What Zarzio contains
- The active substance is filgrastim. Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 30 MU filgrastim in 0.5 ml, corresponding to 60 MU/ml. Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe: Each pre-filled syringe contains 48 MU filgrastim in 0.5 ml, corresponding to 96 MU/ml
- The other ingredients are glutamic acid, sorbitol (E420), polysorbate 80 and water for injections.
What Zarzio looks like and contents of the pack
Zarzio is a clear, colourless to slightly yellowish solution for injection or infusion in a pre-filled syringe.
Zarzio is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
LuxembourgLuxemburg Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Tel 43 5338 2000 BelgiëBelgiqueBelgien Sandoz nv-sa Telecom Gardens Medialaan 40 B-1800 Vilvoorde TélTel 32 27229797
.. 4, , 8, .6 1715 . 359 2 970 47 47 Magyarország Sandoz Hungária Kft. Bartók Béla út 43.-47. H-1114 Budapest Tel. 36 1 430 2890 info.hungarysandoz.com
Malta Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Tel 43 5338 2000 eská republika Sandoz s.r.o. U Nákladového nádraí 10 CZ 130 00 Praha 3 Tel 420 221 421 611 office.czsandoz.com
Danmark Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S Tlf 45 6395 1000 Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel 31 36 52 41 600
Norge Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S Tlf 45 6395 1000 Deutschland NeoCorp AG Am Weidenbach 6 D-82362 Weilheim Tel 49 881 909 5960 infoneocorp.de oder Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 D-83607 Holzkirchen Tel 49 8024 902 4000 infosandoz.d
Eesti Sandoz d.d. Eesti filiaal Pärnu mnt 105 EE 11312 Tallinn Tel 372 6652 400 Österreich Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Tel 43 5338 2000
Polska Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C PL 02 672 Warszawa Tel. 48 22 549 15 00 Novartis Hellas A.E.B.E. 12 .1 144 51 30 210 281 17 12 DEMO 21o . . -, 145 68, , . 210 8161802 infodemo.g
España Sandoz Farmacéutica, SA Avda. Osa Mayor, 4 E-28023 Aravaca Madrid Tel. 34 91 548 84 04 sandoz.respondesandoz.com France Sandoz SAS 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél 33 1 49 64 48 00 Portugal Sandoz Farmacêutica Lda. Alameda da Beloura, Edifício 1 2 andar Esc. 15 P-2710693 Sintra Tel 351 21 924 19 11 sandoz.ptsandoz.com România S.C. Sandoz SRL Str. Livezeni, Nr 7A Târgu Mure, 540472 - RO Tel 40 265 208 120
Slovenija Lek farmacevtska druba d.d. Verovkova 57 SI-1526 Ljubljana Tel 386 1 580 21 11 Ireland Rowex Ltd Bantry Co. Cork - IRL Tel 353 27 50077 regrowa-pharma.ie
Ísland Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S Tlf 45 6395 1000 Slovenská republika Sandoz d.d. - organizaná zloka Galvaniho 15C SK-821 04 Bratislava Tel 421 2 48 200 600
Italia Sandoz S.p.A. Largo Umberto Boccioni, 1 I-21040 Origgio VA Tel 39 02 96541 SuomiFinland Sandoz AS Edvard Thomsens Vej 14 DK-2300 Kööpenhamina S PuhTel 45 6395 1000
..t t 31- 3042 f 357 25372425 Sverige Sandoz AS Edvard Thomsens Vej 14 DK-2300 Körpenhamn S Tel 45 6395 1000
Latvija Sandoz d.d. Prstvniecba Latvij K. Valdemra iela 33 - 30 Rga, LV-1010 Tel 371 67 892 006 United Kingdom Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR UK Tel 44 1276 69 8020 uk.drugsafetysandoz.com
Sandoz Pharmaceuticals d.d filialas
?eimyni?ki- g. 3A
LT ? 09312 Vilnius
Tel: +370 5 2636 038
This leaflet was last approved in
Instructions on how to inject yourself
This section contains information on how to give yourself an injection of Zarzio. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Zarzio is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
How do I inject myself?
You will need to give yourself an injection into the tissue under the skin, known as a subcutaneous injection. Your doctor or nurse will tell you how frequently it should be injected.
What do I need?
To give yourself a subcutaneous injection you will need:
1. A new pre-filled syringe of Zarzio with or without a needle safety guard
2. Alcohol wipes or similar
3. A puncture-proof container for disposing of used syringes safely if you use the Zarzio pre-filled syringe without a needle safety guard.
