Document: Erythromycin Stragen powder for solution for infusion ENG PL change

• Erythromycin Stragen powder for solution for infusion PL
• Erythromycin Stragen powder for solution for infusion ENG PL

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Package leaflet: Information for the patient

Erythromycin Stragen 1 g powder for solution for infusion

erythromycin

Read all of this leaflet carefully before you start using 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 or nurse.

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

What is in this leaflet

1. What Erythromycin Stragen is and what it is used for

2. What you need to know before you use Erythromycin Stragen

3. How to use Erythromycin Stragen

4. Possible side effects

5. How to store Erythromycin Stragen

6. Contents of the pack and other information

1. What Erythromycin Stragen is and what it is used for

Erythromycin Stragen is a powder for solution for infusion. Erythromycin lactobionate, the active substance of this medicine, belongs to the group of antibacterial substances for systemic use (suitable for intravenous injection).

Erythromycin Stragen disrupts the production of proteins by bacteria, and thereby prevents the bacteria from multiplying.

Erythromycin Stragen is used primarily for various bacterial infections of the airways such as pneumonia, whooping cough and diphtheria. Erythromycin Stragen is also used for vaginal infections and for eye inflammation and pneumonia in new-born infants caused by Chlamydiabacteria.

Erythromycin Stragen is also used in the treatment of pneumonia, infections of the skin and soft tissues in people who are intolerant to penicillin or where penicillin is unsuitable for some other reason.

2. What you need to know before you use Erythromycin Stragen

Do not use Erythromycin Stragen:

• if you are allergic to erythromycin;

• if you are allergic to any other of antibiotics from the same group such as clarithomycin or azithromycin;

• if you have certain heart disorders (long QT syndrome, or acquired QT prolongation).

• if you are taking any medicines containing:

• astemizole (a medicine for allergies),

• cisapride (a medicine for gastrointestinal disorders),

• disopyramide (a medicine for heart problems),

• ergotamine (a medicine to prevent migraine),

• dihydroergotamine (a medicine for low blood pressure),

• pimozide (a medicine used for mental illness),

• terfenadine or so-called statins such as simvastatin, atorvastatin and lovastatin (medicines for treating high blood fat levels).

Warnings and precautions

Talk to your doctor or nurse before using Erythromycin Stragen:

• if you have impaired liver function (problems with the way your liver works) or heart problems.

• in case of long-term or severe diarrhoea. Diarrhoea caused by bacteria may occur during and following treatment with Erythromycin Stragen (see section 4).

• if you suffer from myasthenia gravis (a chronic, autoimmune disease, manifested by muscle fatigue), as the symptoms may become worse,

• if you are breast-feeding and the child vomits or becomes irritable when being fed.

• If you have severe impaired renal function. Temporary hearing loss may occur during treatment.

Contact your doctor immediately if you get any of the following symptoms (which indicate angioedema):

• swelling of the face, tongue or throat,

• difficulty swallowing,

• hives and breathing difficulties.

Other medicines and Erythromycin Stragen

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

The section "Do not use Erythromycin Stragen" above lists medicines that must not be taken together with Erythromycin Stragen.

Erythromycin Stragen can affect or can be affected by certain medicines that contain the following active ingredients:

• fluconazole, ketoconazole and itraconazole (used for fungal infections),

• protease inhibitors (used in case of HIV infection),

• clarithromycin, rifampicin (used for bacterial infections),

• digoxin, quinidine (used for heart problems),

• cilostazol (used for intermittent claudication, which is muscle pain in the leg),

• warfarin, acenocoumarol (blood-thinning medicines),

• fexofenadine (used to prevent allergies),

• valproic acid, carbamazepine, phenobarbital or phenytoin (used for epilepsy),

• theophylline (used for asthma and other respiratory problems),

• ciclosporin, tacrolimus (used following organ transplantation),

• bromocriptine (used for Parkinson's disease),

• zopiclone, triazolam, alprazolam, clozapine, midazolam, hexobarbitone, buspirone (used for anxiety, agitation and sleeping disorders),

• alfentanil (to prevent pain during surgery),

• cimetidine, omeprazole (used to treat acid reflux and stomach ulcers),

• colchicine (used for joint pain),

• methylprednisolone (used to suppress the body's immune system for example in case of allergy and inflammation),

• St. John's wort (a natural remedy used to treat depression),

• verapamil (used in case of heart disease, for example, to prevent high blood pressure),

• vinblastine (used for certain types of cancer),

• sildenafil (used for erectile dysfunction),

• tyrosine kinase inhibitors (e.g. imatinib) used against some specific forms of cancer,

• tolterodine (treatment for urinary incontinence).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

Treatment with Erythromycin Stragen should be given onlyif absolutely necessary and only after evaluation by a doctor that the benefits outweigh the potential risks.

Breast-feeding

Erythromycin passes into human milk. Your doctor will decide if you should be administered this medicine, only after making sure that the benefits outweigh the potential risks.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

3. How to use Erythromycin Stragen

Erythromycin Stragen is given to you by a doctor or a nurse as an infusion directly into your blood. The doctor decides the dose, which will be set specifically for you. The dosage depends on the type and severity of the infection.

