TEMO 100 MG

Israel - English - Ministry of Health

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Active ingredient:
TEMOZOLOMIDE
Available from:
PERRIGO ISRAEL AGENCIES LTD, ISRAEL
ATC code:
L01AX03
Pharmaceutical form:
CAPSULES
Composition:
TEMOZOLOMIDE 100 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
HAUPT PHARMA AMAREG GMBH, GERMANY
Therapeutic group:
TEMOZOLOMIDE
Therapeutic area:
TEMOZOLOMIDE
Therapeutic indications:
Temo capsules are indicated for the treatment of patients with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Temo capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma. Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment.
Authorization number:
145 26 33258 00
Authorization date:
2016-01-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

18-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-09-2020

PATIENT PACKAGE INSERT IN ACCORDANCE

WITH THE PHARMACISTS’ REGULATIONS

)PREPARATIONS( - 1986

This medicine is dispensed with a doctor’s

prescription only.

TEMO 5 mg, TEMO 20 mg, TEMO 100 mg,

TEMO 140 mg, TEMO 250 mg

Capsules

Each capsule contains:

Temozolomide 5mg, 20mg, 100mg, 140mg, 250mg

For a list of inactive ingredients, see section 6.1 ”What

Temo

contains“.

also

section

”Important

information

regarding

some

ingredients

Temo”.

Read this entire leaflet carefully before using this

medicine.

This

leaflet

contains

concise

information

about

Temo. If you have any further questions, ask your

doctor or pharmacist.

This

medicine

been

prescribed

your

treatment. Do not pass it on to others. It might harm

them, even if you think that their medical condition is

similar to yours.

This medicine is not intended for children under 3

years of age, since there is no information regarding

use in patients under the age of 3. The information

concerning children over 3 years of age is limited.

1. WHAT IS TEMO AND WHAT IS IT USED FOR?

1.1 What is Temo?

Temo contains the active ingredient temozolomide.

This

medicine

intended

treatment

cancerous tumors or different types of brain tumors.

Temo belongs to the group of cytotoxic medicines or

chemotherapy medicines.

Therapeutic group: Antineoplastic preparation.

1.2 What is Temo used for?

Temo capsules are intended for the treatment of:

Adult

patients

suffering

from

newly

diagnosed

glioblastoma

multiforme

unique

form

brain

tumor(

combined

with

radiation

treatment

subsequently as monotherapy treatment.

Children over 3 years of age, adolescents and adults

suffering from malignant glioma such as glioblastoma

multiforme or anaplastic astrocytoma )unique forms

of brain tumors(, that recur or continue to develop

after standard treatment.

Temo capsules are also intended as a first line of

treatment for adult patients suffering from advanced

metastatic malignant melanoma.

2. BEFORE TAKING TEMO

2.1 Do not take Temo:

allergic

active

ingredient

temozolomide or to any of the other ingredients of

this medicine, listed in section 6.1.

If you have had an allergic reaction to dacarbazine

)an anticancer medicine sometimes called DTIC(

in the past. Signs of an allergic reaction include

feeling

itchy,

breathlessness

wheezing,

swelling of the face, lips, tongue or throat.

If there is a severe decrease of certain blood cells

)myelosuppression(, such as your white blood

cell count and platelet count. These blood cells

are important for fighting infections and for proper

blood clotting. Your doctor will perform blood tests

to make sure you have enough of these blood

cells before starting treatment.

If you are pregnant or breastfeeding.

2.2 Special warnings regarding the use of Temo

Before

treatment

with

Temo,

talk

your

doctor,

pharmacist or nurse in the following cases:

Since

must

observed

closely

development of a serious case of a chest infection

called pneumocystis jirovecii pneumonia )PCP(. If

you are a newly diagnosed patient )glioblastoma

multiforme(, you may receive Temo for 42 days in

combination with radiation. In this case, your doctor

will also prescribe you a medicine that will help

prevent this type of pneumonia )PCP(.

If you have suffered in the past or might be suffering

from hepatitis B. This is because Temo may cause

reactivation

virus

that

causes

hepatitis

B which could even be life-threatening in certain

cases. The patients will be meticulously tested by

their doctor for signs of this infection before starting

treatment.

