat surface, indicated by a purple arrow pointing downward L

’
Clean the adapter for

A hand pressing a white cap onto a glass vial containing gray powder to prepare the medication

’
’ ’

Technical drawing of a syringe with transparent body, internal plunger, cross-shaped handle, and white upper cap on a neutral background Two hands rotating and connecting a container to a syringe via a circular motion indicated by a black curved arrow Two identical warning symbols consisting of a yellow triangle with black border and a black exclamation mark in the center, vertically superimposed

sterile water
’
’
’
’
’

Two hands rotating a syringe to screw it onto a glass vial containing white liquid for drug preparation

water to flow out
Hold the adapter
’

A hand pushing a syringe vertically toward a medication vial to connect the

all the water
’
’

A hand holding a syringe vertically above a vial with two curved arrows indicating a rotational movement for Technical drawing of a syringe with needle attached to a medication vial with a stylized eye observing the contents A hand pushing the plunger of a syringe downward to aspirate liquid from a medical vial with a directional arrow

’

Technical drawing of a syringe with plunger and needle separated from a glass vial containing transparent liquid Panel with black background and a light pink triangular geometric shape positioned on the left side

’

A hand holding a syringe with needle pointing upward Stylized black and white drawing of a syringe with plunger and a medicine vial with a screw cap underneath Technical drawing of a syringe with plunger and needle inserting into the stopper of a glass vial containing transparent liquid

upwards to
remove air
’
’

Medical illustration showing a hand rotating a syringe on a vial and a Drawing of a needle-free syringe being placed into a yellow biological waste container with biohazard symbol

’

Transparent cylindrical vial with internal liquid and a white cap with blue connector placed on a flat gray surface White panel with dark blue border and a gray band at the bottom containing a yellow triangle with a black exclamation mark inside Diagram with two syringe packages and a central device labeled 'Lift here' indicating where to lift the material L

’
’

A hand holds a white cap to place it on top of a glass vial containing transparent liquid with a white label Blue hands holding a syringe-shaped medical device with an arrow indicating rotation of the base to the left

’

Hold the dosing syringe vertically with the tip pointing upwards
’
“ ”

Hands holding a syringe with a downward arrow and a circular magnifier showing graduation marks on the barrel

’

Two hands handling a syringe and a glass vial for drug withdrawal with arrows indicating rotational movement

the adapter for
Press out the air
’

Medical illustration showing two steps for

“ ”

Two hands gripping a syringe with a white cap and graduated body, with a purple arrow pointing downward at the bottom Circular illustration of a syringe with gray liquid reaching the red dosage line on a white background with purple borders Stylized black and white drawing of a pharmaceutical capsule split into two parts with gray shading on a white background

air ’
’ ’
’

Two circular diagrams show a hand holding a syringe with instructions about air bubbles

air bubbles
air
air ’
’ ’ ’
’
’ ’

Medical illustration showing a hand holding a syringe with air bubbles

large air bubbles and
air pockets
remove the air
’

Two hands holding a syringe with a white upper cap and a purple arrow pointing downward indicating the pressure movement

of air

Detail of a syringe with a horizontal red indicator marking the liquid level above the internal black plunger A hand holds an injection pen above a stylized leg with instructions for A hand holds a syringe with dark liquid and graduation marks tilted downward Schematic diagram with arrows indicating a horizontal direction on a pink and gray gradient background with green graphic elements on the left A glass vial with blue cap is inserted via an arrow into a yellow biological waste container with biohazard symbol White medical device with blue tip and white cap with a pink arrow pointing downward

’ ’

Stylized drawing of a syringe with transparent graduated barrel, gray plunger, and conical base on a light gray background

Attach the needle for the

’

Two hands stretching and pulling a plastic strip to open a container with a black arrow and a red cross indicating the action

Locate the needle in the lower compartment and open the package.

Two hands rotating a pre-filled syringe to detach it from its plastic wrapper with a purple arrow indicating the rotational movement

’ ’
does not stop. Remove the needle packaging

Hands removing the white protective cap from a transparent syringe with milliliter graduations and gray plunger on a white background

’ ’

cap from the

Diagram of the human body showing application areas colored in purple on the

’ ’ ’ ’
’

’

’

A hand holds a white swab and rubs it on the skin surface to clean the area before a

’

’

A hand holds a syringe angled at 45 degrees while inserting the

’
’
will administer the

Two hands hold a syringe with needle to inject medication into the upper part of the buttock of a person on a black background

’

A hand holds a syringe with needle pointing downward next to a vial and an arrow indicating the direction of

’
’

A hand grips a syringe with needle and a red curved arrow indicates a downward rotational movement on a gray surface

“ ” ’

Drawing of a syringe with needle being thrown into a yellow biological waste container with biohazard symbol

Do not remove the needle from the dosing syringe
environment.

