50 mg powder for infusion, solution
tigecycline
What Tigecycline Mylan is and what it is used for
Tigecycline Mylan is an antibiotic in the glycylcycline group that works by stopping the growth of bacteria that cause infection.
Your doctor has prescribed Tigecycline Mylan because you or your child over the age of 8 have 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 Mylan is only used when your doctor considers other antibiotics unsuitable.
The tigecycline contained in Tigecycline Mylan may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you receive Tigecycline Mylan
Do not use Tigecycline Mylan:
- 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 a doctor or nurse before receiving Tigecycline Mylan:
- If the wound does not heal normally.
- If you suffer from diarrhea before receiving Tigecycline Mylan. 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).
During treatment with Tigecycline Mylan:
- 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 Mylan 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 Mylan 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.
Children
Tigecycline Mylan should not be used in children under 8 years of age because there is a lack of data on safety and efficacy in this age group and because it can cause permanent defects in the teeth, such as discoloration of developing teeth.
Other medicines and Tigecycline Mylan
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Tigecycline 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 can affect the effectiveness of birth control pills. Talk to your doctor about the need for additional birth control while using tigecycline.
Pregnancy and breastfeeding
Tigecycline can 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 receiving Tigecycline Mylan.
It is not known whether tigecycline passes into breast milk. Consult a doctor before breastfeeding your baby.
Driving ability and use of machinery
Tigecycline can cause side effects such as dizziness. This may impair the ability to drive and operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tigecycline Mylan contains sodium
This medicine contains less than 1 mmol sodium per dose, i.e. it is almost “sodium-free”.
How Tigecycline Mylan is used
Tigecycline Mylan 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 received too much Tigecycline Mylan
If you are concerned that you may have received too much Tigecycline Mylan, talk to your doctor or nurse immediately.
If you have forgotten a dose of Tigecycline Mylan
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 Mylan. 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 ( may affect more than 1 in 10 users) :
- Nausea, vomiting, diarrhea.
Common side effects (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 (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).
Side effects that have 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 that can lead to severe blistering of the skin and peeling of the skin ( Stevens-Johnson syndrome )
- Low levels of fibrinogen in the blood (a protein involved in blood clotting).
How to store Tigecycline Mylan
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25°C.
Use before the expiry date which is stated on the vial and carton after EXP. The expiration date is the last day of the specified month.
Storage after preparation
Chemical and physical stability in use has been demonstrated for tigecycline in admixture with 0.9% sodium chloride solution for injection or glucose 5%. The product can be stored in a refrigerator at 2º to 8ºC for a maximum of 48 hours after the reconstituted solution is immediately added to the intravenous bag.
From a microbiological point of view, the product must be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Tigecycline Mylan 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 L- arginine, hydrochloric acid, and sodium hydroxide (for adjusting pH ).
Appearance and package sizes of the medicine
Tigecycline Mylan is supplied in a vial containing an orange to orange-red lyophilized cake or powder. These vials are distributed to hospitals in a pack of 10 or 1. 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
Mylan Ireland Limited
Unit 35/36 Grange Parade,
Baldoyle Industrial Estate, Dublin 13
Ireland
Manufacturer:
Galenicum Health SL
Avda. Diagonal, 123, 11ª planta
08005 Barcelona
Spain
Paradox Healthcare, Ltd
KW20A Kordin Industrial Park, Paola
PLA 3000
Malta
SAG Manufacturing SLU
Crta. NI, Km 36, San Agustin de Guadalix
28750 Madrid
Spain
Mylan Germany GmbH
Zweigniederlassung Bad Homburg vd Höhe, Benzstrasse 1
Bad Homburg CEO Hohe
Hesse, 61352
Germany
Hikma Italia SpA
Viale Certosa, 10
27100, Pavia (PV)
Italy