If you have a low count of red blood cells )anemia(,

white blood cells and platelets, or blood clotting

problems

before

starting

treatment

developed them during treatment. Your doctor might

reduce the dosage, intervene, stop or change your

treatment. You might also need other treatments. In

certain cases, it may be necessary to stop treatment

with Temo. Blood tests will be performed frequently

during the course of treatment in order to monitor the

side effects of Temo on your blood cells. as you may

have a small risk of additional changes in your blood

cells, including leukemia.

If you have nausea and/or vomiting, which are very

common side effects of Temo )see section 4(, your

doctor may prescribe you an anti-emetic medicine to

help prevent vomiting. If you vomit frequently before

or during treatment, ask your doctor about the best

time to take Temo until the vomiting is under control.

If you vomit after taking the dose, do not take a

second dose on the same day.

If you develop a fever or symptoms of an infection,

refer to your doctor immediately.

If you are older than 70 years of age, since you might

be more prone to infections, bruising or bleeding.

If you have liver or kidney problems, there may be a

need to adjust the dosage of Temo.

When using the medicine, there is a risk of liver

damage, including liver failure that may be life-

threatening. Therefore, it is necessary to perform

liver function tests before and during treatment with

Temo.

!

2.3 Taking other medicines and Temo

taking

have

recently

taken

other

medicines, including non-prescription medicines and

nutritional supplements, tell the attending doctor or

pharmacist. Especially inform the doctor or pharmacist

if you are taking: other medicines used to treat cancer,

other myelosuppressive medicines or valproic acid.

!

2.4 Taking Temo with food and drink

Take the capsules on an empty stomach, for example:

at least an hour before you plan to eat breakfast.

Swallow the capsule/s whole with a glass of water.

!

2.5 Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant or

planning

becoming

pregnant,

consult

your

doctor or pharmacist before taking this medicine. This

is because you must not use Temo during pregnancy

unless explicitly instructed to do so by your doctor.

Female patients or female partners of patients must

avoid pregnancy during treatment and for 6 months

following treatment completion.

Male and female patients taking Temo must use

effective contraceptive means )see also ”Fertility in

men“ below(.

You must stop breastfeeding during treatment with

Temo.

Male fertility:

Temo may cause permanent infertility. Men treated

with Temo should use effective contraceptive means

and not impregnate their partner for up to 6 months

after stopping treatment. It is recommended to seek

advice on conservation of sperm before starting the

treatment.

!

2.6 Driving and use of machinery

Temo may make you feel tired or sleepy. In this case,

do not drive or operate any tools or machinery or ride

a bicycle until you see how this medicine affects you

)see section 4 ”Side effects“(.

!

2.7 Important information about some of the

ingredients of Temo

Temo contains lactose )a type of sugar(. If you have

been told by your doctor that you have an intolerance

to certain sugars, refer to your doctor before taking the

medicine.

!

2.8 Children and adolescents

Do not give this medicine to children under 3 years

of age as it has not been studied. Temo is intended

for the treatment of children from 3 years of age for

different types of brain tumors )such as glioblastoma

multiforme and anaplastic astrocytoma(, that recur

continue

develop

after

standard

treatment.

However, the information on children over 3 years of

age is limited.

3. HOW SHOULD YOU USE TEMO?

Always

take

Temo

exactly

prescribed

doctor. It is very important to check with your doctor

or pharmacist if you are unsure. Mistakes in how you

take the medicine might have severe repercussions on

your health.

Do not exceed the recommended dose.

This

medicine

is

not

intended

for

infants

and

children under 3 years of age.

Your doctor will decide on the exact dose of Temo

you should take, based on body size )height, weight(,

whether

have

been

treated

with

chemotherapy in the past. You may be asked to take

an additional medicine before or after taking Temo in

order to prevent or control nausea and vomiting.

How to take this medicine )for all patients(:

Take your prescribed Temo dose once a day on an

empty stomach, for example, at least one hour before

breakfast. It is preferable to take the dose at the same

time every day. Swallow the capsule whole with a glass

of water.

Do not open, crush or chew the capsule. If a capsule

has been damaged, avoid contact of the capsule’s

powder with the skin and mucous membrane )eyes,

nose(.

Depending on the dosage that will be determined for

you, you may need to swallow more than one capsule

at a time, and you may need to swallow capsules of

different dosages together )dosages – the amount of

active ingredient in the capsule, in milligrams(. The

color of the stripes and the writing on the capsules is

different for the different dosages )see details in the

following table(.