Adults and children over 12 years old or weighing more than 40 kg

The recommended dosageis 15-20 mg/kg/day. If necessary, the dose may be increased to 4 grams per day. Erythromycin Stragen can be given as divided doses every 6 or 8 hours, or as a continuous intravenous infusion.

Use in children over 1 month to 12 years old or weighing up to 40 kg

The usual dose is 15 - 20 mg/kg of body weight divided over 3 - 4 single doses. The doctor will calculate the exact dose your child will receive taking into account his/her body weight.

Use in term newborn infants (birth to 1 month)

The usual dose is 10-15 mg/kg divided over 3 single doses. Your doctor will calculate the exact dose your child will receive taking into account his/her body weight.

Use in patients with renal impairment

Your doctor will avoid giving you additional dose if you have regular dialysis.

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

4. Possible side effects

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

Common(may affect up to 1 in 10 people)

• heart rhythm disorders (arrhythmia),

• upset stomach (in the form of nausea, stomach-ache and diarrhoea); contact your doctor in case of long-term or severe diarrhoea,

• skin rash,

• swelling and pain at the infusions site.

Uncommon(may affect up to 1 in 100 people)

Rare(may affect up to 1 in 1,000 people)

• allergic reaction (anaphylaxis),

• temporary hearing loss (primarily in patients with impaired renal function or at high doses),

• elevated liver counts, blockage of the bile duct (cholestasis), inflammation of the liver (hepatitis).

Not known(frequency cannot be estimated from the available data)

• feeling ill,

• stomach pain,

• inflamed pancreas (pancreatitis),

• vomiting,

• tinnitus (ringing in the ears),

• deafness,

• chest pain,

• heart rhythm disorders,

• palpitations,

• prolonged QTc interval (seen on an ECG),

• fever,

• loss of appetite,

• confusion,

• cramps,

• dizziness,

• hallucinations (seeing or hearing things that are not there),

• inflammation of the kidneys (a condition called interstitial nephritis),

• low blood pressure,

• swelling of the face, lips, tongue or throat, sometimes with shortness of breath or problems swallowing, so-called angioedema,

• itching, changes in the skin and mucous membranes (at times severe),

• severe widespread skin damage (peeling),

• increased number of white blood cells in the blood (eosinophilia),

• some forms of liver inflammation (cholestatic and hepatocellular hepatitis),

• jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems),

• reduced liver function,

• enlargement of the liver,

• liver failure.

Fungal overgrowth in the mouth and vagina may occur.

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 national reporting system. By reporting side effects you can help provide more information on the safety on this medicine.

5. How to store Erythromycin Stragen

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 after “EXP:” The expiry date refers to the last day of that month.

Unopened: This product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Erythromycin Stragen contains

- The other ingredients are: none

What Erythromycin Stragen looks like and contents of the pack

Erythromycin Stragen is available as a powder for solution for infusion. The powder is white to slightly yellow.

The powder is supplied as a single dose vial packed in a carton box.

Each carton box contains 1 vial or 10 vials.

Marketing Authorisation Holder

<[To be completed nationally]>

Manufacturer

<[To be completed nationally]>

This leaflet was last revised in 2016-05-13

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The following information is for healthcare professionals only:

The full information can be found in the Summary of Product Characteristics for Erythromycin Stragen.

Method of administration

Because rapid infusion is closely associated with arrhythmias or hypotension it is recommended that Erythromycin Stragen solution for infusion should be administered slowly. This should be particularly noted in patients with risk factors or previous signs of arrhythmias.

A low infusion rate is also recommended for patients with heart disease and for premature babies.

a) Intermittent infusion: max. 5 ml/min for 20–60 minutes

b) Continuous infusion: infusion for up to 24 hours.

Erythromycin Stragen must not be administered as a bolus injection.

Preparation for administration

1. Preparation of base solution:

A 5% base solution (50 mg erythromycin/ml) is prepared by dissolving the powder in the vial (1 g erythromycin) in 20 ml water for solution for infusion. The base solution must be diluted further before administration.

2. Dilution of base solution

a) Solution for infusion for intermittent infusion:

20 ml base solution is further diluted by adding to 200250 ml of a suitable solution for infusion (see below).

b) Solution for infusion for continuous infusion:

20 ml base solution is further diluted by adding to 500 ml or 1000 ml of a suitable solution for infusion (see below).

Solution for infusion suitable for dilution of base solution:

- 0.9% (9 mg/ml) sodium chloride solution for injection

- Glucose 5%

- Hartman’s solution.

Solutions containing glucose must first have sodium bicarbonate added as a buffer to assure neutrality.

Ensure that the finished solution for infusion is free from particles before administration.

Special precautions for storage

After reconstitution:

After reconstitution, chemical and physical in-use stability in water for injection has been demonstrated for 24 hours when stored at room temperature and for 14 days when stored in a refrigerator at 2-8° C.

After reconstitution and dilution:

After reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 24 hours at room temperature when the solution is diluted in 0.9% (9 mg/ml) sodium chloride solution for injection or Glucose 5% and for 12 hours at room temperature when the solution is diluted in Hartman’s solution.

From a microbiological point of view, once opened, 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 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions