Cidomycin® 80mg/2ml Solution for Injection

Gentamicin

SANOFlO

Technical Leaflet- Cidomycin Injection

The following information is extracted from the SPC.

Technical information for the preparation and administration of Cidomycin.

1.    TRADE NAME OF THE MEDICINAL PRODUCT

Cidomycin® 80mg/2ml Solution for Injection.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ampoule or vial (2ml) contains Gentamicin Sulphate Ph Eur equivalent to 80mg Gentamicin base.

Also contains

Sodium chloride: 12.84 mg/2ml ampoule or vial For a full list of excipients, see section 6.1

3.    PHARMACEUTICAL FORM

Solution for Injection.

Clear, colourless solution.

4.2. Posology and method of administration ADULTS :

Serious infections : If renal function is not impaired, 5mg/kg/daily in divided doses at six or eight hourly intervals. The total daily dose may be subsequently increased or decreased as clinically indicated.

Systemic infections : If renal function is not impaired, 3-5mg/kg/day in divided doses according to severity of infection, adjusting according to clinical response and body weight.

Urinary tract infections : As “Systemic infections”. Or, if renal function is not impaired, 160mg once daily may be used.

PAEDIATRIC PATIENTS :

The daily dose recommended in children aged 1 year and above and adolescents with normal renal function, is ~ 3-6mg/kg body weight per day as 1 (preferred) or up to 2 _ single dose(s).

~ The daily dose in infants after the first month of life is

_ 4.5-7.5mg/kg body weight per day as 1 (preferred) or up

to 2 single dose(s).

The daily dose in neonates and pre-term infants (aged 0-4 weeks old) is 4-7mg/kg body weight per day. Due to the longer half-life, newborns are given the required daily dose in 1 single dose.

THE ELDERLY :

There is some evidence that elderly patients may be more susceptible to aminoglycoside toxicity whether secondary to previous eighth nerve impairment or borderline renal dysfunction. Accordingly, therapy should be closely monitored by frequent determination of gentamicin serum levels, assessment of renal function and signs of ototoxicity.

RENAL IMPAIRMENT :

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cidomycin® 80mg/2ml Solution for Injection

^Gentamicin    SANOFI^

Is this leaflet hard to see or read? Phone 0845 372 7101 for help

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again. •If you have any further questions, ask your

doctor or pharmacist.

•This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Cidomycin is and what it is used for

2.    Before you take Cidomycin

3.    How to take Cidomycin

4.    Possible side effects

5.    How to store Cidomycin

6.    Further information

1. What Cidomycin is and what it is used for

The name of your medicine is Cidomycin 80mg/2ml Solution for Injection (called Cidomycin throughout this leaflet). It contains a medicine called gentamicin. This belongs to a group of antibiotics called ‘aminoglycosides’. Cidomycin is used to treat infections caused by bacteria. This includes infections of the:

•    Urinary tract (including your kidneys or bladder)

•    Chest (including your lungs)

•    Blood - this is sometimes called ‘bacteraemia’ or ‘septicaemia’.

2. Before you have Cidomycin

Do not have this medicine if:

X You have Myasthenia Gravis. This is a disease that causes muscle weakness.

X You are allergic (hypersensitive) to gentamicin, any other antibiotics or to any of the other ingredients of this medicine (see Section 6: Further Information).

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat and tongue.

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Cidomycin.

LU Take special care with Cidomycin Check with your doctor or pharmacist before having this medicine if:

^A You are pregnant, might become pregnant, or think you may be pregnant.

^A You are breast-feeding (see ‘Pregnancy and breast-feeding’ section below)

^A You have any muscle weakness problems ^A You are extremely overweight ^A You have kidney problems, are over 65 years of age or the patient is less than 1 year old.

This is because your doctor will need to keep a careful eye on you during your treatment, to prevent damage to your ears.

He may check your hearing, your balance, how your kidneys are working and the amount of gentamicin in your blood.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Cidomycin.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Cidomycin can affect the way some other medicines work. Also some medicines can affect the way Cidomycin works.