What should I do before I give myself a subcutaneous injection of Zarzio?
1. Take your Zarzio pack out of the refrigerator. Accidental exposure to freezing temperatures does not adversely affect the stability of Zarzio.
2. Do not shake the packing containing the pre-filled syringe.
3. Check that it is the correct strength you need for the dose that your doctor has prescribed.
4. Check the expiry date which is stated on the carton and syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
5. Check the appearance of Zarzio. It must be clear. If it is cloudy or there are particles in it, you must not use it.
6. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Zarzio in any other way (for example, do not warm it in a microwave or in hot water).
7. Do not remove the plastic cover from the needle until you are ready to inject.
8. Wash your hands thoroughly.
9. Find a comfortable, well-lit place and put the syringe, the alcohol wipes and if necessary the puncture-proof container where you can reach them.
How do I prepare the injection?
Before you inject Zarzio you must do the following:
1. Gently remove the plastic cover from the needle without twisting it. Do not touch the needle or push the plunger.
2. Hold the syringe with the needle pointing upwards to check if there are air bubbles in the syringe. If there are air bubbles in it expel all air from the syringe by cautiously pushing the plunger upwards (avoid expelling liquid from the syringe).
3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (ml) that matches the dose of Zarzio that your doctor prescribed.
4. Check again to make sure the correct dose of Zarzio is in the syringe.
5. You can now use the pre-filled syringe.
Where should I give my injection?
The most suitable places to inject yourself are The top of your thighs and The abdomen, except for the area around the navel. Change the place that you inject each time so you dont become sore in one area. If someone is injecting for you, they can also use the back of your arms.
How do I give my injection?
1. Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
2. Insert the needle under the skin at an angle of approximately 45° as shown by your nurse or doctor.
3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and put it in another place.
Pre-filled syringe without needle safety guard 58
4. Always keeping your skin pinched, depress the plunger slowly and evenly.
5. After injecting the liquid, remove the needle and let go of your skin.
6. Put the used syringe in the disposal container. Use each syringe only for one injection.
Pre-filled syringe with needle safety guard
4. Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger 5. After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin. 6. Let go of the plunger. The needle safety guard will rapidly move to cover the needle. 7. Use each syringe only for one injection.
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Disposal of used syringes
The used syringes should be disposed of in accordance with local requirements.
Pre-filled syringe without needle safety guard
- Do not put the cover back on used syringes.
- Put used syringes into the puncture-proof disposal container and keep it out of the reach and sight of children.
- Dispose of the full container as instructed by your doctor, nurse or pharmacist.
- NEVER put used syringes into your normal household waste bin.
Pre-filled syringe with needle safety guard
- The needle safety guard prevents needle stick injuries after use, so no special disposal precautions are required. Dispose of the syringe as instructed by your doctor, nurse or pharmacist.
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
The solution should be visually inspected prior to use. Only clear solutions without particles should be used. Accidental exposure to freezing temperatures does not adversely affect the stability of Zarzio.
Zarzio contains no preservative: In view of the possible risk of microbial contamination, Zarzio syringes are for single use only.
Dilution prior to administration (optional)
If required, Zarzio may be diluted in glucose 50 mg/ml (5%) solution. Zarzio must not be diluted with sodium chloride solutions.
Dilution to a final concentration < 0.2 MU/ml (2 ?g/ml) is not recommended at any time.
For patients treated with filgrastim diluted to concentrations < 1.5 MU/ml (15 ?g/ml), human serum albumin (HSA) should be added to a final concentration of 2 mg/ml.
Example: In a final volume of 20 ml, total doses of filgrastim less than 30 MU (300 ?g) should be given with 0.2 ml of human serum albumin 200 mg/ml (20%) solution Ph. Eur. added.
When diluted in glucose 50 mg/ml (5%) solution, filgrastim is compatible with glass and a variety of plastics including polyvinylchloride, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
After dilution: Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Using the pre-filled syringe with a needle safety guard
The needle safety guard covers the needle after injection to prevent needle stick injury. This does not affect normal operation of the syringe. Depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. While maintaining pressure on the plunger, remove the syringe from the patient. The needle safety guard will cover the needle when releasing the plunger.
Using the pre-filled syringe without a needle safety guard
Administer the dose as per standard protocol.
Any unused product or waste material should be disposed of in accordance with local requirements.