Aclasta 5 Mg/100 Ml Iv Solution For Infusion Novartis

Aclasta 5 Mg/100 Ml Iv Solution For Infusion Novartis

Brand:NOVARTIS-ALCON Pharmaceuticals
Product Code:194
Availability:In Stock

PACKAGE LEAFLET: INFORMATION FOR THE USER
Aclasta® 5 mg solution for infusion

Zoledronic acid

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-                 Keep this leaflet. You may need to read it again.

-                 If you have any further questions, ask your doctor, pharmacist or nurse.

-                 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET
1.               What Aclasta is and what it is used for

2.               What you need to know before you are given Aclasta

3.               How Aclasta is given

4.               Possible side effects

5.               How to store Aclasta

6.               Contents of the pack and other information

1.  WHAT ACLASTA IS AND WHAT IT IS USED FOR
ACLASTA CONTAINS THE ACTIVE SUBSTANCE ZOLEDRONIC ACID. IT BELONGS TO A GROUP OF MEDICINES CALLED BISPHOSPHONATES AND IS USED TO TREAT POST-MENOPAUSAL WOMEN AND ADULT MEN WITH OSTEOPOROSIS OR OSTEOPOROSIS CAUSED BY TREATMENT WITH STEROIDS, AND PAGET’S DISEASE OF THE BONE IN ADULTS.
OSTEOPOROSIS
OSTEOPOROSIS IS A DISEASE THAT INVOLVES THE THINNING AND WEAKENING OF THE BONES AND IS COMMON IN WOMEN AFTER THE MENOPAUSE, BUT CAN ALSO OCCUR IN MEN. AT THE MENOPAUSE, A WOMAN’S OVARIES STOP PRODUCING THE FEMALE HORMONE OESTROGEN, WHICH HELPS KEEP BONES HEALTHY. FOLLOWING THE MENOPAUSE BONE LOSS OCCURS, BONES BECOME WEAKER AND BREAK MORE EASILY. OSTEOPOROSIS COULD ALSO OCCUR IN MEN AND WOMEN BECAUSE OF THE LONG TERM USE OF STEROIDS, WHICH CAN AFFECT THE STRENGTH OF BONES. MANY PATIENTS WITH OSTEOPOROSIS HAVE NO SYMPTOMS BUT THEY ARE STILL AT RISK OF BREAKING BONES BECAUSE OSTEOPOROSIS HAS MADE THEIR BONES WEAKER. DECREASED CIRCULATING LEVELS OF SEX HORMONES, MAINLY OESTROGENS CONVERTED FROM ANDROGENS, ALSO PLAY A ROLE IN THE MORE GRADUAL BONE LOSS OBSERVED IN MEN. IN BOTH WOMEN AND MEN, ACLASTA STRENGTHENS THE BONE AND THEREFORE MAKES IT LESS LIKELY TO BREAK. ACLASTA IS ALSO USED IN PATIENTS WHO HAVE RECENTLY BROKEN THEIR HIP IN A MINOR TRAUMA SUCH AS A FALL AND THEREFORE ARE AT RISK OF SUBSEQUENT BONE BREAKS.
PAGET’S DISEASE OF THE BONE
IT IS NORMAL THAT OLD BONE IS REMOVED AND IS REPLACED WITH NEW BONE MATERIAL. THIS PROCESS IS CALLED REMODELLING. IN PAGET’S DISEASE, BONE REMODELLING IS TOO RAPID AND NEW BONE IS FORMED IN A DISORDERED FASHION, WHICH MAKES IT WEAKER THAN NORMAL. IF THE DISEASE IS NOT TREATED, BONES MAY BECOME DEFORMED AND PAINFUL, AND MAY BREAK. ACLASTA WORKS BY RETURNING THE BONE REMODELLING PROCESS TO NORMAL, SECURING FORMATION OF NORMAL BONE, THUS RESTORING STRENGTH TO THE BONE.
 