Strength

Color of stripes and writing

TEMO 5 mg

"T 5mg" written in green

TEMO 20 mg

"T 20mg" written in orange

TEMO 100 mg

"T 100mg" written in pink

TEMO 140 mg

"T 140mg" written in blue

TEMO 250 mg

"T 250mg" written in black

Make sure that you fully understand and remember the

following points:

The number of capsules you have to take every

”dosing day“. Ask your doctor or pharmacist to write

it down )including the color of the stripes(.

What your dosing days are – the days on which you

take the medicine.

Confirm the dosage with your doctor every time you

start a new treatment cycle, since it might be different

than the previous treatment cycle.

Tests and follow-up

During the course of treatment you must undergo

blood tests frequently in order to monitor the status of

your blood cells.

In addition, a liver function test will be performed before

and during the course of treatment, since there is a risk

of liver damage that may even be life-threatening )see

section 2(.

In case of vomiting after taking the medicine, do not

take another dose that same day.

If you took more Temo than you should have

If you accidently took more Temo capsules than you

were told to, refer to your doctor, pharmacist or nurse

immediately.

If you forgot to take Temo

Take the forgotten dosage as soon as possible during

the same day. If a full day of treatment has passed,

check with your doctor. Do not take a double dose

to make up for a forgotten dose, unless the doctor

instructed you to do so.

Do not take medicines in the dark! Check the label and

the dose each time you take a medicine. Wear glasses

if you need them.

If you have any further questions regarding the use of

this medicine, ask your doctor, pharmacist or nurse.

4. SIDE EFFECTS

As with any medicine, the use of this medicine may

cause side effects in some users.

Refer to your doctor immediately if you have any of

the following signs:

A severe allergic )hypersensitivity( reaction )hives,

wheezing or other breathing difficulties(

Uncontrolled bleeding

Epileptic seizures )convulsions(

Fever

Severe headache that does not go away

Treatment

with

Temo

cause

reduction

the counts of certain kinds of blood cells. This may

cause you increased bruising or bleeding, anemia

)a shortage of red blood cells(, fever, and reduced

resistance to infections. The reduction in blood cell

counts usually lasts a short while. In certain cases, it

may be prolonged and may lead to a very severe form

of anemia )aplastic anemia(. Your doctor will regularly

check your blood to detect changes, and decide if any

treatment is needed. In some cases, the dosage of

Temo will be reduced or the treatment will be stopped.

Side effects from clinical studies:

Temo in combination treatment with radiotherapy in

newly diagnosed glioblastoma patients

Patients

receiving

Temo

combination

with

radiotherapy

experience

different

side

effects

than patients taking Temo alone. The following side

effects may occur, and may require medical attention:

Very common )effects that occur in more than one

in ten users(: loss of appetite, headache, constipation

)difficulty passing stools(, nausea, vomiting, rash, hair

loss, tiredness.

Common )effects that may affect up to 1 in 10 users(:

oral infections, wound infection, a reduction in the

number of blood cells )neutropenia, thrombocytopenia,

lymphocytopenia,

leukopenia(,

increased

blood

sugar levels, weight loss, change in mental status or

alertness,

anxiety/depression,

sleepiness,

difficulty

speaking,

impaired

balance,

dizziness,

confusion,

forgetfulness, difficulty concentrating, inability to fall

asleep or stay asleep, tingling sensation, bruising,

shaking,

abnormal

blurry

vision,

double

vision,

hearing impairment, shortness of breath, cough, blood

clot in the legs, fluid retention, swollen legs, diarrhea,

stomach or abdominal pain, heartburn, upset stomach,

difficulty

swallowing,

mouth,

skin

irritation

redness, dry skin, itchiness, muscle weakness, joint

pain, muscle pains, frequent urination, difficulty holding

in urine, allergic reaction, fever, radiation injury, facial

swelling, pain, abnormal taste, abnormal liver function

test results.

