50 mg powder for infusion, solution
tigecycline
What Tigecycline Accord is and what it is used for
Tigecycline Accord is an antibiotic in the glycylcycline group that works by stopping the growth of bacteria that cause infection.
Your doctor has prescribed Tigecycline Accord because you or your child over 8 years of age has one of the following serious infections.
- Complicated infections in the skin and soft tissues ( tissues under the skin), excluding foot infections in patients with diabetes.
- Complicated infection in the abdominal cavity.
Tigecycline Accord is only used when your doctor considers other antibiotics unsuitable.
What you need to know before you receive Tigecycline Accord
Do not use Tigecycline Accord
- If you are allergic to tigecycline or any of the other ingredients of this medicine (listed in section 6). If you are allergic to tetracycline antibiotics (eg, minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Warnings and precautions
Talk to your doctor or nurse before receiving Tigecycline Accord:
- If the wound does not heal normally.
- If you suffer from diarrhea before receiving Tigecycline Accord. If you get diarrhea during or after your treatment, tell your doctor right away. Do not take any diarrhea medicine without first checking with your doctor.
- If you have had any side effects in the past due to antibiotics belonging to the tetracycline class (eg skin sensitization to sunlight, discoloration of developing teeth, inflammation of the pancreas, and changes in certain laboratory values intended to measure how well your blood clots).
- If you have or have previously had, liver problems. Depending on the condition of your liver, your doctor may reduce the dose to avoid possible side effects.
- If you have a blockage of the bile ducts (cholestasis).
- If you suffer from any type of bleeding disorder or are treated with anticoagulants, this medicine may affect blood clotting.
During treatment with Tigecycline Accord:
- Tell your doctor immediately if you experience symptoms of an allergic reaction.
- Tell your doctor immediately if you experience severe stomach pain, nausea, and vomiting. These symptoms may be signs of inflammation of the pancreas ( acute pancreatitis ).
- For some severe infections, your doctor may consider using Tigecycline Accord together with other antibiotics.
- Your doctor will monitor you closely to make sure no other bacterial infection develops. If you suffer from another bacterial infection, the doctor may prescribe another antibiotic that is specific to that infection.
- Although antibiotics including Tigecycline Accord work against some bacteria, other bacteria and fungi may continue to grow. This is called overgrowth. Your doctor will monitor you for possible infection and treat you if necessary. If you receive Tigecycline Accord, your doctor will monitor you closely to ensure that no other infection develops, and treat you if necessary.
Children
Tigecycline Accord should not be used in children under 8 years of age as there is a lack of data on safety and efficacy in this age group and as it may cause permanent defects on the teeth, such as discoloration of developing teeth.
Other medicines and Tigecycline Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tigecycline Accord may prolong certain tests that measure how well your blood clots. You must tell your doctor if you are taking medicines to avoid excess blood clotting (so-called anticoagulants ). If so, your doctor will monitor you closely.
Tigecycline Accord can affect the effectiveness of birth control pills. Talk to your doctor about the need for additional contraception while using Tigecycline Accord.
Tigecycline Accord may increase the effect of medicines used to suppress the immune system (such as tacrolimus and cyclosporine). You must tell your doctor if you are taking these medicines so that you can be monitored closely.
Pregnancy and breastfeeding
Tigecycline Accord may be harmful to the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
It is not known whether tigecycline passes into breast milk. Consult a doctor before breastfeeding your baby.
Driving ability and use of machinery
Tigecycline Accord can cause side effects such as dizziness. This may impair the ability to drive and operate machinery.
Tigecycline Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is almost “sodium-free”.
How Tigecycline Accord is given
Tigecycline Accord will be administered to you by a doctor or nurse.
The recommended dose for adults is 100 mg as an initial dose followed by 50 mg every 12 hours. This dose is given intravenously (directly into the blood) over 30 to 60 minutes.
The recommended dose for children aged 8 to <12 years is 1.2 mg/kg given every 12 hours intravenously up to a maximum dose of 50 mg every 12 hours.