2.  WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ACLASTA
FOLLOW ALL INSTRUCTIONS GIVEN TO YOU BY YOUR DOCTOR, PHARMACIST OR NURSE CAREFULLY BEFORE YOU ARE GIVEN ACLASTA.
YOU MUST NOT BE GIVEN ACLASTA:
-                 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.
-                 IF YOU ARE PREGNANT.
-                 IF YOU ARE BREAST-FEEDING.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE YOU ARE GIVEN ACLASTA:
-                 IF YOU ARE BEING TREATED WITH ZOMETA, WHICH CONTAINS THE SAME ACTIVE SUBSTANCE AS ACLASTA (ZOMETA IS USED IN ADULT PATIENTS WITH CERTAIN TYPES OF CANCER TO PREVENT BONE COMPLICATIONS OR TO REDUCE THE AMOUNT OF CALCIUM).
-                 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 ACLASTA, 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 ACLASTA.
MONITORING TEST
YOUR DOCTOR SHOULD DO A BLOOD TEST TO CHECK YOUR KIDNEY FUNCTION (LEVELS OF CREATININE) BEFORE EACH DOSE OF ACLASTA. IT IS IMPORTANT FOR YOU TO DRINK AT LEAST 2 GLASSES OF FLUID (SUCH AS WATER), WITHIN A FEW HOURS BEFORE RECEIVING ACLASTA, AS DIRECTED BY YOUR HEALTHCARE PROVIDER.
CHILDREN AND ADOLESCENTS
ACLASTA IS NOT RECOMMENDED FOR ANYONE UNDER 18 YEARS OF AGE. THE USE OF ACLASTA IN CHILDREN AND ADOLESCENTS HAS NOT BEEN STUDIED.
OTHER MEDICINES AND ACLASTA
TELL YOUR DOCTOR, PHARMACIST OR NURSE IF YOU ARE TAKING, HAVE RECENTLY TAKEN OR MIGHT TAKE 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.
PREGNANCY AND BREAST-FEEDING
YOU MUST NOT BE GIVEN ACLASTA IF YOU ARE PREGNANT OR BREAST-FEEDING, THINK YOU MAY BE PREGNANT OR ARE PLANNING TO HAVE A BABY.
ASK YOUR DOCTOR, PHARMACIST OR NURSE FOR ADVICE BEFORE TAKING THIS MEDICINE.
DRIVING AND USING MACHINES
ACLASTA HAS NO OR NEGLIGIBLE INFLUENCE ON THE ABILITY TO DRIVE AND USE MACHINES. IF YOU FEEL DIZZY WHILE TAKING ACLASTA, DO NOT DRIVE OR USE MACHINES UNTIL YOU FEEL BETTER.
3.  HOW ACLASTA IS GIVEN
FOLLOW CAREFULLY ALL INSTRUCTIONS GIVEN TO YOU BY YOUR DOCTOR OR NURSE. CHECK WITH YOUR DOCTOR OR NURSE IF YOU ARE NOT SURE.
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 ACLASTA IS ADMINISTERED TWO OR MORE WEEKS AFTER YOUR HIP REPAIR SURGERY.
IT IS IMPORTANT TO TAKE CALCIUM AND VITAMIN D SUPPLEMENTS (FOR EXAMPLE TABLETS) AS DIRECTED BY YOUR DOCTOR.
FOR OSTEOPOROSIS, ACLASTA 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 INITIAL INFUSION INTO A VEIN BY YOUR DOCTOR OR NURSE. THE INFUSION WILL TAKE AT LEAST 15 MINUTES. ACLASTA 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 ACLASTA. 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.
ACLASTA WITH FOOD AND DRINK
MAKE SURE YOU DRINK ENOUGH FLUIDS (AT LEAST ONE OR TWO GLASSES) BEFORE AND AFTER THE TREATMENT WITH ACLASTA, AS DIRECTED BY YOUR DOCTOR. THIS WILL HELP TO PREVENT DEHYDRATION. YOU MAY EAT NORMALLY ON  THE DAY YOU ARE TREATED WITH ACLASTA. THIS IS ESPECIALLY IMPORTANT IN PATIENTS WHO TAKE DIURETICS (“WATER PILLS”) AND IN ELDERLY PATIENTS.
IF YOU MISSED A DOSE OF ACLASTA
CONTACT YOUR DOCTOR OR HOSPITAL AS SOON AS POSSIBLE TO RE-SCHEDULE YOUR APPOINTMENT.