In particular, tell your doctor if you are taking any of the following:

•    Medicines to thin the blood such as warfarin •Water tablets or injections (diuretics) such as

furosemide or etacrynic acid •Amphotericin B (used to treat fungal infections)

•    Cephalosporin antibiotics such as cephaloridine •Ciclosporin (used in organ transplants or for

severe skin problems)

•    Neostigmine or pyridostigmine (used to treat Myasthenia Gravis)

•    Muscle relaxants - sometimes used during operations which need an anaesthesic

•Indometacin (used to treat pain or swelling)

•    Bisphosphonates (used to treat osteoporosis) •Cisplatin (used to treat some cancers)

•    Botulinum toxin - used to lower the activity of overactive muscles. This is also sometimes used in cosmetic procedures.

These medicines may increase certain side effects (see Section 4: Possible side effects).

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine

if you are pregnant, might become pregnant,

or think you may be pregnant. Cidomycin    m

should not normally be used during pregnancy.

If you are breast-feeding or planning to    ^m

breast-feed, talk to your doctor or pharmacist before taking any medicine.

Important information about some of the ingredients of Cidomycin Cidomycin contains very little sodium. It contains less than 1 mmol sodium (23 mg) per ampoule or vial.

3. How to have Cidomycin

Cidomycin is always given to you by a doctor or nurse. This is because it needs to be given as an injection.

Having this medicine

Your doctor will decide how much to give you, depending on your weight. The correct dose also depends on the type of infection and any other illnesses you may have. Blood samples will be taken by your doctor or nurse to check the dose is right for you.

Adults:

•The usual daily dose in adults is 3-5mg for each kg of body weight •This is split into doses given every 6-8 hours •This dose may be increased or decreased by your doctor depending on your illness Children (aged 1 year and above):

•    The usual daily dose is 3-6mg for each kg of body weight

•    This is given either as 1 single dose (preferred) or split into 2 separate

^doses    11503321-01 *

The recommended dose and precautions for intramuscular and intravenous administration are identical. Gentamicin when given intravenously should be injected directly into a vein or into the drip set tubing over no less than three minutes. If administered by infusion, this should be over no longer than 20 minutes and in no greater volume of fluid than 100ml.

Monitoring Advice

Serum concentration monitoring of gentamicin is recommended, especially in elderly, in newborns and in patients with impaired renal function.

Samples are taken at the end of a dosing interval (trough level). Trough levels should not exceed 2pg/ml administering gentamicin twice daily and 1pg/ml for once daily dose.

4.4 Special Warnings and precautions for use

To avoid adverse events, continuous monitoring (before, during and after) of renal function (serum creatinin, creatinin clearance), control of function of vestibule and cochlea as well as hepatic and laboratory parameters is recommended.

Ototoxicity has been recorded following the use of gentamicin. Groups at special risk include patients with impaired renal function, infants and possibly the elderly. Consequently, renal, auditory and vestibular functions should be monitored in these patients and serum levels determined so as to avoid peak concentrations above 10mg/l and troughs above 2mg/l when administering Gentamicin twice daily and 1mg/l for a once daily dose.

As there is some evidence that risk of both ototoxicity and nephrotoxicity is related to the level of total exposure, duration of therapy should be the shortest possible compatible with clinical recovery. In some patients with impaired renal function there has been a transient rise in blood-urea-nitrogen which has usually reverted to normal during or following cessation of therapy. It is important to adjust the frequency of dosage according to the degree of renal function.

Gentamicin should only be used in pregnancy if considered essential by the physician (see section 4.6 Pregnancy and Lactation.)

Gentamicin should be used with care in conditions characterised by muscular weakness.

In cases of significant obesity gentamicin serum concentrations should be closely monitored and a reduction in dose should be considered.

PHARMACEUTICAL PARTICULARS

6.1    List of Excipients

Sodium Chloride Water for Injections

2N Sodium Hydroxide (for pH adjustment)

2N Sulphuric Acid (for pH adjustment)

6.2    Incompatabilities

In general, gentamicin injection should not be mixed. In particular the following are incompatible in mixed solution with gentamicin injection : penicillins, cephalosporins, erythromycin, heparins, sodium bicarbonate.

*    Dilution in the body will obviate the danger of physical and chemical incompatibility and enable gentamicin to be given concurrently with the drugs listed above either as a bolus injection into the drip tubing, with adequate flushing, or at separate sites. In the case of carbenicillin, administration should only be at a separate site.

*    Carbon dioxide may be liberated on addition of the two solutions. Normally this will dissolve in the solution but under some circumstances small bubbles may form.

6.3    Shelf-life

3 years

6.4    Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5    Nature and contents of container

Cidomycin is supplied in in packs of 5 x 2ml colourless glass ampoules (Type I) with an OPC (one point cut) break system and red and green rings or in packs of 5 x 2ml colourless glass vials (Type I) closed with a chlorobutyl rubber stopper sealed with an aluminium capsule type flip-off.

6.6    Instructions for use/handling

Not applicable.

9.    FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

July 2011

10.    DATE OF REVISION

June 2013

11503321-01

Babies (aged 4 weeks to 1 year):

•    The usual daily dose is 4.5-7.5mg for each kg of body weight

•    This is given either as 1 single dose (preferred) or split into 2 separate doses

Premature babies or new born babies (up to 4 weeks)

•    The usual daily dose is 4-7mg for each kg of body weight

•    This is given in 1 single dose

If you have more Cidomycin than you should

It is most unlikely that you will be given too much medicine by the doctor or nurse. Your doctor or nurse will be checking your progress and checking the medicine that you are given. Ask if you are not sure why you are getting a dose of medicine.

If you forget to have Cidomycin Your doctor or nurse have instructions about when to give you your medicine. It is most unlikely that you will not be given the medicine as it has been prescribed. If you think that you may have missed a dose then talk to your nurse or doctor.

If you stop having Cidomycin It is important that the course of treatment your doctor has prescribed is finished. You may start to feel better but it is important to continue your treatment until the doctor advises. If you stop, your infection may get worse again.

4. Possible side effects

Like all medicines, Cidomycin can cause side effects, although not everybody gets them.

Tell your doctor or nurse as soon as possible if any of the following side effects happen: Ear problems: these may happen because Cidomycin can sometimes damage the ear, especially if your kidneys do not work very well. The side effects are:

•    Difficulty keeping your balance

•    Feeling dizzy

•    Poor hearing.

Kidney problems: if you notice anything unusual when you pass water, such as:

•    If you see any sign of blood in your water (urine)

•    If you find you are passing less water than is normal for you.

Nerve or muscle problems:

•    If you have unusual difficulty in moving which has not happened before

•    If you have a feeling of weakness or unusual tiredness

•    If you have any breathing difficulties that have not happened before

•    Numbness, weakness and pain in the arms and legs (peripheral neuropathy)

If you are not sure if you have any of the above, talk to your doctor or nurse as soon as possible. Tell your doctor or nurse if any of the following side effects get serious or last longer than a few days. Also tell them if you notice any side effects not listed in this leaflet •Allergic (also called hypersensitivity) reactions, such as nettle rash or difficulty breathing

•    Headache

•    Feeling tired

•Purplish or reddish-brown skin colouring

•    Mouth ulcers

•    Feeling or being sick (nausea or vomiting)

•    Rash

•    Bloody diarrhoea

•    Fits or convulsions

•    Feeling confused

•    Depression

•Strange visions or sounds (hallucinations) and memory loss 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cidomycin

•    Keep out of the reach and sight of children •You will not be asked to store your

medicine. It will be brought to you ready to be taken straight away.

•    Do not store this medicine above 25°C.

It should not be kept in a fridge or freezer

•    Do not have Cidomycin after the expiry date. This is stated in month and year on the carton and on the label after “Exp”. The expiry date refers to the last day of that month. If you are not sure when this is, check with your doctor or pharmacist.

•Ask your pharmacist how to dispose of medicines no longer needed. Do not dispose of medicines by flushing down the toilet or a sink or by throwing out with your normal household rubbish. This will help to protect the environment.

6. Further information

What Cidomycin contains

•The active substance is gentamicin sulphate equivalent to 80mg of gentamicin.

•The other ingredients are sulphuric acid and sodium hydroxide for pH adjustment, sodium chloride and water for injections What Cidomycin looks like and content of the pack

The medicine is a clear, colourless solution for injection in 2ml ampoules or vials. Cidomycin is available in packs of 5 glass ampoules with an OPC (one point cut) break system and red and green rings or in packs of 5 glass vials closed with a chlorobutyl rubber stopper sealed with an aluminium capsule type flip-off. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel: 0845 372 7101

Email: uk-medicalinformation@sanofi.com Manufacturer

FAMAR HEALTH CARE SERVICES MADRID, S.A.U.

Avda. Leganes, 62

Alcorcon 28923 (Madrid) Spain

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 01/2015

©Sanofi, 1973 - 2015