The recommended dose for adolescents aged 12 to <18 years is 50 mg given every 12 hours.
Usually, the treatment lasts for 5 to 14 days. Your doctor will decide how long you will be treated.
If you have been given too much Tigecycline Accord
If you are concerned that you may have received too much Tigecycline Accord, talk to your doctor or nurse immediately.
If you have forgotten a dose of Tigecycline Accord
If you are concerned that you may have missed a dose, talk to your doctor or nurse straight away.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pseudomembranous colitis can occur during treatment with most antibiotics, including Tigecycline Accord. It presents as severe, persistent, or bloody diarrhea associated with abdominal pain or fever. This may be a sign of serious intestinal inflammation, which may occur during or after your treatment.
Very common side effects are (may affect more than 1 in 10 users):
- Nausea, vomiting, diarrhea
Common side effects are (may affect up to 1 in 10 users):
- An abscess (accumulation), infection, etc
- Laboratory measurements show that the blood has a reduced ability to clot (coagulate)
- Dizziness
- Blood vessel irritation from injection includes pain, inflammation, swelling, and coagulation
- Stomach pain, digestive problems, loss of appetite
- Increased liver enzymes, hyperbilirubinemia (excess bile pigment in the blood)
- Itching, rash
- Poor or slow wound healing
- Headache
- Increased levels of amylase, which is an enzyme found in the salivary glands and pancreas, increased levels of blood urea nitrogen (BUN)
- Pneumonia
- Low blood sugar
- Sepsis/septic shock (a serious medical condition that can lead to multiple organ failures and death due to sepsis)
- Injection site reaction (pain, redness, inflammation )
- Low levels of protein in the blood.
Uncommon side effects are (may affect up to 1 in 100 users):
- Acute pancreatitis (inflammation of the pancreas, which can result in severe stomach pain, nausea, and vomiting)
- Jaundice (yellowing of the skin), inflammation of the liver
- Low levels of platelets in the blood (which can lead to an increased tendency to bleed and bruise/hematoma).
Rare side effects are (may affect up to 1 in 1,000 users):
- Low levels of fibrinogen in the blood (a protein that is important for blood clotting).
Has been reported (occurring in an unknown number of users):
- Anaphylactic/anaphylactoid hypersensitivity reaction (which can range from mild to severe, including sudden, generalized allergic reaction that can lead to life-threatening shock [eg, difficulty breathing, drop in blood pressure, rapid pulse ]).
- Liver failure
- Skin rash can lead to severe blistering of the skin and peeling of the skin ( Stevens-Johnson syndrome ).
How to store Tigecycline Accord
Keep this medicine out of the sight and reach of children.
No special storage instructions. Use before the expiry date stated on the bottle. The expiration date is the last day of the specified month.
Storage after preparation
Prepared solution: Chemical and physical stability has been demonstrated for 6 hours at 20‑25 °C. From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user and should not exceed the times stated above for chemical and physical stability.
Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 20-25 °C and 48 hours at 2-8 °C. From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user and should not exceed the times stated above for chemical and physical stability.
Tigecycline Accord solution should be yellow to orange after the dissolution of the powder; otherwise, the solution should be discarded.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
- Other ingredients are maltose monohydrate, hydrochloric acid, and sodium hydroxide.
Appearance and package sizes of the medicine
Tigecycline Accord is supplied as a powder for infusion in a vial and looks like an orange powder or cake before dilution. These vials are distributed to hospitals in a package of one vial or ten vials. Not all pack sizes may be marketed.
The powder should be dissolved in the bottle with a small amount of solution. The vial is gently rotated until the medicine has dissolved. The solution from the vial should then be immediately added to a 100 ml infusion bag or another suitable infusion container at the hospital, for intravenous use.
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center,
Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona, Spain
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow
Middlesex, HA1 4HF
UK
or
Accord Healthcare Polska Sp.z o.o
ul. Lutomirska 50
95-200 Pabianice
Poland
or
Laboratory Fundació Dau
C/ C, 12-14 Pol. Ind.
Zona Franca, Barcelona, 08040
Spain