  • ’ ’
Yellow biological waste container with white lid and black biohazard symbol on the front

  • ’

  • ’

  • ’

“ ”
’
’
’
’
’
local representative of the marketing authorisation holder
for use
before use
Instructions for Use
The package leaflet, also supplied in the package, contains all
’
!
“ ’ ”
’
your doctor or nurse
the
the
’
?
’

Medical diagram showing two pre-filled syringes with medication vials next to numbers 1 and 2 on a white background No image was provided for analysis. Please upload the No image was provided for analysis. Please upload the L L Black and white technical drawing of a syringe with liquid inside Transparent glass vial with black cap and white label containing gray powder at the bottom with black indicator lines Stylized illustration of a black medical device with a beige cylindrical center part and a wide grooved base on a white background Diagram with instructions to lift the packaging containing a syringe with needle on the left and a loaded syringe on the right Black and white technical drawing of a clamp-shaped medical device with a toothed upper part and a long cylindrical base
Technical drawing of a horizontal syringe with graduated barrel, gray plunger, and threaded tip for attachment

the

Schematic black and white drawing of two overlapping rectangular blisters with black borders and rounded internal compartments

’

  • ’ ’

  • “ ”

  • ’

  • ’

’

Icon of an analog clock with a mauve-colored sector covering the dial from 12 to 3 o'clock Yellow biological waste container with biohazard symbol next to a bandage and a white sterile gauze Hands washing with soap under a stream of water Blue frame with white background and a horizontal gray band at the bottom containing a yellow triangle with a black exclamation mark inside Medical diagram showing two syringes ready for use L L L L

’

Glass vial with black cap, syringe with gray liquid, and injection device under transparent protective cover on a gray surface Glass vial with black cap and white label containing white powder inside

’
’

Two hands working on a vial: one removes the black cap and the Two identical warning symbols consisting of a yellow triangle with black border and a black exclamation mark in the center, vertically superimposed

’

Two hands opening a transparent plastic package to extract a medical device with a blue cap and white base

’

A hand holds a small glass vial while the

of the adapter
To connect the adapter for

Diagram showing correct insertion of a medical device with green checkmark and the

blue part of the adapter for
of the adapter
the adapter for

’ ’
’

Two hands pressing a transparent medical device downward on a flat surface following the direction of a purple arrow

’
Clean the adapter for

A hand holds a white and blue rubber cap to insert it into the neck of a glass vial containing gray powder

’
’ ’

Technical drawing of a syringe with plunger, transparent barrel with graduations, and a thin downward-pointing metal needle Yellow hazard symbol in the shape of a triangle with black border and black exclamation mark in the center on a black background Two hands rotating and screwing the upper part of a white syringe to connect the two components following a curved arrow Two identical warning symbols consisting of a yellow triangle with black border and a black exclamation mark in the center, vertically superimposed

water to flow out sterile
’
’
’
’
’

Two hands rotating a syringe to screw it onto a glass vial with curved arrows indicating the rotational closing movement

water to flow out
Hold the adapter
’

A hand vertically presses a syringe with needle toward the stopper of a medication vial on a flat surface

all the water
all the sterile water in
will move upwards: it is
’
’

Warning symbol consisting of a yellow triangle with black border containing a black exclamation mark in the center A glass vial, a syringe with needle, and a blister pack of white pills arranged on a light gray surface Two vertical syringes with gray plungers connected via a blue tube to two glass vials containing clear liquid Two hands each gripping a syringe to rotate the glass vial clockwise and counterclockwise following circular arrows Technical drawing of a syringe with needle attached to a medication vial with a stylized eye observing the contents A hand presses the plunger of a syringe downward to aspirate liquid from a glass vial with white stopper

’

Two white syringes with gray plungers connected via blue connectors to two glass vials containing transparent liquid on a white background

’

A hand holds a syringe with needle pointing upward Stylized black and white drawing of a syringe with plunger and a medical vial with screw cap underneath Illustration of a syringe with plunger being inserted into the stopper of a medication vial containing clear liquid

upwards to
remove air
’
’

Two transparent syringes with black plungers positioned vertically above two glass vials containing clear liquid Medical illustration showing a hand rotating a syringe on a vial and a Illustration of an empty syringe with an arrow indicating disposal at Two white cylindrical vials with blue and white caps placed on a flat gray surface with black background White panel with dark blue border and a gray band at the bottom containing a yellow triangle with a black exclamation mark inside Diagram showing three components of a medical device labeled 'Lift here' indicating where to lift the parts for L A hand lifts the rubber stopper from a glass vial containing liquid next to two white rectangular pouches and another vial Two blue hands hold a vertical syringe with an arrow indicating rotation of the base to the right near a hazard symbol

