Isentress

Italy
Brand name Isentress
Form tablets, film-coated
Active substance / Dosage
Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription
ATC code
Registration number 038312
Isentress tablets, film-coated

Package leaflet: Information for the user

  • or nurse
  • or nurse

What
What
What
the Human Immunodeficiency Virus (HIV).

fight the


the pharmacist or nurse
is not a cure for HIV infection. This means you may still get
other illnesses associated with HIV. Continue to see your doctor regularly

the , the
reduction in activity of the immune system,
. Signs of
of
pharmacist or nurse
the
the pharmacist or nurse
of the body
after starting treatment with
following
the pharmacist or nurse
or nurse

  • (agents that counteract or neutralise stomach acid to relieve
  • ’ ’ ’
  • Breastfeeding is not recommended for HIV-positive women as the HIV infection can

or nurse
“ ”
of the or nurse
medicines for HIV
the i

pharmacist or nurse.

  • for the

fighting HIV
“ ”

  • of the

causing a brief interruption in
on the use of
to the nurse

  • including herpes zoster

  • decrease in the

  • loss of

  • ; disorder of

  • pain in the upper part of the

’ the

and increase in fat in the

pharmacist or nurse.
in the

  • to the
  • Keep the bottle tightly closed, with the desiccant (drying agent) protected from moisture

in wastewater
which you no longer use. This will help protect the environment.
Appearance of
“ ”

Holder of the marketing authorisation
uthorisation for placing on the market
България
Merck Sharp & Dohme Bulgaria EOOD
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
MSD A.E.B.E.
Tel: + 30 210 98 97 300
Κύπρος
Tel:
are available on the website of the European Medicines Agency

Package leaflet: Information for the user

  • pharmacist or nurse
  • consult your doctor, pharmacist or nurse

What is Isentress and what is it used for
What is Isentress and what is it used for
What is Isentress
the Human Immunodeficiency Virus (HIV). This is the virus that causes the acquired
cells in your body. Isentress stops the activity of this enzyme. When used in combination with
amount of HIV in your blood (this is called “viral load”) and
help fight the infection).
your body can better fight the infection.
keep the HIV infection under control.

Consult your doctor, pharmacist or nurse before taking
this is not a cure for HIV infection. This means you may continue to
get infections or other diseases associated with HIV. Continue to consult your doctor regularly
a bone disease called osteonecrosis (death of bone tissue due to
to the bone). Duration of HIV infection, use of corticosteroids, alcohol consumption
reduction in activity of the immune system, higher body mass index and advanced
disease. Signs of osteonecrosis include stiffness, aching or pain in the joints (most commonly
hips, knees and shoulders) and difficulty in movement. If you notice
Tell your doctor, pharmacist or nurse if you have previously had
hepatitis
or nurse if you notice any symptoms of
immune reconstitution syndrome
after starting treatment with antiretroviral medicines for HIV infection. These conditions
may occur many months after treatment has started. If you notice any
mediately inform your doctor, pharmacist or nurse
Inform your doctor, pharmacist or nurse if
pharmacist or nurse if you are

  • or neutralise acid in the stomach to relieve

  • ’ ’ ’

  • Breastfeeding is not recommended for HIV-positive women as HIV infection can

nurse
“ ”
of the nurse pharmacist or nurse
used in combination with other HIV medicines.
the i

pharmacist or nurse

  • take all HIV medicines exactly as prescribed and at the exact times

to fight HIV (called
as “drug resistance”).

  • obtain more of it

interruption in taking the medicine, the amount of
on the use of this medicine
to the nurse.

  • herpes zoster

  • appetite

  • loss of

  • stomach or intestinal bleeding

  • swelling of the glands in the neck, armpits and groin

  • increase in appetite;

  • attention disorder;

  • of the

in the upper part of the intestine; blood loss from the

face, and increase in fat in the a

or nurse.
in the

  • refers to the most recent
  • tightly closed, with the desiccant (drying agent) protected from moisture. Do not swallow the desiccant.

in wastewater and household waste.
This will help protect the environment.
Description of the appearance of
with “ ” on one side and smooth on the other.

Holder of the marketing authorisation
holder of the marketing authorisation:
България
Merck Sharp & Dohme Bulgaria EOOD
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
MSD A.E.B.E.
Tel: + 30 210 98 97 300
Κύπρος
Tel:
are available on the website of the European Medicines Agency
: Information for the user

  • or nurse
  • or nurse

What
What
What
the Human Immunodeficiency Virus (HIV).

fight the
ganism can better fight the

the
Isentress is not a cure for HIV infection. This means you may still
contract infections or other diseases associated with HIV.
a bone disease called osteonecrosis (death of bone tissue due to
to the , the
reduction in activity of the immune system,
. Signs of
of
pharmacist or nurse
the
the pharmacist or nurse
of the body
after starting treatment with
following
the pharmacist or nurse
or nurse

  • or neutralise acid in the stomach to relieve

  • ’ ’ ’

  • Breastfeeding is not recommended for HIV-positive women as HIV infection can

or nurse

“ ”

“ ”
of the nurse or nurse
medicines for HIV
the chewable tablet according to the
the i

pharmacist or nurse.

  • take all medicines for HIV

and the
“ ”

  • , obtain more of it

causing a brief interruption in
doubt about the use of
to the nurse

  • or herpes zoster

  • decrease in

  • sensation of loss of

  • in the

  • and in the

  • increase in

  • nervous depression; attention disorder;

  • pain in the upper part of the

and of the blood loss from the

to the nurse.
in the

  • refers to the
  • tightly closed, with the desiccant (drying agent) protected from moisture. Do not swallow the desiccant.

in wastewater
protect the environment
Description of the appearance of Isent
“473” on the other side.