BEFORE STOPPING ACLASTA THERAPY
IF YOU ARE CONSIDERING STOPPING ACLASTA 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  ACLASTA.
IF YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS MEDICINE, ASK YOUR DOCTOR, PHARMACIST OR NURSE.
4.POSSIBLE SIDE EFFECTS
LIKE ALL MEDICINES, THIS MEDICINE CAN CAUSE SIDE EFFECTS, ALTHOUGH NOT EVERYBODY GETS THEM.
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 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 ACLASTA. 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 ACLASTA.
SOME SIDE EFFECTS COULD BE SERIOUS
COMMON (MAY AFFECT UP TO 1 IN 10 PEOPLE)
IRREGULAR HEART RHYTHM (ATRIAL FIBRILLATION) HAS BEEN SEEN IN PATIENTS RECEIVING ACLASTA FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS. IT IS CURRENTLY UNCLEAR WHETHER ACLASTA CAUSES THIS IRREGULAR HEART RHYTHM BUT YOU SHOULD REPORT IT TO YOUR DOCTOR IF YOU EXPERIENCE SUCH SYMPTOMS AFTER YOU HAVE RECEIVED ACLASTA.
SWELLING AND/OR PAIN AT THE INFUSION SITE MAY OCCUR.
UNCOMMON (MAY AFFECT UP TO 1 IN 100 PEOPLE) SKIN REACTIONS SUCH AS REDNESS.
SWELLING, REDNESS, PAIN AND ITCHING TO THE EYES OR EYE SENSITIVITY TO LIGHT.
NOT KNOWN (FREQUENCY CANNOT BE ESTIMATED FROM THE AVAILABLE DATA)
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. THESE COULD BE SIGNS OF BONE DAMAGE IN THE JAW (OSTEONECROSIS). TELL YOUR DENTIST IMMEDIATELY IF YOU EXPERIENCE SUCH SYMPTOMS.
KIDNEY DISORDERS (E.G. DECREASED URINE OUTPUT) MAY OCCUR. YOUR DOCTOR SHOULD DO A BLOOD TEST TO CHECK YOUR KIDNEY FUNCTION BEFORE EACH DOSE OF ACLASTA. IT IS IMPORTANT FOR YOU TO DRINK AT LEAST 2 GLASSES OF FLUID (SUCH AS WATER), WITHIN A FEW HOURS BEFORE RECEIVING ACLASTA, AS DIRECTED BY YOUR HEALTHCARE PROVIDER.
IF YOU EXPERIENCE ANY OF THE ABOVE SIDE EFFECTS, YOU SHOULD CONTACT YOUR DOCTOR IMMEDIATELY.
ACLASTA MAY ALSO CAUSE OTHER SIDE EFFECTS
VERY COMMON (MAY AFFECT MORE THAN 1 IN 10 PEOPLE) FEVER
COMMON (MAY AFFECT UP TO 1 IN 10 PEOPLE)
HEADACHE, DIZZINESS, SICKNESS, VOMITING, DIARRHOEA, 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.
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 HAVE BEEN REPORTED.
UNCOMMON (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, SPINNING SENSATION, INCREASED BLOOD PRESSURE, FLUSHING, COUGH, SHORTNESS OF BREATH, UPSET STOMACH, ABDOMINAL PAIN, CONSTIPATION, DRY MOUTH, HEARTBURN, SKIN RASH, EXCESSIVE SWEATING, 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.
RARE (MAY AFFECT UP TO 1 IN 1,000 PEOPLE)
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.
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, DEHYDRATION SECONDARY TO POST-DOSE SYMPTOMS SUCH AS FEVER, VOMITING AND DIARRHOEA.
REPORTING OF SIDE EFFECTS
IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR, PHARMACIST OR NURSE. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. YOU CAN ALSO REPORT SIDE EFFECTS DIRECTLY (SEE DETAILS BELOW). BY REPORTING SIDE EFFECTS, YOU CAN HELP PROVIDE MORE INFORMATION ON THE SAFETY OF THIS MEDICINE.
United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Ireland