Uncommon )effects that may affect up to 1 in 100

users(: flu-like symptoms, red spots under the skin,

low potassium level in the blood, weight gain, mood

swings,

hallucinations

memory

impairment,

partial

paralysis,

impaired

coordination,

impaired

sensations, partial loss of vision, dryness or pain in

the eyes, deafness, middle ear infection, ringing in

the ears, earaches, palpitations )when you can feel

your heartbeats(, blood clot in the lung, hypertension,

pneumonia, inflammation of the sinuses, bronchitis, a

cold or the flu, swollen abdomen, difficulty controlling

bowel

movements,

hemorrhoids,

peeling

skin,

increased skin sensitivity to sunlight, change in skin

color,

increased

sweating,

muscle

damage,

back

pain, difficulty in urinating, vaginal bleeding, sexual

impotence, absent or heavy menstrual periods, vaginal

irritation, breast pain, hot flushes, shivering, change in

tongue color, changes in sense of smell, thirst, tooth

disorder.

Temo monotherapy treatment in patients with recurring

or progressive glioma or malignant melanoma

The following

side

effects may occur and

require

medical attention:

Very common )effects that occur in more than

one in ten users(: reduced number of blood cells

)neutropenia or lymphocytopenia, thrombocytopenia(,

loss

appetite,

headache,

vomiting,

nausea,

constipation )difficulty passing stools(, tiredness.

Common )effects that may affect up to 1 in 10

users(: weight loss, sleepiness, dizziness, tingling

sensation, shortness of breath, diarrhea, abdominal

pain, upset stomach, rash, itching, hair loss, red spots

under the skin, fever, weakness, shivering, feeling

unwell, pain, changes in sense of taste.

Uncommon )effects that may affect up to 1 in 100

users(:

reduced

blood

cell

counts

)pancytopenia,

anemia, leukopenia(.

Rare )effects that may affect up to 1 in 1,000 users(:

cough, infections including pneumonia.

Very rare )effects that may affect up to 1 in 10,000

users(: skin redness, urticaria )hives(, skin eruptions,

allergic reactions.

Additional side effects:

Cases

elevations

liver

enzymes

have

been

commonly

reported.

Cases

increased

bilirubin,

problems

bile

flow

)cholestasis(,

hepatitis

liver damage, including fatal liver failure, have been

uncommonly reported.

Very rare cases of severe rash with skin swelling,

including on the palms of the hands and soles of the

feet, or painful reddening of the skin and/or blisters on

the body or in the mouth have been observed. Refer to

your doctor immediately if these side effects appear.

Very rare cases of lung side effects, including cases

of non-infectious pneumonia, have been observed with

Temo. Patients usually experience shortness of breath

and cough. If you notice these symptoms, refer to your

doctor.

In very rare cases, patients taking Temo and similar

medicines might be at risk of developing secondary

cancers, including leukemia.

recurring

cytomegalovirus

infections

reactivated

hepatitis

virus

infections

have

been

uncommonly reported.

Cases of brain infections cause by the herpes virus

)meningoencephalitis herpetic(, including fatal cases,

have been uncommonly reported.

Cases of diabetes insipidus have been uncommonly

reported. Signs of diabetes insipidus include passing a

lot of urine and a feeling of thirst.

If a side effect appears, if one of the side effects

worsens

suffer

from

side

effect

mentioned in this leaflet, consult your doctor.

Reporting of side effects:

Side effects can be reported to the Ministry of Health

by clicking on the link ”Report Side Effects of Drug

Treatment“ found on the Ministry of Health homepage

)www.health.gov.il( which directs to the online form for

reporting side effects, or by entering the link:

h t t p s : / / f o r m s . g o v. i l / g l o b a l d a t a / g e t s e q u e n c e /

getsequence.aspx?formType=AdversEffectMedic@

moh.gov.il

Additionally, you can report to Perrigo via the following

address: www.perrigo-pharma.co.il

5. HOW SHOULD THE MEDICINE BE STORED?

Store this medicine out of the reach and sight of

children, preferably in a locked cabinet. Accidental

swallowing can be lethal for children.

Do not use the medicine after the expiry date )exp.

date( that appears on the package. The expiry date

refers to the last day of that month

Storage conditions: Store below 25°C. Can be used

for 3 weeks after first opening, but not later than the

expiry date.

Do not dispose of medicines via wastewater or

household

waste.

your

pharmacist

dispose

medicines

longer

use.

These

measures will help to protect the environment.

6. PACKAGE CONTENTS AND FURTHER

INFORMATION

6.1 What does Temo contain?

In addition to the active ingredient Temozolomide the

medicine also contains:

Lactose anhydrous, Sodium starch glycolate )type A(,

Stearic acid, Tartaric acid, Silica colloidal anhydrous,

Gelatin, Titanium dioxide )E 171(.

