How to use TEICOPLANIN HIKMA 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Teicoplanin Hikma 200 mg powder for solution for injection and infusion EFG
Teicoplanin Hikma 400 mg powder for solution for injection and infusion EFG
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, pharmacist or nurse.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if you think they might be unrelated to this medicine. See section 4.
Contents of the package leaflet
- What is Teicoplanin Hikma and what is it used for
- What you need to know before you use Teicoplanin Hikma
- How to use Teicoplanin Hikma
- Possible side effects
- Storage of Teicoplanin Hikma
- Contents of the pack and further information
1. What is Teicoplanin Hikma and what is it used for
Teicoplanin Hikma is an antibiotic. It contains a medicine called “teicoplanin”. It works by killing the bacteria that cause infections in your body.
Antibiotics are used to treat bacterial infections and will not work for viral infections such as flu or the common cold.
It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.
Do not store or reuse this medicine. If you have any leftover antibiotic after finishing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.
Teicoplanin Hikma is used in adults and children (including newborns) to treat infections in:
- the skin and under the skin - sometimes called “soft tissues”
- bones and joints
- the lung
- the urinary tract
- the heart – sometimes called “endocarditis”
- the abdominal wall - peritonitis
- the blood, when caused by one of the conditions listed above
Teicoplanin can be used to treat some infections caused by the bacteria Clostridioides difficilein the intestine. In this case, the solution should be taken by mouth.
2. What you need to know before you use Teicoplanin Hikma
Do not use Teicoplanin Hikma:
- if you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before starting Teicoplanin Hikma if:
- you are allergic to an antibiotic called “vancomycin”
- you have had a reddening of the upper body (red man syndrome)
- you have a low platelet count (thrombocytopenia)
- you have kidney problems
- you are taking other medicines that may cause hearing and/or kidney problems.
You may have regular tests to check if your blood, kidneys, and/or liver are working properly (see “Other medicines and Teicoplanin Hikma”).
If any of the above applies to you (or if you are not sure), tell your doctor, pharmacist or nurse before using Teicoplanin Hikma.
Severe skin reactions have been reported with the use of teicoplanin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you develop a severe rash or other skin symptoms as described in section 4, stop taking Teicoplanin Hikma and contact your doctor or seek medical attention immediately.
Tests
During treatment, you may have tests to check your blood, kidneys, liver, and/or hearing. This is more likely if:
- your treatment is going to last a long time
- you need to be treated with high loading doses (12 mg/kg twice a day)
- you have kidney problems
- you are taking or may take other medicines that may affect your nervous system, kidneys, and hearing.
In people who are being treated with Teicoplanin Hikma for a long time, bacteria that are not affected by the antibiotic may grow more than usual – your doctor will check for this.
Other medicines and Teicoplanin Hikma
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This is because Teicoplanin Hikma may affect how other medicines work. Also, some medicines may affect how Teicoplanin Hikma works.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
- Aminoglycosides, as they should not be mixed with Teicoplanin Hikma in the same injection. They may also cause hearing and/or kidney problems.
- amphotericin B – a medicine that treats fungal infections that may cause hearing and/or kidney problems
- cyclosporin – a medicine that affects the immune system that may cause hearing and/or kidney problems
- cisplatin – a medicine that treats malignant tumors that may cause hearing and/or kidney problems
- water pills (such as furosemide) also called “diuretics” that may cause hearing and/or kidney problems.
If any of the above applies to you (or if you are not sure), tell your doctor, pharmacist or nurse before using Teicoplanin Hikma.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before using this medicine. They will decide whether you should be given this medicine while pregnant. There may be a potential risk of problems in the inner ear and kidneys.
Tell your doctor if you are breast-feeding before they give you this medicine. They will decide whether you can continue breast-feeding while being given Teicoplanin Hikma.
Animal reproduction studies have not shown any evidence of fertility problems.
Driving and using machines
You may have headaches or feel dizzy while being treated with Teicoplanin Hikma. If this happens, do not drive or use tools or machines.
Teicoplanin Hikma contains sodium
This medicine contains less than 23 mg of sodium (1mmol) per vial; this is essentially “sodium-free”.
3. How to use Teicoplanin Hikma
The recommended dose is:
Adults and children (12 years or older) without kidney problems
Infections of the skin and soft tissues, lung, and urinary tract
- Initial dose (for the first three doses): 400 mg (this is equivalent to 6 mg per kilogram of body weight), given every 12 hours, by injection into a vein or muscle
- Maintenance dose: 400 mg (this is equivalent to 6 mg per kilogram of body weight), given once a day, by injection into a vein or muscle
Infections of the bones and joints, and heart
- Initial dose (for the first three to five doses): 800 mg (this is equivalent to 12 mg per kilogram of body weight), given every 12 hours, by injection into a vein or muscle
- Maintenance dose: 800 mg (this is equivalent to 12 mg per kilogram of body weight), given once a day, by injection into a vein or muscle
Infection caused by the bacteria Clostridioides difficile
The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, it will normally be necessary to reduce your dose after the fourth day of treatment:
- For people with mild to moderate kidney problems - the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day.
