AMPICILLINA 1 G Powder for injectable/infusion solution

Зміст інструкції

1. Ampicillina Ethypharm 1 g powder for injectable solution/for infusion, 2 m powder for injectable solution/for infusion
   1. What is Ampicillina Ethypharm and what is it used for
   2. What you need to know before using Ampicillina Ethypharm
   3. How to use Ampicillina Ethypharm
   4. Possible side effects
   5. How to store Ampicillina Ethypharm
   6. Contents of the pack and other information

Ampicillina Ethypharm 1 g powder for injectable solution/for infusion, 2 m powder for injectable solution/for infusion

ampicillina

Equivalent medicinal product

Read this leaflet carefully before using this medicine as it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Ampicillina Ethypharm is and what it is used for
• 2. What you need to know before you use Ampicillina Ethypharm
• 3. How to use Ampicillina Ethypharm
• 4. Possible side effects
• 5. How to store Ampicillina Ethypharm
• 6. Contents of the pack and other information

1. What is Ampicillina Ethypharm and what is it used for

Ampicillina Ethypharm contains the active ingredient ampicillin, which belongs to the group of drugs
called penicillins. This is a medicine for the treatment of bacterial infections (antibiotics)
that works by killing the bacteria that cause the infections. Ampicillina Ethypharm is used to treat the
infections caused by bacteria sensitive to ampicillin.
Ampicillina Ethypharm is used to treat the following diseases:

• Acute exacerbation of chronic bronchitis (respiratory tract infection)
• Pyelonephritis (upper urinary tract infection)
• Bacterial meningitis (infection of the membranes covering the brain)
• Pneumonia (lung infection) when another penicillin is not helpful or is inappropriate for other reasons
• Intra-abdominal infections (infection of the stomach and intestines)
• Bacterial blood infection associated with any of the above infections.

Ampicillina Ethypharm is also used for the treatment and prevention of endocarditis
(infection of the heart valves).

2. What you need to know before using Ampicillina Ethypharm

Do not use Ampicillina Ethypharm:

• if you know you are allergic (hypersensitive) to ampicillin, other antibiotics called beta-lactam antibiotics (e.g. penicillin or cephalosporin).

Warnings and precautions
Talk to your doctor before using Ampicillina Ethypharm:

• if you have experienced an allergic reaction to any antibiotic;
• if you have experienced any other allergic reaction. Hypersensitivity reactions to ampicillin can more commonly develop in individuals prone to allergic reactions to various substances. These reactions can manifest in various ways and can be of varying intensity - from skin changes to anaphylactic shock (severe allergic reaction);
• if you have been diagnosed with kidney failure. The doctor will adjust the dose of the antibiotic in accordance with the level of kidney failure;
• if you have gastrointestinal diseases, particularly colitis;
• if you have been diagnosed with myasthenia (a disease characterized by great fatigability and muscle weakness).

Talk to your doctor, pharmacist or nurse before using Ampicillina Ethypharm:

• if you are allergic to cephalosporins (another group of antibacterial drugs)
• if you have experienced symptoms of watery diarrhea, often with blood and mucus, abdominal pain and/or fever during or after treatment with ampicillin, tell your doctor. This may be a sign of inflammation of the colon (pseudomembranous enterocolitis). See section 4.

Urine tests
Patients treated with ampicillin may have false positive results on the measurement of
glucose in urine. For this reason, if you need to provide urine samples for the measurement of
glucose, inform your doctor or nurse that you are taking Ampicillina Ethypharm.

Other medicines and Ampicillina Ethypharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

• Allopurinol (medicine used to treat gout) taken together with ampicillin increases the risk of allergic skin rash.
• Methotrexate (medicine used to treat cancer or rheumatism) - ampicillin administered together may increase the side effects of methotrexate.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Ampicillin can be used during pregnancy if your doctor deems it necessary.

Breastfeeding
Ampicillin is excreted in human milk in small amounts. Newborns breastfed with breast milk
may therefore suffer from hypersensitivity reactions, diarrhea or colonization of the mucous membranes by yeasts,
which in some cases may necessitate the discontinuation of breastfeeding.

Fertility
In animal studies, ampicillin has had no effect on fertility.

Driving and operating machinery
Ampicillina Ethypharm has no effects or has negligible effects on the ability to drive or operate
machinery. However, driving or operating machinery is not recommended if you experience side
effects that have a negative impact on concentration (e.g. drowsiness, see section 4.
Possible side effects). If you are unsure, talk to your doctor or pharmacist.

Ampicillina Ethypharm contains sodium
Ampicillina Ethypharm 1 g contains 70 mg of sodium (the main component of table salt) per vial. This is equivalent to 3.5% of the maximum recommended daily intake of sodium
with diet for an adult.
Ampicillina Ethypharm 2 g contains 140 mg of sodium (the main component of table salt) per vial. This is equivalent to 7% of the maximum recommended daily intake of sodium
with diet for an adult.
Talk to your doctor or pharmacist if you need Ampicillina Ethypharm every day for a
prolonged period, especially if you have been advised to follow a low-salt diet
(sodium).
If the product is dissolved or diluted with an isotonic solution of sodium chloride, the additional amount of sodium from the solvent must also be taken into account.

3. How to use Ampicillina Ethypharm

This medicine will be administered to you by healthcare professionals as an injection into a muscle or into a
blood vessel or as an intravenous infusion (infusion) into a blood vessel.
The doctor will determine the appropriate dose for you/your child. The dose depends on the type of infection, the
location of the infection in the body and its severity.

If you use more Ampicillina Ethypharm than you should
If you have taken an excessive dose of Ampicillina Ethypharm or if, for example, a child has accidentally ingested
the medicine, contact your doctor or hospital or emergency room to assess the
risk and receive advice.
Symptoms that you have been given too much ampicillin may include: nausea, vomiting, diarrhea,
loss of consciousness, involuntary muscle contractions, convulsions, coma, kidney failure. In
exceptional cases, a severe allergic reaction (anaphylactic reaction) may occur within 20-40
minutes.
If you have any other questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

If you forget to use Ampicillina Ethypharm
If you think you may have forgotten a dose of Ampicillina Ethypharm, speak to your doctor
or nurse immediately. Do not use a double dose to make up for the missed dose.

If you stop using Ampicillina Ethypharm
Stopping treatment too early may compromise the outcome of therapy and lead to a
relapse, which is more difficult to treat. Please follow your doctor's instructions.
section “the following information is intended exclusively for healthcare professionals”.
If you have any other questions about 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.

Contact your doctor immediately if you experience any of the following side effects:

• Severe acute allergic reaction (anaphylactic reaction), which can be life-threatening. Symptoms that may occur are: itching and rash (urticaria), swelling of the

face, lips and tongue, body or difficulty breathing. These symptoms can be
serious and in rare cases lead to death (rare, may affect up to 1 in 1,000).

• Ampicillina may affect white blood cells and therefore impair defense against infections. If you develop an infection with symptoms such as fever with severe deterioration of general condition or fever with symptoms of local infection such as sore throat/mouth or difficulty urinating, you should consult a doctor as soon as possible to confirm or exclude agranulocytosis with an appropriate test. It is important to then provide information about the drugs used. These reactions are uncommon (may occur in up to 1 in 100).
• Inflammation of the colon with symptoms such as watery diarrhea, often with blood and mucus, abdominal pain and/or fever (pseudomembranous colitis). This reaction is uncommon (may affect up to 1 in 100).

Other side effects that may occur during treatment
The following side effects are common (may affect up to 1 in 10 people):

• Soft stools
• Rash

The following side effects are uncommon (may affect up to 1 in 100 people):

• reduction of red blood cells which can lead to paleness of the skin, weakness and shortness of breath (anemia)
• decrease in platelet count (thrombocytopenia)
• decrease or increase in white blood cell count (leukopenia, eosinophilia)
• inflammation of the tongue and oral mucosa
• nausea and vomiting
• inflammation of the colon
• diarrhea
• urticaria

The following side effects are rare (may affect up to 1 in 1,000 people):

• Severe skin inflammation with peeling (exfoliative dermatitis)
• Skin changes, sometimes severe (erythema multiforme)

Candidiasis
Local pain may occur at intramuscular injections.
Elevated liver parameters may occur.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Ampicillina Ethypharm

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 label and the packaging after
Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions,
After reconstitution the reconstituted solution must be used immediately.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ampicillina Ethypharm contains

• The active ingredient is ampicillin. Each vial contains 1 g or 2 g of ampicillin as ampicillin sodium.
• There are no other ingredients.

Description of the appearance of Ampicillina Ethypharm and contents of the pack
Powder of white or whitish color.
Colorless glass vials (type III) with a nominal capacity of 8ml or 20ml (only for 2g) sealed with a
chlorobutyl rubber stopper and aluminum cap.
Boxes of 100 vials (for the 1g dosage) or 10 vials (for the 2g dosage) are available.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Ethypharm
194 Bureaux de la Colline, Bâtiment D
92 213 Saint Cloud cedex
France

Manufacturer
Medochemie Ltd. Factory B - Agios Athanassios Industrial Area, 48 Iapetou Street, Agios
Athanassios, Limassol 4101, Cyprus
This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
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The following information is intended for healthcare professionals:

Posology
Adults
Intramuscularly: 500 mg 4 times a day.
Intravenous injection: 500 mg to 2 g 4-6 times a day. Inject 2 g slowly over at least 3-4
minutes.
Continuous intravenous infusion: 6 to 12 g per day. If possible use an infusion pump.
Intermittent intravenous infusion: 2 g 4-6 times a day.
For prophylaxis and endocarditis, 2 g may be administered intravenously as a single dose
30 to 60 minutes before the procedure.

If a higher dose than recommended is necessary, it may be administered intravenously.

Children
Intramuscularly: 50 mg/kg of body weight per day. The daily dose should be divided into 4 doses
at intervals of 6 hours.
For newborns and premature infants: 25-50 mg/kg divided into two doses is recommended.
Intravenously: 100-200 mg/kg of body weight per day in case of severe infection. In bacterial
meningitis, the intravenous dose for children may be increased to 400 mg / kg of body weight per
day (divided into four doses) if necessary.
For endocarditis prophylaxis, 50 mg/kg may be administered intravenously as a single dose
30 to 60 minutes before the procedure.

Monitoring during treatment
During long-term treatment (over 2-3 weeks), liver and kidney function and blood count should be monitored.
In case of acute meningitis caused by Listeria monocytogenesand neonatal septicemia, ampicillin is
administered in combination with another antibiotic.
In intra-abdominal infections, ampicillin should be used in combination with other appropriate
antibacterial agents when anaerobic and/or Gram-negative pathogens are known or suspected to contribute to the infectious process.

Special populations
Renal impairment
No dose adjustment is necessary in patients with creatinine clearance (CrCl)
>30 mL/min.
In case of severe renal insufficiency with a glomerular filtration rate equal to or less than 30
mL/min, a dose reduction is recommended as accumulation of ampicillin is predictable:

• with a creatinine clearance between 20 and 30 mL/min, the normal dose should be reduced to 2/3,
• with a creatinine clearance less than 20 mL/min, the normal dose should be reduced to 1/3. As a general rule in patients with severe renal insufficiency, a dose of 1 g of ampicillin every 8 hours should not be exceeded.

Method of administration
Ampicillina Ethypharm 250 mg, 500 mg, 1 g: for intramuscular and intravenous use after
reconstitution.
Ampicillina Ethypharm 2 g: for intravenous use after reconstitution.
Only freshly prepared, clear solutions should be used, prepared immediately before
use. Care must be taken to ensure complete dissolution.

Overdosage
Toxicity: high doses are generally well tolerated. However, for example, with compromised renal function
and impaired blood-brain barrier, a high dose of parenteral administration has produced toxic symptoms. Acute reactions are mainly due to allergic reactions.
Symptoms: Toxic reactions, nausea, vomiting, diarrhea, electrolyte disturbances, loss of consciousness,
muscle fasciculations, myoclonus, cramps, coma. Hemolytic reactions, renal failure, acidosis.
In exceptional cases, an anaphylactic reaction may occur within 20-40 minutes.
Treatment: Symptomatic treatment. In severe cases, hemoperfusion or hemodialysis.
In anaphylactic reactions: Epinephrine (adrenaline) 0.1-0.5 mg slowly intravenously.
Hydrocortisone 200 mg intravenously, optionally promethazine 25 mg intravenously.
Administration of fluids. Correction of acidosis.

Special precautions for disposal
Only freshly prepared, clear solutions should be used, prepared immediately before
use. Care must be taken to ensure complete dissolution. Reconstituted solutions are
clear and slightly yellow.
For single use only.
Ampicillina Ethypharm 1 g:
Solution for intramuscular injection:
The contents of the 1 g vial are dissolved in 3.4 ml of solvent (water for injections).
The solution must be used immediately after reconstitution.

• Solution for intravenous injection: Dissolve the contents of the 1 g vial in 7.4 ml of solvent (water for injections). Chemical and physical stability under conditions of use has been demonstrated for 30 minutes at 25°C.
• Solution for intravenous infusion: Dissolve the contents of the 1 g vial in 7.4 ml of solvent (water for injections). The finished solution may be diluted with the infusion fluids mentioned below with the desired volume, to reach the final concentration, also mentioned in the table below.

Ampicillina Ethypharm 2 g:

• Solution for intravenous injection: Dissolve the contents of the 2 g vial in 10 ml of solvent (water for injections). The solution must be used immediately after reconstitution.
• Solution for intravenous infusion: Dissolve the contents of the 2 g vial in 10 ml of solvent (water for injections). The finished solution may be diluted with the infusion fluids mentioned below with the desired volume, to reach the final concentration, also mentioned in the table below.

Chemical and physical stability during use has been demonstrated for 1 hour at 15-30°C.
From a microbiological point of view, diluted and reconstituted solutions must be used
immediately, unless the opening/reconstitution/dilution procedure excludes the risk of
microbial contamination. If not used immediately, storage times and conditions are the responsibility of the user.
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.

Incompatibilities
Additives to penicillin solutions should not be made with substances for which compatibility studies are lacking.