Zoledroninezuur Zentiva 5 mg/100ml, infusievloeistof

Follow all instructions given to you by your doctor carefully before you are given [Product name].

You should not be given [Product name]

• if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6)
• if you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
• If you have severe kidney problems.

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL

	Common Technical Document	CBG‐MEB
	Zoledronic acid (as monohydrate)
	5 mg/ 100 ml
	Module 1 ‐Section 3.5 Core SPC, Labelling	page 3/10
	and Package Leaflet
-	if you are pregnant.
-	if you are breast‐feeding.

Warnings and precautions

Tell your doctor before you are given [Product name]:

• if you are being treated with <Zoledronic acid 4 mg/5 ml concentrate for solution for infusion>, which contains the same active substance as [Product name]
• if you have a kidney problem, or used to have one.
• if you are unable to take daily calcium supplements.
• if you have had some or all of the parathyroid glands in your neck surgically removed.
• if you have had sections of your intestine removed.

Before you receive treatment with [Product name], tell your doctor if you have (or have had) pain, swelling or numbness in your gums, jaw or both, if your jaw feels heavy, or if you have lost a tooth. Before you receive dental treatment or undergo dental surgery, tell your dentist you are receiving treatment with [Product name].

Children and adolescents

[Product name] is not recommended for anyone under 18 years of age. The use of [Product name] in children and adolescents has not been studied.

Other medicines and [Product name]

Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines.

It is especially important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration.

[Product name] with food and drink

Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with [Product name], as directed by your doctor. This will help to prevent dehydration. You may eat normally on the day you are treated with [Product name].

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL

Common Technical Document	CBG‐MEB
Zoledronic acid (as monohydrate)
5 mg/ 100 ml
Module 1 ‐Section 3.5 Core SPC, Labelling	page 4/10
and Package Leaflet

This is especially important in patients who take diuretics (“water pills”) and in elderly patients.

Pregnancy and breast‐feeding

There is no adequate information on the use of zoledronic acid in pregnant women. Studies in animals have shown reproductive toxicological effects. Additionally, there is no information on the use of [Product name] in breast‐feeding women. You must not be given [Product name] if you are pregnant or plan to become pregnant.

You must not be given [Product name] if you are breast‐feeding.

Ask your doctor, pharmacist or nurse for advice before taking any medicine.

Driving and using machines

If you feel dizzy while taking [Product name], do not drive or use machines until you feel better.

[Product name] contains less than 1 mmol sodium (23 mg) per bag (100 ml), i.e. essentially “sodium-free”.

Follow carefully all instructions given to you by your doctor or nurse. You should check with your doctor or nurse if you are not sure.

Your doctor should do a blood test to check your kidney functions (levels of creatinine) before each dose of [Product name]. It is important for you to drink at least one or two glasses of fluid (such as water), within a few hours before receiving [Product name], as directed by your doctor.

Osteoporosis

The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse. The infusion will take at least 15 minutes.

In case you recently broke your hip, it is recommended that zoledronic acid is administered two or more weeks after your hip repair surgery.

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL

Common Technical Document	CBG‐MEB
Zoledronic acid (as monohydrate)
5 mg/ 100 ml
Module 1 ‐Section 3.5 Core SPC, Labelling	page 5/10
and Package Leaflet

It is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor.

For osteoporosis, zoledronic acid works for one year. Your doctor will let you know when to return for your next dose.

Paget’s disease

The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse. The infusion will take at least 15 minutes. [Product name] may work for longer than one year, and your doctor will let you know if you need to be treated again.

Your doctor may advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given [Product name]. It is important that you follow this advice carefully so that the level of calcium in your blood does not become too low in the period after the infusion. Your doctor will inform you regarding the symptoms associated with hypocalcaemia.

If a dose of [Product name] is missed

Contact your doctor or hospital as soon as possible to re‐schedule your appointment.

Before stopping [Product name] therapy

If you are considering stopping [Product name] treatment, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with [Product name].

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them. In most cases, no specific treatment is required.

Side effects related to the first infusion are very common (occurring in more than 30% of patients) but are less common following subsequent infusions. The

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL

Common Technical Document	CBG‐MEB
Zoledronic acid (as monohydrate)
5 mg/ 100 ml
Module 1 ‐Section 3.5 Core SPC, Labelling	page 6/10
and Package Leaflet

majority of the side effects, such as: fever and chills, pain in the muscles or joints and headache, occur within the first three days following the dose of [Product name]. The symptoms are usually mild to moderate and go away within three days. Your doctor can recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects. The chance of experiencing these side effects decreases with subsequent doses of [Product name].

Very common side effects (may affect more than 1 in 10 people)

Fever

Common side effects (may affect up to 1 in 10 people)

Headache • Dizziness • Sickness • Vomiting • Diarrhea • Pain in the muscles • Pain in the bones and/or joints • Pain in the back, arms or legs • Flu‐like symptoms (e.g. tiredness, chills, joint and muscle pain) • Chills • Feeling of tiredness and lack of interest • Weakness • Pain • Feeling unwell • Skin reactions such as redness • Swelling and/or pain at the infusion site.

In patients with Paget’s disease: symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth.

Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for post‐menopausal osteoporosis. It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.