Each 5 mg capsule contains: 87.30 mg lactose and

0.21 mg sodium.

Each 20 mg capsule contains: 72.30 mg lactose and

0.21 mg sodium.

Each 100 mg capsule contains: 83.60 mg lactose and

0.42 mg sodium.

Each 140 mg capsule contains: 117.04 mg lactose and

0.59 mg sodium.

Each 250 mg capsule contains: 209.00 mg lactose and

1.05 mg sodium.

6.2 What Temo looks like and contents of the

package

Temo 5 mg: white opaque gelatin capsule with two

stripes and "T 5mg" written in green.

Temo 20 mg: white opaque gelatin capsule with two

stripes and "T 20mg" written in orange.

Temo 100 mg: white opaque gelatin capsule with two

stripes and "T 100mg" written in pink.

Temo 140 mg: white opaque gelatin capsule with two

stripes and "T 140mg" written in blue.

Temo 250 mg: white opaque gelatin capsule with two

stripes and "T 250mg" written in black.

capsules

contain

white-beige

light

pink

powder.

Registration

holder

address:

Perrigo

Israel

Agencies Ltd., 1 Rakefet St., Shoham 6085000.

Manufacturer and address: Haupt Pharma Amareg

GmbH,

Regensburg, Germany.

This

leaflet

checked

approved

Ministry of Health in May 2015 and was updated in

accordance with the Ministry of Health’s instructions

in May 2018.

Registration number of the medicine in the National

Drug Registry of the Ministry of Health:

Temo 5 mg:14524.33256

Temo 20 mg:14525.33257

Temo 100 mg:14526.33258

Temo 140 mg:14527.33259

Temo 250 mg:14529.33261

Temo PIL PB0618-06

نول ريغت ,نافجر ,رح تابه ,نييدثلا يف ملأ ,لبهملا يف جيهت ,ديدش فيزن عم .نانسلأا ررضت ,شطع ,مشلا ةساحب ريغت ,ناسللا وأ مقافتم وأ رركتم يقبد مرو مهيدل نيذلا ىضرم ىدل طقف وميت ـب جلاع ثيبخ ينينلايم مرو :يبط جلاع بلطتتو ثدحت دق ةيلاتلا ةيبناجلا ضارعلأا :)ةرشع نم دحاو لمعتسم نم رثكأ ىدل رهظت ضارعأ( ا

ً

دج ةعئاش ةلق وأ

]neutropenia[

تلادعلا ةلق( مدلا ايلاخ دادعت ضافخنإ ,ؤيقت ,عادص ,ماعطلل ةيهشلا نادقف ,)ةيومدلا تاحيفصلا ةلق ,تايوافمللا .قاهرإ ,)زاربلا جارخإب ةبوعص( كاسمإ ,نايثغ ضافخنإ :)نيلمعتسم ١٠ نيب نم ١ ىلع رثؤت دق يتلا ضارعأ( ةعئاش ,نطب ملأ ,لاهسإ ,سفنت قيض ,زخوب روعشلا ,راود ,ساعن ,نزولا تحت نم ءارمح طاقن ,رعش طقاست ,ةكح ,حفط ,مضهلا يف ةبوعص .معطلا يف تاريغت ,ملأ ,ديج ريغ روعش ,نافجر ,فعض ,ةنوخس ,دلجلا :)لمعتسم ١٠٠ نيب نم ١ ىتح ىلع رثؤت دق ةيبناج ضارعأ( ةعئاش ريغ ,]Pancytopenia[ ةلماشلا تايركلا ةلق( مدلا ايلاخ دادعت ضافخنإ .)]ءاضيبلا مدلا ايلاخ ةلق[ تلادعلا ةلق ,مدلا رقف :)لمعتسم ١.٠٠٠ نيب نم ١ ىتح ىلع رثؤت دق يتلا ضارعأ( ةردان .يوئر باهتلإ كلذ يف امب تاثولت ,لاعس ١٠.٠٠٠ نيب نم ١ ىتح ىلع رثؤت دق يتلا ضارعأ( ا