- For people with severe kidney problems and on hemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day.
Treatment of peritonitis in patients on peritoneal dialysis
The initial dose is 6 mg per kilogram of body weight, as a single injection into a vein, followed by:
- Week one: 20 mg/l in each dialysis bag
- Week two: 20 mg/l in alternate dialysis bags
- Week three: 20 mg/l in the dialysis bags used at night.
Babies (from birth to 2 months of age)
- Initial dose (on day one): 16 mg per kilogram of body weight, as an infusion into a vein through a drip.
- Maintenance dose: 8 mg per kilogram of body weight, given once a day, as an infusion into a vein through a drip.
Children (from 2 months to 12 years of age)
- Initial dose (for the first three doses): 10 mg per kilogram of body weight, given every 12 hours, by injection into a vein.
- Maintenance dose: 6 to 10 mg per kilogram of body weight, given once a day, by injection into a vein.
How Teicoplanin Hikma is given
This medicine will normally be given to you by a doctor or nurse.
- It will be given by injection into a vein (intravenously) or into a muscle (intramuscularly).
- It can also be given by infusion into a vein through a drip.
In babies from birth to two months, it will only be given by infusion.
For the treatment of certain infections, the solution may be given by mouth (orally).
If you are given too much Teicoplanin Hikma
It is unlikely that your doctor or nurse will give you too much medicine. However, if you think you have been given too much Teicoplanin Hikma or if you are concerned, talk to your doctor or nurse immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 5620420, indicating the medicine and the amount taken.
If you miss a dose of Teicoplanin Hikma
Your doctor or nurse will have instructions on when to give you Teicoplanin Hikma. It is unlikely that they will not give you the medicine as prescribed. However, if you are concerned, talk to your doctor or nurse.
If you stop treatment with Teicoplanin Hikma
Do not stop this treatment without talking to your doctor, pharmacist or nurse first.
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.
Serious side effects
Stop treatment immediately and contact a doctor or nurse if you notice any of the following serious side effects – you may need urgent medical treatment:
Uncommon(may affect up to 1 in 100 people)
- sudden life-threatening allergic reaction – the signs may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills
Rare(may affect up to 1 in 1,000 people)
- reddening of the upper body
Frequency not known(cannot be estimated from the available data)
- appearance of blisters on the skin, mouth, eyes, or genitals – these could be signs of a condition called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome”
- red, scaly rash all over your body with bumps under the skin (including skin folds, chest, abdomen, back, and arms) and blisters, accompanied by fever - these may be symptoms of something called "acute generalized exanthematous pustulosis (AGEP)".
- "drug reaction with eosinophilia and systemic symptoms (DRESS)". DRESS appears initially as flu-like symptoms and a rash on the face, then a prolonged rash with a high temperature, increased liver enzymes seen in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
Tell your doctor or nurse immediately if you experience any of the above side effects.
Tell your doctor or nurse immediately if you experience any of the following serious side effects – you may need urgent medical treatment:
Uncommon(may affect up to 1 in 100 people)
- inflammation and clot in a vein
- difficulty breathing and wheezing (bronchospasm)
- if you get more infections than usual – these could be signs of a decrease in your blood cell count
Frequency not known(cannot be estimated from the available data)
- lack of white blood cells in the blood – the signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
- kidney problems or changes in kidney function – shown in tests. The frequency or severity of kidney problems may increase if you receive higher doses.
- seizures
- low levels of all types of blood cells
Tell your doctor or nurse immediately if you experience any of the above side effects.
Other side effects
Talk to your doctor, pharmacist or nurse if you get any of the following side effects:
Common(may affect up to 1 in 10 people)
- skin rash, redness, itching
- pain
- fever
Uncommon(may affect up to 1 in 100 people)
- decrease in platelet count
- increase in blood levels of liver enzymes
- increase in blood levels of creatinine (to check your kidney)
- hearing loss, ringing in the ears or the feeling that you or your surroundings are spinning
- nausea or vomiting, diarrhea
- dizziness or headache
Rare(may affect up to 1 in 1,000 people)
- infection (abscesses)
Frequency not known(cannot be estimated from the available data)
- problems at the injection site – such as skin redness, pain, or swelling
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse, even if you think they might be unrelated to this medicine. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Teicoplanin Hikma
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 vial label after EXP. The expiry date is the last day of the month shown.
This medicine does not require any special storage conditions.
Information about the storage and use of Teicoplanin Hikma once it has been reconstituted and is ready to use is detailed in “Practical information for healthcare professionals on the preparation and handling of Teicoplanin Hikma”.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Container Content and Additional Information
Composition of Teicoplanin Hikma
- The active ingredient is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
- The other components are sodium chloride and sodium hydroxide.