Uncommon side effects (may affect up to 1 in 100 people)

Flu • Upper respiratory tract infections • Decreased red cell count • Loss of appetite • Sleeplessness • Sleepiness which may include reduced alertness and awareness • Tingling sensation or numbness • Extreme tiredness • Trembling • Temporary loss of consciousness • Eye infection or irritation or inflammation with pain and redness • Eye sensitivity to light • Spinning sensation • Increased blood pressure • Flushing • Cough • Shortness of breath • Upset stomach • Abdominal pain • Constipation • Dry mouth • Heartburn • Skin rash • Excessive sweating •

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL

Common Technical Document	CBG‐MEB
Zoledronic acid (as monohydrate)
5 mg/ 100 ml
Module 1 ‐Section 3.5 Core SPC, Labelling	page 7/10
and Package Leaflet

Itching • Skin reddening • Neck pain • Stiffness in muscles, bones and/or joints • Joint swelling • Muscle spasms • Shoulder pain • Pain in your chest muscles and rib cage • Joint inflammation • Muscular weakness • Abnormal kidney test results • Abnormal frequent urination • Swelling of hands, ankles or feet • Thirst • Toothache • Taste disturbances.

Frequency not known (frequency cannot be estimated from the available data)

Severe allergic reactions including dizziness and difficulty breathing • Swelling mainly of the face and throat • Decreased blood pressure • Pain in the mouth, teeth and jaw • Swelling or sores inside the mouth • Numbness or a feeling of heaviness in the jaw, or loosening of a tooth • Kidney disorder (e.g. decreased urine output) • Dehydration secondary to post‐dose symptoms such as fever, vomiting and diarrhoea.

Unusual fracture of the thigh bone particularly in patients on long‐term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

Your doctor, pharmacist or nurse knows how to store [Product name] properly.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.
• Store the unopened bag below 25ºC .

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL

Common Technical Document	CBG‐MEB
Zoledronic acid (as monohydrate)
5 mg/ 100 ml
Module 1 ‐Section 3.5 Core SPC, Labelling	page 8/10
and Package Leaflet

• After opening the bag, the product should be used immediately in order to avoid microbial contamination. 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 – 8°C. Allow the refrigerated solution to reach room temperature before administration.

What [Product name] contains

• The active substance is zoledronic acid. Each bag with 100 ml of solution contains 5 mg zoledronic acid anhydrous (as monohydrate). One ml solution contains 0.05 mg zoledronic acid anhydrous
• The other ingredients are: mannitol (E421), sodium citrate dihydrate (E331), sodium hydroxide (E524) for pH‐adjustment, hydrochloric acid (E507) for pH‐ adjustment and water for injections.

What [product name] looks like and contents of the pack

Zoledronic acid is a clear and colourless solution. It comes in a transparent 100 ml plastic bag with one port and one connector with a grey rubber membrane as a ready‐to‐use solution for infusion. It is supplied in packs containing one bag.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Zentiva k.s.

U kabelovny 130, 102 37, Prague 10

Dolní Měcholupy

Tsjechië

Manufacturers:

Synthon BV

Microweg 22

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL

Common Technical Document	CBG‐MEB
Zoledronic acid (as monohydrate)
5 mg/ 100 ml
Module 1 ‐Section 3.5 Core SPC, Labelling	page 9/10
and Package Leaflet
6545 CM Nijmegen
Nederland

Synthon Hispania SL

Castelló 1, Polígono Las Salinas

08830 Sant Boi de Llobregat Spanje

Dit geneesmiddel is geregistreerd onder:

Zoledroninezuur Zentiva 5 mg/100 ml, infusievloeistof RVG 109539

<This medicinal product is authorised in the Member States of the EEA under the

following names:>
Nederland	Zoledroninezuur Zentiva 5 mg/100 ml, infusievloeistof
Bulgarije	Zoledronic acid Zentiva 5mg solution for infusion
Cyprus	Zoledronic acid/zentiva
Duitsland	Zolendron Zentiva 5 mg/100 mg Infusionslösung
Estland	Zoledronic acid Zentiva 5 mg/ 100 ml
Griekenland	Zoledronic acid/zentiva
Hongarije	Zoledronsav‐Zentiva 5 mg/100 ml oldatos infúzió
Frankrijk	Acide zolédronique Zentiva 5 mg/100 ml, solution pour perfusion
Italië	Acido Zolendronico Zentiva
Polen	Zoledronic acid Zentiva
Roemenië	Acid Zoledronic Zentiva 5mg/100ml soluţie perfuzabilă
Portugal	ÁCIDO ZOLENDRÓNICO ZENTIVA
Slovenië	Zoledronska kislina Zentiva 5 mg raztopina za infundiranje
Slowakije	Kyselina zolendrónová Zentiva 5 mg
Letland	Zoledronic acid 5 mg/ 100 ml šķīdums infūzijām
Litouwen	Zoledronic acid Zentiva 5 mg/ 100 ml infuzinis tirpalas
Verenigd Koninkrijk	Zoledronic acid 5mg solution for infusion

This leaflet was last revised in januari 2013

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL

Common Technical Document	CBG‐MEB
Zoledronic acid (as monohydrate)
5 mg/ 100 ml
Module 1 ‐Section 3.5 Core SPC, Labelling	page 10/10
and Package Leaflet

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only (see section 3):

How to prepare and administer [Product name]

[Product name] is ready for use.

For single use only. Any unused solution should be discarded. Only clear solution free from particles and discoloration should be used. [Product name] must not be mixed or given intravenously with any other medicinal product and must be given through a separate vented infusion line at a constant infusion rate. The infusion time must not be less than 15 minutes. [Product name] must not be allowed to come into contact with any calcium-containing solutions. If refrigerated, allow the refrigerated solution to reach room temperature before administration. Aseptic techniques must be followed during preparation of the infusion. The infusion must be conducted according to standard medical practice.

How to store [Product name]

• Keep out of the sight and reach of children.
• Do not use [Product name] after the expiry date which is stated on the carton and bag.
• Store the unopened bag below 25ºC.
• After opening the bag, the product should be used immediately in order to avoid microbial contamination. 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 - 8°C. Allow the refrigerated solution to reach room temperature before administration.

issue date: 14‐05‐12

Document: M1.3.1_03.ZLE.mhy.bag.001.06.core

Author: PL