’

tip pointing upwards
’

Two hands gripping a syringe with a downward arrow and a magnifier showing the liquid level at 1.5 units

’

Hands separating a syringe from a glass vial via a rotational movement indicated by purple curved arrows

the adapter for
’
’

Medical illustration showing how to connect a medication vial to a syringe via a downward and inward movement Two identical warning symbols consisting of a yellow triangle with black border and a black exclamation mark in the center, vertically superimposed A hand grips a syringe with a white cap on the tip and a purple arrow pointing downward indicates the pulling movement

’

Hands unscrewing the cap from the syringe and throwing it into a red biological waste container with biohazard symbol Illustration of a glass vial being thrown with an arrow toward a yellow biological waste container with biohazard symbol

the adapter for
the adapter for

Two hands rotating a syringe to attach it to a glass vial via a blue connector with curved arrows indicating the movement Illustration showing two steps to connect a vial to a syringe via a downward arrow and an inward arrow

“ ”

Hands pressing a syringe downward with magnification showing the liquid level aligned with the black reference line

air ’
’ ’
’

Two circular illustrations show a hand holding a syringe with instructions about air bubbles

air
air
air ’
’ ’ ’
’
’ ’

Drawing showing a hand holding a syringe with air bubbles Warning symbol consisting of a yellow triangle with black border containing a black exclamation mark in the center

large air bubbles and
air pockets
remove the air
’

Two hands holding a syringe with a white upper cap and a purple arrow pointing downward indicating the pressure movement

’air d

Detail of a syringe with a horizontal red indicator marking the liquid level above the internal black plunger Hands screwing a vial onto a syringe and a yellow biological waste container with directional arrow

’ ’

Stylized drawing of a syringe with needle and plunger on a neutral light gray background

Attach the needle for the

’

Two hands incorrectly separating the two parts of a glass ampoule with a black arrow and red cross indicating the action

Locate the needle in the lower compartment and open the package.

Two hands rotating a pre-filled syringe to detach it from its plastic wrapper with a purple arrow indicating the rotational movement

’ ’
does not stop. Remove the needle packaging

Hands removing a white protective cap from a horizontal syringe with milliliter graduations and gray plunger

’ ’

cap from the

Diagram of the human body showing areas colored in purple on the

’ ’ a ’
’

’

’

A hand holds a white swab and rubs it on the skin surface to disinfect the area before a medical treatment

’

’

A hand holds a syringe angled at 45 degrees to the skin to perform a

’
’
will administer the

Two hands hold a syringe with needle to inject medication into the upper part of the buttock of a person

’

A gloved hand grips a syringe with needle pointing downward next to a vial and an arrow indicating the

’
’

A hand grips a syringe with needle being rotated toward the

“ ” ’

Illustration of a syringe with needle being inserted into a yellow container for disposal of biological waste with hazard symbol

Do not remove the needle from the dosing syringe
environment.

  • ’ ’
Yellow biological waste container with white lid and black biohazard symbol on the front

  • ’

  • ’

  • ’

“ ”
’
’
’
’
’
local representative of the marketing authorisation holder
reported during treatment with this medicine. See the end of this section.
If you have any doubts, consult your doctor, pharmacist, or nurse.
consult your doctor, pharmacist, or nurse. See section
What is
What is
’
use and during use of
’
during use
each dose and regularly during use
months after the last dose of Winrevair. Contact your
’
’
essentially “
sodium”.
’
’

  • cm away from the navel,

’
’
’
If you have any questions about the use of this medicine,
to the nurse.

  • A urinary tract infection (kidneys, bladder, or urethra) ’

to your doctor, pharmacist, or nurse. You may also report side effects directly
on the ’
“S ”. The expiry date refers to the last day of that month.
’
Do not dispose of any medicines via wastewater. Unused medicine and waste material must be
disposed of in accordance with local regulations. This will help protect the environment.
2 “ contains sodium”) 2 “Winrevair
”
Description of the appearance of
Marketing Authorisation Holder and Manufacturer
of the marketing authorisation:
България
Merck Sharp & Dohme Bulgaria EOOD
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
MSD A.E.E.
Tel: +30 210 98 97 300
Κύπρος
Tel.: 800 00 673 (+357 22866700)
More detailed information on this medicine is available on the website of the European Medicines
injectable solution must be reconstituted before use and administered
’

for injection
’ ’
’
WITH ANNUAL VALIDITY SUBMITTED BY THE EUROPEAN MEDICINES AGENCY
Conclusions submitted by the European Medicines Agency on

  • Taking into account the provisions of Article 14(11) of Regulation 726/2004/EC, the

marketing authorisation holder, and considers that