bhpardo/ema_en · Datasets at Hugging Face

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EU/ 1/ 99/ 118/ 002
The unabsorbed fraction of ibandronic acid is eliminated unchanged in the faeces.
The rate of administration should be determined by the patient’ s comfort level.
Do not pass it on to others.
4.3 Contraindications
See also section 4.4.
The solution for injection must be administered into a vein only, and not anywhere else in the body.
However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.
These measures will help to protect the environment.
112 9.
B CONDITIONS OF THE MARKETING AUTH ORISATION
This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.
AMMONAPS treatment should be supervised by a physician experienced in the treatment of urea cycle disorders.
Possible side effects 5.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
You might have any of these symptoms and/ or conditions.
• To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when you have removed it from the needle.
However, no clinically significant QT prolongation compared to OBT alone was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of CELSENTRI to prolong the QT interval.
Signs of allergy.
Since there is no significant impact of nucleoside and nucleotide analogues on the P450 enzyme system no dosage adjustment of APTIVUS is required when co-administered with these agents.
NAME OF THE MEDICINAL PRODUCT
24 – 120 hours 0 – 120 hours
• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever
STATEMENT OF ACTIVE SUBSTANCE(S)
Each pre-filled syringe contains 0.5 ml or 0.8 ml of solution.
The amount or timing of insulin, food or exercise may need to be adjusted.
The absolute oral bioavailability of the tablet formulation is 87%.
Steady state is achieved after 4– 7 days of dosing.
Marketing Authorisation Holder:
LOT
AC
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
4.7 Effects on ability to drive and use machines
tinnitus hypoacusis deafness neurosensory hearing impaired
NAME OF THE MEDICINAL PRODUCT
OTHER SPECIAL WARNING(S), IF NECESSARY
No special requirements.
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
After injection, the site of injection should not be massaged.
Lot:
For patients inadequately controlled on glimepiride monotherapy (typically 4 mg).
Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.
Starting dose of 50 IU/ kg 2 times per week by the intravenous route.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Capsule content: hypromellose, hydroxypropyl methylcellulose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate.
Protein C plays a major role in prevention of excessive clot formation thus, prevent and/ or treat intravascular thrombosis.
Lot
Facilities for the treatment of such reactions should be immediately available.
4.
In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated, as dictated by the patient's clinical status.
However, it has been reported that pemetrexed may cause fatigue.
Introduction
6.3 Shelf life
33 For any information about this medicine, please contact the local representative of BAXTER AG given below.
Blood and lymphatic system disorders
The pharmacokinetic profile in patients less than 5 years old was similar to that of older and less severely affected patients.
EU/ 1/ 07/ 410/ 004
It contains two active substances which work together to reduce pressure within the eye.
To remove, push tablets through from this side.
MARKETING AUTHORISATION NUMBER(S)
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
The relationship of the infarct to prior administration of BeneFIX is uncertain.
Patients receiving Atriance should be monitored regularly for changes in blood counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).
5.
28/ 07/ 2006
Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.
67 8.
(-0.60, 1.55)
The doctor will decide how much Angiox you receive, and will prepare the medicine.
Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
Normal sodium chloride solution 9 mg/ ml (0.9%) may be added to dilute to a concentration convenient for administration.
Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed.
AMMONAPS tablets should be taken with a large volume of water.
Irbesartan and its metabolites are eliminated by both biliary and renal pathways.
Solution for injection
OTHER SPECIAL WARNING(S), IF NECESSARY
Name and address of the manufacturers responsible for batch release
6.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
2.
1.
Three major classes of interferons have been identified: alpha, beta, and gamma.
EXPIRY DATE
It is not known whether aripiprazole is excreted in human milk.
6.
Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Not known:
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
SOLUTION SHOULD NEVER BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
In in vitro experiments, tipranavir was observed to inhibit human platelet aggregation at levels consistent with exposures observed in patients receiving APTIVUS/ ritonavir.
{MM/ YYYY}
Insulin in the blood stream has a half-life of a few minutes.
The most frequent undesirable effects attributable to filgrastim were bone pain, and general musculoskeletal pain.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/ relative should tell your doctor if you have ever had a stroke or "mini" stroke.
Slovenija AMGEN zdravila d. o. o.
Tel.: + 48 (22) 576 9000
B.
DATE OF REVISION OF THE TEXT

EU/ 1/ 99/ 118/ 002

The unabsorbed fraction of ibandronic acid is eliminated unchanged in the faeces.

The rate of administration should be determined by the patient’ s comfort level.

Do not pass it on to others.

4.3 Contraindications

See also section 4.4.

