INWIXI 200mg powder lyophilized for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

gemcitabine (gemcitabine hydrochloride)

Available from:

PharmaTech CJSC

ATC code:

L01BC05

INN (International Name):

gemcitabine (gemcitabine hydrochloride)

Dosage:

200mg

Pharmaceutical form:

powder lyophilized for solution for infusion

Units in package:

glass vial 10ml and solvent in ampoule 5ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-05-17

Patient Information leaflet

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
INWIXI
®
200 MG, 1000 MG
POWDER LYOPHILIZED FOR SOLUTION FOR INFUSION
Gemcitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or
pharmacist.
- If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Inwixi is and what it is used for
2. What you need to know before you use Inwixi
3. How to use Inwixi
4. Possible side effects
5. How to store Inwixi
6. Contents of the pack and other information
1.
WHAT INWIXI IS AND WHAT IT IS USED FOR
Inwixi belongs to a group of medicines called ‘cytotoxics’. These
medicines kill dividing cells,
including cancer cells.
Gemcitabine may be given alone or in combination with other
anti-cancer medicines, depending
on the type of cancer you have.
Inwixi is used in the treatment of a number of types of cancer
including:

non-small cell lung cancer (NSCLC), alone or together with cisplatin

pancreatic cancer

breast cancer, together with paclitaxel

ovarian cancer, together with carboplatin

bladder cancer, together with cisplatin
_ _
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
2
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INWIXI
YOU SHOULD NOT BE GIVEN INWIXI

If you are allergic to gemcitabine or any of the other ingredients of
this medicine (listed

in section 6).

If you are breast-feeding.
Tell the doctor if you think any of the above applies to you.
_ _
WARNINGS AND PRECAUTIONS
Before the first infusion you will have samples of your blood taken to
evaluate if you have
sufficient kidney and liver function. Before each infusion you will
also have samples of your
blood taken to check if you have enoug

Summary of Product characteristics

PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
1
SUMMARY OF PRODUCT CHARACTERISTICS
INWIXI
®
200 MG, 1000 MG
POWDER LYOPHILIZED FOR SOLUTION FOR INFUSION
Gemcitabine
_1._
_ _
_NAME OF THE MEDICINAL PRODUCT _
INWIXI
®
_2._
_ _
_ QUALITATIVE AND QUANTITATIVE COMPOSITION: _
One vial contains gemcitabine hydrochloride, equivalent to 200 mg
gemcitabine.
One vial contains gemcitabine hydrochloride, equivalent to 1000 mg
gemcitabine.
Excipients
Each 200 mg vial contains approximately 3.5 mg (0.15 mmol) sodium.
Each 1 g vial contains approximately 17.5 mg (0.75 mmol) sodium.
For a full list of excipients, see section 6.1.
_3._
_ _
_PHARMACEUTICAL FORM _
Powder lyophilized for solution for infusion
Off white colored lyophilized powder.
_4._
_ _
_CLINICAL PARTICULARS _
_ _
_4.1 THERAPEUTIC INDICATIONS _
BLADDER CANCER:
Locally advanced or metastatic bladder cancer, in combination with
cisplatin.
PANCREATIC CANCER:
Locally advanced or metastatic adenocarcinoma of the pancreas.
NON-SMALL CELL LUNG CANCER:
First-line
treatment
of
patients
with
locally
advanced
or
metastatic
non-small
cell
lung
cancer,
in
combination with cisplatin. Gemcitabine monotherapy can be considered
in elderly patients or those with
performance status 2.
PharmaTech CJSC 111 Raffi st. Yerevan, 0064 Republic of Armenia Tel:
[phone] Fax: [phone]
2
OVARIAN CANCER:
Locally advanced or metastatic epithelial ovarian carcinoma, in
combination with carboplatin, in patients
with relapsed disease following a recurrence-free interval of at least
6 months after platinum-based, first line
therapy.
BREAST CANCER:
Unresectable, locally recurrent or metastatic breast cancer, in
combination with paclitaxel, in patients
experiencing a relapse after adjuvant/neoadjuvant chemotherapy. The
preceding chemotherapy should have
included an anthracycline, unless clinically contraindicated.
_4.2 POSOLOGY AND METHOD OF ADMINISTRATION _
For intravenous infusion, following reconstitution. Upon
reconstitution a