Pharmacovigilance Section Irish Medicines Board Kevin O’Malley House Earlsfort Centre

Earlsfort Terrace IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

Malta

ADR Reporting             The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GŻR-1368 Gżira

Website:   www.medicinesauthority.gov.mt

e-mail:    postlicensing.medicinesauthority@gov.mt

5. HOW TO STORE ACLASTA
Your doctor, pharmacist or nurse knows how to store Aclasta 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 bottle after EXP.

-                 The unopened bottle does not require any special storage conditions.

-                 After opening the bottle, 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT ACLASTA CONTAINS
-                 THE ACTIVE SUBSTANCE IS ZOLEDRONIC ACID. EACH BOTTLE WITH 100 ML OF SOLUTION CONTAINS 5 MG ZOLEDRONIC ACID ANHYDROUS (AS MONOHYDRATE).
ONE ML SOLUTION CONTAINS 0.05 MG ZOLEDRONIC ACID (AS MONOHYDRATE).
-                 THE OTHER INGREDIENTS ARE MANNITOL, SODIUM CITRATE AND WATER FOR INJECTIONS.
WHAT ACLASTA LOOKS LIKE AND CONTENTS OF THE PACK
Aclasta is a clear and colourless solution. It comes in 100 ml plastic bottles as a ready-to-use solution for infusion. It is supplied in packs containing one bottle as unit pack, or in multipacks comprising five packs, each containing one bottle. Not all pack sizes may be marketed.

Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road

Horsham

West Sussex, RH12 5AB United Kingdom

Manufacturer  Novartis Pharma GmbH Roonstraße 25

D-90429 Nuremberg Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

LIETUVA
Novartis Pharma Services Inc. Tel: +370 5 269 16 50

БЪЛГАРИЯ
Novartis Pharma Services Inc.

Тел: +359 2 489 98 28

Luxembourg/Luxemburg Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11

ČESKÁ REPUBLIKA
Novartis s.r.o.

Tel: +420 225 775 111

MAGYARORSZÁG
Novartis Hungária Kft. Pharma Tel.: +36 1 457 65 00

DANMARK
Novartis Healthcare A/S Tlf: +45 39 16 84 00

MALTA
Novartis Pharma Services Inc. Tel: +356 2122 2872

DEUTSCHLAND
Novartis Pharma GmbH Tel: +49 911 273 0

NEDERLAND
Novartis Pharma B.V. Tel: +31 26 37 82 111

EESTI
Novartis Pharma Services Inc. Tel: +372 66 30 810

NORGE
Novartis Norge AS Tlf: +47 23 05 20 00

ΕΛΛΆΔΑ
Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12

ÖSTERREICH
Novartis Pharma GmbH Tel: +43 1 86 6570

ESPAÑA
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00

POLSKA
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888

FRANCE
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00

PORTUGAL
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600

HRVATSKA
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220

ROMÂNIA
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01

IRELAND
Novartis Ireland Limited Tel: +353 1 260 12 55

SLOVENIJA
Novartis Pharma Services Inc. Tel: +386 1 300 75 50

ÍSLAND
Vistor hf.

Sími: +354 535 7000

Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439

ITALIA
Novartis Farma S.p.A. Tel: +39 02 96 54 1

SUOMI/FINLAND
Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

ΚΎΠΡΟΣ
Novartis Pharma Services Inc.

Τηλ: +357 22 690 690

SVERIGE
Novartis Sverige AB Tel: +46 8 732 32 00

LATVIJA
Novartis Pharma Services Inc. Tel: +371 67 887 070

UNITED KINGDOM
Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370

THIS LEAFLET WAS LAST REVISED IN 07/2013
OTHER SOURCES OF INFORMATION
DETAILED INFORMATION ON THIS MEDICINE IS AVAILABLE ON THE EUROPEAN MEDICINES AGENCY WEBSITE: HTTP://WWW.EMA.EUROPA.EU
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY (SEE SECTION 3):
HOW TO PREPARE AND ADMINISTER ACLASTA
-                 ACLASTA 5 MG SOLUTION FOR INFUSION 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. Aclasta 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. Aclasta 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 ACLASTA
-                 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 BOTTLE AFTER EXP.
-                 THE UNOPENED BOTTLE DOES NOT REQUIRE ANY SPECIAL STORAGE CONDITIONS.
-                 AFTER OPENING THE BOTTLE, 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.

Write a review



Note: HTML is not translated!

Bad           Good