The solution for injection must be administered into a vein only, and not anywhere else in the body.

However, there is potential for an interaction with drugs that are highly bound to red blood cells e. g. cyclosporin, tacrolimus.

These measures will help to protect the environment.

112 9.

B CONDITIONS OF THE MARKETING AUTH ORISATION

This might happen: • If you take too much insulin • If you eat too little or miss a meal • If you exercise more than usual.

AMMONAPS treatment should be supervised by a physician experienced in the treatment of urea cycle disorders.

Possible side effects 5.

(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu

You might have any of these symptoms and/ or conditions.

• To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when you have removed it from the needle.

However, no clinically significant QT prolongation compared to OBT alone was seen in the Phase 3 clinical studies using the recommended dose of maraviroc or in a specific pharmacokinetic study to evaluate the potential of CELSENTRI to prolong the QT interval.

Signs of allergy.

Since there is no significant impact of nucleoside and nucleotide analogues on the P450 enzyme system no dosage adjustment of APTIVUS is required when co-administered with these agents.

NAME OF THE MEDICINAL PRODUCT

24 – 120 hours 0 – 120 hours

• Having forgotten to take your insulin • Repeatedly taking less insulin than you need • An infection or a fever

STATEMENT OF ACTIVE SUBSTANCE(S)

Each pre-filled syringe contains 0.5 ml or 0.8 ml of solution.

The amount or timing of insulin, food or exercise may need to be adjusted.

The absolute oral bioavailability of the tablet formulation is 87%.

Steady state is achieved after 4– 7 days of dosing.

Marketing Authorisation Holder:

LOT

AC

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

4.7 Effects on ability to drive and use machines

tinnitus hypoacusis deafness neurosensory hearing impaired

NAME OF THE MEDICINAL PRODUCT

OTHER SPECIAL WARNING(S), IF NECESSARY

No special requirements.

If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.

radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),

After injection, the site of injection should not be massaged.

Lot:

For patients inadequately controlled on glimepiride monotherapy (typically 4 mg).

Based on empirical knowledge from similar medicinal products, clinically relevant pharmacokinetic interactions are unlikely to occur.

Starting dose of 50 IU/ kg 2 times per week by the intravenous route.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Capsule content: hypromellose, hydroxypropyl methylcellulose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate.

Protein C plays a major role in prevention of excessive clot formation thus, prevent and/ or treat intravascular thrombosis.

Lot

Facilities for the treatment of such reactions should be immediately available.

4.

In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated, as dictated by the patient's clinical status.

However, it has been reported that pemetrexed may cause fatigue.

Introduction

6.3 Shelf life

33 For any information about this medicine, please contact the local representative of BAXTER AG given below.

Blood and lymphatic system disorders

The pharmacokinetic profile in patients less than 5 years old was similar to that of older and less severely affected patients.

EU/ 1/ 07/ 410/ 004

It contains two active substances which work together to reduce pressure within the eye.

To remove, push tablets through from this side.

MARKETING AUTHORISATION NUMBER(S)

Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.

The relationship of the infarct to prior administration of BeneFIX is uncertain.

Patients receiving Atriance should be monitored regularly for changes in blood counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).

5.

28/ 07/ 2006

Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.

67 8.

(-0.60, 1.55)

The doctor will decide how much Angiox you receive, and will prepare the medicine.

Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.

Normal sodium chloride solution 9 mg/ ml (0.9%) may be added to dilute to a concentration convenient for administration.

Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed.

AMMONAPS tablets should be taken with a large volume of water.

Irbesartan and its metabolites are eliminated by both biliary and renal pathways.

Solution for injection

OTHER SPECIAL WARNING(S), IF NECESSARY

Name and address of the manufacturers responsible for batch release

6.

Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.

2.

1.

Three major classes of interferons have been identified: alpha, beta, and gamma.

EXPIRY DATE

It is not known whether aripiprazole is excreted in human milk.

6.

Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).

Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.

Not known:

If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.

SOLUTION SHOULD NEVER BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.

In in vitro experiments, tipranavir was observed to inhibit human platelet aggregation at levels consistent with exposures observed in patients receiving APTIVUS/ ritonavir.

{MM/ YYYY}

Insulin in the blood stream has a half-life of a few minutes.

The most frequent undesirable effects attributable to filgrastim were bone pain, and general musculoskeletal pain.

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/ relative should tell your doctor if you have ever had a stroke or "mini" stroke.

Slovenija AMGEN zdravila d. o. o.

Tel.: + 48 (22) 576 9000

B.

DATE OF REVISION OF THE TEXT