ً

دج ةردان .ةيسسحت لعف دودر ,يدلج حفط ,ىرش ,دلجلا يف رارمحإ :)لمعتسم :ةيفاضإ ةيبناج ضارعأ لكشب غيلبتلا مت .ةعئاش نايحأب دبكلا تاميزنإ بسن عافترإ تلااح نع غيلبتلا مت ةرارملا ىرجم عم لكاشم ,نيبوريليبلا بسن عافترا تلااح نع عئاش ريغ كلذ يف امب ,دبكلا ررضتو دبكلا باهتلإ ,)]cholestasis[يوارفص دوكر( .توملل ببسملا يدبك روصق نيديلا اتحار لمشي ,دلجلا خافتنا عم ديدش حفطل ا

دج ةردان تلااح تدهوش هجوت .مفلا يف وأ مسجلا يف تلاصيوح وأ/و دلجلل ملؤم رارمحا وأ ,نيمدقلاو .ضارعلأا هذه ترهظ اذإ ا

ً

روف بيبطلل تلااح لمشي ,نيتئرلا يف ةيبناج ضارعلأ ا

دج ةردان تلااح وميت عم تدهوش .يدعملا ريغ نيتئرلا باهتلا نم تنك اذإ بيبطلل هجوت .لاعسو سفنت قيضل ماع لكشب نوج

لاعملا ضرعتي .ضارعلأا هذه ظحلات ةهباشم ةيودأو وميت نولوانتي نيذلا نيج

لاعملل نوكي دق ,ا

دج ةردان تلااح يف مدلا ضاضيبإ كلذ يف امب ,ةيوناث ةيناطرس ضارمأ روطتل ةروطخ هل .)]leukemia[ ايميكول( سوريڤلا نم ةرركتم وأ ةديدج تاثولت نع ةعئاش ريغ ةريتوب غيلبتلا مت ةددجتم ةيلاعف دعب ام تاثولتو ]cytomegalovirus[ ايلاخلل مخضملا .B عونلا نم دبكلا باهتللا ببسملا سوريڤلل سوريڤ اهببسي يتلا غامدلا يف ثولت تلااح نع ةعئاش ريغ ةريتوب غيلبتلا مت meningoencephalitis( يسپرهلا غامدلاو اياحسلا باهتلإ[ سپرهلا .ةتيمم تلااح لمشت يتلاو ,])herpetic diabetes( ةهفتلا ةلاوبلل تلااح نع ةعئاش ريغ ةريتوب غيلبتلا مت لوبلا نم ةريبك ةيمك جاتنإ لمشت ةهفتلا ةلاوبلا تاملاع .)insipidus .شطعلاب روعشلاو تنك اذإ وأ ,ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ,يبناج ضرع رهظ اذإ .بيبطلا ةراشتسا كيلع ,ةرشنلا يف ركذي مل يبناج ضرع نم يناعت :ةيبناج ضارعأ نع غيلبتلا ىلع طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب ةحفصلا ىلع دوجوملا "يئاود جلاع بقع ةيبناج ضارعأ نع غيلبت" طبارلا ىلإ كهجوي يذلا )www.health.gov.il( ةحصلا ةرازو عقومل ةيسيئرلا :طبارلا حفصت قيرط نع وأ ,ةيبناج ضارعأ نع غيلبتلل رشابملا جذومنلا

https://forms.gov.il/globaldata/getsequence/

getsequence.aspx?formType=AdversEffectMedic@

moh.gov.il

يلاتلا ناونعلا ةطساوب وچيريپ ةكرش غيلبت ناكملإاب ,كلذل ةفاضلإاب:www.

perrigo-pharma.co.il

ءاودلا نيزخت ةيفيك )٥

.ةلفقم ةنازخ يف ل

َّ

ضفي ,لافطلأا ةيؤر لاجمو يديأ لوانتم نع ا

ديعب ءاودلا ظفحإ .لافطلأل ا

تيمم نوكي نأ نكمي أطخلاب علبلا

رهظي يذلا )exp. date( ةيحلاصلا خيرات ءاضقنا دعب ءاودلا لامعتسا زوجي لا .رهشلا سفن نم ريخلأا مويلا ىلإ ةيحلاصلا خيرات ريشي .ةبلعلا رهظ ىلع

لولأ حتفلا دعب .ةيوئم ةجرد ٢٥ نود ةرارح ةجردب ظفحلا بجي :نيزختلا طورش .ةيحلاصلا ءاهتنا خيرات دعب سيل نكل ,عيباسأ ٣ ةدمل لامعتسلإا ناكملإاب ةرم

نع يلديصلا لأسإ .ةيتيبلا ةمامقلا وأ فرصلا هايم يف ةيودلأا ءاقلإ زوجي لا ىلع دعاست لئاسولا هذه .لامعتسلإا ديق دعت مل يتلا ةيودلأا نم صلختلا ةيفيك .ةئيبلا ةيامح ةيفاضإ تامولعمو ةبلعلا ىوتحم )٦ ؟وميت يوتحي اذام ١.٦ :ىلع ءاودلا يوتحي ديمولوزوميت ةلاعفلا ةداملل ةفاضلإاب

Lactose anhydrous, Sodium starch glycolate )type A(,

Stearic acid, Tartaric acid, Silica colloidal anhydrous,

Gelatin, Titanium dioxide )E 171(.

مويدوص ٠.

٢١ -و زوتكلا غلم ٨٧.٣٠ :ىلع يوتحت غلم ٥ ةلوسبك لك مويدوص ٠.

٢١ -و زوتكلا غلم ٣٠.٧٢ :ىلع يوتحت غلم ٢٠ ةلوسبك لك مويدوص ٠.

٤٢ -و زوتكلا غلم ٨٣

.٦٠ :ىلع يوتحت غلم ١٠٠ ةلوسبك لك مويدوص ٠.

٥9 -و زوتكلا غلم ١١٧

.٠٤ :ىلع يوتحت غلم ١٤٠ ةلوسبك لك مويدوص ١.

٠٥ -و زوتكلا غلم ٢٠9

.٠٠ :ىلع يوتحت غلم ٢٥٠ ةلوسبك لك ةبلعلا ىوتحم وه امو وميت ودبي فيك ٢.٦ ةباتكو نا

طخ اهيلعو ةموتخم ءاضيب نيتلايج ةلوسبك :غلم ٥ وميت رضخأ نولب ”T ٥mg “ ةباتكو نا

طخ اهيلعو ةموتخم ءاضيب نيتلايج ةلوسبك :غلم ٢٠ وميت يلاقترب نولب ”T ٢٠mg “ ةباتكو نا

طخ اهيلعو ةموتخم ءاضيب نيتلايج ةلوسبك :غلم ١٠٠ وميت يرهز نولب ”T ١٠٠mg “ ةباتكو نا

طخ اهيلعو ةموتخم ءاضيب نيتلايج ةلوسبك :غلم ١٤٠ وميت قرزأ نولب ”T ١٤٠mg “ ةباتكو نا

طخ اهيلعو ةموتخم ءاضيب نيتلايج ةلوسبك :غلم ٢٥٠ وميت دوسأ نولب ”T ٢٥٠mg “ .حتاف يرهز ىلإ جيب ضيبأ نولب قوحسم ىلع تلاوسبكلا يوتحت

,١ تيفيكار عراش ,.ض.م ليئارسإ وچيريپ تلااكو :هناونعو ليجستلا بحاص .٦٠٨٥٠٠٠ ماهوش

.ايناملأ ,چروبسنچير ,.ض.م چيرامأ امراف تپواه :هناونعو جتنملا مسإ

متو ٢٠١٥ رايأ يف قدوصو صح

ف اهنومضمو ةرشنلا هذه ةحصلا ةرازو ترقأ .٢٠١٨ رايأ يف ةحصلا ةرازو تاميلعتل ا

قفو اهثيدحت

:ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجس مقر ١٤٥٢٤ -٣٣٢٥٦ :غلم ٥ وميت ١٤٥٢٥ -٣٣٢٥٧ :غلم ٢٠ وميت ١٤٥٢٦ -٣٣٢٥٨ :غلم ١٠٠ وميت ١٤٥٢٧ -٣٣٢٥9 :غلم ١٤٠ وميت ١٤٥٢9 -٣٣٢٦١ :غلم ٢٥٠ وميت

ىلع .ركذملا ةغيصب ةرشنلا هذه ةغايص تمت ,ةءارقلا نيوهتو ةلوهس لجأ نم .نيسنجلا لاكل صصخم ءاودلا نإف ,كلذ نم مغرلا