Appearance of the Product and Container Content
Teicoplanin Hikma is a white to yellowish lyophilized powder. The powder is packaged in 10 ml vials for Teicoplanin Hikma 200 mg and 20 ml vials for Teicoplanin Hikma 400 mg.
Teicoplanin Hikma is marketed in packs of 1 vial or 10 vials.
Only some package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó 8, 8A e 8B – Fervença
2705-906 Terrugem SNT, Portugal
Tel.: +351 219608410
e-mail: [email protected]
Manufacturer:
Hikma Italia S.P.A.
Viale Certosa, 10
27100 Pavia
Italy
Tel.: +39 0382 1751801
Fax: +39 0382 422745
e-mail: [email protected]
For further information about this medicinal product, please contact the local representative of the marketing authorization holder:
Hikma España, S.L.U.
Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2
28108 - Alcobendas, Madrid
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
AustriaTeicoplanin Hikma 200 mg Powder for solution for injection/infusion or oral solution
Teicoplanin Hikma 400 mg Powder for solution for injection/infusion or oral solution
SpainTeicoplanina Hikma 200 mg powder for injectable solution and perfusion EFG
Teicoplanina Hikma 400 mg powder for injectable solution and perfusion EFG
FranceTeicoplanine Hikma 200 mg powder for injectable solution/perfusion or oral solution
Teicoplanine Hikma 400 mg powder for injectable solution/perfusion or oral solution
IrelandTeicoplanin Hikma 200mg powder for solution for injection/infusion or oral solution
Teicoplanin Hikma 400mg powder for solution for injection/infusion or oral solution
ItalyTeicoplanina Hikma 200mg powder for injectable solution/infusion or oral solution
Teicoplanina Hikma 400mg powder for injectable solution/infusion or oral solution
NetherlandsTeicoplanine Hikma 200 mg powder for solution for injection/infusion or oral solution
Teicoplanine Hikma 400 mg powder for solution for injection/infusion or oral solution
PortugalTeicoplanina Hikma 200 mg Powder for injectable solution or perfusion or oral solution
Teicoplanina Hikma 400 mg Powder for injectable solution or perfusion or oral solution
United KingdomTeicoplanin Hikma 200mg powder for solution for injection/infusion or oral solution
Teicoplanin Hikma 400mg powder for solution for injection/infusion or oral solution
Date of last revision of this leaflet: November 2022
This information is intended only for healthcare professionals:
Practical information for healthcare professionals on the preparation and handling of Teicoplanin Hikma. This medicinal product is for single use only. Form of administration The reconstituted solution can be injected directly or alternatively in a diluted form. Intravenous injection will be administered either as a bolus over 3-5 minutes or as an infusion over 30 minutes. In infants from birth to two months, it will only be administered by infusion. The reconstituted solution can also be administered orally. Preparation of the reconstituted solution:
The reconstituted solutions will contain 200 mg of teicoplanin in 3.0 ml and 400 mg of teicoplanin in 3.0 ml. Only clear and yellowish solutions should be used. The final solution is isotonic with plasma and has a pH of 6.0-8.0.
Preparation of the diluted solution before infusion Teicoplanin Hikma can be administered in the following infusion solutions:
Shelf life of the reconstituted solution: Chemical and physical stability in use of the reconstituted solution with water for injectable preparations has been demonstrated for 24 hours between 2°C and 8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless the reconstitution has been carried out in controlled and validated aseptic conditions. Shelf life of the diluted medicinal product The chemical and physical stability in use of the reconstituted solution prepared as recommended has been demonstrated for 24 hours between 2°C and 8°C. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless the reconstitution/dilution has been carried out in controlled and validated aseptic conditions. Disposal Disposal of the unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations. |
- Country of registration
- Dosage formINJECTABLE, 200 mg
- ATC codeJ01XA02
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to TEICOPLANIN HIKMA 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSIONDosage form: INJECTABLE, 400 mg teicoplaninActive substance: teicoplaninManufacturer: Sanofi Aventis S.A.Prescription requiredDosage form: INJECTABLE, 200 mgActive substance: teicoplaninManufacturer: Accord Healthcare S.L.U.Prescription requiredDosage form: INJECTABLE, 400 mgActive substance: teicoplaninManufacturer: Accord Healthcare S.L.U.Prescription required
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Frequently Asked Questions
TEICOPLANIN HIKMA 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in TEICOPLANIN HIKMA 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION is teicoplanin. This information helps identify medicines with the same composition but different brand names.
TEICOPLANIN HIKMA 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION is manufactured by Hikma Farmaceutica (Portugal) S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether TEICOPLANIN HIKMA 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy TEICOPLANIN HIKMA 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (teicoplanin) include TARGOCID 400 mg POWDER AND SOLVENT FOR INJECTION AND INFUSION SOLUTION, TEICOPLANIN ACCORD 200 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION, TEICOPLANIN ACCORD 400 mg POWDER FOR INJECTION AND INFUSION SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