“ ”
on the other

Holder of the marketing authorisation
holder of the marketing authorisation
България
Merck Sharp & Dohme Bulgaria EOOD
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
MSD A.E.B.E.
Tel: + 30 210 98 97 300
Κύπρος
Tel:
are available on the website of the European Medicines Agency

Patient Information Leaflet

  • to the nurse
  • or to the nurse

What is Isentress and what is it used for
Instructions for use – the o
What is Isentress and what is it used for
What is
virus of the
the activity of this enzyme. When used with other medicines,
ue (this is known as "viral load") and
maintain a healthy immune system to help fight the infection).
your body may better fight the infectio
l’

Talk to your doctor, pharmacist, or nurse before taking
Isentress is not a cure for HIV infection. This means you may still
develop infections or other illnesses associated with HIV
a bone disease called osteonecrosis (death of bone tissue due to lack of
to the o , the use of corticosteroids, alcohol consumption
and severe reduction in immune activity
Symptoms of osteonecrosis include joint stiffness, discomfort, and pain (particularly in
the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptom
the nurse
hepatitis
the pharmacist or the infectio
to an improvement in the body's immune response, enabling it
after starting treatment for HIV infectio
months after the i
the pharmacist or the nurse
rmi the doctor, the pharmacist, or the nurse

  • no or neutralize the acid present in the stomach to reduce

  • ’ ’ ’

  • Breastfeeding is not recommended for HIV-positive women as HIV infection can

or to the nurse


pharmacist or nurse. If you have any doubts, consult your
medicines for HIV.
instructions for use in the leaflet
and the lea
Ensure that your doctor, pharmacist, or the nurs
with water before use.
according to age and
the i
ll weight gain. Your doctor

pharmacist or the nurse.

  • It is important to take all HIV medicines exactly as prescribed and

ere the HIV
also known as "drug resistance").

  • begins to decrease, obtain more from your doctor or

a brief interruption in taking the medicine, the amount of
any doubts about the u
to the nurse.

  • after Zoster

  • decreased appetite

  • ’equi

  • ’intestine;

  • in the groin

  • increased appetite; diabetes; increase in fa

  • nervous tension; attention disorder;

  • of the

upper part of the intestine; bleeding from the anus; stomach discomfort;

face, and increased fat in the abdomen; sweati

contact your doctor, pharmacist, or nurse.
in the

  • after Exp. The expiry date refers to the last day of
  • from moisture.

the leaflet “Instructions for use” for guidance on
and the a
this leaflet and the leaflet with
the instructions for use
Marketing Authorization Holder:
Marketing Authorization Holder:
България
Merck Sharp & Dohme Bulgaria EOOD
Tel.: +359 2 819 3737
Česká republika
Ελλάδα
MSD A.F.B.E.E.
Tel: + 30 210 98 97 300
Κύπρος
Tel:
ale are available on the website of the European Medicines Agency

Instructions for Use:

Instructions for Use

'use.

  • '
  • '
Perspective view of a white medicine box with black text and a folded leaflet underneath Black and white technical drawing of two transparent cylindrical containers with flat lids and a small lateral tab for opening Six white medication sachets arranged in two rows with black rectangular labels displaying unreadable white text Two blue syringes with black graduated scale and white plungers positioned diagonally on a white background Two syringes containing green liquid Two disposable syringes with graduated barrels and plungers ready for use
  • the necessary
Three graduated syringes of different sizes and colors: one large blue, one medium green, and one small transparent, arranged vertically White packaging of the drug Isentress 600 mg Raltegravir with black spaces for batch number and expiration date, barcode, and the text 'For Physician Only' Line drawing of a cylindrical container with a lid lifting upward Black and white line drawing of an empty conical glass with a circular base slightly narrower than the top Illustration of a hand holding a glass under a tap pouring water, with a glass bottle containing liquid and the label 'or' beside it Illustration of a blue syringe with a black arrow indicating the 10ml mark and a pink arrow pushing the plunger downward

the inside

Illustration of a hand holding a blue and grey syringe

'
'
Check for the presence of air bubbles

Drawing of a hand holding a syringe with blue liquid and a magnified view showing air bubbles inside

upwards the
' '
'

Diagram showing a hand holding a syringe with blue liquid and a magnified inset indicating the dosage level between 8 and 10 ml

and into the water and

Two hands preparing medication by inserting a blue syringe with needle into a small transparent vial, with a pink downward arrow Two hands opening a powder sachet above a glass container and another element

'

Drawing of a hand rotating a small glass vial with dashed arrows and a timer showing '45 seconds'

'

Profile of a human face with a red dashed line indicating the injection site

dose in “mL” prescribed

Blue syringe with graduated scale from 1 ml to 10 ml, cylindrical body, plunger, and narrow base on a white background Drawing of a green syringe with a graduated scale indicating milliliters from 0.5 ml to 3 ml on a white background Technical drawing of a graduated syringe with metric scale and a circular magnification showing the 0.1 ml mark indicated by a pink arrow Drawing of a horizontal syringe with a grey plunger pushed to the left by a magenta arrow pointing toward the syringe barrel

'

Two hands removing a syringe from a transparent container with an upward motion Technical drawing of a hand holding a syringe with a circular magnification showing air bubbles inside

Presence of air bubbles
the
' '
'

Line drawing of a human profile looking at a syringe held in hand with a pink arrow pointing toward the syringe Line drawing of two hands using a syringe to administer medication into the mouth of a stylized child

'
'

A hand washing a syringe cap under a stream of water

'
'