וגירפ

לארשי

תויונכוס

מ"עב

חר בו תפקר

םהוש

6083705

.ד.ת

םהוש ,

6085001

:'לט

03-5773545

:סקפ

03-5773730

רבמטפס

2020

,ה/דבכנ ת/חקור ה/אפור

ןוכדע לע םכתא עדייל תשקבמ וגירפ תרבח ןכרצל ןולעה

רישכת םי

Temo 5, 20, 100, 140, 250 mg /

ומט

5

,

20

,

100

,

140

,

250

ג"מ

Dosage Form: capsules

Composition: Each capsule contains 5, 20, 100, 140 or 250 mg temozolomide

ה

ה

היוות לארשיב רישכתל המושרה

:

Temo capsules are indicated for the treatment of patients with malignant

glioma such as glioblastoma multiforme or anaplastic astrocytoma, showing

recurrence or progression after standard therapy. Temo capsules are also

indicated as first line treatment for patients with advanced metastatic

malignant melanoma. Newly diagnosed glioblastoma multiforme

concomitantly with radiotherapy and subsequently as monotherapy treatment.

םימייק .בוהצ עקר לע תוחיטב ינוכדעכ םירדגומה םייתוהמה םייונישה קר םיניוצמ וז העדוהב םניאו םייתוהמ םניאש םיפסונ םינוכדע

.וז העדוהב םיללכנ

ולעה

ןכרצל ןכדועמה

חלשנ

םוסרפל רתאבש תופורתה רגאמב תואירבה דרשמ

https://data.health.gov.il/drugs/index.html#!/byDrug

ספדומ

הינפ י"ע תרבחל

וגירפ מ"עב לארשי :ןופלטב

03-5773700

הכרבב

ןמיש המלע

הנוממ תחקור

לארשי וגירפ וס תויונכ

מ"עב

וגירפ

לארשי

תויונכוס

מ"עב

חר בו תפקר

םהוש

6083705

.ד.ת

םהוש ,

6085001

:'לט

03-5773545

:סקפ

03-5773730

ב תוחיטב ינוכדע

ןכרצל ןולע

3

הפורתב שמתשת דציכ .

אל הפישחל ןוכיסה תא תיחפהל תנמ לע

ל תנווכמ ,ומט .תוסומכה תא חותפל ןיא

4

.

יאוול תועפות

תונפל שי אפורל

דימ

םיאבה םינמיסהמ דחא לכ ךל שי םא

תורומרמצ

יאוול תועפות

דואמ תוחיכש

)הרשע ךותמ דחא שמתשממ רתויב תועיפומש תועפות(

:

ןדבוא

,ןובאית רוביד יישק

שאר באכ

לושלש

תוריצע

ליחב

תואקה

יאוול תועפות תוחיכש דע לע עיפשהל תולולעש תועפות(

1

ךותמ

10

)םישמתשמ

:

העיגפ היצנידרואוקב

לקשמה יווישב

,תרוחרחס

ערפה

תשוחתב ,תוי

,ץוצקע תשוחת

,דער

גירח םעט

,הייארה לש יקלח ןדבוא

,הלופכ הייאר ,הניקת אל הייאר

תובאוכ וא תושבי םייניע

,תושר

םיינזוא באכ ,םיינזואב םילוצלצ

אירב םד שירק

תו

וא

םיילגרב

הובג םד ץחל

)סיטיכנורב( תונופמיס תקלד ,םיסוניסה תקלד ,תואיר תקלד

לועיש ,המישנ רצוק

קזנ

םירירשל

םירירש תשלוח

םירירש יבאכ

םיקרפמב באכ

בג באכ

,םוח

תעפש ייומד םינימסת

באכ

תיללכ השוחת ,

הבוט אל

תעפש וא תוררקתה

לקשמב הדירי

לקשמב הילע

אל יאוול תועפות

תוחיכש דע לע עיפשהל תולולעש תועפות(

1

ךותמ

100

:)םישמתשמ

הימקול ללוכ ינשמ ןטרס

הפב וא ףוגה לע תויחופלש ,החירפ תוצרפתה ,רועה ףוליק ,

החירפ ,באכב הוולמה רועב םדוא םיילגרה תופכבו םיידיה תופכב ללוכ( רועב תוחיפנב הוולמה הרומח

,שמשה רואל רועה לש תרבגומ תושיגר

,)תדפרס( הירקיטרוא

רועה עבצב יוניש ,תרבגומ העזה

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